APRINOIA Therapeutics (APRI) F-1/ARegistration statement (foreign) (amended)

No dealer, salesperson or other person is authorized to give any information or to represent as to anything not contained in this prospectus or in any free writing prospectus we may authorize to be delivered or made available to you. You must not rely on any unauthorized information or representations. This prospectus is an offer to sell, and we are seeking offers to buy, only the ordinary shares offered hereby, and only under circumstances and in jurisdictions where it is lawful to do so. The information contained in this prospectus is current only as of its date, regardless of the time of delivery of this prospectus or any sale of the ordinary shares.

Neither we nor the underwriters have done anything that would permit this offering or the possession or distribution of this prospectus or any filed free writing prospectus in any jurisdiction where other action for that purpose is required, other than in the United States. Persons outside the United States who come into possession of this prospectus or any free writing prospectus filed with the U.S. Securities and Exchange Commission (the “SEC”) must inform themselves about, and observe any restrictions relating to, the offering of the ordinary shares and the distribution of this prospectus or any filed free writing prospectus outside of the United States.

We are a clinical-stage biotechnology company with limited operating history. We expect to continue to incur significant operating losses in the future as we continue our research and development efforts for our current and future diagnostic and therapeutic product candidates and seek to obtain regulatory approval and commercialization of such diagnostic and therapeutic product candidates, if approved.

Investments in biotechnology and pharmaceutical product development are highly speculative because they entail substantial upfront capital expenditures and a significant risk that any potential product candidate will fail to demonstrate adequate effect or an acceptable safety profile, gain regulatory approval and become commercially viable. All of our diagnostic and therapeutic product candidates, including our lead diagnostic candidate, ¹⁸F-APN-1607 (“APN-1607”), a tau PET tracer, are still under clinical or preclinical development and none have been approved for commercial sale. We have not demonstrated an ability to successfully complete late-stage clinical trials, obtain regulatory approvals, arrange for a third-party to manufacture our product candidates at a commercial scale on our behalf, conduct sales and marketing activities necessary for successful commercialization, or obtain reimbursement in the countries of sale. We may encounter unforeseen expenses, difficulties, complications, and delays in achieving our business objectives. Our short history as an operating company makes any evaluation of our future success or capability subject to significant uncertainty. If we do not address these risks successfully or are unable to transition at some point from a company with a research and development focus to a company capable of supporting commercial activities, then our business may be materially harmed.

We have no products approved for commercial sale and have never generated any revenue from product sales and may never be profitable. We have incurred substantial operating losses since we commenced operations in 2015, despite that we have generated certain revenue through our product licensing by providing our third-party and related-party licensees with the right to access our product candidates, and through research and development services performed. For the six months ended June 30, 2023 and the years ended December 31, 2022 and 2021, our net losses were $7.2 million, $28.2 million and $23.3 million, respectively. Our losses have resulted principally from research and development expenses and general and administrative expenses. We have been devoting the majority of our financial resources and efforts to our research and development activities, including preclinical testing, research and development of our diagnostic and therapeutic product candidates for tauopathies and α-synucleinopathies as well as building our tauopathies and α-synucleinopathies research and development capabilities.

None of our diagnostic or therapeutic product candidates have received marketing approval, and we may never be successful in obtaining marketing approval and commercializing them. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. These net losses will adversely impact our shareholders’ deficit and net assets and may fluctuate significantly from quarter to quarter and year to year. We anticipate that our expenses will increase substantially as we:

To become and remain profitable, we must succeed in developing and eventually commercializing products that generate significant revenue. This will require us to be successful in a range of challenging activities, including completing preclinical studies and clinical trials of our product candidates, obtaining regulatory approval, manufacturing, marketing and selling any products for which we may obtain regulatory approval, as well as discovering and developing additional product candidates. We may never succeed in these activities and, even if we do, may never generate revenue that is significant enough to achieve profitability. Because of the numerous risks and uncertainties associated with the development and commercialization of biotechnologies and biopharmaceuticals, we are unable to accurately predict the timing or amount of expenses or when, or if, we will be able to achieve profitability. If we are required by regulatory authorities to perform studies in addition to those currently expected, or if there are any delays in the initiation and completion of our clinical trials or the development of any of our product candidates, our expenses could increase and profitability could be further delayed. If we are unable to maintain adequate working capital, we may default on our payment obligations and may not be able to meet our capital expenditure requirements, which may have a material adverse effect on our business, financial condition and results of operations. Even if we achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable after this offering would depress the value of our ordinary shares and could impair our ability to raise capital, expand our business, maintain our research and development efforts or continue our operations. A decline in the value of our ordinary shares after this offering could also cause you to lose all or part of your investment.

Since our inception in 2015, we have recorded net cash outflow from operating activities and used substantial amounts of cash to fund our operations and expect our expenses to increase substantially during the next few years. The development of biotechnology and biopharmaceutical product candidates is capital intensive. As our product candidates enter and advance through preclinical studies and clinical trials, we will require substantial additional funding to meet our financial needs and to pursue our business objectives.

Based upon our current operating plan, we have determined that additional financing will be required to fund our operations for the next 12 months from the date of the issuance of the accompanying consolidated financial statements included elsewhere in this prospectus and our ability to continue as a going concern is dependent upon obtaining additional capital and financing, including through the consummation of this offering. See “— Our independent registered public accounting firm’s report contains an explanatory paragraph that expresses substantial doubt about our ability to continue as a “going concern” below for a risk relating our ability to continue as a going concern. We do not expect to generate any revenue from product sales unless and until we successfully complete

It is a time-consuming, expensive and uncertain process to identify potential product candidates and conduct preclinical testing and clinical trials, which takes years to complete. We may never generate the necessary data or results required to obtain regulatory approval and achieve product sales. Furthermore, our preclinical or clinical product candidates, if approved, may not achieve commercial success. To date, we have no products approved for commercial sale, nor have we generated any revenue from product sales. Accordingly, we will need to continue to rely on additional financing to achieve our business objectives. Sufficient additional financing may not be available to us on acceptable terms or may not be available to us at all. Also, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. If we raise additional funds through collaboration and licensing arrangements with third parties, we may have to relinquish some rights to our technologies or our product candidates on terms that are not favorable to us. Any additional capital-raising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our current and future product candidates if approved. If we are unable to raise capital when needed or on acceptable terms, we may be forced to delay, reduce or altogether cease our research and development programs or future commercialization efforts.

In connection with our assessment of going concern considerations in accordance with Financial Accounting Standard Board’s Accounting Standards Update (“ASU”) 2014-15, “Disclosures of Uncertainties about an Entity’s Ability to Continue as a Going Concern,” our independent registered public accounting firm expresses substantial doubt regarding our ability to continue as a going concern within one year from the date of issuance of our consolidated financial statements absent of the completion of this offering. We cannot provide assurance that we can increase our cash balance or limit our cash consumption, complete offerings or obtain other capital resources, and thus maintain a sufficient cash balance for our

We expect that significant additional capital may be needed in the future to continue our planned operations, including conducting clinical trials, commercialization efforts, expanded research and development activities and costs associated with operating a public company after the consummation of the offering. If we cannot generate substantial product revenue, until then, we expect to finance our cash needs through any or a combination of securities offerings, debt financings, equity financings, license and collaboration agreements, and research grants. Our additional financing and capital raising activities may cause material dilution to the interests of our shareholders immediately upon the consummation of the offering. As new investors could gain rights, such activities may also result in preferences and privileges senior to our existing shareholders. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest after the offering will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a shareholder. Debt financing and preferred equity financing, if available, could result in fixed payment obligations, and we may be required to accept terms that restrict our ability to incur additional indebtedness, force us to maintain specified liquidity or other ratios or restrict our ability to pay dividends or make acquisitions. If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may be required to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. In addition, we could also be required to seek funds through arrangements with collaborators or others at an earlier stage than otherwise would be desirable. If we raise funds through research grants, we may be subject to certain requirements, which may limit our ability to use the funds or require us to share information from our research and development. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to a third party to develop and market product candidates that we would otherwise prefer to develop and market ourselves. Raising additional capital through any of these or other means could adversely affect our business and the holdings or rights of our shareholders and may cause the market price of our ordinary shares to decline.

We have no products approved for commercial sale and invested a significant portion of our efforts and financial resources in the development of our lead diagnostic product candidate, APN-1607, our anti-tau antibody product candidate, APNmAb005, and degrader programs, all of which are currently or expected to be in clinical development. We cannot commercialize our product candidates in the United States without first obtaining regulatory approval for the product from the U.S. Food and Drug Administration (the “FDA”); similarly, we cannot commercialize our product candidates in jurisdictions without us or our collaboration partner obtaining regulatory approval from comparable regulatory authorities in relevant jurisdictions. To gain regulatory approvals for the commercial sale of any product candidate for a particular indication, we must demonstrate with substantial evidence gathered in preclinical studies and clinical trials that the product candidate is safe and effective for that indication and that the manufacturing facilities, processes and controls comply with regulatory requirements with respect to such product candidate. Before seeking approval for any of our product candidates, we will also need to consult with the FDA or other regulatory authorities regarding the design of our clinical trials and the type and amount of clinical data necessary to pursue and obtain approval for our product candidates. Furthermore, approval policies, regulations, or the type and amount of preclinical and clinical data necessary to gain approval may change during a product candidate’s research and development and may vary among jurisdictions. Our ability to generate revenues from product sales, if ever, will depend heavily on successful clinical development, obtaining regulatory approval and eventual commercialization of these product candidates. We currently generate no revenues from product sales, and we may never be able to develop or commercialize a marketable product. The success of our current and future product candidates will depend on several factors, including the following:

If we or Yitai do not achieve one or more of these factors promptly or at all, we could experience significant delays or an inability to successfully commercialize our current or future product candidates, which would materially adversely affect our business, financial condition and results of operations.

We operate in highly competitive and rapidly changing industries. Our competitors could enter the market with products that compete with our product candidates, which may result in a material decline in sales of our affected product candidates after they are approved for marketing. For instance, certain of our competitors might be evaluating a tau PET tracer candidate in clinical development and/or the same indication as our lead diagnostic product candidate, APN-1607, such as AD and PSP. Our competitors may be able to obtain marketing approval for their respective tau PET tracer candidates before us. Should this occur, the sales of our tau PET tracer candidates, when approved, may experience strong market competition. As a result, our business, financial condition and results of operations may be materially impacted.

We may seek fast track, breakthrough therapy or similar designation for our drug candidates. For example, we plan to apply for fast track designation in the United States for APN-1607. If a drug is intended for the treatment of a serious or life-threatening condition and the drug demonstrates the potential to address unmet medical needs for this condition, the drug sponsor may apply for FDA fast track designation. The FDA has broad discretion whether or not to grant this designation, and even if we believe a particular drug candidate is eligible for this designation, we cannot assure you that the FDA would decide to grant it. Even if we do receive fast track designation, we may not experience a faster development process, review or approval compared to conventional FDA procedures. The FDA may withdraw fast track designation if it believes that the designation is no longer supported by data from our clinical development program.

Additionally, we may, in the future seek a breakthrough therapy designation for some of our product candidates that reach the regulatory review process. A breakthrough therapy is a drug candidate that is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition, and that, as indicated by preliminary clinical evidence, may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. Drugs designated as breakthrough therapies by the FDA are eligible for accelerated approval and increased interaction and communication with the FDA designed to expedite the development and review process.

As with fast-track designation, designation as a breakthrough therapy is within the discretion of the FDA. Accordingly, even if we believe one of our product candidates meets the criteria for designation as a breakthrough therapy, the FDA may disagree and may determine not to grant such a designation. Even if we receive a breakthrough therapy designation for any of our product candidates, the designation may not result in a materially faster development process, review or approval compared to conventional FDA procedures. Further, obtaining a

Our product candidates may not achieve market acceptance among physicians, patients, hospitals, including pharmacy directors and/or third-party payors, as applicable, even if we successfully obtain regulatory approvals from the FDA or other regulatory authorities and can initiate commercialization of our product candidates or any other product candidates we may develop. Thus, our product candidates ultimately may not be commercially successful. The market acceptance of our product candidates, when approved, for commercial sale, will depend on several factors, which may include:

We may need significant resources to educate physicians, patients, third-party payors and others in the medical community on the benefits of our product candidates if approved, and we may never be successful despite our tremendous efforts. Such efforts may require more resources than are typically required due to the complexity and uniqueness of our product candidates. Because we expect sales of our product candidates, if approved, to generate substantially most of our product revenue for the foreseeable future, the failure of our product candidates to find market acceptance would harm our business and could require us to seek additional financing. Furthermore, we may

Results from preclinical or early-stage studies may not be predictive of late-stage clinical studies or product approval by the FDA or comparable foreign regulatory authorities. Positive or timely results observed in preclinical or early-stage studies do not guarantee positive or timely results in late-stage clinical studies. Also, product candidates that show positive preclinical or early clinical results may not show sufficient safety or efficacy in later-stage clinical studies and therefore may fail to obtain regulatory approvals. We also have a pipeline of earlier-stage diagnostic and therapeutic product candidates, and because they are in earlier stages of development, we do not know whether these candidates will be effective and safe for the intended indications in humans. Our product candidates may fail to show the desired safety and efficacy in clinical development despite results in preclinical studies or, in the future, having successfully advanced through Phase 1 clinical trials that are supportive of further development. For example, we received FDA clearance in March 2022 to initiate Phase 1 clinical trial of APNmAb005 but we may fail to achieve success in such trial. If we fail to establish sufficient efficacy and safety profiles for our product candidates, we may need to abandon the clinical development of such product candidates.

Moreover, preclinical and clinical data are frequently susceptible to varying interpretations and analyses. Many companies have nonetheless failed to obtain marketing approval for the product candidates, despite their product candidates’ satisfactory performances in preclinical studies and clinical trials. The FDA and other regulatory authorities have substantial discretion in the approval process and in determining when or whether regulatory approval will be obtained for any of our product candidates. Even if we believe the data collected from clinical trials of our product candidates are promising, such data may not be sufficient to support approval by the FDA or other regulatory authorities.

If we or our collaboration partners are required to conduct additional clinical trials or other testing of any of our current or future product candidates that we or our collaboration partners develop beyond the studies and testing that we or our collaboration partners contemplate if we or our collaboration partners are unable to successfully complete clinical trials of our product candidates or another testing, if the results of these studies or tests are unfavorable or are only modestly favorable or if there are safety concerns associated with our current or future product candidates, we may:

If we experience delays in testing or marketing approvals, our product development costs may increase and we may be required to obtain additional funds to bring our clinical studies to their completion. We cannot assure you that our clinical studies will start as planned or complete on schedule, if at all, or that we will not need to restructure our studies after they have begun. Also, significant clinical study delays could shorten any periods during which we may have the exclusive right to commercialize our product candidates or allow our competitors to bring products to market before we do or shorten any periods during which we have the exclusive right to commercialize our product candidates, which may harm our business and results of operations. Furthermore, some of the factors that cause, or lead to, clinical study delays may ultimately lead to the denial of regulatory approval of our product candidates.

Human clinical trials are difficult to design and implement, in part because they are subject to rigorous regulatory requirements. The failure rate is high for pharmaceutical product candidates proceeding through clinical trials. The design of a clinical trial is crucial and could affect whether its results will support the approval of a product

Patient enrollment in clinical trials of our product candidates is essential to our success. We may experience difficulties in identifying and qualifying patients to participate in our clinical trials for a variety of reasons, including due to disease outbreaks, such as an epidemic or pandemic. The timely completion of clinical trials according to the protocols depends, among other things, on our ability to enroll enough patients who remain in the study until its completion. The enrollment of patients depends on various factors, including:

In particular, some of our clinical trials aim to enroll patients with characteristics that are found in a very small population. For example, PSP and Frontotemporal Dementia (“FTD”), two indications for our lead tau PET tracer candidate, are rare tauopathies with low incidence overall and therefore clinical study enrollment will take longer. Delays in patient enrollment may result in increased costs or may affect the timing or outcome of the planned clinical trials, which could prevent the completion of these clinical trials and adversely affect our ability to advance the development of our product candidates. In addition, many of the factors that may lead to a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates.

Undesirable or unacceptable side effects caused by our product candidates could cause us or regulatory authorities to interrupt, delay or pause clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other regulatory authorities. We may need to abandon or limit the development of our product candidates to certain uses or sub-populations in which such side effects are less prevalent, less severe, or more acceptable from a risk-benefit perspective. Many compounds that initially showed promise in preclinical or early-stage testing have later been found to cause side effects that restricted their use and prevented further development of the compound for larger indications. Occurrence of serious procedure- or treatment-related side effects could impede clinical study enrollment and receipt of marketing approval from the FDA and other regulatory authorities. Adverse events could also adversely affect physician or patient acceptance of our product candidates.

Additionally, if one or more of our product candidates receives marketing approval, and we or others later identify undesirable side effects caused by such products, several potentially significant negative consequences could result, including:

Any of the aforementioned events could prevent us from achieving or maintaining market acceptance of such product candidates, if approved, and could significantly harm our business, results of operations and prospects.

We may not commercialize, market, promote or sell any product candidate without obtaining marketing approval from the FDA or other regulatory authorities, and we may never obtain such approvals. It is impossible to predict accurately when or if any of our product candidates will prove effective or safe in humans and will receive regulatory approval. Before obtaining marketing approval from regulatory authorities for the commercial sale of any of our product candidates, we must demonstrate through lengthy, complex, and expensive preclinical studies and clinical trials that our product candidates are both safe and effective for use in each proposed indication. Clinical trials are expensive, difficult to design and implement, can take many years to complete and are uncertain as to outcome. A failure of one or more clinical trials can occur at any stage of clinical development.

We may experience numerous unforeseen events prior to, during or because of clinical trials that could delay or prevent our ability to receive marketing approval or commercialize any of our product candidates, including:

To the extent that the results of the trials are not satisfactory for the FDA or other regulatory authorities to approve our new drug application (“NDA”) or other comparable applications, the commercialization of our product candidates may be significantly delayed, or we may be required to expend significant additional resources, which may not be available to us, to conduct additional trials in support of potential approval of our product candidates.

All of our product candidates are still in the preclinical development or clinical stage, and the risk of failure is high. Before we can commence registrational clinical trials for a product candidate, we must complete extensive preclinical testing and studies to obtain regulatory clearance to initiate registrational human clinical trials. We cannot assure of the timely completion or outcome of our preclinical testing and studies and cannot predict if the FDA or other regulatory authorities will accept our proposed clinical programs or if the outcome of our preclinical testing and studies will ultimately support the further development of our programs. As a result, we cannot guarantee that we or our collaboration partner will be able to submit IND applications or similar applications for our preclinical programs on the timelines we expect, or at all, and we cannot guarantee that submission of IND applications or similar applications will result in the FDA or other regulatory authorities allowing registrational clinical trials to begin.

We focus on the development of a pipeline of diagnostic and therapeutic product candidates targeting two types of neurodegenerative diseases – tauopathies and α-synucleinopathies, including our lead diagnostic product candidate, APN-1607, for the diagnosis of AD and PSP, and APNmAb005, primarily for the treatment of AD and potentially other rare tauopathies, and the progression of these product candidates through clinical development. We also have a broad portfolio of earlier-stage product candidates with great potential regarding the diagnosis and treatment of neurodegenerative diseases. However, we may not be able to develop product candidates that are safe and effective, or which compare favorably with other commercially available alternatives. Even if we are successful

If any of these events occur, we may be forced to abandon our development efforts for a program or programs, or we may not be able to identify, discover, develop or commercialize additional product candidates, which would have a material adverse effect on our business and could potentially cause us to cease operations.

Even if we receive approval from the FDA or other regulatory authorities to market our product candidates, we cannot assure you that any such product candidates will be successfully commercialized, widely accepted in the marketplace or more effective than other commercially available alternatives. Further, because of our limited financial and managerial resources, we are required to focus our research programs on certain product candidates and specific diseases. As a result, we may fail to capitalize on viable commercial products or profitable market opportunities, be required to forego or delay the pursuit of opportunities with other product candidates or other diseases that may later prove to have greater commercial potential, or relinquish valuable rights to such product candidates through collaboration, licensing or other royalty arrangements in cases in which it would have been advantageous for us to retain sole development and commercialization rights.

If we do not successfully develop and commercialize product candidates or collaborate with others to do so, we will not be able to obtain product revenue in future periods, which could significantly harm our financial position and adversely affect the trading price of our ordinary shares after the consummation of the offering.

Given the limited resources and capital available to support our business operations, we must decide which product candidates to pursue and the amount of resources to allocate to each product candidate. Therefore, we are currently primarily focused on the development of diagnostic and therapeutic product candidates for two types of neurodegenerative diseases – tauopathies and α-synucleinopathies, such as our lead diagnostic product candidate, APN-1607, for the diagnosis of AD and PSP, our lead therapeutic product candidate, APNmAb005 for the treatment of PSP and AD, and our lead therapeutic product candidate. Our decisions concerning the allocation of research, collaboration, management and financial resources toward compounds, diagnostic and therapeutic product candidates or therapeutic areas may not lead to the development of viable commercial products and may divert resources away

FDA may designate a product as an orphan drug if the product is designed to treat a rare disease or condition according to the Orphan Drug Act. A rare disease or condition is defined as a patient population of fewer than 200,000 in the United States, or a patient population greater than 200,000 in the United States where there is no reasonable expectation that the cost associated with the development of the drug will be recovered from sales in the United States. ODD presents financial incentives such as opportunities for grant funding towards clinical study costs, tax advantages and user-fee waivers. Furthermore, if a product is the first FDA approval for the indication to receive an ODD, the product is entitled to orphan drug exclusivity and the FDA may not approve any other application to market the same drug for the same indication for seven years, except in limited circumstances, such as a showing of clinical superiority over the product with orphan exclusivity or where the manufacturer is unable to assure sufficient product quantity.

As of the date of this prospectus, we hold an ODD for APN-1607 in PSP. We may seek to obtain ODD for APN-1607 in other indications or for certain of our other product candidates. However, we may not be successful in obtaining such ODD, and even if we do, we may not be the first to obtain marketing approval for any orphan indication due to the competition from the market and uncertainties associated with developing pharmaceutical products. Further, even if we obtain ODD for a product, the orphan drug exclusivity may not effectively protect the product from competition because different diagnostics or therapies with different working mechanisms and can be approved for the same condition. ODD neither curtails the development period or regulatory review time needed before the commercialization of a product candidate nor presents the product candidate any advantage in the regulatory review or approval process. ODD may not be able to safeguard our market exclusivity in a particular market, and if we fail to obtain or maintain orphan drug exclusivity for such product candidates, we may be subject to earlier competition and our potential revenue will be reduced.

As a company with operations outside of the United States, our business is subject to risks associated with conducting business outside of the United States. For example, certain of our operations, suppliers and clinical trial relationships are located outside the United States. Accordingly, our future results could be harmed by various factors, including, without limitation, the following:

Our lead diagnostic product candidate, APN-1607, is being studied in a Phase 3 clinical trial in AD in mainland China through our collaboration with Yitai. Our subsidiary in Suzhou, China shall provide consulting services to Yitai to support the development and regulatory activities for certain clinical study of the product with the aim to obtain marketing authorization of such product in the field of Tau imaging tracer in mainland China. These afore-mentioned activities are governed by laws and regulations of mainland China. According to the relevant laws and regulations in mainland China, APN-1607 cannot be commercialized without Yitai obtaining the marketing approval from the China’s National Medical Products Administration (“NMPA”), and we cannot guarantee that the marketing approval of APN-1607 for the diagnosis of AD in mainland China could be obtained in a timely manner or at all. Failure to obtain such approval in a timely manner or at all would materially and adversely affect our business in mainland China. As a general matter, the PRC government could also interfere in, or exercise control over, the operations of Yitai and our Suzhou subsidiary, by the promulgation of new laws or regulations, or the new interpretation of existing laws and regulations, which could result in a material adverse change in our operations.

Our ability to compete in the highly competitive biotechnology industry depends upon our ability to attract and retain our key personnel, highly qualified management, research and development, clinical, financial and business development personnel. We are highly dependent on our world-class management team with extensive scientific, preclinical, clinical and regulatory expertise. See “Business — Our Management Team” for more details regarding our management team. Although we have entered into employment arrangements with the members of our senior management, each of them may terminate their employment with us at any time and will continue to be able to do so after the offering. We do not maintain “key person” insurance for any of our employees.

Recruiting and retaining qualified personnel will be critical to our success. We need scientific and clinical personnel to support our research and development, and clinical programs. We will also need commercialization, regulatory, supply chain and sales and marketing personnel if we progress the development of any of our product candidates to the commercialization stage. The loss of the services of members of our senior management or other key employees could hinder our research, development and commercialization objectives and seriously harm our ability to successfully implement our business strategy. While we have entered into non-competition agreements with our employees, there is no guarantee that these agreements will be fully complied with by such employees after their departure from us. Furthermore, replacing members of our senior management and key employees may be difficult and may take an extended time because of the limited number of individuals in our industry with the breadth of skills and experience required to successfully develop, gain regulatory approval of and commercialize our product candidates. Our success also depends on our ability to continue to attract, retain and motivate highly skilled junior, mid-level and senior managers, as well as junior, mid-level and senior scientific and medical personnel. Competition

We had 72 full-time employees as of June 30, 2023. We expect to need additional managerial, operational, financial and other personnel, including personnel to support our preclinical or early-stage research, product development and planned future commercialization efforts, as our development plans and commercialization strategies progress and develop, and as we transition into operating as a public company. Future growth will impose significant added responsibilities on members of management, including:

There is a finite number of individuals with experience in neurodegenerative diseases, and the competition for these individuals is high. Our future financial performance and our ability to commercialize our product candidates will depend, in part, on our ability to effectively manage any future growth, and our management may also have to divert a disproportionate amount of its attention away from day-to-day activities to devote a substantial amount of time to managing these growth activities.

If we are not able to effectively expand our organization by hiring new employees, we may not be able to successfully implement the tasks necessary to further develop and commercialize our product candidates and, accordingly, may not achieve our research, development and commercialization goals.

In addition to enlarging our talent pool, we are increasing the size of our research facilities and building our product development capabilities, which requires substantial capital expenditures and technology. If these capital expenditures are higher than expected, it may adversely affect our financial condition and capital sufficiency. Furthermore, if we could not expand our research facilities as planned, it may restrict our ability to speedily enlarge the size of our talent pool to support our business and growth goals.

Health pandemics or epidemics could adversely impact our business, including our clinical trials. For example, although the COVID-19 pandemic has not had a material adverse impact on our business and operations as of the date of this prospectus, we cannot predict the potential future impacts of COVID-19 on us and third parties with whom we conduct business. We may experience disruptions that could severely impact our business and clinical trials, including:

We have adopted four equity incentive plans to grant share-based compensation awards to employees, directors and consultants to incentivize their performance and align their interests with ours, namely, the Equity Incentive Plan of APRINOIA adopted on June 19, 2018, the Equity Incentive Plan #2 of APRINOIA adopted on September 3, 2019, the Equity Incentive Plan #3 of APRINOIA adopted on November 9, 2021, and the Equity Incentive Plan #4 of APRINOIA adopted on July 25, 2022 (collectively, the “Equity Incentive Plans” and each an “Equity Incentive Plan”). As of the date of this prospectus, options to purchase a total of 5,859,802 ordinary shares have been granted under the Equity Incentive Plans, in which 2,068,052 options were exercised and fully paid and 335,652 options were canceled or forfeited, resulting in 3,456,098 options outstanding.

Following the consummation of this offering, we may continue to grant options and other types of awards under the Equity Incentive Plans or potentially other share incentive plans. We believe the granting of share-based compensation is of significant importance to our ability to attract and retain key personnel and employees, and we will continue to grant share-based compensation awards to employees in the future. As a result, our expenses associated with share-based compensation may increase, which may have an adverse effect on our results of operations. We may re-evaluate the vesting schedules, lock-up period, exercise price or other key terms applicable to the grants under our currently effective employee stock option plans from time to time. If we choose to do so, we may experience a substantial change in our share-based compensation charges in the reporting periods following the consummation of the offering.

We are required by laws and regulations to test our product candidates on animals before initiating clinical studies in humans. There has been certain controversy and adverse publicity regarding animal testing activities. Animal rights groups have protested against animal testing activities and pressed for legislation and regulation, attempting to stop animal testing activities. If the animal rights groups are successful, our research and development activities may be disrupted, postponed or subjected to additional expenses.

We rely on our information technology and other internal infrastructure systems to operate our business. Our information technology system includes corporate servers, leased lines and connection to the internet. We also employ reasonable security measures to protect our information technology system. Nonetheless, we bear the risk of possible systemic failure of our information technology system, which could disrupt our business operations. Such disruption could cause interruptions in our collaborations with our partners and delays in our research and development work. The loss of product development or clinical study data could result in delays in our regulatory approval efforts and significantly increase our costs. We could incur liability and experience delays in our development programs and the development of our product candidates if any disruption or security breach were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information.

We collect, maintain and process, and our third-party vendors, collaborators, contractors and consultants collect, maintain and process on our behalf, sensitive information, including confidential business information and

In the United States, there are numerous federal and state privacy and data security laws and regulations governing the collection, use, disclosure and protection of personal information, including federal and state health information privacy laws, federal and state security breach notification laws, and federal and state consumer protection laws. Each of these constantly evolving laws can be subject to varying interpretations. For example, regulations promulgated under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) establish privacy and security standards that limit the use and disclosure of individually identifiable health information, or protected health information, and require the implementation of administrative, physical and technological safeguards to protect the privacy of protected health information and ensure the confidentiality, integrity and availability of electronically protected health information. Determining whether protected health information has been handled in compliance with applicable privacy standards and our contractual obligations can be complex and may be subject to changing interpretation. The U.S. Department of Health and Human Services (“HHS”) has the discretion to impose penalties without attempting to first resolve violations. HHS enforcement activity can result in financial liability and reputational harm, and responses to such enforcement activity can consume significant internal resources.

In addition, states in the United States are constantly adopting new laws or amending existing laws, requiring attention to frequently changing regulatory requirements. For example, the California Consumer Privacy Act (“CCPA”) which went into effect on January 1, 2020, gives California residents expanded rights to access and delete their personal information, opt-out of certain personal information sharing, and receive detailed information about how their personal information is used. The CCPA provides for civil penalties for violations, as well as a private right of action for data breaches that is expected to increase data breach litigation. The CCPA may increase our compliance costs and potential liability. Although there are limited exemptions for certain health-related information, including certain clinical trial data, the precise application and scope of these exemptions as well as how they would apply to our business is not yet clear. As currently written, the CCPA may impact our business activities and exemplifies the vulnerability of our business to the evolving regulatory environment related to personal data and protected health information. Some observers have noted that the CCPA could mark the beginning of a trend toward more stringent privacy legislation in the United States, which could increase our potential liability and adversely affect our business.

We may be required to put in place additional mechanisms to ensure compliance with the new data protection rules, as compliance with these and any other applicable privacy and data security laws and regulations is a rigorous and time-intensive process. If we or our third-party vendors, collaborators, contractors and consultants fail to comply with any such laws or regulations, we may face regulatory investigations, significant fines and penalties, reputational damage or be required to change our business practices, all of which could adversely affect our business, financial condition and results of operations.

We are continuously exploring potential business and licensing partners for the co-development of diagnostic or therapeutic drugs for neurodegenerative diseases and for the commercialization of our diagnostic and therapeutic product candidates. If our current or future business and licensing partners, such as National Institute for Quantum Science and Technology (“QST”) from which we obtained an exclusive worldwide license for its patent for APN-1607, terminates its agreement with us at any time, it could delay or prevent the development of our product candidates and probably harm our business, financial condition, commercialization prospects and results of operations.

Maintaining good relationships with our current and future business and licensing partners is important for our business. If our relationships with our current or future business and licensing partners were to deteriorate substantially or such strategic partners were to challenge our use of their intellectual property, our business, financial condition, commercialization prospects and results of operations could be adversely affected.

We will need substantial additional cash and resources to fund and support our product candidate development, the possible commercialization of product candidates and, if approved, the sales and marketing of our future products. Therefore, we may decide to enter into new collaborations, strategic alliances, or create joint ventures with other pharmaceutical or biopharmaceutical companies for the further development and potential commercialization of our product candidates.

When seeking potential collaborators, we face substantial competition. Negotiating and documenting collaborations are complicated and time-consuming. Potential delays in establishing new collaborations for our product candidates could delay the development and commercialization of our product candidates and could also diminish their competitiveness when, if ever, they reach the market. We may also be restricted under existing and future collaboration agreements from entering into strategic partnerships or collaboration agreements on certain terms with other potential collaborators. We may not be able to negotiate collaborations on acceptable terms, or at all, for any of our existing or future product candidates, as potential collaborators may think that our pipeline or research and development pipeline is inadequately developed or not advanced enough to justify a collaborative effort, or that our existing or future product candidates do not have the necessary potential to demonstrate safety and efficacy in the target population. In such a case that we failed to establish and maintain collaboration for a particular product candidate, we may cut or restrict or delay the development of such product candidate and may also cut or restrict or delay the development of one or more of our other product candidates, interrupting its potential commercialization. Also, if we failed to establish and maintain a collaboration for a particular product candidate, we may end up increasing our expenditures and undertake development or commercialization activities at our own expense for which we have not budgeted. If we elect to increase our expenditures to fund development or commercialization activities on our own, we may need to obtain additional capital, which may not be available to us on acceptable terms or at all. If we do not have sufficient funds, we will not be able to bring our product candidates to market and generate product revenue. Even if we are successful in establishing a new collaboration, we cannot assure that we will be able to progress the development and commercialization of the applicable product candidates as planned, or that we will achieve the revenues that would justify such collaboration, and we could be subject to the following risks, each of which may materially harm our business, commercialization prospects and financial condition:

We have depended on and intend to continue to depend on third-party clinical research organizations (“CROs”) to monitor and manage data for our current preclinical and clinical studies of our product candidates. Even if we depend on CROs for the execution of our preclinical and clinical studies and retain control over only certain aspects of CROs’ activities, we are directly responsible for ensuring that each of our studies is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards. Our dependence on the CROs does not relieve us of our responsibilities imposed by regulatory authorities. We and our CROs and other vendors are required to comply with current good manufacturing practices (“cGMP”) current good clinical practice (“cGCP”) and Good Laboratory Practice (“GLP”) which are regulations and guidelines enforced by the FDA and other regulatory authorities for our product candidates in preclinical and clinical studies. Regulatory authorities enforce these regulations through

If we terminate our relationships with any of these third-party CROs, we may not be able to find a proper replacement or do so on commercially reasonable terms. Moreover, as CROs are third-party contractors and not our employees, we cannot control whether they have dedicated sufficient time and resources to our ongoing preclinical studies or clinical trials. The remedies available to us are largely contractual remedies under our agreements with such CROs. We may have to extend, delay, or terminate our clinical trials and may not be able to obtain regulatory approval for or successfully commercialize our product candidates, if these CROs do not successfully carry out their contractual duties or responsibilities or proceed as scheduled or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our protocols, regulatory requirements, or for other reasons. Also, we may incur higher costs than anticipated with CROs. As a result, our results of operations and the commercial prospects for our product candidates would be harmed, our costs could increase, and our ability to generate revenue could be delayed.

Replacing or adding new CROs involves extra cost and requires management time and focus. There is a transition period when a new CRO commences work. As a result, delays may occur and our ability to meet our desired clinical development timelines may be impaired. Though we carefully manage our relationships with our CROs, we cannot assure that we will not encounter CRO-related challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition and prospects.

We currently rely on and expect to continue to rely on third-party suppliers including CMOs for the manufacturing and supply of chemical compounds for the clinical studies of our current and future product candidates and commercial scale production of future approved products. We expect to continue to rely on such third-party suppliers or CMOs for the manufacture of any of our product candidates on a clinical or commercial scale if approved. Reliance on third-party providers may expose us to different risks than if we were to manufacture product candidates ourselves. Our CMOs must use facilities, which were approved by the FDA or other regulatory authorities pursuant to inspections that will be conducted after we submit our NDA or comparable marketing application with the FDA or other regulatory authority, to manufacture our product candidates. We do not have control over whether our third-party suppliers or CMOs have properly complied with these laws, regulations and applicable cGMP standards and other laws and regulations, such as those related to environmental health and safety matters. If third-party suppliers or CMOs cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or others, they will not be able to secure and/or maintain regulatory approval for their manufacturing facilities. Moreover, we have no control over the ability of our third-party suppliers or CMOs to maintain adequate quality control, quality assurance and qualified personnel. If the FDA or other regulatory authority does not approve these facilities for the manufacture of our product candidates or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for or market our product candidates, if approved. Any failure to achieve and maintain compliance with these laws, regulations and standards could subject us to the risk that we may have to suspend the manufacturing of our product candidates or that obtained approvals could be revoked, which would adversely affect our business and reputation.

Furthermore, third-party suppliers or CMOs may breach their contractual obligation because of factors beyond our control. As third-party suppliers or CMOs often encounter difficulties involving production yields, quality control and quality assurance, as well as shortages of qualified personnel, they may early terminate or refuse to renew their agreements because of their own financial difficulties or business priorities, potentially when it is costly or inconvenient for us. If we were unable to timely secure proper replacement or come up with another satisfactory solution, our clinical studies could be disrupted or delayed or our commercial activities could be harmed.

An increase in the costs of components or raw materials may also adversely influence our business, financial condition and results of operations. Also, components or raw materials supplies could be disrupted from time to time and, if disrupted, we cannot assure that supplies could resume within a reasonable timeframe and at an acceptable cost or at all. Our current and anticipated future dependence upon third-party suppliers or CMOs for the manufacturing of our current and future product candidates may adversely affect our future profit margins and our ability to commercialize any products that receive marketing approval on a timely and competitive basis.

We may evaluate various acquisitions and strategic collaborations in the future, including licensing or acquiring complementary products, intellectual property rights, technologies or businesses, as we may deem appropriate to carry out our business plan. Any potential acquisition or strategic collaboration may entail numerous risks, including:

Additionally, if we undertake acquisitions, we may issue dilutive securities, assume or incur debt obligations, incur large one-time expenses and acquire intangible assets that could result in significant future amortization expenses. Moreover, we may not be able to locate suitable acquisition opportunities, and this inability could impair our ability to grow or obtain access to technology or products that may be important to the development of our business.

All jurisdictions in which we conduct or intend to conduct our pharmaceutical-industry activities regulate these activities in great depth and detail. We are currently focusing our activities in the United States and Asia. These geopolitical areas all strictly regulate the pharmaceutical industry, and in doing so they employ broadly similar regulatory strategies, including regulation of product development and approval, manufacturing, and marketing, sales and distribution of products. However, there are differences in the regulatory regimes – some minor, some significant – that make for a more complex and costly regulatory compliance burden for a company like ours that plans to operate in each of these regions.

The process of obtaining regulatory approvals and compliance with appropriate laws and regulations require the expenditure of substantial time and financial resources. Failure to comply with the applicable requirements at any time during the product development process, approval process, or after approval, may subject us to administrative or judicial sanctions. These sanctions could include a regulator’s refusal to approve pending applications, withdrawal

The time required to obtain approval by the FDA or other regulatory authorities is unpredictable and typically takes many years following the commencement of preclinical studies and clinical trials and depends on numerous factors, including the substantial discretion of the regulatory authorities. Our product candidates could be delayed or fail to receive regulatory approval for many reasons, including:

The FDA and/or other regulatory authorities may require more information, including additional preclinical, chemistry, manufacturing and controls information and/or clinical data, to support approval, which may delay or prevent approval and our commercialization plans, or we may decide to abandon the development of such product candidate.

Changes in regulatory requirements and guidance may also occur, and we may need to amend clinical trial protocols submitted to applicable regulatory authorities to reflect these changes. Amendments may require us to resubmit clinical trial protocols to institutional review boards (“IRBs”) or ethics committees for re-examination, which may impact the costs, timing or successful completion of a clinical trial.

If we experience delays in the completion of, or the termination of, a clinical trial of any of our product candidates, the commercial prospects of that product candidate will be harmed, and our ability to generate product revenues from that product candidate will be delayed. Furthermore, any delays in completing our clinical trials will increase our costs, slow down our product development and approval process, and jeopardize our ability to

Our development activities, regulatory filings and manufacturing operations also could be harmed or delayed by a shutdown of the U.S. government, including the FDA, or governments and regulatory authorities in other jurisdictions. For example, as of May 2021, the FDA noted it is continuing to ensure timely reviews of applications for medical products during the COVID-19 pandemic in line with its user fee performance goals. However, the FDA may not be able to continue its current pace and approval timelines could be extended, including where a pre-approval inspection or an inspection of clinical sites is required and due to the COVID-19 pandemic and travel restrictions the FDA is unable to complete such required inspections during the review period. The FDA has developed a rating system to assist in determining when and where it is safest to conduct prioritized domestic inspections. In May 2021, certain inspections, such as foreign preapproval, surveillance, and for-cause inspections that are not deemed mission-critical, were temporarily suspended. In April 2021, the FDA issued guidance for the industry formally announcing plans to employ remote interactive evaluations, using risk management methods, to meet user fee commitments and goal dates and in May 2021, announced plans to continue progress toward resuming standard operation levels. Should the FDA determine that an inspection is necessary for approval and an inspection cannot be completed during the review cycle due to restrictions on travel, and the FDA does not determine a remote interactive evaluation to be adequate, the agency has stated that it generally intends to issue a complete response letter or defer action on the application until an inspection can be completed. In July 2021, the FDA issued a Q&A to further illustrate the actions that it may take when it cannot inspect a facility due to factors including travel restrictions. In 2020 and 2021, a number of companies announced receipt of complete response letters due to the FDA’s inability to complete required inspections for their applications. Regulatory authorities outside the United States may adopt similar restrictions or other policy measures in response to the COVID-19 pandemic or other situations and may experience delays in their regulatory activities. If the FDA or other health authorities are delayed or unable to complete required regulatory inspections of our development activities, regulatory filings or manufacturing operations, or we do not satisfactorily complete such inspections, our business could be materially harmed.

Our product candidates and the activities associated with their development and commercialization, including their design, research, testing, manufacture, safety, efficacy, quality control, recordkeeping, labeling, packaging, storage, approval, advertising, promotion, sale, distribution, import, export, and reporting of safety and other post-market information, are subject to comprehensive regulation by the FDA or other regulatory authorities. Failure to obtain marketing approval for a product candidate will prevent us from commercializing the product candidate. We have not received approval to market any of our product candidates from regulatory authorities in any jurisdiction. We have only limited experience in filing and supporting the applications necessary to gain marketing approvals and may rely on third-party CROs to assist us in this process. Obtaining marketing approval requires the submission of extensive preclinical and clinical data and supporting information to regulatory authorities for each diagnostic or therapeutic indication to establish the product candidate’s safety and efficacy. Securing marketing approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities by, the regulatory authorities. Our product candidates may not be effective, may be only moderately effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude our obtaining marketing approval or prevent or limit commercial use. If any of our product candidates receives marketing approval, the accompanying label may limit its approved use, which could limit sales of the product.

The process of obtaining marketing approvals in the United States and elsewhere is expensive and may take many years, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the product candidates involved. Securing marketing approval requires the submission of extensive preclinical and clinical data and supporting information to regulatory authorities for each diagnostic or therapeutic indication to establish the product candidate’s safety and efficacy. Securing marketing approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities by, the regulatory authorities. The FDA or other regulatory authorities may determine that our product candidates are not safe and effective, only moderately effective or have undesirable or unintended side

In addition, changes in marketing approval policies during the development period, changes in or the enactment of additional statutes or regulations, or changes in regulatory review for each submitted product application may cause delays in the approval or rejection of an application. Regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may decide that our data is insufficient for approval and require additional preclinical, clinical or other studies. In addition, varying interpretations of the data obtained from preclinical and clinical testing could delay, limit or prevent marketing approval of a product candidate. Any marketing approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the approved product not commercially viable.

If we experience delays in obtaining approval or if we fail to obtain approval of our product candidates, the commercial prospects for our product candidates may be harmed and our ability to generate revenue will be impaired.

To market and sell our products in other jurisdictions outside of the United States in the future, we or our collaboration partner must obtain separate marketing approvals and comply with numerous and varying regulatory requirements. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from those in the United States, including additional preclinical studies or clinical trials as clinical studies conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions.

The time required to obtain approval may differ substantially from that required to obtain approval from the FDA. The regulatory approval process outside the United States generally includes all of the risks associated with obtaining approval from the FDA. Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not guarantee that we or our collaboration partner will be able to obtain or maintain regulatory approval in any other jurisdiction, but a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in others. For example, even if the FDA grants marketing approval of a product candidate, other regulatory authorities must also approve the manufacturing, marketing and promotion of the product candidate in those countries. In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our products is also subject to approval. If we fail to comply with the regulatory requirements in international markets and/or to receive applicable marketing approvals, our target market will be reduced and our ability to realize the full market potential of our product candidates will be harmed.

Our collaboration partner, Yitai, a wholly-owned subsidiary of Dongcheng Pharma, is currently conducting and we may in the future conduct clinical trials for our product candidates outside the United States. The acceptance of data from clinical trials conducted outside the United States by the FDA may be subject to certain conditions or may not be accepted at all. The FDA will generally not consider the data from a foreign clinical trial not conducted under an IND unless (i) the trial was well-designed and well-conducted in accordance with GCP requirements, including requirements for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials in a way that provides assurance that the data and reported results are credible and accurate and that the rights, safety, and well-being of trial subjects are protected, and (ii) the FDA is able to validate the data from the trial through an onsite inspection, if necessary. In cases where data from foreign clinical trials are intended to serve as the sole basis for marketing approval in the United States, the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the U.S. population and U.S. medical practice; (ii) the trials were performed by clinical investigators of recognized competence; and (iii) the data may be considered valid without the need for an on-site inspection by the FDA or, if the FDA considers such as an inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means. Additionally, the FDA’s clinical trial requirements, including sufficient size of patient populations and statistical power, must be met. Many foreign regulatory authorities have similar approval requirements. In addition, such foreign trials would be subject to the applicable local laws of the foreign jurisdictions where

The FDA and other federal and state agencies, including the U.S. Department of Justice (“DOJ”) closely regulate compliance with all requirements governing prescription drug products, including requirements pertaining to marketing and promotion of products in accordance with the provisions of the approved labeling and manufacturing of products in accordance with cGMP requirements. The FDA and DOJ impose stringent restrictions on manufacturers’ communications regarding off-label use and if we do not market our future approved products for their approved indications, or if other of our marketing claims are deemed false or misleading, we may be subject to enforcement action. Violations of such requirements may lead to investigations alleging violations of the Food, Drug and Cosmetic Act and other statutes, including the False Claims Act and other federal and state healthcare fraud and abuse laws as well as state consumer protection laws.

Our failure to comply with all regulatory requirements, and later discovery of previously unknown adverse events or other problems with our future approved products, manufacturers or manufacturing processes, may yield various results, including:

Non-compliance by us or any current or future collaboration partners with regulatory requirements regarding safety monitoring or pharmacovigilance, and with requirements related to the development of products for the pediatric population, can also result in significant financial penalties. Similarly, failure to comply with regulatory requirements regarding the protection of personal information can also lead to significant penalties and sanctions.

If any of these events occurs, our ability to sell such products may be impaired, and we may incur substantial additional expenses to comply with regulatory requirements, which could adversely affect our business, financial condition, and results of operations.

We are exposed to the risk of employee and third-party fraud or other misconduct or failure to comply with applicable regulatory requirements. Any past, current or future misconduct or non-compliance by our prior, existing or future employees, independent contractors, partners or vendors, with any industry or regulatory standards or requirements may result in a material adverse effect on our operations or harm to our reputation. Misconduct by employees and independent contractors, such as CMOs, consultants, commercial partners, and vendors, could include failures to comply with regulations of the FDA and/or other comparable regulatory authorities, to provide accurate information to such regulators, to comply with manufacturing standards we have established, to comply with healthcare fraud and abuse laws, to report financial information or data accurately or to disclose unauthorized activities to us. Particularly, sales, marketing and other business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of business activities, including, but not limited to, research, manufacturing, distribution, pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Employee and independent contractor misconduct could also involve the improper use of individually identifiable information, including, without limitation, information obtained during clinical trials, which could result in regulatory sanctions and serious harm to our reputation.

It is not always possible to identify and deter employee and independent contractor misconduct, and any precautions we take to detect and prevent improper activities may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with such laws. If any such actions are instituted against us, those actions could have a significant impact on our business, including the imposition of significant civil, criminal and administrative penalties, damages, monetary fines, disgorgement of profits, imprisonment, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, or other government-supported healthcare in other jurisdictions, contractual damages, reputational harm, diminished profits and future earnings, additional reporting or oversight obligations if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with the law and curtailment or restructuring of our operations, any of which could adversely affect our ability to operate.

In the United States and many other countries, rising healthcare costs have been a concern for governments, patients and the health insurance sector, which resulted in several changes to laws and regulations, and may result in further legislative and regulatory action regarding the healthcare and health insurance systems that could affect our ability to profitably sell any product candidates for which we obtain marketing approval. We expect that healthcare reform measures may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for any future approved products. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product candidates.

Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products. We cannot be sure whether additional legislative changes will be enacted, or whether any regulations, guidance or interpretations will be changed, or what the impact of such changes on the regulatory approvals of our diagnostic and therapeutic product candidates may be.

For example, in the United States, there have been numerous judicial, administrative, executive, and legislative challenges to certain aspects of the Affordable Care Act (the “ACA”), and there could be additional challenges and amendments to the ACA in the future, which could have a material adverse impact on our business, results of operations and financial condition. See “Government Regulation—United States Regulation—Healthcare Reform” for a detailed discussion of healthcare reform initiatives of importance to the pharmaceutical industry.

We are subject to export control and import laws and regulations, including the U.S. Export Administration Regulations, U.S. Customs regulations, various economic and trade sanctions regulations administered by the U.S. Treasury Department’s Office of Foreign Assets Controls, the U.S. Foreign Corrupt Practices Act of 1977, as amended, and other applicable state and national anti-bribery and anti-money laundering laws in the countries in which we conduct activities. Anti-corruption laws are interpreted broadly and prohibit companies and their employees, agents, contractors, and other collaborators from authorizing, promising, offering, or providing, directly or indirectly, improper payments or anything else of value to recipients in the public or private sector. We may engage third parties to sell our products outside the United States to conduct clinical trials, and/or to obtain necessary permits, licenses, patent registrations, and other regulatory approvals. We have direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities, and other organizations. We can be held liable for the corrupt or other illegal activities of our employees, agents, contractors, and other collaborators, even if we do not explicitly authorize or have the actual knowledge of such activities. Any violations of the laws and regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, the loss of export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm, and other consequences.

We are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal of hazardous materials and wastes. Our operations involve the use of hazardous materials, including chemicals and biological materials. Our operations also produce hazardous waste products. We generally contract with third parties for the disposal of these materials and wastes. We cannot eliminate the risk of contamination or injury from these materials. In the event of contamination or injury resulting from our use of hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties for failure to comply with such laws and regulations.

Although we maintain insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities. We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of biological or hazardous materials.

Furthermore, we are subject to numerous international, national, municipal and local environmental, health and safety laws and regulations relating to, among other matters, safe working conditions, product stewardship and environmental protection. However, environmental and social laws and regulations have tended to become increasingly stringent. To the extent regulatory changes occur in the future, they could result in, among other things, increased costs to our company.

In addition, we may incur substantial costs to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations may impair our research, development or production efforts. Our failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.

Healthcare providers, physicians and third-party payors in the United States and elsewhere will play a primary role in the recommendation and prescription of any product candidates for which we obtain marketing approval. Our current and future arrangements with healthcare professionals, consultants, customers and third-party payors may expose us to broadly applicable healthcare laws, including, without limitation, the U.S. federal Anti-Kickback Statute and the U.S. federal False Claims Act, that may constrain the business or financial arrangements and relationships through which we sell, market and distribute any product candidates for which we obtain marketing approval. In

Further, the ACA, among other things, amended the intent requirement of the federal Anti-Kickback Statute and certain criminal statutes governing healthcare fraud. A person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it. In addition, the ACA provided that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act.

Because of the breadth of these laws and the narrowness of their exceptions and safe harbors, it is possible that our business activities can be subject to challenge under one or more of such laws. The scope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform. Federal and state enforcement bodies have recently increased their scrutiny of interactions between healthcare companies and healthcare providers, which has led to many investigations, prosecutions, convictions and settlements in the healthcare industry.

We will incur substantial costs to ensure that our internal operations and future business arrangements with third parties will comply with applicable healthcare laws and regulations. If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, including, without limitation, damages, monetary fines, imprisonment, disgorgement of profits, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, additional reporting or oversight obligations if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with the law and curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and pursue our strategy. If any of the physicians or other healthcare providers or entities with whom we expect to do business, including future collaborators, are found not complying with applicable laws, they may be subject to significant criminal, civil or administrative sanctions, including exclusions from participation in government healthcare programs, as result of which our business could also be affected.

We may not be successful in establishing sales, marketing and distribution capabilities for our product candidates. We may need to work with third parties to market and distribute our product candidates, if approved. We

Should any of these risks materialize, or should we fail to find suitable collaborators, this could have a material adverse effect on our business, prospects, financial condition and results of operations.

The availability of coverage and reimbursement from government and health administration authorities, private health insurers and other third-party payors for our future approved products is important for the successful commercialization of our product candidates. Many governments and third-party payors have been increasingly scrutinizing the pricing of new technologies and require greater levels of evidence of favorable clinical outcomes and cost-effectiveness before extending coverage to these new technologies. Given such challenges to prices and increasing levels of evidence of the benefits and clinical outcomes, we cannot be sure that coverage will be available for any of our current or future product candidates that we commercialize and, if available, that the reimbursement rates will be adequate. If we are unable to obtain adequate levels of coverage and reimbursement for our product candidates, their marketability will be negatively and materially impacted.

Third-party payors may deny coverage and reimbursement status altogether of a given product, or cover the product but may also establish prices at levels that are too low to enable us to realize an appropriate return on our investment in such product development. Because the rules and regulations regarding coverage and reimbursement change frequently, in some cases at short notice, even when there is favorable coverage and reimbursement, future changes may occur that adversely impact the favorable status. Further, the net reimbursement for pharmaceutical products may be subject to additional reductions if there are changes to laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the United States.

The unavailability or inadequacy of third-party coverage and reimbursement could have a material adverse effect on the market acceptance of our product candidates and the future revenues we may expect to receive from those products. In addition, we are unable to predict what additional legislation or regulation relating to the healthcare industry or third-party coverage and reimbursement may be enacted in the future, or what effect such legislation or regulation would have on our business.

We have never commercialized a product candidate, and we currently do not carry any sales force, marketing or distribution capabilities. We may have to develop our own sales and marketing team or outsource these activities to a third party to successfully commercialize our product candidates if approved.

Factors that may affect our ability to commercialize our product candidates on our own include attracting and retaining enough sales and marketing talents, obtaining access to or persuading adequate numbers of radiologists to utilize our future approved diagnostics when administrating PET scans for potential patients, or persuading adequate

Our projections of both the number of people who have the neurodegenerative diseases that we are targeting, as well as the size of the patient population subset of people with tauopathies and α-synucleinopathies and who have the potential to benefit from treatment with our product candidates, are based on our beliefs and estimates. These estimates have been derived from a variety of sources, including scientific literature, surveys of clinics, patient foundations, or market research and may prove to be incorrect. Further, new studies may change the estimated incidence or prevalence of neurodegenerative diseases. The number of patients may turn out to be fewer than expected. Additionally, the potentially addressable patient population for our product candidates may be limited or may not be amenable to treatment with our product candidates. For example, if the treatment of AD is not as effective or available as our beliefs and estimates, the willingness of potential patients to be screened for AD may decrease and our projections regarding the size of the addressable market of diagnostics for AD may be incorrect. The market opportunities for our diagnostic product candidates, such as APN-1607, may be limited, as the relevant effective treatments for those patients may be unavailable.

We are exposed to potential product liability and professional indemnity risks that are inherent in the research, development, manufacturing, marketing and use of pharmaceutical product candidates. Currently we have no product candidate approved for commercial sale; however, our current and future use of product candidates in clinical studies, and the sale of any approved products in the future, may expose us to liability claims. These claims might be made by patients that use the product, healthcare providers, pharmaceutical companies or others selling such products. Any claims against us, regardless of their merit, could be difficult and costly to defend and could materially adversely affect the market for our product candidates or any prospects for commercialization of our product candidates.

Although the clinical study process is designed to identify and assess potential side effects, it is always possible that a drug, even after regulatory approval, may exhibit unforeseen side effects. If any of our product candidates were to cause adverse side effects during clinical studies or after approval of the product candidate, we may be exposed to substantial liabilities. Physicians and patients may not comply with any warnings that identify known potential adverse effects and patients who should not use our product candidates. We purchase liability insurance in connection with the clinical studies that we undertake in amounts that we consider to be consistent with industry norms. Our liabilities may exceed our insurance coverage. We intend to expand our insurance coverage to include the sale of commercial products if we obtain marketing approval for any of our product candidates. However, we may not be able to maintain insurance coverage at a reasonable cost or obtain insurance coverage that will be adequate to satisfy any liability that may arise. If a successful product liability claim or series of claims is brought against us for uninsured liabilities or in excess of insured liabilities, our assets may not be sufficient to cover such claims and our business operations could be impaired. Should any of such events occur, our business could be materially and adversely affected, financial condition and results of operations.

We face an inherent risk of product liability exposure related to the testing of our product candidates in human clinical trials and will face an even greater risk if we commercially sell any products that we may develop. If we cannot successfully defend ourselves against claims that our product candidates or products caused injuries, we will incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

While we maintain liability insurance, which covers certain bodily injury or damage in connection with the clinical trials for our product candidates, our insurance coverage may not be adequate to cover all liabilities that we may incur. We may need to increase our insurance coverage as we expand our clinical trials or if we commence commercialization of our product candidates. Insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.

The life of a patent and the protection it affords is limited. For example, in the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S. non-provisional filing date. Even if we successfully obtain patent protection for an approved product candidate, it may face competition from generic or biosimilar medications. Manufacturers of generic or biosimilar drugs may challenge the scope, validity or enforceability of our patents in court or before a patent office, and we may not be successful in enforcing or defending those intellectual property rights and, as a result, may not be able to develop or market the relevant product exclusively, which would materially adversely affect any potential sales of that product.

Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such product candidates might expire before or shortly after such product candidates are commercialized. As a result, our patents and patent applications may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours. Even if we believe that we are eligible for certain patent term extensions, there can be no assurance that the applicable authorities, including the FDA and the U.S. Patent and Trademark Office (“USPTO”) in the United States, and any equivalent regulatory authority in other countries, will agree with our assessment of whether such extensions are available, and such authorities may refuse to grant extensions to our patents, or may grant more limited extensions than we request. For example, depending upon the timing, duration and specifics of any FDA marketing approval of any product candidates we may develop, one or more of our U.S. patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Action of 1984 (the “Hatch-Waxman Amendments”). The Hatch-Waxman Amendments permit a patent extension term of up to five years as compensation for patent term lost during the FDA regulatory review process. A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, only one patent may be extended and only those claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended. In addition, we may not be granted an extension for a number of reasons, including, for example, failing to exercise due diligence during the testing phase or regulatory review process, failing to apply within applicable deadlines, failing to apply prior to the expiration of relevant patents, or otherwise failing to satisfy applicable requirements. Moreover, the applicable time period or the scope of patent protection afforded could be less than we request. If we are unable to obtain patent term extension or term of any such extension is less than we request, our competitors may obtain approval of competing products following our patent expiration, and our business could be harmed.

The pending patent applications, if issued, for our product candidates are expected to expire on various dates as described in the section entitled “Business—Intellectual Property.” Upon the expiration of our patents that may issue from our pending patent applications, we will not be able to assert such patent rights against potential competitors, which would materially adversely affect our business, financial condition, results of operations and prospects.

Our commercial success depends in part on our ability to obtain and maintain patent and other proprietary protection in the United States and other countries with respect to our proprietary technology and products. We seek to protect our proprietary position by filing patent applications in the United States and abroad related to our novel technologies and product candidates. Any disclosure to or misappropriation by third parties of our confidential proprietary information could enable competitors to quickly duplicate or surpass our technological achievements, thus eroding our competitive position in our market. Moreover, the patent applications we own, co-own or license may fail to result in issued patents in the United States or in other foreign countries.

The patent prosecution process is expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection. Moreover, in some circumstances, we do not have the right to control the preparation, filing and prosecution of patent applications, or to maintain the patents, covering technology that we license from third parties. Therefore, these patents and applications may not be prosecuted and enforced in a manner consistent with the best interests of our business.

Prosecution of our patent portfolio is at a very early stage. Much of our patent portfolio consists of pending applications (including priority applications) in United States, Europe, and under the PCT that have not been examined. Neither priority applications nor PCT applications can themselves give rise to issued patents. Rather, protection for the inventions disclosed in these applications must be further pursued by applicable deadlines via on-provisional or national stage applications that are subject to examination. As applicable deadlines for the priority and PCT applications become due, we will need to decide whether and in which countries or jurisdictions to pursue patent protection for the various inventions claimed in these applications, and we can only pursue and obtain patents in those jurisdictions where we pursue protection. Moreover, the coverage claimed in a patent application can be significantly reduced before the patent is issued, and its scope can be reinterpreted after issuance. Even if patent applications we own currently or in the future issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors or other third parties from competing with us, or otherwise provide us with any competitive advantage. Any patents that we own or in-license may be challenged, narrowed, circumvented, or invalidated by third parties. Consequently, we do not know whether any of our platform advances and product candidates we may develop will be protectable or remain protected by valid and enforceable patents. Our competitors or other third parties may be able to circumvent our patents by developing similar or alternative technologies or products in a non-infringing manner.

We may not be aware of all third-party intellectual property rights potentially relating to our current and future product candidates. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Therefore, we cannot be certain that we were the first to make the inventions claimed in our patents or pending patent applications, or that we were the first to file for patent protection of such inventions. Similarly, should we own or in-license any patents or patent applications in the future, we may not be certain that we or the applicable licensor were the first to file for patent protection for the inventions claimed in such patents or patent applications. As a result, the issuance, scope, validity and commercial value of our patent rights cannot be predicted with any certainty.

We may be subject to a third-party pre-issuance submission of prior art to the USPTO or become involved in opposition, derivation, reexamination, post-grant, inter partes review or interference proceedings, in the United States or elsewhere, challenging our patent rights or the patent rights of others. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, hold unenforceable or invalidate, our patent rights, allow third parties to commercialize our technology or product candidates and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third-party patent rights, which could significantly harm our business and results of operations. Moreover, we may have to participate in interference proceedings declared by the USPTO to determine priority of invention or in post-grant challenge proceedings, such as oppositions in the courts or patent offices in the United States or elsewhere,

Our pending and future patent applications may not result in patents being issued that protect our technology or product candidates, in whole or in part, or which effectively prevent others from commercializing competitive technologies and products. Moreover, the coverage claimed in a patent application can be significantly reduced before the patent is issued, and its scope can be reinterpreted after issuance. Even if our patent applications issue as patents, they may not issue in a form that will provide us with any meaningful protection against competing products or processes sufficient to achieve our business objectives, prevent competitors from competing with us or otherwise provide us with any competitive advantage. Our competitors or other third parties may be able to circumvent our patents, should they issue, by developing similar or alternative technologies or products in a non-infringing manner. Our competitors or other third parties may seek approval to market their own products similar to or otherwise competitive with our products. In these circumstances, we may need to defend and/or assert our patents, including by filing lawsuits alleging patent infringement. In any of these types of proceedings, a court or other agency with jurisdiction may find our patents invalid and/or unenforceable. Consequently, we do not know whether any of our technologies and product candidates will be protectable or remain protected by valid and enforceable patents.

In addition, given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our intellectual property may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours. Any of the foregoing could have a material adverse effect on our business.

We may involve in intellectual property-related litigation or other proceedings to protect ourselves or enforce our rights, as competitors may infringe our patents or the patents of our licensors or collaborators. To counter such infringement, we may be required to file claims against those competitors, which can be expensive and time-consuming. If we or our collaboration partner were to initiate legal proceedings against a third party to enforce a patent covering one of our product candidates, the defendant could counterclaim that the patent covering our product candidate is invalid or unenforceable, or that we infringe the defendant’s patents. It is common for a defendant’s counterclaims to allege invalidity or unenforceability in patent litigation in the United States. Such validity challenges could be based on a variety of grounds including an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, obviousness-type double patenting, lack of written description, or non-enablement. Such unenforceability assertion could be based on grounds including that someone connected with the prosecution of the patent made a misleading statement or withheld relevant information from the USPTO during prosecution. Furthermore, third parties may raise similar claims before administrative bodies in the United States or abroad, even outside the context of litigation. Such mechanisms include re-examination, post-grant review, inter partes review, interference and derivation proceedings as well as equivalent proceedings in foreign jurisdictions. The outcome following legal assertions of invalidity and unenforceability is unpredictable. Such proceedings or patent litigations could result in the revocation or cancellation of or amendment to our patents in such a way that they no longer cover our product candidates or otherwise provide any competitive advantage. An adverse result in any proceeding could put one or more of our patents at risk of being invalidated or interpreted narrowly, which could have a material adverse effect on our business and financial condition.

Also, given the substantial amount of discovery required in connection with intellectual property litigation, certain of our confidential information may be compromised by disclosure during this type of litigation. There could be public announcements of the results of hearings, motions, decisions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a material adverse effect on the price of our ordinary shares.

We generally enter into confidentiality and intellectual property assignment arrangements with our employees, consultants, outside scientific collaborators, sponsored researchers and other advisors. However, these agreements may be breached and may not effectively assign intellectual property rights to us. For example, disputes may arise from conflicting obligations of consultants or others who are involved in developing our technology and product candidates. Litigation may be necessary to defend against these and other claims challenging inventorship or ownership. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could have a material adverse effect on our business. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

A third party may hold intellectual property rights, including patent rights, that are important or necessary to the development or manufacture of our product candidates. It may be necessary for us to use the patented or proprietary technology of third parties to commercialize our product candidates, in which case we would be required to obtain a license from these third parties. Such a license may not be available on commercially reasonable terms, or at all, and we could be forced to accept unfavorable contractual terms. In that event, we may be required to expend significant time and resources to redesign our technology, product candidates, or the methods for manufacturing them or to develop or license replacement technology, all of which may not be feasible on a technical or commercial basis. If we are unable to do so, our business could be harmed.

The licensing or acquisition of third-party intellectual property rights is a competitive area, and several more established companies may pursue strategies to license or acquire third-party intellectual property rights that we may consider attractive or necessary. These established companies may have a competitive advantage over us due to their size, capital resources and greater clinical development and commercialization capabilities. In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. We also may be unable to license or acquire third-party intellectual property rights on terms that would allow us to make an appropriate return on our investment or at all. If we are unable to successfully obtain rights to required third party intellectual property rights or maintain the existing intellectual property rights we have, we may have to abandon the development of the relevant program or product candidate, which could have a material adverse effect on our business, financial condition, results of operations, and prospects.

We expect to rely on trademarks as one means to distinguish any of our product candidates that are approved for marketing from the products of our competitors. We have not yet selected trademarks for our product candidates and have not yet begun the process of applying to register trademarks for our product candidates. Once we select trademarks and apply to register them, our trademark applications may not be approved. Third parties may oppose our trademark applications, or otherwise challenge our use of the trademarks. If our trademarks are successfully challenged, we could be forced to rebrand our products, which could result in loss of brand recognition and could require us to devote resources to advertising and marketing new brands. Our competitors may infringe our trademarks and we may not have adequate resources to enforce our trademarks.

In addition, any proprietary name we propose to use with our clinical-stage product candidates or any other product candidate in the United States must be approved by the FDA, regardless of whether we have registered it, or applied to register it, as a trademark. The FDA typically conducts a review of proposed product names, including an evaluation of the potential for confusion with other product names. If the FDA objects to any of our proposed proprietary product names, we may be required to expend significant additional resources to identify a suitable proprietary product name that would qualify under applicable trademark laws, not infringe the existing rights of third parties and be acceptable to the FDA.

If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected. Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete

The patent position of biotechnology and pharmaceutical companies generally is highly uncertain. Changes in either the patent laws or interpretation of the patent laws in the United States and other jurisdictions may diminish the value of our patents or narrow the scope of our patent protection. In addition, the protections offered by laws of different countries vary. No consistent policy regarding the breadth of claims allowed in biotechnology and pharmaceutical patents has emerged to date in the United States or in other jurisdictions. In addition, the determination of patent rights concerning pharmaceutical compounds and technologies commonly involves complex legal and factual questions, which has in recent years been the subject of much litigation. As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain. Furthermore, recent changes in patent laws in the United States may affect the scope, strength, validity and enforceability of our patent rights or the nature of proceedings that may be brought by or against us related to our patent rights. Additionally, the U.S. Supreme Court has ruled on several patent cases in recent years either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. For example, in the case, Assoc. for Molecular Pathology v. Myriad Genetics, Inc., the U.S. Supreme Court held that certain claims to DNA molecules are not patentable. In addition to increasing uncertainty concerning our ability to obtain patents in the future, this combination of events has created uncertainty concerning the value of patents, once obtained. Depending on decisions by the U.S. Congress, the U.S. federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that could weaken our ability to obtain patents or to enforce any patents that we might obtain in the future.

Filing, prosecuting and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States could be less extensive than those in the United States. In some cases, we may not be able to obtain patent protection for certain technology outside the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States, even in jurisdictions where we do pursue patent protection. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, even in jurisdictions where we do pursue patent protection or from selling or importing products made using our inventions in and into the United States or other jurisdictions.

Competitors may use our technologies in jurisdictions where we have not pursued and obtained patent protection to develop their products and, further, may export otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as that in the United States. These products may compete with our product candidates and preclinical programs and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property protection, particularly those relating to biotechnology products, which could make it difficult for us to stop the infringement of our patents, if pursued and obtained, or marketing of competing products in violation of our intellectual property and other proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license. Moreover, the initiation of proceedings by third parties to challenge the scope or validity of our patent rights in foreign jurisdictions could result in substantial cost and divert our efforts and attention from other aspects of our business. Accordingly, our efforts to enforce our intellectual property and proprietary rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

Besides the protection afforded by patents, we seek to rely on trade secret protection and confidentiality agreements to protect proprietary know-how that is not patentable, processes for which patents are difficult to enforce and any other elements of our product discovery and development processes that involve proprietary know-how, information or technology that is not covered by patents. Trade secrets, however, may be difficult to protect. Although we require all of our employees to assign their inventions to us, and require all of our employees and key consultants who have access to our proprietary know-how, information, or technology to enter into confidentiality agreements, we cannot be certain that our trade secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques. Furthermore, the laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws of the United States. As a result, we may encounter significant problems in protecting and defending our intellectual property both in the United States and abroad. If we are unable to prevent unauthorized material disclosure of our intellectual property to third parties, we will not be able to establish or maintain a competitive advantage in our market, which could materially adversely affect our business, operating results and financial condition.

Periodic maintenance, renewal fees, annuity fees and various other government fees on patents and applications are due to be paid to the USPTO and other patent agencies in several stages over the lifetime of the patent and applications. The USPTO and other patent agencies require compliance with several procedural, documentary, fee payment and other similar provisions during the patent application process. While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means per the applicable rules, there are situations in which non-compliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Non-compliance events that could result in abandonment or lapse of a patent or patent application include failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. If we fail to maintain the patents and patent applications covering our products or product candidates, our competitors might be able to enter the market, which would harm our business.

Natural disasters, acts of war or terrorism or other factors beyond our control may adversely affect the economy, infrastructure and livelihood of the people in the regions where we conduct our business. Our operations may be under the threat of floods, earthquakes, sandstorms, snowstorms, fire or drought, power, water or fuel shortages, failures, malfunction and breakdown of information management systems, unexpected maintenance, or technical problems, or may be susceptible to potential wars or terrorist attacks. Serious natural disasters may result in loss of lives, injury, destruction of assets and disruption of our business and operations. Acts of war or terrorism may also injure our employees, cause loss of lives, disrupt our business network and destroy our markets. Furthermore, eruptions of regional tensions, such as the ongoing military conflict involving Ukraine and Russia, and the related sanctions against Russia have resulted in major economic shocks worldwide and substantial volatility across global financial markets. Any of these factors and other factors beyond our control could have an adverse effect on the overall business sentiment and environment, cause uncertainties in the regions where we conduct business, cause our business to suffer in ways that we cannot predict and materially and adversely impact our business, financial conditions and results of operations.

Many of our employees, consultants and advisors are currently or were previously employed at universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although we try to ensure that our employees, consultants and advisors do not use the proprietary information or know-how of third parties in their work for us, we may be subject to claims that we or these individuals have inadvertently or otherwise used intellectual property, including trade secrets or other proprietary information, of any such individual’s former employer. We may also in the future be subject to claims that we have caused such individual to breach the terms of his or her non-competition or non-solicitation agreement. Litigation may be necessary to defend against these potential claims.

In addition, while it is our policy to require each of our employees and contractors who may be involved in the conception, development or reduction to practice of intellectual property to execute an at-will employment, confidential information, and invention assignment agreement assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with all such parties who, in fact, conceives, develops or reduces to practice intellectual property that we regard as our own or such employees and contractors may breach the agreement and claim the developed intellectual property as their own. Our assignment agreements may not be self-executing or may be breached, and we may be forced to bring claims against third parties or defend claims they may bring against us, to determine the ownership of what we regard as our intellectual property. Such claims could have a material adverse effect on our business, financial condition, results of operations and prospects.

If we fail in prosecuting or defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. A court could prohibit us from using technologies or features that are essential to our product candidates if such technologies or features are found to incorporate or be derived from the trade secrets or other proprietary information of the former employers. Even if we are successful in prosecuting or defending against such claims, litigation could result in substantial costs and could be a distraction to management. In addition, any litigation or threat thereof may adversely affect our ability to hire employees or contract with independent service providers. Moreover, a loss of key personnel or their work product could hamper or prevent our ability to commercialize our product candidates.

As a company with less than US$1.235 billion in revenues for our last fiscal year, we qualify as an “emerging growth company” pursuant to the JOBS Act, and we may take advantage of certain reduced reporting and other requirements that are otherwise applicable generally to public companies. These provisions include exemption from the auditor attestation requirement under Section 404 of the Sarbanes-Oxley Act of 2002 (“Section 404”) in the assessment of the emerging growth company’s internal control over financial reporting and permission to delay adopting new or revised accounting standards until such time as those standards apply to private companies. As a result, if we elect not to comply with such reporting and other requirements, in particular the auditor attestation requirements, our investors may not have access to certain information they may deem important.

The JOBS Act also provides that an emerging growth company does not need to comply with any new or revised financial accounting standards until such date that a private company is otherwise required to comply with such new or revised accounting standards. We may elect to take advantage of the extended transition period for complying with new or revised accounting standards until those standards would otherwise apply to private companies. As a result, our results of operations and financial statements may not be comparable to the results of operations and financial statements of other companies that have adopted the new or revised accounting standards. If we cease to be an emerging growth company, we will no longer be able to take advantage of these exemptions or the extended transition period for complying with new or revised accounting standards.

We will be a PFIC for any taxable year in which (1) 75% or more of our gross income consists of passive income or (2) 50% or more of the value of our assets (generally determined on the basis of a weighted quarterly average) consists of assets that produce, or are held for the production of, passive income. For purposes of these tests, passive

Based on our analysis of our income, assets, and activities, we believe that we were not a PFIC for our taxable year ended December 31, 2023. However, as the determination of whether we are a PFIC for any taxable year is a fact-intensive determination made after the end of such taxable year applying principles and methodologies that in some circumstances are unclear and subject to varying interpretation, there can be no assurance that we will not be treated as a PFIC for any prior, current or future taxable year. The total value of our assets for PFIC testing purposes (including goodwill) may be determined in part by reference to the market price of our ordinary shares from time to time, which may fluctuate considerably. Accordingly, if our market capitalization declines while we hold a substantial amount of cash and cash-equivalents for any taxable year we may be a PFIC for that taxable year. Under the income test, our status as a PFIC depends on the composition of our income for the relevant taxable year which will depend on the transactions we enter into in the future and our corporate structure. The composition of our income and assets is also affected by how we spend the cash we raise in any offering, including this global offering. Even if we determine that we are not a PFIC for a taxable year, there can be no assurance that the Internal Revenue Service will agree with our conclusion and that the Internal Revenue Service would not successfully challenge our position. Accordingly, our U.S. counsel expresses no opinion with respect to our PFIC status for any prior, current or future taxable year.

Prior to this initial public offering, there has been no public market for our shares. We have applied to list our ordinary shares on Nasdaq under the symbol “APRI.” If an active trading market for our ordinary shares does not develop after this offering, the market price and liquidity of our ordinary shares will be materially and adversely affected. The initial public offering price for our ordinary share was determined by negotiation between us and the underwriter based upon several factors, and we can provide no assurance that the trading price of our ordinary shares after this offering will not decline below the initial public offering price. As a result, investors in our securities may experience a significant decrease in the value of their ordinary shares.

The trading price of our ordinary shares is likely to be volatile and could fluctuate widely due to multiple factors, some of which are beyond our control. This may happen because of broad market and industry factors. In addition to market and industry factors, the price and trading volume for the ordinary shares may be highly volatile for factors specific to our own operations, including the following:

Any of these factors may result in large and sudden changes in the volume and price at which the ordinary shares will trade.

In the past, shareholders of public companies have often brought securities class action suits against companies following periods of instability in the market price of their securities. If we were involved in a class action suit, it could divert a significant amount of our management’s attention and other resources from our business and operations and require us to incur significant expenses to defend the suit, which could harm our operating results. Any such class action suit, whether or not successful, could harm our reputation and restrict our ability to raise capital in the future. In addition, if a claim is successfully made against us, we may be required to pay significant damages, which could have a material adverse effect on our business, operating results and financial condition.

Future sales of a substantial number of our ordinary shares in the public market after this offering, or the perception that these sales might occur, could depress the market price of our ordinary shares and could impair its ability to raise capital through the sale of additional equity securities.

We will be subject to the reporting requirements of the Securities Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Act, Nasdaq listing requirements and other applicable securities rules and regulations. As such, we will incur additional legal, accounting and other expenses following this offering.

These expenses may increase even more if we no longer qualify as an “emerging growth company,” as defined in Section 2(a) of the Securities Act. The Exchange Act requires, among other things, that we file annual and current reports with respect to its business and operating results. The Sarbanes-Oxley Act requires, among other things, that we maintain effective disclosure controls and procedures and internal control over financial reporting. We may need to hire more employees after this offering or engage outside consultants to comply with these requirements, which will increase its costs and expenses after this offering.

Changing laws, regulations and standards relating to corporate governance and public disclosure are creating uncertainty for public companies, increasing legal and financial compliance costs and making some activities more time-consuming. These laws, regulations and standards are subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. We expect these laws and regulations to increase its legal and financial compliance costs after the offering and to render some activities more time-consuming and costly, although we are currently unable to estimate these costs with any degree of certainty.

Many members of our management team will have limited experience managing a publicly traded company, interacting with public company investors and complying with the increasingly complex laws pertaining to public companies. Our management team may not successfully or efficiently manage the transition to being a public company subject to significant regulatory oversight and reporting obligations under the federal securities laws and regulations and the continuous scrutiny of securities analysts and investors. The need to establish the corporate infrastructure demanded of a public company may divert the management’s attention from implementing its growth strategy, which could prevent us from improving its business, financial condition and results of operations. Furthermore, we expect these rules and regulations to make it more difficult and more expensive for us to obtain director and officer liability insurance, and consequently we may be required to incur substantial costs to maintain the same or similar coverage. These additional obligations could have a material adverse effect on its business,

As a result of disclosure of information in this prospectus and in filings required of a public company, our business and financial condition will become more visible, which we believe may result in threatened or actual litigation, including by competitors and other third parties. If such claims are successful, our business and operating results could be adversely affected, and, even if the claims do not result in litigation or are resolved in our favor, these claims, and the time and resources necessary to resolve them, could cause an adverse effect on its business, financial condition, results of operations, prospects and reputation.

Prior to this offering, we have been a private company with limited accounting personnel and other resources with which to address our internal controls and procedures. Our management has not completed an assessment of the effectiveness of our internal control over financial reporting and our independent registered public accounting firm has not conducted an audit of our internal control over financial reporting.

In connection with the audits of our consolidated financial statements included in this prospectus, two material weaknesses were identified in our internal control over financial reporting. Under standards established by the PCAOB, a “material weakness” is a deficiency, or combination of deficiencies in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the annual or interim financial statements will not be prevented or detected on a timely basis. The material weaknesses that have been identified relate to our lack of segregation of duties related to journal entries and account reconciliations, and lack of a formal review process that includes multiple levels of review in the financial reporting process.

We are in the process of implementing a number of measures to address the material weaknesses that have been identified including: (i) hiring experienced accounting and financial reporting personnel with U.S. GAAP and SEC reporting experience, (ii) expanding the capabilities of existing accounting and financial reporting personnel through continuous training and education in the accounting and reporting requirements under U.S. GAAP, and SEC rules and regulations, (iii) enhancing internal audit function as well as engaging an external consulting firm to assist us in assessing compliance with the SEC requirements and improve overall internal control, and (iv) developing, communicating and implementing more comprehensive accounting policies and period-end closing procedures for our accounting and financial reporting personnel. However, we cannot predict the success of such plan or the outcome of our assessment of these plans at this time. If we are unable to remediate the material weakness we have identified, or if we identify additional material weaknesses in the future or otherwise fail to develop and maintain an effective system of internal controls, we may not be able to produce timely and accurate financial statements. The failure to implement and maintain effective internal control over financial reporting could result in errors in our financial statements that could result in a restatement of its financial statements, which in turn could have a material adverse effect on our financial condition and results of operations.

In addition, we cannot assure you that we will not identify material weaknesses after this offering. Upon becoming a public company, we will be subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act and the rules and regulations of the applicable listing standards of the Nasdaq. Any failure to implement and maintain effective internal control over financial reporting also could adversely affect the results of periodic management evaluations and annual independent registered public accounting firm attestation reports regarding the effectiveness of our internal control over financial reporting that we will eventually be required to include in our periodic reports that will be filed with the SEC. Ineffective internal control over financial reporting could expose us to increased risk of fraud or misuse of corporate assets and subject us to potential delisting from the stock exchange on which we are listed, regulatory investigations and civil or criminal sanctions. We may also be required to restate our financial statements from prior periods. If we fail to achieve and maintain an effective internal control environment, we could suffer material misstatements in our financial statements and fail to meet our reporting obligations, which would likely cause investors to lose confidence in our reported financial information. This could in turn limit our access to capital markets, harm our financial condition and results of operations, and lead to a decline in the market price of our ordinary shares.

It is expected that we will retain most, if not all, of our available funds and any future earnings after this offering to fund the development and growth of our business. As a result, it is not expected that we will pay any cash dividends in the foreseeable future.

Following completion of this offering, our board of directors will have complete discretion as to whether to distribute dividends. Even if the board of directors decides to declare and pay dividends, the timing, amount and form of future dividends, if any, will depend on the future results of operations and cash flow, capital requirements and surplus, the amount of distributions, if any, received by us from subsidiaries, our financial condition, contractual restrictions and other factors deemed relevant by the board of directors. There is no guarantee that our Ordinary Shares will appreciate in value after the offering or that the trading price of our ordinary shares will not decline.

If you purchase our ordinary shares in this offering, you will pay more for your ordinary shares than the amount paid by our existing shareholders for their ordinary shares on a per share basis. As a result, you will experience immediate and substantial dilution of approximately US$11.15 per share, representing the difference between the initial public offering price of US$12.00 per share, the midpoint of the estimated public offering price range shown on the front cover of this prospectus, and our net tangible book value per share as of June 30, 2023, after giving effect to the net proceeds to us from this offering. “Dilution” for a more complete description of how the value of your investment in our ordinary shares will be diluted upon the completion of this offering.

The trading market for our ordinary shares after this offering will be influenced by the research and reports that equity research analysts publish about us and our business. We do not currently have and may never obtain research coverage by equity research analysts. Equity research analysts may elect not to provide research coverage of our ordinary shares after the consummation of this offering, and such lack of research coverage may adversely affect the market price of our ordinary shares. In the event we do have equity research analyst coverage, we will not have any control over the analysts or the content and opinions included in their reports. The price of our ordinary shares could decline if one or more equity research analysts downgrade our ordinary shares or issue other unfavorable commentary or research about us. If one or more equity research analysts cease coverage of us or fail to publish reports on us regularly, demand for our ordinary shares could decrease, which in turn could cause the trading price or trading volume of our ordinary shares to decline.

Because we are a foreign private issuer under the Exchange Act, we are exempt from certain provisions of the securities rules and regulations in the United States that are applicable to U.S. domestic issuers, including: (i) the rules under the Exchange Act requiring the filing of quarterly reports on Form 10-Q or current reports on Form 8-K with the SEC; (ii) the sections of the Exchange Act regulating the solicitation of proxies, consents, or authorizations in respect of a security registered under the Exchange Act; (iii) the sections of the Exchange Act requiring insiders to file public reports of their stock ownership and trading activities and liability for insiders who profit from trades made in a short period of time; and (iv) the selective disclosure rules by issuers of material nonpublic information under Regulation FD.

We will be required to file an annual report on Form 20-F within four months of the end of each fiscal year. In addition, we intend to publish our results on a quarterly basis through press releases, distributed pursuant to the rules and regulations of Nasdaq. Press releases relating to financial results and material events will also be furnished to the SEC on Form 6-K. However, the information we are required to file with or furnish to the SEC will be less extensive and less timely compared to that required to be filed with the SEC by U.S. domestic issuers. As a result, you may not be afforded the same protections or information, which would be made available to you, were you investing in a U.S. domestic issuer.

We are an exempted company limited by shares incorporated under the laws of the Cayman Islands, and following this offering, will conduct a portion of our operations outside the United States. A portion of our assets are located outside of the United States. A portion of our officers and directors reside outside the United States and a portion of the assets of those persons are located outside of the United States. As a result, it could be difficult or impossible for you to bring an action against us or against these individuals outside of the United States in the event that you believe that your rights have been infringed upon under the applicable securities laws or otherwise. Even if you are successful in bringing an action of this kind, the laws of the Cayman Islands could render you unable to enforce a judgment against our assets or the assets of our directors and officers.

In addition, our corporate affairs will be governed by our amended and restated memorandum and articles of association, the Companies Act and the common law of the Cayman Islands. The common law of the Cayman Islands is derived in part from comparatively limited judicial precedent in the Cayman Islands as well as from the common law of England, the decisions of whose courts are of persuasive authority, but are not binding, on a court in the Cayman Islands. The rights of our ordinary shareholders and the fiduciary duties of our directors under Cayman Islands law may not be as clearly established as they would be under statutes or judicial precedent in some jurisdictions in the United States. In particular, the Cayman Islands has a different body of securities laws than the United States. Some U.S. states, such as Delaware, may have more fully developed and judicially interpreted bodies of corporate law than the Cayman Islands.

Shareholders of Cayman Islands exempted companies like us have no general rights under Cayman Islands law to inspect corporate records or to obtain copies of lists of shareholders of these companies (other than the memorandum and articles of association, the registers of mortgages and charges, and copies of any special resolutions passed by the shareholders of such companies). The Registrar of Companies of the Cayman Islands shall make available the list of the names of the current directors of the Company (and where applicable the current alternate directors of the Company) for inspection by any person upon payment of a fee by such person. Our directors will have discretion under our amended and restated memorandum and articles of association to determine whether or not, and under what conditions, our corporate records may be inspected by our ordinary shareholders, but we are not obliged to make them available to the ordinary shareholders. This may make it more difficult for you to obtain the information needed to establish any facts necessary for a shareholder to motion or to solicit proxies from other shareholders in connection with a proxy contest. See “Description of Share Capital—Our Post-Offering Amended and Restated Memorandum and Articles of Association—Inspection of Books and Records.”

Certain corporate governance practices in the Cayman Islands, which is our home country, differ significantly from requirements for companies incorporated in other jurisdictions such as the United States. To the extent we choose to follow home country practice with respect to corporate governance matters, our shareholders may be afforded less protection than they otherwise would under rules and regulations applicable to U.S. domestic issuers.

As a result of all of the above, our shareholders may have more difficulty in protecting their interests in the face of actions taken by management, members of the board of directors or controlling shareholders than they would as public shareholders of a company incorporated in the United States.

We are an exempted company incorporated in the Cayman Islands, and, after the consummation of this offering, will be listed on Nasdaq. Nasdaq market rules permit a foreign private issuer like us to follow the corporate governance practices of its home country. Certain corporate governance practices in the Cayman Islands, which is our home country, may differ significantly from Nasdaq corporate governance listing standards applicable to domestic U.S. companies.

Among other things, we are not required to have: (i) a majority of the board of directors consist of independent directors; (ii) a compensation committee consisting of independent directors; (iii) a nominating committee consisting of independent directors; or (iv) regularly scheduled executive sessions with only independent directors each year.

For U.S. federal income tax purposes, each “Ten Percent Shareholder” (as defined below) in a non-U.S. corporation that is classified as a “controlled foreign corporation” (a “CFC”) generally is required to include in income such Ten Percent Shareholder’s pro rata share of the CFC’s “Subpart F income,” investment of earnings in U.S. property, and “global intangible low-taxed income,” even if the CFC has made no distributions to its shareholders. Subpart F income generally includes dividends, interest, rents, royalties, gains from the sale of securities and income from certain transactions with related parties, and “global intangible low-taxed income” generally consists of net income of the CFC, other than Subpart F income and certain other types of income, in excess of certain thresholds. A non-U.S. corporation generally will be classified as a CFC if Ten Percent Shareholders own, directly, indirectly or constructively (through attribution), more than 50% of either the total combined voting power of all classes of stock entitled to vote of such corporation or of the total value of the stock of such corporation. A “Ten Percent Shareholder” is a United States person (as defined by the Internal Revenue Code of 1986, as amended) who owns or is considered to own, directly, indirectly or constructively, 10% or more of either the total combined voting power of all classes of stock entitled to vote of such corporation or the total value of the stock of such corporation. The determination of CFC status is complex and includes certain “downward attribution” rules pursuant to which our non-U.S. subsidiaries may be treated as constructively owned by our U.S. subsidiaries and, therefore, our non-U.S. subsidiaries may be treated as CFCs. Prospective holders of our ordinary shares that may be or become Ten Percent Shareholders should consult their tax advisors with respect to the potential adverse tax consequences of investing in us.

Our tax treatment is subject to changes in tax laws, regulations, and treaties, or the interpretation thereof, tax policy initiatives and reforms under consideration, and the practices of tax authorities in jurisdictions in which we operate. The income and other tax rules in the jurisdictions in which we operate are constantly under review by taxing authorities and other governmental bodies. Changes to tax laws (which changes may have retroactive application) could adversely affect us or our shareholders. We are unable to predict what tax proposals may be proposed or enacted in the future or what effect such changes would have on our business, but such changes, to the extent they are brought into tax legislation, regulations, policies, or practices, could affect our financial position and overall or effective tax rates in the future in countries where we have operations and where we are organized or resident for tax purposes, and increase the complexity, burden, and cost of tax compliance. We urge investors to consult with their legal and tax advisors regarding the implication of potential changes in tax laws on an investment in our ordinary shares.

Pursuant to our amended and restated articles of association to be in effect prior to the completion of this offering, unless we consent in writing to the selection of an alternative forum, the courts of the Cayman Islands shall have exclusive jurisdiction to hear, settle and/or determine any dispute, controversy or claim (including any non-contractual dispute, controversy or claim) whether arising out of or in connection with these articles or otherwise, including any questions regarding their existence, validity, formation or termination, or the Cayman Forum Provision. The Cayman Forum Provision will not apply to any causes of action arising under the Securities Act or Exchange Act. Our amended and restated articles of association further provide that unless we consent in writing to the selection of an alternative forum, to the fullest extent permitted by relevant law, the federal district courts of the United States shall be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act, regardless of whether such legal suit, action, or proceeding also involves parties other than us, or the Federal Forum Provision. In addition, our amended and restated articles of association provide that any person or entity purchasing or otherwise acquiring any shares or other securities in us is deemed to have notice of and consented to the Cayman Forum Provision and the Federal Forum Provision. Notwithstanding the above, holders of our ordinary shares or other securities cannot and will not be deemed to have waived our compliance with the U.S. federal securities laws and the rules and regulations thereunder.

This prospectus contains forward-looking statements that reflect our current expectations and views of future events. The forward-looking statements are contained principally in the sections entitled “Prospectus summary,” “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and “Business.” Known and unknown risks, uncertainties and other factors, including those listed under “Risk Factors,” may cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements.

You can identify some of these forward-looking statements by words or phrases, such as “may,” “will,” “expect,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “is/are likely to,” “potential,” “continue” or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements include statements relating to:

These forward-looking statements involve various risks and uncertainties. Although we believe that our expectations expressed in these forward-looking statements are reasonable, our expectations may later be found to be incorrect. Our actual results could be materially different from our expectations. Important risks and factors that could cause our actual results to be materially different from our expectations are generally set forth in “Prospectus Summary,” “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” “Business,” and other sections in this prospectus. You should read thoroughly this prospectus and the documents that we refer to with the understanding that our actual future results may be materially different from and worse than what we expect. We qualify all of our forward-looking statements by these cautionary statements.

The forward-looking statements made in this prospectus relate only to events or information as of the date on which the statements are made in this prospectus. Except as required by law, we undertake no obligation to update

We estimate that we will receive net proceeds from this offering of approximately $20.5 million (or approximately $23.8 million if the underwriters exercise their option to purchase additional ordinary shares in full), after deducting the estimated underwriting discounts and commissions and the estimated offering expenses payable by us. These estimates are based upon an assumed initial public offering price of $12.00 per ordinary share, which is the midpoint of the price range shown on the front page of this prospectus.

A $1.00 increase or decrease in the assumed initial public offering price of $12.00 per ordinary share would increase or decrease, as applicable, the net proceeds to us from this offering by $1.9 million (or approximately $2.1 million if the underwriters exercise their option to purchase additional ordinary shares in full), assuming the number of ordinary shares offered by us, as set forth on the front cover of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

The principal purposes of this offering are to obtain additional capital to support our operations, establish a public market for our ordinary shares and facilitate our future access to the public capital markets. We intend to use the net proceeds from this offering, together with our existing cash and cash equivalents, as follows:

Based on our current operating plan, we believe that the net proceeds from this offering, together with our existing cash and cash equivalents, will enable us to fund our planned operating expenses and capital expenditures through at least the next nine months. We have based this estimate on assumptions that may prove to be inaccurate, and we could use our available capital resources sooner than we expect. The expected net proceeds from this offering, together with our existing cash and cash equivalents, will not be sufficient for us to fund any of our product candidates through regulatory approval and commercialization, and we will need to raise substantial additional capital in order to do so. To obtain the capital necessary to fund our programs through regulatory approval and commercialization, we expect to finance our cash needs primarily through equity offerings and potentially through debt financings, collaborations, licenses, and development agreements.

Our expected use of the net proceeds from this offering represents our intentions based upon our current plans and business conditions. As of the date of this prospectus, we cannot predict with certainty all of the particular uses for the net proceeds to be received upon the completion of this offering or the amounts that we will actually spend on the uses set forth above. We believe that opportunities may exist from time to time to expand our current business through acquisitions of, or investments in, complementary businesses, products or technologies. While we have no current agreements, commitments or understandings for any specific acquisition or investments at this time, we may use a portion of the net proceeds for these purposes.

Our management will have broad discretion over the use of the net proceeds from this offering. The amounts and timing of our expenditures will depend upon numerous factors, including our ability to obtain additional financing, the amount of cash obtained through our existing collaborations and future collaborations, if any, and any unforeseen cash needs.

Pending any use described above, we may invest the net proceeds of this offering in short- and intermediate-term interest-bearing obligations, investment-grade instruments, certificates of deposit or direct or guaranteed obligations of the U.S. government.

Our board of directors has discretion on whether to distribute dividends, subject to the amended and restated memorandum and articles of association of our company and certain requirements of Cayman Islands law. In addition, our shareholders may by ordinary resolution declare a dividend, but no dividend may exceed the amount recommended by our board of directors. In either case, all dividends are subject to certain restrictions under Cayman Islands law, namely that our company may only pay dividends out of our profits or share premium account, and provided always that in no circumstances may a dividend be paid if this would result in our company being unable to pay its debts as they fall due in the ordinary course of business immediately following the date on which the distribution or dividend is paid. Even if we decide to pay dividends, the form, frequency and amount will depend upon our future operations and earnings, capital requirements and surplus, general financial condition, contractual restrictions and other factors that the board of directors may deem relevant.

We do not have any present plan to pay any cash dividends on our ordinary shares in the foreseeable future after this offering. We currently intend to retain most, if not all, of our available funds and any future earnings to operate and expand our business. Cash dividends on our ordinary shares, if any, will be paid in U.S. dollars.

The following table sets forth our capitalization as of June 30, 2023

The pro forma as adjusted information set forth below is illustrative only and will be adjusted based on the actual initial public offering price and other terms of this offering determined at pricing. You should read this information in conjunction with our financial statements and the related notes that appear elsewhere in this prospectus, as well as the sections of this prospectus titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”

If you invest in our ordinary shares, your interest will be diluted to the extent of the difference between the initial public offering price per ordinary share and our net tangible book value per ordinary share after this offering. Dilution results from the fact that the initial public offering price per ordinary share is substantially in excess of the book value per ordinary share attributable to the existing shareholders for our presently outstanding ordinary shares and holders of our preferred shares which will automatically convert into our ordinary shares upon the completion of this offering.

Our net tangible book value as of June 30, 2023, was approximately negative $8.37 per ordinary share. Net tangible book value per ordinary share represents the amount of total tangible assets, minus the amount of total liabilities, divided by the total number of ordinary shares outstanding. Pro forma net tangible book value per ordinary share is calculated after giving effect to the conversion of all of our outstanding convertible preferred shares and convertible promissory notes and associated interest, including the convertible promissory notes issued subsequent to June 30, 2023. Dilution is determined by subtracting pro forma net tangible book value per ordinary share from the assumed public offering price per ordinary share.

Without taking into account any other changes in such net tangible book value after June 30, 2023, other than to give effect to our issuance and sale of 2,000,000 ordinary shares in this offering at an assumed initial public offering price of $12.00 per ordinary share, the midpoint of the estimated public offering price range, and after deduction of underwriting discounts and commissions and estimated offering expenses payable by us (assuming the over-allotment option is not exercised), our pro forma as adjusted net tangible book value as of June 30, 2023 would have been $0.85 per outstanding ordinary share. This represents an immediate increase in net tangible book value of $0.73 per ordinary share to existing shareholders on a pro forma as adjusted basis and an immediate dilution in net tangible book value of $11.15 per ordinary share to purchasers of ordinary shares in this offering. The following table illustrates such dilution:

A $1.00 change in the assumed public offering price of $12.00 per ordinary share, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase or decrease, as applicable, our pro forma as adjusted net tangible book value after giving effect to the offering by $1.9 million, the pro forma as adjusted net tangible book value per ordinary share after giving effect to this offering by $0.07 per ordinary share and the dilution in pro forma as adjusted net tangible book value per ordinary share to new investors in this offering by $0.93 per ordinary share, assuming no change to the number of ordinary shares offered by us as set forth on the cover page of this prospectus, and after deducting underwriting discounts and commissions and estimated offering expenses. The pro forma information discussed above is illustrative only. Our net tangible book value following the completion of this offering is subject to adjustment based on the actual initial public offering price of our ordinary shares and other terms of this offering determined at pricing.

A $1.00 change in the assumed public offering price of $12.00 per ordinary share, which is the midpoint of the price range set forth on the cover page of this prospectus, would, increase or decrease, as applicable, the consideration paid by new investors, total consideration paid by all shareholders, average price per ordinary share paid by new investors, and average price per ordinary share paid by all shareholders by $2.0 million,, $2.0 million,, $1.00 and $0.07, respectively, assuming no change to the number of ordinary shares offered by us as set forth on the cover page of this prospectus, and after deducting underwriting discounts and commissions and estimated offering expenses payable by us.

The discussion and tables above also assume no exercise of any outstanding share options outstanding as of the date of this prospectus. As of the date of this prospectus, there are 3,456,098 ordinary shares issuable upon exercise of outstanding share options at a weighted average exercise price of $0.63 per ordinary share, and there were 11,250 ordinary shares available for future issuance upon exercise of future grants under our equity incentive plans upon the completion of this offering. To the extent that any of these options are exercised, there will be further dilution to new investors. In addition, we may choose to raise additional capital because of market conditions or strategic considerations, even if we believe that we have sufficient funds for our current or future operating plans. If we raise additional capital through the sale of equity or convertible debt securities, the issuance of these securities could result in further dilution to our shareholders.

We are incorporated under the laws of the Cayman Islands as an exempted company with limited liability. We are incorporated in the Cayman Islands to take advantage of certain benefits associated with being a Cayman Islands exempted company, such as:

However, certain disadvantages accompany incorporation in the Cayman Islands. These disadvantages include but are not limited to:

Our memorandum and articles of association do not contain provisions requiring that disputes, including those arising under the securities laws of the United States, between us, our officers, directors and shareholders, be arbitrated.

All of our directors are nationals or residents of jurisdictions other than the United States and most of their assets are located outside the United States. As a result, it may be difficult for a shareholder to effect service of process within the United States upon these individuals, or to bring an action against us or these individuals in the United States, or to enforce against us or them judgments obtained in United States courts, including judgments predicated upon the civil liability provisions of the securities laws of the United States or any state in the United States.

Maples and Calder (Hong Kong) LLP, our counsel as to Cayman Islands law, has advised us that there is uncertainty as to whether the courts of the Cayman Islands would (i) recognize or enforce judgments of U.S. courts obtained against us or our directors or officers that are predicated upon the civil liability provisions of the federal securities laws of the United States or the securities laws of any state in the United States, or (ii) entertain original actions brought in the Cayman Islands against us or our directors or officers that are predicated upon the federal securities laws of the United States or the securities laws of any state in the United States.

Maples and Calder (Hong Kong) LLP has informed us that although there is no statutory enforcement in the Cayman Islands of judgments obtained in the federal or state courts of the United States (and the Cayman Islands are not a party to any treaties for the reciprocal enforcement or recognition of such judgments), the courts of the Cayman Islands would recognize and enforce a final and conclusive judgement in personam obtained in federal or state courts in the United States under which a sum of money is payable (other than a sum of money payable in respect of multiple damages, taxes or other charges of a like nature, a fine or a penalty or similar fiscal or revenue obligations) or, in certain circumstances, an in personam judgment for non-monetary relief, and would give a judgment based thereon provided that: (a) such courts had proper jurisdiction over the parties subject to such judgment; (b) such courts did not contravene the rules of the natural justice of Cayman Islands; (c) such judgment was not obtained by fraud; (d) such judgment was not obtained in a manner, and is not a kind the enforcement of which, is contrary to natural justice or the public policy of the Cayman Islands; (e) no new admissible evidence relevant to the action is submitted prior to the rendering of the judgment by the courts of the Cayman Islands; and (f) there is due compliance with the correct procedures under the laws of the Cayman Islands. However, the Cayman Islands courts are unlikely to enforce a punitive judgment of a United States court predicated upon the civil liability provisions of the federal securities laws in the United States without retrial on the merits if such judgment is determined by the courts of the Cayman Islands to give rise to obligations to make payments that may be regarded as fines, penalties or punitive in nature. A Cayman Islands court may stay enforcement proceedings if concurrent proceedings are being brought elsewhere.

We are a clinical-stage biotechnology company committed to protecting patients’ brain health and changing clinical outcomes for a broad range of neurodegenerative diseases by developing novel, highly sensitive and selective diagnostic tools and novel therapeutics.

Our name, APRINOIA, merges “apricum,” the Latin word for sunlight, and “noia,” the Greek suffix for the mind, reflecting our mission to shed light on ways to better diagnose and treat dreaded neurodegenerative diseases with a vision to offer a brighter future for our patients with novel diagnostic tools and targeted therapeutics.

Since our inception in 2015, our operations have focused on organizing and staffing our company, business planning, raising capital, establishing our intellectual property portfolio, conducting research and development activities, including drug discovery, preclinical studies and clinical trials, and providing general and administrative support for these operations. We do not have any product candidates approved for commercialization and have not generated any revenue from product sales.

We have funded our operations to date primarily through equity and debt financing and licensing arrangements. We have received net proceeds of $65.9 million from the sale of preferred shares and $16.5 million from issuance of convertible notes through June 30, 2023. During the six months ended June 30, 2023, we recognized $6.6 million net upfront payment under the Yitai License Agreement (as defined below) and $1.9 million payment under the Yitai Service Agreement (as defined below) from Yantai Yitai Pharmaceutical Technology Co., Ltd. (“Yitai”), a wholly-owned subsidiary of our collaboration partner and related party, Yantai Dongcheng Biochemicals Co., Ltd (together with its subsidiaries, “Dongcheng Pharma”), pursuant to the license and commercialization agreement with Dongcheng and Yitai (the “Yitai License Agreement”) and assignment and consulting service agreement (the “Yitai Service Agreement”, together with the Yitai License Agreement, “Yitai Agreements”). As of June 30, 2023, we had $7.7 million in cash.

We have incurred significant operating losses since our inception – our total comprehensive loss was $7.5 million, $28.7 million and $23.4 million for the six months ended June 30, 2023 and the years ended December 31, 2022 and 2021, respectively. We expect to continue to incur net losses for the foreseeable future, and we expect that our research and development expenses, general and administrative expenses and capital expenditures will continue to increase substantially for the foreseeable future in connection with our ongoing activities, as we:

Because of the numerous risks and uncertainties associated with product development, we may never achieve or sustain profitability and, unless and until we are able to develop and commercialize our product candidates, we will need to continue to raise additional capital. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through public or private equity or debt financings, or potentially other capital sources, such as collaboration or licensing arrangements with third parties or other strategic transactions. There are no assurances that we will be successful in obtaining an adequate level of financing to support our business plans when needed on acceptable terms, or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities or the ownership interest of our shareholders upon consummation of this offering, will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our shareholders upon consummation of this offering. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaboration or licensing arrangements with third parties or other strategic transactions, we may have to relinquish rights to our intellectual property, future revenue streams, research programs, or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise capital as and when needed, or on attractive terms, we may have to significantly delay, reduce, or discontinue the development and commercialization of our product candidates or scale back or terminate our pursuit of new in-licenses and acquisitions.

Based upon our current operating plan, we have determined that additional financing will be required to fund our operations for the next twelve months from the date of the issuance of the accompanying consolidated financial statements included elsewhere in this prospectus and our ability to continue as a going concern is dependent upon obtaining additional capital and financing, including through the consummation of this offering. See “––Liquidity and Capital Resources––Funding Requirements” below for more details.

On January 17, 2023, we entered into a business combination agreement (the “Business Combination Agreement”) with Ross Acquisition Corp II (“RAC”), APRINOIA Therapeutics Holdings Limited (“PubCo”), APRINOIA Therapeutics Merger Sub 1, Inc. (“Merger Sub 1”), APRINOIA Therapeutics Merger Sub 2, Inc. (“Merger Sub 2), and APRINOIA Therapeutics Merger Sub 3, Inc. (“Merger Sub 3”), pursuant to which RAC will merge with and into Merger Sub 1, with Merger Sub 1 being the surviving entity, Merger Sub 2 will merge with and into APRINOIA, with APRINOIA being the surviving entity, and APRINOIA will merge with and into Merger Sub 3, with Merger Sub 3 being the surviving entity (collectively, the “Business Combination”). In connection with the Business Combination, we and RAC entered into an advance agreement (the “Advance Agreement”), pursuant to which, we agreed to advance up to an aggregate of $990,000 to RAC’s trust account from March 2023 through August 2023. During the six months ended June 30, 2023, we made advance payments of $660,000 to RAC. Subsequent to June 30, 2023 prior to the termination of the Business Combination, we made additional advance payments of $330,000 to RAC. On August 21, 2023, we and RAC terminated the Business Combination Agreement in a mutual decision. As a result of the termination, the Business Combination Agreement is of no further force and effect, with the exception of the specified provisions in Section 11.02 of the Business Combination Agreement – Effect of Termination, which shall survive the termination of the Business Combination Agreement and remain in full force and effect in accordance with their respective terms. Subsequent to the termination of the Business Combination, we contemplate our initial public offering (“IPO”). Because the Business Combination has been terminated, we will expense approximately $2,700,000 in capitalized deferred operating costs related to the Business Combination

We currently generate revenue through our product licensing by providing our third-party and related party licensees with the right to access our product candidates, and through providing our data and documentation for certain clinical research and studies. To date, we have not generated revenue from product sales. Our ability to generate product revenue and to become profitable in the future will depend on our ability to successfully develop, obtain regulatory approval for, and commercialize our product candidates.

The largest component of our total operating expenses has historically been, and we expect will continue to be, research and development expenses, which consist primarily of costs incurred in connection with our research activities and include:

Research and development costs are expensed as incurred. Costs for certain activities, such as preclinical studies and clinical trials, are generally recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and investigators. We currently do not track research and development expenses by program.

Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect our research and development expenses to increase over the next several years as our existing clinical programs progress and as we seek to advance our preclinical product candidates into clinical development and initiate clinical trials of additional product candidates. We also expect to incur increased research and development expenses as we selectively identify and develop additional product candidates. However, it is difficult to determine with certainty the duration and completion costs of our current or future preclinical programs and clinical trials of our product candidates.

The duration, costs and timing of clinical trials and development of our product candidates will depend on a variety of factors that include, but are not limited to, the following:

A change in the outcome of any of these variables with respect to the development of any of our product candidates could significantly change the costs and timing associated with the development of such product candidate. In addition, the probability of success for each product candidate will depend on numerous factors, including competition, manufacturing capability and commercial viability. We will determine which programs to pursue and how much to fund each program in response to the scientific and clinical success of each product candidate, as well as an assessment of each product candidate’s commercial potential. Because our product candidates are still in clinical and preclinical development and the outcome of these efforts is uncertain, we cannot estimate the actual amounts necessary to successfully complete the development and commercialization of product candidates and whether, or when, we may achieve profitability.

General and administrative expenses consist primarily of personnel expenses, including salaries, benefits and share-based compensation expense, if any, for personnel in executive, finance, accounting, business development, legal and human resource functions. General and administrative expenses also include corporate facility costs not otherwise included in research and development expenses, legal fees related to intellectual property and corporate matters and fees for accounting and consulting services. General and administrative costs are expensed as incurred, and we accrue for services provided by third parties related to the above expenses by monitoring the status of services provided and adjusting our accruals as actual costs become known.

We expect our general and administrative expenses to increase in the foreseeable future to support our continued research and development activities, potential commercialization of our product candidates and operating as a public company. These increased costs are anticipated to be related to the hiring of additional personnel, developing commercial infrastructure, fees to outside consultants, lawyers and accountants, and costs associated with being a public company such as accounting, audit, legal, regulatory, compliance and director and officer insurance costs, as well as investor and public relations expenses.

The following table summarizes our results of operations for the periods or years indicated:

Revenue for the six months ended June 30, 2023 was $9.0 million, compared to $0.3 million for the six months ended June 30, 2022. The net increase of $8.7 million was primarily due to the $6.6 million net upfront payment we recognized under the Yitai License Agreement and $1.9 million payment recognized under the Yitai Service Agreement.

The following table summarizes our research and development expenses for the six months ended June 30, 2023 and 2022:

Research and development expenses for the six months ended June 30, 2023 were $11.1 million, compared to $11.3 million for the six months ended June 30, 2022. The net decrease of $0.2 million was primarily due to a decrease of $2.1 million in outsourced research fees as we minimized the utilization of third-party consultants, offset by an increase of $1.1 million in personnel expenses, including share-based compensation expense and an increase of $0.9 million in facility and lab supplies and other research and development expenses as a result of increased headcount and internal research and development activities to support our programs.

The following table summarizes our general and administrative expenses for the six months ended June 30, 2023 and 2022:

General and administrative expenses for the six months ended June 30, 2023 were $4.7 million, compared to $2.8 million for the six months ended June 30, 2022. The net increase of $1.9 million was primarily due to an increase of $1.5 million in personnel expenses due to increased headcount, and an increase of $0.2 million in legal, professional and consulting fees relating to the aforementioned Business Combination, which was terminated subsequent to June 30, 2023.

Interest expense, net for the six months ended June 30, 2023 was $1.4 million, compared to $0.01 million for the six months ended June 30, 2022. This increase of $1.4 million was primarily due to the interest charge, including the associated amortization of debt discount and issuance costs, recognized from the various convertible promissory notes issued in December 2022 and during the six months ended June 30, 2023 in an aggregate principal amount of $16.7 million. These notes bear an interest rate of 5% per annum.

Change in fair value of derivative liabilities was $0.5 million for the six months ended June 30, 2023, compared to zero for the six months ended June 30, 2022. The derivative liabilities are related to the embedded redemption features in connection with the convertible notes that were issued in December 2022 and during the six months ended June 30, 2023. The derivative liabilities were recorded at their fair value at issuance and are subsequently remeasured to fair value at each reporting date.

Other income (expense), net for the six months ended June 30, 2023 was income of $0.6 million, compared to income of $0.2 million for the six months ended June 30, 2022. This increase of $0.4 million was primarily attributable to gains realized on foreign currency transactions due to changes in foreign currency exchange rates.

Provision for income taxes of $0.05 million and $0.01 million for the six months ended June 30, 2023 and 2022, respectively, was generated as a result of taxable income in the United States.

As a result of the foregoing, we had a net loss of $7.2 million and $13.7 million for the six months ended June 30, 2023 and 2022, respectively.

Revenue for the year ended December 31, 2022 was $0.4 million, compared to $0.6 million for the year ended December 31, 2021. The net decrease of $0.2 million was primarily due to decreases in research and development service arrangements of $0.1 million due to one-time upfront payments received in 2021 and a decrease in material fees of $0.1 million as a result of reduced orders in 2022.

The following table summarizes our research and development expenses for the years ended December 31, 2022 and 2021:

Research and development expenses for the year ended December 31, 2022 were $21.6 million, compared to $19.7 million for the year ended December 31, 2021. The net increase of $1.9 million was primarily due to an increase of $3.7 million in personnel expenses, including share-based compensation expense and $0.4 million in facilities and lab supplies as a result of additional research and development employees to support our programs, and an increase of $0.2 million in legal, professional and consulting fees as a result of our operational expansion. These increases were partially offset by a decrease of $2.4 million in outsourced research services as we minimized the utilization of third-party consultants in research and development activities and therefore handled more of these activities internally.

The following table summarizes our general and administrative expenses for the years ended December 31, 2022 and 2021:

General and administrative expenses for the year ended December 31, 2022 were $7.0 million, compared to $4.8 million for the year ended December 31, 2021. The net increase of $2.2 million was primarily due to (i) an increase of $1.5 million in employee compensation to our general and administrative personnel as a result of our operational expansion and (ii) a net increase of $0.7 million in legal, professional and consulting fees relating to certain proposed business combinations.

Interest expense, net for the year ended December 31, 2022 was $0.07 million, compared to $0.04 million for the year ended December 31, 2021. This increase of $0.03 million was primarily due to a slight increase in short-term borrowings from financial institutions in 2022 as compared to 2021.

Other income (expense), net for the year ended December 31, 2022 was $0.1 million, compared to $0.7 million for the year ended December 31, 2021. This decrease of $0.6 million was primarily attributable to a decrease in grant revenue relating to grants received from government-sponsored entities for research and development activities.

Provision for income taxes of $0.02 million for the year ended December 31, 2022 was generated as a result of taxable income in the United States. Provision for income taxes of zero for the year ended December 31, 2021 was due to tax loss carryforwards.

As a result of the foregoing, we had a net loss of $28.2 million and $23.3 million for the year ended December 31, 2022 and 2021, respectively.

We do not currently have any approved products and have not generated any revenue from product sales. We have funded our operations to date primarily through equity and debt financing and licensing arrangements. We have received net proceeds of $65.9 million from the sale of preferred shares and $16.5 million from issuance of convertible notes through June 30, 2023. During the six months ended June 30, 2023, we recognized $6.6 million net upfront payment under the Yitai License Agreement and $1.9 million payment under the Yitai Service Agreement. As of June 30, 2023, we had $7.7 million in cash.

Since our inception, we have incurred significant operating losses. We expect to incur significant expenses and operating losses for the foreseeable future as we advance the preclinical studies and clinical development of our research programs and product candidates. We expect that our research and development and general and administrative expenses will increase in connection with conducting additional clinical trials and preclinical studies for our current and future research programs and product candidates, contracting with CROs and CDMOs to support clinical trials and preclinical studies, expanding our intellectual property portfolio, and providing general and administrative support for our operations. As a result, we expect that we will need additional capital to fund our operations.

Based upon our current operating plan, we have determined that additional financing will be required to fund our operations for the next 12 months from the date of the issuance of the accompanying consolidated financial statements included elsewhere in this prospectus and our ability to continue as a going concern is dependent upon obtaining additional capital and financing, including through the consummation of this offering. We do not expect to generate any revenue from product sales unless and until we successfully complete development and obtain regulatory approval for one or more of our product candidates which we expect will take several years. As a result, until we can generate substantial product revenue, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, including collaborations, licenses and other similar arrangements.

However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. If we do raise additional capital through public or private equity offerings, the ownership interest of our existing shareholders, including investors in this offering, will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our shareholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise funds through additional collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies. If we are unable to raise capital, we may reduce costs through delaying the development timelines of certain programs or termination of such programs.

Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical products, we are unable to estimate the exact amount of our operating capital requirements. Our future funding requirements will depend on many factors, including, but not limited to:

Further, our operating plans may change, and we may need additional funds to meet operational needs and capital requirements for clinical trials and other research and development activities. Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated product development programs. These matters raise substantial doubt about our ability to continue as a going concern for a period of twelve months from the issue date of this prospectus. The financial statements included elsewhere in this prospectus have been prepared assuming that we will continue to operate as a going concern, which contemplate the realization of assets and settlement of liabilities in the normal course of business and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from uncertainty related to our ability to continue as a going concern.

The following table shows a summary of our cash flows for the periods or years indicated:

Net cash used in operating activities was $5.5 million for the six months ended June 30, 2023, compared to $9.8 million for the six months ended June 30, 2022. The decrease of $4.3 million was primarily due to an improvement in net loss that was driven by revenue recognized under the Yitai License Agreement and the Yitai Service Agreement. This decrease was partially offset by a decrease in operating assets and liabilities.

Net cash used in operating activities in the six months ended June 30, 2023 consisted primarily of a net loss of $7.2 million, as adjusted for certain non-cash items totaling $2.0 million, which was primarily driven by non-cash

Net cash used in operating activities in the six months ended June 30, 2022 consisted primarily of a net loss of $13.7 million, as adjusted for certain non-cash items totaling $0.3 million, which included share based compensation expense of $0.2 million and depreciation of property and equipment of $0.1 million. Additionally, there was an increase in operating assets and liabilities of $3.5 million, primarily attributable to an increase in accounts payable of $3.2 million and decreases in short-term and long-term prepaid expenses and other assets totaling $1.5 million, partially offset by a decrease in accrued expenses and other current liabilities of $1.0 million.

Net cash used in operating activities was $17.2 million for the year ended December 31, 2022, compared to $24.3 million for the year ended December 31, 2021. The decrease of $7.1 million was primarily due to an increase in operating assets and liabilities and share-based compensation expense, partially offset by a deterioration in net loss.

Net cash used in operating activities in 2022 consisted primarily of a net loss of $28.2 million, as adjusted for certain non-cash items, primarily including a net increase in operating assets and liabilities of $8.6 million and share-based compensation expense of $1.9 million. The increase in operating assets and liabilities was primarily attributable to an increase in accounts payable of $7.9 million.

Net cash used in operating activities in 2021 consisted primarily of a net loss of $23.3 million, as adjusted for certain non-cash items, primarily including a net decrease in operating assets and liabilities of $2.3 million and share-based compensation expense of $0.9 million. The decrease in operating assets and liabilities was primarily attributable to a decrease in accounts payables of $2.6 million.

Net cash used in investing activities in the six months ended June 30, 2023 and 2022 was $0.8 million and $0.9 million, respectively, consisting primarily of notes receivable – related party of $0.7 million in 2023 and purchases of property and equipment of $0.9 million in 2022.

Net cash used in investing activities for the year ended December 31, 2022 was $2.0 million, consisting of purchases of property and equipment.

Net cash used in investing activities for the year ended December 31, 2021 was $0.3 million, consisting primarily of purchases of property and equipment of $0.5 million, partially offset by a cash inflow related to proceeds from disposal of property and equipment of $0.2 million.

Net cash provided by financing activities for the six months ended June 30, 2023 was $13.3 million, consisting primarily of proceeds from issuance of convertible notes of $15.2 million during 2023, including $10.8 million of proceeds from related party convertible notes, as well as proceeds from the exercise of share options of $0.3 million and proceeds from related party payables of $0.3 million. These financing cash inflows were partially offset by the repayments of short-term borrowings and related party payables of $0.7 million and $1.2 million, respectively, and cash settlements related to deferred offering costs of $0.6 million associated with the Business Combination, which was terminated subsequent to June 30, 2023.

Net cash provided by financing activities for the six months ended June 30, 2022 was $9.0 million, consisting primarily of net proceeds of $9.0 million received from the issuance of preferred shares.

Net cash provided by financing activities for the year ended December 31, 2022 was $11.4 million, consisting primarily of proceeds from issuance of preferred shares of $9.0 million, proceeds from short-term borrowings of $1.5 million, proceeds from issuance of convertible notes of $1.4 million, including $1.0 million proceed from a related party convertible note, and proceeds from related party payables of $0.9 million. These financing cash inflows were partially offset by the repayment of short-term borrowings of $0.7 million, and cash settlements related to deferred offering costs associated with certain proposed business combination of $0.7 million.

Since the date of our incorporation, we have not engaged in any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.

Effective July 14, 2023, Dr. Mark S. Shearman was appointed as CEO of our company. Dr. Shearman, who holds a Ph.D. in neuroscience, has extensive experience in pharmaceutical research, drug development and strategic partnerships. Dr. Shearman succeeds the previous CEO of our company, Dr. Ming-Kuei Jang, who assumed the role of president of our company’s Asia operations and remained in his position as chairman of the board of directors of our company, or the board. On September 28, 2023, the board appointed Dr. Shearman to replace Ms. Yen Tzu-Chen on the board, effective October 10, 2023.

On October 4, 2023, we entered into a $200,000 loan agreement with our Chief Financial Officer. The loan bears an annual interest rate of 7%. We repaid all principal and interest due per the loan agreement in January 2024.

Effective November 15, 2023, Hiroki Narita resigned from the board of directors of our company. On November 17, 2023, our board of directors appointed Roger Pomerantz to replace Mr. Narita on the board, effective November 30, 2023. Effective December 9, 2023, Paul Tempest resigned from the board of directors of our company. Effective February 14, 2024, Kuk-Hyun Kyung resigned from the Board of Directors of our company.

On December 25, 2023, our board of directors approved the transfer of all intellectual properties of APRINOIA Therapeutics Limited, a subsidiary of our company registered in Hong Kong, to a new subsidiary registered in Ireland. The new subsidiary will be registered under the name of APRINOIA Therapeutics Limited and is wholly owned by our company.

On November 10 and 20, 2023, we issued two convertible promissory notes to new investors for aggregate consideration of $500,000. Each note bears a simple interest rate of 5% per annum and is due one year after the date of note issuance. On December 12 and 18, 2023, we renewed two convertible promissory notes, with an aggregate principal amount of $1,400,000, with its respective investor. Each renewed note bears a simple interest of 5% per annum from the issuance date of the original note and an increased simple interest of 8% per annum from the date of renewal, and is due one year after the renewal date of such note. On December 21, 2023, a convertible note that was issued to one of our officers for consideration of $50,000 matured. On January 24, 2024 we fully repaid the note in the amount of $52,500, including interest. On January 9, 2024, we issued convertible promissory notes to two new investors for an aggregate consideration of $4,000,000. Each note is convertible at the option of its holder upon certain specific events, bears a simple interest rate of 8% per annum and is due one year after the date of note issuance. On January 12, 2024, we renewed a convertible promissory note with a principal amount of $3,000,000. The renewed promissory note bears a simple interest of 5% per annum from the issuance date of the original note and an increased simple interest of 8% per annum from the date of renewal and is due one year after the renewal date.

On January 12, 2024, a convertible promissory note that was issued for consideration of $7,500,000 matured and we executed an agreement with the investor to extend the maturity date to February 15, 2024 for the purpose of renegotiating the terms of the note. We agreed to increase the interest rate to the equivalent of 12.5% per annum during the period of extension and all other terms and conditions of the note remain unchanged (including the terms

On February 7, 2024, we renewed the promissory note with Dr. Ming-Kuei Jang, with terms substantially the same as those offered to other investors for their renewed promissory notes, including an increased 8% per annum simple interest from the date of the renewal.

We are exposed to market risks in the ordinary course of our business. Market risk represents the risk of loss that may impact our financial position due to adverse changes in financial market prices and rates. Our market risk exposure is primarily the result of fluctuations in foreign exchange and interest rate risk.

Our reporting currency is the U.S. dollar. We maintain the financial statements of certain subsidiaries in their local currency which is also such entity’s functional currency and therefore are exposed to foreign exchange risk relating to multiple foreign currencies. However, most of our expenses are incurred in U.S. dollars, and the majority of our cash is held in U.S. dollars. Accordingly, assets and liabilities are generally translated into U.S. dollars at the current rates of exchange as of the balance sheet date, and revenues and expenses are translated using weighted average rates prevailing during the period. Adjustments from foreign currency translation, net of tax are included as a separate component of accumulated other comprehensive income (loss). Exchange gains or losses arising from foreign currency transactions are included in other income (expense), net in the consolidated statements of operations and comprehensive loss.

The volatility of exchange rates depends on many factors that we cannot forecast with reliable accuracy. We have experienced and will continue to experience fluctuations in foreign exchange gains and losses related to changes in foreign currency exchange rates. In the event our foreign currency denominated assets, liabilities, revenue, or expenses increase, our results of operations may be more greatly affected by fluctuations in the exchange rates of the currencies in which we do business, resulting in unrealized foreign exchange gains or losses. We have not engaged in the hedging of foreign currency transactions to date, although we may choose to do so in the future.

A hypothetical 10% change in the relative value of the U.S. dollar to other currencies during any of the periods presented would not have had a material effect on our consolidated financial statements, but could result in significant unrealized foreign exchange gains or losses for any given period.

Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of interest rates. Our cash flow interest rate risk is mainly concentrated on the fluctuation of interest rates on bank balances and variable rates arising from our bank borrowings, which is being regularly monitored and evaluated by reference to anticipated changes in market interest rate by us. As of June 30, 2023 and December 31, 2022, we had cash and cash equivalents of $7.7 million and $1.2 million, and short-term borrowings of $0.7 million and $1.5 million respectively. We generally hold our cash in interest-bearing demand deposit accounts. Due to the nature of our cash and the balance of our bank borrowings, a hypothetical 1% change in interest rates would not have a material effect on our operational performance. Our cash and bank borrowings are held for working capital purposes. We do not enter into financial instruments for trading or speculative purposes.

A description of recently issued accounting pronouncements that may potentially impact our financial position, results of operations or cash flows is disclosed in Note 2 to our consolidated financial statements included elsewhere in this prospectus.

Our management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which are presented in U.S. dollars and have been prepared in conformity with

The preparation of our financial statements in conformity with U.S. GAAP requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities and expenses, and the disclosure of contingent assets and liabilities at the date of consolidated financial statements and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in our consolidated financial statements include, but not limited to, revenue recognition, the fair value of derivative liabilities, the inputs and model assumptions related to the valuation of our share options, and the fair value of our ordinary shares. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We believe that the accounting policies discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates. For further information, refer to Note 1 “Nature of Business and Basis of Presentation” and Note 2 “Summary of Significant Accounting Policies” to our consolidated financial statements included elsewhere in this prospectus.

Under ASC 606 – Revenue Recognition (“ASC 606”), we recognize revenue when our customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements within the scope of ASC 606, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price, including variable consideration, if any; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. We only apply the five-step model to contracts when it is probable that the entity will collect the consideration to which it is entitled in exchange for the goods or services it transfers to the customer.

At contract inception, once the contract is determined to be within the scope of ASC 606, we assess whether the promised goods or services promised within each contract are distinct and, therefore, represent a separate performance obligation. Goods and services that are determined not to be distinct are combined with other promised goods and services until a distinct bundle is identified. In determining whether goods or services are distinct, we evaluate certain criteria, including whether (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (capable of being distinct) and (ii) the good or service is separately identifiable from other goods or services in the contract (distinct in the context of the contract).

We then determine the transaction price, which is the amount of consideration we expect to be entitled from a customer in exchange for the promised goods or services for each performance obligation and recognize the associated revenue as each performance obligation is satisfied. Our estimate of the transaction price for each contract includes all variable consideration to which we expect to be entitled. Variable consideration includes payments in the form of royalties and milestone payments. If an arrangement includes milestone payments, we evaluate whether the milestones are considered probable of being reached and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. For arrangements with product licenses that include sales-based royalties or milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties or milestone payments relate, we recognize royalty revenue and sales-based milestones at the later of (i) when the related sales occur, or (ii) when the performance obligation to which the royalty or milestone payment has been allocated has been satisfied. At the end of each reporting period, we re-evaluate the estimated variable consideration included in the transaction price and any related constraint and, as necessary, adjust the estimate of the overall transaction price. Any adjustments will be recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment.

ASC 606 requires us to allocate the arrangement consideration on a relative standalone selling price basis for each performance obligation after determining the transaction price of the contract and identifying the performance obligations to which that amount should be allocated. The relative standalone selling price is defined in the revenue standard as the price at which an entity would sell a promised good or service separately to a customer. We then

We currently generate revenue through our product licensing by providing third-party and related party licensees with the right to access our product candidates and through providing data and documentation for certain clinical research and studies. All of our revenues that are earned and received in mainland China are subject to a Chinese value-added tax (“VAT”) at applicable tax rates of gross proceeds. We report applicable revenues net of the Chinese VAT for all the periods presented in the accompanying interim condensed consolidated statements of operations and comprehensive loss. An entity that is a VAT general taxpayer is allowed to offset qualified input VAT on purchases against its output VAT liabilities. The VAT payable is reflected in accrued expenses and other current liabilities while the VAT receivable is reflected in prepaid expenses and other current assets in the accompanying condensed consolidated financial statements.

The terms of the licensing arrangements include payment to us for a combination of one or more of the following: upfront license fees, development and regulatory milestone payments, and material fees. We use judgment to determine whether milestones or other variable considerations should be included in the transaction price.

We grant licensees a worldwide, non-exclusive, non-transferable, non-sublicensable license to manufacture and use our product candidates with support services for a development program for a defined period of time (generally two to six years). A “development program” refers to one or more scientific research or development studies owned, controlled, and sponsored by the licensees including, without limitation, the use of our product candidates in any clinical studies of the licensees’ products in the specified research fields and geographical territories pursuant to the terms of the licensing agreement. If the license to our intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, we will recognize revenue from upfront license fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. The license granted is considered a functional license under ASC 606 and is a single performance obligation. We recognize revenue for the upfront license fees at a point in time.

We grant licensees a non-exclusive, non-transferable, fully paid, royalty-free license, without right of sublicense, to use our background intellectual property solely to the extent required for the licensees to perform their obligations pursuant to the terms of the licensing agreement for a defined period of time (generally three years). At the inception of each arrangement that includes payments based on the achievement of certain development and regulatory events, we evaluate whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within our or the licensee’s control, such as regulatory approvals, are not considered probable of being achieved until regulatory approval is received. The licensees have no contractual right to take possession of our background intellectual property and we are the sole owner of inventions and intellectual property relating to the chemical matter generated during the course of the licensing agreement. The development and regulatory milestone payments contain multiple preclinical and clinical performance milestones, and each milestone represents a performance obligation that also drives the licensee payment schedule. At the end of each subsequent reporting period, we will re-evaluate the probability of achieving such development and regulatory milestones and any related constraint, and if necessary, adjust our estimate of the overall transaction price. Upon the completion of the licensing agreement, all results generated in the performance of the work plan during the term are jointly owned by both parties. “Results” refer to any information or data including, but not limited to, raw data, method, protocol, analysis, conclusions and reports, generated under the work plan. The license granted is considered a functional license under ASC 606. We recognize revenue for development and regulatory milestone payments based on the related labor utilization over the achievement of the milestones pursuant to the terms of the licensing agreement.

In connection with the licensing agreement, certain materials and supplies are also paid for by licensees on a transactional basis. We recognize these revenues as the materials and supplies are delivered at a point in time

The research and development arrangements represent the promises to transfer our data and documentation for certain clinical research and studies to customers. We recognize these revenues as the goods are delivered at a point in time.

We account for all share-based payment awards granted to employees and non-employees as share-based compensation expense at fair value. We grant equity awards under our share-based compensation programs. The measurement date for employee and non-employee awards is the date of grant, and share-based compensation costs are recognized as expense over the requisite service period, which is the vesting period, on a straight-line basis. Share-based compensation expense is classified in the accompanying consolidated statements of operations and comprehensive loss based on the function to which the related services are provided. We recognize share-based compensation expense for the portion of awards that have vested. Forfeitures are recorded as they occur. There have been no performance conditions attached to the share options granted to date. The fair value of each share option grant is estimated on the date of grant using the Binomial option pricing model with assumptions as follows:

Our valuation of our ordinary shares is prepared using a market approach, based on precedent transactions in the shares, to estimate our total equity value using an option-pricing method (“OPM”). The OPM method derives an equity value such that the value indicated for our ordinary shares by allocating the equity value to each of our securities. Key inputs into the OPM calculation include the risk-free rate, expected time to liquidity and volatility. A reasonable discount for lack of marketability is applied to the total equity value to arrive at an estimate of the total fair value of equity on a non-marketable basis.

The derivative liabilities relate to the embedded redemption features in connection with the convertible notes. The fair value of the embedded redemption features at issuance of the convertible notes and each reporting period was estimated based on significant inputs not observable in the market, which represent Level 3 measurements within the fair value hierarchy. We used a scenario-based model (“SBM”) and a discounted cash flow method to incorporate estimates and assumptions concerning company prospects and market indications into a model to estimate the value of the derivative liability. An SBM considers a range of various potential scenario outcomes assumed to occur with associated probabilities. Cash flow outcomes are then discounted to present value to estimate fair value. The most significant estimates and assumptions used as inputs in the SBM valuation technique impacting the fair value of the embedded redemption features are the timing and probability of a successful financing, delay or renegotiation and

We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. We have elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that we (i) are no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, the accompanying consolidated financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates. The JOBS Act also exempts us from having to provide an auditor attestation of internal control over financial reporting under Sarbanes-Oxley Act Section 404(b).

As described in Note 2 “Summary of Significant Accounting Policies” to our consolidated financial statements included elsewhere in this prospectus, we early adopted certain accounting standards, as the JOBS Act does not preclude an emerging growth company from adopting a new or revised accounting standard earlier than the time that such standard applies to private companies. We expect to use the extended transition period for any other new or revised accounting standards during the period in which we remain an emerging growth company.

We will remain an emerging growth company until the earlier of: (1) the last day of the fiscal year (a) following the fifth anniversary of the completion of the completion of this offering, (b) in which we have total annual gross revenue of at least $1.235 billion, or (c) in which we are deemed to be a large accelerated filer, which means the market value of our common equity that is held by nonaffiliates exceeds $700 million as of the end of the prior fiscal year’s second fiscal quarter; and (2) the date on which we have issued more than $1.00 billion in non-convertible debt during the prior three-year period. References herein to “emerging growth company” shall have the meaning associated with it in the JOBS Act.

This prospectus contains estimates, projections and other information concerning our industry, our business and the markets for our product candidates, including data regarding the estimated size of such markets and the incidence of certain medical conditions. We obtained the industry, market and similar data set forth in this prospectus from our internal estimates and research and from academic and industry research, publications, surveys and studies conducted by third parties, including governmental agencies. In some cases, we do not expressly refer to the sources from which this data is derived. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances that are assumed in this information. While we believe that the data we use from third parties are reliable, we have not separately verified this data. Further, while we believe that our internal research is reliable, such research has not been verified by any third party. You are cautioned not to give undue weight to any such information, projections and estimates.

We are a clinical-stage biotechnology company committed to protecting patients’ brain health and changing clinical outcomes for a broad range of neurodegenerative diseases by developing novel, highly sensitive and selective diagnostic tools and novel therapeutics.

Our name, APRINOIA, merges “apricum,” the Latin word for sunlight, and “noia,” the Greek suffix for the mind, reflecting our mission to shed light on ways to better diagnose and treat dreaded neurodegenerative diseases with a vision to offer a brighter future for patients with novel diagnostic tools and targeted therapeutics worldwide.

Neurodegenerative diseases are relentless and largely fatal, resulting from progressive loss of nerve cells in the brain and, depending on the specific disorders, can affect a broad range of cognitive, behavioral, and motor functions, such as memory, thinking, speaking, walking, and breathing. Although our understanding of the underlying pathophysiology has grown over the past decade due to advances in neuroscience, a significant unmet need remains for both accurate, safe and personalized diagnostics and effective and safe treatments.

In harnessing the power of precision neuroscience, we are developing several different diagnostic and therapeutic platforms to detect and target both common and neurodegenerative disorders marked by abnormal protein aggregates of tau and alpha-synuclein (“α-Syn”) that are toxic to brain cells.

Tauopathies and synucleinopathies affect approximately 50 million and 10 million people worldwide, respectively, and collectively account for most cases of dementia and movement disorders, resulting in devastating emotional and socio-economic consequences, including prolonged hospitalizations, nursing home placement and death. See “––Overview of Unmet Medical Needs and Market Opportunities in Neurodegenerative Diseases” for more information.

As detailed below, we are developing three platforms to diagnose and treat these disorders, namely: (1) positron emission tomography (“PET”) diagnostic tracers for tau and α-Syn aggregates, with ¹⁸F-APN-1607 (INN: florzolotau (18F)) (“APN-1607”) being a 3 carboxy-terminal (“3R”)/4 carboxy-terminal domains (“4R”) tau PET tracer for the diagnosis of PSP and related disorders, as well as AD; (2) an antibody platform, with APNmAb005 being a novel monoclonal antibody designed to offer greater selectivity for pathologic forms of tau that contribute to the pathogenesis of AD and primary tauopathies; and (3) a protein degrader platform based on the proteolysis targeting chimeras (“PROTAC”) that targets pathological α-Syn and tau proteins, which we believe potentially represents one of the more innovative therapeutic approaches for the treatment of neurodegenerative diseases, an area previously thought to be undruggable by traditional small molecules.