SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
We make “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), in this prospectus and any accompanying prospectus supplement, including the documents that we incorporate by reference herein and therein. Our forward-looking statements are subject to risks and uncertainties and include information about our current expectations and possible or assumed future results of our operations. When we use words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “could,” “plan,” “potential,” “predict,” “forecast,” “projected,” “intend” or similar expressions, or make statements regarding our intent, belief, or current expectations, we are making forward-looking statements. Our forward-looking statements also include, without limitation, statements about our liquidity and capital resources; our ability to continue to operate as a going concern; our ability to develop FPC for other indications; our ability to successfully execute on our business strategy and development of new indications, and statements regarding our anticipated future financial condition, operating results, cash flows and business plans. Because these forward-looking statements are based on estimates and assumptions that are subject to significant business, economic and competitive uncertainties, many of which are beyond our control or are subject to change, actual results could be materially different from the anticipated future results, performance or achievements expressed or implied by any forward-looking statements. Such business, economic and competitive uncertainties include:
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any further increases in raw material, labor, fuel or other input costs, particularly if we are unable to pass these cost increases along to our customers;
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the duration over which our cash balances will fund our operations;
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our ability to continue as a going concern;
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our ability to obtain additional financing and raise capital as necessary to fund operations or pursue business opportunities;
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our ability to satisfy the covenants in our supply agreements;
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our expectations regarding our ability to enter into marketing and other partnership agreements, including amendments to our existing agreements;
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our ability to comply with affirmative and negative covenants under our secured loan with Innovatus Life Sciences Lending Fund I, LP;
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the effects of the COVID-19 pandemic on patients, our customers and distributors, and our business, including manufacturing operations and suppliers, as well as the actions by governments, businesses and individuals in response to the pandemic;
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the acceptance of our products by doctors, patients or payors;
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the availability of adequate reimbursement for our products from insurance companies and the government;
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our ability to use existing inventory before shelf life expiration;
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the safety and efficacy of our products;
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our expectations regarding the timing of submissions to, and decisions made by, the U.S. Food and Drug Administration, and other regulatory agencies, including foreign regulatory agencies;
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our ability to secure adequate protection for, and licensure of, our intellectual property;
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our estimates regarding the capacity of manufacturing and other facilities to support our products;
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our ability to successfully commercialize our products;
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the rate and degree of market acceptance and clinical utility of our products;
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our ability to obtain and/or retain major customers and distributors;
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our ability to compete against other companies and research institutions;