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What changed in EyePoint, Inc.'s 10-K — 2023 vs 2024

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Paragraph-level year-over-year comparison of EyePoint, Inc.'s 2023 and 2024 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2024 report.

+556 added−570 removedSource: 10-K (2025-03-06) vs 10-K (2024-03-08)

Top changes in EyePoint, Inc.'s 2024 10-K

556 paragraphs added · 570 removed · 397 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

167 edited+62 added−81 removed233 unchanged
Biggest changeThe key elements of our strategy include: • Advance EYP-1901 through Phase 3 clinical development for wet AMD, NPDR and DME • Advance EYP-1901 into clinical trials in additional indications, potentially including myopic choroidal neovascularization (CNV) and retinal vein occlusion (RVO) • Advance EYP-2301 into clinical development for serious retinal diseases • Expand product pipeline through in-license, partnership or acquisition with initial focus on molecules that can be delivered using our Durasert ® technology. • Leverage our drug delivery technologies through research collaborations and out-licenses with other pharmaceutical and biopharmaceutical companies, institutions and other organizations.
Biggest changeThe key elements of our strategy include: • Advance DURAVYU™ through Phase 3 clinical development for wet AMD • Plan Phase 3 for DURAVYU™ in DME after EOP2 meeting with FDA • Advance DURAVYU™ into clinical trials in additional indications • Leverage our new state-of-the-art manufacturing facility to support the Company’s next phase of growth • Advance EYP-2301 into clinical development for serious retinal diseases • Expand product pipeline through in-license, partnership or acquisition with focus on molecules that can utilize our Durasert ® technology • Leverage our drug delivery technologies through research collaborations and out-licenses with other pharmaceutical and biopharmaceutical companies, institutions and other organizations The Unmet Need in the Treatment of Retinal Eye Disease – Duration of Action and a New Mechanism of Action (MOA) We are committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases leveraging our best-in-class sustained delivery Durasert ® technology, including bioerodible Durasert E™.
Once the FDA accepts for filing an ANDA or 505(b)(2) application containing a Paragraph IV certification, the applicant must within 20 days provide notice to the RLD NDA holder and patent owner that the application has been submitted and provide the 20 factual and legal basis for the applicant’s assertion that the patent is invalid or not infringed.
Once the FDA accepts for filing an ANDA or 505(b)(2) application containing a Paragraph IV certification, the applicant must within 20 days provide notice to the RLD NDA holder and patent owner that the application has been submitted and provide the factual and legal basis for the applicant’s assertion that the patent is invalid or not infringed.
An NDA under Section 505(b)(1) of the FD&C Act is a comprehensive application to support approval of a product candidate that includes, among other things, data and information to demonstrate that the proposed drug is safe and effective for its proposed uses, that production methods are adequate to ensure its identity, strength, quality, and purity of the drug, and that proposed labeling is appropriate and contains all necessary information.
An NDA under Section 505(b)(1) of the FD&C Act is a comprehensive application to support approval of a product candidate that includes, among other things, data and information to demonstrate that the proposed drug is safe and effective for its proposed uses, that production methods are adequate to ensure its identity, strength, quality, and purity of the drug, and that proposed labeling is 18 appropriate and contains all necessary information.
It is possible that the Affordable Care Act, as currently enacted or as it may be amended in the future, and other healthcare reform measures, including those that may be adopted in the future, could have a material adverse effect on our industry generally and on our ability to maintain or increase sales of our products or product candidates for which we receive regulatory approval or to successfully commercialize our products and product candidates.
It is possible that the Affordable Care Act, as currently enacted or as it may be amended in the future, and other healthcare reform measures, including those that may be adopted in the future, could have a material adverse effect on our industry generally and on our ability to maintain or increase sales of our product candidates for which we receive regulatory approval or to successfully commercialize our product candidates.
Healthcare Privacy Laws We may be subject to federal, state, and foreign laws and regulations governing data privacy and security of health information, and the collection, use, disclosure, and protection of health-related and other personal information, including state data breach notification laws, state health information and/or genetic privacy laws, and federal and state consumer protection laws, such as Section 5 of the FTC Act, many of which differ from each other in significant ways, thus complicating compliance efforts.
Healthcare Privacy Laws We may be subject to federal, state, and foreign laws and regulations governing data privacy and security of health information, and the collection, use, disclosure, and protection of health-related and other personal information, including state data breach notification laws, state health information and/or genetic privacy laws, and federal and state consumer protection laws, such as Section 5 of the FTC Act and the Health Breach Notification Rule, many of which differ from each other in significant ways, thus complicating compliance efforts.
As a result, increasingly high barriers are being erected to the entry of new products. In addition, we may face competition for our product candidates from lower-priced products in foreign countries that have placed price controls on pharmaceutical products. In addition, in some countries, cross-border imports from low-priced markets exert a commercial pressure on pricing within a country.
As a result, increasingly high barriers are being erected to the entry of new products. In addition, we may face competition for our product candidates from lower-priced 28 products in foreign countries that have placed price controls on pharmaceutical products. In addition, in some countries, cross-border imports from low-priced markets exert a commercial pressure on pricing within a country.
The process of obtaining regulatory marketing approvals and the subsequent compliance with appropriate federal, state, local, and foreign statutes and regulations require the expenditure of substantial time and financial resources and may not be successful. Development and Approval Under the FD&C Act, FDA approval of an NDA is required before any new drug can be marketed in the U.S.
The process of obtaining regulatory marketing approvals and the subsequent compliance with appropriate federal, state, local, and foreign statutes and regulations require the expenditure of substantial time and financial resources and may not be successful. 17 Development and Approval Under the FD&C Act, FDA approval of an NDA is required before any new drug can be marketed in the U.S.
In addition to competitive base salaries, these programs include annual discretionary bonuses, equity awards, a 401(k) plan and employer match, an employee stock purchase program, tax advantaged health savings and flexible spending accounts, paid time off, family leave and flexible work schedules, among others. Our broad-based equity programs includes all employees.
In addition to competitive base salaries, these programs include annual discretionary bonuses, equity awards, a 401(k) plan and employer match, an employee stock purchase program, tax advantaged health savings and flexible spending accounts, paid time off, family leave and flexible work schedules, among others. Our broad-based equity programs include all employees.
Civil monetary penalties could also be applied if we are found to have charged 340B covered entities more than the statutorily mandated ceiling price or HRSA could terminate our agreement to participate in the 340B program, in which case federal payments may not be available under Medicaid or Medicare Part B for our covered outpatient drugs.
Civil monetary penalties could also be applied if we are found to have charged 340B covered entities more than the statutorily mandated ceiling price or HRSA could terminate an agreement to participate in the 340B program, in which case federal payments may not be available under Medicaid or Medicare Part B for our covered outpatient drugs.
Our issued patents cover DEXYCU ® until at least May 2034 and cover the injection dosing guides until at least June of 2039. Human Capital Resources To achieve our Company goals, it is critical to attract and retain top talent with experience in clinical development, regulatory, manufacturing and other functional areas crucial to executing on our strategy.
Our issued patents cover DEXYCU ® until at least May 2034 and cover the injection dosing guides until at least June of 2039. Human Capital Resources To achieve our Company goals, it is critical to attract and retain top talent with experience in clinical development, regulatory, research, manufacturing and other functional areas crucial to executing on our strategy.
European/UK data protection laws, including the GDPR, generally restrict the transfer of personal data from the European Economic Area (EEA), including the EU, United Kingdom and Switzerland, to the U.S. and most other countries (except those deemed to be adequate by the European Commission/UK Secretary of State as applicable) unless the parties to the transfer have implemented specific safeguards to protect the transferred personal data.
European/UK data protection laws, including the GDPR, generally restrict the transfer of personal data from the European Economic Area (EEA), United Kingdom and Switzerland, to the U.S. and most other countries (except those deemed to be adequate by the European Commission/UK Secretary of State as applicable) unless the parties to the transfer have implemented specific safeguards to protect the transferred personal data.
ITEM 1. B USINESS Overview EyePoint Pharmaceuticals (Nasdaq: EYPT) is a clinical-stage biopharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious retinal diseases. The Company's pipeline leverages its proprietary bioerodible Durasert E ™ technology (Durasert E ™ ) for sustained intraocular drug delivery.
ITEM 1. B USINESS Overview EyePoint Pharmaceuticals (Nasdaq: EYPT) is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to help improve the lives of patients with serious retinal diseases. The Company's pipeline leverages its proprietary bioerodible Durasert E™ technology (Durasert E™) for sustained intraocular drug delivery.
Medicare Part D prescription drug plans may use formularies to limit the number of drugs that will be covered in any therapeutic class and/or impose differential cost sharing or other utilization management techniques. 26 Medicare Part D coverage may be available for any future product candidates for which we receive marketing approval and commercialize.
Medicare Part D prescription drug plans may use formularies to limit the number of drugs that will be covered in any therapeutic class and/or impose differential cost sharing or other utilization management techniques. Medicare Part D coverage may be available for any future product candidates for which we receive marketing approval and commercialize.
By offering needs-based supplemental training, management development and effective communications training our employee satisfaction scores have increased. We survey our employees on a regular basis and report the results of those surveys back to management and our board of directors. 14 As a company our success is rooted in the diversity of our teams and our commitment to inclusion.
By offering needs-based supplemental training, management development and effective communications training our employee satisfaction scores have increased. We survey our employees on a regular basis and report the results of those surveys back to management and our board of directors. As a company our success is rooted in the diversity of our teams and our commitment to inclusion.
The federal civil False Claims Act prohibits any person from, among other things, knowingly presenting, or causing to be presented, a false or fraudulent claim for payment of government funds, or knowingly making, using, or causing to be made or used, a false record or statement material to an obligation to pay money to the government or knowingly concealing or knowingly and 28 improperly avoiding, decreasing, or concealing an obligation to pay money to the federal government.
The federal civil False Claims Act prohibits any person from, among other things, knowingly presenting, or causing to be presented, a false or fraudulent claim for payment of government funds, or knowingly making, using, or causing to be made or used, a false record or statement material to an obligation to pay money to the government or knowingly concealing or knowingly and improperly avoiding, decreasing, or concealing an obligation to pay money to the federal government.
Our principal executive office is located at 480 Pleasant Street, Suite C400, Watertown, Massachusetts 02472, and our telephone number is (617) 926-5000. Additional Information Our website address is www.eyepointpharma.com . Information contained on, or connected to, our website is not incorporated by reference into this Annual Report on Form 10-K.
Our principal executive office is located at 480 Pleasant Street, Suite C400, Watertown, Massachusetts 02472, and our telephone number is (617) 926-5000. 31 Additional Information Our website address is www.eyepointpharma.com . Information contained on, or connected to, our website is not incorporated by reference into this Annual Report on Form 10-K.
Although we are not directly subject to HIPAA, other than potentially with respect to providing 29 certain employee benefits, we could be subject to criminal penalties if we or our affiliates or agents knowingly obtain individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA.
Although we are not directly subject to HIPAA, other than potentially with respect to providing certain employee benefits, we could be subject to criminal penalties if we or our affiliates or agents knowingly obtain individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA.
We may obtain health information from third parties that are subject to privacy and security requirements under HIPAA and we could potentially be subject to criminal penalties if we, our affiliates, or our agents knowingly obtain individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA.
We may obtain health information from third parties that are subject to privacy and 29 security requirements under HIPAA and we could potentially be subject to criminal penalties if we, our affiliates, or our agents knowingly obtain individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA.
The Company retained rights under the Company’s intellectual property to, among other things, conduct clinical trials on the Licensed Product in the Betta Field in the Betta Territory. 10 In consideration for the rights granted by the Company, Betta agreed to pay the Company tiered, mid-to-high single-digit royalties based upon annual net sales of Licensed Products in the Betta Territory.
The Company retained rights under the Company’s intellectual property to, among other things, conduct clinical trials on the Licensed Product in the Betta Field in the Betta Territory. In consideration for the rights granted by the Company, Betta agreed to pay the Company tiered, mid-to-high single-digit royalties based upon annual net sales of Licensed Products in the Betta Territory.
The main regulatory standard for ensuring pharmaceutical quality is the Current Good Manufacturing Practice (cGMPs) regulation for human pharmaceuticals. Manufacturing of our clinical trial materials (CTM) and of our commercial products is subject to these cGMPs which govern record-keeping, manufacturing processes 11 and controls, personnel, quality control and quality assurance, among other activities.
The main regulatory standard for ensuring pharmaceutical quality is the Current Good Manufacturing Practice (cGMPs) regulation for human pharmaceuticals. Manufacturing of our clinical trial materials (CTM) and of our commercial products is subject to these cGMPs which govern record-keeping, manufacturing processes and controls, personnel, quality control and quality assurance, among other activities.
Even if such additional information and data are submitted, the FDA may decide that the NDA still does not meet the standards for approval. Data from clinical trials are not always conclusive and the FDA may interpret data differently than the sponsor. FDA approval of any application 18 may include many delays or never be granted.
Even if such additional information and data are submitted, the FDA may decide that the NDA still does not meet the standards for approval. Data from clinical trials are not always conclusive and the FDA may interpret data differently than the sponsor. FDA approval of any application may include many delays or never be granted.
The actual protection afforded by a patent, which can vary from country to country, depends upon the type of patent, the scope of its coverage, and the availability of legal remedies in the country. Patent term 13 extension may be available in various countries to compensate for a patent office delay or a regulatory delay in approval of the product.
The actual protection afforded by a patent, which can vary from country to country, depends upon the type of patent, the scope of its coverage, and the availability of legal remedies in the country. Patent term extension may be available in various countries to compensate for a patent office delay or a regulatory delay in approval of the product.
The sponsoring company, the FDA, or the IRB may suspend or terminate a clinical trial at any time on various grounds, including a finding that the patients are being exposed to an unacceptable health risk. Further, success in early-stage clinical trials does 17 not assure success in later-stage clinical trials.
The sponsoring company, the FDA, or the IRB may suspend or terminate a clinical trial at any time on various grounds, including a finding that the patients are being exposed to an unacceptable health risk. Further, success in early-stage clinical trials does not assure success in later-stage clinical trials.
This date range is estimated and based on certain assumptions, including that certain applications will be granted, all necessary fees will be paid and no terminal disclaimers or other limitations on expiration are required for certain patents or applications. The latest expiring U.S patent listed in the U.S.
This date range is estimated and based on certain 14 assumptions, including that certain applications will be granted, all necessary fees will be paid and no terminal disclaimers or other limitations on expiration are required for certain patents or applications. The latest expiring U.S patent listed in the U.S.
A major public health interest defined by three cumulative criteria: (i) the seriousness of the disease (for example, heavy disabling or life-threatening diseases) to be treated, (ii) the absence or insufficiency of 21 an appropriate alternative therapeutic approach, and (iii) anticipation of high therapeutic benefit.
A major public health interest defined by three cumulative criteria: (i) the seriousness of the disease (for example, heavy disabling or life-threatening diseases) to be treated, (ii) the absence or insufficiency of an appropriate alternative therapeutic approach, and (iii) anticipation of high therapeutic benefit.
Incoming raw materials and components from suppliers are inspected upon arrival according to pre-specified criteria prior to use in the CTM or the commercial product. During product manufacture, in-process tests are conducted on intermediate products according to pre-specified criteria; testing is finally conducted on the finished product prior to its release.
Incoming raw materials and components from suppliers are inspected upon arrival according to pre-specified criteria prior to use in the CTM or the commercial product. During 12 product manufacture, in-process tests are conducted on intermediate products according to pre-specified criteria; testing is finally conducted on the finished product prior to its release.
The maximum period of restoration is five years, and the patent cannot be extended to more than 14 years from the date of FDA approval of the product. Only one patent claiming each approved product is eligible for restoration and the patent holder must apply for restoration within 60 days of approval. The U.S.
The maximum period of restoration is five years, and the patent cannot be extended to more than 14 years from the date of 21 FDA approval of the product. Only one patent claiming each approved product is eligible for restoration and the patent holder must apply for restoration within 60 days of approval. The U.S.
On July 10, 2017, we entered into an amended and restated collaboration agreement with Alimera (the Amended Alimera Agreement), pursuant to which we (i) expanded the license to Alimera to our proprietary Durasert ® sustained-release drug delivery technology platform to include uveitis, including chronic non-infectious uveitis affecting the posterior segment of the eye, in EMEA and (ii) converted the net profit share arrangement for each licensed product (including ILUVIEN) under the original collaboration agreement with Alimera (the Prior Alimera Agreement) to a sales-based royalty on a calendar quarter basis commencing July 1, 2017, with payments from Alimera due 60 days following the end of each calendar quarter.
On July 10, 2017, we entered into an amended and restated collaboration agreement with ANI (the Amended ANI Agreement), pursuant to which we (i) expanded the license to ANI to our proprietary Durasert ® sustained-release drug delivery technology platform to include uveitis, including chronic non-infectious uveitis affecting the posterior segment of the eye, in EMEA and (ii) converted the net profit share arrangement for each licensed product (including ILUVIEN) under the original collaboration agreement with ANI (the Prior ANI Agreement) to a sales-based royalty on a calendar quarter basis commencing July 1, 2017, with payments from ANI due 60 days following the end of each calendar quarter.
The 340B program, which is administered by the Health Resources and Services Administration, or HRSA, requires participating manufacturers to agree to charge statutorily defined covered entities no more than the 340B “ceiling price” for 25 the manufacturer’s covered outpatient drugs.
The 340B program, which is administered by the Health Resources and Services Administration, or HRSA, requires participating manufacturers to agree to charge statutorily defined covered entities no more than the 340B “ceiling price” for the manufacturer’s covered outpatient drugs.
Such claims are to be resolved through an ADR panel of government officials rendering a decision that may be appealed to federal court. An ADR proceeding could subject us to onerous procedural requirements and could result in additional liability.
Such claims are to be resolved through an ADR panel of 26 government officials rendering a decision that may be appealed to federal court. An ADR proceeding could subject us to onerous procedural requirements and could result in additional liability.
Part D prescription drug plan sponsors are not required to pay for all covered Part D drugs, and each drug plan can develop its own drug formulary that identifies which drugs it will cover and at what tier or level.
Part D prescription drug plan sponsors are not required to pay for all covered Part D drugs, and each drug plan generally can develop its own drug formulary that identifies which drugs it will cover and at what tier or level.
The GDPR regulates the processing of personal data (including health data from clinical trials) and places certain obligations on the processing of such personal data including ensuring the lawfulness of processing personal data (including obtaining valid consent of the individuals to whom the personal data relates, where applicable), the processing details disclosed to the individuals, the adequacy, relevance and necessity of the personal data collected, the retention of personal data collected, the sharing of personal data with third parties, the transfer of personal data out of the European Economic Area/UK to third countries including the U.S., contracting requirements (such as with clinical trial sites and vendors), the use of personal data in accordance with individual rights, the security of personal data and security breach/incident notifications.
The GDPR regulates the processing of personal data (including health data from clinical trials) and places certain obligations on the processing of such personal data including ensuring the lawfulness of processing personal data (including obtaining valid consent of the individuals to whom the personal data relates, where applicable), the processing details disclosed to the individuals, the adequacy, relevance and necessity of the personal data collected, the retention of personal data collected, the sharing of personal data with third parties, the transfer of personal data out of the European Economic Area/UK to third countries including the U.S., contracting requirements (such as with clinical trial sites and vendors), the use of personal data in accordance with individual rights, the security of personal data and cybersecurity incident notifications.
On July 10, 2023, the European Commission adopted its 30 adequacy decision for the EU-U.S. Data Privacy Framework, meaning that personal data can now flow freely from the E.U. to U.S. companies that participate in the Data Privacy Framework.
On July 10, 2023, the European Commission adopted its adequacy decision for the EU-U.S. Data Privacy Framework, meaning that personal data can now flow freely from the E.U. to U.S. companies that participate in the Data Privacy Framework.
Our patents generally cover the design, formulation, manufacturing methods, and use of our sustained release therapeutics, devices and technologies. For example, we own and/or license U.S. and foreign patents and patent applications for our DURASERT ® technology and our VERISOME ® technology.
Our patents generally cover the design, formulation, manufacturing methods, and use of our sustained release therapeutics, devices and technologies. For example, we own and/or license U.S. and foreign patents and patent applications for our Durasert ® technology.
A generic version of an approved drug is approved by means of an abbreviated NDA, or ANDA, by which the sponsor demonstrates that the proposed product is the same as the approved, brand-name drug, which is referred to as the reference listed drug (RLD).
Generic Drugs. A generic version of an approved drug is approved by means of an abbreviated NDA, or ANDA, by which the sponsor demonstrates that the proposed product is the same as the approved, brand-name drug, which is referred to as the reference listed drug (RLD).
The lower limit of the non-inferiority margin is defined as a -4.5 letters by the FDA with 5 letters representing one line on the eye chart. • Continued positive safety and tolerability profile with no EYP-1901-related ocular or systemic SAEs. • 89% and 85% reduction in treatment burden, respectively, for the 2mg and 3mg EYP-1901 doses, when comparing the injections in the 6 months prior to entry into the study vs. the injections administered during the study following EYP-1901 dosing. • 65% and 64% of eyes were supplement free up to six-months, respectively, for the 2mg and 3mg doses of EYP-1901. • Both EYP-1901 doses demonstrated strong anatomic control with OCT difference below 10 microns at week 32 compared to the aflibercept control. • Patient discontinuation up to week 32 was low at 4% with no EYP-1901 related discontinuation.
The lower limit of the non-inferiority margin is defined as a -4.5 letters by the FDA with 5 letters representing one line on the eye chart. • Continued positive safety and tolerability profile with no DURAVYU™-related ocular or systemic SAEs. • 89% and 85% reduction in treatment burden, respectively, for the 2mg and 3mg DURAVYU™ doses, when comparing the injections in the 6 months prior to entry into the study vs. the injections administered during the study following DURAVYU™ dosing. • 65% and 64% of eyes were supplement free up to six-months, respectively, for the 2mg and 3mg doses of DURAVYU™. • Both DURAVYU™ doses demonstrated strong anatomic control with OCT difference below 10 microns at week 32 compared to the aflibercept control. • Patient discontinuation up to week 32 was low at 4% with no DURAVYU™ related discontinuation.
Unlike the centralized authorization procedure, the decentralized marketing authorization procedure requires a separate application to, and leads to separate approval by, the competent authorities of each EU Member State in which the product is to be marketed.
Unlike the centralized authorization procedure, the decentralized marketing authorization procedure requires a separate application to, and leads to separate approval by, the competent authorities of each EU Member State in which the product is to be 22 marketed.
Medicare program, outpatient prescription drugs may be covered under Medicare Part D. Medicare Part D is a voluntary prescription drug benefit, through which Medicare beneficiaries may enroll in prescription drug plans offered by private entities for coverage of outpatient prescription drugs.
Medicare program, certain outpatient prescription drugs may be covered under Medicare Part D. Medicare Part D is a voluntary prescription drug benefit, through which Medicare beneficiaries may enroll in prescription drug plans offered by private entities for coverage of certain outpatient prescription drugs.
The governments of the EU Member States influence the price of pharmaceutical products through their pricing and reimbursement rules and control of national healthcare systems that fund a large part of the cost of 27 those products to consumers.
The governments of the EU Member States influence the price of pharmaceutical products through their pricing and reimbursement rules and control of national healthcare systems that fund a large part of the cost of those products to consumers.
Although the discussion below 16 focuses on regulation in the U.S., we currently out-license certain of our products and may seek approval for, and market, other products in other countries in the future.
Although the discussion below focuses on regulation in the U.S., we currently out-license certain of our products and may seek approval for, and market, other products in other countries in the future.
Under the Betta License Agreement, the Company granted to Betta an exclusive, sublicensable, royalty-bearing license under certain of the Company’s intellectual property to develop, use (but not make or have made), sell, offer for sale, and import the Company’s product candidate, EYP-1901, an investigational sustained delivery intravitreal anti-VEGF treatment that combines a bioerodible formulation of the Company’s proprietary sustained-release technology with the compound vorolanib (the Licensed Product), in the field of ophthalmology (the Betta Field) in the Greater Area of China, including China, the Hong Kong Special Administrative Region, the Macau Special Administrative Region, and Taiwan (the Betta Territory).
Under the Betta License Agreement, the Company granted to Betta an exclusive, sublicensable, royalty-bearing license under certain of the Company’s intellectual property to develop, use (but not make or have made), sell, offer for sale, and import the Company’s product candidate, DURAVYU™, an investigational sustained delivery intravitreal anti-VEGF treatment that combines a bioerodible formulation of the Company’s proprietary sustained-release technology with the compound vorolanib (the Licensed Product), in the field of ophthalmology (the Betta Field) in the Greater Area of China, including China, the Hong Kong Special Administrative Region, the Macau Special Administrative Region, and Taiwan (the Betta Territory).
Healthcare Reform The Patient Protection and Affordable Care Act, as amended, which we refer to as the Affordable Care Act is a sweeping measure intended to expand healthcare coverage within the U.S., primarily through the imposition of health insurance mandates on employers and individuals, the provision of subsidies to eligible individuals enrolled in plans offered on the health insurance exchanges, and expansion of the Medicaid program.
Healthcare Reform The Patient Protection and Affordable Care Act, as amended, which we refer to as the Affordable Care Act, is a sweeping measure intended to expand healthcare coverage within the U.S., primarily through the imposition of certain health insurance mandates, the provision of subsidies to eligible individuals enrolled in plans offered on the health insurance exchanges, and expansion of the Medicaid program.
Alimera’s share of contingently recoverable accumulated ILUVIEN commercialization losses under the Prior Alimera Agreement, capped at $25 million, are to be reduced as follows: (i) $10.0 million was cancelled in lieu of an upfront license fee on the effective date of the Amended Alimera Agreement; (ii) for calendar years 2019 and 2020, 50% of earned sales-based royalties in excess of 2% will be offset against the quarterly royalty payments otherwise due from Alimera; (iii) in March 2020, another $5 million was cancelled upon Alimera’s receipt of regulatory approval for ILUVIEN for the uveitis indication; and (iv) commencing in calendar year 2021, 20% of earned sales-based royalties in excess of 2% will be offset against the quarterly royalty payments due from Alimera until such time as the balance of the original $25 million of recoverable commercialization losses has been fully recouped.
ANI's share of contingently recoverable accumulated ILUVIEN commercialization losses under the Prior ANI Agreement, capped at $25 million, are to be reduced as follows: (i) $10.0 million was cancelled in lieu of an upfront license fee on the effective date of the Amended ANI Agreement; (ii) for calendar years 2019 and 2020, 50% of earned sales-based royalties in excess of 2% will be offset against the quarterly royalty payments otherwise due from ANI; (iii) in March 2020, another $5 million was cancelled upon ANI's receipt of regulatory approval for ILUVIEN for the uveitis indication; and (iv) commencing in calendar year 2021, 20% of earned sales-based royalties in excess of 2% will be offset against the quarterly royalty payments due from ANI until such time as the balance of the original $25 million of recoverable commercialization losses has been fully recouped.
The acquired Aerpio patent portfolio now includes approximately 150 U.S. or ex-U.S. patents and pending applications that claim compositions of matter, pharmaceutical compositions and/or methods of use for both small molecule and mono and bi-specific antibody inhibitors of the protein tyrosine phosphatase (VE-PTP). One of the small molecules is razuprotafib.
The acquired Aerpio patent portfolio now includes approximately 155 U.S. or ex-U.S. patents and pending applications that claim compositions of matter, pharmaceutical compositions and/or methods of use for both small molecule and mono and bi-specific antibody inhibitors of the protein tyrosine phosphatase (VE-PTP). One of the small molecules is razuprotafib.
This PIP covers all subsets in a pediatric population, unless the EMA has granted either, a product-specific waiver, a class waiver, or a deferral for one or more of the measures included in the PIP. Where all measures provided in the agreed PIP are completed, a six-month extension period of qualifying Supplementary Protection Certificates is granted.
This PIP 23 covers all subsets in a pediatric population, unless the EMA has granted either, a product-specific waiver, a class waiver, or a deferral for one or more of the measures included in the PIP. Where all measures provided in the agreed PIP are completed, a six-month extension period of qualifying Supplementary Protection Certificates (SPC) is granted.
DEXYCU ® DEXYCU ® (dexamethasone intraocular suspension) 9%, for intraocular administration, was approved by the FDA in February 2018 for the treatment of post-operative ocular inflammation and commercially launched in the U.S. in March 2019 with a primary focus on its use immediately following cataract surgery.
Our Approved Product DEXYCU ® DEXYCU ® (dexamethasone intraocular suspension) 9%, for intraocular administration, was approved by the FDA in February 2018 for the treatment of post-operative ocular inflammation and commercially launched in the U.S. in March 2019 with a primary focus on its use immediately following cataract surgery.
In addition, legislation may be introduced that, if passed, would further expand the 340B program to additional covered entities or would require participating manufacturers to agree to provide 340B discounted pricing on drugs used in an inpatient setting.
In addition, legislation may be introduced that, if passed, would, for example, further expand the 340B program to additional covered entities or would require participating manufacturers to agree to provide 340B discounted pricing on drugs used in an inpatient setting.
In addition, claims submitted to federally-funded healthcare programs, such as Medicare and Medicaid, for drugs priced based on incorrect pricing data provided by a manufacturer can implicate the federal civil False Claims Act. Civil monetary penalties could be due if we fail to offer discounts to beneficiaries under the Medicare Part D coverage gap discount program.
In addition, claims submitted to federally-funded healthcare programs, such as Medicare and Medicaid, for drugs priced based on incorrect pricing data provided by a manufacturer can implicate the federal civil False Claims Act. Civil monetary penalties could be due if a manufacturer fails to offer discounts to beneficiaries under the Medicare Part D coverage gap discount program.
Product Distribution Channel We previously established a distribution channel in the United States for the commercialization of YUTIQ ® and DEXYCU ® that provided physicians with several options for ordering our products. This includes agreements with a nationally recognized third-party logistics provider (3PL), several distributors, and a specialty pharmacy provider for physicians who prefer to use a traditional buy-and-bill model.
Product Distribution Channel We previously established a distribution channel in the United States for the commercialization of DEXYCU ® that provided physicians with several options for ordering our products. This included agreements with a nationally recognized third-party logistics provider (3PL), several distributors, and a specialty pharmacy provider for physicians who prefer to use a traditional buy-and-bill model.
Originally designed to enroll 144 patients, the trial enrolled 160 patients in total due to strong investigator and patient interest. All enrolled patients were previously treated with a standard-of-care anti-VEGF therapy and were randomly assigned to one of two doses of EYP-1901 (approximately 2 mg or 3 mg) or an aflibercept control.
Originally designed to enroll 144 patients, the trial enrolled 160 patients in total due to strong investigator and patient interest. All enrolled patients were previously treated with a standard-of-care anti-VEGF therapy and were randomly assigned to one of two doses of DURAVYU™ (approximately 2 mg or 3 mg) or an aflibercept control.
The VERONA DME Phase 2 clinical trial, is a three arm trial with two separate doses of EYP-1901 and an aflibercept control. VERONA is evaluating EYP-1901 as a potential six-month treatment in previously treated DME patients. The two EYP-1901 doses are administered as a single injection on Day 1 following the aflibercept injection on the same visit.
The VERONA DME Phase 2 clinical trial is a three arm trial with two separate doses of DURAVYU™ and an aflibercept control. VERONA is evaluating DURAVYU™ as a potential six-month treatment in previously treated DME patients. The two DURAVYU™ doses are administered as a single injection on Day 1 following the aflibercept injection on the same visit.
Our systems and our contractors are required to comply with cGMP requirements, and we assess compliance regularly through performance monitoring and audits. EYP-1901 Production, assembly, and packaging of EYP-1901 CTM is done in the Class 10,000 clean rooms located at our Watertown, MA facility.
Our systems and our contractors are required to comply with cGMP requirements, and we assess compliance regularly through performance monitoring and audits. DURAVYU™ Production, assembly, and packaging of DURAVYU™ CTM is done in the Class 10,000 clean rooms located at our Watertown, MA facility.
The last expiring patent covering the vorolanib compound licensed to us by Equinox Science and used in EYP-1901 expires in September 2037, but the Company has filed an additional patent application for EYP-1901 that, if issued, would extend coverage of EYP-1901 until at least 2041.
The last expiring patent covering the vorolanib compound licensed to us by Equinox Science and used in DURAVYU™ expires in September 2037, but the Company has filed an additional patent application for DURAVYU™ that, if issued, would extend coverage of DURAVYU™ until at least 2041.
In addition to retroactive Medicaid rebates and the potential for issuing 340B program refunds, if we are found to have knowingly submitted false AMP, Best Price, or Non-FAMP information to the government, we may be liable for significant civil monetary penalties per item of false information.
In addition to retroactive Medicaid rebates and the potential for issuing 340B program refunds, if we are found to knowingly submit false AMP, Best Price, or Non-FAMP information to the government, we may be liable for significant civil monetary penalties per item of false information.
Further, we are focused on bringing new mechanisms of action to the treatment of disease in addition to the current 6 standard of care. Unlike many chronic diseases that are treated with drugs addressing multiple mechanisms of action, most retinal diseases are currently addressed using a single mechanism of action.
Further, we are focused on bringing a new mechanism of action to the treatments of disease in addition to the current standard of care. Unlike many chronic diseases that are treated with drugs addressing multiple mechanisms of action, most retinal diseases are currently addressed using a single mechanism of action.
EYP-1901 is delivered with a single intravitreal injection in the physician's office, similar to current FDA approved anti-VEGF treatments. The primary non-inferiority efficacy endpoint was change in BCVA compared to the aflibercept control, approximately six-months after the EYP-1901 injection.
DURAVYU™ is delivered with a single intravitreal injection in the physician's office, similar to current FDA approved anti-VEGF treatments. The primary non-inferiority efficacy endpoint was change in BCVA compared to the aflibercept control, approximately six-months after the DURAVYU™ injection.
On December 17, 2020, we sold our interest in royalties payable to us under our license agreement with Alimera in connection with Alimera’s sales of ILUVIEN ® to SWK Funding, LLC (SWK) in exchange for a one-time $16.5 million payment from SWK. Intellectual Property We own or license patents in the U.S. and other countries.
On December 17, 2020, we sold our interest in royalties payable to us under our license agreement with ANI in connection with ANI's sales of ILUVIEN ® to SWK Funding, LLC (SWK) in exchange for a one-time $16.5 million payment from SWK. Intellectual Property We own or license patents in the U.S. and other countries.
These or any other public policy changes could impact the market conditions for our products. We further expect continued scrutiny on government price reporting and pricing more generally from Congress, agencies, and other bodies.
These or any other public policy changes could impact the market conditions for our product candidates. We further expect continued scrutiny on government price reporting and pricing more generally from Congress, agencies, and other bodies.
However, Hispanics are expected to account for the greatest rate of increase, with a nearly six-fold rise in the number of expected cases from 2010 to 2050. Age is the greatest risk factor for developing AMD and individuals aged 50+ are more prone to the disease.
White Americans are expected to continue to account for the majority of cases. However, Hispanics are expected to account for the greatest rate of increase, with a nearly six-fold rise in the number of expected cases from 2010 to 2050. Age is the greatest risk factor for developing AMD and individuals aged 50+ are more prone to the disease.
Statutory or regulatory changes or CMS guidance could affect the pricing of our approved products, and could negatively affect our results of operations.
Statutory or regulatory changes or CMS guidance could affect the pricing of our approved products, once commercialized, and could negatively affect our results of operations.
All four FDA-approved Durasert ® products utilize a non-erodible formulation of Durasert ® . For these products, the drug core matrix is coated with one or more polymer layers, and the permeability of those layers and other design aspects control the rate and duration of drug release.
The four FDA-approved Durasert ® products utilize a non-erodible formulation of Durasert ® . For these products, the insert is coated with one or more polymer layers, and the permeability of those layers and other design aspects control the rate and duration of drug release.
(Kodiak) announced its phase 3 wet AMD GLEAM and GLIMMER studies did not meet their primary efficacy endpoints of showing non-inferior visual acuity gains for tarcocimab dosed every 8 to 24 weeks after 3 monthly loading doses compared to aflibercept.
In July 2023, Kodiak Sciences Inc. (Kodiak) announced its phase 3 wet AMD GLEAM and GLIMMER studies did not meet their primary efficacy endpoints of showing non-inferior visual acuity gains for Tarcocimab dosed every 8 to 24 weeks after 3 monthly loading doses compared to aflibercept.
AXPAXLI (formerly OTX-TKI) – Ocular Therapeutix, Inc. In February 2023, Ocular Therapeutix, Inc. (Ocular Therapeutix) presented 10-month data for OTX-TKI demonstrating a favorable safety and efficacy profile in a controlled Phase 1 trial of patients that were measured dry at screening. OTX-TKI utilizes axitinib, a TKI, formulated in a hydrogel and delivered through an intravitreal injection.
(Ocular Therapeutix) presented 10-month data for OTX-TKI demonstrating a favorable safety and efficacy profile in a controlled Phase 1 trial of patients that were measured dry at screening. OTX-TKI utilizes axitinib, a TKI, formulated in a hydrogel and delivered through an intravitreal injection.
The upward adjustment in the rebate amount per unit is equal to the excess amount of the current AMP over the inflation-adjusted AMP from the first full quarter of sales. Rebates under the Medicaid Drug Rebate Program are no longer subject to a cap as of January 1, 2024, which could increase our rebate liability.
The upward adjustment in the rebate amount per unit is equal to the excess amount of the current AMP over the inflation-adjusted AMP from the first full quarter of sales. Rebates under the Medicaid Drug Rebate Program are no longer subject to a cap as of January 1, 2024.
This included a continuation of a clinically significant reduction in treatment burden of 73% at 12 months. The data also reported that 35% of patients in the trial did not require a supplemental anti-VEGF treatment up-to the twelve-month visit. DAVIO 2 is a multi-center randomized, double-masked controlled Phase 2 clinical trial of EYP-1901 in previously treated patients with wet AMD.
This included a continuation of a clinically significant reduction in treatment burden of 73% at 12 months. The data also reported that 30% of patients in the trial did not require a supplemental anti-VEGF treatment up-to the twelve-month visit. DAVIO 2 was a multi-center randomized, double-masked controlled Phase 2 clinical trial of DURAVYU™ in previously treated patients with wet AMD.
OPT-302 and aflibercept combination therapy yielded the largest proportion of DME patients who gained ≥10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters from baseline to week 12.20 Opthea has initiated phase 3 trials for OPT-302 in combination with and in comparison to ranibizumab and aflibercept for nAMD patients. According to Opthea, these trials are currently enrolling.
OPT-302 and aflibercept combination therapy yielded the largest proportion of DME patients who gained ≥10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters from baseline to week 12. Opthea has initiated phase 3 trials for OPT-302 in combination with, and in comparison, to ranibizumab and aflibercept for nAMD patients.
There are several effective and safe treatments for wet AMD available on the market, including large molecule anti-VEGF intravitreal injectable drugs marketed under the brands names Lucentis, Eylea, Eylea HD, Vabysmo, Beovu, and Avastin (off label use).
There are multiple short acting effective and safe treatments for wet AMD available on the market, including large molecule anti-VEGF intravitreal injectable drugs marketed under the brands names Lucentis, Eylea, Eylea HD, Vabysmo, Beovu, and Avastin (off label).
We have participated in and, if we obtain approval to commercialize additional products, we expect to participate in, and have certain price reporting obligations to, the Medicaid Drug Rebate Program. This program requires us to pay a rebate for each unit of drug reimbursed by Medicaid.
We have participated in and, if we obtain approval to commercialize additional products, we expect to participate in, and would have certain price reporting obligations with respect to, the Medicaid Drug Rebate Program. This program would require us to pay a rebate for each unit of drug reimbursed by Medicaid.
In addition to the safety and efficacy demonstrated in the DAVIO clinical trial, vorolanib has also demonstrated encouraging neuroprotection data in preclinical in-vivo studies potentially bringing an additional treatment benefit.
In addition to the safety and efficacy demonstrated in the DAVIO, DAVIO 2 and VERONA clinical trials, vorolanib has also demonstrated encouraging neuroprotection data in preclinical in-vivo studies potentially bringing an additional treatment benefit.
We embrace our Company culture and strive to foster a collaborative, inclusive, and productive work environment. As of February 29, 2024, we had 121 full-time employees all located in the United States. None of our employees are represented by a collective bargaining agreement and none are represented by labor union.
We embrace our Company culture and strive to foster a collaborative, inclusive, and productive work environment. As of February 28, 2025, we had 165 full-time employees all located in the United States. None of our employees are represented by a collective bargaining agreement and none are represented by labor union.
In addition to FDA approved products, there are a number of investigational treatments in development including the following: REGENXBIO Inc., Adverum Biotechnologies, Inc., 4D Molecular Therapeutics (4DMT), 4D Molecular Therapeutics (4DMT), as well as several others in early development are developing gene therapy treatments for retinal diseases, such as wet AMD and DME.
In addition to FDA approved products, there are multiple investigational treatments in development including the following: REGENXBIO Inc., Adverum Biotechnologies, Inc., 4D Molecular Therapeutics (4DMT), as well as several others in early development are advancing gene therapy treatments for retinal diseases, such as wet AMD and DME.
During fiscal 2023 our voluntary turnover rate was 7.6%, which is below the average voluntary turnover rates for Boston-area biotech companies. The success of our business is fundamentally connected to the well-being of our employees. Accordingly, we are committed to their health, safety, and wellness.
During fiscal 2024 our voluntary turnover rate was 5.31%, which is below the average voluntary turnover rates for Boston-area biotech companies. The success of our business is fundamentally connected to the well-being of our employees. Accordingly, we are committed to their health, safety, and wellness.
The IRA, which, among other things, requires the Secretary of Health and Human Services Secretary to negotiate, with respect to Medicare units and subject to a specified cap, the price of a set number of certain high Medicare spend drugs and biologicals per year starting in 2026.
The IRA, among other things, requires the Secretary of Health and Human Services Secretary to negotiate, with respect to Medicare units and subject to a specified cap, the price of a set number of certain high Medicare spend drugs and biologicals per year with the first negotiated prices taking effect starting in 2026.
These products include YUTIQ ® (fluocinolone acetonide intravitreal implant or FA 0.18 mg) and ILUVIEN (FA intravitreal implant) 0.19 mg, which are both licensed to Alimera Sciences Inc. (Alimera), and Retisert ® (FA intravitreal implant 0.59 mg) and Vitrasert ® (ganciclovir intravitreal implant 4.5 mg), which are both licensed to Bausch & Lomb.
These products include YUTIQ ® (fluocinolone acetonide intravitreal implant or FA 0.18 mg) and ILUVIEN (FA intravitreal implant) 0.19 mg, which are both licensed to ANI, and Retisert ® (FA intravitreal implant 0.59 mg) and Vitrasert ® (ganciclovir intravitreal implant 4.5 mg), which were both licensed to Bausch & Lomb.
Moreover, under a final regulation effective January 13, 2021, HRSA established an administrative dispute resolution (ADR), process for claims by covered entities that a manufacturer has engaged in overcharging, and by manufacturers that a covered entity violated the prohibitions against diversion or duplicate discounts.
Moreover, under final regulations HRSA has established an administrative dispute resolution (ADR) process for claims by covered entities that a manufacturer has engaged in overcharging, and by manufacturers that a covered entity violated the prohibitions against diversion or duplicate discounts.
Our Product Candidates EYP-1901 for wet AMD, NPDR and DME EYP-1901 is an investigational product deploying vorolanib, a selective and patent protected TKI, that potentially brings a new mechanism of action and treatment paradigm for serious eye diseases beyond existing anti-VEGF large molecule ligand blocking therapies. EYP-1901 utilizes our bioerodible Durasert E Ô technology.
Our Product Candidates DURAVYU™ 1 for wet AMD and DME DURAVYU™ is an investigational product deploying vorolanib, a selective and patent protected TKI, that potentially brings a new mechanism of action and treatment paradigm for retinal diseases beyond existing anti-VEGF large molecule ligand blocking therapies. DURAVYU™ utilizes our bioerodible Durasert E™ technology. 1.
In addition, manufacturers are currently required to provide to CMS a 70% discount on brand name prescription drugs utilized by Medicare Part D beneficiaries when those beneficiaries are in the coverage gap phase of the Part D benefit design.
In addition, manufacturers were required to provide to CMS a 70% discount on brand name prescription drugs utilized by Medicare Part D beneficiaries when those beneficiaries are in the coverage gap phase of the Part D benefit design, through December 31, 2024.
The rebate amount is computed each quarter based on our report to CMS of current quarterly AMP and Best Price for our drug. We are required to report revisions to AMP or Best Price within a period not to exceed 12 quarters from the quarter in which the data was originally due.
The rebate amount would be computed each quarter based on our report to CMS of current quarterly AMP and Best Price for our drugs, if commercialized. We would be required to report revisions to AMP or Best Price within a period not to exceed 12 quarters from the quarter in which the data was originally due.
The HTA Regulation provides the basis for permanent and sustainable cooperation at the EU level for joint clinical assessments in these areas and is therefore complementary to Directive 2011/24/EU. The HTA Regulation was finally adopted on December 13, 2021, and entered into force on January 11, 2022.
The HTA Regulation provides the basis for permanent and sustainable cooperation at the EU level for joint clinical assessments in these areas and is therefore complementary to Directive 2011/24/EU. The HTA Regulation was adopted on December 13, 2021, and entered into force on January 11, 2022. The HTA Regulation applies to all EU Member States from January 12, 2025.
HRSA issued a final regulation regarding the calculation of the 340B ceiling price and the imposition of civil monetary penalties on manufacturers that knowingly and intentionally overcharge covered entities, which became effective on January 1, 2019. It is currently unclear how HRSA will apply its enforcement authority under this regulation.
HRSA has issued a final regulation regarding the calculation of the 340B ceiling price and the imposition of civil monetary penalties on manufacturers that knowingly and intentionally overcharge covered entities. It is unclear how HRSA will apply its enforcement authority under this regulation.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

175 edited+63 added−51 removed280 unchanged
Biggest changeWe believe that our cash, cash equivalents and investments in marketable securities, combined with anticipated net cash inflows from net product sales, will fund our operating plan through topline data for the Phase 3 wet AMD clinical trials related to EYP-1901 into 2026, under current expectations regarding the timing and outcomes of our Phase 3 clinical trial for EYP-1901 for the treatment of wet AMD, and through Phase 2 clinical trials for the treatment of NPDR and DME.
Biggest changeAs of December 31, 2024, our cash, cash equivalents, and investments in marketable securities totaled $370.9 million. We believe that our cash, cash equivalents and investments in marketable securities will enable us to fund operations into 2027 beyond topline Phase 3 data for DURAVYU™ in wet AMD , expected in 2026.
Pharmaceutical and other healthcare companies also are subject to other federal false claim laws, including federal criminal healthcare fraud and false statement statutes that extend to non-government health benefit programs. • HIPAA imposes criminal and civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement, in connection with the delivery of, or payment for healthcare benefits, items or services by a healthcare benefit program, which includes both government and privately funded benefits programs; similar to the U.S. federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. • HIPAA, and its implementing regulations, impose certain obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information and impose notification obligations in the event of a breach of the privacy or security of individually identifiable health information. • Numerous federal and state laws and regulations that address privacy and data security, including state data breach notification laws, state health information and/or genetic privacy laws, and federal and state consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act, or FTC Act), govern the collection, use, disclosure and protection of health-related and other personal information, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
Pharmaceutical and other healthcare companies also are subject to other federal false claim laws, including federal criminal healthcare fraud and false statement statutes that extend to non-government health benefit programs. • HIPAA imposes criminal and civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement, in connection with the delivery of, or payment for healthcare benefits, items or services by a healthcare benefit program, which includes both government and privately funded benefits 44 programs; similar to the U.S. federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. • HIPAA, and its implementing regulations, impose certain obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information and impose notification obligations in the event of a breach of the privacy or security of individually identifiable health information. • Numerous federal and state laws and regulations that address privacy and data security, including state data breach notification laws, state health information and/or genetic privacy laws, and federal and state consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act, or FTC Act), govern the collection, use, disclosure and protection of health-related and other personal information, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
The following examples are illustrative: • others may be able to make drug and device components that are the same as or similar to our product candidates but that are not covered by the claims of the patents that we own or have exclusively licensed; • we or any of our licensors or collaborators might not have been the first to make the inventions covered by the issued patent or pending patent application that we own or have exclusively licensed; • we or any of our licensors or collaborators might not have been the first to file patent applications covering certain of our inventions; • others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; • the prosecution of our pending patent applications may not result in granted patents; • granted patents that we own or have licensed may not cover our products or may be held not infringed, invalid or unenforceable, as a result of legal challenges by our competitors; • with respect to granted patents that we own or have licensed, especially patents that we either acquire or in-license, if certain information was withheld from or misrepresented to the patent examiner, such patents might be held to be unenforceable; 53 • patent protection on our product candidates may expire before we are able to develop and commercialize the product, or before we are able to recover our investment in the product; • our competitors might conduct research and development activities in the U.S. and other countries that provide a safe harbor from patent infringement claims for such activities, as well as in countries in which we do not have patent rights, and may then use the information learned from such activities to develop competitive products for sale in markets where we intend to market our product candidates; • we may not develop additional proprietary technologies that are patentable; • the patents of others may have an adverse effect on our business; and • we may choose not to file a patent application for certain technologies, trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property.
The following examples are illustrative: • others may be able to make drug and device components that are the same as or similar to our product candidates but that are not covered by the claims of the patents that we own or have exclusively licensed; • we or any of our licensors or collaborators might not have been the first to make the inventions covered by the issued patent or pending patent application that we own or have exclusively licensed; • we or any of our licensors or collaborators might not have been the first to file patent applications covering certain of our inventions; • others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; • the prosecution of our pending patent applications may not result in granted patents; • granted patents that we own or have licensed may not cover our products or may be held not infringed, invalid or unenforceable, as a result of legal challenges by our competitors; • with respect to granted patents that we own or have licensed, especially patents that we either acquire or in-license, if certain information was withheld from or misrepresented to the patent examiner, such patents might be held to be unenforceable; • patent protection on our product candidates may expire before we are able to develop and commercialize the product, or before we are able to recover our investment in the product; • our competitors might conduct research and development activities in the U.S. and other countries that provide a safe harbor from patent infringement claims for such activities, as well as in countries in which we do not have patent rights, and may then use the information learned from such activities to develop competitive products for sale in markets where we intend to market our product candidates; • we may not develop additional proprietary technologies that are patentable; • the patents of others may have an adverse effect on our business; and • we may choose not to file a patent application for certain technologies, trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property.
In addition, some states have laws requiring pharmaceutical sales representatives to be registered or licensed, and still others impose limits on co-pay assistance that pharmaceutical companies can offer to patients. • The Physician Payments Sunshine Act, implemented as the Open Payments program, and its implementing regulations, require certain manufacturers of drugs, devices, biologics, and medical supplies that are reimbursable under Medicare, 44 Medicaid, or the Children’s Health Insurance Program to report annually to the CMS information related to certain payments made in the preceding calendar year and other transfers of value to physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, certified nurse-midwives, and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.
In addition, some states have laws requiring pharmaceutical sales representatives to be registered or licensed, and still others impose limits on co-pay assistance that pharmaceutical companies can offer to patients. • The Physician Payments Sunshine Act, implemented as the Open Payments program, and its implementing regulations, require certain manufacturers of drugs, devices, biologics, and medical supplies that are reimbursable under Medicare, Medicaid, or the Children’s Health Insurance Program to report annually to the CMS information related to certain payments made in the preceding calendar year and other transfers of value to physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, certified nurse-midwives, and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.
Although we try to ensure that our employees, consultants, independent contractors and advisors do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that these individuals or we have inadvertently or otherwise used or disclosed confidential information and/or intellectual property, including trade secrets or other proprietary information, of the companies that any such individual currently or formerly worked for or provided services to.
Although we try to ensure that our employees, consultants, independent contractors and advisors do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that these individuals or we have inadvertently or otherwise used or disclosed confidential information and/or intellectual property, including trade secrets or other proprietary 53 information, of the companies that any such individual currently or formerly worked for or provided services to.
This will require us to be successful in a range of challenging activities, including completing pre-clinical testing and clinical trials of our product candidates, discovering additional product candidates, obtaining regulatory approval for these product candidates, manufacturing, marketing, and selling any products for which we or our 32 licensees may obtain regulatory approval, satisfying any post-marketing requirements and obtaining reimbursement for our products from private insurance or government payors.
This will require us to be successful in a range of challenging activities, including completing pre-clinical testing and clinical trials of our product candidates, discovering additional product candidates, obtaining regulatory approval for these product candidates, manufacturing, marketing, and selling any products for which we or our licensees may obtain regulatory approval, satisfying any post-marketing requirements and obtaining reimbursement for our products from private insurance or government payors.
We, the FDA, other regulatory authorities outside the United States, or an IRB may suspend a clinical trial at any time for various reasons, including if it appears that the clinical trial is exposing participants to unacceptable health risks or if the FDA or one or more other regulatory authorities outside the United States find deficiencies in our investigational new drug application or similar application outside the United States or the conduct of the trial.
We, the FDA, other regulatory authorities outside the United States, or an IRB may suspend a clinical trial at any time for various reasons, including if it appears that the clinical trial is exposing participants to unacceptable health risks or if the FDA or one or more other regulatory authorities outside the United States find deficiencies in our investigational new drug application or similar 36 application outside the United States or the conduct of the trial.
In addition, guidance on implementation and compliance practices may be issued, updated or otherwise revised. Enforcement by European and UK regulators is generally active, and failure to comply with the GDPR or applicable Member State/UK local law may result in fines, amongst other things (such as notices requiring compliance within a certain timeframe).
In addition, guidance on implementation and compliance practices may be issued, updated or otherwise revised. Enforcement by European and UK regulators is generally active, and failure to comply with the GDPR or applicable Member State/UK local law may result in fines, amongst other things (such as notices requiring 62 compliance within a certain timeframe).
We anticipate that our expenses will continue to be significant if, and as, we: • continue the research and pre-clinical and clinical development of our product candidates, including EYP-1901 and EYP-2301; • initiate additional pre-clinical studies, clinical trials, or other studies or trials for EYP-1901, EYP-2301, and our other product candidates; • add additional operational, financial and management information systems, and personnel, including personnel to support our development and commercialization planning efforts; • continue to perform tasks associated with the ongoing DOJ Subpoena; • hire additional commercial, clinical, manufacturing and scientific personnel, and engage third party commercial, clinical and manufacturing organizations; • further develop the manufacturing process for our product candidates; • change or add additional manufacturers or suppliers; • seek regulatory approvals for our product candidates that successfully complete clinical trials; • seek to identify and validate additional product candidates; • acquire or in-license other products, product candidates, and technologies; • maintain, protect, and expand our intellectual property portfolio; • create additional infrastructure to support our product development and planned future commercial sale efforts; and • experience any delays or encounter issues with any of the above.
We anticipate that our expenses will continue to be significant if, and as, we: • continue the research and pre-clinical and clinical development of our product candidates, including DURAVYU™ and EYP-2301; • initiate additional pre-clinical studies, clinical trials, or other studies or trials for DURAVYU™, EYP-2301, and our other product candidates; • add additional operational, financial and management information systems, and personnel, including personnel to support our development and commercialization planning efforts; • continue to perform tasks associated with the ongoing DOJ Subpoena; • hire additional commercial, clinical, manufacturing and scientific personnel, and engage third party commercial, clinical and manufacturing organizations; • further develop the manufacturing process for our product candidates; • change or add additional manufacturers or suppliers; • seek regulatory approvals for our product candidates that successfully complete clinical trials; • seek to identify and validate additional product candidates; • acquire or in-license other products, product candidates, and technologies; • maintain, protect, and expand our intellectual property portfolio; • create additional infrastructure to support our product development and planned future commercial sale efforts; and • experience any delays or encounter issues with any of the above.
Adverse pricing limitations may hinder our ability to recoup our investment in one or more of our products. Our success also depends in part on the extent to which coverage and reimbursement for our product candidates, once commercialized, and related treatments will be available from government health administration authorities, private health insurers and other organizations.
Adverse pricing limitations may hinder our ability to recoup our investment in one or more of our products. 40 Our success also depends in part on the extent to which coverage and reimbursement for our product candidates, once commercialized, and related treatments will be available from government health administration authorities, private health insurers and other organizations.
We may become party to, or threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to our product candidates, including interference or derivation proceedings before the USPTO. Numerous U.S. and foreign issued patents and pending patent applications owned by third parties exist in the fields in which we are developing our product candidates.
We may become party to, or threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to our product candidates, including interference or derivation proceedings before the USPTO. Numerous U.S. and foreign issued patents and 52 pending patent applications owned by third parties exist in the fields in which we are developing our product candidates.
In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us to license, develop, or commercialize current or future product candidates. We may not be able to protect our intellectual property rights throughout the world.
In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us to license, develop, or commercialize current or future product candidates. 51 We may not be able to protect our intellectual property rights throughout the world.
In these circumstances, we may need to defend or assert our patents by various means, including filing lawsuits alleging patent infringement requiring us to engage in complex, lengthy and costly litigation, or other proceedings. In any of these types of proceedings, a court or government agency with jurisdiction may find our patents invalid, unenforceable or not 52 infringed.
In these circumstances, we may need to defend or assert our patents by various means, including filing lawsuits alleging patent infringement requiring us to engage in complex, lengthy and costly litigation, or other proceedings. In any of these types of proceedings, a court or government agency with jurisdiction may find our patents invalid, unenforceable or not infringed.
In addition, to the extent that we have to file patent litigation in a federal court against a U.S. patent holder, we would be required to initiate the proceeding in the state of incorporation or residency of such entity. With respect to the validity question, for example, we cannot be certain that no invalidating 50 prior art exists.
In addition, to the extent that we have to file patent litigation in a federal court against a U.S. patent holder, we would be required to initiate the proceeding in the state of incorporation or residency of such entity. With respect to the validity question, for example, we cannot be certain that no invalidating prior art exists.
The degree of market acceptance and commercial success of our product candidates will depend on a number of factors, including the following: • the acceptance of our product candidates by patients and the medical community and the availability, perceived advantages and relative cost, safety and efficacy of alternative and competing treatments; • the effectiveness and timeliness of our preclinical studies and clinical trials, and the usefulness of the data; • our ability to obtain reimbursement for our product candidates from third party payors at levels sufficient to support commercial success; • the sufficiency of our existing cash resources into 2026; • our access to needed capital; • the cost effectiveness of our products; • the effectiveness of our distribution strategies and operations; • our ability and the ability of our contract manufacturing organizations, or CMOs, as applicable, to manufacture commercial supplies of our products, to remain in good standing with regulatory agencies, and to develop, validate and maintain commercially viable manufacturing processes that are, to the extent required, compliant with cGMP regulations; • the degree to which the approved labeling supports promotional initiatives for commercial success; • a continued acceptable safety profile of our products; • results from additional clinical trials of our products or further analysis of clinical data from completed clinical trials of our products by us or our competitors; • our ability to enforce our intellectual property rights; • our products’ potential advantages over other therapies; • our ability to avoid third-party patent interference or patent infringement claims; and • maintaining compliance with all applicable regulatory requirements.
The degree of market acceptance and commercial success of our product candidates will depend on a number of factors, including the following: • the acceptance of our product candidates by patients and the medical community and the availability, perceived advantages and relative cost, safety and efficacy of alternative and competing treatments; • the effectiveness and timeliness of our preclinical studies and clinical trials, and the usefulness of the data; • our ability to obtain reimbursement for our product candidates from third party payors at levels sufficient to support commercial success; • the sufficiency of our existing cash into 2027; • our access to needed capital; • the cost effectiveness of our products; • the effectiveness of our distribution strategies and operations; • our ability and the ability of our contract manufacturing organizations, or CMOs, as applicable, to manufacture commercial supplies of our products, to remain in good standing with regulatory agencies, and to develop, validate and maintain commercially viable manufacturing processes that are, to the extent required, compliant with cGMP regulations; • the degree to which the approved labeling supports promotional initiatives for commercial success; • a continued acceptable safety profile of our products; • results from additional clinical trials of our products or further analysis of clinical data from completed clinical trials of our products by us or our competitors; • our ability to enforce our intellectual property rights; • our products’ potential advantages over other therapies; • our ability to avoid third-party patent interference or patent infringement claims; and • maintaining compliance with all applicable regulatory requirements.
The FCP is based on the Non-FAMP, which we calculate and report to the VA on a quarterly and annual basis. We do not currently participate in the Tricare 41 Retail Pharmacy program, under which we would need to pay quarterly rebates on utilization of innovator products that are dispensed through the Tricare Retail Pharmacy network to TRICARE beneficiaries.
The FCP is based on the Non-FAMP, which we calculate and report to the VA on a quarterly and annual basis. We do not currently participate in the Tricare Retail Pharmacy program, under which we would need to pay quarterly rebates on utilization of innovator products that are dispensed through the Tricare Retail Pharmacy network to TRICARE beneficiaries.
These generic equivalents would be significantly less costly than ours to bring to market, and companies that produce generic equivalents are generally able to offer their products at lower prices. Thus, after the introduction of a generic competitor, a significant percentage of the sales of any branded product are typically lost to the generic product.
These generic equivalents would be significantly less costly than ours to bring to market, and companies that produce generic equivalents are generally able to offer their products at lower prices. Thus, after the introduction of a generic competitor, a significant 48 percentage of the sales of any branded product are typically lost to the generic product.
Therefore, we cannot be certain that we were the first to make the inventions claimed in our pending patent applications, that we were the first to file for patent protection of such inventions, or that we have found all of the potentially relevant prior art relating to our patents and patent applications that could invalidate one or more of our patents or prevent one or more of our patent applications from issuing.
Therefore, we cannot be certain that we were the first to make the inventions claimed in our pending patent applications, that we were the first to file for patent protection of such inventions, or that we have found all of the potentially relevant prior art relating 50 to our patents and patent applications that could invalidate one or more of our patents or prevent one or more of our patent applications from issuing.
Any inability on 39 our part to successfully commercialize our product candidates in the U.S. or any foreign territories where they may be approved, or any significant delay in such approvals, could have a material adverse impact on our ability to execute upon our business strategy and our future business prospects.
Any inability on our part to successfully commercialize our product candidates in the U.S. or any foreign territories where they may be approved, or any significant delay in such approvals, could have a material adverse impact on our ability to execute upon our business strategy and our future business prospects.
Misconduct by these employees could include intentional, reckless and/or negligent conduct or unauthorized activity that violates: • FDA regulations, including those laws requiring the reporting of true, complete and accurate information to the FDA; • manufacturing standards; • federal and state healthcare fraud and abuse laws and regulations; or 56 • laws that require the true, complete, and accurate reporting of financial information or data.
Misconduct by these employees could include intentional, reckless and/or negligent conduct or unauthorized activity that violates: • FDA regulations, including those laws requiring the reporting of true, complete and accurate information to the FDA; • manufacturing standards; • federal and state healthcare fraud and abuse laws and regulations; or • laws that require the true, complete, and accurate reporting of financial information or data.
Funds paid in satisfaction of judgments, fines, and expenses may be funds we need for the operation of our business and the development of our product candidates, thereby affecting our ability to attain profitability. 58 GENERAL RISK FACTORS We will need to grow the size of our organization, and we may experience difficulties in managing this growth.
Funds paid in satisfaction of judgments, fines, and expenses may be funds we need for the operation of our business and the development of our product candidates, thereby affecting our ability to attain profitability. GENERAL RISK FACTORS We will need to grow the size of our organization, and we may experience difficulties in managing this growth.
The commencement and completion of clinical trials may be delayed or precluded by a number of factors, including: • decisions not to pursue development of product candidates due to pre-clinical or clinical trial results or market factors; • lack of sufficient funding; • failure to reach agreement with the FDA or other regulatory agency requirements for clinical trial design or scope of the development program; • delays or inability to attract clinical investigators for trials; • clinical sites dropping out of a clinical trial; • time required to add new clinical sites; • delays or inability to recruit patients in sufficient numbers or at the expected rate; • decisions by licensees not to exercise options for products or not to pursue or promote products licensed to them; • adverse side effects; • failure of trials to demonstrate safety and efficacy; • patients’ delays or failure to complete participation in a clinical trial or inability to follow patients adequately after treatment; • changes in the design or manufacture of a product candidate; • failures by, changes in our (or our licensees’) relationship with, or other issues at, CROs, vendors, and investigators responsible for pre-clinical testing and clinical trials; • imposition of a clinical hold following an inspection of our clinical trial operations or trial sites by the FDA or foreign regulatory authorities; • delays or failures in obtaining required IRB approval; • inability to obtain supplies and/or to manufacture sufficient quantities of materials for use in clinical trials, including vorolanib; • our inability to manufacture EYP-1901 to scale, necessary to execute our Phase 3 study in an acceptable time period; • stability issues with clinical materials; • failure to comply with GLP, GCP, cGMP or similar foreign regulatory requirements that affect the conduct of pre-clinical and clinical studies and the manufacturing of product candidates; • requests by regulatory authorities for additional data or clinical trials; • governmental or regulatory agency assessments of pre-clinical or clinical testing that differ from our (or our licensees’) interpretations or conclusions; • governmental or regulatory delays, or changes in approval policies or regulations; and • developments, clinical trial results and other factors with respect to competitive products and treatments, a process which may also create a more competitive environment for patient accrual in clinical trials.
The commencement and completion of clinical trials may be delayed or precluded by a number of factors, including: • decisions not to pursue development of product candidates due to pre-clinical or clinical trial results or market factors; • lack of sufficient funding; • failure to reach agreement with the FDA or other regulatory agency requirements for clinical trial design or scope of the development program; • delays or inability to attract clinical investigators for trials; • clinical sites dropping out of a clinical trial; • time required to add new clinical sites; • delays or inability to recruit patients in sufficient numbers or at the expected rate; • decisions by licensees not to exercise options for products or not to pursue or promote products licensed to them; • adverse side effects; • failure of trials to demonstrate safety and efficacy; • patients’ delays or failure to complete participation in a clinical trial or inability to follow patients adequately after treatment; • changes in the design or manufacture of a product candidate; • failures by, changes in our (or our licensees’) relationship with, or other issues at, CROs, vendors, and investigators responsible for pre-clinical testing and clinical trials; • imposition of a clinical hold following an inspection of our clinical trial operations or trial sites by the FDA or foreign regulatory authorities; • delays or failures in obtaining required IRB approval; • inability to obtain supplies and/or to manufacture sufficient quantities of materials for use in clinical trials, including vorolanib; • our inability to manufacture DURAVYU™ to scale, necessary to execute our Phase 3 clinical trials in an acceptable time period; • stability issues with clinical materials; • failure to comply with GLP, GCP, cGMP or similar foreign regulatory requirements that affect the conduct of pre-clinical and clinical studies and the manufacturing of product candidates; • requests by regulatory authorities for additional data or clinical trials; • governmental or regulatory agency assessments of pre-clinical or clinical testing that differ from our (or our licensees’) interpretations or conclusions; • governmental or regulatory delays, or changes in approval policies or regulations; and • developments, clinical trial results and other factors with respect to competitive products and treatments, a process which may also create a more competitive environment for patient accrual in clinical trials.
Under a Rule 10b5-1 trading plan, a broker executes trades pursuant to parameters established by the employee, director, or officer when entering into the plan, without further direction from the employee, officer, or director. A Rule 10b5-1 trading plan may be amended or terminated in some circumstances.
Under a Rule 10b5-1 trading plan, a broker executes trades pursuant to parameters established by the employee, director, or officer when entering into the plan, without further direction from the 59 employee, officer, or director. A Rule 10b5-1 trading plan may be amended or terminated in some circumstances.
Our failure to submit monthly/quarterly AMP and Best Brice data on a timely basis could result in a significant civil monetary penalty per day for each day the information is late beyond the due date.
Our failure to submit monthly/quarterly AMP and Best Brice data on a timely basis could result in a significant civil monetary penalty per day for 42 each day the information is late beyond the due date.
It is possible that defects of form in the preparation or filing of our patents or patent applications may exist, or may arise in the future, such as with respect to proper priority claims, inventorship, claim scope, or patent term adjustments.
It is possible that defects of form in the preparation or filing of our patents or patent applications may exist, or may arise in the future, such as with respect to proper priority 49 claims, inventorship, claim scope, or patent term adjustments.
Because we have relied on third parties, our internal capacity to perform these functions is limited. Outsourcing these functions involves risks that third parties may not perform to our standards, may not produce results in a timely manner or may fail to perform at all.
Because we have relied on third parties, our internal capacity to perform certain functions is limited. Outsourcing these functions involves risks that third parties may not perform to our standards, may not produce results in a timely manner or may fail to perform at all.
Regardless of merit or eventual outcome, liability claims may result in: • injury to our reputation and significant negative media attention; • termination of clinical trial sites or entire trial programs that we conduct in the future relating to EYP-1901 or our other product candidates; • withdrawal of clinical trial participants from any future clinical trial relating to EYP-1901, and EYP-2301or our other product candidates; • significant costs to defend the related litigation; • substantial money awards to patients; • loss of revenue; • diversion of management and scientific resources from our business operations; and • an increase in product liability insurance premiums or an inability to maintain product liability insurance coverage.
Regardless of merit or eventual outcome, liability claims may result in: • injury to our reputation and significant negative media attention; • termination of clinical trial sites or entire trial programs that we conduct in the future relating to DURAVYU™ or our other product candidates; • withdrawal of clinical trial participants from any future clinical trial relating to DURAVYU™, and EYP-2301or our other product candidates; • significant costs to defend the related litigation; • substantial money awards to patients; • loss of revenue; • diversion of management and scientific resources from our business operations; and • an increase in product liability insurance premiums or an inability to maintain product liability insurance coverage.
The GDPR regulates the processing of personal data (including health data from clinical trials) and places certain obligations on the processing of personal data including ensuring the lawfulness of processing personal data (including obtaining valid consent of the individuals to whom the personal data relates, where applicable), the processing details disclosed to the individuals, the adequacy, relevance and necessity of the personal data collected, the retention of personal data, the sharing of personal data with third parties, the transfer of personal data out of the European Economic Area/UK to third countries including the U.S., contracting requirements (such as with clinical trial sites and vendors), the use of personal data in accordance with individual rights, the security of personal data and security breach/incident notifications.
The GDPR regulates the processing of personal data (including health data from clinical trials) and places certain obligations on the processing of personal data including ensuring the lawfulness of processing personal data (including obtaining valid consent of the individuals to whom the personal data relates, where applicable), the processing details disclosed to the individuals, the adequacy, relevance and necessity of the personal data collected, the retention of personal data, the sharing of personal data with third parties, the transfer of personal data out of the European Economic Area/UK to third countries including the U.S., contracting requirements (such as with clinical trial sites and vendors), the use of personal data in accordance with individual rights, the security of personal data cybersecurity incident notifications.
For example, with the use of any newly marketed drug by a wider patient population, serious adverse events may occur from time to time that initially do not appear to relate to the drug itself.
For example, with the use of any newly marketed drug by a wider patient population, serious adverse events may occur from 45 time to time that initially do not appear to relate to the drug itself.
The cGMP requirements govern, among other things, recordkeeping, production processes and controls, personnel and quality control. To ensure that we continue to meet these requirements, we have and will continue to expend significant time, money, and effort.
The cGMP requirements govern, among 56 other things, recordkeeping, production processes, and controls, personnel, and quality control. To ensure that we continue to meet these requirements, we have and will continue to expend significant time, money, and effort.
The steps we have taken to protect our proprietary rights may not be adequate to 49 preclude misappropriation of our proprietary information or infringement of our intellectual property rights, both inside and outside the U.S.
The steps we have taken to protect our proprietary rights may not be adequate to preclude misappropriation of our proprietary information or infringement of our intellectual property rights, both inside and outside the U.S.
Despite these efforts, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches. In addition, our trade secrets may otherwise become known, including through a potential cybersecurity breach, or may be independently developed by competitors.
Despite these efforts, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we 54 may not be able to obtain adequate remedies for such breaches. In addition, our trade secrets may otherwise become known, including through a potential cybersecurity incident, or may be independently developed by competitors.
In addition, newly discovered safety issues may subject us to substantial potential liabilities and adversely affect our financial condition and business. The Affordable Care Act and any changes in healthcare laws may increase the difficulty and cost for us to commercialize our approved products in the U.S. and affect the prices we may obtain.
In addition, newly discovered safety issues may subject us to substantial potential liabilities and adversely affect our financial condition and business. The Affordable Care Act and any changes in healthcare laws may increase the difficulty and cost for us to commercialize our future products in the U.S. and affect the prices we may obtain.
In February 2022, we requested a PREA Deferral Extension because of the unavoidable delays in this program due, among other things, to the Pandemic. The extension was granted by the FDA, extending the study deadline to June 30, 2025. As of December 31, 2023, the study remains ongoing.
In February 2022, we requested a PREA Deferral Extension because of the unavoidable delays in this program due, among other things, to the Pandemic. The extension was granted by the FDA, extending the study deadline to June 30, 2025. As of December 31, 2024, the study remains ongoing.
If any such inspection or audit identifies a failure to comply with applicable regulations or if a violation of our product specifications or applicable regulation occurs independent of such an inspection or audit, FDA may issue a Form FDA-483 and/or an untitled or warning letter, or we or the FDA may require remedial measures that may be costly and/or time consuming for us to implement and that may include the temporary or permanent suspension of commercial sales, recalls, market withdrawals, seizures or the temporary or permanent closure of a facility.
If any such inspection or audit identifies a failure to comply with applicable regulations or if a violation of our product specifications or applicable regulation occurs independent of such an inspection or audit, the FDA may issue a Form FDA-483 and/or a warning letter, which may require remedial measures that may be costly and time consuming for us to implement and that may include the temporary or permanent suspension of commercial sales, recalls, market withdrawals, seizures or the temporary or permanent closure of a facility.
In addition, while the clinical trials of our product candidates, including our lead product candidate, EYP-1901, are designed based on the available relevant information, in view of the uncertainties inherent in drug development, such clinical trials may not be designed with a focus on indications, patient populations, dosing regimens, safety or efficacy parameters or other variables that will provide the necessary safety and efficacy data to support regulatory approval to commercialize the product.
In addition, while the clinical trials of our product candidates, including our lead product candidate, DURAVYU™, are designed based on the available relevant information, in view of the uncertainties inherent in drug development, such clinical trials may not be designed with a focus on indications, patient populations, dosing regimens, safety or efficacy parameters or other variables that will provide the necessary safety and efficacy data to support regulatory approval to commercialize the product.
Any delay, interruption or other issues that arise in the manufacture, fill-finish, packaging, or storage of our products as a result of a failure of our facilities or the facilities or operations of third parties to pass any regulatory agency inspection could significantly impair our commercial partners' ability to commercialize our products.
Any delay, interruption or other issues that arise in the manufacture, fill-finish, packaging, or storage of our products as a result of a failure of our facilities or the facilities or operations of third parties to pass any regulatory agency inspection could significantly impair our ability to commercialize our products.
Though we carefully manage our relationships with our CROs, there can be no assurance that we will not encounter similar 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.
Though we carefully manage our relationships with our CROs, CMOs, and CDMOs, there can be no assurance that we will not encounter similar 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.
Market acceptance by physicians, patients and third party payors of EYP-1901 or other products we may commercialize in the future will depend on a number of factors, some of which are beyond our control, including: • their efficacy, safety, and other potential advantages in relation to alternative treatments; • their relative convenience and ease of administration; • the availability of adequate coverage or reimbursement by third parties, such as insurance companies and other healthcare payors, and by government healthcare programs, including Medicare and Medicaid; • the prevalence and severity of adverse events; • their cost of treatment in relation to alternative treatments, including generic products; • the extent and strength of our third party manufacturer and supplier support; 38 • the extent and strength of marketing and distribution support; • the limitations or warnings contained in a product’s approved labeling; and • distribution and use restrictions imposed by the FDA or other regulatory authorities outside the United States.
Market acceptance by physicians, patients and third party payors of DURAVYU™ or other products we may commercialize in the future will depend on a number of factors, some of which are beyond our control, including: • their efficacy, safety, and other potential advantages in relation to alternative treatments; • their relative convenience and ease of administration; • the availability of adequate coverage or reimbursement by third parties, such as insurance companies and other healthcare payors, and by government healthcare programs, including Medicare and Medicaid; • the prevalence and severity of adverse events; • their cost of treatment in relation to alternative treatments, including generic products; • the extent and strength of our third party manufacturer and supplier support; • the extent and strength of marketing and distribution support; • the limitations or warnings contained in a product’s approved labeling; and 35 • distribution and use restrictions imposed by the FDA or other regulatory authorities outside the United States.
Vorolanib is a small molecule TKI that has been previously studied by Tyrogenex in Phase 1 and 2 clinical trials as an orally delivered therapy for the treatment of wet AMD. The Phase 2 clinical trial was discontinued due to systemic toxicity. There can be no assurance that such systemic toxicities will not occur in our clinical trial for EYP-1901.
Vorolanib is a small molecule TKI that has been previously studied by Tyrogenex in Phase 1 and 2 clinical trials as an orally delivered therapy for the treatment of wet AMD. The Phase 2 clinical trial was discontinued due to systemic toxicity. There can be no assurance that such systemic toxicities will not occur in our clinical trial for DURAVYU™.
If we, and with respect to YUTIQ ® , Alimera, fail to comply with applicable regulatory requirements for YUTIQ ® or DEXYCU ® , a regulatory authority may: • issue a warning letter asserting that we are in violation of the law; • seek an injunction or impose civil or criminal penalties or monetary fines; • suspend, modify or withdraw regulatory approval; 43 • suspend any ongoing clinical trials; • refuse to approve a pending NDA or a pending application for marketing authorization or supplements to an NDA or to an application for marketing authorization submitted by us; • seize our product; and/or • refuse to allow us to enter into supply contracts, including government contracts.
If we fail to comply with applicable regulatory requirements for DEXYCU ® , a regulatory authority may: • issue a warning letter asserting that we are in violation of the law; • seek an injunction or impose civil or criminal penalties or monetary fines; • suspend, modify or withdraw regulatory approval; • suspend any ongoing clinical trials; • refuse to approve a pending NDA or a pending application for marketing authorization or supplements to an NDA or to an application for marketing authorization submitted by us; • seize our product; and/or • refuse to allow us to enter into supply contracts, including government contracts.
Our dependence upon third parties for the manufacture of our vorolanib could adversely affect our profit margins or our ability to develop and deliver products on a timely and competitive basis. If for any reason we are unable to obtain or retain third-party manufacturers on commercially acceptable terms, we may not be able to sell EYP-1901 as planned.
Our dependence upon third parties for the manufacture of our vorolanib could adversely affect our profit margins or our ability to develop and deliver products on a timely and competitive basis. If for any reason we are unable to obtain or retain third-party manufacturers on commercially acceptable terms, we may not be able to sell DURAVYU™ as planned.
Once we commercialize any new products, we may participate in, and have certain price reporting obligations to, the Medicaid Drug Rebate Program. This program requires us to pay a rebate for each unit of drug reimbursed by Medicaid.
Once we commercialize any new products, we may participate in, and have certain price reporting obligations to, the Medicaid Drug Rebate Program. This program requires manufacturers to pay a rebate for each unit of drug reimbursed by Medicaid.
RISKS RELATED TO OUR RELIANCE ON THIRD PARTIES The development and commercialization of our lead product candidate, EYP-1901, is dependent on intellectual property we license from Equinox Science and active pharmaceutical ingredient (API) supply of vorolanib. If we breach our agreement with Equinox Science, or the agreement is terminated, we could lose license rights that are material to our business.
RISKS RELATED TO OUR RELIANCE ON THIRD PARTIES The development and commercialization of our lead product candidate, DURAVYU™, is dependent on intellectual property we license from Equinox Science and active pharmaceutical ingredient (API) supply of vorolanib. If we breach our agreement with Equinox Science, or the agreement is terminated, we could lose license rights that are material to our business.
Pre-clinical and clinical data can be 36 interpreted in different ways. Accordingly, the FDA or foreign regulatory authorities could interpret these data in different ways from us or our partners, which could delay, limit or prevent regulatory approval.
Pre-clinical and clinical data can be 38 interpreted in different ways. Accordingly, the FDA or foreign regulatory authorities could interpret these data in different ways from us or our partners, which could delay, limit or prevent regulatory approval.
Actual cash requirements could differ from our 31 projections due to many factors, including, the timing and results of our Phase 2 and Phase 3 clinical trials for EYP-1901, additional investments in research and development programs such as EYP-2301, the costs associated with the ongoing efforts for responding to the subpoena from the U.S.
Actual cash requirements could differ from our projections due to many factors, including, the timing and results of our Phase 2 and Phase 3 clinical trials for DURAVYU™, additional investments in research and development programs such as EYP-2301, the costs associated with the ongoing efforts for responding to the subpoena from the U.S.
The amount of additional capital we will require will be influenced by many factors, including, but not limited to: • our clinical development plans for EYP-1901 for the treatment of wet AMD, NPDR, and DME and our other product candidates, including EYP-2301; • the outcome, timing and cost of the regulatory approval process for EYP-1901 and our other product candidates, including the potential for the FDA to require that we perform more studies and clinical trials than those we currently expect; • whether and to what extent we internally fund, whether and when we initiate, and how we conduct other product development programs; 33 • whether and when we are able to enter into strategic arrangements for our products or product candidates and the nature of those arrangements; • the costs involved in preparing, filing, and prosecuting patent applications, and maintaining, and enforcing our intellectual property rights; • changes in our operating plan, resulting in increases or decreases in our need for capital; • our views on the availability, timing and desirability of raising capital; and • the costs of operating as a public company.
The amount of additional capital we will require will be influenced by many factors, including, but not limited to: • our clinical development plans for DURAVYU™ for the treatment of wet AMD and DME and our other product candidates, including EYP-2301; • the outcome, timing and cost of the regulatory approval process for DURAVYU™ and our other product candidates, including the potential for the FDA (and other equivalent foreign regulatory bodies) to require that we perform more studies and clinical trials than those we currently expect; • whether and to what extent we internally fund, whether and when we initiate, and how we conduct other product development programs; • whether and when we are able to enter into strategic arrangements for our products or product candidates and the nature of those arrangements; • the costs involved in preparing, filing, and prosecuting patent applications, and maintaining, and enforcing our intellectual property rights; • changes in our operating plan, resulting in increases or decreases in our need for capital; • our views on the availability, timing and desirability of raising capital; and • the costs of operating as a public company.
Furthermore, if we encounter delays or difficulties with manufacturers in producing vorolanib, the distribution, marketing and subsequent sales of EYP-1901 could be adversely affected. A long-term inability to meet demand for our products could result in impairment of our brands overall future and the carrying value of the assets associated with our brands.
Furthermore, if we encounter delays or difficulties with manufacturers in producing vorolanib, the distribution, marketing and subsequent sales of DURAVYU™ could be adversely affected. A long-term inability to meet demand for our products could result in impairment of our brands overall future and the carrying value of the assets associated with our brands.
For instance, HIPAA imposes certain obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information and imposes notification obligations in the event of a breach of the privacy or security of individually identifiable health information on entities subject to HIPAA and their business 59 associates that perform certain activities that involve the use or disclosure of protected health information on their behalf.
For instance, HIPAA imposes certain obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of protected health information and imposes notification obligations in the event of a breach of the privacy or security of protected health information on entities subject to HIPAA and their business associates that perform certain activities that involve the use or disclosure of protected health information on their behalf.
Pursuant to our license agreement with Equinox, we acquired exclusive rights to patents, patent applications and know-how owned or controlled by Equinox relating to the compound vorolanib, a tyrosine kinase inhibitor. Our lead product candidate, EYP-1901, utilizes vorolanib in combination with our proprietary Durasert E™ sustained release technology.
Pursuant to our license agreement with Equinox, we acquired exclusive rights to patents, patent applications and know-how owned or controlled by Equinox relating to the compound vorolanib, a tyrosine kinase inhibitor. Our lead product candidate, DURAVYU™, utilizes vorolanib in combination with our proprietary Durasert E™ sustained release technology.
As a result, we may forego or delay pursuit of opportunities with EYP-1901 or other product candidates for the treatment of other indications that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities.
As a result, we may forego or delay pursuit of opportunities with DURAVYU™ or other product candidates for the treatment of other indications that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities.
For example, even if EYP-1901 gains approval by the FDA, physicians and patients may not immediately be receptive to it and may be slow to adopt it. If EYP-1901 does not achieve an adequate level of acceptance among physicians, patients and third party payors, we may not generate meaningful revenues from EYP-1901 and we may not become profitable.
For example, even if DURAVYU™ gains approval by the FDA, physicians and patients may not immediately be receptive to it and may be slow to adopt it. If DURAVYU™ does not achieve an adequate level of acceptance among physicians, patients and third party payors, we may not generate meaningful revenues from DURAVYU™ and we may not become profitable.
Additionally, any agreements we have entered into, or we may enter into. in the future with collaborators in connection with the development or commercialization of EYP-1901 or any of our other product candidates, may entitle us to indemnification against product liability losses, but such indemnification may not be available or adequate should any claim arise.
Additionally, any agreements we have entered into, or we may enter into. in the future with collaborators in connection with the development or commercialization of DURAVYU™ or any of our other product candidates, may entitle us to indemnification against product liability losses, but such indemnification may not be available or adequate should any claim arise.
If we, our agents, or our third party partners fail to comply or are alleged to have failed to comply with these or other applicable data protection and privacy laws and regulations, or if we were to experience a data breach involving personal information, we could be subject to government enforcement actions or private lawsuits.
If we, our agents, or our third party partners fail to comply or are alleged to have failed to comply with these or other applicable data protection and privacy laws and regulations, or if we were to experience a cybersecurity incident involving personal information, we could be subject to government enforcement actions or private lawsuits.
Among the provisions of the Affordable Care Act that have been implemented since enactment and are of importance to the commercialization of our product candidates in the U.S. are the following: • an annual, nondeductible fee on any entity that manufactures or imports specified branded prescription drugs or biologic agents; • an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program; 45 • expansion of healthcare fraud and abuse laws, including the U.S. civil False Claims Act and the Anti-Kickback Statute, new government investigative powers, and enhanced penalties for noncompliance; • a Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for a manufacturer’s outpatient drugs to be covered under Medicare Part D (such manufacturer discounts were increased from 50% to 70% as required by the Bipartisan Budget Act of 2018) (the IRA sunsets the coverage gap discount program effective 2025); • extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations; • price reporting requirements for drugs that are inhaled, infused, instilled, implanted, or injected; • expansion of eligibility criteria for Medicaid programs; • addition of entity types eligible for participation in the Public Health Service Act’s 340B drug pricing program; • a requirement to annually report certain information regarding drug samples that manufacturers and distributors provide to physicians; and • a Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.
Among the provisions of the Affordable Care Act that have been implemented since enactment and are of importance to the commercialization of our product candidates in the U.S. are the following: • an annual, nondeductible fee on any entity that manufactures or imports specified branded prescription drugs or biologic agents; • an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program; • expansion of healthcare fraud and abuse laws, including the U.S. civil False Claims Act and the Anti-Kickback Statute, new government investigative powers, and enhanced penalties for noncompliance; • a Medicare Part D coverage gap discount program, in which manufacturers agreed to offer certain point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for a manufacturer’s outpatient drugs to be covered under Medicare Part D (the IRA sunsets the coverage gap discount program effective 2025); • extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations; • price reporting requirements for drugs that are inhaled, infused, instilled, implanted, or injected; • expansion of eligibility criteria for Medicaid programs; • addition of entity types eligible for participation in the Public Health Service Act’s 340B drug pricing program; • a requirement to annually report certain information regarding drug samples that manufacturers and distributors provide to physicians; and • a Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.
We may never achieve profitability from future operations. Our ability to generate revenue and achieve profitability depends on our ability, alone or with strategic collaboration partners, to successfully complete the development of, and obtain the regulatory approvals necessary for, the manufacture and commercialization of our product candidates, including EYP-1901.
We may never achieve profitability from future operations. Our ability to generate revenue and achieve profitability depends on our ability, alone or with strategic collaboration partners, to successfully complete the development of, and obtain the regulatory approvals necessary for, the manufacture and commercialization of our product candidates, including DURAVYU™.
Furthermore, until such time as we are able to build a broader product candidate pipeline, if ever, any adverse developments with respect to our leading product candidate, EYP-1901, would have a more significant adverse effect on our overall business than if we maintained a broader portfolio of product candidates.
Furthermore, until such time as we are able to build a broader product candidate pipeline, if ever, any adverse developments with respect to our leading product candidate, DURAVYU™, would have a more significant adverse effect on our overall business than if we maintained a broader portfolio of product candidates.
We do not know the extent to which any of our product candidates, including EYP-1901, if approved, will generate significant revenue for us, if at all. We may never succeed in these activities and, even if we do, we may never generate revenues significant enough to achieve profitability.
We do not know the extent to which any of our product candidates, including DURAVYU™, if approved, will generate significant revenue for us, if at all. We may never succeed in these activities and, even if we do, we may never generate revenues significant enough to achieve profitability.
We will need to raise additional capital in the future, which may not be available on favorable terms and may be dilutive to stockholders or impose operational restrictions. We will need to raise additional capital in the future to help fund the development and commercialization of EYP-1901 and our other product candidates, if approved.
We will need to raise additional capital in the future, which may not be available on favorable terms and may be dilutive to stockholders or impose operational restrictions. We will need to raise additional capital in the future to help fund the development and commercialization of DURAVYU™ and our other product candidates, if approved.
For example, we are developing our leading product candidate, EYP-1901, for the treatment of wet AMD. Although we believe wet AMD is a common condition and a leading cause of vision loss for people age 50 and older, our estimates of the potential market opportunity for EYP-1901 may be incorrect.
For example, we are developing our leading product candidate, DURAVYU™, for the treatment of wet AMD. Although we believe wet AMD is a common condition and a leading cause of vision loss for people age 50 and older, our estimates of the potential market opportunity for DURAVYU™ may be incorrect.
Changes to the manufacturer discount program could change our overall discount liability under the Part D program, as participating manufacturers, as a general matter, will be required to offer discounts on the negotiated price of a drug on a larger universe of units but at a lower discount rate.
Changes to the manufacturer discount program could change our overall discount liability under the Part D program, as participating manufacturers, as a general matter, are required to offer discounts on the negotiated price of a drug on a larger universe of units but at a lower discount rate.
If we, or a regulatory authority, discover previously unknown problems with YUTIQ ® or DEXYCU ® , such as adverse events of unanticipated severity or frequency, or problems with a facility where the product is manufactured, a regulatory authority may impose restrictions relative to YUTIQ ® , DEXYCU ® or their respective manufacturing facilities, including requiring recall or withdrawal of the product from the market, suspension of manufacturing, or other FDA action or other action by foreign regulatory authorities.
If we, or a regulatory authority, discover previously unknown problems with DEXYCU ® , such as adverse events of unanticipated severity or frequency, or problems with a facility where the product is manufactured, a regulatory authority may impose restrictions relative to DEXYCU ® or its manufacturing facilities, including requiring recall or withdrawal of the product from the market, suspension of manufacturing, or other FDA action or other action by foreign regulatory authorities.
The commercial manufacture of medical products is complex and requires significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls. Manufacturers of medical products often encounter difficulties in production, particularly in scaling out and validating initial production and ensuring the absence of 55 contamination.
The commercial manufacture of medical products is complex and requires significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls. Manufacturers of medical products often encounter difficulties in production, particularly in scaling up and validating initial production and ensuring the absence of contamination.
If the market opportunities for our product candidates, including EYP-1901, are smaller than we believe they are, our results of operations may be adversely affected and our business may suffer. We focus our research and product development primarily on treatments for eye diseases.
If the market opportunities for our product candidates, including DURAVYU™, are smaller than we believe they are, our results of operations may be adversely affected and our business may suffer. We focus our research and product development primarily on treatments for eye diseases.
The latest analysis performed under Section 382, performed through September 30, 2018, confirmed that the exercise of certain warrants in late September 2018 resulted in a greater than 50% cumulative ownership change, which will cause annual limitations on the use of our then existing NOL balances and other pre-change tax attributes.
The latest analysis performed under Section 382, performed through December 31, 2023, confirmed that the exercise of certain warrants in late September 2018 resulted in a greater than 50% cumulative ownership change, which will cause annual limitations on the use of our then existing NOL balances and other pre-change tax attributes.
Results from pre-clinical testing, early clinical trials, prior clinical trials, investigator-sponsored studies, and other data and information often do not accurately predict final pivotal clinical trial results. EYP-1901 relies on vorolanib as its active pharmaceutical agent.
Results from pre-clinical testing, early clinical trials, prior clinical trials, investigator-sponsored studies, and other data and information often do not accurately predict final pivotal clinical trial results. DURAVYU™ relies on vorolanib as its active pharmaceutical agent.
Our projections of both the number of people who have these diseases, as well as the subset of people with these diseases who have the potential to benefit from treatment with our products and product candidates, such as our projections of the number of patients with wet AMD, NPDR, and DME who may benefit from treatment with EYP-1901 if it is approved for use, are based on estimates.
Our projections of both the number of people who have these diseases, as well as the subset of people with these diseases who have the potential to benefit from treatment with our products and product candidates, such as our projections of the number of patients with wet AMD and DME who may benefit from treatment with DURAVYU™ if it is approved for use, are based on estimates.
Although there were no reported EYP-1901-related ocular or systematic serious adverse events (SAEs) in our Phase 2 clinical data, we cannot rule out that issues may arise in the future.
Although there were no reported DURAVYU™-related ocular or systematic serious adverse events (SAEs) in our Phase 2 clinical data, we cannot rule out that issues may arise in the future.
We may expend significant resources to pursue our lead product candidate, EYP-1901 for the potential treatment of wet AMD, NPDR and DME and fail to capitalize on the potential of EYP-1901, or our other product candidates, for the potential treatment of other indications that may be more profitable or for which there is a greater likelihood of success.
We may expend significant resources to pursue our lead product candidate, DURAVYU™ for the potential treatment of wet AMD and DME and fail to capitalize on the potential of DURAVYU™, or our other product candidates, for the potential treatment of other indications that may be more profitable or for which there is a greater likelihood of success.
ILUVIEN ® is Alimera Sciences Inc.’s trademark. The reports we file or furnish with the SEC, including this Annual Report on Form 10-K, also contain trademarks, trade names and service marks of other companies, which are the property of their respective owners.
ILUVIEN ® is ANI Pharmaceuticals, Inc.’s trademark. The reports we file or furnish with the SEC, including this Annual Report on Form 10-K, also contain trademarks, trade names and service marks of other companies, which are the property of their respective owners.
As we anticipate that CMS’s implementation of the drug price negotiation program will evolve, and that there will be related legislative, administrative, and legal developments, our understanding of whether our products are likely to be selected for negotiation under this program, and whether they may be subject to additional downward pricing pressure, is likely to evolve as well, which could impact our understanding of our business and financial condition.
As we anticipate that CMS’s implementation of the drug price negotiation program will evolve, and that there will be related legislative, administrative, and legal developments, our understanding of whether our product candidates, if commercialized, are likely to be selected for negotiation under this program, and whether they may be subject to additional downward pricing pressure, is likely to evolve as well, which could impact our understanding of our business and financial condition.
We may find it difficult to enroll patients in our clinical trials, which could delay or prevent clinical trials of our product candidates. Identifying and qualifying patients to participate in clinical trials of our product candidates, including EYP-1901, is critical to our success.
We may find it difficult to enroll patients in our clinical trials, which could delay or prevent clinical trials of our product candidates. Identifying and qualifying patients to participate in clinical trials of our product candidates, including DURAVYU™, is critical to our success.
Because we have limited financial and managerial resources, we focus on research programs and product candidates for specific indications. Specifically, with regard to EYP-1901, we initially focused our efforts on the treatment of wet AMD, but have since expanded our efforts to include the treatment of NPDR and DME.
Because we have limited financial and managerial resources, we focus on research programs and product candidates for specific indications. Specifically, with regard to DURAVYU™, we initially focused our efforts on the treatment of wet AMD, but have since expanded our efforts to include the treatment of DME.
Even though regulatory approvals for YUTIQ ® and DEXYCU ® have been obtained in the U.S., the FDA and state regulatory authorities may still impose significant restrictions on the indicated uses or marketing of YUTIQ ® and DEXYCU ® , or impose ongoing requirements for potentially costly post-approval studies or post-marketing surveillance.
Even though regulatory approval for DEXYCU ® has been obtained in the U.S., the FDA and state regulatory authorities may still impose significant restrictions on the indicated uses or marketing of DEXYCU ® , or impose ongoing requirements for potentially costly post-approval studies or post-marketing surveillance.
If our agreement with Equinox is terminated by Equinox for our uncured material breach, we would lose our license and all rights to the use of vorolanib, from Equinox, for EYP-1901.
If our agreement with Equinox is terminated by Equinox for our uncured material breach, we would lose our license and all rights to the use of vorolanib, from Equinox, for DURAVYU™.
Our price reporting and other obligations under the Medicaid Drug Rebate Program, Medicare Part B, the 340B program, and the VA/FSS program are described in the risk factor entitled “Our products and product candidates, if approved and commercialized, may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives which could harm our business”.
If we commercialize any future products, we may have reporting and other obligations under the Medicaid Drug Rebate Program, Medicare Part B, the 340B program, and the VA/FSS program, which are described in the risk factor entitled “Our products and product candidates, if approved and commercialized, may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives which could harm our business”.
If we experience delays in the completion of, or the termination of, any clinical trial of any of our product candidates, including EYP-1901, the commercial prospects of such product candidate will be 35 harmed, and our ability to generate product revenues from such product candidate will be delayed.
If we experience delays in the completion of, or the termination of, any clinical trial of any of our product candidates, including DURAVYU™, the commercial prospects of such product candidate will be harmed, and our ability to generate product revenues from such product candidate will be delayed.
Starting in 2023, manufacturers must pay refunds to Medicare for single source drugs or biologicals, or biosimilar biological products, reimbursed under Medicare Part B and packaged in single-dose containers or single-use packages, for units of discarded drug reimbursed by Medicare Part B in excess of 10 percent of total allowed charges under Medicare Part B for that drug.
Manufacturers were required to pay refunds to Medicare for single source drugs or biologicals, or biosimilar biological products, reimbursed under Medicare Part B and packaged in single-dose containers or single-use packages, for units of discarded drug reimbursed by Medicare Part B in excess of 10 percent of total allowed charges under Medicare Part B for that drug.
With respect to the drug price negotiation program, if any of our products were selected for negotiation and, as a result, a “maximum fair price” for such product were set, our Medicare revenue would materially decrease, and our Medicaid drug rebate program rebate and 340B drug pricing program liability would materially increase in addition.
With respect to the drug price negotiation program, if any of our product candidates, if commercialized, were selected for negotiation and, as a result, a “maximum fair price” for such product were set, our Medicare revenue could materially decrease, and our Medicaid drug rebate program rebate and 340B drug pricing program liability could materially increase in addition.
We received a subpoena from the U.S. Attorney’s Office for the District of Massachusetts seeking production of documents related to sales, marketing and promotional practices, including as pertain to DEXYCU ® . If the DOJ commences an action against us, the action could have a material adverse effect on our business, financial condition, results of operations, and cash flows.
Attorney’s Office for the District of Massachusetts seeking production of documents related to sales, marketing and promotional practices, including as pertain to DEXYCU ® . If the DOJ commences an action against us, the action could have a material adverse effect on our business, financial condition, results of operations, and cash flows.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeProcess for Assessing, Identifying and Managing Material Risks from Cybersecurity Threats In the event of a cybersecurity incident, we maintain a regularly tested incident response program. Pursuant to the program and its escalation protocols, designated personnel are responsible for assessing the severity of an incident and associated threat, and handling it in accordance with that severity level.
Biggest changeWe also maintain cybersecurity insurance providing coverage for certain costs related to cybersecurity-related incidents that impact our own systems, networks, and technology or the systems, networks and technology of our contractors, consultants, vendors and other business partners. 63 Process for Assessing, Identifying and Managing Material Risks from Cybersecurity Threats Pursuant to the program and its escalation protocols, designated personnel are responsible for assessing the severity of an incident and associated threat, and handling it in accordance with that severity level.
We have relationships with a number of third-party service providers to assist with cybersecurity containment and remediation efforts. 61 Governance Upon a notification of concerning factors which may be indicative that a notable cybersecurity incident has occurred, the Cyber Security Subcommittee (Cyber Security Subcommittee) consisting of the Chief Legal Officer, Chief People Officer & SVP of IT, Associate General Counsel, Head of Information Technology, and a member of the Financial Reporting team, meets to make an initial assessment.
Governance Upon a notification of concerning factors which may be indicative that a notable cybersecurity incident has occurred, the Cyber Security Subcommittee (Cyber Security Subcommittee) consisting of the Chief Legal Officer, Chief People Officer & SVP of IT, Associate General Counsel, Head of Information Technology, and a member of the Financial Reporting team, meets to make an initial assessment.
Our team leverages over 25 years of experience in various cyber security functions. Our SVP of IT, and her team, is responsible for the day-to-day management of the cybersecurity program. The SVP of IT provides periodic briefings for our senior management team on cybersecurity matters, including the prevention, detection, mitigation, and remediation of cybersecurity incidents and cybersecurity threats.
Our team leverages over 25 years of experience in various IT leadership roles, including oversight of cyber security functions. Our SVP of IT, and her team, is responsible for the day-to-day management of the cybersecurity program.
Department leaders are asked to consider the severity and likelihood of certain risk factors, drawing upon their company knowledge and past business experience. While we maintain a robust cybersecurity program, the techniques used to infiltrate information technology systems continue to evolve. Accordingly, we may not be able to timely detect threats or anticipate and implement adequate security measures.
While we maintain a robust cybersecurity program, the techniques used to infiltrate information technology systems continue to evolve. Accordingly, we may not be able to timely detect threats or anticipate and implement adequate security measures.
Cybersecurity Risks Our cybersecurity risk management processes are integrated into our overall Enterprise Risk Management (“ERM”) process. As part of our ERM process, department leaders identify, assess, and evaluate risks impacting our operations across the Company, including those risks related to cybersecurity.
As part of our ERM process, department leaders identify, assess, and evaluate risks impacting our operations across the Company, including those risks related to cybersecurity. Department leaders are asked to consider the severity and likelihood of certain risk factors, drawing upon their company knowledge and past business experience.
On a quarterly basis, the SVP of IT reports to the Audit Committee on information technology and cybersecurity matters, including key information technology risks. The SVP of IT also apprises the Audit Committee and full Board of Cyber Security Incidents consistent with our incident response program, promptly.
The SVP of IT also apprises the Audit Committee and full Board of Cyber Security Incidents consistent with our incident response program, promptly . Cybersecurity Risks Our cybersecurity risk management processes are integrated into our overall Enterprise Risk Management (“ERM”) process.
Board Oversight While the Board of Directors has overall responsibility for risk oversight, our Audit Committee oversees cybersecurity risk matters. The Audit Committee is responsible for reviewing, discussing with management, and overseeing the Company’s cybersecurity and privacy risk exposures and policies.
The Audit Committee is responsible for reviewing, discussing with management, and overseeing the Company’s cybersecurity and privacy risk exposures and policies. On a quarterly basis, the SVP of IT reports to the Audit Committee on information technology and cybersecurity matters , including key information technology risks.
For additional information, see “Item 1A—Risk Factors.” To date, we have not experienced any material cybersecurity incidents or threats.
For additional information, see “Item 1A—Risk Factors.” As of December 31, 2024, we have not experienced any material risks from cybersecurity threats, including as a result of any previous cybersecurity incidents or threats, that have materially affected the business strategy, results of operations or financial condition of the Company or are reasonably likely to have such a material effect.
Added
We have relationships with a number of third-party service providers to assist with cybersecurity containment and remediation efforts.
Added
The SVP of IT provides periodic briefings for our senior management team on cybersecurity matters, including the prevention, detection, mitigation, and remediation of cybersecurity incidents and cybersecurity threats. Board Oversight While the Board of Directors has overall responsibility for risk oversight, our Audit Committee oversees cybersecurity risk matters.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeProperties IX, LLC for a new standalone manufacturing facility, including office and lab space located at 600 Commerce Drive, Northbridge, Massachusetts. The new leased premises will consist of approximately 40,000 square feet.
Biggest changeRent for the extension period would be at the fair market rent for comparable space in comparable properties in the Watertown area. 64 On January 23, 2023, we entered into a lease agreement with V.E. Properties IX, LLC for a new standalone manufacturing facility, including office and lab space located at 600 Commerce Drive, Northbridge, Massachusetts.
We have the option to extend the lease for one additional 5-year term. We believe our leased facilities are adequate for our present and anticipated needs. Please refer to Note 8 to the Consolidated Financial Statements, included under Item 15, "Exhibits and Financial Statement Schedules," for further details. 62
We believe our leased facilities are adequate for our present and anticipated needs. Please refer to Note 8 to the Consolidated Financial Statements, included under Item 15, "Exhibits and Financial Statement Schedules," for further details.
The lease includes a lease term of fifteen years and four months, with two options to extend the lease term for either five years or ten years at 95% of the then-prevailing fair market rent.
The new leased premises consist of approximately 41,141 square feet. The lease includes a non-cancellable lease term of fifteen years and four months, with two options to extend the lease term for two additional terms of either five years or ten years at 95% of the then-prevailing fair market rent.
The amendment also reinstated our right to extend the lease for the space we occupy after May 31, 2025, for one additional period of five years. Rent for the extension period would be at the fair market rent for comparable space in comparable properties in the Watertown area. On January 23, 2023, we entered into a lease agreement with V.E.
The amendment also reinstated our right to extend the lease for the space we occupy after May 31, 2025, for one additional period of five years.
Removed
The lease term will commence upon the substantial completion of construction to prepare the premises for our intended use, which is currently expected to occur in the second half of 2024 (the “Lease Commencement Date”). Our obligation to pay base rent will begin four months following the Lease Commencement Date.
Added
The lease term, under ASC 842, commenced during the second quarter of 2024. The Company entered into an amendment to the Northbridge Lease, effective September 30, 2024. Pursuant to the amendment, the Company's obligation to pay base rent began March 1, 2025. The Company is responsible for real estate taxes, maintenance, and other operating expenses applicable to the leased premises.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeAt this time, we are unable to predict the duration, scope, or outcome of this matter or whether it could have a material impact on our financial condition, results of operation or cash flow. ITEM 4. MINE SAFE TY DISCLOSURES Not applicable. 63 PART II
Biggest changeAt this time, we are unable to predict the duration, scope, or outcome of this matter or whether it could have a material impact on our financial condition, results of operation or cash flow. ITEM 4. MINE SAFE TY DISCLOSURES Not applicable. 65 PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOC KHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Our common stock is traded on the Nasdaq Global Market under the trading symbol “EYPT.” As of February 29, 2024, we had approximately 38 holders of record of our common stock.
Biggest changeITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOC KHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Our common stock is traded on the Nasdaq Global Market under the trading symbol “EYPT.” As of February 28, 2025, we had approximately 36 holders of record of our common stock.
Recent Sales of Unregistered Securities Other than as previously disclosed in our Current Reports on Form 8-K or Quarterly Reports on Form 10-Q filed with the SEC, we did not issue any unregistered equity securities during the 12 months ended December 31, 2023. Purchases of Equity Securities by the Issuer and Affiliated Purchasers None. ITEM 6. [RESE RVED] 64
Recent Sales of Unregistered Securities Other than as previously disclosed in our Current Reports on Form 8-K or Quarterly Reports on Form 10-Q filed with the SEC, we did not issue any unregistered equity securities during the 12 months ended December 31, 2024. Purchases of Equity Securities by the Issuer and Affiliated Purchasers None. ITEM 6. [RESE RVED] 66

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeWe can terminate the agreements at any time without penalty, and if terminated, we would be liable only for services through the termination date plus non-cancellable CRO obligations to third parties. 68 Results of Operations Years Ended December 31, 2023 and 2022 (in thousands except percentages) Year Ended December 31, Change 2023 2022 Amounts % Revenues: Product sales, net $ 14,232 $ 39,905 $ (25,673 ) -64 % License and collaboration agreements 30,797 362 30,435 8407 % Royalty income 989 1,137 (148 ) -13 % Total revenues 46,018 41,404 4,614 11 % Operating expenses: Cost of sales, excluding amortization of acquired intangible assets 4,632 8,326 (3,694 ) -44 % Research and development 64,662 49,642 15,020 30 % Sales and marketing 11,689 25,507 (13,818 ) -54 % General and administrative 40,102 34,817 5,285 15 % Amortization of acquired intangible assets — 2,050 (2,050 ) -100 % Impairment of acquired intangible assets — 20,699 (20,699 ) -100 % Total operating expenses 121,085 141,041 (19,956 ) -14 % Loss from operations (75,067 ) (99,637 ) 24,570 -25 % Other income (expense): Interest and other income, net 6,949 2,131 4,818 226 % Interest expense (1,247 ) (3,189 ) 1,942 -61 % Gain (loss) on extinguishment of debt (1,347 ) (1,559 ) 212 -14 % Total other income (expense), net 4,355 (2,617 ) 6,972 -266 % Net loss before income taxes $ (70,712 ) $ (102,254 ) $ 31,542 -31 % Provision for income taxes $ (83 ) $ — $ (83 ) Net loss $ (70,795 ) $ (102,254 ) $ 31,459 -31 % Net loss per share - basic and diluted $ (1.82 ) $ (2.74 ) $ 0.92 -34 % Weighted average shares outstanding - basic and diluted 38,904 37,317 1,587 4 % Net loss $ (70,795 ) $ (102,254 ) $ 31,459 -31 % Product Sales, net Product sales, net represents the gross sales of YUTIQ ® and DEXYCU ® less provisions for product sales allowances.
Biggest changeResults of Operations Years Ended December 31, 2024 and 2023 (in thousands except percentages) Year ended December 31, Change 2024 2023 Amounts % Revenues: Product sales, net $ 3,164 $ 14,232 $ (11,068 ) -78 % License and collaboration agreements 38,496 30,797 7,699 25 % Royalty income 1,613 989 624 63 % Total revenues 43,273 46,018 (2,745 ) -6 % Operating expenses: Cost of sales 3,712 4,632 (920 ) -20 % Research and development 132,926 64,662 68,264 106 % Sales and marketing 131 11,689 (11,558 ) -99 % General and administrative 52,358 40,102 12,256 31 % Total operating expenses 189,127 121,085 68,042 56 % Loss from operations (145,854 ) (75,067 ) (70,787 ) 94 % Other income (expense): Interest and other income, net 15,088 6,949 8,139 117 % Interest expense (14 ) (1,247 ) 1,233 -99 % Gain (loss) on extinguishment of debt — (1,347 ) 1,347 -100 % Total other income, net 15,074 4,355 10,719 246 % Net loss before income taxes $ (130,780 ) $ (70,712 ) $ (60,068 ) 85 % Provision for income taxes $ (90 ) $ (83 ) $ (7 ) 8 % Net loss $ (130,870 ) $ (70,795 ) $ (60,075 ) 85 % Net loss per share - basic and diluted $ (2.32 ) $ (1.82 ) $ (0.50 ) 27 % Weighted average shares outstanding - basic and diluted 56,298 38,904 17,394 45 % Product Sales, net Product sales, net represents the gross sales of YUTIQ ® .
By their nature, these estimates, judgments and assumptions are subject 66 to an inherent degree of uncertainty, and management evaluates them on an ongoing basis for changes in facts and circumstances. Changes in estimates are recorded in the period in which they become known. Actual results may differ from our estimates under different assumptions or conditions.
By their nature, these estimates, judgments and assumptions are subject to an inherent degree of uncertainty, and management evaluates them on an ongoing basis for changes in facts and circumstances. Changes in estimates are recorded in the period in which they become known. Actual results may differ from our estimates under different assumptions or conditions.
During the fiscal year ended December 31, 2023, we sold 15,294,116 shares in the December 2023 underwritten stock offering for gross proceeds of $230.0 million, and we sold 902,769 shares of our Common Stock utilizing our at-the-market facility (ATM) at a weighted average price of $11.05 per share for gross proceeds of approximately $10.0 million.
During the year ended December 31, 2023, we sold 15,294,116 shares in the December 2023 underwritten stock offering for gross proceeds of $230.0 million, and we sold 902,769 shares of our Common Stock utilizing our at-the-market facility (ATM) at a weighted average price of $11.05 per share for gross proceeds of approximately $10.0 million.
These reserves were based on the amounts earned, or to be claimed on the related sales, and were classified either as reductions of product revenue and accounts receivable or a current liability, depending on how the amount was to be settled.
These reserves were based on the amounts earned, or to be 69 claimed on the related sales, and were classified either as reductions of product revenue and accounts receivable or a current liability, depending on how the amount was to be settled.
Applying the practical expedient in paragraph 606-10-32-18, we do not assess whether a significant financing component exists if the period between when we perform our obligations under the contract and when the customer pays is one year or less. None of our contracts contained a significant financing component as of December 31, 2023.
Applying the practical expedient in paragraph 606-10-32-18, we do not assess whether a significant financing component exists if the period between when we perform our obligations under the contract and when the customer pays is one year or less. None of our contracts contained a significant financing component as of December 31, 2024.
Actual cash requirements could differ from management’s projections due to many factors including additional investments in research and development programs, clinical trial expenses for EYP-1901and potentially EYP-2301, competing technological and market developments and the costs of any strategic acquisitions and/or development of complementary business opportunities.
Actual cash requirements could differ from management’s projections due to many factors including additional investments in research and development programs, clinical trial expenses for DURAVYU™ and potentially EYP-2301, competing technological and market developments and the costs of any strategic acquisitions and/or development of complementary business opportunities.
This was further offset by changes in working capital of $58.9 million, including $44.5 million of deferred revenue related to the agreement to license YUTIQ ® product rights to Alimera, and $14.4 million of other working capital changes.
This was further offset by changes in working capital of $58.9 million, including $44.5 million of deferred revenue related to the agreement to license YUTIQ ® product rights to ANI, and $14.4 million of other working capital changes.
The following Management’s Discussion and Analysis (MD&A) provides a narrative of our results of operations for the year ended December 31, 2023, and the comparable period ended December 31, 2022, respectively, and our financial position as of December 31, 2023 and 2022, respectively.
The following Management’s Discussion and Analysis (MD&A) provides a narrative of our results of operations for the year ended December 31, 2024, and the comparable period ended December 31, 2023, respectively, and our financial position as of December 31, 2024 and 2023, respectively.
On May 17, 2023, we utilized a portion of the Upfront Payment from the Alimera PRA (see Note 3) to repay in full all outstanding amounts under the SVB Loan Agreement. The SVB Loan Agreement was terminated, and all security interests and other liens granted to or held by the Lender were terminated and released.
On May 17, 2023, we utilized a portion of the Upfront Payment from the ANI PRA (see Note 3) and repaid in full all outstanding amounts under the SVB Loan Agreement. The SVB Loan Agreement was then terminated, and all security interests and other liens granted to or held by the Lender were terminated and released.
During the year ended December 31, 2023, the Company recognized $2.1 million of revenue from sales of product supply to Alimera under the commercial supply agreement (CSA). Customer demand had a direct impact on product orders from our specialty distributors that we recorded as net product sales.
During the year ended December 31, 2024, the Company recognized $2.6 million of revenue from sales of product supply to ANI under the commercial supply agreement (CSA). Customer demand had a direct impact on product orders from our specialty distributors that we recorded as net product sales.
FINANCIAL STATEMEN TS AND SUPPLEMENTARY DATA The information required by this item may be found on pages F-1 through F-29 of this Annual Report on Form 10-K. ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOU NTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE None.
FINANCIAL STATEMEN TS AND SUPPLEMENTARY DATA The information required by this item may be found in this Annual Report on Form 10-K. ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOU NTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE None.
For those milestone payments which are contingent on the occurrence of particular future events, we determine that these need to be considered for inclusion in the calculation of total consideration from the contract as a component of variable consideration using the most-likely amount method.
For those milestone payments which are contingent on the occurrence of particular future events, we determine that these need to be considered for inclusion in the calculation of total consideration from the contract as a component of variable consideration using the most-likely amount method. As such, we assess each milestone to determine the probability and substance behind achieving each milestone.
The amount of additional capital we will require will be influenced by many factors, including, but not limited to: 1. the scope, progress, results, and costs of clinical trials of EYP-1901, as a sustained delivery intravitreal VEGF treatment for wet AMD, NPDR, and DME 2. our expectations regarding the timing and clinical development of our product candidates, including EYP-1901 and EYP-2301; 3. the duration, scope and outcome of the DOJ Subpoena and its impact on our financial condition, results of operations, or cash flows; 4. whether and to what extent we internally fund, whether and when we initiate, and how we conduct additional pipeline product development programs; 5. payments we receive under any new collaboration agreements or payments expected from existing agreements; 6. whether and when we are able to enter into strategic arrangements for our products or product candidates and the nature of those arrangements; 7. the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing any patent claims; 8. changes in our operating plan, resulting in increases or decreases in our need for capital; and 9. our views on the availability, timing, and desirability of raising capital. 71 We do not know if additional capital will be available when needed or on terms favorable to us or our stockholders.
The amount of additional capital we will require will be influenced by many factors, including, but not limited to: 1. the scope, progress, results, and costs of clinical trials of DURAVYU™, as a sustained delivery intravitreal treatment for wet AMD and DME; 73 2. our expectations regarding the timing and clinical development of our product candidates, including DURAVYU™ and EYP-2301; 3. the duration, scope, and outcome of the DOJ Subpoena and its impact on our financial condition, results of operations, or cash flows; 4. whether and to what extent we internally fund, whether and when we initiate, and how we conduct additional pipeline product development programs; 5. payments we receive under any new collaboration agreements or payments expected from existing agreements; 6. whether and when we are able to enter into strategic arrangements for our products or product candidates and the nature of those arrangements; 7. the costs involved in preparing, filing, prosecuting, maintaining, defending, and enforcing any patent claims; 8. the costs and timing to implement corrective and preventive actions required by the Warning Letter to the satisfaction of the FDA; 9. changes in our operating plan, resulting in increases or decreases in our need for capital; and 10. our views on the availability, timing, and desirability of raising capital.
EYP-1901 is presently in Phase 2 clinical trials as a sustained delivery treatment for wet age-related macular degeneration (wet AMD), the leading cause of vision loss among people 50 years of age and older in the United States, non-proliferative diabetic retinopathy (NPDR), and diabetic macular edema (DME).
DURAVYU™ is presently in Phase 3 clinical trials as a sustained delivery treatment for wet age-related macular degeneration (wet AMD), the leading cause of vision loss among people 50 years of age and older in the United States, and in Phase 2 clinical trial for diabetic macular edema (DME).
Net product revenue represented product purchased by our distributors whereas customer demand represented purchases of product by physician practices and ASCs from our specialty distributors. License and collaboration agreement License and collaboration agreement revenues increased by $30.4 million, to $30.8 million in 2023 compared to $0.4 million in 2022.
Net product revenue represented product purchased by our distributors whereas customer demand represented purchases of product by physician practices and ASCs from our specialty distributors. 71 License and collaboration agreement License and collaboration agreement revenues increased by $7.7 million, to $38.5 million in 2024 compared to $30.8 million for 2023.
Our pipeline leverages our proprietary Durasert E ™ technology for sustained intraocular drug delivery. The Company’s lead product candidate, EYP-1901, is an investigational sustained delivery treatment for anti-vascular endothelial growth factor (anti-VEGF) -mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor with Durasert E ™ .
The Company’s lead product candidate, DURAVYU™, is an investigational sustained delivery treatment for anti-vascular endothelial growth factor (anti-VEGF) mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor with bioerodible Durasert E™.
As such, we assess each milestone to determine the 67 probability and substance behind achieving each milestone. Given the inherent uncertainty associated with these future events, we will not recognize revenue from such milestones until there is a high probability of occurrence, which typically occurs near or upon achievement of the event.
Given the inherent uncertainty associated with these future events, we will not recognize revenue from such milestones until there is a high probability of occurrence, which typically occurs near or upon achievement of the event.
Net cash provided by financing activities for fiscal 2023 totaled $187.1 million and consisted of the following: (i) $215.9 million of net proceeds from the issuance of 15,294,116 shares of our common stock; (ii) $40.5 million used to pay off the SVB loan; (iii) $1.4 million used to pay debt extinguishment costs related to the SVB loan; (iv) $9.6 million of net proceeds from the issuance of 902,769 shares of our common stock sold utilizing our ATM (v) $3.4 million of proceeds from exercise of employee stock options and stock issued under our employee stock purchase plan Net cash used in financing activities for fiscal 2022 totaled $0.7 million and consisted of the following: (i) $38.2 million used to pay off the CRG loan; (ii) $2.3 million used to pay debt extinguishment costs related to the CRG loan; (iii) $30.0 million of proceeds from the issuance for long-term debt related to the SVB loan; and (iv) $10.5 million of net proceeds from the revolving facility. 72 Off-Balance Sheet Arrangements We do not have any off-balance sheet arrangements that have, or are reasonably likely to have, a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources that would be material to investors.
Net cash used in investing activities for the year ended December 31, 2023, consisted of $3.5 million for the purchase of property and equipment, partially offset by $0.2 million of net cash provided by the sale of marketable securities. 74 Net cash provided by financing activities for the year ended December 31, 2024 totaled $164.0 million and consisted of the following: (i) $163.3 million of net proceeds from the issuance of 14,636,363 shares of our common stock in follow on offering and issuance of 1,299,506 shares of our common stock sold utilizing our ATM; and (ii) $1.5 million of proceeds from exercise of employee stock options and stock issued under our employee stock purchase plan Net cash provided by financing activities for fiscal 2023 totaled $187.1 million and consisted of the following: (i) $215.9 million of net proceeds from the issuance of 15,294,116 shares of our common stock; (ii) $40.5 million used to pay off the SVB loan; (iii) $1.4 million used to pay debt extinguishment costs related to the SVB loan; (iv) $9.6 million of net proceeds from the issuance of 902,769 shares of our common stock sold utilizing our ATM; and (v) $3.4 million of proceeds from exercise of employee stock options and stock issued under our employee stock purchase plan Off-Balance Sheet Arrangements We do not have any off-balance sheet arrangements that have, or are reasonably likely to have, a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources that would be material to investors.
Collaboration, licensing, or other agreements may not be available on favorable terms, or at all. If we seek to sell our equity securities, we do not know whether and to what extent we will be able to do so, or on what terms.
If we seek to sell our equity securities, we do not know whether and to what extent we will be able to do so, or on what terms.
The MD&A should be read together with our consolidated financial statements and related notes included on pages F-1 through F-29 of this Annual Report on Form 10-K. Overview We are a company committed to developing and commercializing innovative therapeutics to help improve the lives of patients with serious retinal diseases.
The MD&A should be read together with our consolidated financial statements and related notes included in this Annual Report on Form 10-K. Overview We are a company committed to developing and commercializing innovative therapeutics to help improve the lives of patients with serious retinal diseases. Our pipeline leverages our proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery.
Net cash used in investing activities for the year ended December 31, 2022, consisted of $15.1 million of net cash used to purchase marketable securities, as well as $2.2 million for the purchase of property and equipment.
Net cash used in investing activities for the year ended December 31, 2024, consisted of $215.3 million of net cash purchases of marketable securities and $4.1 million for the purchase of property and equipment.
We incurred lower interest expense due to the repayment of the SVB Loan (as the term is defined below) on May 17, 2023.
Interest expense decreased by $1.2 million, or 99%, to $0.0 million for 2024, compared to $1.2 million for 2023. We incurred lower interest expense due to the repayment of the SVB Loan (as the term is defined below) on May 17, 2023.
Operating cash outflows for the year ended December 31, 2022 totaled $65.0 million, primarily due to our net loss of $102.3 million, reduced by $40.3 million of non-cash expenses, which included $20.7 million of impairment of the DEXYCU ® finite-lived intangible asset, $14.2 million of stock-based compensation, $2.1 million of amortization of intangible assets, $1.9 million of provision for excess and obsolete inventory, and $1.6 million of loss on extinguishment of debt.
Operating cash inflows for the year ended December 31, 2023, totaled $1.9 million, primarily due to our net loss of $70.8 million reduced by $13.8 million of non-cash expenses, which included $12.1 million of stock-based compensation, $1.3 million of loss on extinguishment of debt, and $0.7 million for the provision of excess and obsolete inventory.
This increase was driven by revenue recognized as the combined performance obligations under the Alimera license and supply agreement are fulfilled. Royalty Income Royalty income decreased by $0.1 million, or 13%, to $1.0 million in 2023 compared to $1.1 million in 2022.
This increase was driven by a full year of revenue recognized as the combined performance obligations under the ANI license and supply agreement are fulfilled, compared to eight months of recognition in the prior year. Royalty Income Royalty income increased by $0.6 million, or 63%, to $1.6 million in 2024 compared to $1.0 million for 2023.
We make our assessments of the services performed based on various factors, including reporting from third-party CROs and internal tracking of work performed during the period, which are subject to management’s judgment. Our financial obligations under the agreements are determined by the services that we request from time to time under the agreements.
In determining the prepaid and accrued balances, we make assessments of the services performed based on various factors, including reporting from third-party CROs and internal tracking of work performed during the period, which are subject to management’s judgment. Actual results could differ from our estimates.
Loss on extinguishment of debt in 2022 was for the early repayment of the loan made to the Company by CRG Servicing LLC on February 13, 2019 (CRG Loan) resulting in a $1.6 million non-cash write-off of the remaining balance of unamortized debt discount. 70 Recently Adopted and Recently Issued Accounting Pronouncements For a full discussion of recently adopted and recently issued accounting pronouncements, see Note 2, "Significant Accounting Policies" to the Consolidated Financial Statements included under Item 15, "Exhibits and Financial Statement Schedules." Liquidity and Capital Resources We have had a history of operating losses and an absence of significant recurring cash inflows from revenue, and at December 31, 2023, we had a total accumulated deficit of $742.1 million.
Recently Adopted and Recently Issued Accounting Pronouncements For a full discussion of recently adopted and recently issued accounting pronouncements, see Note 2, "Significant Accounting Policies" to the Consolidated Financial Statements included under Item 15, "Exhibits and Financial Statement Schedules." Liquidity and Capital Resources We have had a history of operating losses and an absence of significant recurring cash inflows from revenue, and at December 31, 2024, we had a total accumulated deficit of $873.0 million.
Gross proceeds to the Company in the offering, before underwriting discounts and estimated expenses of the offering, were approximately $230.0 million. R&D Highlights • In February 2023, we entered into a research collaboration with Rallybio Corporation to evaluate sustained delivery of their inhibitor of complement component 5 (C5) using our proprietary Durasert E ™ technology for sustained intraocular drug delivery.
Sanders, M.D., FASRS to the Company’s Board of Directors. • In February 2023, we entered into a research collaboration with RallyBio Corporation to evaluate sustained delivery of their inhibitor of complement component 5 (C5) using our proprietary Durasert E ™ technology for sustained intraocular drug delivery. The Company and Rally Bio terminated their research collaboration in Q1 of 2025.
Our operations have been financed primarily from public and private offerings of our common stock, issuance of debt and a combination of license fees, milestone payments, royalty income and other fees received from collaboration partners.
Our operations have been financed primarily from public and private offerings of our common stock, issuance of debt and a combination of license fees, milestone payments, royalty income and other fees received from collaboration partners. Financing Activities Also during the year ended December 31, 2024, we completed an underwritten public offering with gross proceeds of $161.0 million.
This decrease was primarily driven by (i) $10.5 million related to the discontinuation of YUTIQ ® commercialization activities due to the agreement that granted the license and rights to YUTIQ ® to Alimera in May 2023, (ii) discontinuation of promotional activities for DEXYCU ® in 2023 of $3.9 million, and (iii) $0.4 million of other marketing activities.
Sales and Marketing Sales and marketing expenses decreased by $11.6 million, or 99%, to $0.1 million for 2024 from $11.7 million for 2023. This decrease was primarily driven by discontinuation of YUTIQ ® commercialization activities due to the agreement that granted the license and rights to YUTIQ ® to ANI in May 2023.
Our consolidated statements of historical cash flows are summarized as follows (in thousands): Year Ended December 31, 2023 2022 Change Cash flows from operating activities: Net loss $ (70,795 ) $ (102,254 ) $ 31,459 Changes in operating assets and liabilities 58,882 (3,023 ) 61,905 Other adjustments to reconcile net loss to cash flows from operating activities: 13,788 40,272 (26,484 ) Net cash (used in) provided by operating activities $ 1,875 $ (65,005 ) $ 66,880 Net cash (used in) provided by investing activities $ (3,315 ) $ (17,265 ) $ 13,950 Net cash (used in) provided by financing activities $ 187,070 $ (690 ) $ 187,760 Operating cash inflows for the year ended December 31, 2023, totaled $1.9 million, primarily due to our net loss of $70.8 million reduced by $13.8 million of non-cash expenses, which included $12.1 million of stock-based compensation, $1.3 million of loss on extinguishment of debt, and $0.7 million for the provision of excess and obsolete inventory.
Our consolidated statements of historical cash flows are summarized as follows (in thousands): Year ended December 31, 2024 2023 Change Cash flows from operating activities: Net loss $ (130,870 ) $ (70,795 ) $ (60,075 ) Changes in operating assets and liabilities (27,773 ) 58,882 (86,655 ) Other adjustments to reconcile net loss to cash flows from operating activities: 32,417 13,788 18,629 Net cash (used in) provided by operating activities $ (126,226 ) $ 1,875 $ (128,101 ) Net cash (used in) provided by investing activities $ (219,355 ) $ (3,315 ) $ (216,040 ) Net cash provided by (used in) financing activities $ 164,022 $ 187,070 $ (23,048 ) Operating cash outflows for the year ended December 31, 2024, totaled $126.2 million, primarily due to our net loss of $130.9 million offset by $32.4 million of non-cash expenses, which included $36.7 million of stock-based compensation.
The decrease was primarily attributable to Ocumension Royalties. 69 Cost of Sales, Excluding Amortization of Acquired Intangible Assets Cost of sales, excluding amortization of acquired intangible assets, decreased by $3.7 million to $4.6 million for fiscal 2023 from $8.3 million in the prior year.
The increase was primarily attributable to increased Ocumension Therapeutics royalties from YUTIQ ® product sales in China. Cost of Sales Cost of sales decreased by $0.9 million to $3.7 million for 2024 from $4.6 million for 2023. This decrease was primarily due to lower commercial product sales year over year.
Product sales, net decreased by $25.7 million, or 64%, to $14.2 million for 2023 compared to $39.9 million for the prior year. This decrease was driven by license and rights for YUTIQ ® to Alimera in May 2023 and de minimis DEXYCU ® sales in 2023 due to the loss of pass-through reimbursement as of January 1, 2023.
Product sales, net decreased by $11.1 million, or 78%, to $3.2 million for 2024 compared to $14.2 million for 2023. This decrease was driven by the agreement to license YUTIQ ® product rights to ANI in May 2023.
Future Funding Requirements At December 31, 2023, we had cash, cash equivalents, and investments in marketable securities of $331.0 million. We expect that our cash and investments in marketable securities will fund our operating plan through topline data for the planned Phase 3 wet AMD pivotal trials into 2026.
Future Funding Requirements At December 31, 2024, we had cash, cash equivalents, and investments in marketable securities of $370.9 million. We expect that our cash and investments in marketable securities will enable us to fund our operations into 2027.
Amounts not expected to be recognized within one year following the balance sheet date are classified as non-current deferred revenue. Please refer to Note 3 for further details on the license and collaboration agreements into which we have entered and corresponding amounts of revenue recognized for the years ended December 31, 2023 and 2022.
Amounts not expected to be recognized within one year following the balance sheet date are classified as non-current deferred revenue.
This increase was attributable primarily to (i) $11.8 million in increased clinical trial costs, related to the ongoing Phase 2 DAVIO2 and PAVIA clinical trials, and (ii) $3.5 million of increased personnel related costs for investment in new employees across the research and clinical organizations. These increases were partially offset by a $0.2 million decrease in other administrative costs.
This increase was attributable primarily to (i) $26.6 million in increased clinical trial costs, related to the ongoing Phase 2 DAVIO2, PAVIA, and VERONA clinical trials of DURAVYU™ and initiation of Phase 3 LUGANO and LUCIA trials of DURAVYU™, (ii) $21.4 million of increased personnel related costs across the research and clinical organizations, including a $13.8 million increase of stock-based compensation due mainly to increased share price of grants, (iii) $11.7 million in increased spend related to non clinical trial development of DURAVYU™, and (iv) a $5.0 million milestone payment made in connection with the completion of a Phase 2 clinical trial.
This increase was attributable primarily to a (i) $3.4 million increase in personnel and related expenses, including a $0.7 million increase of stock-based compensation, and a (ii) $2.2 million increase in professional fees. These increases were partially offset by a $0.3 million decrease in other administrative costs.
General and Administrative General and administrative expenses increased by $12.3 million, or 31%, to $52.4 million for 2024 from $40.1 million for 2023. This increase was attributable primarily to a (i) $13.6 million increase in personnel and related expenses, including a $11.2 million increase of stock-based compensation due mainly to increased share price of grants.
There was no amortization or impairment of acquired intangible assets for 2023 due to the write-off of the DEXYCU ® intangible asset in the fourth quarter of 2022. Interest (Expense) Income Interest income from investments in marketable securities and institutional money market funds increased $4.8 million, to $6.9 million for 2023 compared to $2.1 million for the prior year.
This increase was partially offset by $1.3 million reduction in professional fees in 2024 compared to 2023. Interest (Expense) Income Interest income from investments in marketable securities and institutional money market funds increased by $8.1 million, to $15.1 million for 2024 compared to $6.9 million for 2023.
Duty has focused primarily on biotechnology and specialty pharmaceuticals clients for much of his career, advising senior executives and boards on a range of financing activities and strategic transactions. 65 • On December 8, 2023, we announced the closing of an underwritten public offering of 13,529,411 shares of our common stock, which included the exercise in full by the underwriters of their option to purchase an additional 1,764,705 shares of common stock, at the public offering price of $17.00 per share.
We sold 14,636,363 shares of our common stock, which included the exercise in full by the underwriters of their option to purchase an additional 1,909,090 shares of common stock. The shares of common stock were sold at a public offering price of $11.00 per share. • In October 2024, we announced the grand opening of our Northbridge, MA manufacturing facility.
We expect to initiate pivotal Phase 3 clinical trials in wet AMD in the second half of 2024. Fiscal 2023 Overview The fiscal year ended December 31, 2023, was highlighted by the following events: • In January 2023, we announced that Jay S.
Fiscal 2024 Overview The fiscal year ended December 31, 2024, was highlighted by the following events: • In March 2024, we announced the appointment of Ramiro Ribeiro, M.D., Ph.D. as Chief Medical Officer. Dr.
Recognition of Expense in Outsourced Clinical Trial Agreements We recognize research and development expense with respect to outsourced agreements for clinical trials with contract research organizations (CROs) as the services are provided, based on information provided by CROs and our assessment of the services performed.
Please refer to Note 3 for further details on the license and collaboration agreements into which we have entered and corresponding amounts of revenue recognized for the years ended December 31, 2024 and 2023. 70 Recognition of Expense in Outsourced Clinical Trial Agreements We record accruals for estimated ongoing research and development costs, including costs with respect to outsourced agreements for clinical trials with contract research organizations (CROs).
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Duker, M.D., who served as the Company’s Chief Operating Officer (COO) since November 2021, had been promoted to the additional role of President. In addition to continuing to oversee his duties as COO, in his expanded role, Dr.
Added
Ribeiro is a trained retinal specialist and joins EyePoint from Apellis Pharmaceuticals, where he served as Vice President, Head of Clinical Development. • On April 23, 2024, an end of Phase 2 meeting was held with the Food and Drug Administration (FDA) to discuss our proposed phase 3 (pivotal) clinical program for wet AMD indication. • On June 26, 2024, we hosted an R&D Day in New York City, featuring presentations from EyePoint’s management team as well as key opinion leader (KOL) guest speakers.
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Duker has also been overseeing regulatory affairs. • In January 2023, we entered into a lease agreement to design and construct a 40,000-square-foot manufacturing facility in Northbridge, Massachusetts to support the global manufacturing of programs, including EYP-1901 and YUTIQ ® . • In May 2023, we entered into a definitive agreement pursuant to which we granted an exclusive license and rights to YUTIQ ® to Alimera Sciences, Inc.
Added
R&D day highlights included: o Phase 3 plans for DURAVYU™ in wet AMD, including key design elements of the Phase 3 LUGANO and LUCIA pivotal trials o Positive twelve-month safety and efficacy data from the Phase 2 DAVIO 2 clinical trial evaluating DURAVYU™ for the treatment of wet AMD o The VERONA trial, a Phase 2 trial of DURAVYU™ in DME patients has completed enrollment with 27 patients • In July 2024, Marcia Sellos-Moura, formerly SVP, Program Leadership, assumed a new position as SVP, Head of Development and Program Management, continuing to report to Dr.
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(Alimera). Under the terms of the agreement, Alimera received global rights to YUTIQ ® outside of China, Hong Kong, Taiwan, Macau and Southeast Asia, where YUTIQ ® is exclusively licensed to Ocumension Therapeutics (Ocumension) and we will continue to receive royalties from Ocumension for its YUTIQ ® sales.
Added
Jay S. Duker, President and CEO of the Company. In her expanded role, Dr.
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In exchange for the rights granted to Alimera under the agreement, we received a $75 million upfront cash payment at closing and will receive an additional $7.5 million in equal $1.875 million quarterly installments in 2024.
Added
Sellos-Moura will manage both the R&D and Product Development teams in addition to Program Management. • On September 3, 2024, we announced the appointment of esteemed industry leader Fred Hassan to our Board of Directors. • On October 31, 2024, we completed an underwritten public offering with gross proceeds of $161.0 million.
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In addition, commencing in 2025, we will receive a low to mid double-digit royalty on Alimera’s related U.S. net sales above defined thresholds for the calendar years 2025-2028. • In May 2023, we received confirmation from the FDA that the September 2021 inspection of our Watertown, MA facility had been classified as Voluntary Action Indicated (VAI) and was no longer considered Official Action Indicated.
Added
The 40,000 square foot Good Manufacturing Process (cGMP) compliant commercial manufacturing facility was built to meet U.S. FDA and 67 European Medicines Agency (EMA) and will support global manufacturing across our portfolio, including lead pipeline asset, DURAVYU™ upon potential regulatory approval.
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A VAI classification means that the agency is not prepared to take or recommend further regulatory action. • In July 2023, we announced the appointment of Jay S. Duker, M.D. as President and Chief Executive Officer (CEO). Dr. Duker transitioned from his most recent role as President and Chief Operating Officer (COO). Dr.
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R&D Highlights • In February 2024, we announced results from new subgroup analyses from the Phase 2 DAVIO 2 clinical trial of DURAVYU™.
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Duker was also appointed to the Board of Directors of the Company (Board), effective July 10, 2023. Nancy S. Lurker transitioned to the role of Executive Vice Chair from the position of CEO. • In October 2023, we announced the promotion of George O.
Added
The presented analyses of the data reveal: in the sub-group of patients who were supplement-free up to 6 months, the DURAVYU™ groups demonstrated numerical superiority in change in BCVA along with strong anatomic control compared to the aflibercept control group.
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Elston, our Chief Financial Officer, to Executive Vice President and Chief Financial Officer. • In October 2023, we announced the appointment of Stuart Duty to the Company’s Board of Directors. Mr. Duty is an experienced financial executive with over 30 years of experience in finance and investment banking. Mr.
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This result confirms that the positive topline data from the Phase 2 DAVIO 2 trial were driven by DURAVYU™ and not by study eyes requiring supplemental injection; visual and anatomical outcomes were not meaningfully influenced by differences in patient baseline BCVA, duration of wet AMD diagnosis, or historical treatment burden; and DURAVYU™ outcomes are consistent and durable in a range of wet AMD patient types. • In May 2024, we announced topline results of our Phase 2 PAVIA clinical trial evaluating DURAVYU™ (vorolanib intravitreal insert), previously known as EYP-1901, in patients with non-proliferative diabetic retinopathy (NPDR).
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The initial focus will be on geographic atrophy, an advanced form of age-related macular degeneration that leads to irreversible vision loss. • In March 2023, we completed enrollment in the Phase 2 "Durasert E ™ and Vorolanib in Ophthalmology 2" (DAVIO 2) clinical trial evaluating EYP-1901 as a potential six-month maintenance treatment for wet AMD.
Added
The data demonstrated that DURAVYU™ has a biologic effect in patients with NPDR with a favorable safety and tolerability profile, however the trial did not meet the pre-specified primary endpoint.
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The trial enrolled a total of 160 patients.
Added
The Company has no plans to further advance DURAVYU™ in NPDR. • In May 2024, we completed enrollment in the VERONA trial, a Phase 2 trial of DURAVYU™ in DME patients. The trial enrolled 27 patients with topline data anticipated in the first quarter of 2025. • In June 2024, we announced alignment on pathway to approval with U.S.
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All patients were previously treated with a standard-of-care anti-VEGF therapy and were randomly assigned to one of two doses of EYP-1901 or to an aflibercept on-label control. • In June 2023, we completed enrollment in the Phase 2 clinical trial evaluating EYP-1901 as a potential nine-month treatment for moderately severe to severe NPDR.
Added
Food and Drug Administration (FDA) based on positive End of Phase 2 meeting in April 2024 for two non-inferiority trials, 6-month redosing of DURAVYU™ and sham for masking with a one-year endpoint.
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The trial enrolled 77 patients randomly assigned to one of two doses of EYP-1901 (approximately 2 mg or 3 mg), or to the control group receiving a sham injection. EYP-1901 is delivered with a single intravitreal injection at the physician's office.
Added
Each trial is expected to enroll approximately 400 patients with active wet AMD, including previously treated and treatment naïve patients, randomly assigned to either a 2.7mg dose of DURAVYU™ or an on-label aflibercept control. All patients to receive three monthly loading doses of aflibercept prior to DURAVYU™ with randomization occurring on Day 1.
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The primary efficacy endpoint of the trial is improvement of at least two diabetic retinopathy severity scale (DRSS) levels as of week 36 after the EYP-1901 injection.
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The LUGANO (US) trial remains on track to randomize patients for inclusion in 2024 with LUCIA (US/ex-US) to follow. • In June 2024, we announced positive twelve-month safety and efficacy data from the Phase 2 DAVIO 2 clinical trial evaluating DURAVYU™ for the treatment of wet AMD. • In August 2024, we presented on sustained-release vorolanib highlighting selective pan-VEGF receptor inhibition and anti-angiogenic effects in VEGF-mediated ocular diseases at the American Retina Forum (ARF) 2024 National Meeting demonstrating the durable efficacy, reliable safety and reduced injection burden of treatment with DURAVYU™. • In September 2024, we presented a comparison of tyrosine kinase inhibitors being developed for intravitreal delivery at the Retina Society 57th Annual Meeting, demonstrating the differentiation of DURAVYU™ with immediate bioavailability and controlled release via zero-order kinetics for at least six months. • In October 2024, we announced positive interim 16-week data for the ongoing open label Phase 2 VERONA clinical trial of DURAVYU™ for DME.
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Secondary endpoints include reduction in vision-threatening complications, occurrence of diabetic macular edema and/or proliferative disease, retinal ischemia/nonperfusion and safety. • In July 2023 we presented the interim safety and patient demographics of the DAVIO 2 clinical trial in wet AMD at the OIS Retina Innovation Summit.
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DURAVYU™ 2.7mg demonstrated an early, sustained, and clinically meaningful improvement in BCVA and anatomical control as measured by optical coherence tomography (OCT) versus the aflibercept control arm. Notably, both DURAVYU™ doses showed an immediate benefit over aflibercept control in both BCVA and CST demonstrating the differentiated drug release profile of DURAVYU™ with immediate bioavailability.
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As of July 1, 2023, there were no reported drug related ocular serious adverse events (SAEs) or drug related systemic SAEs.
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Additionally, a favorable safety and tolerability profile continued for both DURAVYU™ arms. • In October 2024, we announced first patient dosed in the Phase 3 LUGANO clinical trial of DURAVYU™ in wet AMD. Subsequently, in December 2024, we announced the first patient dosed in the second Phase 3 LUCIA clinical trial of DURAVYU™ in wet AMD.
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An analysis of the reported patient demographics suggests that Phase 2 DAVIO 2 patients have, on average, better starting visual acuity and less central subfield thickness than the Phase 1 DAVIO cohort. • In September 2023 we announced positive interim masked safety data for our lead product candidate EYP-1901 from the ongoing Phase 2 PAVIA trial evaluating EYP-1901 as a potential nine-month treatment for moderately severe to severe NPDR, and DAVIO 2 trial as a potential six-month maintenance treatment for wet AMD.
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The LUGANO and LUCIA clinical trials are designed for potential global regulatory and commercial success with every six-month re-dosing in both trials.
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All treatment arms in the PAVIA trial have reached at least three-months post-dosing follow-up as of September 1, 2023.
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With over 160 trial sites committed and robust DAVIO 2 data the company anticipates rapid enrollment of both trials with topline data anticipated in 2026. • In October 2024, we presented DAVIO 2 twelve-month data at the American Academy of Ophthalmology (AAO) 2024 Subspecialty Day, at the 24th EURetina Congress in September and the Retina Society 57th Annual Meeting in September. • In February 2025, we announced positive six-month results for the ongoing Phase 2 VERONA clinical trial evaluating DURAVYU™.
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Approximately 170 patients have received EYP-1901 with a minimum of three months of follow-up post injection from the ongoing Phase 2 PAVIA and DAVIO 2 clinical trials and the completed DAVIO 1 trial with no reported drug-related ocular severe adverse events (SAEs) and no reported drug-related systemic SAEs. • In September 2023, we disclosed the advancement of pipeline program EYP-2301 into pre-clinical development.
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The clinical trial met its primary endpoint with extended time to first supplemental injection compared to aflibercept control for both DURAVYU™ doses. The trial also demonstrated clinically meaningful outcomes including continued safety with no DURAVYU™ related ocular or systemic serious adverse events (SAEs) and an early and sustained improvement in vision and anatomical control.
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EYP-2301 delivers razuprotafib, a small molecule inhibitor of vascular endothelial protein tyrosine phosphatase (VE-PTP) with potential vasculature stabilizing activity, utilizing Durasert E™. • On December 4, 2023, we announced positive topline data for our lead product candidate, EYP-1901, from our Phase 2 DAVIO 2 clinical trial in wet age-related macular degeneration.
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DURAVYU™ 2.7mg demonstrated a +7.1 letter BCVA gain and 68 76-micron CST reduction at week 24, with a supplement-free rate of 73% versus 50% for eyes treated with aflibercept. These positive Phase 2 VERONA results add to a robust dataset across another key indication demonstrating the best-in-class potential for DURAVYU™ in serious retinal diseases.
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Data from the DAVIO 2 clinical trial demonstrated that EYP-1901 achieved all primary and secondary endpoints.
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Recent Developments • On January 8, 2025, we announced the appointment of renowned retina specialist and industry pioneer Reginald J.

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Other EYPT 10-K year-over-year comparisons