[Business Update and Second Quarter 2025 Financial Results Overview](index=1&type=section&id=Business%20Update%20and%20Second%20Quarter%202025%20Financial%20Results%20Overview) [Business Highlights and Strategic Direction](index=1&type=section&id=Business%20Highlights%20and%20Strategic%20Direction) Ocugen reported Q2 2025 financial results and business updates, emphasizing late-stage gene therapy trials, partnerships, and restructuring for three BLA filings within three years - Initiated dosing in **OCU410ST Phase 2/3 GARDian3 pivotal confirmatory clinical trial**[1](index=1&type=chunk) - Actively dosing patients in **OCU400 Phase 3 liMeliGhT clinical trial** and on track for **2026 BLA filing**[1](index=1&type=chunk) - Proposed OrthoCellix reverse merger aims to unlock NeoCart/regenerative cell therapy value and focus capital on modifier gene therapy platform[1](index=1&type=chunk)[2](index=2&type=chunk) - Signed binding term sheet for exclusive Korean rights to OCU400 with upfront and near-term development milestone payments totaling up to **$11 million**[1](index=1&type=chunk)[3](index=3&type=chunk) [Strategic Business Developments](index=1&type=section&id=Strategic%20Business%20Developments) [OrthoCellix Reverse Merger](index=1&type=section&id=OrthoCellix%20Reverse%20Merger) Ocugen announced a proposed reverse merger with OrthoCellix and Carisma Therapeutics to establish a Nasdaq-listed regenerative cell therapy company focused on NeoCart® technology for articular knee cartilage defects - Proposed reverse merger with OrthoCellix and Carisma Therapeutics to create a Nasdaq-listed, late clinical-stage regenerative cell therapy company focused on orthopedic diseases[2](index=2&type=chunk) - The combined company will develop **NeoCart® technology** for articular knee cartilage defects, which has **RMAT designation** and FDA concurrence for a single, confirmatory Phase 3 clinical trial[2](index=2&type=chunk) [OCU400 Korean Licensing Agreement](index=1&type=section&id=OCU400%20Korean%20Licensing%20Agreement) Ocugen secured a binding term sheet for exclusive Korean rights to OCU400, including upfront and milestone fees, sales milestones, and a 25% royalty on net sales, with Ocugen manufacturing commercial supply - Signed a binding term sheet for exclusive Korean rights to OCU400 with a well-established leader in the pharmaceutical and healthcare sector in Korea[3](index=3&type=chunk) - The license agreement includes upfront and milestone fees, sales milestones of **$1 million for every $15 million of net sales in Korea**, and a royalty of **25% on net sales**[3](index=3&type=chunk) - Ocugen will manufacture commercial supply of OCU400 under terms of a supply agreement[3](index=3&type=chunk) [Corporate Leadership and Advocacy](index=2&type=section&id=Corporate%20Leadership%20and%20Advocacy) Ocugen strengthened its leadership team and hosted the NSCEB and U.S. Rep. Chrissy Houlahan, leading to the announcement of a bipartisan BIOTech Caucus to increase awareness and support for biotechnology - Made important appointments to the Board of Directors, Retina Scientific Advisory Board, and Leadership Team to provide scientific and strategic know-how[2](index=2&type=chunk) - Hosted the National Security Commission on Emerging Biotechnology (NSCEB) and U.S. Rep. Chrissy Houlahan at its manufacturing facility, highlighting biotech innovation[9](index=9&type=chunk) - Rep. Houlahan subsequently announced the bipartisan BIOTech Caucus to build greater awareness and understanding of biotechnology among lawmakers[9](index=9&type=chunk) [Clinical Pipeline Progress](index=1&type=section&id=Clinical%20Pipeline%20Progress) [Modifier Gene Therapy Platform](index=2&type=section&id=Modifier%20Gene%20Therapy%20Platform) Ocugen's novel first-in-class modifier gene therapy platform is advancing with OCU400 on track for 2026 BLA/MAA filings, OCU410ST initiating Phase 2/3 trials, and OCU410 showing encouraging Phase 1 and interim Phase 2 data - The modifier gene therapy platform is a novel first-in-class platform designed to address complex diseases potentially caused by imbalances in multiple gene networks[10](index=10&type=chunk)[15](index=15&type=chunk) [OCU410ST for Stargardt Disease](index=1&type=section&id=OCU410ST%20for%20Stargardt%20Disease) OCU410ST for Stargardt disease received Rare Pediatric Disease Designation from the FDA, and dosing commenced in July for the Phase 2/3 GARDian3 pivotal confirmatory clinical trial, building on positive Phase 1 data - FDA granted **Rare Pediatric Disease Designation (RPDD)** to OCU410ST in May, underscoring the urgent need to address Stargardt disease, which has no FDA-approved treatment[4](index=4&type=chunk)[10](index=10&type=chunk) - Initiated dosing in the **OCU410ST Phase 2/3 GARDian3 pivotal confirmatory clinical trial** in July after FDA clearance in June[1](index=1&type=chunk)[5](index=5&type=chunk)[10](index=10&type=chunk) - Phase 1 GARDian trial demonstrated **48% slower lesion growth** at 12-month follow-up and a statistically significant (p=0.031) and clinically meaningful improvement of nearly **2-line/9-letter gain in BCVA** in treated eyes[5](index=5&type=chunk) [OCU410 for Geographic Atrophy (GA)](index=2&type=section&id=OCU410%20for%20Geographic%20Atrophy%20(GA)) OCU410 for Geographic Atrophy has shown positive preliminary efficacy and safety data from its Phase 1 trial, including slower GA lesion growth and visual acuity gains, supported by encouraging interim Phase 2 results - Positive preliminary efficacy and safety data from the OCU410 Phase 1 ArMaDa clinical trial at 12 months demonstrated **no drug-related serious adverse events (SAEs)**[6](index=6&type=chunk) - Phase 1 data showed **23% slower geographic atrophy (GA) lesion growth** in treated eyes versus fellow eyes and a **2-line/10-letter gain in visual acuity**[6](index=6&type=chunk)[10](index=10&type=chunk) - Preliminary results from ongoing Phase 2 clinical trial (N=31), 6-month interim analysis, demonstrated **27% slower lesion growth** and preservation of retinal tissue[6](index=6&type=chunk)[10](index=10&type=chunk) [OCU400 for Retinitis Pigmentosa (RP)](index=2&type=section&id=OCU400%20for%20Retinitis%20Pigmentosa%20(RP)) The OCU400 Phase 3 liMeliGhT clinical trial for retinitis pigmentosa is actively recruiting patients and remains on track for BLA and MAA submissions in 2026, with EMA eligibility granted and DSMB recommending continued dosing - Patients are actively being recruited in the United States and Canada for the **OCU400 Phase 3 liMeliGhT clinical trial**[7](index=7&type=chunk) - The trial remains on track for **BLA and MAA submissions in 2026**, and the European Medicines Agency has granted eligibility for MAA submission through the centralized procedure[1](index=1&type=chunk)[7](index=7&type=chunk)[10](index=10&type=chunk) - Data and Safety Monitoring Board (DSMB) convened and found **no SAEs related to OCU400** and recommended to continue study dosing as planned[10](index=10&type=chunk) [Other Clinical Programs](index=2&type=section&id=Other%20Clinical%20Programs) Ocugen is advancing other clinical programs, including OCU500, an inhaled vaccine, with a Phase 1 clinical trial expected to begin in Q3 2025, and OCU200, an ophthalmic biologic, slated to complete its Phase 1 clinical trial in H2 2025 [OCU500 Inhaled Vaccines](index=2&type=section&id=OCU500%20Inhaled%20Vaccines) The National Institute of Allergy and Infectious Diseases intends to initiate the Phase 1 clinical trial for OCU500, an inhaled vaccine, in the third quarter of 2025 - The National Institute of Allergy and Infectious Diseases (NIAID) intends to initiate the **Phase 1 clinical trial for OCU500** in the **third quarter of 2025**[8](index=8&type=chunk) [OCU200 Ophthalmic Biologic](index=3&type=section&id=OCU200%20Ophthalmic%20Biologic) For OCU200, an ophthalmic biologic product, the DSMB has approved the continuation of dosing in the third cohort, and the company plans to complete the Phase 1 clinical trial in the second half of 2025 - DSMB approved continuation of dosing in the **third cohort for OCU200**[11](index=11&type=chunk) - The Company intends to complete the **Phase 1 clinical trial for OCU200** in the **second half of 2025**[11](index=11&type=chunk) [Second Quarter 2025 Financial Performance](index=3&type=section&id=Second%20Quarter%202025%20Financial%20Performance) [Key Financial Highlights](index=3&type=section&id=Key%20Financial%20Highlights) Ocugen's Q2 2025 financial performance showed decreased cash, cash equivalents, and restricted cash compared to year-end 2024, providing a cash runway into Q1 2026, with reduced operating expenses and net loss per common share Cash, Cash Equivalents, and Restricted Cash (in millions) | Metric | June 30, 2025 | December 31, 2024 | | :----- | :------------ | :---------------- | | Cash, Cash Equivalents, and Restricted Cash | $27.3 million | $58.8 million | - The Company's cash runway is projected into the **first quarter of 2026**[16](index=16&type=chunk)[17](index=17&type=chunk) Total Operating Expenses (Three Months Ended June 30, in millions) | Expense Type | Q2 2025 | Q2 2024 | | :----------- | :------ | :------ | | Total Operating Expenses | $15.2 million | $16.6 million | | Research and Development | $8.4 million | $8.9 million | | General and Administrative | $6.8 million | $7.7 million | Net Loss Per Common Share (Three Months Ended June 30) | Metric | Q2 2025 | Q2 2024 | | :----- | :------ | :------ | | Net Loss Per Common Share | $0.05 | $0.06 | - **292.2 million shares of common stock outstanding** as of June 30, 2025[16](index=16&type=chunk) [Conference Call and Webcast Details](index=3&type=section&id=Conference%20Call%20and%20Webcast%20Details) [Conference Call and Webcast Information](index=3&type=section&id=Conference%20Call%20and%20Webcast%20Information) Ocugen hosted a conference call and webcast on August 1, 2025, at 8:30 a.m. ET to discuss financial results and business highlights, with participation details provided and a replay available for approximately 45 days - A conference call and webcast were scheduled for **August 1, 2025, at 8:30 a.m. ET** to discuss financial results and business highlights[1](index=1&type=chunk)[13](index=13&type=chunk) - Dial-in numbers: **(800) 715-9871** for U.S. callers and **(646) 307-1963** for international callers; Conference ID: **9627149**[14](index=14&type=chunk) - Webcast available on the events section of the Ocugen investor site, with a replay and archived webcast available for approximately **45 days**[14](index=14&type=chunk) [About Ocugen, Inc.](index=3&type=section&id=About%20Ocugen%2C%20Inc.) [Company Profile and Mission](index=3&type=section&id=Company%20Profile%20and%20Mission) Ocugen, Inc. is a pioneering biotechnology company focused on gene therapies for blindness diseases, utilizing its breakthrough modifier gene therapy platform with a gene-agnostic approach to address complex diseases affecting millions globally - Ocugen, Inc. is a pioneering biotechnology leader in gene therapies for blindness diseases[15](index=15&type=chunk) - Utilizes a breakthrough **modifier gene therapy platform** with a gene-agnostic approach to address significant unmet medical needs for large patient populations[15](index=15&type=chunk) - Programs are in development for inherited retinal diseases and blindness diseases affecting millions, including retinitis pigmentosa, Stargardt disease, and geographic atrophy[15](index=15&type=chunk) [Cautionary Note on Forward-Looking Statements](index=4&type=section&id=Cautionary%20Note%20on%20Forward-Looking%20Statements) [Forward-Looking Statements Disclosure](index=4&type=section&id=Forward-Looking%20Statements%20Disclosure) This section serves as a cautionary note, indicating that the press release contains forward-looking statements regarding Ocugen's strategy, clinical programs, financial condition, and potential transactions, which are subject to numerous risks and uncertainties - The press release contains forward-looking statements regarding strategy, business plans, clinical programs, financial condition, and anticipated regulatory filings[17](index=17&type=chunk) - Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from current expectations[17](index=17&type=chunk) - Risks include that preliminary clinical trial results may not be indicative of final data, and that definitive agreements for the Korean license or OrthoCellix merger may be delayed or not executed[17](index=17&type=chunk) [Contact Information](index=4&type=section&id=Contact%20Information) [Media and Investor Relations Contact](index=4&type=section&id=Media%20and%20Investor%20Relations%20Contact) For media and investor inquiries, Tiffany Hamilton, AVP, Head of Communications, is listed as the primary contact for Ocugen - Contact for inquiries: **Tiffany Hamilton, AVP, Head of Communications**[18](index=18&type=chunk) - Email: **Tiffany.Hamilton@ocugen.com**[18](index=18&type=chunk) [Condensed Consolidated Financial Statements](index=5&type=section&id=Condensed%20Consolidated%20Financial%20Statements) [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The unaudited condensed consolidated balance sheets present Ocugen's financial position as of June 30, 2025, compared to December 31, 2024, detailing assets, liabilities, and stockholders' equity Condensed Consolidated Balance Sheets (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | **Assets** | | | | Cash | $27,013 | $58,514 | | Prepaid expenses and other current assets | $5,870 | $3,168 | | Total current assets | $32,883 | $61,682 | | Property and equipment, net | $15,445 | $16,554 | | Restricted cash | $312 | $307 | | Other assets | $4,954 | $3,899 | | Total assets | $53,594 | $82,442 | | **Liabilities and Stockholders' Equity** | | | | Accounts payable | $4,237 | $4,243 | | Accrued expenses and other current liabilities | $12,899 | $15,500 | | Operating lease obligations | $853 | $519 | | Current portion of long term debt | — | $1,326 | | Total current liabilities | $17,989 | $21,588 | | Operating lease obligations, less current portion | $3,945 | $3,313 | | Long term debt, net | $28,025 | $27,345 | | Other non-current liabilities | $583 | $564 | | Total non-current liabilities | $32,553 | $31,222 | | Total liabilities | $50,542 | $52,810 | | Common Stock | $2,924 | $2,915 | | Treasury stock | $(48) | $(48) | | Additional paid-in capital | $370,474 | $366,938 | | Accumulated other comprehensive income | $12 | $48 | | Accumulated deficit | $(370,31) | $(340,221) | | Total stockholders' equity | $3,052 | $29,632 | | Total liabilities and stockholders' equity | $53,594 | $82,442 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The unaudited condensed consolidated statements of operations and comprehensive loss provide a detailed breakdown of Ocugen's revenues, operating expenses, and net loss for the three and six months ended June 30, 2025, compared to the same periods in 2024 Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except per share) | Metric | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :------------------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Collaborative arrangement revenue | $1,373 | $1,141 | $2,854 | $2,155 | | Total revenue | $1,373 | $1,141 | $2,854 | $2,155 | | Research and development expenses | $8,402 | $8,902 | $17,932 | $15,728 | | General and administrative expenses | $6,766 | $7,688 | $13,218 | $14,092 | | Total operating expenses | $15,168 | $16,590 | $31,150 | $29,820 | | Loss from operations | $(13,795) | $(15,449) | $(28,296) | $(27,665) | | Interest (expense) income, net | $(1,058) | $173 | $(1,972) | $475 | | Other (expense) income, net | $114 | $(4) | $179 | $(14) | | Net loss | $(14,739) | $(15,280) | $(30,089) | $(27,204) | | Foreign currency translation adjustment | $(28) | $3 | $(36) | $8 | | Comprehensive loss | $(14,767) | $(15,277) | $(30,125) | $(27,196) | | Net loss attributable to common shareholders— basic and diluted | $(14,739) | $(15,259) | $(30,089) | $(27,157) | | Weighted shares used in calculating net loss per common share — basic and diluted | 292,067,192 | 257,353,857 | 292,032,072 | 257,293,247 | | Net loss per share attributable to common shareholders — basic and diluted | $(0.05) | $(0.06) | $(0.10) | $(0.11) | | Net loss attributable to Series B Convertible Preferred shareholders — basic and diluted | — | $(21) | — | $(47) | | Weighted shares used in calculating net loss per Series B Convertible Preferred Stock — basic and diluted | — | 54,745 | — | 54,745 | | Net loss per share attributable to Series B Convertible Preferred shareholders — basic and diluted | — | $(0.38) | — | $(0.86) |

Company Performance - Ocugen reported a quarterly loss of $0.05 per share, which was better than the Zacks Consensus Estimate of a loss of $0.06, representing an earnings surprise of +16.67% [1] - The company posted revenues of $1.37 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 1.93%, compared to revenues of $1.14 million a year ago [2] - Over the last four quarters, Ocugen has surpassed consensus EPS estimates two times but has not beaten consensus revenue estimates [2] Stock Movement and Outlook - Ocugen shares have increased by approximately 28% since the beginning of the year, outperforming the S&P 500's gain of 7.8% [3] - The future performance of Ocugen's stock will largely depend on management's commentary during the earnings call and the company's earnings outlook [4][6] - The current consensus EPS estimate for the upcoming quarter is -$0.06 on revenues of $1.2 million, and for the current fiscal year, it is -$0.23 on revenues of $2.86 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Ocugen belongs, is currently in the top 40% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Ocugen's stock performance [5]

Financial Data and Key Metrics Changes - The company's cash, cash equivalents, and restricted cash totaled $27.3 million as of June 30, 2025, down from $58.8 million as of December 31, 2024 [23] - Total operating expenses for the three months ended June 30, 2025, were $15.2 million, compared to $16.6 million for the same period in 2024 [23] Business Line Data and Key Metrics Changes - The OCU400 Phase three Limelight clinical trial for retinitis pigmentosa is currently recruiting patients in the United States and Canada, with BLA and MAA filings expected in 2026 [9] - The OCU410 ST clinical trial for Stargardt disease has achieved key milestones, including the first patient dosing and rare pediatric disease designation [12][13] - Preliminary data for OCU410 ST shows a 23% slower lesion growth compared to untreated eyes after a single subretinal injection [15] Market Data and Key Metrics Changes - The OCU400 gene therapy has the potential to address over 100 different mutations associated with retinitis pigmentosa, which currently lacks approved treatment options for approximately 298,000 patients in the US and Europe [11] - Stargardt disease affects around 100,000 individuals in the US and Europe, with no FDA-approved treatment available [12] Company Strategy and Development Direction - The company aims to file three biological licensing applications and market authorization applications in the next three years [7] - A regional partnership for OCU400 has been signed, with plans to close the definitive agreement by September [16] - The proposed reverse merger with OrthoCelix is intended to create a NASDAQ-listed late clinical stage regenerative cell therapy company [17] Management's Comments on Operating Environment and Future Outlook - Management expressed enthusiasm about the progress of their modified gene therapy platform and the positive response from recent collaborations [7][9] - The company is actively exploring strategic partnerships to enhance funding and minimize shareholder dilution [56] Other Important Information - The Data and Safety Monitoring Board reported no serious adverse events related to OCU400, allowing the study to continue as planned [12] - Leadership changes were made to strengthen the company's internal expertise and critical functions [20][21] Q&A Session Summary Question: Are there any other deals that you might be looking to execute? - The company is continuously looking for potential partnership opportunities, including regional partnerships for all gene therapy programs [28] Question: Can you remind us how many sites are included in the Stargardt Phase three trial? - There are 15 centers activated for the Stargardt trial, and the company does not anticipate challenges in enrolling patients due to the lack of approved products [33][34] Question: Can you talk about the potential interim update for OCU410? - An interim analysis for the geographic atrophy trial is expected in the fourth quarter, providing structural and functional outcomes [43] Question: When will we get feedback from the EMA regarding the pivotal study? - Feedback from the EMA regarding Stargardt is expected by the fourth quarter of this year [46] Question: How does the company plan to bring in additional funds? - The company is working on potential business development opportunities and partnerships to bring in non-dilutive funding [56]

Financial Data and Key Metrics Changes - The company's cash, cash equivalents, and restricted cash totaled $27.3 million as of June 30, 2025, down from $58.8 million as of December 31, 2024 [22] - Total operating expenses for the three months ended June 30, 2025, were $15.2 million, including $8.4 million in research and development expenses and $6.8 million in general and administrative expenses, compared to $16.6 million in the same period of 2024 [22][23] Business Line Data and Key Metrics Changes - The OCU400 Phase three Limelight clinical trial for retinitis pigmentosa is actively recruiting patients in the United States and Canada, with a target for BLA and MAA filings in 2026 [7] - The OCU410 ST clinical trial for Stargardt disease has achieved key milestones, including the first patient dosing in July 2025 [12] - Preliminary data for OCU410 ST and OCU410 shows favorable safety and efficacy with improved structural and functional outcomes [8] Market Data and Key Metrics Changes - The OCU400 therapy has the potential to address over 100 different mutations associated with retinitis pigmentosa, which currently lacks approved treatment options for approximately 298,000 patients in the US and Europe [10] - Stargardt disease affects around 100,000 individuals in the US and Europe combined, with an estimated one million people globally, and there is currently no FDA-approved treatment available [11] Company Strategy and Development Direction - The company aims to file three biological licensing applications and market authorization applications in the next three years, focusing on providing one-time therapies for significant unmet medical needs [6] - A regional partnership for OCU400 has been signed with a well-established leader in the pharmaceutical sector in Korea, allowing the company to retain rights in larger geographies [16] - The proposed reverse merger with OrthoCelix is intended to create a NASDAQ-listed late clinical stage regenerative cell therapy company, focusing on orthopedic diseases [17] Management's Comments on Operating Environment and Future Outlook - Management expressed enthusiasm about the progress of their modified gene therapy platform and the positive response from the FDA regarding their clinical trials [6][12] - The company is actively exploring strategic partnerships to enhance its financial position and drive long-term strategy [23] Other Important Information - The Data and Safety Monitoring Board reported no serious adverse events related to OCU400, recommending the continuation of the study [11] - Leadership changes were made to strengthen the company's internal expertise, including the appointment of a new Chief Development Officer and Executive Vice President of Commercial and Business Development [20] Q&A Session Summary Question: Are there any other deals that you might be looking to execute? - The company is continuously looking for potential partnership opportunities, including regional partnerships for all gene therapy programs [27] Question: How many sites are included in the Stargardt Phase three trial? - The trial has 15 centers activated, and the company does not anticipate challenges in enrolling Stargardt patients due to the lack of approved products [32] Question: What does a 27% lesion growth reduction in GA mean for patients? - A 27% reduction in lesion growth is expected to significantly help patients maintain their visual function over time [34] Question: Was there a futility analysis during the DSMB review? - There was no futility analysis; the review was purely for safety [40] Question: When will the interim analysis for geographic atrophy be updated? - The interim analysis data is expected in the fourth quarter, providing structural and functional outcomes [41] Question: What is the regulatory path for OCU400 in Korea? - The company expects to use US FDA approval to gain approval in Korea without needing further clinical trials [63]

Core Viewpoint - Ocugen, Inc. is advancing its gene therapy programs for blindness diseases, with significant clinical trial progress and strategic partnerships aimed at supporting future Biologics License Application (BLA) filings [2][11]. Business Development - The company is focused on securing strategic partnerships, including a licensing agreement for OCU400 in Korea, which includes sales milestones of $1 million for every $15 million in net sales and a 25% royalty on net sales [3]. - A proposed reverse merger with OrthoCellix and Carisma Therapeutics aims to create a Nasdaq-listed regenerative cell therapy company, enhancing focus on orthopedic diseases and the NeoCart technology [2]. Clinical Trials and Designations - The FDA has granted Rare Pediatric Disease Designation (RPDD) to OCU410ST for Stargardt disease, highlighting the unmet medical need for this condition affecting approximately 100,000 people in the U.S. and Europe [4]. - The OCU410ST Phase 2/3 GARDian3 clinical trial has commenced, building on positive results from the Phase 1 trial, which showed a 48% slower lesion growth in treated eyes [5]. - Preliminary data from the OCU410 Phase 1 ArMaDa trial indicated a 23% slower geographic atrophy lesion growth and a 2-line/10-letter gain in visual acuity [6]. Financial Performance - As of June 30, 2025, the company reported cash and cash equivalents of $27.3 million, down from $58.8 million at the end of 2024, providing a cash runway into the first quarter of 2026 [16]. - Total operating expenses for Q2 2025 were $15.2 million, a decrease from $16.6 million in Q2 2024, with research and development expenses at $8.4 million [16][25]. - The company reported a net loss of $0.05 per common share for Q2 2025, compared to a net loss of $0.06 per common share in the same period of 2024 [16][26].

Core Insights - Ocugen, Inc. is enhancing its Retina Scientific Advisory Board and Executive Leadership Team to strengthen its expertise and guidance as it aims for three Biologics License Applications (BLAs) in the next three years [1][2] Leadership and Advisory Board Updates - The company has appointed three renowned retinal surgeons to its Retina Scientific Advisory Board to provide innovative therapeutic options for patients with serious retinal diseases [2][3][4][5] - New members include Dr. Jeffrey S. Heier, Dr. Peter K. Kaiser, and Dr. Arshad M. Khanani, who bring extensive experience in retinal research and clinical trials [3][4][5][6] - Dr. Lejla Vajzovic continues as the SAB chair, alongside existing members Dr. David S. Boyer and Dr. Carl D. Regillo [6] Strategic Appointments - Vijay Tammara, PhD, has been appointed as Chief Development Officer, bringing over 32 years of regulatory experience and a track record of successful marketing authorizations [8][9] - Abhi Gupta, MBA, has been named Executive Vice President of Commercial and Business Development, with over 20 years of experience in gene therapy and corporate development [10][11] Company Focus and Goals - Ocugen aims to optimize its R&D and clinical efforts while pursuing strategic partnerships and developing a commercial strategy [7] - The company is focused on delivering paradigm-changing gene therapies for inherited retinal diseases and other blindness conditions affecting millions globally [12]

Core Viewpoint - Ocugen, Inc. has initiated dosing for the first patient in its Phase 2/3 GARDian3 clinical trial for OCU410ST, a gene therapy aimed at treating Stargardt disease, marking a significant milestone in addressing the unmet medical needs of patients suffering from this condition [1][2]. Company Overview - Ocugen, Inc. is a biotechnology company focused on developing gene therapies for blindness diseases, aiming to provide innovative solutions for patients globally [9]. Clinical Trial Details - The Phase 2/3 GARDian3 trial will enroll 51 participants diagnosed with Stargardt disease, with 34 receiving a one-time subretinal injection of OCU410ST and 17 in a control group [4]. - The primary objective of the trial is to evaluate the reduction in atrophic lesion size, with key secondary endpoints including improvements in best corrected visual acuity (BCVA) and low luminance visual acuity (LLVA) [4]. Previous Trial Results - The Phase 1 GARDian trial showed promising results, with a 48% slower lesion growth at 12-month follow-up in treated eyes compared to untreated eyes, and a statistically significant improvement in BCVA [2][3]. Future Plans - Ocugen plans to submit a Biologics License Application (BLA) for OCU410ST in 2027, as part of its strategy to file three BLAs over the next three years [5]. Disease Background - Stargardt disease is the most common form of inherited macular degeneration, leading to progressive vision loss due to the degeneration of photoreceptor cells in the retina [7][8].

Company Overview - Ocugen, Inc. is a pioneering biotechnology leader focused on gene therapies for blindness diseases, utilizing a breakthrough modifier gene therapy platform to address significant unmet medical needs for large patient populations [3] Upcoming Events - The company will host a conference call and live webcast to discuss its second quarter 2025 financial results and provide a business update on August 1, 2025, at 8:30 a.m. ET [1] - A pre-market earnings announcement will be issued on the same day, with dial-in numbers provided for U.S. and international callers [2] Business Focus - Ocugen's modifier gene therapies aim to address complex diseases potentially caused by imbalances in multiple gene networks, with current programs in development for inherited retinal diseases and blindness diseases affecting millions globally, including retinitis pigmentosa, Stargardt disease, and geographic atrophy [3]

Core Viewpoint - Carisma Therapeutics Inc. and OrthoCellix, Inc. have announced a definitive merger agreement to combine in an all-stock transaction, focusing on the development of OrthoCellix's NeoCart® technology for knee cartilage defects and planning to initiate a Phase 3 clinical trial endorsed by the FDA [1][2][4]. Company Overview - Carisma Therapeutics is a biotechnology company specializing in macrophage engineering for therapies targeting fibrosis and cancer [11]. - OrthoCellix is a clinical-stage company developing regenerative cell therapies for orthopedic diseases, with its lead program being the NeoCart® technology aimed at repairing knee cartilage defects [10][3]. NeoCart® Technology - NeoCart® is an autologous cartilage implant technology that utilizes patient cells to repair articular cartilage defects, combining a fortified 3D scaffold with patented bioprocessing technology to produce functional cartilage [3][10]. - The technology has received Regenerative Medicine Advanced Therapy (RMAT) designation and FDA concurrence for a single, confirmatory Phase 3 clinical trial, which is anticipated to launch by the end of 2025 [4][6]. Merger Details - Under the merger agreement, OrthoCellix will merge into a wholly-owned subsidiary of Carisma, with OrthoCellix continuing as a subsidiary and the surviving entity [5][6]. - The merger will result in OrthoCellix stockholders owning approximately 90% of the combined company, while existing Carisma stockholders will own about 10%, subject to adjustments based on Carisma's net cash and financing proceeds [6][8]. Financial Aspects - Carisma plans to enter into subscription agreements for private financing with Ocugen and other investors to support the Phase 3 trial of NeoCart® without additional costs to Ocugen [5][6]. - The merger has been unanimously approved by the boards of both companies and is expected to close in the second half of 2025, pending customary closing conditions [8].

Company Overview - Ocugen Inc. is a clinical-stage biotechnology company focused on developing modifier gene therapies for rare inherited retinal diseases that lead to progressive vision loss [1]. Pipeline and Focus - The company is particularly concentrating on therapies for diseases that cause vision impairment, indicating a specialized approach within the biotechnology sector [1].