Ocugen(OCGN) - 2025 Q2 - Quarterly Report

Disclosure Regarding Forward-Looking Statements Forward-Looking Statements Overview The report includes forward-looking statements on strategy and operations, cautioning investors about inherent risks - The report contains forward-looking statements regarding strategy, future operations, financial position, revenues, costs, prospects, plans, and objectives[10] - Statements involve known and unknown risks, uncertainties, and other important factors that may cause actual results to differ materially[10] - Key forward-looking statements include estimates for expenses, future revenues, capital requirements, and progress of product candidates OCU400, OCU410, OCU410ST[11] - Investors should not place undue reliance on forward-looking statements, as the company does not assume any obligation to update them, except as required by law[12][13] PART I—FINANCIAL INFORMATION Item 1. Financial Statements (Unaudited) This section presents the unaudited condensed consolidated financial statements for the periods ended June 30, 2025 Condensed Consolidated Balance Sheets Condensed Consolidated Balance Sheets | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--- | :--- | :--- | | Cash | $27,013 | $58,514 | | Total current assets | $32,883 | $61,682 | | Total assets | $53,594 | $82,442 | | Total current liabilities | $17,989 | $21,588 | | Total liabilities | $50,542 | $52,810 | | Total stockholders' equity | $3,052 | $29,632 | - Cash decreased significantly from $58.5 million at December 31, 2024, to $27.0 million at June 30, 2025[19] - Total stockholders' equity decreased from $29.6 million to $3.1 million, primarily due to accumulated deficit[19] Condensed Consolidated Statements of Operations and Comprehensive Loss Condensed Consolidated Statements of Operations and Comprehensive Loss | Metric | Three months ended June 30, 2025 (in thousands) | Three months ended June 30, 2024 (in thousands) | Six months ended June 30, 2025 (in thousands) | Six months ended June 30, 2024 (in thousands) | | :--- | :--- | :--- | :--- | :--- | | Collaborative arrangement revenue | $1,373 | $1,141 | $2,854 | $2,155 | | Total operating expenses | $15,168 | $16,590 | $31,150 | $29,820 | | Net loss | $(14,739) | $(15,280) | $(30,089) | $(27,204) | | Net loss per common share — basic and diluted | $(0.05) | $(0.06) | $(0.10) | $(0.11) | - Collaborative arrangement revenue increased by $0.2 million (19.9%) for the three months ended June 30, 2025, and by $0.7 million (32.4%) for the six months ended June 30, 2025[21][154][160] - Net loss for the six months ended June 30, 2025, was $(30.1) million, an increase from $(27.2) million in the prior year, primarily due to increased R&D and interest expenses[21][161][163] Condensed Consolidated Statements of Stockholders' Equity Condensed Consolidated Statements of Stockholders' Equity | Metric | December 31, 2024 (in thousands) | June 30, 2025 (in thousands) | | :--- | :--- | :--- | | Common Stock Shares | 291,489,058 | 292,313,561 | | Additional Paid-in Capital | $366,938 | $370,474 | | Accumulated Deficit | $(340,221) | $(370,310) | | Total Stockholders' Equity | $29,632 | $3,052 | - Accumulated deficit increased by approximately $30.1 million from December 31, 2024, to June 30, 2025, reflecting the net loss incurred during the period[22] - Total stockholders' equity decreased significantly from $29.6 million to $3.1 million over the six-month period[22] Condensed Consolidated Statements of Cash Flows Condensed Consolidated Statements of Cash Flows | Cash Flow Activity | Six months ended June 30, 2025 (in thousands) | Six months ended June 30, 2024 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | $(30,087) | $(20,506) | | Net cash used in investing activities | $(190) | $(2,865) | | Net cash used in financing activities | $(1,184) | $(100) | | Net decrease in cash and restricted cash | $(31,497) | $(23,463) | | Cash and restricted cash at end of period | $27,325 | $15,999 | - Net cash used in operating activities increased to $30.1 million for the six months ended June 30, 2025, from $20.5 million in the prior year, primarily due to higher net loss[27][170][171] - Cash used in financing activities increased to $1.2 million, mainly due to the repayment of part of the EB-5 loan[27][173] Notes to Condensed Consolidated Financial Statements Note 1. Nature of Business and Going Concern The company's recurring net losses and insufficient cash raise substantial doubt about its ability to continue as a going concern - Ocugen is a biotechnology company focused on discovering, developing, and commercializing novel gene therapies[29] - The company incurred net losses of $30.1 million and $27.2 million for the six months ended June 30, 2025 and 2024, respectively, and has an accumulated deficit of $370.3 million[30] - Current cash of $27.0 million is insufficient to fund operations for the next 12 months, indicating substantial doubt about the company's ability to continue as a going concern[30][32] - Ocugen plans to merge its NeoCart business with Carisma Therapeutics Inc, with Ocugen expected to own over 50% of the combined company[33][36][38] Note 2. Summary of Significant Accounting Policies This note outlines significant accounting policies, including a revision to EPS calculation for Series B Preferred Stock - The company revised its financial statements to treat Series B Convertible Preferred Stock as a second class of common stock for EPS purposes[40][41] Impact of Revision on Net Loss Attributable to Common Shareholders (Three Months Ended June 30, 2024) | Metric | As Previously Reported (in thousands) | Adjustment (in thousands) | As Adjusted (in thousands) | | :--- | :--- | :--- | :--- | | Net loss attributable to common shareholders | $(10,292) | $(4,967) | $(15,259) | | Net loss per share attributable to common shareholders | $(0.04) | | $(0.06) | - The company adopted ASU 2023-07 on segment reporting in fiscal year 2024 with no impact on reportable segments[69][70][71][72] Cash and Restricted Cash Reconciliation (in thousands) | Category | As of June 30, 2025 | As of June 30, 2024 | | :--- | :--- | :--- | | Cash | $27,013 | $15,697 | | Restricted cash | $312 | $302 | | Total cash and restricted cash | $27,325 | $15,999 | Note 3. License and Development Agreements Ocugen has a co-development and commercialization agreement with CanSinoBIO for its modifier gene therapy product candidates - Ocugen has a co-development and commercialization agreement with CanSinoBIO for modifier gene therapy product candidates OCU400, OCU410, and OCU410ST[73] - CanSinoBIO is responsible for manufacturing in its territory (China, Hong Kong, Macau, Taiwan), while Ocugen holds exclusive rights elsewhere[73] - Collaborative arrangement revenue was approximately $2.9 million for the six months ended June 30, 2025, compared to $2.2 million for the same period in 2024[78] - The contract liability related to these arrangements was $6.6 million as of June 30, 2025, down from $8.8 million as of June 30, 2024[79] Note 4. Fair Value Measurements The fair value of the company's debt instruments approximates their carrying value based on Level 2 inputs - The fair value of borrowings under the EB-5 Loan Agreement and Loan and Security Agreement approximates their carrying value, using Level 2 inputs[80] Note 5. Property and Equipment Net property and equipment decreased to $15.4 million at June 30, 2025, from $16.6 million at year-end 2024 Property and Equipment, Net | Category | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--- | :--- | :--- | | Furniture and fixtures | $455 | $433 | | Machinery and equipment | $3,235 | $3,192 | | Leasehold improvements | $16,089 | $16,089 | | Total property and equipment, net | $15,445 | $16,554 | - Total property and equipment, net, decreased by approximately $1.1 million from December 31, 2024, to June 30, 2025[81] Note 6. Operating Leases The company's future minimum lease payments total $6.3 million, with a present value of $4.8 million - The company leases office, laboratory, and manufacturing space, with its Malvern, Pennsylvania GMP facility lease including an option to extend for up to five years[82] Future Minimum Base Rent Payments | For the years ending December 31, | Amount (in thousands) | | :--- | :--- | | Remainder of 2025 | $642 | | 2026 | $1,259 | | 2027 | $1,197 | | 2028 | $1,216 | | 2029 | $985 | | 2030 | $387 | | Thereafter | $661 | | Total | $6,347 | | Less: present value adjustment | $(1,549) | | Present value of minimum lease payments | $4,798 | Note 7. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities decreased to $12.9 million, driven by lower deferred revenue and employee-related expenses Accrued Expenses and Other Current Liabilities | Category | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--- | :--- | :--- | | Research and development | $250 | $160 | | Clinical | $388 | $740 | | Professional fees | $1,153 | $977 | | Employee-related | $1,671 | $2,433 | | Deferred revenue relating to collaborative arrangements | $6,603 | $8,368 | | Other | $2,834 | $2,822 | | Total accrued expenses and other current liabilities | $12,899 | $15,500 | - Deferred revenue from collaborative arrangements decreased by $1.8 million, and employee-related accrued expenses decreased by $0.8 million[84] Note 8. Debt The company's debt includes an EB-5 Loan and a Loan and Security Agreement with a variable interest rate - The EB-5 Loan Agreement had $1.5 million principal outstanding as of June 30, 2025, down from $2.5 million at December 31, 2024[90] - The Loan and Security Agreement, entered in November 2024, provided $29.2 million in net proceeds, with a $30.0 million principal outstanding as of June 30, 2025[91] - The Loan and Security Agreement matures on November 1, 2028, with the first 24 months being interest-only, and bears interest at a variable rate (greater of prime + 4.25% or 12.25%)[90] - Lenders have the right to convert up to $6.0 million of outstanding principal into common stock at 80% of the trading price on the conversion date[90] Scheduled Debt Maturities (in thousands) | For the years ending December 31, | Total Maturities | | :--- | :--- | | 2025 | $0 | | 2026 | $1,250 | | 2027 | $16,000 | | 2028 | $13,750 | | 2029 and thereafter | $500 | | Total Debt | $31,500 | Note 9. Equity The company raised $32.3 million in net proceeds from a public offering and increased its authorized capital stock - In July 2024, Ocugen issued and sold 30.4 million shares of common stock at $1.15 per share in a public offering, generating $32.3 million in net proceeds[94] - An additional $2.4 million in net proceeds was received in August 2024 from the underwriter's exercise of its option to purchase 2.3 million shares[94] - In July 2024, the company's authorized capital stock was increased to 400 million shares (390 million common, 10 million preferred)[95] - The Series B Convertible Preferred Stock, previously issued to Bharat Biotech, was redeemed in May 2024 through a Stock Forfeiture Agreement[98] Note 10. Warrants As of June 30, 2025, the company had 0.6 million warrants outstanding with a weighted average exercise price of $6.23 - As of June 30, 2025, 0.6 million warrants were outstanding[98] - The outstanding warrants had a weighted average exercise price of $6.23 per share and expire between 2026 and 2027[98] Note 11. Stock-Based Compensation Stock-based compensation expense was $3.7 million for the six months ended June 30, 2025, with $12.5 million unrecognized Stock-Based Compensation Expense | Expense Category | Three months ended June 30, 2025 (in thousands) | Three months ended June 30, 2024 (in thousands) | Six months ended June 30, 2025 (in thousands) | Six months ended June 30, 2024 (in thousands) | | :--- | :--- | :--- | :--- | :--- | | General and administrative | $1,104 | $1,333 | $2,203 | $2,649 | | Research and development | $741 | $565 | $1,527 | $1,010 | | Total | $1,845 | $1,898 | $3,730 | $3,659 | - As of June 30, 2025, the company had $12.5 million of unrecognized stock-based compensation expense, expected to be recognized over a weighted-average period of 2.2 years[99] Stock Option Activity (June 30, 2025) | Metric | Number of Shares | Weighted Average Exercise Price | | :--- | :--- | :--- | | Options outstanding at Dec 31, 2024 | 16,197,148 | $2.01 | | Granted | 7,585,836 | $0.90 | | Exercised | (158,164) | $0.44 | | Forfeited | (391,490) | $2.36 | | Expired | (21,573) | $0.93 | | Options outstanding at June 30, 2025 | 23,211,757 | $1.65 | PSUs Unvested Activity (June 30, 2025) | Metric | Number of Shares | Weighted Average Grant-Date Fair Value | | :--- | :--- | :--- | | PSUs unvested at Dec 31, 2024 | 872,352 | $1.71 | | Granted | 3,314,445 | $1.58 | | PSUs unvested at June 30, 2025 | 4,186,797 | $1.61 | Note 12. Net Loss Per Share of Common Stock Net loss per common share was $(0.10) for the six months ended June 30, 2025, with potentially dilutive securities excluded Net Loss Per Share Calculation | 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 | | :--- | :--- | :--- | :--- | :--- | | Net loss attributable to common shareholders | $(14,739) | $(15,259) | $(30,089) | $(27,157) | | Weighted shares used in calculating net loss per common share | 292,067,192 | 257,353,857 | 292,032,072 | 257,293,247 | | Net loss per share attributable to common shareholders | $(0.05) | $(0.06) | $(0.10) | $(0.11) | - Potentially dilutive securities totaling 28.9 million as of June 30, 2025 were excluded from diluted EPS calculation due to their antidilutive effect[109] Note 13. Commitments and Contingencies The company is involved in legal proceedings, including a dismissed securities class action and several stockholder derivative lawsuits - Commitments include license and development agreements, lease obligations, and debt agreements[110] - A securities class action lawsuit filed in April 2024 was dismissed with prejudice in July 2025, though plaintiffs have 30 days to appeal[111] - Multiple stockholder derivative lawsuits are stayed pending resolution of the securities class action motion to dismiss[112] - The company believes the lawsuits are without merit and intends to vigorously defend, with no current assessment of likely outcome or material loss[114] Note 14. Segment Reporting Ocugen operates as a single operating and reportable segment focused on gene therapies - Ocugen operates as one operating and reportable segment focused on gene therapies, with revenue from the CanSinoBIO co-development agreement[115] - The CEO, as CODM, reviews financial information and uses net loss at the consolidated level for resource allocation and performance assessment[116] Segment Profit or Loss and Significant Expenses (Six Months Ended June 30, in thousands) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Collaborative arrangement revenue | $2,854 | $2,155 | | Total research and development | $17,932 | $15,728 | | General and administrative | $13,218 | $14,092 | | Loss from operations | $(28,296) | $(27,665) | | Segment and consolidated net loss | $(30,089) | $(27,204) | Note 15. Subsequent Events The company received and subsequently regained compliance with the Nasdaq minimum bid price requirement in July 2025 - On July 1, 2025, Ocugen received a Nasdaq notice for non-compliance with the minimum bid price requirement ($1.00 per share)[120] - The company regained compliance by July 28, 2025, by maintaining a minimum closing bid price of $1.00 or more for ten consecutive business days[120] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses financial results, pipeline progress, and liquidity challenges, emphasizing the need for additional funding Overview Ocugen is a biotechnology company developing a pipeline of gene therapies, biologic therapies, and vaccines - OCU400 is in a Phase 3 trial for Retinitis Pigmentosa, with BLA/MAA filings anticipated in 2026[123][137][140] - OCU410ST initiated dosing in a pivotal trial for Stargardt disease, targeting a BLA submission in 2027[124][143] - OCU410 completed dosing in a Phase 1/2 trial for geographic atrophy, showing positive preliminary data[125][148] - OCU200 dosed its first patient in a Phase 1 trial for DME, DR, and wet AMD, with completion expected in H2 2025[126][149][150] - NeoCart is a Phase 3-ready regenerative medicine cell therapy for knee cartilage injuries[131][151] - OCU500, an inhaled mucosal vaccine for COVID-19, is expected to begin a Phase 1 trial in Q3 2025[131][152] Recent Events The company announced a planned merger of its NeoCart business and a licensing term sheet for OCU400 in Korea - Ocugen entered into a Merger Agreement on June 22, 2025, to merge its NeoCart product candidate business with Carisma Therapeutics Inc[128] - Ocugen is estimated to own more than 50% of the combined company and will continue to consolidate OrthoCellix, with the merger expected to close in Q4 2025[130][134] - Ocugen entered a binding term sheet for exclusive Korean rights to OCU400, expecting up to $11 million in upfront/near-term milestones and a 25% royalty on net sales[135] Results of Operations Net loss decreased for the three-month period but increased for the six-month period ended June 30, 2025 Financial Performance (Three Months Ended June 30, in thousands) | Metric | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Collaborative revenue | $1,373 | $1,141 | $232 | | Research and development | $8,402 | $8,902 | $(500) | | General and administrative | $6,766 | $7,688 | $(922) | | Net loss | $(14,739) | $(15,280) | $541 | - Research and development expense decreased by $0.5 million for the three months ended June 30, 2025, due to a decrease in OCU500 preclinical activities[155] - General and administrative expense decreased by $0.9 million for the three months, mainly due to reduced professional services fees[156] Financial Performance (Six Months Ended June 30, in thousands) | Metric | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Collaborative revenue | $2,854 | $2,155 | $699 | | Research and development | $17,932 | $15,728 | $2,204 | | General and administrative | $13,218 | $14,092 | $(874) | | Net loss | $(30,089) | $(27,204) | $(2,885) | - Research and development expense increased by $2.2 million for the six months, primarily due to increased headcount-related expenses[161] - Interest (expense) income, net, decreased by $2.5 million for the six months, due to interest expense on long-term debt leveraged in Q4 2024[163] Liquidity and Capital Resources The company's current cash is insufficient to fund operations for the next 12 months, raising going concern doubts - As of June 30, 2025, Ocugen had $27.0 million in cash, which is insufficient to fund operations for the next 12 months[165][177][178] - Since inception through June 30, 2025, the company raised $368.9 million, primarily from equity sales[165] - In November 2024, Ocugen secured $29.2 million in net proceeds from a Loan and Security Agreement[166] - In July 2024, a public offering generated $34.7 million in net proceeds from the sale of 32.7 million common shares[167] - Net cash used in operating activities was $30.1 million for the six months ended June 30, 2025, compared to $20.5 million in the prior year[169][170][171] - Future funding requirements are significant and depend on clinical trial progress, regulatory approvals, and commercialization costs[175][179] - The company is exploring various funding strategies, including equity/debt placements and strategic arrangements, but there is no assurance of success[177] Item 3. Quantitative and Qualitative Disclosures About Market Risk This section states that there are no applicable quantitative and qualitative disclosures about market risk - This item is not applicable[184] Item 4. Controls and Procedures Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025 - As of June 30, 2025, the company's disclosure controls and procedures were deemed effective by management[185] - No material changes in internal control over financial reporting occurred during the three months ended June 30, 2025[186] PART II—OTHER INFORMATION Item 1. Legal Proceedings This section refers to Note 13 for a discussion of legal proceedings, including class action and derivative lawsuits - For a discussion of legal proceedings, refer to Note 13 in the notes to the condensed consolidated financial statements[188] Item 1A. Risk Factors This section updates risk factors, highlighting new risks related to the planned merger with Carisma Therapeutics Inc - No material changes to risk factors were reported, except as set forth in this section[189] - Risks associated with the planned merger with Carisma Therapeutics Inc include the possibility of non-completion, which could lead to significant costs and negative publicity[190][192][193] - Potential lawsuits arising from the proposed merger could delay or prevent its consummation and incur significant costs[194] - Geopolitical events, global conflicts, and trade policies could adversely affect business, supply chain, and clinical trial costs[195][196][197] - Changes in funding or disruptions at government agencies like the FDA and SEC could hinder product development timelines and business operations[198][201][202] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds No unregistered sales or un-reported purchases of equity securities occurred during the period - No unregistered sales of equity securities or un-reported purchases of equity securities occurred during the period[203] Item 3. Defaults Upon Senior Securities The company reported no defaults upon senior securities - There were no defaults upon senior securities[204] Item 4. Mine Safety Disclosures This item is not applicable to the company - This item is not applicable[205] Item 5. Other Information No directors or officers adopted or terminated Rule 10b5-1 trading plans during the quarter - No directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading plans during the three months ended June 30, 2025[206] Item 6. Exhibits This section lists the exhibits filed with the report, including merger agreements, certifications, and XBRL documents - Exhibits include the Third Amendment to the Exclusive License Agreement, the Agreement and Plan of Merger with Carisma Therapeutics Inc, and various certifications[207] Signatures The report is duly signed by the Principal Executive Officer and Principal Financial Officer as of August 4, 2025 - The report is signed by Shankar Musunuri, Ph.D., MBA, Chairman, CEO, & Co-Founder (Principal Executive Officer), and Ramesh Ramachandran, CPA, MBA, CMA, Chief Accounting Officer (Principal Financial Officer)[213] - Signatures are dated August 4, 2025[213]