Ocugen(OCGN) - 2025 Q1 - Quarterly Report

PART I—FINANCIAL INFORMATION Financial Statements (Unaudited) This section presents the unaudited condensed consolidated financial statements for Q1 2025, including balance sheets, statements of operations, and cash flows, highlighting the company's going concern status Condensed Consolidated Balance Sheet Highlights (in thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash | $37,800 | $58,514 | | Total current assets | $43,964 | $61,682 | | Total assets | $64,460 | $82,442 | | Liabilities and Stockholders' Equity | | | | Total current liabilities | $16,886 | $21,588 | | Total liabilities | $48,546 | $52,810 | | Total stockholders' equity | $15,914 | $29,632 | | Total liabilities and stockholders' equity | $64,460 | $82,442 | Condensed Consolidated Statements of Operations (in thousands, except per share data) | | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | Collaborative arrangement revenue | $1,481 | $1,014 | | Research and development | $9,529 | $6,826 | | General and administrative | $6,453 | $6,404 | | Loss from operations | ($14,501) | ($12,216) | | Net loss | ($15,350) | ($11,924) | | Net loss per share — basic and diluted | ($0.05) | ($0.05) | Condensed Consolidated Statements of Cash Flows (in thousands) | | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($19,357) | ($10,595) | | Net cash used in investing activities | ($102) | ($2,352) | | Net cash used in financing activities | ($1,245) | ($145) | | Net (decrease) in cash and restricted cash | ($20,712) | ($13,087) | | Cash and restricted cash at end of period | $38,109 | $26,375 | - The company has incurred recurring net losses and its cash of $37.8 million as of March 31, 2025, is not sufficient to fund operations for the next 12 months, raising substantial doubt about its ability to continue as a going concern[29][31] - Revenue from the co-development and commercialization agreement with CanSinoBIO was approximately $1.5 million for Q1 2025, compared to $1.0 million in Q1 2024[69][74] - As of March 31, 2025, the company has total debt of $31.5 million, primarily from a Loan and Security Agreement and an EB-5 Loan Agreement, with significant maturities in 2027 and 2028[86][88] Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses Q1 2025 financial results, highlighting progress across key technology platforms and a wider net loss of $15.4 million due to increased R&D expenses, reinforcing liquidity challenges and going concern doubts - The company provided key updates on its clinical pipeline, including progress in Phase 3 for OCU400 (RP), Phase 2 for OCU410 (dAMD), FDA alignment for OCU410ST (Stargardt) pivotal trial, and initiation of Phase 1 for OCU200 (DME/DR/wet AMD) and OCU500 (COVID-19 Vaccine)[117][118] Results of Operations Comparison (in thousands) | | Three months ended March 31, 2025 | Three months ended March 31, 2024 | Change | | :--- | :--- | :--- | :--- | | Collaborative arrangement revenue | $1,481 | $1,014 | $467 | | Research and development | $9,529 | $6,826 | $2,703 | | General and administrative | $6,453 | $6,404 | $49 | | Loss from operations | ($14,501) | ($12,216) | ($2,285) | | Net loss | ($15,350) | ($11,924) | ($3,426) | - R&D expenses increased by $2.7 million year-over-year, primarily due to a $1.3 million increase in employee-related costs and higher clinical trial activity for OCU410/410ST ($0.7 million) and OCU400 ($0.3 million)[137] - As of March 31, 2025, the company had $37.8 million in cash and cash equivalents, which management believes will only fund operations into Q1 2026, insufficient for the next 12 months[140][152] - The company requires significant additional funding, exploring options like equity/debt placements, strategic arrangements, and government funding, as inability to secure it raises substantial doubt about its going concern ability[153][154] Quantitative and Qualitative Disclosures About Market Risk The company states this item is not applicable, indicating no significant exposure to market risks requiring quantitative and qualitative disclosure - The company states this section is not applicable[159] Controls and Procedures Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - Based on an evaluation as of March 31, 2025, the principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures are effective[160] - There were no changes in internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[161] PART II—OTHER INFORMATION Legal Proceedings The company is defending against a securities class action lawsuit and stockholder derivative lawsuits, believing them without merit and unable to assess the financial impact - The company is defending against a securities class action lawsuit and multiple stockholder derivative lawsuits related to alleged violations of the Exchange Act[107][109] - Management believes the lawsuits are without merit, and as the outcome cannot be determined and a loss is not considered probable or reasonably estimable, no accrual has been recorded[110] Risk Factors This section updates risk factors, emphasizing new or heightened risks from geopolitical events and potential disruptions at U.S. government agencies like the FDA and SEC - Geopolitical issues, including global conflicts, sanctions, and tariffs, could disrupt the supply chain, increase costs for international clinical trials, and adversely affect the business[165][166] - Changes in funding, staffing, or potential shutdowns at government agencies like the FDA and SEC could hinder their ability to review and approve new products in a timely manner, negatively impacting the company's business[167][171] - Uncertainty surrounding the new U.S. presidential administration's policies for the FDA and other regulatory agencies could create new challenges or a more costly environment for therapeutic development[172] Unregistered Sales of Equity Securities and Use of Proceeds The company reports no unregistered sales of equity securities or issuer purchases of its own equity securities during the quarter ended March 31, 2025 - The company confirms there were no unregistered sales of equity securities or issuer purchases of equity securities during the period that were not previously reported[173] Defaults Upon Senior Securities The company reports no defaults upon its senior securities during the reporting period - The company reports "None"[174] Mine Safety Disclosures The company states this item is not applicable to its business operations - The company states this section is "Not applicable"[174] Other Information This section discloses a Certificate of Correction for Series C Preferred Stock voting rights and confirms no Rule 10b5-1 trading plan adoptions or terminations by directors or officers - A Certificate of Correction was filed to clarify voting rights of the Series C Preferred Stock, all shares of which were redeemed as of June 28, 2024, and none are outstanding[175] - During the three months ended March 31, 2025, no directors or officers adopted or terminated a Rule 10b5-1 trading plan or a non-Rule 10b5-1 trading arrangement[178] Exhibits This section lists exhibits filed with the Quarterly Report on Form 10-Q, including a Certificate of Correction, various agreements, and required CEO/CAO certifications - The report lists all exhibits filed, including a Certificate of Correction (Exhibit 3.1), various agreements, and required CEO/CAO certifications (Exhibits 31.1, 31.2, 32.1)[179]