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Outlook Therapeutics(OTLK) - 2025 Q3 - Quarterly Report

PART I. FINANCIAL INFORMATION Item 1. Financial Statements (Unaudited) This section presents the unaudited interim consolidated financial statements, including balance sheets, statements of operations, stockholders' deficit, and cash flows, along with detailed notes explaining the company's organization, liquidity, accounting policies, fair value measurements, equity investments, accrued expenses, debt, commitments, equity, and stock-based compensation Consolidated Balance Sheets | Metric | June 30, 2025 | September 30, 2024 | | :-------------------------- | :------------ | :----------------- | | Total Assets | $22,391,540 | $28,823,154 | | Total Liabilities | $59,581,265 | $101,899,664 | | Total Stockholders' Deficit | $(37,189,725) | $(73,076,510) | - Warrant liability significantly decreased from $59,099,013 as of September 30, 2024, to $7,451,124 as of June 30, 202513 Consolidated Statements of Operations | Metric (Three months ended June 30) | 2025 | 2024 | Change | | :---------------------------------- | :------------ | :------------ | :------------ | | Revenues, net | $1,505,322 | $— | $1,505,322 | | Gross profit | $1,065,507 | $— | $1,065,507 | | Net (loss) income | $(20,152,502) | $44,409,187 | $(64,561,689) | | Net (loss) income per share, basic | $(0.55) | $1.91 | $(2.46) | | Metric (Nine months ended June 30) | 2025 | 2024 | Change | | :--------------------------------- | :------------ | :------------ | :------------ | | Revenues, net | $1,505,322 | $— | $1,505,322 | | Gross profit | $1,065,507 | $— | $1,065,507 | | Net loss | $(49,132,094) | $(81,057,995) | $31,925,901 | | Net loss per share, basic | $(1.60) | $(4.82) | $3.22 | Consolidated Statements of Stockholders' Deficit - Total stockholders' deficit improved from $(73,076,510) at October 1, 2024, to $(37,189,725) at June 30, 202518 - Additional paid-in capital increased by $84,823,145 during the nine months ended June 30, 2025, primarily due to common stock sales and warrant exercises18 - Accumulated deficit increased by $49,132,094 during the nine months ended June 30, 2025, reflecting net losses18 Consolidated Statements of Cash Flows | Cash Flow Activity (Nine months ended June 30) | 2025 | 2024 | Change | | :--------------------------------------------- | :------------ | :------------ | :------------ | | Net cash used in operating activities | $(39,452,240) | $(51,811,963) | $12,359,723 | | Net cash provided by financing activities | $33,425,516 | $60,444,368 | $(27,018,852) | | Net (decrease) increase in cash | $(6,026,724) | $8,632,405 | $(14,659,129) | | Cash and cash equivalents at end of period | $8,900,814 | $32,024,387 | $(23,123,573) | Notes to Unaudited Interim Consolidated Financial Statements 1. Organization and Description of Business - LYTENAVA (bevacizumab gamma) received Marketing Authorization from the European Commission in May 2024 and from the UK MHRA in July 2024 for wet age-related macular degeneration (AMD)23 - Commercial sales of LYTENAVA commenced in Germany and the UK in June 202523 - The Biologics License Application (BLA) for ONS-5010/LYTENAVA was resubmitted to the FDA in February 2025, with a PDUFA goal date of August 27, 202524 - The NORSE EIGHT trial did not meet its pre-specified non-inferiority endpoint at week 8 but demonstrated an improvement in vision, biologic activity, and a favorable safety profile24 2. Liquidity - The Company has an accumulated deficit of $592,416,994 as of June 30, 2025, and has incurred recurring losses and negative cash flows from operations since inception25 - There is substantial doubt about the Company's ability to continue as a going concern, as existing cash and cash equivalents are insufficient to fund operations for one year from the report date2528 - Subsequent to June 30, 2025, the Company generated $1,875,835 in net proceeds from the sale of 940,478 common shares under the ATM Agreement26 - Management is evaluating various funding strategies, including licensing, marketing arrangements, debt, equity issuances, and product sales28 3. Basis of Presentation and Summary of Significant Accounting Policies - A 1-for-20 reverse stock split of common stock was implemented effective March 14, 202432 - Inventory is valued at the lower of cost or net realizable value, computed on a weighted average basis. As of June 30, 2025, total inventory was $4,126,716, consisting of $3,749,493 in work-in-process and $377,223 in finished goods3435 - Revenue from LYTENAVA sales is recognized upon physical delivery to customers, with gross product sales reduced by Gross-to-Net (GTN) estimates for sales returns, administrative fees, and rebates373843 4. Fair Value Measurements | Liabilities (Level 3 Fair Value) | June 30, 2025 | September 30, 2024 | | :------------------------------- | :------------ | :----------------- | | Unsecured convertible promissory note | $34,437,000 | $29,440,000 | | Warrant liability | $7,451,124 | $59,099,013 | | Total | $41,888,124 | $88,539,013 | - The fair value of unsecured convertible promissory notes is estimated using a binomial lattice model, while warrant liabilities are estimated using the Black-Scholes option pricing model5257 - During the nine months ended June 30, 2025, $13,262,801 of warrant liability balance was reclassified into additional paid-in capital upon the exercise of certain Private Placement Warrants5255 5. Equity Method Investment - The Company holds a 20% equity method investment in Beijing Syntone Biopharma Ltd (Syntone JV) for the development, commercialization, and manufacture of ONS-5010/LYTENAVA in the greater China market58 - The maximum exposure to a loss from this investment is approximately $3,000,000, comprising the initial investment and future capital contributions59 6. Accrued Expenses | Accrued Expense Category | June 30, 2025 | September 30, 2024 | | :----------------------- | :------------ | :----------------- | | Compensation | $1,930,744 | $1,012,962 | | Severance and related costs | $300,055 | $— | | Professional fees | $717,324 | $1,798,767 | | Research and development | $1,310,055 | $41,373 | | Total Accrued Expenses | $5,313,670 | $3,237,468 | - During the nine months ended June 30, 2025, the Company recognized $1,428,455 in cash-based severance charges and $2,079,083 in non-cash stock-based compensation related to the former CEO's departure and a workforce reduction61 7. Debt - On March 13, 2025, the Company issued the March 2025 Note for $33,100,000 to Avondale Capital, LLC, using the proceeds to pay off the December 2022 Note6668 - The March 2025 Note matures on July 1, 2026, bears interest at prime rate plus 3% (minimum 9.5%), and requires quarterly debt reduction obligations of at least $3,000,00069 - The March 2025 Note is convertible into common stock at a Conversion Price of $2.26 per share (subject to adjustments), with a beneficial ownership limitation of 4.99% (or 9.99% if market capitalization falls below $25,000,000)717275 8. Commitments and Contingencies - The Company is a defendant in a securities class action lawsuit (filed November 3, 2023) and a shareholder derivative action (filed October 10, 2024), both alleging violations related to BLA statements and CMC controls for ONS-5010/LYTENAVA7778 - The outcome of these lawsuits is uncertain, and potential defense and disposition costs could be material, though no reserve for potential liability has been established7981 - The Company entered into a new five-year corporate office lease in March 2024, commencing May 1, 2024, with total undiscounted lease payments of $315,002 as of June 30, 20258283 9. Common Stock and Stockholders' Equity - The number of authorized common stock shares was increased from 60,000,000 to 260,000,000 on March 11, 202585 - During the nine months ended June 30, 2025, the Company sold 3,202,004 shares under the ATM Offering, generating $5.3 million in net proceeds94 - A Warrant Inducement Transaction in January 2025 resulted in the exercise of 7,074,637 existing warrants at a reduced price ($2.51/share) and the issuance of 14,149,274 new inducement warrants ($2.26/share), generating $15.9 million in net proceeds9596 - An Underwritten Public Offering in May 2025 sold 9,285,714 common shares and warrants for 18,571,428 shares, generating $11.6 million in net proceeds100 - As of June 30, 2025, there were 43,479,051 shares of common stock issued and outstanding, and 39,811,227 shares issuable upon the exercise of outstanding warrants13101 10. Stock-Based Compensation - The 2024 Equity Incentive Plan authorizes 7,293,901 shares for issuance, with 4,281,053 shares available for grant as of June 30, 2025103 | Stock-Based Compensation Expense (Nine months ended June 30) | 2025 | 2024 | | :----------------------------------------------------------- | :---------- | :---------- | | Research and development | $289,889 | $615,735 | | Selling, general and administrative | $6,757,008 | $3,363,692 | | Total | $7,046,897 | $3,979,427 | - Performance-based stock options (190,000 outstanding as of June 30, 2025) are contingent upon FDA approval of ONS-5010/LYTENAVA, and no expense was recognized as achievement was not deemed probable111 11. Subsequent Events - Robert Charles Jahr was appointed President, Chief Executive Officer, and director, effective July 1, 2025, succeeding Lawrence Kenyon112 - The One Big Beautiful Bill Act (OBBBA) was enacted on July 4, 2025, and the Company is currently assessing its impact on its consolidated financial statements114 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on the company's financial condition and results of operations, highlighting the commercial launch of LYTENAVA in Europe, the ongoing BLA review in the U.S., and the significant liquidity challenges and going concern doubt. It details revenue generation, expense changes, and financing activities Overview - ONS-5010/LYTENAVA is approved for wet AMD in the EU (May 2024) and UK (July 2024), with commercial launch in Germany and UK in June 2025118122 - The U.S. BLA for ONS-5010/LYTENAVA was resubmitted in February 2025, with an FDA PDUFA goal date of August 27, 2025124 - The NORSE EIGHT trial did not meet its primary non-inferiority endpoint at week 8, but week 12 data showed a mean +5.5 letter improvement in BCVA for ONS-5010/LYTENAVA, meeting the non-inferiority margin at that timepoint, with a continued favorable safety profile124127 - The estimated global anti-VEGF retina market is approximately $16 billion, with significant opportunities in Europe ($3.6 billion) and the United States ($8.5 billion)119121 Macroeconomic and Geopolitical Factors - Global uncertainties, including inflation, interest rates, tariffs, and trade tensions, may materially adversely affect commercialization efforts for LYTENAVA and the ability to access additional capital130 - Current or future tariffs could increase research and development expenses, disrupt the supply chain, and delay development timelines, placing the Company at a competitive disadvantage131132 - ONS-5010/LYTENAVA is currently manufactured in the U.S132 Going Concern - The Company has incurred net losses and negative cash flows from operations since inception, with a net loss of $49.1 million for the nine months ended June 30, 2025, and an accumulated deficit of $592.4 million13325 - Existing cash and cash equivalents as of June 30, 2025, combined with $1.9 million in net proceeds from ATM sales post-June 30, 2025, are insufficient to fund operations for one year, raising substantial doubt about the Company's ability to continue as a going concern136 Components of our Results of Operations Revenues, net - Revenue is recognized from sales of LYTENAVA (bevacizumab gamma) in the UK and Germany, which became commercially available in June 2025137 Cost of revenues - Cost of revenues primarily includes direct manufacturing, production, and packaging materials for LYTENAVA sales. Prior to regulatory approval in Europe, these costs were expensed as research and development138 Research and development expenses - Research and development costs are expensed as incurred, covering expenses for CROs, manufacturing, scientific development services, employee-related costs, regulatory activities, and laboratory supplies139140146 - The successful development of product candidates is highly uncertain, with costs and timing varying significantly based on factors like clinical trial duration, patient enrollment, and regulatory approvals141142 Selling, general and administrative expenses - Selling, general and administrative expenses include distribution, salaries, stock-based compensation, travel, recruiting, facility costs, intellectual property, and professional fees144 - These expenses are anticipated to increase with regulatory approval and preparation for commercial operations, particularly for sales and marketing145 Loss on equity method investment - Represents the Company's proportionate share of the net loss of its equity method investee147 Interest expense (income), net - Consists of original issue discount and debt issuance costs written off, net of interest income from short-term investments. Convertible promissory notes are accounted for at fair value148 Loss (gain) from change in fair value of promissory notes - Reflects changes in the fair value of convertible promissory notes, which are recorded in the consolidated statements of operations and primarily driven by variations in risk yield, stock price, and the remaining term of the notes149 Warrant related expenses - Represents the excess of the fair value of warrants upon issuance over the net proceeds from private placements, recorded in the consolidated statement of operations150 Warrant inducement expenses - Composed of remeasurement charges for existing warrants exercised in a warrant inducement transaction at a modified, reduced exercise price, and the fair value of concurrently issued inducement warrants151 Loss (gain) from change in fair value of warrant liability - Reflects changes in the fair value of warrants classified as liabilities, which are re-measured at each balance sheet date with changes recognized in the statements of operations152 Income taxes - The Company has not recorded U.S. federal or state income tax benefits due to uncertainty of realizing benefits from net losses and R&D tax credits154 - As of September 30, 2024, the Company had federal NOL carryforwards of $406.7 million and state NOL carryforwards of $242.5 million154 - NOLs may be subject to limitations under Section 382 of the Internal Revenue Code due to past or future ownership changes155 Results of Operations Comparison of Three Months Ended June 30, 2025 and 2024 | Metric (Three months ended June 30) | 2025 | 2024 | Change | | :---------------------------------- | :------------ | :------------ | :------------ | | Revenues, net | $1,505,322 | $— | $1,505,322 | | Gross profit | $1,065,507 | $— | $1,065,507 | | Research and development | $7,134,706 | $11,201,754 | $(4,067,048) | | Selling, general and administrative | $9,679,481 | $8,360,933 | $1,318,548 | | Net (loss) income | $(20,152,502) | $44,409,187 | $(64,561,689) | - Research and development expenses decreased by $4.1 million, primarily due to a $4.2 million reduction in ONS-5010/LYTENAVA development expenses as the NORSE EIGHT clinical trial completed enrollment160 - Selling, general and administrative expenses increased by $1.3 million, driven by $2.3 million in Europe launch expenses and $0.8 million in compensation, partially offset by a $1.4 million reduction in professional fees161162 - The loss from change in fair value of warrant liability increased by $61.5 million, from a gain of $(59,454,222) in 2024 to a loss of $1,999,610 in 2025, primarily due to an increase in common stock price157166 Comparison of Nine Months Ended June 30, 2025 and 2024 | Metric (Nine months ended June 30) | 2025 | 2024 | Change | | :--------------------------------- | :------------ | :------------ | :------------ | | Revenues, net | $1,505,322 | $— | $1,505,322 | | Gross profit | $1,065,507 | $— | $1,065,507 | | Research and development | $21,201,875 | $29,240,046 | $(8,038,171) | | Selling, general and administrative | $29,610,692 | $19,585,738 | $10,024,954 | | Net loss | $(49,132,094) | $(81,057,995) | $31,925,901 | - Research and development expenses decreased by $8.0 million, primarily due to a $7.6 million reduction in ONS-5010/LYTENAVA development expenses associated with the NORSE EIGHT clinical trial completion172173 - Selling, general and administrative expenses increased by $10.0 million, driven by $7.2 million in Europe launch expenses and $4.4 million in combined cash and stock-based compensation (including severance), partially offset by a $1.0 million reduction in professional fees174 - Warrant related expenses decreased by $37.5 million (from $37,490,012 in 2024 to $0 in 2025), while warrant inducement expenses increased by $33.9 million (from $0 in 2024 to $33,856,814 in 2025)168177178 Liquidity and Capital Resources - The Company has funded operations with $598.1 million from equity and debt securities and $29.0 million from collaboration/licensing agreements through June 30, 2025180 - Existing cash and cash equivalents as of June 30, 2025, plus $1.9 million in net proceeds from ATM sales post-June 30, 2025, are insufficient to fund operations for one year, raising substantial doubt about the Company's ability to continue as a going concern194199 - Future operations are highly dependent on additional financing, successful commercialization of ONS-5010/LYTENAVA, and the success of research and development efforts196 - Management is evaluating various funding strategies, including licensing, marketing arrangements, additional debt, equity issuances (e.g., ATM offerings), and potential future product sales200 Funding Requirements - Near-term focus is on supporting the FDA BLA review for ONS-5010/LYTENAVA and preparing for its potential U.S. launch197 - The Company anticipates incurring net losses and negative cash flow from operations for the foreseeable future197 - Primary uses of capital include compensation, manufacturing, R&D services, legal, regulatory, and administrative costs198 - Failure to secure sufficient funding could necessitate modifying clinical trial plans, workforce reductions, scaling back activities, discontinuing development programs, or liquidating assets200 Cash Flows | Cash Flow Activity (Nine months ended June 30) | 2025 | 2024 | Change | | :--------------------------------------------- | :------------ | :------------ | :------------ | | Net cash used in operating activities | $(39,452,240) | $(51,811,963) | $12,359,723 | | Net cash provided by financing activities | $33,425,516 | $60,444,368 | $(27,018,852) | Operating Activities - Net cash used in operating activities decreased by $12.4 million to $39.5 million for the nine months ended June 30, 2025, primarily due to non-cash adjustments and a net cash inflow from changes in operating assets and liabilities203 - Changes in operating assets and liabilities included a $6.2 million decrease in prepaid expenses and a $3.0 million increase in accounts payable and accrued expenses, partially offset by a $4.1 million increase in inventory and a $1.8 million increase in accounts receivable203 Financing Activities - Net cash provided by financing activities totaled $33.4 million for the nine months ended June 30, 2025, a decrease of $27.0 million year-over-year201205 - Primary sources of funds included $33.1 million from the March 2025 Note, $16.8 million from warrant exercises, $12.1 million from the Public Offering, and $5.3 million from ATM sales205 - Proceeds were used to repay the December 2022 Note ($32.9 million) and make payments on the March 2025 Note ($1.0 million)205 Description of Indebtedness - The March 2025 Note, issued for $33.1 million to Avondale Capital, LLC, matures on July 1, 2026, and bears interest at the prime rate plus 3% (minimum 9.5%)207208 - The Company is obligated to repay a minimum of $3,000,000 of the outstanding balance each calendar quarter, convertible into common stock at a Conversion Price of $2.26 per share (subject to adjustments)208214 - The note includes a Beneficial Ownership Limitation of 4.99% (or 9.99% if market capitalization falls below $25,000,000) and provisions for acceleration upon Trigger Events, with interest accruing at 22% per annum upon default212213 Critical Accounting Policies and Significant Judgments and Estimates Revenue Recognition - Revenue from sales of LYTENAVA (bevacizumab gamma) is recognized in accordance with ASC Topic 606 upon physical delivery of the product to pharmaceutical wholesalers/distributors216217 - Gross product sales are reduced by Gross-to-Net (GTN) estimates, including sales returns, administrative fees, and rebates, which are based on external information and management's informed judgments218220 Item 3. Quantitative and Qualitative Disclosures About Market Risk As a "Smaller Reporting Company," the company is not required to provide quantitative and qualitative disclosures about market risk - The Company is not required to provide disclosures about market risk as it qualifies as a "Smaller Reporting Company"219 Item 4. Controls and Procedures The company's disclosure controls and procedures were evaluated as effective at a reasonable assurance level as of June 30, 2025. New processes and controls related to LYTENAVA commercialization in the UK and Germany (revenue recognition, inventory) were implemented during the quarter, with documentation and testing planned for the fiscal year ending September 30, 2025 Evaluation of Disclosure Controls and Procedures - Management concluded that the Company's disclosure controls and procedures were effective, at the reasonable assurance level, as of June 30, 2025221 Changes in Internal Control over Financial Reporting - During the third fiscal quarter ended June 30, 2025, new processes and controls were implemented related to the commercialization of LYTENAVA in the UK and Germany, specifically for revenue recognition and inventory222 - No other changes in internal control over financial reporting materially affected, or are reasonably likely to materially affect, the Company's internal control over financial reporting222 PART II. OTHER INFORMATION Item 1. Legal Proceedings The company is involved in a securities class action lawsuit and a shareholder derivative action, both alleging violations related to BLA statements and CMC controls for ONS-5010/LYTENAVA. Motions to dismiss are pending in both cases. The outcome is uncertain, and potential costs could be material, though no reserve has been established - A securities class action lawsuit was filed on November 3, 2023, alleging violations of the Exchange Act related to allegedly false and misleading statements about the BLA for ONS-5010/LYTENAVA and deficient CMC controls224 - A shareholder derivative action was filed on October 10, 2024, against certain officers and directors, alleging breach of fiduciary duties based on similar alleged misstatements225 - Motions to dismiss are currently pending in both lawsuits. The outcome is uncertain, and the Company cannot estimate the possible material costs, thus no reserve has been established224226 Item 1A. Risk Factors This section updates previously disclosed risk factors, emphasizing the adverse impact of international trade policies, the company's history of significant losses and negative cash flows, its minimal revenue generation, and its high dependence on the successful regulatory approval and commercialization of ONS-5010/LYTENAVA International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects. - Global trade restrictions, tariffs, and trade tensions, particularly from new U.S. government policies, may adversely impact the Company's business, financial condition, and prospects229231 - Tariffs could increase R&D expenses (APIs, raw materials, equipment), disrupt supply chains, and delay development timelines, placing the Company at a competitive disadvantage232 - Foreign governments may adopt non-tariff measures or retaliatory actions, such as decreased intellectual property protection or delays in regulatory approvals, increasing international legal and operational risks233 We have incurred significant losses and negative cash flows from operations since our inception and expect to continue to incur significant losses and negative cash flows from operations for at least the next 12 months. - The Company has incurred net losses in each year since its inception, including $49.1 million for the nine months ended June 30, 2025, and has a substantial accumulated deficit133235 - Success is substantially dependent on the ability to generate revenue from ONS-5010/LYTENAVA sales236 - Significant expenses and operating losses are expected for at least the next 12 months, with anticipated increases due to commercialization, clinical development, and regulatory efforts238240 We have generated minimal revenue from product sales and may never be profitable. - The Company has generated minimal revenue from ONS-5010/LYTENAVA sales in the EU and UK and may never achieve profitability239 - Future profitability depends on successful development, regulatory and marketing approvals, and commercialization of ONS-5010/LYTENAVA and other product candidates239241 - Achieving profitability requires securing sufficient capital, obtaining market acceptance, and ensuring adequate reimbursement for its products241244247 We are highly dependent on the success of ONS-5010/LYTENAVA, our only product that has been approved in the EU and UK. If ONS-5010/LYTENAVA does not receive regulatory approval outside the EU and UK, or is not successfully commercialized, our business may be harmed. - The Company's business is highly dependent on the success of ONS-5010/LYTENAVA, its only product approved for commercial sale in the EU and UK245248 - Failure to obtain regulatory approval for ONS-5010/LYTENAVA outside the EU and UK, or to successfully commercialize it, would significantly harm the business245249 - The FDA approval process is extensive, lengthy, expensive, and uncertain, with potential for delays or denials due to various factors including efficacy, safety, manufacturing, or regulatory disagreements251252 - Past BLA challenges include a Complete Response Letter (CRL) due to CMC issues and lack of substantial evidence, requiring an additional clinical trial (NORSE EIGHT), which did not meet its primary non-inferiority endpoint at week 8251253 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds No unregistered sales of equity securities or use of proceeds occurred during the three months ended June 30, 2025 - No unregistered sales of equity securities or use of proceeds during the three months ended June 30, 2025255 Item 3. Defaults Upon Senior Securities No defaults upon senior securities occurred during the three months ended June 30, 2025 - No defaults upon senior securities during the three months ended June 30, 2025256 Item 4. Mine Safety Disclosures This item is not applicable to the company - This item is not applicable to the Company257 Item 5. Other Information No directors or Section 16 officers adopted or terminated Rule 10b5-1 trading plans during the three months ended June 30, 2025 - None of the Company's directors or Section 16 officers adopted or terminated any Rule 10b5-1 trading plans during the three months ended June 30, 2025258 Item 6. Exhibits This section lists the exhibits filed with the Form 10-Q, including the Restated Certificate of Incorporation, Executive Employment Agreement for the new CEO, Master Services Agreement, and various certifications - Exhibits include the Restated Certificate of Incorporation, Certificate of Amendment, Second Amended and Restated Bylaws, Executive Employment Agreement for Robert C. Jahr, Master Services Agreement, and various certifications259 SIGNATURES The report is signed by Lawrence A. Kenyon, Chief Financial Officer, on behalf of Outlook Therapeutics, Inc - The report was signed by Lawrence A. Kenyon, Chief Financial Officer, on August 14, 2025267