PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The unaudited interim consolidated financial statements for the period ended March 31, 2024, reflect a significant increase in **net loss**, primarily driven by **non-cash expenses** related to **warrant liabilities** and **changes in the fair value of promissory notes** [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) As of March 31, 2024, **total assets** increased to **$59.0 million**, **total liabilities** surged to **$193.3 million**, and **stockholders' deficit** worsened to **$(134.2) million**, primarily due to **warrant liability** and **convertible notes** Consolidated Balance Sheets Summary (in thousands) | Balance Sheet Item | March 31, 2024 | September 30, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | **$47,229** | **$23,392** | | Total current assets | **$57,786** | **$30,979** | | **Total assets** | **$59,029** | **$32,301** | | **Liabilities & Stockholders' Deficit** | | | | Unsecured convertible promissory note | **$44,745** | **$35,551** | | Warrant liability | **$139,185** | **$6** | | Total current liabilities | **$54,080** | **$46,732** | | **Total liabilities** | **$193,265** | **$46,738** | | **Total stockholders' deficit** | **$(134,236)** | **$(14,438)** | [Consolidated Statements of Operations](index=5&type=section&id=Consolidated%20Statements%20of%20Operations) For the three and six months ended March 31, 2024, **net losses** significantly increased due to large **non-cash expenses** from **warrant liabilities** and **promissory notes**, alongside higher **research and development costs** Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended Mar 31, 2024 | Three Months Ended Mar 31, 2023 | Six Months Ended Mar 31, 2024 | Six Months Ended Mar 31, 2023 | | :--- | :--- | :--- | :--- | :--- | | Research and development | **$13,509** | **$545** | **$18,038** | **$10,407** | | General and administrative | **$5,431** | **$6,293** | **$11,225** | **$12,119** | | Loss from operations | **$(18,940)** | **$(6,838)** | **$(29,263)** | **$(22,526)** | | Warrant related expenses | **$34,098** | **$0** | **$34,098** | **$0** | | Change in fair value of warrant liability | **$49,615** | **$(19)** | **$49,668** | **$(49)** | | **Net loss** | **$(114,289)** | **$(6,654)** | **$(125,467)** | **$(25,317)** | | Net loss per share, basic and diluted | **$(8.01)** | **$(0.52)** | **$(9.20)** | **$(2.09)** | [Consolidated Statements of Cash Flows](index=7&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) **Net cash used in operating activities** increased to **$32.3 million** for the six months ended March 31, 2024, while **financing activities** provided **$56.1 million**, resulting in a **net increase in cash and cash equivalents** of **$23.8 million** Consolidated Statements of Cash Flows Summary (in thousands) | Cash Flow Activity | Six Months Ended Mar 31, 2024 | Six Months Ended Mar 31, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | **$(32,299)** | **$(17,016)** | | Net cash provided by financing activities | **$56,137** | **$43,248** | | **Net increase in cash and cash equivalents** | **$23,837** | **$26,232** | | Cash and cash equivalents at end of period | **$47,229** | **$43,629** | [Notes to Unaudited Interim Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Interim%20Consolidated%20Financial%20Statements) The notes detail the company's **business focus** on **ONS-5010**, its significant **liquidity challenges** leading to a **going concern** doubt, and key financial events including a **reverse stock split**, a major **private placement**, **warrant liability classification**, **convertible debt terms**, and a pending **securities class action lawsuit** - The company's financial statements have been prepared on a **going concern** basis, but **recurring losses** and **negative cash flows** raise **substantial doubt** about its ability to continue. Management believes **existing cash**, combined with **recent financing** and **potential warrant exercises**, will be **sufficient to fund operations through 2025**[26](index=26&type=chunk)[28](index=28&type=chunk)[31](index=31&type=chunk) - A **one-for-twenty reverse stock split** was implemented on **March 14, 2024**. All **common share** and **per-share data** have been adjusted to reflect this split for all periods presented[35](index=35&type=chunk) - In **March 2024**, a **private placement** raised **$55.5 million in net proceeds** through the issuance of **8,571,423 shares** and **warrants** to purchase **12,857,133 shares**. The **warrants** were classified as a **liability**, and their **fair value** at issuance exceeded the **net proceeds**, resulting in a **$34.1 million charge** to **warrant related expenses**[85](index=85&type=chunk)[86](index=86&type=chunk)[90](index=90&type=chunk) - A **securities class action lawsuit** was filed against the company in **November 2023**, alleging **false and misleading statements** related to the **Biologics License Application (BLA)** for **ONS-5010**. The company **cannot estimate the possible cost** and has not established a **reserve**[74](index=74&type=chunk)[75](index=75&type=chunk)[77](index=77&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the status of its lead product candidate, **ONS-5010**, including the **FDA's Complete Response Letter (CRL)** which requires an additional **clinical trial (NORSE EIGHT)**, and the recent **positive CHMP opinion** in the **EU**, while addressing **substantial doubt** about its ability to continue as a **going concern** and outlining a plan to fund operations through **2025** via **recent financing** and **potential warrant exercises** [Overview](index=24&type=section&id=Overview) Outlook Therapeutics is focused on launching **ONS-5010**, initiating the **NORSE EIGHT trial** under an **FDA Special Protocol Assessment (SPA)** after a **Complete Response Letter (CRL)**, while the **EMA's CHMP** issued a **positive opinion** for **ONS-5010** in **March 2024** - The **FDA** issued a **Complete Response Letter (CRL)** for the **ONS-5010 BLA**, citing **CMC issues** and requiring an additional **adequate and well-controlled clinical trial**[128](index=128&type=chunk) - The company initiated the **NORSE EIGHT trial** in **January 2024** under an **FDA Special Protocol Assessment (SPA)** to address the **clinical deficiency** in the **CRL**, with **topline results** expected by the end of **calendar year 2024**[129](index=129&type=chunk)[131](index=131&type=chunk)[135](index=135&type=chunk) - The **EMA's CHMP** issued a **positive opinion** for **ONS-5010** in **March 2024** for the treatment of **wet AMD** in the **EU**, with a final decision from the **European Commission** expected within approximately **67 days**[132](index=132&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) The company's **net loss** increased substantially for both the three and six-month periods ended March 31, 2024, compared to the prior year, primarily driven by higher **R&D expenses** related to the **NORSE EIGHT clinical trial** and significant **non-cash charges** related to **warrants** and **convertible debt** Comparison of Operating Results (in thousands) | Metric | Three Months Ended Mar 31, 2024 | Three Months Ended Mar 31, 2023 | Six Months Ended Mar 31, 2024 | Six Months Ended Mar 31, 2023 | | :--- | :--- | :--- | :--- | :--- | | Research and development | **$13,509** | **$545** | **$18,038** | **$10,407** | | General and administrative | **$5,431** | **$6,293** | **$11,225** | **$12,119** | | **Net loss** | **$(114,289)** | **$(6,654)** | **$(125,467)** | **$(25,317)** | - **R&D expenses** for **Q2 2024** increased by **$13.0 million YoY**, mainly due to **$8.6 million** in costs for the **NORSE EIGHT clinical trial** and a prior-year reduction of expense from a **$3.9 million refund** of **FDA BLA submission fees**[170](index=170&type=chunk) - **G&A expenses** for **Q2 2024** decreased by **$0.9 million YoY**, primarily due to a **$1.9 million reduction** in **professional fees** from **halting commercial launch activities**, partially offset by higher **compensation costs**[171](index=171&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) The company has a history of **net losses** and **negative cash flows**, raising **substantial doubt** about its ability to continue as a **going concern**, but management believes that with expected proceeds from **warrant exercises**, it has **sufficient capital to support operations through 2025** - The company does not believe its **cash** as of **March 31, 2024**, plus **$5.0 million** raised in **April 2024**, is **sufficient to fund operations for one year**, resulting in a **going concern** warning[141](index=141&type=chunk)[201](index=201&type=chunk)[206](index=206&type=chunk) - Management believes that if it can call its **outstanding warrants for exercise**, the proceeds, combined with **current cash**, would be **sufficient to fund operations through 2025**[141](index=141&type=chunk)[201](index=201&type=chunk)[206](index=206&type=chunk) - In **March 2024**, the company raised **$55.5 million in net proceeds** from a **private placement of common stock and warrants**[200](index=200&type=chunk) Cash Flow Summary (in thousands) | Cash Flow Activity | Six Months Ended Mar 31, 2024 | Six Months Ended Mar 31, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | **$(32,300)** | **$(17,016)** | | Net cash provided by financing activities | **$56,137** | **$43,248** | | Net increase in cash and cash equivalents | **$23,837** | **$26,232** | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a **Smaller Reporting Company**, Outlook Therapeutics is **not required** to provide this disclosure - The company is **exempt** from this **disclosure requirement** as it qualifies as a **Smaller Reporting Company**[218](index=218&type=chunk) [Item 4. Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the **CEO** and **CFO**, evaluated the company's **disclosure controls and procedures** and concluded they were **effective** at a reasonable assurance level as of March 31, 2024, with **no material changes** in **internal control over financial reporting** during the **second fiscal quarter** - The **CEO** and **CFO** concluded that the company's **disclosure controls and procedures** were **effective** as of the end of the period covered by the report[219](index=219&type=chunk) - **No changes** in **internal control over financial reporting** occurred during the quarter that have **materially affected**, or are reasonably likely to **materially affect**, **internal controls**[220](index=220&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) The company is facing a **securities class action lawsuit** filed on **November 3, 2023**, alleging violations of the **Exchange Act** due to allegedly **false and misleading statements** regarding the **Biologics License Application (BLA)** for **ONS-5010** between **December 29, 2022**, and **August 29, 2023**, with an **uncertain outcome** and **no reserve** established - A **securities class action lawsuit** was filed against the company and certain officers on **November 3, 2023**[222](index=222&type=chunk) - The complaint alleges **false and misleading statements** related to the **BLA** for **ONS-5010**, specifically concerning evidence supporting its **efficacy and unresolved CMC controls**[222](index=222&type=chunk) - The company **cannot estimate the possible cost** from this matter and has not established any **reserve for potential liability**[223](index=223&type=chunk) [Item 1A. Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) There have been **no material changes** to the **risk factors** previously disclosed in the company's **Form 10-K** for the fiscal year ended September 30, 2023 - As of **March 31, 2024**, **no material changes** have been made to the **risk factors** disclosed in the **Annual Report on Form 10-K** filed on **December 22, 2023**[225](index=225&type=chunk) [Item 5. Other Information](index=39&type=section&id=Item%205.%20Other%20Information) On **May 13, 2024**, the company filed a **Certificate of Elimination** to remove its **Series A, Series B, and Series A-1 Convertible Preferred Stock** designations, returning them to the status of **authorized but unissued preferred stock**, and concurrently filed a **Restated Certificate of Incorporation** - On **May 13, 2024**, the company filed a **Certificate of Elimination** for its **Series A, B, and A-1 Convertible Preferred Stock**, as **no shares were outstanding**[230](index=230&type=chunk)[231](index=231&type=chunk) - Immediately following the elimination, the company filed a **Restated Certificate of Incorporation**[231](index=231&type=chunk)

Core Insights - Outlook Therapeutics is progressing towards regulatory approval for ONS-5010, an ophthalmic formulation of bevacizumab for retinal diseases, with anticipated marketing authorization in the EU and UK [2][4][10] - The company reported a significant net loss of $114.3 million for the second quarter of fiscal year 2024, compared to a net loss of $6.7 million in the same period last year [12][13] - The NORSE EIGHT clinical trial is underway in the US, with topline data expected in Q4 2024, and the company plans to resubmit the ONS-5010 Biologics License Application (BLA) by the end of 2024 [2][6][7] Regulatory Progress - The company received a positive opinion from the CHMP for ONS-5010 in the EU, with a decision from the European Commission expected within approximately 67 days [5][9] - The marketing application for ONS-5010 has been submitted in the UK under the International Recognition Procedure, allowing reliance on the CHMP's positive opinion [10] - The FDA has agreed to a non-inferiority study for ONS-5010, which, if successful, will satisfy the requirement for a second adequate and well-controlled clinical trial [4][8] Financial Performance - For the fiscal second quarter ended March 31, 2024, the adjusted net loss attributable to common stockholders was $22.1 million, or $1.55 per share, compared to $6.7 million, or $0.52 per share, in the same quarter of the previous year [12][13] - The company closed private placements raising $65 million, with potential additional proceeds of up to $107 million from warrant exercises [14] - As of March 31, 2024, Outlook Therapeutics had cash and cash equivalents of $47.2 million [14][26] Clinical Development - The NORSE EIGHT trial involves approximately 400 newly diagnosed wet AMD subjects, with over 30% of required subjects currently enrolled [7] - The primary endpoint of the NORSE EIGHT trial is the mean change in Best Corrected Visual Acuity (BCVA) from baseline to week 8 [7] - Full enrollment for the NORSE EIGHT trial is expected by Q3 2024, with topline results planned for Q4 2024 [6][7] Future Outlook - The company is planning for potential commercial launches of ONS-5010 in the EU and UK in Q1 2025, with FDA approval anticipated in 2025 [6][11] - Outlook Therapeutics aims to be the first to market with an approved ophthalmic formulation of bevacizumab for retinal diseases in the US, EU, and UK [11][20]

UK submission for national MAA review follows recently received positive opinion from Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) concerning the authorization of ONS-5010/LYTENAVA™ (bevacizumab gamma) ISELIN, N.J., May 13, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company working to achieve regulatory approval for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of retinal dise ...

ISELIN, N.J., May 02, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced it will present at the 2024 Retina World Congress being held May 9-12, 2024 in Fort Lauderdale, FL. Details for the presentations are as follows: Session: Retina UnpluggedPanelist: Russell Trenary, President and Chief Executive OfficerD ...

ISELIN, N.J., April 29, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced it will present at the OIS Retina Innovation Showcase being held May 4, 2024 in Seattle, WA. Details for the presentations are as follows: Innovation Showcase: Company PresentationRussell Trenary, President and Chief Executive Officer ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-37759 OUTLOOK THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 38-3982704 (Sta ...

[Cautionary Note Regarding Forward-Looking Statements and Industry Data](index=3&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements%20and%20Industry%20Data) [Cautionary Note Regarding Forward-Looking Statements and Industry Data](index=3&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements%20and%20Industry%20Data) This section advises readers that the Annual Report on Form 10-K contains forward-looking statements based on management's beliefs and assumptions, which are subject to risks and uncertainties, and notes that industry data and market estimates are inherently uncertain and may differ from actual events - All statements other than historical facts are considered 'forward-looking statements,' including those related to future events, financial performance, and guidance[11](index=11&type=chunk) - Forward-looking statements are based on management's beliefs and assumptions and information currently available, but actual events or results may differ materially due to inaccurate assumptions or unknown risks[11](index=11&type=chunk) - Industry, business, and market data, including disease prevalence and market size estimates, are based on projections and market research, which are inherently subject to uncertainties[12](index=12&type=chunk) [Selected Risks Affecting Our Business](index=4&type=section&id=Selected%20Risks%20Affecting%20Our%20Business) [Selected Risks Affecting Our Business](index=4&type=section&id=Selected%20Risks%20Affecting%20Our%20Business) This section outlines key risks associated with investing in the company's common stock, including significant financial losses, going concern doubts, high dependence on its sole product candidate ONS-5010, regulatory approval challenges, intense competition, reliance on third-party manufacturers, intellectual property disputes, and potential delisting from Nasdaq - The company has incurred significant losses and negative cash flows since inception and expects this to continue for at least the next 12 months, with no product sales revenue to date[16](index=16&type=chunk) - There is substantial doubt about the company's ability to continue as a going concern, requiring significant additional funding for ONS-5010 development and operations, which may not be available on acceptable terms[16](index=16&type=chunk) - The business is highly dependent on the success of ONS-5010, its only active product candidate; failure to complete clinical development, receive regulatory approval, or commercialize it successfully would harm the business[16](index=16&type=chunk) - The company faces intense competition and rapid technological change, with competitors potentially developing more effective therapies or achieving market approval sooner, adversely affecting commercialization[16](index=16&type=chunk) - The common stock may be delisted from The Nasdaq Capital Market if the company fails to regain compliance with Nasdaq's continued listing standards, negatively impacting stock price and capital market access[18](index=18&type=chunk) [PART I](index=6&type=section&id=PART%20I) [ITEM 1. Business](index=6&type=section&id=ITEM%201.%20Business) Outlook Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing ONS-5010 (LYTENAVA), an ophthalmic formulation of bevacizumab, for retinal indications like wet AMD, DME, and BRVO - Outlook Therapeutics is developing ONS-5010 (LYTENAVA (bevacizumab-vikg)) as the first FDA-approved ophthalmic formulation of bevacizumab for wet AMD, DME, and BRVO[20](index=20&type=chunk)[22](index=22&type=chunk)[31](index=31&type=chunk) - The FDA issued a Complete Response Letter (CRL) for ONS-5010's BLA due to CMC issues, open manufacturing inspection observations, and a lack of substantial evidence, requiring an additional adequate and well-controlled clinical trial (NORSE EIGHT)[22](index=22&type=chunk)[42](index=42&type=chunk) - A Marketing Authorization Application (MAA) for ONS-5010 is under review by the European Medicines Agency (EMA), with an estimated decision in the first half of calendar 2024[23](index=23&type=chunk) - ONS-5010 is positioned to mitigate risks associated with off-label use of repackaged bevacizumab (Avastin), which currently accounts for approximately **66.3% of new patient starts** in the US for wet AMD[24](index=24&type=chunk)[37](index=37&type=chunk) - The company's strategy includes direct launch in the US and potential strategic partnerships for ex-US markets, leveraging executive team expertise and outsourcing manufacturing to reduce costs[29](index=29&type=chunk)[33](index=33&type=chunk) ONS-5010 Clinical Trial Status | Trial Name | Status/Key Outcome | | :----------- | :------------------- | | NORSE ONE | Completed, positive safety/efficacy, proof-of-concept topline results (Aug 2020) | | NORSE TWO | Completed, pivotal Phase 3, met primary and key secondary efficacy endpoints (Aug 2021) | | NORSE THREE | Completed, positive safety profile (Mar 2021) | | NORSE EIGHT | Planned, additional adequate and well-controlled clinical trial required by FDA; SPA submitted (Dec 2023) | | NORSE FOUR | Planned, registration trial for BRVO (SPA agreement with FDA) | | NORSE FIVE | Planned, registration trial for DME (SPA agreement with FDA) | | NORSE SIX | Planned, registration trial for DME (SPA agreement with FDA) | | NORSE SEVEN | Enrolling, compares safety of vial vs. pre-filled syringe for sBLA submission | - The company has collaboration and license agreements, including a royalty-free license for ONS-5010 in greater China with a PRC joint venture (**80% Syntone, 20% Outlook Therapeutics**) and commercial license agreements with Selexis for ONS-5010 and legacy biosimilar candidates[64](index=64&type=chunk)[68](index=68&type=chunk)[69](index=69&type=chunk) - Manufacturing of ONS-5010 is outsourced to FujiFilm Diosynth Biotechnologies and Ajinomoto Bio-pharma Services, with a supply agreement for pre-filled ophthalmic syringes[85](index=85&type=chunk) - The competitive landscape for wet AMD includes approved VEGF inhibitors (EYLEA, BEOVU, LUCENTIS, SUSVIMO, VABYSMO) and biosimilar ranibizumab, with ONS-5010 aiming to be a lower-cost, on-label alternative to off-label Avastin[91](index=91&type=chunk) - The company holds three US patents, sixteen foreign patents, and numerous pending applications related to ONS-5010 formulations, antibody purification, and methods of use, with expected expiration dates ranging from **2034 to 2039**[92](index=92&type=chunk)[93](index=93&type=chunk)[94](index=94&type=chunk) - The regulatory approval process in the US involves preclinical studies, IND submission, clinical trials (Phase 1, 2, 3), BLA submission and review, and post-approval requirements, all subject to extensive FDA regulation[95](index=95&type=chunk)[96](index=96&type=chunk)[97](index=97&type=chunk)[98](index=98&type=chunk)[99](index=99&type=chunk)[103](index=103&type=chunk)[104](index=104&type=chunk)[105](index=105&type=chunk)[106](index=106&type=chunk)[107](index=107&type=chunk)[108](index=108&type=chunk)[109](index=109&type=chunk)[110](index=110&type=chunk)[111](index=111&type=chunk)[112](index=112&type=chunk) - As of September 30, 2023, the company had **24 full-time employees**, with **7 primarily engaged in R&D**, and none represented by a labor union[135](index=135&type=chunk) [ITEM 1A. Risk Factors](index=27&type=section&id=ITEM%201A.%20Risk%20Factors) This section details the significant risks facing Outlook Therapeutics, categorized into financial, product development, commercialization, reliance on third parties, intellectual property, business operations, and stock ownership - The company has incurred net losses of **$59.0 million** in FY2023 and **$66.1 million** in FY2022, with no product sales revenue since inception, and expects to continue incurring significant losses for at least the next 12 months[139](index=139&type=chunk)[145](index=145&type=chunk) - There is substantial doubt about the company's ability to continue as a going concern, with current cash resources insufficient to fund operations through June 2024, necessitating additional funding for ONS-5010 development and operations[150](index=150&type=chunk)[151](index=151&type=chunk)[154](index=154&type=chunk) - The company is highly dependent on ONS-5010, its only active product candidate; failure to obtain regulatory approval or successful commercialization would severely harm the business[161](index=161&type=chunk) - Clinical drug development is a lengthy, expensive, and uncertain process, with potential for substantial delays, failure to demonstrate safety and efficacy, or undesirable side effects that could delay or prevent regulatory approval[167](index=167&type=chunk)[168](index=168&type=chunk)[178](index=178&type=chunk) - The company faces intense competition from major pharmaceutical and biotechnology companies with greater resources, and other anti-VEGF therapies may be approved and commercialized before ONS-5010[221](index=221&type=chunk)[222](index=222&type=chunk)[223](index=223&type=chunk)[225](index=225&type=chunk) - Commercial success depends on market acceptance by physicians, patients, and third-party payors, which is uncertain, especially given the continued off-label use of Avastin[227](index=227&type=chunk)[231](index=231&type=chunk) - Reliance on third parties for manufacturing, clinical trials, and other services poses risks, including failure to meet deadlines, comply with regulations, or maintain supply, which could harm the business[249](index=249&type=chunk)[250](index=250&type=chunk)[251](index=251&type=chunk)[253](index=253&type=chunk)[256](index=256&type=chunk) - The company's ability to protect its intellectual property is crucial, but patent rights are uncertain, expensive to enforce, and vulnerable to infringement claims or challenges by third parties[271](index=271&type=chunk)[276](index=276&type=chunk)[290](index=290&type=chunk)[296](index=296&type=chunk)[297](index=297&type=chunk)[298](index=298&type=chunk) - Global economic and political conditions, disease outbreaks, and healthcare reform measures could adversely affect business, financial condition, and results of operations[324](index=324&type=chunk)[326](index=326&type=chunk)[339](index=339&type=chunk)[344](index=344&type=chunk) - A pending securities class action lawsuit against the company and certain officers alleges false and misleading statements related to the BLA, which could result in substantial damages and divert management's attention[334](index=334&type=chunk)[335](index=335&type=chunk)[337](index=337&type=chunk) - The company's common stock may be delisted from The Nasdaq Capital Market if it fails to regain compliance with the minimum bid price requirement, leading to reduced liquidity and access to capital markets[369](index=369&type=chunk)[370](index=370&type=chunk)[373](index=373&type=chunk)[374](index=374&type=chunk) [ITEM 1B. Unresolved Staff Comments](index=79&type=section&id=ITEM%201B.%20Unresolved%20Staff%20Comments) This item states that there are no unresolved staff comments from the SEC - No unresolved staff comments are applicable to the company[413](index=413&type=chunk) [ITEM 2. Properties](index=79&type=section&id=ITEM%202.%20Properties) The company's headquarters are located in Iselin, New Jersey, occupying approximately 2,711 square feet of office and warehouse space under a lease expiring in March 2024 - The company's headquarters are in Iselin, New Jersey, occupying **2,711 square feet** of office and warehouse space[414](index=414&type=chunk) - The current lease for the headquarters expires in March 2024[414](index=414&type=chunk) [ITEM 3. Legal Proceedings](index=79&type=section&id=ITEM%203.%20Legal%20Proceedings) This section discloses a pending securities class action lawsuit filed against the company and certain officers in November 2023, alleging violations of the Exchange Act due to allegedly false and misleading statements regarding ONS-5010's BLA - A securities class action lawsuit was filed on November 3, 2023, against the company and certain officers in the U.S. District Court for the District of New Jersey[415](index=415&type=chunk) - The lawsuit alleges violations of the Securities Exchange Act of 1934, claiming false and misleading statements related to ONS-5010's BLA, including an alleged lack of evidence for wet AMD treatment and deficient CMC controls[415](index=415&type=chunk) - The plaintiffs seek damages, interest, and reasonable costs, including attorneys' fees. The company cannot estimate the possible cost, but it could be material, and no reserve has been established[415](index=415&type=chunk)[416](index=416&type=chunk) [ITEM 4. Mine Safety Disclosures](index=80&type=section&id=ITEM%204.%20Mine%20Safety%20Disclosures) This item states that mine safety disclosures are not applicable to the company - Mine safety disclosures are not applicable[418](index=418&type=chunk) [PART II](index=81&type=section&id=PART%20II) [ITEM 5. Market for Registrant's Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities](index=81&type=section&id=ITEM%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%2C%20and%20Issuer%20Purchases%20of%20Equity%20Securities) This section provides information on the company's common stock market, stockholder count, dividend policy, and equity compensation plans, noting the common stock trades on The Nasdaq Capital Market and the company has never paid cash dividends - The company's common stock is traded on The Nasdaq Capital Market under the symbol "OTLK"[421](index=421&type=chunk) - As of December 14, 2023, there were approximately **80 stockholders of record**[422](index=422&type=chunk) - The company has never declared or paid any cash dividends on its capital stock and does not anticipate paying any in the foreseeable future, intending to retain future earnings for business development[423](index=423&type=chunk)[402](index=402&type=chunk) - No equity securities were repurchased by the issuer during the fiscal year ended September 30, 2023[426](index=426&type=chunk) [ITEM 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=82&type=section&id=ITEM%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides an overview of Outlook Therapeutics' financial performance and condition, highlighting its focus on ONS-5010 development despite recurring losses and negative cash flows, and details the impact of the FDA's Complete Response Letter (CRL) on ONS-5010's BLA and the need for additional funding - The company's primary focus is on launching ONS-5010 as the first FDA-approved ophthalmic bevacizumab for wet AMD, DME, and BRVO, with an EMA MAA review ongoing[429](index=429&type=chunk)[432](index=432&type=chunk) - The FDA issued a CRL for ONS-5010's BLA, requiring an additional clinical trial (NORSE EIGHT) and CMC data, delaying potential approval[431](index=431&type=chunk)[436](index=436&type=chunk) - The company has incurred significant net losses (**$59.0 million** in FY2023, **$66.1 million** in FY2022) and negative cash flows, with an accumulated deficit of **$467.9 million** as of September 30, 2023[439](index=439&type=chunk)[446](index=446&type=chunk) - Current cash resources (**$23.4 million** as of Sep 30, 2023) are insufficient to fund operations for one year, raising substantial doubt about the company's ability to continue as a going concern, especially considering the NORSE EIGHT trial costs and the April 2024 debt maturity[446](index=446&type=chunk)[489](index=489&type=chunk)[502](index=502&type=chunk) - The company plans to seek additional funding through licensing, equity/debt offerings, and collaborations, and is negotiating to extend the maturity of its December 2022 Note[446](index=446&type=chunk)[479](index=479&type=chunk)[489](index=489&type=chunk)[504](index=504&type=chunk) Consolidated Net Loss (FY2023 vs. FY2022) | Metric | Year ended September 30, 2023 | Year ended September 30, 2022 | Change | | :-------------------------------- | :----------------------------- | :----------------------------- | :------- | | Research and development | $26,452,942 | $42,330,856 | $(15,877,914) | | General and administrative | $26,673,440 | $20,739,897 | $5,933,543 | | Loss from operations | $(53,126,382) | $(63,070,753) | $9,944,371 | | Net loss | $(58,982,668) | $(66,052,264) | $7,069,596 | - R&D expenses decreased by **$15.9 million** in FY2023, primarily due to a **$6.2 million BLA submission fee refund** and a **$1.7 million decrease** in stock-based compensation[470](index=470&type=chunk) - G&A expenses increased by **$5.9 million** in FY2023, mainly due to a **$5.8 million rise** in professional fees for pre-launch preparations of ONS-5010[471](index=471&type=chunk) Cash Flow Summary (FY2023 vs. FY2022) | Activity | Year ended September 30, 2023 | Year ended September 30, 2022 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(42,973,398) | $(56,674,559) | | Net cash provided by financing activities | $48,968,568 | $59,594,047 | | Net increase in cash and cash equivalents | $5,995,170 | $2,919,488 | - Financing activities in FY2023 included **$23.2 million** from a registered direct equity offering, **$7.2 million** from ATM offerings, and **$30.0 million** from the December 2022 Note issuance, partially offset by **$10.2 million** in debt payments[495](index=495&type=chunk) - The December 2022 Note has a face amount of **$31.8 million**, bears **9.5% interest**, and matures on April 1, 2024 (extended from Jan 1, 2024), convertible into common stock at **$2.00/share** (subject to adjustment) and includes covenants and potential default acceleration[497](index=497&type=chunk)[499](index=499&type=chunk)[580](index=580&type=chunk)[582](index=582&type=chunk) [ITEM 7A. Quantitative and Qualitative Disclosures about Market Risk](index=95&type=section&id=ITEM%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a 'Smaller Reporting Company,' the company is not required to provide quantitative and qualitative disclosures about market risk - The company is a 'Smaller Reporting Company' and is not required to provide quantitative and qualitative disclosures about market risk[510](index=510&type=chunk) [ITEM 8. Consolidated Financial Statements and Supplementary Data](index=96&type=section&id=ITEM%208.%20Consolidated%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the audited consolidated financial statements for Outlook Therapeutics, Inc. and its subsidiary for the years ended September 30, 2023, and 2022, including the Report of Independent Registered Public Accounting Firm, Consolidated Balance Sheets, Statements of Operations, Stockholders' Equity, and Cash Flows, along with detailed notes - The independent auditor's report (KPMG LLP) expresses an unqualified opinion on the consolidated financial statements but highlights substantial doubt about the company's ability to continue as a going concern due to recurring losses and negative cash flows[515](index=515&type=chunk)[516](index=516&type=chunk) Consolidated Balance Sheet Highlights (as of September 30) | Metric | 2023 | 2022 | | :-------------------------------- | :----------- | :----------- | | Cash and cash equivalents | $23,391,982 | $17,396,812 | | Total current assets | $30,979,198 | $27,520,446 | | Total assets | $32,300,601 | $28,527,751 | | Current portion of long-term debt | $35,551,000 | $10,915,015 | | Total current liabilities | $46,732,159 | $19,729,775 | | Total liabilities | $46,738,378 | $19,791,180 | | Accumulated deficit | $(467,918,186) | $(408,935,518) | | Total stockholders' (deficit) equity | $(14,437,777) | $8,736,571 | Consolidated Statements of Operations Highlights (Year ended September 30) | Metric | 2023 | 2022 | | :-------------------------------- | :------------- | :------------- | | Research and development | $26,452,942 | $42,330,856 | | General and administrative | $26,673,440 | $20,739,897 | | Loss from operations | $(53,126,382) | $(63,070,753) | | Net loss | $(58,982,668) | $(66,052,264) | | Net loss per share, basic and diluted | $(0.24) | $(0.31) | | Weighted average shares outstanding | 250,176,633 | 212,079,472 | Consolidated Statements of Cash Flows Highlights (Year ended September 30) | Activity | 2023 | 2022 | | :-------------------------------- | :-------------- | :-------------- | | Net cash used in operating activities | $(42,973,398) | $(56,674,559) | | Net cash provided by financing activities | $48,968,568 | $59,594,047 | | Net increase in cash and cash equivalents | $5,995,170 | $2,919,488 | | Cash and cash equivalents at end of year | $23,391,982 | $17,396,812 | - The company's liquidity is a concern, with an accumulated deficit of **$467.9 million** and **$36.8 million** in debt (December 2022 Note) due April 1, 2024, requiring substantial additional financing[541](index=541&type=chunk)[542](index=542&type=chunk) - The December 2022 Note, measured at fair value, was **$35.55 million** as of September 30, 2023, with a fair value estimated using a binomial lattice model considering stock price, volatility, risk-free rate, and credit-adjusted discount rate[570](index=570&type=chunk)[572](index=572&type=chunk)[573](index=573&type=chunk) - As of September 30, 2023, the company had federal and state NOL carryforwards of **$371.7 million** and **$207.5 million**, respectively, and R&D tax credit carryforwards of **$11.2 million** and **$0.8 million**, respectively, with a full valuation allowance recorded against deferred tax assets[663](index=663&type=chunk) [Report of Independent Registered Public Accounting Firm](index=97&type=section&id=8.1%20Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) KPMG LLP, the independent auditor, issued an unqualified opinion on the consolidated financial statements for FY2023 and FY2022, but highlighted a 'going concern' matter due to the company's recurring losses and negative cash flows - KPMG LLP issued an unqualified opinion on the consolidated financial statements for the years ended September 30, 2023 and 2022[515](index=515&type=chunk) - The auditor noted a 'going concern' issue due to recurring losses, negative cash flows, and an accumulated deficit, raising substantial doubt about the company's ability to continue operations[516](index=516&type=chunk) - A critical audit matter involved the evaluation of prepaid and accrued research and development expenses for contract manufacturing organizations (CMOs), requiring subjective judgment due to evidence regarding progress towards completion of work phases[523](index=523&type=chunk) [Consolidated Balance Sheets](index=99&type=section&id=8.2%20Consolidated%20Balance%20Sheets) The consolidated balance sheets show the company's financial position as of September 30, 2023, and 2022, with an increase in cash and cash equivalents to **$23.4 million** in 2023, but also a significant rise in current portion of long-term debt to **$35.55 million** and total current liabilities to **$46.73 million**, resulting in a total stockholders' deficit of **$(14.44) million** Consolidated Balance Sheet (as of September 30) | Metric | 2023 | 2022 | | :-------------------------------- | :----------- | :----------- | | Cash and cash equivalents | $23,391,982 | $17,396,812 | | Prepaid expenses and other current assets | $7,587,216 | $10,123,634 | | Total current assets | $30,979,198 | $27,520,446 | | Total assets | $32,300,601 | $28,527,751 | | Current portion of long-term debt | $35,551,000 | $10,915,015 | | Total current liabilities | $46,732,159 | $19,729,775 | | Total liabilities | $46,738,378 | $19,791,180 | | Accumulated deficit | $(467,918,186) | $(408,935,518) | | Total stockholders' (deficit) equity | $(14,437,777) | $8,736,571 | [Consolidated Statements of Operations](index=100&type=section&id=8.3%20Consolidated%20Statements%20of%20Operations) The consolidated statements of operations show a net loss of **$58.98 million** for the year ended September 30, 2023, an improvement from **$66.05 million** in 2022, driven by a significant decrease in research and development expenses, partially offset by an increase in general and administrative expenses Consolidated Statements of Operations (Year ended September 30) | Metric | 2023 | 2022 | | :-------------------------------- | :------------- | :------------- | | Research and development | $26,452,942 | $42,330,856 | | General and administrative | $26,673,440 | $20,739,897 | | Loss from operations | $(53,126,382) | $(63,070,753) | | Loss on equity method investment | $10,998 | $48,730 | | Interest expense, net | $1,559,748 | $1,487,456 | | Loss on extinguishment of debt | $577,659 | $1,025,402 | | Change in fair value of promissory notes | $3,756,000 | $882,903 | | Change in fair value of warrant liability | $(50,919) | $(465,780) | | Loss before income taxes | $(58,979,868) | $(66,049,464) | | Income tax expense | $2,800 | $2,800 | | Net loss | $(58,982,668) | $(66,052,264) | | Net loss per share, basic and diluted | $(0.24) | $(0.31) | | Weighted average shares outstanding | 250,176,633 | 212,079,472 | [Consolidated Statements of Stockholders' Equity (Deficit)](index=101&type=section&id=8.4%20Consolidated%20Statements%20of%20Stockholders%27%20Equity%20(Deficit)) The consolidated statements of stockholders' equity (deficit) show a shift from a positive equity of **$8.74 million** in 2022 to a deficit of **$(14.44) million** in 2023, primarily due to the net loss of **$58.98 million** in 2023, partially offset by **$30.24 million** from common stock sales and **$5.55 million** in stock-based compensation expense Consolidated Statements of Stockholders' Equity (Deficit) (as of September 30) | Metric | 2023 | 2022 | | :-------------------------------- | :----------- | :----------- | | Common Stock Shares | 260,257,517 | 227,310,572 | | Common Stock Amount | $2,602,574 | $2,273,105 | | Additional Paid-in Capital | $450,877,835 | $415,398,984 | | Accumulated Deficit | $(467,918,186) | $(408,935,518) | | Total Stockholders' Equity (Deficit) | $(14,437,777) | $8,736,571 | - Issuance of common stock from sales, net of costs, contributed **$30,236,301** in 2023 and **$62,264,732** in 2022 to additional paid-in capital[533](index=533&type=chunk) - Stock-based compensation expense was **$5,547,019** in 2023 and **$7,710,804** in 2022[533](index=533&type=chunk) [Consolidated Statements of Cash Flows](index=102&type=section&id=8.5%20Consolidated%20Statements%20of%20Cash%20Flows) The consolidated statements of cash flows indicate a net increase in cash and cash equivalents of **$5.99 million** in 2023, up from **$2.92 million** in 2022, primarily driven by **$48.97 million** in cash provided by financing activities in 2023, which offset **$42.97 million** used in operating activities Consolidated Statements of Cash Flows (Year ended September 30) | Activity | 2023 | 2022 | | :-------------------------------- | :-------------- | :-------------- | | Net loss | $(58,982,668) | $(66,052,264) | | Net cash used in operating activities | $(42,973,398) | $(56,674,559) | | Net cash provided by financing activities | $48,968,568 | $59,594,047 | | Net increase in cash and cash equivalents | $5,995,170 | $2,919,488 | | Cash and cash equivalents at beginning of year | $17,396,812 | $14,477,324 | | Cash and cash equivalents at end of year | $23,391,982 | $17,396,812 | - Operating activities used **$43.0 million** in cash in 2023, primarily from the net loss, partially offset by non-cash items and changes in operating assets and liabilities[493](index=493&type=chunk) - Financing activities provided **$49.0 million** in cash in 2023, mainly from equity offerings (**$30.0 million**) and the issuance of the December 2022 Note (**$30.0 million**), offset by debt payments (**$10.2 million**)[495](index=495&type=chunk) [Notes to Consolidated Financial Statements](index=103&type=section&id=8.6%20Notes%20to%20Consolidated%20Financial%20Statements) The notes to the consolidated financial statements provide detailed disclosures on the company's organization, liquidity, accounting policies, fair value measurements, debt, equity, and income taxes, reiterating the going concern uncertainty and providing specifics on the December 2022 Note, equity offerings, and R&D expenses [Organization and Operations](index=103&type=section&id=8.6.1%20Organization%20and%20Operations) Outlook Therapeutics, Inc. is a biopharmaceutical company incorporated in Delaware, focused on developing and commercializing ONS-5010 for retinal indications, which received a CRL from the FDA for its BLA, while an MAA with the EMA is under review - Outlook Therapeutics, Inc. was reincorporated in Delaware in October 2015 and changed its name in November 2018[539](index=539&type=chunk) - The company's primary focus is on developing and commercializing ONS-5010, an ophthalmic formulation of bevacizumab for retinal indications[539](index=539&type=chunk) - The FDA issued a Complete Response Letter (CRL) for ONS-5010's BLA, requiring an additional clinical trial and CMC data for approval in wet AMD[540](index=540&type=chunk) - A Marketing Authorization Application (MAA) for ONS-5010 has been validated for review by the EMA, with an estimated decision in early 2024[540](index=540&type=chunk) [Liquidity](index=103&type=section&id=8.6.2%20Liquidity) The company has an accumulated deficit of **$467.9 million** and **$36.8 million** in debt due April 1, 2024, leading to substantial doubt about its ability to continue as a going concern, necessitating additional financing and negotiations to extend the December 2022 Note maturity - The company has incurred recurring losses and negative cash flows, with an accumulated deficit of **$467,918,186** as of September 30, 2023[541](index=541&type=chunk) - As of September 30, 2023, the company had **$36,763,381** of principal, accrued interest, and exit fees due under the December 2022 Note, maturing on April 1, 2024[541](index=541&type=chunk) - Management believes current cash resources are insufficient to fund operations for one year from the Form 10-K filing date, raising substantial doubt about the company's ability to continue as a going concern[542](index=542&type=chunk) - Future operations are highly dependent on additional financing, revenue-generating partnerships, R&D success, competitive therapies, and regulatory approval/market acceptance of products[543](index=543&type=chunk)[545](index=545&type=chunk) [Basis of Presentation and Summary of Significant Accounting Policies](index=104&type=section&id=8.6.3%20Basis%20of%20Presentation%20and%20Summary%20of%20Significant%20Accounting%20Policies) The financial statements are prepared in conformity with U.S. GAAP, consolidating Outlook Therapeutics, Inc. and its Australian subsidiary, with key accounting policies including expensing R&D costs as incurred, accounting for equity investments using the equity method, and measuring equity-classified stock-based awards at fair value on the grant date - Consolidated financial statements are prepared in conformity with U.S. GAAP and include Outlook Therapeutics, Inc. and its wholly-owned Australian subsidiary[546](index=546&type=chunk) - The company accounts for equity investments where it has significant influence (e.g., Syntone JV) under the equity method of accounting[548](index=548&type=chunk) - Research and development costs are expensed as incurred, including third-party services for product candidate development, clinical trials, manufacturing, and regulatory compliance[563](index=563&type=chunk) - Equity classified stock-based awards are measured at fair value on the grant date and expensed over the vesting period[561](index=561&type=chunk) - The company uses estimates and judgments in preparing financial statements, particularly for prepaid and accrued R&D expenses, which are based on contract terms and estimated progress[549](index=549&type=chunk)[508](index=508&type=chunk) [Fair Value Measurements](index=107&type=section&id=8.6.4%20Fair%20Value%20Measurements) The company's financial instruments measured at fair value on a recurring basis include the unsecured convertible promissory note and warrant liability, both classified as Level 3, with the December 2022 Note's fair value estimated using a binomial lattice model and the warrant liability using the Black-Scholes option pricing model Fair Value Measurements (as of September 30, 2023) | Liabilities | Level 1 | Level 2 | Level 3 | | :----------------------------- | :------ | :------ | :---------- | | Unsecured convertible promissory note | $— | $— | $35,551,000 | | Warrant liability | $— | $— | $6,219 | | Total | $— | $— | $35,557,219 | - The December 2022 Note's fair value is estimated using a binomial lattice model, with key assumptions including a term of **0.3 years**, stock price of **$0.22**, volatility of **71.0%**, risk-free rate of **5.5%**, and a credit-adjusted discount rate of **22.8%** as of September 30, 2023[572](index=572&type=chunk)[573](index=573&type=chunk) - The warrant liability is revalued each reporting period using the Black-Scholes option pricing model, with a fair value of **$6,219** as of September 30, 2023, down from **$57,138** in 2022, reflecting a decline in common stock price[570](index=570&type=chunk)[573](index=573&type=chunk) [Equity Method Investment](index=108&type=section&id=8.6.5%20Equity%20Method%20Investment) The company holds a **20%** non-controlling interest in Beijing Syntone Biopharma Ltd (Syntone JV), accounted for using the equity method, which holds a royalty-free license for ONS-5010 in the greater China market, with the company's maximum exposure to loss limited to its initial investment and committed future capital contributions of approximately **$2.1 million** - The company owns a **20% non-controlling interest** in Beijing Syntone Biopharma Ltd (Syntone JV), with Syntone PRC owning **80%**[574](index=574&type=chunk) - The investment is accounted for using the equity method, as the company can exert significant influence but does not control Syntone JV's operations[574](index=574&type=chunk) - Syntone JV has a royalty-free license for the development, commercialization, and manufacture of ONS-5010 in the greater China market[574](index=574&type=chunk) - The company's maximum exposure to loss from Syntone JV is limited to its initial investment and committed future capital contributions totaling approximately **$2.1 million**[575](index=575&type=chunk) [Accrued Expenses](index=109&type=section&id=8.6.6%20Accrued%20Expenses) Accrued expenses decreased from **$3.43 million** in 2022 to **$2.75 million** in 2023, primarily driven by a significant reduction in accrued compensation, partially offset by an increase in research and development accruals Accrued Expenses (as of September 30) | Category | 2023 | 2022 | | :-------------------- | :----------- | :----------- | | Compensation | $919,970 | $1,976,252 | | Research and development | $1,234,192 | $744,154 | | Professional fees | $165,192 | $564,423 | | Other accrued expenses | $426,386 | $143,071 | | Total | $2,745,740 | $3,427,900 | [Debt](index=109&type=section&id=8.6.7%20Debt) The company's debt primarily consists of the December 2022 Note, an unsecured convertible promissory note with a face amount of **$31.82 million**, bearing **9.5% interest** and maturing on April 1, 2024, which was issued to repay the November 2021 Note and is accounted for at fair value Debt (as of September 30) | Debt Type | 2023 | 2022 | | :-------------------------------- | :----------- | :----------- | | Unsecured convertible promissory note (fair value) | $35,551,000 | $— | | Unsecured promissory note | $— | $11,114,518 | | Total debt, net of unamortized loan costs | $35,551,000 | $10,915,015 | - The December 2022 Note, with a face amount of **$31.82 million**, was issued to Streeterville Capital, LLC, in December 2022, with net proceeds of **$18.05 million** after repaying the November 2021 Note[579](index=579&type=chunk) - The December 2022 Note bears **9.5% interest** per annum and its maturity date was amended in December 2023 to April 1, 2024, with a one-time cash fee of **$475,000** paid to the Lender[580](index=580&type=chunk)[582](index=582&type=chunk) - The company elected to account for the December 2022 Note at fair value and recognized **$2,074,964** of interest expense related to original issue discount and other debt issuance costs in FY2023[583](index=583&type=chunk) - The November 2021 Note (**$10.22 million** face amount) was fully prepaid and cancelled in December 2022, resulting in a **$0.58 million loss** on debt extinguishment in FY2023[584](index=584&type=chunk)[585](index=585&type=chunk) [Commitments and Contingencies](index=111&type=section&id=8.6.8%20Commitments%20and%20Contingencies) This section outlines the company's commitments, including milestone and royalty payments under Selexis commercial license agreements for ONS-5010 and legacy biosimilars, and details ongoing legal proceedings, specifically a securities class action lawsuit filed in November 2023 - The company has commercial license agreements with Selexis for ONS-3010, ONS-1045 (covering ONS-5010), and ONS-1050, requiring milestone payments and low single-digit royalties on net sales[593](index=593&type=chunk)[594](index=594&type=chunk) - A securities class action lawsuit was filed on November 3, 2023, alleging violations of the Exchange Act related to ONS-5010's BLA, with potential material costs[601](index=601&type=chunk)[602](index=602&type=chunk) - The company's corporate office lease in Iselin, New Jersey, is a three-year term commencing April 2021, and it also has equipment finance leases[604](index=604&type=chunk)[605](index=605&type=chunk) Lease Cost Components (Year ended September 30) | Lease Cost Component | 2023 | 2022 | | :--------------------- | :----- | :----- | | Total finance lease cost | $1,399 | $3,141 | | Operating lease cost | $44,867 | $44,867 | | Total lease cost | $46,266 | $48,008 | Future Minimum Payments Under Noncancelable Finance Leases (as of September 30, 2023) | Year | Finance Leases | | :--- | :------------- | | 2024 | $4,383 | | Total undiscounted lease payments | $4,383 | | Less: Imputed interest | $116 | | Total lease obligations | $4,267 | [Stockholders' Equity](index=114&type=section&id=8.6.9%20Stockholders%27%20Equity) The number of authorized common stock shares increased to **425 million** in March 2023, with the company raising **$23.2 million** net proceeds from a registered direct equity offering in December 2022 and **$6.08 million** net from the BTIG ATM Offering in FY2023 - The number of authorized common stock shares increased from **325,000,000 to 425,000,000** in March 2023[611](index=611&type=chunk) - In December 2022, the company issued **28,460,831 common shares** in a registered direct equity offering, generating **$23.2 million** in net proceeds[612](index=612&type=chunk) - The company terminated the Wainwright ATM Agreement in May 2023 and entered into the BTIG ATM Offering, selling **3,578,223 shares** for **$6.08 million** net proceeds in FY2023[618](index=618&type=chunk)[620](index=620&type=chunk)[622](index=622&type=chunk) - As of September 30, 2023, there were **260,257,517 shares** of common stock issued and outstanding[527](index=527&type=chunk) Outstanding Common Stock Warrants (as of September 30, 2023) | Expiration Date | Shares Issuable | Exercise Price Per Share | | :---------------- | :-------------- | :----------------------- | | December 22, 2024 | 277,128 | $12.00 | | February 26, 2024 | 1,747,047 | $0.9535 | | February 24, 2025 | 172,864 | $1.27 | | April 13, 2025 | 145,686 | $12.00 | | May 31, 2025 | 62,437 | $12.00 | | June 22, 2025 | 191,268 | $1.51875 | | December 28, 2025 | 515,755 | $1.0500 | | January 28, 2026 | 2,116,364 | $1.25 | | November 23, 2026 | 2,100,000 | $1.5625 | | Total | 7,328,549 | | [Preferred Stock](index=116&type=section&id=8.6.10%20Preferred%20Stock) The company's board of directors is authorized to issue up to **10 million** shares of preferred stock in various series, but as of September 30, 2023, no shares of preferred stock were issued and outstanding - The board of directors is authorized to issue up to **10,000,000 shares** of preferred stock in one or more series[626](index=626&type=chunk) - Previously designated series include Series A Convertible Preferred Stock, Series A-1 Convertible Preferred Stock, and Series B Convertible Preferred Stock, each with specific dividend, voting, or conversion rights[626](index=626&type=chunk)[627](index=627&type=chunk)[628](index=628&type=chunk)[630](index=630&type=chunk)[631](index=631&type=chunk) - As of September 30, 2023, and 2022, there were no shares of preferred stock issued and outstanding[626](index=626&type=chunk) [Stock-Based Compensation](index=117&type=section&id=8.6.11%20Stock-Based%20Compensation) The company recognized **$5.55 million** in stock-based compensation expense in FY2023, down from **$7.71 million** in FY2022, with **$9.18 million** of unrecognized compensation expense for stock options expected to be recognized over **2.3 years** as of September 30, 2023 Stock-Based Compensation Expense (Year ended September 30) | Category | 2023 | 2022 | | :------------------------ | :--------- | :--------- | | Research and development | $986,598 | $2,691,330 | | General and administrative | $4,560,421 | $5,019,474 | | Total | $5,547,019 | $7,710,804 | - The 2015 Equity Incentive Plan authorizes **42,265,841 shares**, with **17,414,910 shares** remaining available for grant as of September 30, 2023[633](index=633&type=chunk) - As of September 30, 2023, there were **23,956,279 stock options** outstanding with a weighted average exercise price of **$1.44**, and **$9,176,983** of unrecognized compensation expense[636](index=636&type=chunk)[638](index=638&type=chunk) - Performance-based stock options totaling **700,000 shares** were outstanding as of September 30, 2023, with no expense recognized in FY2023 as performance conditions were not considered probable of achievement[642](index=642&type=chunk)[643](index=643&type=chunk) [Collaboration Arrangements](index=120&type=section&id=8.6.12%20Collaboration%20Arrangements) The company has a joint venture agreement with Syntone's PRC-based affiliate, forming Beijing Syntone Biopharma Ltd (Syntone JV), where the company holds a **20%** ownership and the JV has a royalty-free license for ONS-5010 in the greater China market - The company entered a joint venture agreement with Syntone's PRC-based affiliate, forming Beijing Syntone Biopharma Ltd (Syntone JV)[648](index=648&type=chunk) - The company owns **20%** of Syntone JV, which holds a royalty-free license for the development, commercialization, and manufacture of ONS-5010 in the greater China market[649](index=649&type=chunk) - An initial investment of **$900,000** was made in June 2020, with a commitment for up to **$2.1 million** in additional capital contributions[650](index=650&type=chunk) [Related-Party Transactions](index=121&type=section&id=8.6.13%20Related-Party%20Transactions) Related-party transactions primarily involve MTTR, LLC, and its principals, including current executive officers Mr. Dagnon and Mr. Evanson, with a strategic partnership agreement terminated in March 2020 leading to common share issuance and subsequent individual consulting agreements - A strategic partnership agreement with MTTR, LLC, which included current executive officers Mr. Dagnon and Mr. Evanson as principals, was terminated effective March 19, 2020[651](index=651&type=chunk)[652](index=652&type=chunk)[653](index=653&type=chunk) - Upon termination, **7,244,739 shares** of common stock were issued to MTTR's four principals, and individual consulting agreements were established[653](index=653&type=chunk)[654](index=654&type=chunk) - MTTR and its principals earned **$185,552** in FY2023 and **$526,435** in FY2022 from consulting fees and expense reimbursement[655](index=655&type=chunk) - In December 2021, Mr. Dagnon and Mr. Evanson entered employment agreements with base salaries of **$450,000** and received grants of **800,000 stock options** each, plus **200,000 performance-based options**[656](index=656&type=chunk)[658](index=658&type=chunk) [Income Taxes](index=122&type=section&id=8.6.14%20Income%20Taxes) The company recorded an income tax expense of **$2,800** in both FY2023 and FY2022, primarily state tax, and has significant U.S. federal and state NOL carryforwards and R&D tax credit carryforwards, but a full valuation allowance is recorded against deferred tax assets due to uncertainty of realization Income Tax Benefit (Year ended September 30) | Tax Type | 2023 | 2022 | | :--------- | :----- | :----- | | State tax | $2,800 | $2,800 | - As of September 30, 2023, the company had federal and state NOL carryforwards of **$371.7 million** and **$207.5 million**, respectively, and federal and state R&D tax credit carryforwards of **$11.2 million** and **$0.8 million**, respectively[663](index=663&type=chunk) - A full valuation allowance is recorded against the company's deferred tax assets due to uncertainty of realizing a benefit from these items, with the allowance increasing by **$17.1 million** in FY2023[663](index=663&type=chunk) - The Inflation Reduction Act of 2022, effective for tax years beginning after December 31, 2022, is not expected to have a material impact on the company's financial statements[669](index=669&type=chunk) [ITEM 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=125&type=section&id=ITEM%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) This item states that there have been no changes in or disagreements with accountants on accounting and financial disclosure - There have been no changes in or disagreements with accountants on accounting and financial disclosure[671](index=671&type=chunk) [ITEM 9A. Controls and Procedures](index=125&type=section&id=ITEM%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of September 30, 2023, and internal control over financial reporting was also deemed effective based on the COSO 2013 framework - As of September 30, 2023, the company's disclosure controls and procedures were evaluated and deemed effective[672](index=672&type=chunk) - Management concluded that internal control over financial reporting was effective as of September 30, 2023, based on the COSO 2013 Internal Control-Integrated Framework[674](index=674&type=chunk) - As a smaller reporting company, the independent registered accounting firm is not required to issue an attestation report on internal control over financial reporting[675](index=675&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter ended September 30, 2023[676](index=676&type=chunk) [ITEM 9B. Other Information](index=126&type=section&id=ITEM%209B.%20Other%20Information) On December 21, 2023, the company amended its December 2022 Convertible Promissory Note with Streeterville Capital, LLC, extending the maturity date to April 1, 2024, in exchange for a one-time cash fee of **$475,000** - On December 21, 2023, the company amended the December 2022 Convertible Promissory Note with Streeterville Capital, LLC[678](index=678&type=chunk) - The amendment extended the maturity date of the December 2022 Note to April 1, 2024[678](index=678&type=chunk) - A one-time cash fee of **$475,000** was paid to the Lender in connection with the amendment[678](index=678&type=chunk) [PART III](index=127&type=section&id=PART%20III) [ITEM 10. Directors, Executive Officers and Corporate Governance](index=127&type=section&id=ITEM%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) This item incorporates information regarding directors, executive officers, corporate governance, and the Code of Business Conduct and Ethics by reference from the company's definitive Proxy Statement for the next Annual Meeting of Stockholders - Information on directors, executive officers, and corporate governance is incorporated by reference from the 2024 Proxy Statement[682](index=682&type=chunk)[684](index=684&type=chunk) - The company has adopted a Code of Business Conduct and Ethics applicable to all employees, officers, and directors, publicly available on its website[683](index=683&type=chunk) [ITEM 11. Executive Compensation](index=127&type=section&id=ITEM%2011.%20Executive%20Compensation) This item incorporates information regarding executive compensation by reference from the company's definitive Proxy Statement for the next Annual Meeting of Stockholders - Information on executive compensation is incorporated by reference from the 2024 Proxy Statement[684](index=684&type=chunk) [ITEM 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=128&type=section&id=ITEM%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) This item incorporates information regarding security ownership of certain beneficial owners and management, as well as equity compensation plan information, by reference from the company's definitive Proxy Statement for the next Annual Meeting of Stockholders - Information on security ownership of certain beneficial owners and management, and equity compensation plans, is incorporated by reference from the 2024 Proxy Statement[685](index=685&type=chunk) [ITEM 13. Certain Relationships and Related Transactions, and Director Independence](index=128&type=section&id=ITEM%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) This item incorporates information regarding certain relationships and related transactions, and director independence, by reference from the company's definitive Proxy Statement for the next Annual Meeting of Stockholders - Information on certain relationships and related transactions, and director independence, is incorporated by reference from the 2024 Proxy Statement[686](index=686&type=chunk) [ITEM 14. Principal Accounting Fees and Services](index=128&type=section&id=ITEM%2014.%20Principal%20Accounting%20Fees%20and%20Services) This item incorporates information regarding principal accounting fees and services by reference from the company's definitive Proxy Statement for the next Annual Meeting of Stockholders - Information on principal accounting fees and services is incorporated by reference from the 2024 Proxy Statement[687](index=687&type=chunk) [PART IV](index=129&type=section&id=PART%20IV) [ITEM 15. Exhibits and Financial Statement Schedules](index=129&type=section&id=ITEM%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists all exhibits and financial statement schedules filed as part of the Annual Report on Form 10-K, including various corporate documents, equity incentive plans, commercial license agreements, and recent debt amendments - The financial statements required by Item 15(a) are filed in Item 8 of this Annual Report on Form 10-K[692](index=692&type=chunk) - Financial statement schedules are omitted because they are not applicable, not required, or the information is included in the financial statements or notes[692](index=692&type=chunk) - Exhibits include the Amended and Restated Certificate of Incorporation, Bylaws, Equity Incentive Plans (2011 and 2015), Employee Stock Purchase Plan, Indemnity Agreements, Consulting Agreements, Selexis Commercial License Agreements, Investor Rights Agreement, Stock Purchase Agreements, Convertible Promissory Notes, and At-the-market Sales Agreements[691](index=691&type=chunk)[693](index=693&type=chunk)[694](index=694&type=chunk) - Exhibit 10.30 is an Amendment to the Convertible Promissory Note, dated December 21, 2023, between the Company and Streeterville Capital, LLC[694](index=694&type=chunk) [ITEM 16. Form 10-K Summary](index=132&type=section&id=ITEM%2016.%20Form%2010-K%20Summary) This item indicates that no Form 10-K Summary is provided - No Form 10-K Summary is provided[696](index=696&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-37759 OUTLOOK THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 38-3982704 (State o ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to OUTLOOK THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 38-3982704 (State or other jurisdiction of incor ...

| --- | --- | --- | --- | |-------|---------------|------------------------------------------------------------------------------------------------------------------------|-------| | | | | | | | | | | | | | Enhancing the standard of care for retinal disorders by working to achieve the first FDA approval for bevacizumab in | | | | ophthalmology | | 2 | NASDAQ: OTLK outlooktherapeutics.com This presentation contains forward-looking statements about Outlook Therapeutics, Inc. ("Outlook Therapeutics" or the "Co ...