ISELIN, N.J., June 11, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on the commercialization and development of ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma), for the treatment of retina diseases, today announced that it will present at the Virtual Investor Pitch Conference on June 18, 2024 at 12:00 PM ET. A live video webcast of the presentation will be available on the Events page of the Investors section of the Outlook Therapeutics web ...

Live video webcast on Tuesday, June 18th at 12:00 PM ET A live video webcast of the presentation will be available on the Events page of the Investors section of the Outlook Therapeutics website (outlooktherapeutics.com). A webcast replay will be available two hours following the live presentation and will be accessible for 90 days. About Outlook Therapeutics, Inc. Investor Inquiries: Jenene Thomas Chief Executive Officer JTC Team, LLC T: 833.475.8247 OTLK@jtcir.com ISELIN, N.J., June 11, 2024 (GLOBE NEWSWI ...

LYTENAVA™ (bevacizumab gamma) becomes first ophthalmic formulation of bevacizumab to receive European Commission Marketing Authorization for the treatment of wet AMD European Commission decision applies automatically to all 27 EU Member States and, within 30 days, also to Iceland, Norway and Liechtenstein LYTENAVA™ (bevacizumab gamma) receives ten years of market exclusivity in EU Advancing toward commercial launch of LYTENAVA™ (bevacizumab gamma) in EU expected in calendar Q1 2025 Strategic partnership wit ...

Financial Data and Key Metrics Changes - The company reported a successful capital raise with gross proceeds of up to $172 million, including $65 million in cash and an additional $107 million available upon full cash exercise of warrants [97] - The increase in R&D expenses during the fiscal second quarter was expected as the company began recruiting and initiating clinical trial sites for NORSE EIGHT [24] Business Line Data and Key Metrics Changes - The company is actively engaged with the FDA regarding the BLA resubmission and has reached an agreement on a Special Protocol Assessment for the NORSE EIGHT study [4][22] - Over 30% of patients have been enrolled in the NORSE EIGHT study, with expectations to complete enrollment in the third quarter of this year [22][31] Market Data and Key Metrics Changes - The European market opportunity for ONS-5010 is significant, with approximately 3 million injections per year, similar to the US market [27] - The company anticipates potential approval in the EU this quarter and in the UK by the third quarter of 2024, with initial launches expected in early 2025 [5][20] Company Strategy and Development Direction - The company aims to enhance the standard of care for treating wet AMD by achieving the first approval for an ophthalmic formulation of bevacizumab [96] - The strategy includes working with Cencora to leverage their infrastructure for launching ONS-5010 in Europe while maintaining a customer-facing approach [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming approvals in both the EU and the US, highlighting the importance of the NORSE EIGHT study data for resubmission of the BLA [20][22] - The company believes that the current cash position will support operations through 2025, aligning with anticipated approvals and launches [8][21] Other Important Information - The company is utilizing non-GAAP adjusted results to eliminate noise from non-cash quarterly fair value changes for warrants and convertible notes [8] - The management emphasized the importance of maintaining a strong relationship with the FDA through ongoing discussions and meetings [64][89] Q&A Session Summary Question: What data sets are especially derisking for NORSE EIGHT? - Management highlighted the non-inferiority results from the NORSE TWO trial as a key indicator of potential success for NORSE EIGHT [28] Question: How large is the European market opportunity for ONS-5010 relative to the US? - The European market is similar in size to the US, with about 3 million injections per year, although there is some price compression [27] Question: How many sites are currently enrolling patients? - The company has over 60 sites enrolling patients, with 30% of patients already enrolled [31][35] Question: What is the latest thinking regarding DME and BRVO indications? - The company has pipeline studies planned for DME and BRVO, but the initial focus remains on wet AMD [39] Question: What preparations are being made for the launch in Europe? - The company has inventory ready and is working with contract manufacturers to ensure sufficient supply for both Europe and the US [43][44] Question: Will production need to move to Europe for commercialization? - Initially, there is no need to move production, but the company will evaluate future needs based on market demands [86] Question: What is the timeline for addressing CMC questions with the FDA? - The company expects to handle Type C and D meetings within the second and third quarters of this year [89]

Exhibit 99.1 Outlook Therapeutics Reports Financial Results for Second Quarter Fiscal Year 2024 and Provides Corporate Update ISELIN, N.J., May 15, 2024 — 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 diseases, today announced financial results for the second quarter of fiscal year 2024 and provided a corporate update. As previously announced, ...

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 ...