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, 2022 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 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended September 30, 2022 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 Number: 001-37759 OUTLOOK THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 38-3982704 (State or other ...

Corporate Presentation September 2022 NASDAQ: OTLK outlooktherapeutics.com | --- | --- | --- | |---------------|---------------------------------------------------------------------------------------|-------| | | | | | | Enhancing the standard of care for retinal disorders by working to achieve the first | | | ophthalmology | FDA approval for bevacizumab in | 2 | Disclaimer This presentation contains forward-looking statements about Outlook Therapeutics, Inc. ("Outlook Therapeutics" or the "Company") based ...

[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The unaudited statements show a significant net loss and accumulated deficit, reflecting the company's pre-commercial stage [Consolidated Balance Sheets](index=6&type=section&id=Consolidated%20Balance%20Sheets) Total assets grew to $38.6 million, driven by increased cash, while stockholders' equity rose due to stock offerings Consolidated Balance Sheet Highlights (as of June 30, 2022 vs. September 30, 2021) | Metric | June 30, 2022 | September 30, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $26,021,429 | $14,477,324 | | Total current assets | $37,513,385 | $21,508,147 | | Total assets | $38,587,727 | $22,811,451 | | **Liabilities & Equity** | | | | Total current liabilities | $18,429,964 | $6,752,217 | | Total liabilities | $18,505,632 | $18,204,002 | | Accumulated deficit | $(394,590,493) | $(342,883,254) | | Total stockholders' equity | $20,082,095 | $4,607,449 | [Consolidated Statements of Operations](index=8&type=section&id=Consolidated%20Statements%20of%20Operations) Net loss for the nine months ended June 30, 2022, widened to $51.7 million due to higher R&D and G&A expenses Statement of Operations Summary | Metric | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Nine Months Ended June 30, 2022 | Nine Months Ended June 30, 2021 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $11,249,191 | $8,545,279 | $33,341,333 | $29,023,253 | | General and administrative | $5,774,769 | $2,929,717 | $15,741,888 | $9,267,962 | | Loss from operations | $(17,023,960) | $(11,474,996) | $(49,083,221) | $(38,291,215) | | Net loss | $(17,539,961) | $(12,196,547) | $(51,707,239) | $(39,758,982) | | Net loss per share | $(0.08) | $(0.07) | $(0.25) | $(0.27) | [Consolidated Statements of Stockholders' Equity (Deficit)](index=9&type=section&id=Consolidated%20Statements%20of%20Stockholders'%20Equity%20(Deficit)) Stockholders' equity increased to $20.1 million, primarily driven by over $60 million raised from stock sales Changes in Stockholders' Equity (Nine Months Ended June 30, 2022) | Description | Amount | | :--- | :--- | | Balance at October 1, 2021 | $4,607,449 | | Sale of common stock, net of issuance costs | $60,641,318 | | Stock-based compensation expense | $6,334,717 | | Net loss | $(51,707,239) | | Other (warrant/option exercises) | $205,850 | | **Balance at June 30, 2022** | **$20,082,095** | [Consolidated Statements of Cash Flows](index=10&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Net cash from financing of $58.0 million offset operating cash use, resulting in a period-end cash balance of $26.0 million Cash Flow Summary (Nine Months Ended June 30) | Metric | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(46,423,872) | $(45,263,124) | | Net cash provided by financing activities | $57,967,977 | $52,419,173 | | Net increase in cash and cash equivalents | $11,544,105 | $7,156,049 | | Cash and cash equivalents at end of period | $26,021,429 | $19,692,035 | [Notes to Unaudited Interim Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Interim%20Consolidated%20Financial%20Statements) Notes highlight the company's focus on ONS-5010, going concern risks, and significant financing activities - The company is a pre-commercial biopharmaceutical firm focused on developing and commercializing ONS-5010, an ophthalmic formulation of bevacizumab for retinal indications[21](index=21&type=chunk) - There is **substantial doubt about the company's ability to continue as a going concern** due to recurring losses, an accumulated deficit of **$394.6 million**, and upcoming debt maturities[24](index=24&type=chunk) - In November 2021, the company raised **$54.0 million in net proceeds** from an underwritten public offering of 46 million shares of common stock at $1.25 per share[60](index=60&type=chunk)[149](index=149&type=chunk) - During the nine months ended June 30, 2022, the company sold 3.44 million shares under its At-the-Market (ATM) Offering, generating **$6.9 million in gross proceeds**[63](index=63&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses rising expenses and limited cash runway, raising substantial doubt about the company's going concern status [Overview](index=30&type=section&id=Overview) The company is focused on the BLA re-submission for its sole product candidate, ONS-5010, for retinal indications - The company's primary goal is to launch the first FDA-approved ophthalmic formulation of bevacizumab (ONS-5010) for retinal indications[90](index=90&type=chunk) - The company voluntarily withdrew its BLA for ONS-5010 in May 2022 and plans to **re-submit it by September 2022** after confirming the additional information required by the FDA[91](index=91&type=chunk) - The pivotal NORSE TWO trial met its primary endpoint, with **41.7% of patients treated with ONS-5010 gaining at least 15 letters in vision**, compared to 23.1% for ranibizumab (p=0.0052)[92](index=92&type=chunk)[93](index=93&type=chunk) [Going Concern](index=32&type=section&id=Going%20Concern) Existing cash of $26.0 million is insufficient to fund operations beyond Q1 2023, raising substantial going concern doubt - Current cash resources of **$26.0 million** as of June 30, 2022, are expected to fund operations only into the **first calendar quarter of 2023**[99](index=99&type=chunk) - **Substantial doubt exists about the company's ability to continue as a going concern** due to recurring losses and an unsecured promissory note of **$10.8 million maturing on January 1, 2023**[101](index=101&type=chunk)[102](index=102&type=chunk) [Results of Operations](index=40&type=section&id=Results%20of%20Operations) The nine-month net loss widened to $51.7 million, driven by increased R&D spending and pre-launch G&A expenses Comparison of Three Months Ended June 30, 2022 and 2021 | Metric | 2022 | 2021 | Change | | :--- | :--- | :--- | :--- | | Research and development | $11,249,191 | $8,545,279 | $2,703,912 | | General and administrative | $5,774,769 | $2,929,717 | $2,845,052 | | **Net loss** | **$(17,539,961)** | **$(12,196,547)** | **$(5,343,414)** | Comparison of Nine Months Ended June 30, 2022 and 2021 | Metric | 2022 | 2021 | Change | | :--- | :--- | :--- | :--- | | Research and development | $33,341,333 | $29,023,253 | $4,318,080 | | General and administrative | $15,741,888 | $9,267,962 | $6,473,926 | | **Net loss** | **$(51,707,239)** | **$(39,758,982)** | **$(11,948,257)** | - The increase in R&D expenses for the nine-month period was primarily due to **$3.1 million in BLA submission fees** and a **$1.6 million increase in stock-based compensation** from vested performance-based options[136](index=136&type=chunk) [Liquidity and Capital Resources](index=45&type=section&id=Liquidity%20and%20Capital%20Resources) The company relies on equity and debt financing, but its current cash of $26.0 million is only sufficient until Q1 2023 - The company's cash of **$26.0 million** as of June 30, 2022, is projected to fund operations into the **first calendar quarter of 2023**[151](index=151&type=chunk)[155](index=155&type=chunk) - In November 2021, the company raised **$54.0 million in net proceeds** from an underwritten public offering[149](index=149&type=chunk)[161](index=161&type=chunk) - During the nine months ended June 30, 2022, the company generated **$6.7 million in net proceeds** from its ATM Offering[150](index=150&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=51&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This disclosure is not required as the company qualifies as a Smaller Reporting Company - As a "Smaller Reporting Company", this item and the related disclosure are not required[167](index=167&type=chunk) [Controls and Procedures](index=51&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2022 - The chief executive officer and chief financial officer concluded that the company's **disclosure controls and procedures were effective** as of the end of the period[168](index=168&type=chunk) - There have been **no material changes in internal control over financial reporting** during the third fiscal quarter ended June 30, 2022[169](index=169&type=chunk) [PART II. OTHER INFORMATION](index=52&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=52&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material pending legal proceedings - The company is not party to any material pending legal proceedings[170](index=170&type=chunk) [Risk Factors](index=52&type=section&id=Item%201A.%20Risk%20Factors) A new risk factor has been added concerning the Russia-Ukraine conflict's potential business impact - A new risk factor has been added regarding the armed conflict between Russia and Ukraine, which could adversely affect the company's business, financial condition, and results of operations through significant market and other disruptions[171](index=171&type=chunk)[172](index=172&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=54&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item is not applicable for the reporting period - Not applicable[178](index=178&type=chunk) [Defaults Upon Senior Securities](index=54&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable for the reporting period - Not applicable[179](index=179&type=chunk) [Mine Safety Disclosures](index=54&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable for the reporting period - Not applicable[180](index=180&type=chunk) [Other Information](index=54&type=section&id=Item%205.%20Other%20Information) There is no other information to report for this period - None[181](index=181&type=chunk) [Exhibits](index=55&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the report, including key agreements and officer certifications - Exhibits filed include corporate governance documents, an amended investor rights agreement, an executive employment agreement, and required officer certifications (31.1, 31.2, 32.1)[183](index=183&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q OUTLOOK THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 38-3982704 (State or other jurisdiction of incorporation or organization) (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, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the ...

Corporate Presentation May 2022 NASDAQ: OTLK outlooktherapeutics.com | --- | --- | --- | |---------------|------------------------------------------------------------------------------------------------------------------------|-------| | | | | | | Enhancing the standard of care for retinal disorders by working to achieve the first FDA approval for bevacizumab in | | | ophthalmology | | 2 | Disclaimer This presentation contains forward-looking statements about Outlook Therapeutics, Inc. ("Outlook Therapeutic ...

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, 2021 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 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended September 30, 2021 OR Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒ ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File ...

ONS-5010 Overview - ONS-5010 (bevacizumab-vikg) targets the $13.1 billion global ophthalmic anti-VEGF market[6] - The company aims to submit a U S FDA BLA in calendar Q1 2022 for ONS-5010, with a launch anticipated in Q1 2023[6] - Over 50% of the U S market is available for conversion to ONS-5010, representing billions in yearly sales[7] Clinical Trial Results - In the NORSE TWO trial, 41% of ONS-5010 subjects experienced a gain of at least 15 letters in BCVA at 11 months, compared to 23% in the ranibizumab group (p = 0 0052)[52] - The mean change in BVCA through 11 months in the NORSE TWO trial was 11 2 letters for ONS-5010 versus 5 8 letters for ranibizumab (p = 0 0043)[52] - In NORSE TWO, 73 5% of subjects in the ONS-5010 group experienced at least one treatment-emergent adverse event (TEAE), compared to 76 5% in the ranibizumab group[53] Market and Competitive Landscape - Unapproved bevacizumab represents 50% of U S wet AMD market injections[17] - The DR/DME market is expected to be impacted by biosimilars and lower-cost alternatives with a -2 2% CAGR, while the wAMD market is expected to grow due to new entrants and earlier diagnosis, with a 4 1% CAGR[15] - A survey indicated that 84% of retinal specialists (U S + EU) expressed interest or high interest in an FDA-approved ophthalmic bevacizumab to treat wet AMD, DME, and BRVO[27]

CORPORATE PRESENTATION August 2021 NASDAQ: OTLK outlooktherapeutics.com Disclaimer This presentation contains forward-looking statements about Outlook Therapeutics, Inc. ("Outlook Therapeutics" or the "Company") based on management's current expectations, which are subject to known and unknown uncertainties and risks. Words such as "anticipated," "initiate," "expect," "intend," "plan," "believe," "seek," "estimate," "may," "will," and variations of these words or similar expressions are intended to identify ...