ISELIN, N.J., Sept. 03, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on optimizing the standard of care for bevacizumab for the treatment of retina diseases, today announced that it will present at the EURETINA Innovation Spotlight being held as part of the 25th EURETINA Congress on September 3, 2025 in Le Palais des Congrès, Paris. Details for the presentations are as follows: Session: VEGF Related and Other Retinal Indications Title: Optimising th ...

ISELIN, N.J., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on optimizing the standard of care for bevacizumab for the treatment of retina diseases, today announced that a Type A Meeting request has been submitted to the U.S. Food and Drug Administration (FDA) to discuss the complete response letter (CRL) dated August 27, 2025 regarding the biologics license application (BLA) resubmission for ONS-5010, an investigational ophthalmic formulat ...

Key Takeaways OTLK stock dropped 54.1% after the FDA issued a second CRL for ONS-5010 in wet AMD.The CRL cited insufficient efficacy as ONS-5010 missed the NORSE EIGHT non-inferiority endpoint.OTLK will meet with the FDA for clarity regarding requirements.Shares of Outlook Therapeutics (OTLK) tumbled 54.1% after the FDA issued a second complete response letter (CRL) rejecting its biologics license application (BLA) resubmission for ONS-5010 in wet age-related macular degeneration (wet AMD).The CRL cited a s ...

Outlook Therapeutics, Inc. OTLK stock plunged on Thursday after the U.S. Food and Drug Administration (FDA) update.Outlook Therapeutics traded lower, with a session volume of 26.41 million compared to the average volume of 1.51 million as per data from Benzinga Pro.FDA UpdateThe agency issued a complete response letter (CRL) to its biologics license application (BLA) resubmission, indicating that the FDA cannot approve the application in its present form for the treatment of wet age-related macular degenera ...

Summary of Outlook Therapeutics Conference Call Company Overview - **Company**: Outlook Therapeutics (OTLK) - **Product**: LYTENAVA, an ophthalmic formulation of bevacizumab for the treatment of wet AMD (Age-related Macular Degeneration) Key Points FDA Response and Regulatory Status - Outlook Therapeutics received a Complete Response Letter (CRL) from the FDA regarding the BLA resubmission for LYTENAVA, indicating a deficiency related to evidence of efficacy [3][4] - The pivotal NORSE TWO study met its primary endpoint, demonstrating efficacy, but the confirmatory NORSE ONE trial did not meet its primary efficacy endpoint [3][4] - The FDA did not require another study but indicated that there was insufficient confirmatory evidence for approval [4] - Outlook Therapeutics plans to engage with the FDA through a Type A meeting to clarify expectations and determine the best path forward [4][8] Market Context and Product Differentiation - Compounded bevacizumab has been used off-label for wet AMD, representing about 55% of the anti-VEGF market in the U.S. [5] - LYTENAVA is designed to provide a safer, consistent, and regulated alternative to compounded bevacizumab, ensuring quality and dosing reliability [5] - The company has received marketing authorization in Europe and the UK, with LYTENAVA now commercially available in Germany and the UK [6] Financial Outlook and Cash Management - Outlook Therapeutics estimates having sufficient cash for at least the next quarter, focusing on cash conservation while launching in Europe [7][48] - The European market is projected to be around $600 million, with Germany identified as a key market due to its large bevacizumab usage [16][35] - The company aims to achieve break-even in the European business by early 2026, depending on investment and market expansion [31] Commercial Strategy and Expansion Plans - The company is expanding its commercial footprint in Europe, particularly in Germany, the UK, Scotland, and Ireland [13][35] - Plans to assess opportunities in other countries like Austria and the Netherlands are underway [14] - The focus remains on maximizing revenue growth in approved markets while maintaining operational discipline [8][14] Future Considerations - The company is evaluating existing data from the NORSE program to determine what additional confirmatory evidence may be acceptable to the FDA [20][28] - Real-world evidence from Europe may be leveraged to address FDA data requirements, although specifics are yet to be determined [44] - Outlook Therapeutics is committed to pursuing LYTENAVA as a safe and consistent alternative for patients in the U.S. [8][9] Debt Management - The company has approximately $30 million in convertible notes, with no immediate pressure from debt service [40][41] - The maturity date for the debt is July 1, 2026, allowing time to strategize for repayment [41] Conclusion - Despite the setback with the FDA, Outlook Therapeutics remains committed to its mission and is actively pursuing opportunities in the European market while preparing for further discussions with the FDA to clarify the path forward for LYTENAVA in the U.S. [8][9]

FDA issues Complete Response Letter (CRL) for resubmitted ONS-5010 BLAOutlook Therapeutics plans to work with FDA to address the Agency’s issuesCompany to host a conference call and webcast today, August 28th at 8:30 AM ET ISELIN, N.J., Aug. 28, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced that the U.S. Food and Drug Administration (FDA) has issue ...

Group 1 - The FDA decision on ONS-5010 (Lytenava) is imminent, marking a critical inflection point for Outlook Therapeutics (OTLK) [1] - ONS-5010 has already been validated in Europe, indicating potential for market acceptance [1] - The focus is on identifying biotechnology companies that innovate through unique mechanisms, first-in-class therapies, or platform technologies [1] Group 2 - The analysis emphasizes the importance of evaluating the science behind drug candidates, competitive landscape, clinical trial design, and market opportunities [1] - The biotech sector is characterized by the potential for breakthrough science to yield significant returns, necessitating careful scrutiny [1]

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited interim consolidated financial statements, including balance sheets, statements of operations, stockholders' deficit, and cash flows, along with detailed notes explaining the company's organization, liquidity, accounting policies, fair value measurements, equity investments, accrued expenses, debt, commitments, equity, and stock-based compensation [Consolidated Balance Sheets](index=7&type=section&id=Consolidated%20Balance%20Sheets%20as%20of%20June%2030%2C%202025%20and%20September%2030%2C%202024) | Metric | June 30, 2025 | September 30, 2024 | | :-------------------------- | :------------ | :----------------- | | Total Assets | $22,391,540 | $28,823,154 | | Total Liabilities | $59,581,265 | $101,899,664 | | Total Stockholders' Deficit | $(37,189,725) | $(73,076,510) | - Warrant liability significantly decreased from **$59,099,013** as of September 30, 2024, to **$7,451,124** as of June 30, 2025[13](index=13&type=chunk) [Consolidated Statements of Operations](index=8&type=section&id=Consolidated%20Statements%20of%20Operations%20for%20the%20Three%20and%20Nine%20Months%20Ended%20June%2030%2C%202025%20and%202024) | Metric (Three months ended June 30) | 2025 | 2024 | Change | | :---------------------------------- | :------------ | :------------ | :------------ | | Revenues, net | $1,505,322 | $— | $1,505,322 | | Gross profit | $1,065,507 | $— | $1,065,507 | | Net (loss) income | $(20,152,502) | $44,409,187 | $(64,561,689) | | Net (loss) income per share, basic | $(0.55) | $1.91 | $(2.46) | | Metric (Nine months ended June 30) | 2025 | 2024 | Change | | :--------------------------------- | :------------ | :------------ | :------------ | | Revenues, net | $1,505,322 | $— | $1,505,322 | | Gross profit | $1,065,507 | $— | $1,065,507 | | Net loss | $(49,132,094) | $(81,057,995) | $31,925,901 | | Net loss per share, basic | $(1.60) | $(4.82) | $3.22 | [Consolidated Statements of Stockholders' Deficit](index=9&type=section&id=Consolidated%20Statements%20of%20Stockholders'%20Deficit%20for%20the%20Three%20and%20Nine%20Months%20Ended%20June%2030%2C%202025%20and%202024) - Total stockholders' deficit improved from **$(73,076,510)** at October 1, 2024, to **$(37,189,725)** at June 30, 2025[18](index=18&type=chunk) - Additional paid-in capital increased by **$84,823,145** during the nine months ended June 30, 2025, primarily due to common stock sales and warrant exercises[18](index=18&type=chunk) - Accumulated deficit increased by **$49,132,094** during the nine months ended June 30, 2025, reflecting net losses[18](index=18&type=chunk) [Consolidated Statements of Cash Flows](index=10&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20Nine%20Months%20Ended%20June%2030%2C%202025%20and%202024) | Cash Flow Activity (Nine months ended June 30) | 2025 | 2024 | Change | | :--------------------------------------------- | :------------ | :------------ | :------------ | | Net cash used in operating activities | $(39,452,240) | $(51,811,963) | $12,359,723 | | Net cash provided by financing activities | $33,425,516 | $60,444,368 | $(27,018,852) | | Net (decrease) increase in cash | $(6,026,724) | $8,632,405 | $(14,659,129) | | Cash and cash equivalents at end of period | $8,900,814 | $32,024,387 | $(23,123,573) | [Notes to Unaudited Interim Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Interim%20Consolidated%20Financial%20Statements) [1. Organization and Description of Business](index=11&type=section&id=1.%20Organization%20and%20Description%20of%20Business) - LYTENAVA (bevacizumab gamma) received Marketing Authorization from the European Commission in May 2024 and from the UK MHRA in July 2024 for wet age-related macular degeneration (AMD)[23](index=23&type=chunk) - Commercial sales of LYTENAVA commenced in Germany and the UK in June 2025[23](index=23&type=chunk) - The Biologics License Application (BLA) for ONS-5010/LYTENAVA was resubmitted to the FDA in February 2025, with a PDUFA goal date of August 27, 2025[24](index=24&type=chunk) - The NORSE EIGHT trial did not meet its pre-specified non-inferiority endpoint at week 8 but demonstrated an improvement in vision, biologic activity, and a favorable safety profile[24](index=24&type=chunk) [2. Liquidity](index=11&type=section&id=2.%20Liquidity) - The Company has an accumulated deficit of **$592,416,994** as of June 30, 2025, and has incurred recurring losses and negative cash flows from operations since inception[25](index=25&type=chunk) - There is substantial doubt about the Company's ability to continue as a going concern, as existing cash and cash equivalents are insufficient to fund operations for one year from the report date[25](index=25&type=chunk)[28](index=28&type=chunk) - Subsequent to June 30, 2025, the Company generated **$1,875,835** in net proceeds from the sale of **940,478** common shares under the ATM Agreement[26](index=26&type=chunk) - Management is evaluating various funding strategies, including licensing, marketing arrangements, debt, equity issuances, and product sales[28](index=28&type=chunk) [3. Basis of Presentation and Summary of Significant Accounting Policies](index=13&type=section&id=3.%20Basis%20of%20Presentation%20and%20Summary%20of%20Significant%20Accounting%20Policies) - A **1-for-20 reverse stock split** of common stock was implemented effective March 14, 2024[32](index=32&type=chunk) - Inventory is valued at the lower of cost or net realizable value, computed on a weighted average basis. As of June 30, 2025, total inventory was **$4,126,716**, consisting of **$3,749,493** in work-in-process and **$377,223** in finished goods[34](index=34&type=chunk)[35](index=35&type=chunk) - Revenue from LYTENAVA sales is recognized upon physical delivery to customers, with gross product sales reduced by Gross-to-Net (GTN) estimates for sales returns, administrative fees, and rebates[37](index=37&type=chunk)[38](index=38&type=chunk)[43](index=43&type=chunk) [4. Fair Value Measurements](index=20&type=section&id=4.%20Fair%20Value%20Measurements) | Liabilities (Level 3 Fair Value) | June 30, 2025 | September 30, 2024 | | :------------------------------- | :------------ | :----------------- | | Unsecured convertible promissory note | $34,437,000 | $29,440,000 | | Warrant liability | $7,451,124 | $59,099,013 | | Total | $41,888,124 | $88,539,013 | - The fair value of unsecured convertible promissory notes is estimated using a binomial lattice model, while warrant liabilities are estimated using the Black-Scholes option pricing model[52](index=52&type=chunk)[57](index=57&type=chunk) - During the nine months ended June 30, 2025, **$13,262,801** of warrant liability balance was reclassified into additional paid-in capital upon the exercise of certain Private Placement Warrants[52](index=52&type=chunk)[55](index=55&type=chunk) [5. Equity Method Investment](index=23&type=section&id=5.%20Equity%20Method%20Investment) - The Company holds a **20%** equity method investment in Beijing Syntone Biopharma Ltd (Syntone JV) for the development, commercialization, and manufacture of ONS-5010/LYTENAVA in the greater China market[58](index=58&type=chunk) - The maximum exposure to a loss from this investment is approximately **$3,000,000**, comprising the initial investment and future capital contributions[59](index=59&type=chunk) [6. Accrued Expenses](index=23&type=section&id=6.%20Accrued%20Expenses) | Accrued Expense Category | June 30, 2025 | September 30, 2024 | | :----------------------- | :------------ | :----------------- | | Compensation | $1,930,744 | $1,012,962 | | Severance and related costs | $300,055 | $— | | Professional fees | $717,324 | $1,798,767 | | Research and development | $1,310,055 | $41,373 | | Total Accrued Expenses | $5,313,670 | $3,237,468 | - During the nine months ended June 30, 2025, the Company recognized **$1,428,455** in cash-based severance charges and **$2,079,083** in non-cash stock-based compensation related to the former CEO's departure and a workforce reduction[61](index=61&type=chunk) [7. Debt](index=24&type=section&id=7.%20Debt) - On March 13, 2025, the Company issued the March 2025 Note for **$33,100,000** to Avondale Capital, LLC, using the proceeds to pay off the December 2022 Note[66](index=66&type=chunk)[68](index=68&type=chunk) - The March 2025 Note matures on July 1, 2026, bears interest at prime rate plus **3%** (minimum **9.5%**), and requires quarterly debt reduction obligations of at least **$3,000,000**[69](index=69&type=chunk) - The March 2025 Note is convertible into common stock at a Conversion Price of **$2.26** per share (subject to adjustments), with a beneficial ownership limitation of **4.99%** (or **9.99%** if market capitalization falls below **$25,000,000**)[71](index=71&type=chunk)[72](index=72&type=chunk)[75](index=75&type=chunk) [8. Commitments and Contingencies](index=27&type=section&id=8.%20Commitments%20and%20Contingencies) - The Company is a defendant in a securities class action lawsuit (filed November 3, 2023) and a shareholder derivative action (filed October 10, 2024), both alleging violations related to BLA statements and CMC controls for ONS-5010/LYTENAVA[77](index=77&type=chunk)[78](index=78&type=chunk) - The outcome of these lawsuits is uncertain, and potential defense and disposition costs could be material, though no reserve for potential liability has been established[79](index=79&type=chunk)[81](index=81&type=chunk) - The Company entered into a new five-year corporate office lease in March 2024, commencing May 1, 2024, with total undiscounted lease payments of **$315,002** as of June 30, 2025[82](index=82&type=chunk)[83](index=83&type=chunk) [9. Common Stock and Stockholders' Equity](index=30&type=section&id=9.%20Common%20Stock%20and%20Stockholders'%20Equity) - The number of authorized common stock shares was increased from **60,000,000** to **260,000,000** on March 11, 2025[85](index=85&type=chunk) - During the nine months ended June 30, 2025, the Company sold **3,202,004** shares under the ATM Offering, generating **$5.3 million** in net proceeds[94](index=94&type=chunk) - A Warrant Inducement Transaction in January 2025 resulted in the exercise of **7,074,637** existing warrants at a reduced price (**$2.51/share**) and the issuance of **14,149,274** new inducement warrants (**$2.26/share**), generating **$15.9 million** in net proceeds[95](index=95&type=chunk)[96](index=96&type=chunk) - An Underwritten Public Offering in May 2025 sold **9,285,714** common shares and warrants for **18,571,428** shares, generating **$11.6 million** in net proceeds[100](index=100&type=chunk) - As of June 30, 2025, there were **43,479,051** shares of common stock issued and outstanding, and **39,811,227** shares issuable upon the exercise of outstanding warrants[13](index=13&type=chunk)[101](index=101&type=chunk) [10. Stock-Based Compensation](index=38&type=section&id=10.%20Stock-Based%20Compensation) - The 2024 Equity Incentive Plan authorizes **7,293,901** shares for issuance, with **4,281,053** shares available for grant as of June 30, 2025[103](index=103&type=chunk) | Stock-Based Compensation Expense (Nine months ended June 30) | 2025 | 2024 | | :----------------------------------------------------------- | :---------- | :---------- | | Research and development | $289,889 | $615,735 | | Selling, general and administrative | $6,757,008 | $3,363,692 | | Total | $7,046,897 | $3,979,427 | - Performance-based stock options (**190,000** outstanding as of June 30, 2025) are contingent upon FDA approval of ONS-5010/LYTENAVA, and no expense was recognized as achievement was not deemed probable[111](index=111&type=chunk) [11. Subsequent Events](index=41&type=section&id=11.%20Subsequent%20Events) - Robert Charles Jahr was appointed President, Chief Executive Officer, and director, effective July 1, 2025, succeeding Lawrence Kenyon[112](index=112&type=chunk) - The One Big Beautiful Bill Act (OBBBA) was enacted on July 4, 2025, and the Company is currently assessing its impact on its consolidated financial statements[114](index=114&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=42&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations, highlighting the commercial launch of LYTENAVA in Europe, the ongoing BLA review in the U.S., and the significant liquidity challenges and going concern doubt. It details revenue generation, expense changes, and financing activities [Overview](index=42&type=section&id=Overview) - ONS-5010/LYTENAVA is approved for wet AMD in the EU (May 2024) and UK (July 2024), with commercial launch in Germany and UK in June 2025[118](index=118&type=chunk)[122](index=122&type=chunk) - The U.S. BLA for ONS-5010/LYTENAVA was resubmitted in February 2025, with an FDA PDUFA goal date of August 27, 2025[124](index=124&type=chunk) - The NORSE EIGHT trial did not meet its primary non-inferiority endpoint at week 8, but week 12 data showed a mean **+5.5 letter improvement** in BCVA for ONS-5010/LYTENAVA, meeting the non-inferiority margin at that timepoint, with a continued favorable safety profile[124](index=124&type=chunk)[127](index=127&type=chunk) - The estimated global anti-VEGF retina market is approximately **$16 billion**, with significant opportunities in Europe (**$3.6 billion**) and the United States (**$8.5 billion**)[119](index=119&type=chunk)[121](index=121&type=chunk) [Macroeconomic and Geopolitical Factors](index=46&type=section&id=Macroeconomic%20and%20Geopolitical%20Factors) - Global uncertainties, including inflation, interest rates, tariffs, and trade tensions, may materially adversely affect commercialization efforts for LYTENAVA and the ability to access additional capital[130](index=130&type=chunk) - Current or future tariffs could increase research and development expenses, disrupt the supply chain, and delay development timelines, placing the Company at a competitive disadvantage[131](index=131&type=chunk)[132](index=132&type=chunk) - ONS-5010/LYTENAVA is currently manufactured in the U.S[132](index=132&type=chunk) [Going Concern](index=48&type=section&id=Going%20Concern) - The Company has incurred net losses and negative cash flows from operations since inception, with a net loss of **$49.1 million** for the nine months ended June 30, 2025, and an accumulated deficit of **$592.4 million**[133](index=133&type=chunk)[25](index=25&type=chunk) - Existing cash and cash equivalents as of June 30, 2025, combined with **$1.9 million** in net proceeds from ATM sales post-June 30, 2025, are insufficient to fund operations for one year, raising substantial doubt about the Company's ability to continue as a going concern[136](index=136&type=chunk) [Components of our Results of Operations](index=48&type=section&id=Components%20of%20our%20Results%20of%20Operations) [Revenues, net](index=48&type=section&id=Revenues%2C%20net) - Revenue is recognized from sales of LYTENAVA (bevacizumab gamma) in the UK and Germany, which became commercially available in June 2025[137](index=137&type=chunk) [Cost of revenues](index=48&type=section&id=Cost%20of%20revenues) - Cost of revenues primarily includes direct manufacturing, production, and packaging materials for LYTENAVA sales. Prior to regulatory approval in Europe, these costs were expensed as research and development[138](index=138&type=chunk) [Research and development expenses](index=48&type=section&id=Research%20and%20development%20expenses) - Research and development costs are expensed as incurred, covering expenses for CROs, manufacturing, scientific development services, employee-related costs, regulatory activities, and laboratory supplies[139](index=139&type=chunk)[140](index=140&type=chunk)[146](index=146&type=chunk) - The successful development of product candidates is highly uncertain, with costs and timing varying significantly based on factors like clinical trial duration, patient enrollment, and regulatory approvals[141](index=141&type=chunk)[142](index=142&type=chunk) [Selling, general and administrative expenses](index=50&type=section&id=Selling%2C%20general%20and%20administrative%20expenses) - Selling, general and administrative expenses include distribution, salaries, stock-based compensation, travel, recruiting, facility costs, intellectual property, and professional fees[144](index=144&type=chunk) - These expenses are anticipated to increase with regulatory approval and preparation for commercial operations, particularly for sales and marketing[145](index=145&type=chunk) [Loss on equity method investment](index=52&type=section&id=Loss%20on%20equity%20method%20investment) - Represents the Company's proportionate share of the net loss of its equity method investee[147](index=147&type=chunk) [Interest expense (income), net](index=52&type=section&id=Interest%20expense%20(income)%2C%20net) - Consists of original issue discount and debt issuance costs written off, net of interest income from short-term investments. Convertible promissory notes are accounted for at fair value[148](index=148&type=chunk) [Loss (gain) from change in fair value of promissory notes](index=52&type=section&id=Loss%20(gain)%20from%20change%20in%20fair%20value%20of%20promissory%20notes) - Reflects changes in the fair value of convertible promissory notes, which are recorded in the consolidated statements of operations and primarily driven by variations in risk yield, stock price, and the remaining term of the notes[149](index=149&type=chunk) [Warrant related expenses](index=52&type=section&id=Warrant%20related%20expenses) - Represents the excess of the fair value of warrants upon issuance over the net proceeds from private placements, recorded in the consolidated statement of operations[150](index=150&type=chunk) [Warrant inducement expenses](index=52&type=section&id=Warrant%20inducement%20expenses) - Composed of remeasurement charges for existing warrants exercised in a warrant inducement transaction at a modified, reduced exercise price, and the fair value of concurrently issued inducement warrants[151](index=151&type=chunk) [Loss (gain) from change in fair value of warrant liability](index=52&type=section&id=Loss%20(gain)%20from%20change%20in%20fair%20value%20of%20warrant%20liability) - Reflects changes in the fair value of warrants classified as liabilities, which are re-measured at each balance sheet date with changes recognized in the statements of operations[152](index=152&type=chunk) [Income taxes](index=53&type=section&id=Income%20taxes) - The Company has not recorded U.S. federal or state income tax benefits due to uncertainty of realizing benefits from net losses and R&D tax credits[154](index=154&type=chunk) - As of September 30, 2024, the Company had federal NOL carryforwards of **$406.7 million** and state NOL carryforwards of **$242.5 million**[154](index=154&type=chunk) - NOLs may be subject to limitations under Section 382 of the Internal Revenue Code due to past or future ownership changes[155](index=155&type=chunk) [Results of Operations](index=53&type=section&id=Results%20of%20Operations) [Comparison of Three Months Ended June 30, 2025 and 2024](index=53&type=section&id=Comparison%20of%20Three%20Months%20Ended%20June%2030%2C%202025%20and%202024) | Metric (Three months ended June 30) | 2025 | 2024 | Change | | :---------------------------------- | :------------ | :------------ | :------------ | | Revenues, net | $1,505,322 | $— | $1,505,322 | | Gross profit | $1,065,507 | $— | $1,065,507 | | Research and development | $7,134,706 | $11,201,754 | $(4,067,048) | | Selling, general and administrative | $9,679,481 | $8,360,933 | $1,318,548 | | Net (loss) income | $(20,152,502) | $44,409,187 | $(64,561,689) | - Research and development expenses decreased by **$4.1 million**, primarily due to a **$4.2 million** reduction in ONS-5010/LYTENAVA development expenses as the NORSE EIGHT clinical trial completed enrollment[160](index=160&type=chunk) - Selling, general and administrative expenses increased by **$1.3 million**, driven by **$2.3 million** in Europe launch expenses and **$0.8 million** in compensation, partially offset by a **$1.4 million** reduction in professional fees[161](index=161&type=chunk)[162](index=162&type=chunk) - The loss from change in fair value of warrant liability increased by **$61.5 million**, from a gain of **$(59,454,222)** in 2024 to a loss of **$1,999,610** in 2025, primarily due to an increase in common stock price[157](index=157&type=chunk)[166](index=166&type=chunk) [Comparison of Nine Months Ended June 30, 2025 and 2024](index=58&type=section&id=Comparison%20of%20Nine%20Months%20Ended%20June%2030%2C%202025%20and%202024) | Metric (Nine months ended June 30) | 2025 | 2024 | Change | | :--------------------------------- | :------------ | :------------ | :------------ | | Revenues, net | $1,505,322 | $— | $1,505,322 | | Gross profit | $1,065,507 | $— | $1,065,507 | | Research and development | $21,201,875 | $29,240,046 | $(8,038,171) | | Selling, general and administrative | $29,610,692 | $19,585,738 | $10,024,954 | | Net loss | $(49,132,094) | $(81,057,995) | $31,925,901 | - Research and development expenses decreased by **$8.0 million**, primarily due to a **$7.6 million** reduction in ONS-5010/LYTENAVA development expenses associated with the NORSE EIGHT clinical trial completion[172](index=172&type=chunk)[173](index=173&type=chunk) - Selling, general and administrative expenses increased by **$10.0 million**, driven by **$7.2 million** in Europe launch expenses and **$4.4 million** in combined cash and stock-based compensation (including severance), partially offset by a **$1.0 million** reduction in professional fees[174](index=174&type=chunk) - Warrant related expenses decreased by **$37.5 million** (from **$37,490,012** in 2024 to **$0** in 2025), while warrant inducement expenses increased by **$33.9 million** (from **$0** in 2024 to **$33,856,814** in 2025)[168](index=168&type=chunk)[177](index=177&type=chunk)[178](index=178&type=chunk) [Liquidity and Capital Resources](index=62&type=section&id=Liquidity%20and%20Capital%20Resources) - The Company has funded operations with **$598.1 million** from equity and debt securities and **$29.0 million** from collaboration/licensing agreements through June 30, 2025[180](index=180&type=chunk) - Existing cash and cash equivalents as of June 30, 2025, plus **$1.9 million** in net proceeds from ATM sales post-June 30, 2025, are insufficient to fund operations for one year, raising substantial doubt about the Company's ability to continue as a going concern[194](index=194&type=chunk)[199](index=199&type=chunk) - Future operations are highly dependent on additional financing, successful commercialization of ONS-5010/LYTENAVA, and the success of research and development efforts[196](index=196&type=chunk) - Management is evaluating various funding strategies, including licensing, marketing arrangements, additional debt, equity issuances (e.g., ATM offerings), and potential future product sales[200](index=200&type=chunk) [Funding Requirements](index=66&type=section&id=Funding%20Requirements) - Near-term focus is on supporting the FDA BLA review for ONS-5010/LYTENAVA and preparing for its potential U.S. launch[197](index=197&type=chunk) - The Company anticipates incurring net losses and negative cash flow from operations for the foreseeable future[197](index=197&type=chunk) - Primary uses of capital include compensation, manufacturing, R&D services, legal, regulatory, and administrative costs[198](index=198&type=chunk) - Failure to secure sufficient funding could necessitate modifying clinical trial plans, workforce reductions, scaling back activities, discontinuing development programs, or liquidating assets[200](index=200&type=chunk) [Cash Flows](index=66&type=section&id=Cash%20Flows) | Cash Flow Activity (Nine months ended June 30) | 2025 | 2024 | Change | | :--------------------------------------------- | :------------ | :------------ | :------------ | | Net cash used in operating activities | $(39,452,240) | $(51,811,963) | $12,359,723 | | Net cash provided by financing activities | $33,425,516 | $60,444,368 | $(27,018,852) | [Operating Activities](index=68&type=section&id=Operating%20Activities) - Net cash used in operating activities decreased by **$12.4 million** to **$39.5 million** for the nine months ended June 30, 2025, primarily due to non-cash adjustments and a net cash inflow from changes in operating assets and liabilities[203](index=203&type=chunk) - Changes in operating assets and liabilities included a **$6.2 million** decrease in prepaid expenses and a **$3.0 million** increase in accounts payable and accrued expenses, partially offset by a **$4.1 million** increase in inventory and a **$1.8 million** increase in accounts receivable[203](index=203&type=chunk) [Financing Activities](index=68&type=section&id=Financing%20Activities) - Net cash provided by financing activities totaled **$33.4 million** for the nine months ended June 30, 2025, a decrease of **$27.0 million** year-over-year[201](index=201&type=chunk)[205](index=205&type=chunk) - Primary sources of funds included **$33.1 million** from the March 2025 Note, **$16.8 million** from warrant exercises, **$12.1 million** from the Public Offering, and **$5.3 million** from ATM sales[205](index=205&type=chunk) - Proceeds were used to repay the December 2022 Note (**$32.9 million**) and make payments on the March 2025 Note (**$1.0 million**)[205](index=205&type=chunk) [Description of Indebtedness](index=68&type=section&id=Description%20of%20Indebtedness) - The March 2025 Note, issued for **$33.1 million** to Avondale Capital, LLC, matures on July 1, 2026, and bears interest at the prime rate plus **3%** (minimum **9.5%**)[207](index=207&type=chunk)[208](index=208&type=chunk) - The Company is obligated to repay a minimum of **$3,000,000** of the outstanding balance each calendar quarter, convertible into common stock at a Conversion Price of **$2.26** per share (subject to adjustments)[208](index=208&type=chunk)[214](index=214&type=chunk) - The note includes a Beneficial Ownership Limitation of **4.99%** (or **9.99%** if market capitalization falls below **$25,000,000**) and provisions for acceleration upon Trigger Events, with interest accruing at **22%** per annum upon default[212](index=212&type=chunk)[213](index=213&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=70&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) [Revenue Recognition](index=70&type=section&id=Revenue%20Recognition) - Revenue from sales of LYTENAVA (bevacizumab gamma) is recognized in accordance with ASC Topic 606 upon physical delivery of the product to pharmaceutical wholesalers/distributors[216](index=216&type=chunk)[217](index=217&type=chunk) - Gross product sales are reduced by Gross-to-Net (GTN) estimates, including sales returns, administrative fees, and rebates, which are based on external information and management's informed judgments[218](index=218&type=chunk)[220](index=220&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=72&type=section&id=Item%203.%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 not required to provide disclosures about market risk as it qualifies as a "Smaller Reporting Company"[219](index=219&type=chunk) [Item 4. Controls and Procedures](index=73&type=section&id=Item%204.%20Controls%20and%20Procedures) The company's disclosure controls and procedures were evaluated as effective at a reasonable assurance level as of June 30, 2025. New processes and controls related to LYTENAVA commercialization in the UK and Germany (revenue recognition, inventory) were implemented during the quarter, with documentation and testing planned for the fiscal year ending September 30, 2025 [Evaluation of Disclosure Controls and Procedures](index=73&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) - Management concluded that the Company's disclosure controls and procedures were effective, at the reasonable assurance level, as of June 30, 2025[221](index=221&type=chunk) [Changes in Internal Control over Financial Reporting](index=73&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) - During the third fiscal quarter ended June 30, 2025, new processes and controls were implemented related to the commercialization of LYTENAVA in the UK and Germany, specifically for revenue recognition and inventory[222](index=222&type=chunk) - No other changes in internal control over financial reporting materially affected, or are reasonably likely to materially affect, the Company's internal control over financial reporting[222](index=222&type=chunk) [PART II. OTHER INFORMATION](index=74&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=74&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in a securities class action lawsuit and a shareholder derivative action, both alleging violations related to BLA statements and CMC controls for ONS-5010/LYTENAVA. Motions to dismiss are pending in both cases. The outcome is uncertain, and potential costs could be material, though no reserve has been established - A securities class action lawsuit was filed on November 3, 2023, alleging violations of the Exchange Act related to allegedly false and misleading statements about the BLA for ONS-5010/LYTENAVA and deficient CMC controls[224](index=224&type=chunk) - A shareholder derivative action was filed on October 10, 2024, against certain officers and directors, alleging breach of fiduciary duties based on similar alleged misstatements[225](index=225&type=chunk) - Motions to dismiss are currently pending in both lawsuits. The outcome is uncertain, and the Company cannot estimate the possible material costs, thus no reserve has been established[224](index=224&type=chunk)[226](index=226&type=chunk) [Item 1A. Risk Factors](index=74&type=section&id=Item%201A.%20Risk%20Factors) This section updates previously disclosed risk factors, emphasizing the adverse impact of international trade policies, the company's history of significant losses and negative cash flows, its minimal revenue generation, and its high dependence on the successful regulatory approval and commercialization of ONS-5010/LYTENAVA [International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects.](index=74&type=section&id=International%20trade%20policies%2C%20including%20tariffs%2C%20sanctions%20and%20trade%20barriers%20may%20adversely%20affect%20our%20business%2C%20financial%20condition%2C%20results%20of%20operations%20and%20prospects.) - Global trade restrictions, tariffs, and trade tensions, particularly from new U.S. government policies, may adversely impact the Company's business, financial condition, and prospects[229](index=229&type=chunk)[231](index=231&type=chunk) - Tariffs could increase R&D expenses (APIs, raw materials, equipment), disrupt supply chains, and delay development timelines, placing the Company at a competitive disadvantage[232](index=232&type=chunk) - Foreign governments may adopt non-tariff measures or retaliatory actions, such as decreased intellectual property protection or delays in regulatory approvals, increasing international legal and operational risks[233](index=233&type=chunk) [We have incurred significant losses and negative cash flows from operations since our inception and expect to continue to incur significant losses and negative cash flows from operations for at least the next 12 months.](index=76&type=section&id=We%20have%20incurred%20significant%20losses%20and%20negative%20cash%20flows%20from%20operations%20since%20our%20inception%20and%20expect%20to%20continue%20to%20incur%20significant%20losses%20and%20negative%20cash%20flows%20from%20operations%20for%20at%20least%20the%20next%2012%20months.) - The Company has incurred net losses in each year since its inception, including **$49.1 million** for the nine months ended June 30, 2025, and has a substantial accumulated deficit[133](index=133&type=chunk)[235](index=235&type=chunk) - Success is substantially dependent on the ability to generate revenue from ONS-5010/LYTENAVA sales[236](index=236&type=chunk) - Significant expenses and operating losses are expected for at least the next 12 months, with anticipated increases due to commercialization, clinical development, and regulatory efforts[238](index=238&type=chunk)[240](index=240&type=chunk) [We have generated minimal revenue from product sales and may never be profitable.](index=78&type=section&id=We%20have%20generated%20minimal%20revenue%20from%20product%20sales%20and%20may%20never%20be%20profitable.) - The Company has generated minimal revenue from ONS-5010/LYTENAVA sales in the EU and UK and may never achieve profitability[239](index=239&type=chunk) - Future profitability depends on successful development, regulatory and marketing approvals, and commercialization of ONS-5010/LYTENAVA and other product candidates[239](index=239&type=chunk)[241](index=241&type=chunk) - Achieving profitability requires securing sufficient capital, obtaining market acceptance, and ensuring adequate reimbursement for its products[241](index=241&type=chunk)[244](index=244&type=chunk)[247](index=247&type=chunk) [We are highly dependent on the success of ONS-5010/LYTENAVA, our only product that has been approved in the EU and UK. If ONS-5010/LYTENAVA does not receive regulatory approval outside the EU and UK, or is not successfully commercialized, our business may be harmed.](index=80&type=section&id=We%20are%20highly%20dependent%20on%20the%20success%20of%20ONS-5010%2FLYTENAVA%2C%20our%20only%20product%20that%20has%20been%20approved%20in%20the%20EU%20and%20UK.%20If%20ONS-5010%2FLYTENAVA%20does%20not%20receive%20regulatory%20approval%20outside%20the%20EU%20and%20UK%2C%20or%20is%20not%20successfully%20commercialized%2C%20our%20business%20may%20be%20harmed.) - The Company's business is highly dependent on the success of ONS-5010/LYTENAVA, its only product approved for commercial sale in the EU and UK[245](index=245&type=chunk)[248](index=248&type=chunk) - Failure to obtain regulatory approval for ONS-5010/LYTENAVA outside the EU and UK, or to successfully commercialize it, would significantly harm the business[245](index=245&type=chunk)[249](index=249&type=chunk) - The FDA approval process is extensive, lengthy, expensive, and uncertain, with potential for delays or denials due to various factors including efficacy, safety, manufacturing, or regulatory disagreements[251](index=251&type=chunk)[252](index=252&type=chunk) - Past BLA challenges include a Complete Response Letter (CRL) due to CMC issues and lack of substantial evidence, requiring an additional clinical trial (NORSE EIGHT), which did not meet its primary non-inferiority endpoint at week 8[251](index=251&type=chunk)[253](index=253&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=84&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds occurred during the three months ended June 30, 2025 - No unregistered sales of equity securities or use of proceeds during the three months ended June 30, 2025[255](index=255&type=chunk) [Item 3. Defaults Upon Senior Securities](index=84&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities occurred during the three months ended June 30, 2025 - No defaults upon senior securities during the three months ended June 30, 2025[256](index=256&type=chunk) [Item 4. Mine Safety Disclosures](index=84&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - This item is not applicable to the Company[257](index=257&type=chunk) [Item 5. Other Information](index=84&type=section&id=Item%205.%20Other%20Information) No directors or Section 16 officers adopted or terminated Rule 10b5-1 trading plans during the three months ended June 30, 2025 - None of the Company's directors or Section 16 officers adopted or terminated any Rule 10b5-1 trading plans during the three months ended June 30, 2025[258](index=258&type=chunk) [Item 6. Exhibits](index=84&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including the Restated Certificate of Incorporation, Executive Employment Agreement for the new CEO, Master Services Agreement, and various certifications - Exhibits include the Restated Certificate of Incorporation, Certificate of Amendment, Second Amended and Restated Bylaws, Executive Employment Agreement for Robert C. Jahr, Master Services Agreement, and various certifications[259](index=259&type=chunk) [SIGNATURES](index=86&type=section&id=SIGNATURES) The report is signed by Lawrence A. Kenyon, Chief Financial Officer, on behalf of Outlook Therapeutics, Inc - The report was signed by Lawrence A. Kenyon, Chief Financial Officer, on August 14, 2025[267](index=267&type=chunk)

[Corporate and Financial Highlights](index=1&type=section&id=Corporate%20and%20Financial%20Highlights) The company reported its first commercial revenue in Q3 FY2025, alongside a net loss, while achieving European market entry and progressing its U.S. FDA BLA review [Financial Highlights](index=1&type=section&id=Financial%20Highlights) Outlook Therapeutics reported its first-ever revenue in Q3 FY2025, alongside a GAAP net loss and an improved adjusted net loss, concluding the quarter with a reduced cash position Q3 FY2025 vs Q3 FY2024 Financial Results | Metric | Q3 FY2025 | Q3 FY2024 | | :--- | :--- | :--- | | Revenue | $1.5 million | $0 | | Net Loss Attributable to Common Stockholders | $20.2 million | N/A (Net Income of $44.4M due to non-cash gains) | | Net Loss per Share (basic & diluted) | $0.55 | $0.89 | | Adjusted Net Loss Attributable to Common Stockholders | $15.8 million | $19.2 million | | Adjusted Net Loss per Share (basic & diluted) | $0.44 | $0.83 | - The company's cash and cash equivalents stood at **$8.9 million** as of June 30, 2025[5](index=5&type=chunk) - Adjustments to net loss for Q3 FY2025 primarily excluded a **$2.3 million** loss from change in fair value of promissory notes and a **$2.0 million** loss from change in fair value of warrant liability[4](index=4&type=chunk) [Corporate and Operational Highlights](index=1&type=section&id=Corporate%20and%20Operational%20Highlights) Outlook Therapeutics has successfully transitioned into a commercial-stage company with the first commercial sales of LYTENAVA™ in Europe, with a significant near-term U.S. FDA PDUFA goal date for ONS-5010 - The company achieved its first commercial sales of LYTENAVA™ (bevacizumab gamma) in Europe, with the first patients dosed in Germany and the UK[7](index=7&type=chunk)[8](index=8&type=chunk) - The U.S. Food and Drug Administration (FDA) has set a PDUFA goal date of August 27, 2025, for the review of the Biologics License Application (BLA) for ONS-5010[6](index=6&type=chunk)[7](index=7&type=chunk) [Business and Product Update](index=2&type=section&id=Business%20and%20Product%20Update) The company provides updates on the commercial launch of LYTENAVA™ in Europe, the U.S. regulatory progress for ONS-5010, and key product characteristics [European Commercial Update](index=2&type=section&id=European%20Commercial%20Update) LYTENAVA™ (bevacizumab gamma) is now commercially available in Germany and the UK for treating wet age-related macular degeneration (wet AMD), being the first and only authorized ophthalmic formulation of bevacizumab for this indication in the European Union and the UK, supported by a strategic collaboration with Cencora - LYTENAVA™ is the first and only authorized ophthalmic formulation of bevacizumab for treating wet AMD in adults in the European Union and UK[9](index=9&type=chunk) - The company aims to mitigate risks associated with the current off-label use of repackaged bevacizumab, which is frequently used in Europe (approx. **2.8 million** injections annually) and the U.S. (approx. **2.7 million** injections annually)[10](index=10&type=chunk) - A strategic collaboration with Cencora is in place to support market access and efficient distribution of LYTENAVA™ globally[11](index=11&type=chunk) [U.S. Regulatory Update](index=2&type=section&id=U.S.%20Regulatory%20Update) The FDA has accepted the resubmitted Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg) for the treatment of wet AMD, undergoing a Class 2, six-month review with a PDUFA goal date of August 27, 2025, and expected to receive 12 years of regulatory exclusivity if approved - The FDA acknowledged the BLA resubmission for ONS-5010 in April 2025 and set a PDUFA goal date of August 27, 2025[12](index=12&type=chunk) - The resubmission was based on efficacy and safety data from the NORSE EIGHT clinical trial, conducted to address the FDA's requirement for a second adequate and well-controlled study[13](index=13&type=chunk) - Upon potential approval, ONS-5010, to be branded as LYTENAVA™ in the U.S., is expected to receive **12 years** of regulatory exclusivity[12](index=12&type=chunk) [About ONS-5010 / LYTENAVA™](index=3&type=section&id=About%20ONS-5010%20%2F%20LYTENAVA%E2%84%A2) ONS-5010 / LYTENAVA™ is an ophthalmic formulation of bevacizumab, a monoclonal antibody that neutralizes vascular endothelial growth factor (VEGF) to reduce blood vessel formation and leakage in the retina, approved for wet AMD in the EU and UK, and currently an investigational product in the United States - The product is a recombinant humanized monoclonal antibody (mAb) that selectively binds to and neutralizes all isoforms of human VEGF[16](index=16&type=chunk) - It has received Marketing Authorization from the European Commission and the UK's MHRA for the treatment of wet AMD[14](index=14&type=chunk)[17](index=17&type=chunk) - In the United States, ONS-5010 / LYTENAVA™ (bevacizumab-vikg) remains an investigational product pending FDA approval[15](index=15&type=chunk)[18](index=18&type=chunk) [Financial Statements and Non-GAAP Reconciliation](index=3&type=section&id=Financial%20Statements%20and%20Non-GAAP%20Reconciliation) This section presents the company's consolidated statements of operations and balance sheet, along with a reconciliation of GAAP to non-GAAP financial measures [Consolidated Statements of Operations](index=5&type=section&id=Consolidated%20Statements%20of%20Operations) For Q3 FY2025, Outlook Therapeutics reported its first revenues, leading to a gross profit, and incurred significant operating expenses, resulting in a net loss Q3 FY2025 Statement of Operations Highlights (in thousands) | Line Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Revenues, net | $1,505 | $0 | | Gross profit | $1,065 | $0 | | Research and development | $7,135 | $11,202 | | Selling, general and administrative | $9,679 | $8,361 | | Loss from operations | $(15,749) | $(19,563) | | Net (loss) income | $(20,152) | $44,409 | | Net loss per share, diluted | $(0.55) | $(0.89) | [Condensed Consolidated Balance Sheet](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheet) As of June 30, 2025, the company's balance sheet reflects a decrease in cash and cash equivalents, with total assets significantly lower than current liabilities, resulting in a substantial stockholders' deficit Balance Sheet Highlights (in thousands) | Line Item | June 30, 2025 | September 30, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $8,901 | $14,928 | | Total assets | $22,392 | $28,823 | | Current liabilities | $31,489 | $42,554 | | Total stockholders' deficit | $(37,190) | $(73,077) | [Non-GAAP Financial Measures and Reconciliation](index=3&type=section&id=Non-GAAP%20Financial%20Measures%20and%20Reconciliation) Outlook Therapeutics utilizes non-GAAP measures, such as adjusted net loss, to present a clearer view of core operating performance by excluding specific non-cash items, demonstrating an improved adjusted net loss compared to the prior year - The company uses non-GAAP financial measures, such as "adjusted net loss attributable to common stockholders," to exclude non-cash items like changes in fair value of warrants and promissory notes, which management believes are not related to its core business[19](index=19&type=chunk) GAAP to Non-GAAP Reconciliation for Q3 (in thousands) | Line Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net (loss) income attributable to common stockholders (GAAP) | $(20,152) | $44,409 | | Adjustments (e.g., fair value changes, warrant expenses) | $4,324 | $(63,625) | | Adjusted net loss attributable to common stockholders (non-GAAP) | $(15,828) | $(19,216) |

Company Performance - Oncobiologics reported a quarterly loss of $0.44 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.42, but an improvement from a loss of $0.83 per share a year ago, indicating a year-over-year improvement in losses [1] - The company posted revenues of $1.51 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 40.98%, compared to zero revenues a year ago [2] - Over the last four quarters, Oncobiologics has surpassed consensus EPS estimates two times [2] Stock Performance - Oncobiologics shares have increased by approximately 12.7% since the beginning of the year, outperforming the S&P 500's gain of 10% [3] - The current Zacks Rank for Oncobiologics is 3 (Hold), indicating that the shares are expected to perform in line with the market in the near future [6] Future Outlook - The current consensus EPS estimate for the coming quarter is -$0.33 on revenues of $5.78 million, and for the current fiscal year, it is -$1.89 on revenues of $6.42 million [7] - The outlook for the Medical - Biomedical and Genetics industry, in which Oncobiologics operates, is currently in the bottom 41% of over 250 Zacks industries, suggesting potential challenges ahead [8]