Core Viewpoint - Outlook Therapeutics, Inc. has announced a public offering of 9,285,714 shares of common stock at a price of $1.40 per share, along with warrants to purchase an additional 18,571,428 shares, aiming to raise approximately $13.0 million in gross proceeds [1][2]. Group 1: Offering Details - The public offering includes common stock sold in combination with warrants, where each share sold comes with a warrant to purchase two additional shares at an exercise price of $1.40 [1]. - The offering is expected to close on May 27, 2025, pending customary closing conditions [1]. - BTIG, LLC is acting as the sole book-running manager for the offering [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for working capital and other general corporate purposes [2]. Group 3: Company Overview - Outlook Therapeutics focuses on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg), aimed at enhancing the standard of care for retinal diseases [5]. - LYTENAVA™ is the first ophthalmic formulation of bevacizumab to receive marketing authorization in Europe for treating wet age-related macular degeneration (wet AMD) [5]. - The company plans to initiate the commercial launch of LYTENAVA™ in the EU and the UK in the second quarter of 2025, while the product remains investigational in the United States [5].

Core Viewpoint - Outlook Therapeutics, Inc. has initiated an underwritten public offering of its common stock and accompanying warrants, aimed at enhancing the standard of care for bevacizumab in treating retina diseases [1][2] Group 1: Offering Details - The offering is subject to market conditions, and there is no assurance regarding its completion or the actual size and terms [1] - The net proceeds from the offering will be utilized for working capital and other general corporate purposes [2] - BTIG, LLC is serving as the sole book-running manager for the offering [2] Group 2: Regulatory and Product Information - The securities are being offered under a shelf registration statement declared effective by the SEC on April 5, 2024 [3] - Outlook Therapeutics is focused on the development of ONS-5010/LYTENAVA™ (bevacizumab-vikg), which is the first ophthalmic formulation of bevacizumab approved for wet age-related macular degeneration in the EU and UK [5] - The company plans to initiate the commercial launch of LYTENAVA™ in the EU and UK in the second quarter of 2025, while the product is still investigational in the U.S. [5]

Financial Performance - For the fiscal second quarter ended March 31, 2025, Outlook Therapeutics reported a net loss of $46.4 million, or $1.50 per share, compared to a net loss of $114.3 million, or $8.01 per share, for the same period last year[11]. - The adjusted net loss for the fiscal second quarter was $12.5 million, or $0.40 per share, down from an adjusted net loss of $22.1 million, or $1.55 per share, in the fiscal second quarter of 2024[11]. - For the three months ended March 31, 2025, the net loss attributable to common stockholders was $46.358 million, compared to a net loss of $114.289 million for the same period in 2024, representing a 59.3% improvement[26]. - The adjusted net loss attributable to common stockholders (non-GAAP) for the three months ended March 31, 2025, was $12.450 million, compared to $22.057 million in 2024, a reduction of 43.5%[26]. - The company reported a loss from operations of $12.391 million for the three months ended March 31, 2025, compared to a loss of $18.940 million in the same period of 2024, a 34.5% decrease[26]. - The loss before income taxes for the six months ended March 31, 2025, was $28.977 million, a significant improvement from $125.464 million in the same period of 2024, representing a 77.0% reduction[26]. Cash and Assets - As of March 31, 2025, Outlook Therapeutics had cash and cash equivalents of $7.6 million[13]. - Cash and cash equivalents decreased to $7.556 million as of March 31, 2025, from $14.928 million in 2024, a decline of 49.3%[24]. - Total assets decreased to $19.075 million as of March 31, 2025, from $28.823 million in 2024, a decline of 33.7%[24]. - The total stockholders' deficit decreased to $32.463 million as of March 31, 2025, from $73.077 million in 2024, reflecting a 55.6% improvement[24]. Product Development and Regulatory Approvals - The FDA has set a PDUFA goal date of August 27, 2025, for the approval of ONS-5010 (bevacizumab-vikg) for the treatment of wet AMD[8]. - LYTENAVA™ is the first authorized ophthalmic formulation of bevacizumab for treating wet AMD in the EU and UK, with approximately 2.8 million injections annually in Europe and 2.7 million in the U.S. for retinal diseases[6]. - The BLA resubmission for ONS-5010 was based on data from the NORSE EIGHT trial, which demonstrated efficacy and safety for the treatment of wet AMD[9]. - If approved, ONS-5010/LYTENAVA™ will receive 12 years of regulatory exclusivity in the United States[8]. - The company may seek authorization for LYTENAVA™ in other European countries, Japan, and additional markets[7]. Strategic Collaborations and Launch Plans - The company is on track for the commercial launch of LYTENAVA™ (bevacizumab gamma) in Germany and the UK in Q2 CY2025, following marketing authorizations granted in May 2024 and July 2024[3][4]. - Outlook Therapeutics has entered into a strategic collaboration with Cencora to support the global commercial launch of LYTENAVA™ following regulatory approvals[7]. Research and Development Expenses - Research and development expenses for the six months ended March 31, 2025, were $14.067 million, down from $18.038 million in the same period of 2024, indicating a 22.0% decrease[26]. - The company incurred warrant inducement expenses of $33.857 million for the three months ended March 31, 2025, compared to no such expenses in the same period of 2024[26].

Product Development and Market Approval - ONS-5010/LYTENAVA is the first ophthalmic formulation of bevacizumab approved in the EU and UK for wet AMD, with plans to launch in the US in Q2 2025[110]. - The FDA issued a Complete Response Letter for the BLA of ONS-5010/LYTENAVA on August 29, 2023, citing CMC issues and the need for an additional clinical trial[115]. - The NORSE EIGHT trial, involving 400 subjects, did not meet the pre-specified non-inferiority endpoint at week 8, but showed improvement in vision and a favorable safety profile[119]. - The mean improvement in best corrected visual acuity (BCVA) was +4.2 letters for ONS-5010/LYTENAVA and +6.3 letters for ranibizumab at week 8[119]. - The FDA's PDUFA goal date for a decision on the resubmitted BLA is August 27, 2025, with potential for 12 years of regulatory exclusivity if approved[116]. - The company has agreements with the FDA on SPAs for three additional registration clinical trials for ONS-5010/LYTENAVA[121]. Financial Performance and Losses - The company reported a net loss of $46.4 million for the three months ended March 31, 2025, compared to a net loss of $114.3 million for the same period in 2024, reflecting a decrease of $67.9 million[146]. - The company anticipates incurring additional losses until significant sales of ONS-5010/LYTENAVA or other product candidates can be generated[125]. - The company has substantial doubt about its ability to continue as a going concern, as existing cash and cash equivalents are insufficient to fund operations for the next year[127]. - Net loss for the six months ended March 31, 2025 was $28.98 million, a significant improvement compared to a net loss of $125.47 million for the same period in 2024, reflecting a change of $96.49 million[155]. - The company has incurred net losses and negative cash flows from operations, funding its activities with $584.0 million in net proceeds from equity and debt securities[163]. Research and Development Expenses - Research and development expenses decreased by $9.1 million to $4.4 million for the three months ended March 31, 2025, primarily due to a reduction in expenses related to the ONS-5010/LYTENAVA development[147]. - Research and development expenses for the six months ended March 31, 2025 decreased by $4.0 million to $14.1 million compared to $18.0 million for the same period in 2024, primarily due to a $3.3 million decrease in ONS-5010/LYTENAVA development expenses[156]. General and Administrative Expenses - General and administrative expenses increased by $2.6 million to $8.0 million for the three months ended March 31, 2025, driven by prelaunch expenses for ONS-5010/LYTENAVA in Europe[148]. - General and administrative expenses increased by $8.7 million to $19.9 million for the six months ended March 31, 2025, driven by $4.7 million in prelaunch expenses for ONS-5010/LYTENAVA in Europe[157]. Financing and Capital Management - The company has funded operations with $584.0 million in net proceeds from equity and debt securities and $29.0 million from collaboration and licensing agreements as of March 31, 2025[125]. - The company anticipates needing additional financing to fund operations and fully commercialize ONS-5010/LYTENAVA, exploring various strategic opportunities for funding[164]. - The company sold 1,926,742 shares of common stock under the At-the-Market Offering, generating approximately $3.2 million in net proceeds during the six months ended March 31, 2025[166]. - On March 13, 2025, the company issued an unsecured convertible promissory note for $33.1 million to pay off the December 2022 Note[170]. - The company recognized warrant inducement charges associated with warrants exercised, resulting in net proceeds of $15.9 million from the Warrant Inducement Transaction[171]. - The company plans to finance future operations through licensing arrangements, equity issuance, and potential product sales, with risks of dilution and unfavorable terms[178]. Market Overview - The total anti-VEGF retina market in Europe is estimated at approximately $3.6 billion, with around 1.52 million treated patients and 8.3 million total anti-VEGF units[111]. - The US anti-VEGF retina market is estimated at $8.5 billion, with 55% of off-label repackaged bevacizumab injections used as first-line agents[112]. - The global market for anti-VEGF retina is approximately $16 billion[113]. Economic Factors - Macroeconomic factors, including inflation and interest rates, may adversely affect the rollout of LYTENAVA in key markets[122]. Cash Flow and Operating Activities - Net cash used in operating activities for the six months ended March 31, 2025, was $27.6 million, primarily due to a net loss of $29.0 million[180]. - Net cash provided by financing activities during the same period was $20.2 million, driven by proceeds from the issuance of the March 2025 Note and warrant exercises[182]. Warrant and Liability Management - The loss from change in fair value of warrant liability was $42.3 million for the six months ended March 31, 2025, compared to a gain of $49.7 million for the same period in 2024, reflecting a change of $92.0 million[155]. - Syntone agreed to exercise existing warrants for 1,071,429 shares at a reduced price of $2.51, with potential net proceeds of approximately $2.4 million pending regulatory approval[172]. - The conversion price for the March 2025 Note is set at $2.26 per share, subject to adjustments based on market conditions[190].

Core Insights - Outlook Therapeutics is on track to transition into a commercial-stage company with the planned launch of LYTENAVA™ (bevacizumab gamma) in Germany and the UK for wet AMD treatment in Q2 2025 [2][3] - The company anticipates potential FDA approval for ONS-5010 / LYTENAVA™ (bevacizumab-vikg) in the US by August 27, 2025, which would provide a much-needed approved ophthalmic formulation of bevacizumab [2][6] Financial Performance - For the fiscal second quarter ended March 31, 2025, the company reported a net loss of $46.4 million, or $1.50 per share, a significant reduction from a net loss of $114.3 million, or $8.01 per share, in the same period last year [10][26] - The adjusted net loss for the same period was $12.5 million, or $0.40 per share, compared to an adjusted net loss of $22.1 million, or $1.55 per share, for the fiscal second quarter of 2024 [10][11] Product Development and Regulatory Updates - LYTENAVA™ (bevacizumab gamma) is the first authorized ophthalmic formulation of bevacizumab for wet AMD in the EU and UK, with approximately 2.8 million injections annually in Europe and 2.7 million in the US for retinal diseases [4][16] - The FDA has acknowledged the resubmission of the Biologics License Application (BLA) for ONS-5010, which is undergoing a Class 2 review with a six-month review period [6][9] Market Strategy and Collaborations - Outlook Therapeutics has entered a strategic collaboration with Cencora to support the global commercial launch of LYTENAVA™ following regulatory approvals, aiming for efficient distribution and market access [5][16] - The company is also exploring authorization in additional European countries and Japan, indicating a broader market strategy [5]

Core Viewpoint - Outlook Therapeutics has received FDA acknowledgment for the resubmission of the Biologics License Application (BLA) for ONS-5010, an investigational ophthalmic formulation of bevacizumab for treating wet age-related macular degeneration (wet AMD), with a PDUFA goal date set for August 27, 2025 [1][2] Group 1: Company Developments - The BLA resubmission is based on the efficacy and safety data from the NORSE EIGHT clinical trial and additional chemistry, manufacturing, and controls (CMC) information requested by the FDA [2] - If approved, ONS-5010 will be marketed as LYTENAVA™ in the United States and is expected to receive 12 years of regulatory exclusivity [1][2] - The company is preparing for the commercial launch of LYTENAVA™ in the EU and UK, anticipated in the second quarter of 2025 [6] Group 2: Product Information - ONS-5010 / LYTENAVA™ is the first ophthalmic formulation of bevacizumab to receive marketing authorization in the EU and UK for wet AMD [3][6] - Bevacizumab-vikg is a recombinant humanized monoclonal antibody that targets all isoforms of human vascular endothelial growth factor (VEGF), inhibiting its biological activity and reducing retinal issues associated with wet AMD [5] Group 3: Regulatory Context - The FDA has classified the BLA as a Class 2 review, which entails a six-month review period from the resubmission date [1][2] - The company believes that the complete data set from the NORSE EIGHT trial, along with additional CMC information, provides sufficient evidence for the approval of the BLA in the United States [2]

Core Viewpoint - Outlook Therapeutics has re-submitted its Biologics License Application (BLA) for ONS-5010, an investigational ophthalmic product for the treatment of wet age-related macular degeneration (wet AMD), to the FDA, following regulatory approval in the EU and UK for its ophthalmic formulation of bevacizumab [1][8] Group 1: Regulatory Developments - The BLA resubmission is based on the efficacy and safety data from the NORSE EIGHT study and additional chemistry, manufacturing, and controls (CMC) information requested by the FDA [2] - A decision from the FDA regarding the BLA is expected within six months [2] Group 2: Clinical Trial Insights - NORSE EIGHT was a randomized, controlled, parallel-group, masked, non-inferiority study involving 400 newly diagnosed wet AMD subjects [3] - In the NORSE EIGHT study, ONS-5010 showed a mean improvement of 4.2 letters in best corrected visual acuity (BCVA) at week 8, which did not meet the pre-specified non-inferiority endpoint [3] - The 12-week analysis indicated that ONS-5010 demonstrated a mean improvement in BCVA of 3.3 to 5.5 letters, compared to a mean improvement of 4.5 to 6.5 letters in the ranibizumab arm [4] Group 3: Product Information - ONS-5010, branded as LYTENAVA™, is an ophthalmic formulation of bevacizumab for treating wet AMD and has received marketing authorization in the EU and UK [5][8] - In the U.S., ONS-5010 is still investigational and, if approved, would be the first FDA-approved ophthalmic formulation of bevacizumab for retinal indications [8]

Core Viewpoint - Outlook Therapeutics has received regulatory approval in the EU and UK for the first authorized ophthalmic formulation of bevacizumab for treating wet age-related macular degeneration (wet AMD) [2][4] Company Overview - Outlook Therapeutics is a biopharmaceutical company focused on developing and commercializing ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for retinal diseases, including wet AMD [4] - LYTENAVA™ is the first ophthalmic formulation of bevacizumab to receive marketing authorization from the European Commission and MHRA for wet AMD treatment [4] - The company plans to initiate the commercial launch of LYTENAVA™ in the EU and UK in the second quarter of 2025 [4] Clinical Development - In the United States, ONS-5010 / LYTENAVA™ is currently investigational and is undergoing a non-inferiority study for wet AMD treatment [4] - Successful results from the study may allow the company to resubmit a Biologics License Application (BLA) to the FDA [4] - If approved, ONS-5010 / LYTENAVA™ would be the first approved ophthalmic formulation of bevacizumab for retinal indications in the U.S. [4] Investor Engagement - The company participated in the Virtual Investor "Top 5 for '25" On-Demand Conference, where the CFO and Interim CEO presented key reasons for investor interest in Outlook Therapeutics [3]

Regulatory Approvals and Clinical Trials - The company received marketing authorization for ONS-5010/LYTENAVA for the treatment of wet AMD from the European Commission on May 27, 2024, valid throughout the EEA, providing eight years of data exclusivity and ten years of market exclusivity[102]. - The company plans to launch ONS-5010/LYTENAVA in Germany and the UK in Q2 2025, following approvals in the EU and UK[102]. - The FDA issued a Complete Response Letter on August 29, 2023, indicating that the BLA for ONS-5010/LYTENAVA could not be approved due to CMC issues and the need for an additional clinical trial[106]. - The NORSE EIGHT trial, involving approximately 400 subjects, did not meet the pre-specified non-inferiority endpoint at week 8, with a mean difference of -2.257 BCVA letters compared to ranibizumab[109]. - At week 12, the NORSE EIGHT trial showed a mean improvement of 5.5 letters in the ONS-5010/LYTENAVA arm and 6.5 letters in the ranibizumab arm, indicating potential for approval[111]. - The company plans to resubmit the BLA for ONS-5010/LYTENAVA in Q1 2025, expecting 12 years of regulatory exclusivity in the US if approved[111]. - The company has agreements with the FDA on three Special Protocol Assessments for additional registration clinical trials for ONS-5010/LYTENAVA[113]. - The company aims to mitigate risks associated with off-label use of unapproved bevacizumab with the approval of ONS-5010/LYTENAVA in the US[114]. Financial Performance and Funding - The company reported a net income of $17.4 million for the three months ended December 31, 2024, but incurred a net loss of $11.2 million for the same period in 2023[119]. - As of December 31, 2024, the company has funded operations with $532.6 million from equity and debt securities sales, and $29.0 million from collaboration and licensing agreements[119]. - There is substantial doubt about the company's ability to continue as a going concern due to insufficient cash and cash equivalents to fund operations for the next year[120]. - The company has federal and state NOL carryforwards of $406.7 million and $242.5 million, respectively, which will begin to expire in 2030 and 2039[142]. - The company has not generated any revenue from product sales and anticipates incurring additional losses until significant sales can be achieved[119]. - The company anticipates needing additional financing to support operations and the commercial development of ONS-5010/LYTENAVA, with potential strategies including licensing arrangements and equity issuance[153]. - The company sold 1,000,000 shares under the BTIG ATM Offering, generating approximately $1.7 million in net proceeds during the three months ended December 31, 2024[155]. - The company entered into a Warrant Inducement Transaction, receiving net proceeds of $15.7 million from the exercise of existing warrants[158]. - The company expects to incur net losses and negative cash flow for the foreseeable future, heavily dependent on successful financing and regulatory approvals[163]. - As of December 31, 2024, the company does not believe that existing cash and cash equivalents, along with net proceeds from the Warrant Inducement Transaction, are sufficient to fund operations for the next year[166]. - The company may need to modify clinical trial plans, reduce workforce, or seek bankruptcy protection if adequate financing is not obtained[168]. Expenses and Cash Flow - Research and development expenses increased by $5.1 million to $9.66 million for the three months ended December 31, 2024, compared to $4.53 million in 2023, primarily due to expenses related to the NORSE EIGHT clinical trial for ONS-5010/LYTENAVA[146]. - General and administrative expenses rose by $6.2 million to $11.95 million for the three months ended December 31, 2024, compared to $5.79 million in 2023, driven by $2.5 million in prelaunch expenses for Europe and a $3.3 million increase in compensation costs[147]. - The company has incurred net losses and negative cash flows since inception, funding operations with $532.6 million from equity and debt securities[152]. - For the three months ended December 31, 2024, the company reported a net cash used in operating activities of $10.97 million, compared to $13.03 million for the same period in 2023, reflecting a decrease of approximately 15.6%[169][171]. - The net cash provided by financing activities for the three months ended December 31, 2024, was $1.74 million, primarily from the sale of common stock under the BTIG ATM Offering[172]. Debt and Financial Obligations - The December 2022 Note has a face value of $31.8 million, with an original issue discount of $1.8 million, and its maturity was extended to April 1, 2024[174]. - The January 2025 Note, amounting to $33.1 million, is intended to fully settle the December 2022 Note and is expected to close after the 2025 annual meeting of stockholders[177]. - The January 2025 Note will bear interest at the prime rate plus 3%, with a minimum repayment obligation of $3 million each quarter starting in Q2 2025[178].

Financial Performance - Outlook Therapeutics reported a net income of $17.4 million, or $0.72 per share, for the fiscal first quarter ended December 31, 2024, compared to a net loss of $11.2 million, or $0.86 per share, for the same period last year[11]. - The adjusted net loss for the fiscal first quarter was $21.6 million, or $0.89 per share, compared to an adjusted net loss of $10.1 million, or $0.78 per share, for the fiscal first quarter of 2024[11]. - For the three months ended December 31, 2024, total operating expenses were $21,607,000, compared to $10,323,000 for the same period in 2023, representing a 109.5% increase[23]. - The net income for the three months ended December 31, 2024, was $17,378,000, compared to a net loss of $11,178,000 for the same period in 2023[23]. - The basic and diluted net income per share for the three months ended December 31, 2024, was $0.72, compared to a loss of $0.86 per share for the same period in 2023[23]. - Adjusted net loss attributable to common stockholders for the three months ended December 31, 2024, was $(21,591,000), compared to $(10,132,000) for the same period in 2023[27]. - The weighted average shares outstanding, basic and diluted, increased to 24,234,000 for the three months ended December 31, 2024, from 13,013,000 for the same period in 2023[27]. Cash and Assets - Cash and cash equivalents decreased to $5,703,000 as of December 31, 2024, from $14,928,000 as of September 30, 2024[25]. - Total assets decreased to $17,006,000 as of December 31, 2024, from $28,823,000 as of September 30, 2024[25]. - Current liabilities increased to $48,237,000 as of December 31, 2024, compared to $42,554,000 as of September 30, 2024[25]. - The total stockholders' deficit improved to $(50,290,000) as of December 31, 2024, from $(73,077,000) as of September 30, 2024[25]. Product Development and Market Opportunity - The company plans to launch LYTENAVA™ (bevacizumab gamma) in Germany and the UK in Q2 CY2025, following marketing authorizations received in May and July 2024[3][4]. - Over 2.5 million off-label injections of repackaged bevacizumab are administered annually in Europe, with approximately 1.6 million in Germany alone, indicating a significant market opportunity for LYTENAVA™[6]. - The resubmission of the ONS-5010 Biologics License Application (BLA) is on track for Q1 CY2025, with potential US FDA approval anticipated in Q3 CY2025[5][8]. - In the NORSE EIGHT clinical trial, ONS-5010 demonstrated a mean improvement of 5.5 letters in best corrected visual acuity (BCVA) at week 12, indicating positive efficacy[10]. - The complete data set from the NORSE EIGHT trial showed a reduction in central retinal thickness of -123.9 microns for ONS-5010 treated eyes, comparable to -127.3 microns for the ranibizumab group[10]. - Outlook Therapeutics aims to provide an approved ophthalmic formulation of bevacizumab, enhancing treatment options for wet AMD patients[2]. - The company anticipates potential commercial launch of LYTENAVA™ in Germany and the UK, with expected revenue generation timing still to be determined[20]. Strategic Collaborations - Outlook Therapeutics received $17.8 million in gross proceeds from a warrant exercise inducement in January 2025, enhancing its cash position[14]. - The company has entered into a strategic collaboration with Cencora to support the global commercial launch of LYTENAVA™ following regulatory approvals[7].