Latest news with #LYTENAVA™
Associated Press
3 days ago
- Business
- Associated Press
Outlook Therapeutics Appoints Biopharmaceutical Industry and Commercial Leader Bob Jahr as Chief Executive Officer
Well-established executive with over 20 years of experience building and leading commercial teams across diverse therapeutic markets and geographies Career focused on driving business growth and developing an integrated commercial strategy to deliver results ISELIN, N.J., July 01, 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 the appointment of Bob Jahr as Chief Executive Officer (CEO). Mr. Jahr has also been appointed to the Outlook Therapeutics Board of Directors. Lawrence A. Kenyon, who has served as Outlook Therapeutics' Chief Financial Officer (CFO) and interim CEO, will continue serving as CFO and as a member of the Board of Directors. 'We are very pleased to welcome Bob to the executive leadership team as we continue to execute on our path forward. Bob's experience, track record and deep understanding of the biopharmaceutical industry will be invaluable as we scale as a commercial entity. With our launch in Europe underway and potential U.S. Food and Drug Administration (FDA) approval in the coming months, we believe this appointment is timely and positions us to drive value for our stakeholders,' commented Faisal G. Sukhtian, Chairman of the Outlook Therapeutics Board of Directors. Mr. Jahr brings more than 20 years of experience in the biopharmaceutical industry building and leading commercial teams spanning therapeutic areas including rare disease, oncology, hematology, autoimmunology, neuroscience, cardiovascular and inflammation. Over the course of his career, he has led operational and commercial efforts for multiple billion dollar assets and franchises. 'LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma) has the potential to truly transform the global retina market and offer a much-needed ophthalmic formulation of bevacizumab for wet AMD,' added Mr. Jahr. 'With the commercial launch underway in Europe and potential FDA approval in the U.S. in the near term, I am excited to join the team at such a pivotal time for Outlook Therapeutics. I look forward to adding the depth and breadth of my experience to Outlook Therapeutics and continue building momentum to position it as a leader in the ophthalmology market.' Mr. Jahr joins Outlook Therapeutics having most recently served as the Chief Commercial Officer for Sobi North America (NA), where he oversaw commercial strategy, planning and execution excellence, which includes accountability for all marketing, sales, operations and market access activities. During his tenure at Sobi NA, Mr. Jahr led the immunology and hematology franchises, and three global development asset teams focused on preparing for regulatory submission, life cycle management and launch. Prior to his role at Sobi NA he served as General Manager & Vice President Head of International Markets at UCB Pharma SA (UCB) where he managed the company's portfolio in markets including China, Japan, Brazil, AUS, Canada, Middle East and Latin America. He also served as VP Head of US Payer Value, Pricing, Strategy & Innovation at UCB where he was responsible for developing teams during a period of expansion and launches. Prior to UCB he held leadership roles in sales, marketing, operations, payor strategy, and market access at Amgen. Mr. Jahr holds a Master of Business Administration degree and a Bachelor of Science degree in Business Administration and Management from University of Montana. Inducement Grant Additionally, Outlook Therapeutics announced that the independent members of its Board of Directors approved the issuance of an option to purchase 800,000 shares of common stock to Mr. Jahr in accordance with Nasdaq Listing Rule 5635(c)(4), as a material inducement to Mr. Jahr's start of employment with Outlook Therapeutics. The option will be issued on July 1, 2025 with an exercise price per share equivalent to the closing price of Outlook Therapeutics' common stock on the date of grant. The option will vest over four years, with 25% of the shares subject to the option vesting on the first anniversary of the grant date, with the remaining shares vesting in equal monthly installments over the three years thereafter, subject to Mr. Jahr's continuous service through the applicable vesting date. About Outlook Therapeutics, Inc. Outlook Therapeutics is a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma) to enhance the standard of care for bevacizumab for the treatment of retina diseases. LYTENAVA™ (bevacizumab gamma) is the first ophthalmic formulation of bevacizumab to receive European Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics commenced commercial launch of LYTENAVA™ (bevacizumab gamma) in Germany and the UK as a treatment for wet AMD. In the United States, ONS-5010/LYTENAVA™ (bevacizumab-vikg) is investigational, and a BLA has been resubmitted to the FDA. If approved in the United States, ONS-5010/LYTENAVA™, would be the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD. Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical facts are 'forward-looking statements,' including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as 'anticipate,' 'believe,' 'continue,' 'expect,' 'may,' 'plan,' 'potential,' 'will,' or 'would' the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include, among others, expectations concerning the therapeutic potential of ONS-5010/LYTENAVA™ as a treatment of wet AMD, Outlook Therapeutics' commercialization strategy, the market opportunity for ONS-5010/LYTENAVA™, expectations concerning decisions of regulatory bodies and the timing thereof, ONS-5010/LYTENAVA™'s potential as the first FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal indications, including wet AMD, in the United States and other statements that are not historical fact. Although Outlook Therapeutics believes that it has a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting Outlook Therapeutics and are subject to risks, uncertainties and factors relating to its operations and business environment, all of which are difficult to predict and many of which are beyond its control. These risk factors include those risks associated with developing and commercializing pharmaceutical product candidates, risks of conducting clinical trials and risks in obtaining necessary regulatory approvals, the content and timing of decisions by regulatory bodies, the sufficiency of Outlook Therapeutics' resources, unanticipated or greater than anticipated impacts or delays due to macroeconomic and geopolitical conditions (including the long-term impacts of ongoing overseas conflicts, tariffs and trade tensions, fluctuations in inflation and interest rates and other economic uncertainty), as well as those risks detailed in Outlook Therapeutics' filings with the Securities and Exchange Commission (SEC), including the Annual Report on Form 10-K for the fiscal year ended September 30, 2024, filed with the SEC on December 27, 2024, the Quarterly Report on Form 10-Q for fiscal quarter ended March 31, 2025 and future quarterly reports Outlook Therapeutics files with the SEC. These risks may cause actual results to differ materially from those expressed or implied by forward-looking statements in this press release. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Outlook Therapeutics does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law. Investor Inquiries: Jenene Thomas Chief Executive Officer JTC Team, LLC T: 908.824.0775 [email protected]
Yahoo
10-06-2025
- Business
- Yahoo
Outlook Therapeutics® Announces SMC Recommendation of LYTENAVA™ (bevacizumab gamma) for the Treatment of Wet AMD
ISELIN, N.J., June 10, 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 the Scottish Medicines Consortium (SMC) acceptance of LYTENAVA™ (bevacizumab gamma) for use within NHS Scotland for the treatment of wet age-related macular degeneration (wet AMD). LYTENAVA™ (bevacizumab gamma) is the first and only licensed ophthalmic formulation of bevacizumab for use in treating wet AMD in adults in the United Kingdom (UK) and has an initial 10 years of market exclusivity from the date of initial marketing authorization from the Medicines and Healthcare products Regulatory Agency. 'Receiving the SMC recommendation of LYTENAVA™ (bevacizumab gamma) for patients with wet AMD is a significant milestone for our company and a testament to our commitment to improving patient outcomes,' commented Jedd Comiskey, Senior Vice President, Head of Europe, Outlook Therapeutics. 'This acceptance will allow patients in Scotland to have access to an additional important treatment option. Our focus now is to work closely with healthcare providers to ensure a smooth rollout and to continue our mission of advancing healthcare solutions that make a real difference in people's lives.' The SMC acceptance follows the news from Outlook Therapeutics earlier this month that LYTENAVA™ is now commercially available in the UK for the treatment of wet AMD. The recommendation was based on the results from Outlook Therapeutics' wet AMD clinical program for ONS-5010 / LYTENAVA™, which consists of three completed registration clinical trials - NORSE ONE, NORSE TWO and NORSE THREE, as well as studies and peer reviewed literature substituting or supporting certain tests and studies. Dr. Manjit Mehat, Senior Clinical Lecturer at The University of Edinburgh, NHS Consultant Ophthalmologist, and Vision Scotland Eye Surgeon noted, 'This decision marks a significant step forward in ongoing efforts to provide the best possible care for patients needing licensed anti-VEGF treatments to control their wet AMD.' Outlook Therapeutics has entered into a strategic collaboration with Cencora (formerly AmerisourceBergen) to support the commercial launch of LYTENAVA™ globally following regulatory approvals. The collaboration and integrated approach is designed to support market access and efficient distribution of LYTENAVA™ to benefit all stakeholders, including retina specialists, providers and patients in the European Union and UK and, if approved, in the United States. About LYTENAVA™ (bevacizumab gamma) ONS-5010 / LYTENAVA™ is an ophthalmic formulation of bevacizumab for the treatment of wet AMD. LYTENAVA™ (bevacizumab gamma) is the subject of a centralized Marketing Authorization granted by the European Commission in the EU and Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the treatment of wet AMD. In the United States, ONS-5010 / LYTENAVA ™ (bevacizumab-vikg) is investigational. In certain European Union Member States ONS-5010/LYTENAVA™ must receive pricing and reimbursement approval before it can be sold. Bevacizumab-vikg (bevacizumab gamma in the EU and UK) is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF's biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal injection, the binding of bevacizumab to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina. About Outlook Therapeutics, Inc. Outlook Therapeutics is a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma) to enhance the standard of care for bevacizumab for the treatment of retina diseases. LYTENAVA™ (bevacizumab gamma) is the first ophthalmic formulation of bevacizumab to receive European Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics commenced commercial launch of LYTENAVA™ (bevacizumab gamma) in Germany and the UK as a treatment for wet AMD. In the United States, ONS-5010/LYTENAVA™ is investigational, and a BLA has been resubmitted to the FDA. If approved in the United States, ONS-5010/LYTENAVA™, would be the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD. Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical facts are 'forward-looking statements,' including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as 'anticipate,' 'believe,' 'continue,' 'expect,' 'may,' 'plan,' 'potential,' 'will,' or 'would' the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include, among others, expectations concerning the therapeutic potential of ONS-5010/LYTENAVA™ as a treatment of wet AMD, expectations concerning the relationship with Cencora and the benefits and potential expansion thereof, Outlook Therapeutics' plans for commercial launch of LYTENAVA™ in additional countries in the EU, Outlook Therapeutics' commercialization strategy, the market opportunity for ONS-5010/LYTENAVA™, expectations concerning decisions of regulatory bodies and the timing thereof, ONS-5010/LYTENAVA™'s potential as the first FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal indications, including wet AMD, in the United States and other statements that are not historical fact. Although Outlook Therapeutics believes that it has a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting Outlook Therapeutics and are subject to risks, uncertainties and factors relating to its operations and business environment, all of which are difficult to predict and many of which are beyond its control. These risk factors include those risks associated with developing and commercializing pharmaceutical product candidates, risks of conducting clinical trials and risks in obtaining necessary regulatory approvals, the content and timing of decisions by regulatory bodies, the sufficiency of Outlook Therapeutics' resources, unanticipated or greater than anticipated impacts or delays due to macroeconomic and geopolitical conditions (including the long-term impacts of ongoing overseas conflicts, tariffs and trade tensions, fluctuations in inflation and interest rates and other economic uncertainty), as well as those risks detailed in Outlook Therapeutics' filings with the Securities and Exchange Commission (SEC), including the Annual Report on Form 10-K for the fiscal year ended September 30, 2024, filed with the SEC on December 27, 2024, the Quarterly Report on Form 10-Q for fiscal quarter ended March 31, 2025 and future quarterly reports Outlook Therapeutics files with the SEC. These risks may cause actual results to differ materially from those expressed or implied by forward-looking statements in this press release. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Outlook Therapeutics does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law. Investor Inquiries:Jenene ThomasChief Executive OfficerJTC Team, LLCT: 908.824.0775OTLK@ Media Inquiries:Ellie BlundellSenior Account ExecutiveHanover CommunicationsT: +44 7738 832195eblundell@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
23-05-2025
- Business
- Yahoo
Outlook Therapeutics® Announces Pricing of $13.0 Million Public Offering
ISELIN, N.J., May 23, 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 the pricing of an underwritten public offering of 9,285,714 shares of its common stock, together with accompanying warrants to purchase 18,571,428 shares of its common stock. The combined public offering price of common stock and accompanying warrant is $1.40. The common stock is being sold in combination with an accompanying warrant to purchase two shares of common stock issued for each share of common stock sold. The accompanying warrant has an exercise price of $1.40 per share, will become exercisable immediately and will expire five years from the date of issuance. The offering is expected to close on May 27, 2025, subject to the satisfaction of customary closing conditions. The gross proceeds from the offering, before deducting the underwriting discounts and commissions and offering expenses payable by Outlook Therapeutics are expected to be approximately $13.0 million. Outlook Therapeutics intends to use the net proceeds from the offering for working capital and other general corporate purposes. BTIG, LLC is acting as sole book-running manager for the offering. The securities described above are being offered by Outlook Therapeutics pursuant to a shelf registration statement on Form S-3 (No. 333-278340) that was declared effective by the Securities and Exchange Commission (SEC) on April 5, 2024. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC's website located at Copies of the preliminary prospectus supplement and the final prospectus supplement relating to this offering may be obtained, when available, by contacting: BTIG, LLC, 65 East 55th Street, New York, New York 10022, by telephone at (212) 593-7555 or by email at ProspectusDelivery@ This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that state or jurisdiction. About Outlook Therapeutics, Therapeutics is a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma) to enhance the standard of care for bevacizumab for the treatment of retina diseases. LYTENAVA™ (bevacizumab gamma) is the first ophthalmic formulation of bevacizumab to receive European Commission and Medicines and Healthcare products Regulatory Agency Marketing Authorization for the treatment of wet age-related macular degeneration (wet AMD). Outlook Therapeutics is working to initiate its commercial launch of LYTENAVA™ (bevacizumab gamma) in the European Union and the United Kingdom as a treatment for wet AMD, expected in the second quarter of calendar year 2025. In the United States, ONS-5010/LYTENAVA™ is investigational, and a Biologics License Application has been resubmitted to the U.S. Food and Drug Administration. If approved in the United States, ONS-5010/LYTENAVA™, would be the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD. Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical facts are 'forward-looking statements,' including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as 'anticipate,' 'believe,' 'continue,' 'expect,' 'may,' 'plan,' 'potential,' 'will,' or 'would' the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include, among others, statements regarding the gross proceeds from the offering, the use of proceeds from the offering, the completion of the offering, expectations concerning decisions of regulatory bodies and the timing thereof, plans for commercial launch of LYTENAVA™ in the EU and the UK and the timing thereof and other statements that are not historical fact. Although Outlook Therapeutics believes that it has a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting Outlook Therapeutics and are subject to risks, uncertainties and factors relating to its operations and business environment, all of which are difficult to predict and many of which are beyond its control. These risk factors include fluctuations in Outlook Therapeutics' stock price, changes in market conditions and satisfaction of customary closing conditions related to the offering, risks in obtaining necessary regulatory approvals, the content and timing of decisions by regulatory bodies, and the sufficiency of Outlook Therapeutics' resources, as well as those risks detailed in Outlook Therapeutics' filings with the SEC, including the Annual Report on Form 10-K for the fiscal year ended September 30, 2024, filed with the SEC on December 27, 2024, and subsequent filings with the SEC, which include uncertainty of market conditions and future impacts related to macroeconomic factors, including as a result of the ongoing overseas conflicts, tariffs and trade tensions, fluctuations in interest rates and inflation, and potential future bank failures on the global business environment. These risks may cause actual results to differ materially from those expressed or implied by forward-looking statements in this press release. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Outlook Therapeutics does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law. Investor Inquiries:Jenene ThomasChief Executive OfficerJTC Team, LLCT: 908.824.0775OTLK@ Source: Outlook Therapeutics, in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
28-02-2025
- Business
- Associated Press
Outlook Therapeutics® Re-Submits Biologics License Application for ONS-5010 as a Treatment for Wet AMD to the U.S. Food and Drug Administration
Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union (EU) and the United Kingdom (UK) for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced it has re-submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010, an investigational ophthalmic product which, if approved, will be branded as LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD). 'We remain committed to bringing an ophthalmic bevacizumab to market in the United States and providing retina patients suffering from wet AMD with a much needed treatment option that has the potential to address the problems associated with unapproved repackaged bevacizumab. Our team has worked diligently to address the FDA's requests and we believe this resubmission provides the necessary evidence to support approval of the ONS-5010 BLA in the United States,' commented Lawrence Kenyon, Chief Financial Officer and Interim Chief Executive Officer of Outlook Therapeutics. 'This resubmission marks a very significant milestone and puts us another step closer to a transformed Outlook Therapeutics.' The ONS-5010 BLA resubmission is based on the efficacy and safety demonstrated in NORSE EIGHT, as well as additional chemistry, manufacturing and controls (CMC) information requested by the FDA. As previously announced, following Type A meetings with the FDA in Q4 CY2023 to address the ONS-5010 Complete Response Letter (CRL), the FDA informed Outlook Therapeutics that, in order to meet the FDA's requirement for a second adequate and well-controlled clinical trial of ONS-5010, it could conduct a non-inferiority study evaluating ONS-5010 versus ranibizumab in a 12 week study of treatment naïve patients with a primary efficacy endpoint at 8 weeks (NORSE EIGHT). Outlook Therapeutics believes that the complete data set for NORSE EIGHT and the additional CMC information in the BLA resubmission, combined with the data from the other NORSE clinical trials, provides the required evidence to support approval of the ONS-5010 BLA in the United States. A decision from the FDA is expected within six months. NORSE EIGHT was a randomized, controlled, parallel-group, masked, non-inferiority study of 400 newly diagnosed, wet AMD subjects randomized in a 1:1 ratio to receive 1.25 mg ONS-5010 / LYTENAVA™ or 0.5 mg ranibizumab intravitreal injections. Subjects received injections at Day 0 (randomization), Week 4, and Week 8 visits. The primary endpoint is the mean change in best corrected visual acuity (BCVA) from baseline to week 8. In November 2024, Outlook Therapeutics reported that in NORSE EIGHT, ONS-5010 demonstrated a mean 4.2 letter improvement in best corrected visual acuity (BCVA), which did not meet the pre-specified non-inferiority endpoint at week 8 set forth in the special protocol assessment (SPA) with the FDA. In January 2025, Outlook Therapeutics announced results from the completed analysis of the 12-week safety and efficacy results for NORSE EIGHT, which indicated that ONS-5010 demonstrated clinically meaningful anatomic and functional improvements at each study timepoint. BCVA data across all study timepoints demonstrated an improvement in vision, increasing over time, and the presence of biologic activity. Results from the 12-week analysis demonstrated a mean improvement in BCVA of 3.3 to 5.5 letters in the ONS-5010 arm across the 4, 8, and 12 week timepoints measured in the study, compared to a mean 4.5 to 6.5 letter improvement in the ranibizumab arm over the same timepoints. Additionally, the complete NORSE EIGHT data set showed that anatomical response was similar between treatments, with a reduction in central retinal thickness of -123.9 microns for ONS-5010 treated eyes and -127.3 microns for the ranibizumab group, virtually no difference between the arms. Central retinal thickness is a key indicator of effectiveness used by retina specialists in the treatment of wet AMD. About ONS-5010 / LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) ONS-5010 / LYTENAVA™ is an ophthalmic formulation of bevacizumab for the treatment of wet AMD. LYTENAVA™ (bevacizumab gamma) is the subject of a centralized Marketing Authorization granted by the European Commission in the European Union (EU) and Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) for the treatment of wet AMD. In the United States, ONS-5010 / LYTENAVA™ (bevacizumab-vikg) is investigational. Bevacizumab-vikg (bevacizumab gamma in the EU and UK) is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF's biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal injection, the binding of bevacizumab to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina. About Outlook Therapeutics, Inc. Outlook Therapeutics is a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma), for the treatment of retina diseases, including wet AMD. LYTENAVA™ (bevacizumab gamma) is the first ophthalmic formulation of bevacizumab to receive European Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics is working to initiate its commercial launch of LYTENAVA™ (bevacizumab gamma) in the EU and the UK as a treatment for wet AMD, expected in the second quarter of calendar 2025. In the United States, ONS-5010/LYTENAVA™ is investigational, and a BLA has been resubmitted to the FDA in the United States. If approved in the United States, ONS-5010/LYTENAVA™, would be the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD. Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical facts are 'forward-looking statements,' including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as 'anticipate,' 'believe,' 'continue,' 'expect,' 'may,' 'plan,' 'potential,' 'will,' or 'would' the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include, among others, Outlook Therapeutics' ability to remediate or otherwise resolve deficiencies identified in the CRL issued by the FDA in the resubmitted BLA, expectations concerning decisions of regulatory bodies and the timing thereof, expectations concerning the therapeutic potential of LYTENAVA™ as a treatment of wet AMD, ONS-5010/LYTENAVA™'s potential as the first FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal indications, including wet AMD, in the United States, Outlook Therapeutics' plans for commercial launch of LYTENAVA™ in the UK and EU and timing thereof, Outlook Therapeutics' commercialization strategy, and other statements that are not historical fact. Although Outlook Therapeutics believes that it has a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting Outlook Therapeutics and are subject to risks, uncertainties and factors relating to its operations and business environment, all of which are difficult to predict and many of which are beyond its control. These risk factors include those risks associated with developing and commercializing pharmaceutical product candidates, risks of conducting clinical trials and risks in obtaining necessary regulatory approvals, the content and timing of decisions by regulatory bodies, the sufficiency of Outlook Therapeutics' resources, as well as those risks detailed in Outlook Therapeutics' filings with the Securities and Exchange Commission (SEC), including the Annual Report on Form 10-K for the fiscal year ended September 30, 2024, filed with the SEC on December 27, 2024, and future quarterly reports Outlook Therapeutics files with the SEC, which include uncertainty of market conditions and future impacts related to macroeconomic factors, including as a result of the ongoing overseas conflicts, high interest rates, inflation and potential future bank failures on the global business environment. These risks may cause actual results to differ materially from those expressed or implied by forward-looking statements in this press release. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Outlook Therapeutics does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law. Jenene Thomas JTC Team, LLC T: 908.824.0775
