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OTLK

Outlook Therapeutics Inc
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Outlook Therapeutics Announces Creation of Global Retina Advisory Council
* Advisory Council to collaborate on outreach to retinal clinicians to support development and commercialization of ONS-5010, an investigational ophthalmic formulation of bevacizumab MONMOUTH JUNCTION, N.J., Nov. 19, 2020 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, today announced the creation of its Global Retina Advisory Council. Mark Humayun, MD, PhD, has agreed to act as Chairman of the Advisory Council and Firas Rahhal, MD, has agreed to join him as an inaugural member.The Global Retina Advisory Council is being established by Outlook Therapeutics to ensure that it has access to guidance and advice on all relevant topics from a group of pre-eminent global specialists in retinal medicine. Outlook Therapeutics intends to include additional expert advisors from around the world as it advances its ongoing clinical program and pre-commercialization planning for ONS-5010/LYTENAVA™ (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for treatment of wet age-related macular degeneration (wet AMD) and other retinal diseases.“As we expand our pre-commercialization activities in anticipation of our planned BLA filing for ONS-5010 to treat wet AMD in mid-2021, collaborating with leading experts in the retinal field will be critical to lay the groundwork for the eventual adoption by the clinical community,” said Lawrence Kenyon, President, CEO and CFO of Outlook Therapeutics. “We thank Drs. Humayun and Rahhal for agreeing to join us to help bring the first approved ophthalmic formulation of bevacizumab to market. We anticipate that ONS-5010, if approved, will address the potential issues that retinal clinicians and their patients currently experience with unapproved repackaged IV bevacizumab from compounding pharmacists.”Mark Humayun, MD, PhD, is Medical Advisor at Outlook Therapeutics and a recognized retinal specialist worldwide, with over 250 publications and more than 125 issued patents. Over the course of his career, Dr. Humayun has received several research awards, including the 2005 Innovator of the Year award (R&D magazine) and more recently the 2020 Medal for Innovations in Healthcare Technology (Institute of Electrical and Electronics Engineers). He also has been recognized for his clinical work, voted by U.S. News and World Report as one of the top 1% of Ophthalmologists in America. Most notably, in 2016 Dr. Humayun received the National Medal of Technology and Innovation from President Barack Obama for his innovative work on bioengineered implants including the development of the Argus II, the world’s first FDA-approved artificial retinal prosthesis.Firas Rahhal, MD, is a partner at Retina-Vitreous Associates Medical Group in Los Angeles and is an Associate Clinical Professor of Ophthalmology at the UCLA School of Medicine – Jules Stein Eye Institute. He has published dozens of scientific papers and is a frequent presenter at major international scientific meetings. He has extensive expertise in advancing clinical development programs, having been an investigator in over 100 national or international trials, many of which led to novel therapies for vitreo-retinal diseases. Dr. Rahhal has been consistently named “Top Doctor” by his physician peers in the Los Angeles Magazine annual review. He is Board Certified by the American Board of Ophthalmology and is a member of the American Academy of Ophthalmology, the American Society of Retina Specialists, and The Retina Society. He is Co-Director of the RVA-USC Joint Vitreoretinal Fellowship training program.“I am honored to be the Chairman of the Global Retina Advisory Council and look forward to working closely with Dr. Rahhal and the Outlook Therapeutics management team to advance Outlook Therapeutics’ clinical program for ONS-5010 for the treatment of retina indications. The potential for an FDA-approved ophthalmic formulation of bevacizumab would be a significant addition to the retinal treatment armamentarium, and is anticipated to provide physicians a safe, approved formulation of a drug they are already using off-label in more than 50% of all wet AMD cases,” added Dr. Humayun.Outlook Therapeutics’ clinical program for ONS-5010 is on track to report pivotal Phase 3 data in mid-2021, with an expected new Biologics License Application (BLA) to be submitted to the U.S. Food and Drug Administration (FDA) for treatment of wet AMD in the second half of next year. If all goes as planned, Outlook Therapeutics anticipates FDA approval for ONS-5010 in mid-2022 as the first and only approved bevacizumab to treat wet AMD. In addition to the planned BLA filing in the United States, Outlook Therapeutics is also engaged with regulatory authorities in Europe and other major markets for anticipated approvals in those markets. Outlook Therapeutics also intends to initiate registration clinical trials for ONS-5010 for DME and BRVO.With an enhanced safety and cost-effectiveness profile, Outlook Therapeutics expects ONS-5010, if approved, to be widely adopted by payors and clinicians worldwide and to become the first-line drug of choice for payor-mandated “step edit” in the United States for retinal indications. Outlook Therapeutics is also engaged with several life sciences companies that could result in a strategic partnership and definitive agreement for ONS-5010 as soon as the end of 2020.About ONS-5010 / LYTENAVA™ (bevacizumab-vikg)ONS-5010 / LYTENAVA™ (bevacizumab-vikg) is an investigational ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection for the treatment of wet AMD and other retinal diseases. Because no currently approved ophthalmic formulations of bevacizumab are available, clinicians wishing to treat retinal patients with bevacizumab have had to use unapproved repackaged IV bevacizumab provided by compounding pharmacists, products that have known risks of contamination and inconsistent potency and availability. If approved, ONS-5010 will reduce the need for use of unapproved repackaged IV bevacizumab from compounding pharmacists for retinal disease.ONS-5010 is a full-length, humanized anti-VEGF (Vascular Endothelial Growth Factor) recombinant monoclonal antibody (or mAb) that inhibits VEGF and associated angiogenic activity. VEGF is a protein that promotes the growth of new abnormal blood vessels. With wet AMD, abnormally high levels of VEGF are secreted in the eye and lead to loss of vision. Anti-VEGF injection therapy blocks this growth. Since the advent of anti-VEGF therapy, it has become the standard-of-care treatment option within the retina community globally.About Outlook Therapeutics, Inc.Outlook Therapeutics is a late clinical-stage biopharmaceutical company working to develop ONS-5010/LYTENAVA™ (bevacizumab-vikg) as the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, including wet AMD, DME and BRVO. If ONS-5010 is approved, Outlook Therapeutics expects to commercialize it as the first and only FDA-approved ophthalmic formulation of bevacizumab-vikg for use in treating a range of retinal diseases in the United States, United Kingdom, Europe, Japan and other markets. Outlook Therapeutics expects to file ONS-5010 with the U.S. FDA as a new BLA under the PHSA 351(a) regulatory pathway, initially for wet AMD. For more information, please visit www.outlooktherapeutics.com.Forward-Looking StatementsThis 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 “potential,” “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “project,” “believe,” “estimate,” “predict,” “intend” or “continue,” the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include statements about potential benefits of establishing the Global Retina Advisory Council, ONS-5010’s potential as the first FDA-approved ophthalmic formulation of bevacizumab-vikg, including benefits therefrom to patients, payors and physicians, the ability of ONS-5010 to gain widespread acceptance in the retinal treatment community, the timing of completion of, and pivotal safety and efficacy data from, the pivotal Phase 3 trial, the timing of BLA submission and sufficiency of exposures to support such submission, statements about commercial launch of ONS-5010, and plans for regulatory approvals in other markets. 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 pharmaceutical product candidates, risks of conducting clinical trials, risks in obtaining necessary regulatory approvals, and risks of funding such ongoing development, as well as those risks detailed in Outlook Therapeutics’ filings with the Securities and Exchange Commission, which include the uncertainty of future impacts related to the ongoing COVID-19 pandemic. 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.CONTACTS:Media Inquiries:Harriet Ullman Assistant Vice President LaVoieHealthScience T: 617-669-3082 hullman@lavoiehealthscience.comInvestor Inquiries: Jenene Thomas Chief Executive Officer JTC Team, LLC T: 833.475.8247 OTLK@jtcir.com
GlobeNewswire · 11/19 13:05
Virtual KOL Roundtable Recap: Outlook Therapeutics and Firas Rahhal, MD, Discussed wet AMD Treatment Landscape and ONS-5010/LYTENAVA
* Dr. Rahhal, a leading retinal clinician, offered insight on wet AMD treatment and the potential of ONS-5010/LYTENAVA™ (bevacizumab-vikg), if approved, to improve available treatment options * Outlook Therapeutics detailed ongoing development and pre-commercial planning of ONS-5010/LYTENANA™ * Webcast replay from the event is now available: click here MONMOUTH JUNCTION, N.J., Nov. 11, 2020 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, held its previously announced virtual KOL Roundtable on October 29, 2020 featuring Firas Rahhal, MD, a partner at Retina-Vitreous Associates Medical Group and Associate Clinical Professor of Ophthalmology at the UCLA School of Medicine, and Outlook Therapeutics’ management team – Lawrence Kenyon, President, CEO and CFO, Terry Dagnon, COO, and Jeff Evanson, CCO.“Gaining perspective from a practicing clinician who frequently uses available anti-VEGF treatment options for his patients provides invaluable insight as we continue to advance the clinical development of our investigational ophthalmic formulation of bevacizumab, ONS-5010/LYTENAVA™. We believe ONS-5010, if approved, is strategically positioned to address many of the shortcomings in the treatment landscape for wet AMD that were discussed during the Roundtable, as it would offer patients and clinicians an approved ophthalmic formulation of a therapeutic that is already widely used. We thank Dr. Rahhal for taking the time to join us for our discussion and believe the retina physician point of view is important when looking at the opportunity Outlook Therapeutics presents,” commented Mr. Kenyon.Treatment BackgroundThe Roundtable opened with a discussion of current treatment options for retinal diseases, including wet age-related macular degeneration (wet AMD), diabetic macular edema (DME) and branch retinal vein occlusion (BRVO). Such retinal diseases are characterized by excessive growth of abnormal blood vessels under the retina, which if untreated leads to vision loss and even blindness. Anti-VEGF medications control this abnormal growth, and for the past 15 years have become the standard of care for treating these diseases.Bevacizumab is an anti-VEGF drug, but it is not approved for ophthalmic use. Although there are three anti-VEGF drugs currently approved to treat ophthalmic disease, they are extremely expensive. As a result, physicians who wish to treat their retinal patients with a less expensive anti-VEGF drug often use unapproved, repackaged IV bevacizumab from compounding pharmacists. ONS-5010, if approved, will be the first and only on-label ophthalmic formulation of bevacizumab-vikg for the treatment of wet AMD. Payors have also weighed in on the value of bevacizumab in treating retinal diseases. Many now require use of off-label bevacizumab as a first-line treatment option before they will cover more expensive alternatives. The Centers for Medicare and Medicaid Services has issued guidance to this effect and a few major payors have also mandated its use. If approved, ONS-5010/LYTENAVA™ will offer a new, approved treatment option for wet-AMD in the estimated $13 billion global market for anti-VEGF retina therapies.Dr. Rahhal: The Need for an Approved Bevacizumab for Ophthalmic UseDr. Rahhal expanded on his personal experience over many years of treating patients with retinal diseases. In his practice, Dr. Rahhal treats approximately 50% of his wet AMD patients with repackaged IV bevacizumab from compounding pharmacists, a percentage which he said he believes is reasonably typical of other U.S. retinal practices. Although he appreciates the significant cost savings of using off-label bevacizumab, he has at times encountered problems related to inconsistent potency, particulate contamination in the syringes, microbial contamination and syringe malfunctions. Problems can arise, he stated, as a result of variability across batches from different compounding pharmacies and from their storage practices. Additionally, silicone oil droplets can contaminate syringes, which when injected intravitreally, potentially can lead to an accumulation of silicone in patients’ eyes, causing vision problems. “In my experience, there remains an unmet need for an FDA-approved and cGMP-produced bevacizumab that is specifically formulated for ophthalmic use. What the team at Outlook Therapeutics has set out to accomplish with ONS-5010, if approved, would be a valuable addition to the treatment armamentarium,” commented Dr. Rahhal. “Additionally, I believe that if Outlook Therapeutics commercializes ONS-5010, if approved, in a silicone-free, pre-filled syringe that meets the strict specifications for ophthalmic use, the product would gain widespread acceptance by the retinal treatment community. I am excited about the potential of ONS-5010 and look forward to the read-out of the pivotal data from the Phase 3 study next year. I believe ONS-5010, if approved, would be a significant improvement over the off-label bevacizumab that many doctors are already using.”Management Update on Outlook Therapeutics’ Development Program   The Roundtable concluded with an update from Outlook Therapeutics’ management on the current clinical development program and anticipated commercialization strategy for ONS-5010/LYTENAVA™. Management reported that the investigational compound is currently in Phase 3 registration clinical trials, with an expected read-out of pivotal data in mid-2021. Results from these trials will comprise the complete data package that is expected to be submitted to the U.S. Food and Drug Administration (FDA) for a new Biologics License Application (BLA) in the second half of 2021.Outlook Therapeutics’ management emphasized that they intend to commercialize ONS-5010, if approved, at a responsible price, and in both unit-dose vials and pre-filled ophthalmic syringes. In anticipation of a first approval from the FDA in mid-2022, Outlook Therapeutics is engaged in launch planning, including distribution, physician and patient outreach, key opinion leader support and payor community engagement. In addition to the planned BLA filing in the United States, management indicated that they are also engaged with regulatory authorities in Europe and other major markets for anticipated approvals in those markets. Outlook Therapeutics also expects to initiate registration clinical trials for ONS-5010 for DME and BRVO.A webcast replay of the KOL roundtable discussion is now available on the Events page of the Investors section of Outlook Therapeutics’ website (outlooktherapeutics.com).About ONS-5010 / LYTENAVA™ (bevacizumab-vikg)ONS-5010 / LYTENAVA™ (bevacizumab-vikg) is an investigational ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection for the treatment of wet AMD and other retinal diseases. Because no currently approved ophthalmic formulations of bevacizumab are available, clinicians wishing to treat retinal patients with bevacizumab have had to use unapproved repackaged IV bevacizumab provided by compounding pharmacists, products that have known risks of contamination and inconsistent potency and availability. If approved, ONS-5010 will reduce the need for use of unapproved repackaged IV bevacizumab from compounding pharmacists for retinal disease.ONS-5010 is a full-length, humanized anti-VEGF (Vascular Endothelial Growth Factor) recombinant monoclonal antibody (or mAb) that inhibits VEGF and associated angiogenic activity. VEGF is a protein that promotes the growth of new abnormal blood vessels. With wet AMD, abnormally high levels of VEGF are secreted in the eye and lead to loss of vision. Anti-VEGF injection therapy blocks this growth. Since the advent of anti-VEGF therapy, it has become the standard-of-care treatment option within the retina community globally.About Outlook Therapeutics, Inc.        Outlook Therapeutics is a late clinical-stage biopharmaceutical company working to develop ONS-5010/LYTENAVA™ (bevacizumab-vikg) as the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, including wet AMD, DME and BRVO. If ONS-5010 is approved, Outlook Therapeutics expects to commercialize it as the first and only FDA-approved ophthalmic formulation of bevacizumab-vikg for use in treating a range of retinal diseases in the United States, United Kingdom, Europe, Japan and other markets. Outlook Therapeutics expects to file ONS-5010 with the U.S. FDA as a new BLA under the PHSA 351(a) regulatory pathway, initially for wet AMD. For more information, please visit www.outlooktherapeutics.com.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 “potential,” “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “project,” “believe,” “estimate,” “predict,” “intend” or “continue,” the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include statements about ONS-5010’s potential as the first FDA-approved ophthalmic formulation of bevacizumab-vikg, including benefits therefrom to patients, payors and physicians, the ability of ONS-5010 to gain widespread acceptance in the retinal treatment community, the timing of completion of, and pivotal safety and efficacy data from, the pivotal Phase 3 trial, the timing of BLA submission and sufficiency of exposures to support such submission, statements about commercial launch of ONS-5010, and plans for regulatory approvals in other markets. 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 pharmaceutical product candidates, risks of conducting clinical trials, risks in obtaining necessary regulatory approvals, and risks of funding such ongoing development, as well as those risks detailed in Outlook Therapeutics’ filings with the Securities and Exchange Commission, which include the uncertainty of future impacts related to the ongoing COVID-19 pandemic. 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.CONTACTS: Media Inquiries: Harriet Ullman Assistant Vice President LaVoieHealthScience T: 617-669-3082 hullman@lavoiehealthscience.com Investor Inquiries:        Jenene Thomas Chief Executive Officer JTC Team, LLC T: 833.475.8247  OTLK@jtcir.com
GlobeNewswire · 11/11 14:05
Outlook Therapeutics Secures $10 Million in Additional Working Capital
GlobeNewswire · 11/05 13:05
Outlook Therapeutics Completes Patient Enrollment of Open-Label Safety Study for ONS-5010/LYTENAVA™ (bevacizumab-vikg)
* Full enrollment of 195 subjects in NORSE THREE achieved in less than one month, significantly ahead of schedule * All planned clinical trials for ONS-5010/LYTENAVA™ BLA for wet AMD now fully enrolled or completed * Pivotal data expected in mid-2021 from ongoing, fully enrolled Phase 3 registration trial for ONS-5010 (NORSE TWO) with new BLA filing expected in second half of 2021 MONMOUTH JUNCTION, N.J., Nov. 03, 2020 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, today announced the completion of patient enrollment for its planned open-label safety study evaluating ONS-5010/LYTENAVA™ (NORSE THREE). Patient enrollment for the study was completed in less than one month, significantly ahead of the planned four-month enrollment schedule.The open-label safety study enrolled 195 subjects with a range of retinal diseases for which an anti-VEGF drug is a therapeutic option, including wet age-related macular degeneration (AMD), diabetic macular edema (DME) and branch retinal vein occlusion (BRVO). Subjects enrolled in the study are receiving three monthly intravitreal (IVT) doses of ONS-5010/LYTENAVA™. The data from this study will be included in the complete data package to support the planned Biologics License Application (BLA) for wet AMD, on schedule for submission to the United States Food and Drug Administration (FDA) in the second half of 2021.“I am delighted to see the enthusiasm for ONS-5010 that our clinical trial investigators have shown and their ability to rapidly enroll patients. The expedited manner in which enrollment was completed strengthens our confidence that an FDA-approved ophthalmic formulation of bevacizumab represents a significant unmet need in the ophthalmic community,” said Mark Humayun, MD, PhD, Medical Advisor to Outlook Therapeutics.While unapproved repackaged IV bevacizumab from compounding pharmacies is already widely used in treating retinal diseases, ONS-5010, if approved, will be the first and only on-label ophthalmic formulation of bevacizumab-vikg for the treatment of wet AMD. It will offer a new, approved treatment option for wet-AMD, in the estimated $13 billion global market for anti-VEGF retina therapies.“On behalf of the entire Outlook Therapeutics team, I would like to express our deep appreciation to the dedicated clinicians conducting this safety study as part of our ONS-5010 registration program,” added Lawrence Kenyon, President, CEO and CFO, Outlook Therapeutics. “The speed with which we completed enrollment in this safety study tells us a lot about the confidence of physicians and patients in ONS-5010. We believe that we remain well-positioned to file a new BLA for wet AMD as planned in 2021, now that all three of the planned clinical trials have either been completed or are fully enrolled.”  In addition to the planned BLA filing in the United States, Outlook Therapeutics is also engaged with regulatory authorities in Europe and other major markets for anticipated approvals in those markets. Outlook Therapeutics also intends to initiate registration clinical trials for ONS-5010 for DME and BRVO.Commercial launch planning for ONS-5010, including distribution, physician and patient outreach, key opinion leader support and payor community engagement, remains ongoing. With an enhanced safety and cost-effectiveness profile, Outlook Therapeutics expects ONS-5010, if approved, to be widely adopted by payors and clinicians worldwide and to become the first-line drug of choice for payor-mandated “step edit” in the United States for retina indications. Outlook Therapeutics is also engaged with several life sciences companies that could result in a strategic partnership and definitive agreement for ONS-5010 as soon as the end of 2020.About ONS-5010 / LYTENAVA™ (bevacizumab-vikg)ONS-5010 / LYTENAVA™ (bevacizumab-vikg) is an investigational ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection for the treatment of wet AMD and other retinal diseases. Because no currently approved ophthalmic formulations of bevacizumab are available, clinicians wishing to treat retinal patients with bevacizumab have had to use unapproved repackaged IV bevacizumab provided by compounding pharmacists, products that have known risks of contamination and inconsistent potency and availability. If approved, ONS-5010 will reduce the need for use of unapproved repackaged IV bevacizumab from compounding pharmacists for retinal disease.ONS-5010 is a full-length, humanized anti-VEGF (Vascular Endothelial Growth Factor) recombinant monoclonal antibody (or mAb) that inhibits VEGF and associated angiogenic activity. VEGF is a protein that promotes the growth of new abnormal blood vessels. With wet AMD, abnormally high levels of VEGF are secreted in the eye and lead to loss of vision. Anti-VEGF injection therapy blocks this growth. Since the advent of anti-VEGF therapy, it has become the standard-of-care treatment option within the retina community globally.About Outlook Therapeutics, Inc.        Outlook Therapeutics is a late clinical-stage biopharmaceutical company working to develop ONS-5010/LYTENAVA™ (bevacizumab-vikg) as the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, including wet AMD, DME and BRVO. If ONS-5010 is approved, Outlook Therapeutics expects to commercialize it as the first and only FDA-approved ophthalmic formulation of bevacizumab-vikg for use in treating a range of retinal diseases in the United States, United Kingdom, Europe, Japan and other markets. Outlook Therapeutics expects to file ONS-5010 with the U.S. FDA as a new BLA under the PHSA 351(a) regulatory pathway, initially for wet AMD. For more information, please visit www.outlooktherapeutics.com.Forward-Looking StatementsThis 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 “expect,” “will,” “could,” “may,” “might,” “should,” “plan,” “anticipate,” “project,” “believe,” “estimate,” “predict,” “potential,” “intend” or “continue,” the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include statements about the timing of completion of, and pivotal safety and efficacy data from, the pivotal Phase 3 trial, the timing of BLA submission, sufficiency of exposures and clinical trials conducted to support such submission, ONS-5010’s potential as the first FDA-approved ophthalmic formulation of bevacizumab-vikg, including benefits therefrom to patients, payors and physicians, statements about commercial launch of ONS-5010, the timing of entry into a strategic partnership and definitive agreement with a global ophthalmic company, including its ability to do so, and plans for regulatory approvals in other markets. 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 pharmaceutical product candidates, risks of conducting clinical trials, risks in obtaining necessary regulatory approvals, and risks of negotiating strategic partnership agreements, as well as those risks detailed in Outlook Therapeutics’ filings with the Securities and Exchange Commission, which include the uncertainty of future impacts related to the ongoing COVID-19 pandemic. 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.CONTACTS:Media Inquiries: Harriet Ullman Assistant Vice President LaVoieHealthScience T: 617-669-3082 hullman@lavoiehealthscience.comInvestor Inquiries:        Jenene Thomas Chief Executive Officer JTC Team, LLC T: 833.475.8247  OTLK@jtcir.com
GlobeNewswire · 11/03 13:35
Outlook Therapeutics Announces Initiation of Supplemental Open-Label Safety Study for ONS-5010 / LYTENAVA (bevacizumab-vikg)
GlobeNewswire · 10/13 13:05
Enrollment underway in Outlook Therapeutics' ONS-5010 supplemental study for wet AMD
Outlook Therapeutics (OTLK) has initiated and enrolled the first patients in its planned supplemental open-label safety study evaluating ONS-5010 / LYTENAVA (bevacizumab-vikg) for the treatment of wet age-related macular degeneration
Seekingalpha · 10/13 12:19
Outlook Therapeutics Reports Initiation Of Supplemental Open-Label Safety Study For ONS-5010/LYTENAVA; First Subjects Have Been Enrolled
Outlook Therapeutics, Inc. (NASDAQ:OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, today
Benzinga · 10/13 12:06
These 2 Penny Stocks Could See Outsized Gains, Says Oppenheimer
TipRanks · 10/12 20:30
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The average OTLK stock price target is 5.25 with a high estimate of 8.00 and a low estimate of 3.250.
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Institutions: 49
Institutional Holdings: 4.09M
% Owned: 3.21%
Shares Outstanding: 127.18M
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About OTLK
Outlook Therapeutics, Inc., formerly Oncobiologics, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on identifying, developing, manufacturing and commercializing biosimilar therapeutics. It is focused on monoclonal antibodies (mAbs) in the disease areas of immunology and oncology. The Company offers BioSymphony Platform. The Company has identified approximately eight biosimilar product candidates, of which two product candidates are ONS-3010 and ONS-1045. ONS-3010 is an adalimumab (Humira) biosimilar. The Company has initiated Phase III preparatory activities for ONS-3010. Its second product candidate, ONS-1045, is a bevacizumab (Avastin) biosimilar. The Company's other preclinical product candidate, ONS-1050, a trastuzumab (Herceptin) biosimilar, interferes with the human epidermal growth factor receptor 2 (HER2). ONS-4010 is a biosimilar to denosumab (Prolia/Xgeva), which is a human mAb. Its other biosimilar product, ONS-1055, is a biosimilar to cetuximab.
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