Outlook Therapeutics Inc

Outlook Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which engages in the development of ONS-5010/LYTENAVA. Its pipeline includes unmet patient needs, repackaged IV bevacizumab, and anti-VEGF. The company was founded by Pankaj Mohan on January 5, 2010 and is headquartered in Iselin, NJ.

Earnings data Q1 2021

Earnings data Q2 2021

Earnings data Q3 2021

Earnings data Q4 2021

Earnings data Q1 2022

Earnings data Q2 2022

Earnings data Q3 2022

Earnings data Q4 2022

Earnings data Q1 2023

Earnings data Q2 2023

Earnings data Q3 2023

Earnings data Q4 2023

Earnings data Q1 2024

Earnings data Q2 2024

Earnings data Q3 2024

Earnings data Q4 2024

Outlook Therapeutics progresses well with ONS-5010, eyes global expansion

Outlook Therapeutics is well-positioned for potential approvals in Europe and the US in 2024 and 2025.
Strong financial backing and progress in key studies indicate a positive trajectory.
Challenges include addressing FDA queries and ensuring smart approval processes.
Opportunities lie in leveraging existing infrastructure, pricing discussions, and FDA agreements.

Outlook Therapeutics advances clinical trials and secures EU market entry

Outlook Therapeutics made significant progress with marketing authorization and clinical trial advancements.
Financial stability improved with reduced convertible notes and ample cash reserves.
Challenges lie in managing expenses, addressing analyst inquiries, and preparing for commercial launch.

Revenue

Cost of revenue

Gross profit

Operating expenses

SG&A

Other

Operating income

EBITDA

Net income

Earnings per share

Total assets

Current assets

Cash & equivalents

Receivables

Inventory

Non-current assets

Net PPE

Intangibles

Total liabilities

Current liabilities

Short term debt

Income tax payable

Non-current liabilities

Long-term debt

Total equity

Stockholders equity

Minority interest

Total liabilities & equity

Total debt

Net debt

Book value per share

Cash from operations

Funds from operations

Change in working capital

Cash from investing

Capital expenditure

Purchase/sale of investments

Purchase/sale of business

Other sources

Cash from financing

Change in stock

Change in debt

Cash dividends paid

Cash from other sources

Net change in cash

Free cash flow

Today, we revisit Outlook Therapeutics for the first time since March 2021. The company recently temporarily withdrew its marketing application for its main asset, clouding the outlook on this small-cap name even further.

Outlook Therapeutics: A One-Buck Lottery Ticket

Outlook Therapeutics (NASDAQ:OTLK) Inc said it has voluntarily withdrawn the biologics license application (BLA) for its ophthalmic formulation of bevacizumab (ONS-5010 or Lytenava) after the US Food and Drug Administration (FDA) requested additional information.  The company added that it is actively working to respond to the FDA's request and plans to resubmit a revised BLA by September.

Outlook Therapeutics opts to resubmit BLA for wet AMD drug after FDA requests more info

ISELIN, N.J., May 31, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced that the U.S. Food and Drug Administration (FDA) has requested additional information in order to complete the filing of the Company's Biologics License Application (BLA) for ONS-5010/ LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD). Outlook Therapeutics has voluntarily withdrawn its BLA for ONS-5010 and is actively working to respond to the FDA's request. The Company plans to re-submit a revised BLA by September 2022.

Outlook Therapeutics Provides Update on Biologics License Application (BLA) Submission for ONS-5010 as a Treatment for Wet AMD

ISELIN, N.J., May 18, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced that Lawrence Kenyon, Chief Financial Officer of Outlook Therapeutics, will present at the H.C. Wainwright Global Investment Conference being held May 23-26, 2022 in Miami, FL and virtually.

Outlook Therapeutics to Present at the H.C. Wainwright Global Investment Conference

Advanced Micro Devices

Outlook Therapeutics (NASDAQ:OTLK) Inc ended its fiscal second quarter with $58.4 million in cash – enough to launch its lead drug ONS-5010 without raising significant additional capital, it said. ONS-5010, which will be sold under the brand name Lytenava, is an investigational ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection for the treatment of wet age-related macular degeneration (AMD) and other retinal diseases.

Outlook Therapeutics ends fiscal 2Q with $58.4M in cash as it ramps up pre-commercial activities for wet AMD treatment Lytenava

ISELIN, N.J., May 13, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced recent corporate highlights and financial results for its fiscal second quarter ended March 31, 2022.

Outlook Therapeutics Reports Financial Results for Second Quarter Fiscal Year 2022 and Provides Corporate Update

Outlook Therapeutics (NASDAQ:OTLK) Inc has said its chief operations officer Terry Dagnon will discuss the company's wet age-related macular degeneration (AMD) drug Lytenava as part of a panel at the 2022 World Retina Conference later this month.  The conference is taking place from May 12-15, 2022, in Fort Lauderdale, Florida.

Outlook Therapeutics says its COO to talk wet AMD drug Lytenava at World Retina Conference this week

ISELIN, N.J., May 10, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced that Terry Dagnon, Chief Operations Officer of Outlook Therapeutics, will be a panelist at the Retina World Congress 2022 taking place May 12-15, 2022 in Fort Lauderdale, Florida.

Outlook Therapeutics to Participate in Retina World Congress 2022

Live moderated video webcast on Wednesday, May 11th at 1:00 PM ET Live moderated video webcast on Wednesday, May 11th at 1:00 PM ET

Outlook Therapeutics to Participate at the Virtual Investor 2022 CEO Spotlight

Outlook Therapeutics (NASDAQ:OTLK) Inc revealed that BioLexis Private Limited, a strategic shareholder in the pre-commercial biopharmaceutical company, is being reorganized and has resulted in GMS Holdings emerging as its largest shareholder. The Singapore and Iselin, New Jersey-based biopharma company noted that the BioLexis reorganization, which does not entail any changes in the indirect ownership of Outlook Therapeutics (NASDAQ:OTLK), provides GMS Holdings with “increased flexibility” to support Outlook's growth as its largest shareholder.

Outlook Therapeutics says BioLexis reorganization results in GMS Holdings becoming its largest shareholder

SINGAPORE and ISELIN, N.J., April 22, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, and BioLexis Pte Ltd. (“BioLexis”), a strategic shareholder in Outlook Therapeutics, today announced that BioLexis is being reorganized. The BioLexis reorganization, which does not entail any changes in the indirect ownership of Outlook Therapeutics, provides GMS Holdings with increased flexibility to support the future growth of Outlook Therapeutics as its largest shareholder.

BioLexis Reorganization Results in GMS Holdings as Largest Shareholder in Outlook Therapeutics

ISELIN, N.J., April 05, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced that Russ Trenary, President and Chief Executive Officer of Outlook Therapeutics, will be presenting at the Wet AMD and DME Drug Development Summit taking place April 5-7, 2022 in Boston, Massachusetts.

Outlook Therapeutics to Present at Wet AMD and DME Drug Development Summit

Outlook Therapeutics (NASDAQ:OTLK) Inc said it has submitted its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for ONS-5010, an investigational therapy for the treatment of wet age-related macular degeneration (wet AMD). If approved, the treatment will be branded as LYTENAVA (bevacizumab-vikg) and could replace the current practice of using unapproved repackaged IV bevacizumab sourced from compounding pharmacies, products that have known risks of contamination and inconsistent potency and availability.

Outlook Therapeutics submits Biologics License Application to US FDA for its investigational therapy to treat wet age-related macular degeneration

ISELIN, N.J., March 31, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced it has submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010, an investigational therapy which, if approved, will be branded as LYTENAVA™ (bevacizumab-vikg), for the treatment of wet age-related macular degeneration (wet AMD). If approved, LYTENAVA™ (bevacizumab-vikg) could replace the current practice of using unapproved repackaged IV bevacizumab sourced from compounding pharmacies for the treatment of wet AMD. “This BLA submission for our investigational ONS-5010 not only marks a very significant moment for Outlook Therapeutics, but represents a real step forward for potentially providing an on-label, FDA-approved alternative for the most frequently used anti-VEGF treatment in wet AMD patients in the United States,” said Russ Trenary, President and Chief Executive Officer, Outlook Therapeutics. “If approved for marketing, we hope to see our ophthalmic bevacizumab become a valuable on-label therapy offering clinicians and their patients a safe and effective ophthalmic formulation of a treatment whose value has been proven over many years of clinical practice. We are excited for the potential to offer an ophthalmic bevacizumab formulation that ships straight from our factory partners to distribution centers while avoiding the risks of using unapproved repackaged IV bevacizumab that is approved for intravenous use but not for intravitreal administration.”

Outlook Therapeutics Submits Biologics License Application to the U.S. Food and Drug Administration for ONS-5010 as a Treatment for Wet AMD

ISELIN, N.J., March 03, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced that Alicia Tozier has been appointed as Senior Vice President, Marketing and Market Access.

Outlook Therapeutics Bolsters Commercialization Expertise with Appointment of Alicia Tozier as Senior Vice President of Marketing and Market Access

Pivotal Phase 3 data from the NORSE TWO registration trial to be presented by Lawrence Lee, MD, MBBS, FRANZCO, FRACS Pivotal Phase 3 data from the NORSE TWO registration trial to be presented by Lawrence Lee, MD, MBBS, FRANZCO, FRACS

Outlook Therapeutics to Present at the RANZCO 52nd Annual Scientific Congress

Citius Pharmaceuticals

Ra Medical Systems Inc

Biotech penny stocks to watch as Ukraine-Russia conflict builds steam. The post Biotech Penny Stocks To Buy For Under $5 As Russia Ukraine Conflict Heats Up appeared first on Penny Stocks to Buy, Picks, News and Information | PennyStocks.com.

Biotech Penny Stocks To Buy For Under $5 As Russia Ukraine Conflict Heats Up

ISELIN, N.J., Feb. 14, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced recent corporate highlights and financial results for its fiscal first quarter ended December 31, 2021.

Outlook Therapeutics Reports Financial Results for First Quarter Fiscal Year 2022 and Provides Corporate Update

Live video webcast presentation on Friday, February 18th at 10:40 AM ET Live video webcast presentation on Friday, February 18th at 10:40 AM ET

Outlook Therapeutics to Present at the 11th Annual SVB Leerink Global Healthcare Conference

ISELIN, N.J., Feb. 08, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced the appointment of Joel Prieve as Senior Vice President, Commercial Operations.

Outlook Therapeutics Expands Commercial Team with Appointment of Senior Vice President of Commercial Operations

Biofrontera

Spectrum Pharma

Are these on your list of penny stocks to watch right now? The post 3 Top Penny Stocks To Buy For Under $5 Today appeared first on Penny Stocks to Buy, Picks, News and Information | PennyStocks.com.

3 Top Penny Stocks To Buy For Under $5 Today

ISELIN, N.J., Jan. 25, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today provided a business outlook for 2022.

Outlook Therapeutics Provides a Corporate Update and Business Outlook

Amyris

Desktop Metal

Danimer Scientific

4 penny stocks to buy right now according to top Wall Street analysts. The post 4 Best Penny Stocks To Buy Now According To Top Wall Street Analysts appeared first on Penny Stocks to Buy, Picks, News and Information | PennyStocks.com.

4 Best Penny Stocks To Buy Now According To Top Wall Street Analysts

Outlook's drug ONS-5010 has a unique value prop that will set it apart in the wet AMD landscape.

Outlook Therapeutics: Likely FDA Approval, Possible Buyout

Live video webcast presentation on Tuesday, January 25th at 3:00 PM ET Live video webcast presentation on Tuesday, January 25th at 3:00 PM ET

News for Outlook Therapeutics Inc Stock (OTLK)