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Outlook Therapeutics, Inc. (ONS) Create: Alert

All | News | Filings
Date FiledTypeDescription
08/14/2023 8-K Quarterly results
Docs: "Outlook Therapeutics® Reports Financial Results for Third Quarter Fiscal Year 2023 and Reiterates Key Anticipated Near-Term Milestones · Prescription Drug User Fee Act goal date of August 29, 2023 for ONS-5010, an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration ISELIN, N.J., August 14, 2023 — Outlook Therapeutics, Inc. , a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of wet AMD, today announced recent corporate highlights and financial results for its fiscal third quarter ended June 30, 2023. Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics, commented, “We continue to be focused on our pre-launch activi..."
05/16/2023 8-K Entry into a Material Definitive Agreement, Termination of a Material Definitive Agreement, Financial Statements and Exhibits...
Docs: "Opinion of Cooley LLP",
"At-the-market-sales agreement between the Company and BTIG, LLC"
05/15/2023 8-K Quarterly results
Docs: "Outlook Therapeutics® Reports Financial Results for Second Quarter Fiscal Year 2023 and Provides Corporate Update ● Upcoming Prescription Drug User Fee Act goal date of August 29, 2023 for ONS-5010, an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration ● Pre-launch commercial activities continue in preparation for potential approval and launch of ONS-5010 ISELIN, N.J., May 15, 2023 – Outlook Therapeutics, Inc. , 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 second quarter ended March 31, 2023. “We continue to make sig..."
02/14/2023 8-K Quarterly results
12/29/2022 8-K Quarterly results
12/23/2022 8-K Entry into a Material Definitive Agreement, Unregistered Sales of Equity Securities, Other Events, Financial Statements and E...
Docs: "Form of Warrant",
"Opinion of Cooley LLP",
"Form of Securities Purchase Agreement, by and between the Company and the Purchasers",
"Letter Agreement, by and between the Company and M.S. Howells & Co",
"Outlook Therapeutics Announces $25 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules"
12/22/2022 8-K Entry into a Material Definitive Agreement, Creation of a Direct Financial Obligation or an Obligation under an Off-Balance S...
Docs: "Exhibit E",
"EXHIBIT A",
"Outlook Therapeutics® Announces Validation of Marketing Authorization Application by the European Medicines Agency for ONS-5010 as a Treatment for Wet AMD · Decision for potential approval expected from European Commission in early 2024 · Submission follows the U.S. FDA acceptance of the ONS-5010 BLA for wet AMD, with a PDUFA date of August 29, 2023 ISELIN, N.J., December 22, 2022 — Outlook Therapeutics, Inc. , a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced the validation of its Marketing Authorization Application by the European Medicines Agency for ONS-5010 / LYTENAVA™ , an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related ..."
11/23/2022 8-K Quarterly results
08/15/2022 8-K Quarterly results
08/10/2022 8-K Quarterly results
06/17/2022 8-K Quarterly results
06/07/2022 8-K Quarterly results
05/31/2022 8-K Quarterly results
05/13/2022 8-K Quarterly results
04/22/2022 8-K Entry into a Material Definitive Agreement, Financial Statements and Exhibits  Interactive Data
Docs: "AMENDED AND RESTATED INVESTOR RIGHTS AGREEMENT"
03/31/2022 8-K Other Events  Interactive Data
03/25/2022 8-K Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements...
02/14/2022 8-K Quarterly results
Docs: "Outlook Therapeutics Reports Financial Results for First Quarter Fiscal Year 2022 and Provides Corporate Update · Outlook Therapeutics remains on track to submit new U.S. FDA Biologics License Application for first ophthalmic formulation of bevacizumab · Commercial launch planning underway · Financed through the anticipated approval of the ONS-5010 BLA ISELIN, N.J., February 14, 2022 — Outlook Therapeutics, Inc. , 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. Recent Corporate Highlights · Expanded commercial team with appoi..."
12/23/2021 8-K Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements...
Docs: "[signatures to follow on next page]",
"[signatures to follow on next page]"
12/22/2021 8-K Quarterly results
Docs: "Outlook Therapeutics Reports Financial Results for Fiscal Year 2021 and Provides Corporate Update · Positive clinical data reported for ONS-5010 / LYTENAVA™ in 2021 from multiple clinical trials, including statistically significant top-line efficacy and safety data from pivotal Phase 3 NORSE TWO trial for wet age-related macular degeneration · Recent financing activities expected to provide funding through the anticipated approval of the ONS-5010 biologics license application expected in the first calendar quarter of 2023 · Pre-launch commercial planning underway in anticipation of ONS-5010 approval ISELIN, N.J., December 22, 2021 — Outlook Therapeutics, Inc. , a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formu..."
11/29/2021 8-K Entry into a Material Definitive Agreement, Unregistered Sales of Equity Securities, Other Events, Financial Statements and E...
Docs: "Amended and Restated Underwriting Agreement",
"UNDERWRITER COMMON STOCK PURCHASE WARRANT OUTLOOK THERAPEUTICS, Inc. Warrant Shares: [__] Issue Date: November 29, 2021 Initial Exercise Date: November 29, 2021 THIS UNDERWRITER COMMON STOCK PURCHASE WARRANT certifies that, for value received, [NAME] or its assigns is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the date set forth above and on or prior to 5:00 p.m. on November 23, 2026 but not thereafter, to subscribe for and purchase from Outlook Therapeutics, Inc., a Delaware corporation , up to [__] shares of the Company’s Common Stock, as defined in Section 1 herein. The purchase price of one share of Common Stock under this Warrant shall be equal to the Exercise Price, as defined in Section 2 . Th...",
"485 Route 1 South Building F, Suite 320 Iselin, New Jersey 08830",
"Outlook Therapeutics Announces $10 Million Bought Deal Offering of Common Stock ISELIN, N.J., November 23, 2021 -- Outlook Therapeutics, Inc . , 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 that it has entered into an underwriting agreement with H.C. Wainwright & Co., LLC under which the underwriter has agreed to purchase on a firm commitment basis 8,000,000 shares of common stock of Outlook Therapeutics, at a price to the public of $1.25 per share, less underwriting discounts and commissions. The closing of the offering is expected to occur on or about November 29, 2021, subject to satisfaction of customary closing conditions. H.C. Wainw...",
"Outlook Therapeutics Increases Previously Announced Bought Deal Offering of Common Stock to $50 Million ISELIN, N.J., November 23, 2021 -- Outlook Therapeutics, Inc . , a late clinical-stage biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, announced today that, due to demand, the underwriter has agreed to increase the size of the previously announced public offering and purchase on a firm commitment basis 40,000,000 shares of common stock of Outlook Therapeutics, at a price to the public of $1.25 per share, less underwriting discounts and commissions. The closing of the offering is expected to occur on or about November 29, 2021, subject to satisfaction of customary cl...",
"Outlook Therapeutics Announces Closing of $57.5 Million Bought Deal, Including Full Exercise of Underwriter’ s Option to Purchase Additional Shares ISELIN, N.J., November 29, 2021 — Outlook Therapeutics, Inc . , a late clinical-stage biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, today announced the closing of its previously announced underwritten public offering of 46,000,000 shares of common stock of the Company at a price to the public of $1.25 per share, which includes the exercise in full of the underwriter’ s option to purchase additional shares.. H.C. Wainwright & Co. acted as the sole book-running manager for the offering. The gross proceeds to Outlook Therap..."
11/16/2021 8-K Entry into a Material Definitive Agreement, Creation of a Direct Financial Obligation or an Obligation under an Off-Balance S...
Docs: "NOW, THEREFORE, in consideration of the above recitals and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Company and Investor hereby agree as follows: 1. Purchase and Sale of Note . 1.1. Purchase of Note . Company hereby agrees to issue and sell to Investor and Investor hereby agrees to purchase from Company the Note. In consideration thereof, Investor agrees to pay the Purchase Price to Company. 1.2. Form of Payment . On the Closing Date , Investor shall pay the Purchase Price to Company via wire transfer of immediately available funds against delivery of the Note. 1.3. Closing Date . Subject to the satisfaction of the conditions set forth in Section 5 and Section 6 below, the date of the issuance and sale of the Note pursuant to this...",
"PROMISSORY NOTE",
"Outlook Therapeutics, Inc. Note Amendment This Note Amendment , dated November 16, 2021 , is made with respect to that certain Promissory Note dated November 4, 2020 in the original principal amount of $10,220,000.00 issued to Streeterville Capital, LLC, a Utah limited liability company , pursuant to that certain Note Purchase Agreement, dated as of November 4, 2020 , and is entered into by and between Outlook Therapeutics, Inc., a Delaware corporation , and Lender. Capitalized terms used in this Amendment and not otherwise defined in this Amendment have the respective meanings ascribed to them in the NPA and the Note.   Recitals"
11/12/2021 8-K Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements...
Docs: "AMENDMENT NO.1 TO CONSULTING AGREEMENT",
"AMENDMENT NO.1 TO CONSULTING AGREEMENT"
08/13/2021 8-K Quarterly results
Docs: "Outlook Therapeutics Reports Financial Results for Third Quarter of Fiscal Year 2021 and Provides Corporate Update · Reported positive, statistically significant top-line efficacy and safety data from pivotal Phase 3 NORSE TWO trial of ONS-5010 / LYTENAVA™ for the treatment of wet age-related macular degeneration · On track to submit new U.S. BLA for ONS-5010 in the first quarter of calendar 2022 and pre-commercial launch planning underway ISELIN, N.J., August 13, 2021 — Outlook Therapeutics, Inc. , 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 third quarter ended June ..."
08/03/2021 8-K Investor presentation
Docs: "Outlook Therapeutics Reports Positive Efficacy and Safety Data from Pivotal Phase 3 NORSE TWO Trial of ONS-5010 / LYTENAVA™ for the Treatment of Wet AMD · In NORSE TWO, ONS-5010 achieved statistically significant and clinically relevant primary and key secondary efficacy endpoints with 41% of subjects gaining at least 15 letters · In NORSE TWO, ONS-5010 was safe and well tolerated · Management to host conference call and webcast today at 8:00 a.m. ET ISELIN, N.J., August 3, 2021 — Outlook Therapeutics, Inc . , a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced positive clinical and highly statistically significant top-line results ...",
"Investor Presentation"
07/30/2021 8-K Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements...
Docs: "Executive Employment Agreement by and between Lawrence Kenyon and Outlook Therapeutics, Inc"
07/09/2021 8-K Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements...
Docs: "Executive Employment Agreement by and between C. Russell Trenary III and Outlook Therapeutics, Inc",
"Outlook Therapeutics Appoints C. Russell Trenary III as President and Chief Executive Officer July 7, 2021 Experienced executive with a track-record of successful eye care product launches Appointment reflects Outlook Therapeutics’ dedication to transition to commercial-stage company ISELIN, N.J., July 07, 2021 -- Outlook Therapeutics, Inc . , 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 C. Russell Trenary III as President, Chief Executive Officer and a member of the Board of Directors. Lawrence A. Kenyon, who has served as Outlook Therapeutics’ President, CEO and CFO since June 2018, will continue serving as CFO and as a member o..."
05/14/2021 8-K Quarterly results
03/26/2021 8-K Entry into a Material Definitive Agreement, Departure of Directors or Certain Officers; Election of Directors; Appointment of...
Docs: "Certificate of Amendment to Amended and Restated Certificate of Incorporation",
"Second Amended and Restated Bylaws",
"Opinion of Cooley LLP",
"At The Market Offering Agreement between the Company and H.C. Wainwright & Co."
02/16/2021 8-K Quarterly results
02/11/2021 8-K Quarterly results
02/02/2021 8-K Quarterly results
12/28/2020 8-K Quarterly results
Docs: "Outlook Therapeutics Reports Financial Results for Fiscal Year 2020 and Provides Corporate Update · All planned clinical trials for ONS-5010 / LYTENAVA™ wet AMD BLA now fully enrolled or completed · Pivotal data expected in mid-2021 from ongoing, fully enrolled Phase 3 registration trial for ONS-5010 with new BLA filing expected in second half of 2021 MONMOUTH JUNCTION, N.J., December 23, 2020 — Outlook Therapeutics, Inc. , 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 its corporate highlights and financial results for its fiscal year ended September 30, 2020. Outlook Therapeutics also provided a clinical de..."
11/06/2020 8-K Entry into a Material Definitive Agreement, Creation of a Direct Financial Obligation or an Obligation under an Off-Balance S...
Docs: "Note Purchase Agreement between the Company and Streeterville Capital, LLC",
"Promissory Note",
"Outlook Therapeutics Secures $10 Million in Additional Working Capital MONMOUTH JUNCTION, N.J., November 5, 2020 — Outlook Therapeutics, Inc. , 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 issuance of a $10.2 million unsecured promissory note to an accredited investor for $10.0 million cash proceeds, which will be used to pay off existing demand notes and to provide additional working capital. “This non-dilutive funding provides us with additional flexibility as we continue to make great progress in advancing ONS-5010/LYTENAVA™ towards our planned Biologics License Application for wet AMD in the second half of 2021. ..."
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