On November 17, 2021 Odonate Therapeutics, Inc. (NASDAQ: ODT) reported that it will commence a share repurchase plan for up to 20 million shares in order to return capital to stockholders (Press release, Odonate Therapeutics, NOV 17, 2021, View Source [SID1234595740]). This action is in connection with the Company’s previously announced decision to discontinue the development of tesetaxel. Repurchases may be made from time to time at the Company’s discretion. The plan has no time limit and can be discontinued at any time. There can be no assurance as to the timing or number of shares of any repurchases.

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As of September 30, 2021, as reported in its recently filed Form 10-Q, the Company had total stockholders’ equity of $71.4 million, or $1.85 per share, based on 38.5 million shares outstanding.

On November 17, 2021, Arcus Biosciences, Inc. ("Arcus") reported that entered into an amendment to its Option, License and Collaboration Agreement with Gilead Sciences, Inc. ("Gilead") dated May 27, 2020 (the "Collaboration Agreement") (Filing, 8-K, Arcus Biosciences, NOV 17, 2021, View Source [SID1234595756]). Pursuant to the amendment, Gilead exercised its options to three Arcus programs—its anti-TIGIT program (including domvanalimab and AB308), adenosine receptor antagonist program (including etrumadenant) and CD73 program (including quemliclustat). This transaction is subject to review under the Hart-Scott-Rodino Antitrust Improvements Act. Upon closing, Gilead will pay Arcus an aggregate of $725 million in option fees for its option exercise with respect to these three programs. Thereafter, in accordance with the terms of the Collaboration Agreement, as amended for these three programs, the companies will co-develop, equally share global development costs and equally share all profits and losses for the United States, subject to certain expense caps on Arcus’s spending and true-up adjustments. Gilead will obtain rights to exclusively commercialize these optioned programs outside of the U.S., subject to the rights of Arcus’s existing collaboration partners to any territories, and Gilead will pay to Arcus tiered royalties as a percentage of revenues ranging from the mid-teens to the low twenties.

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In addition, the parties agreed to collaborate on discovery and early development of drug candidates against two novel research targets ("research programs") for which Arcus will lead performance of discovery and early development activities. With respect to these two research programs, Gilead has the right to exercise its option, on a program-by-program basis, upon Arcus’s completion of certain IND-enabling activities for an option payment of $60 million. If the option is exercised by Gilead at this stage, the collaboration terms for optioned programs will be applicable to each research program except, with respect to commercialization outside of the U.S., Gilead would pay to Arcus tiered royalties as a percentage of revenues ranging from high single digits to low double digits. If Gilead declines to exercise its option at this stage, Gilead maintains an option, on a program-by-program basis, which must be exercised prior to the expiration of a prescribed period following the achievement of a development milestone in such program and Arcus’s delivery to Gilead of the requisite data package. If the option is exercised by Gilead at this later stage, the collaboration terms for optioned programs will be applicable to the joint development program including that, with respect to commercialization outside of the U.S., Gilead would pay to Arcus tiered royalties as a percentage of revenues ranging from the high-teens to the low twenties.

In connection with Gilead’s exercise of its options to three Arcus programs, the parties agreed to amend the $100 million option continuation payment due on the second anniversary of the Collaboration Agreement (the "2022 Continuation Payment"). Upon closing for all three programs, Gilead will no longer be obligated to make the 2022 Continuation Payment. In the event closing only occurs for one program, the 2022 Continuation Payment will be reduced to $67 million. In the event closing only occurs for two programs, the 2022 Continuation Payment will be reduced to $34 million.

The foregoing is only a brief description of the material terms of the amendment to the Collaboration Agreement and does not purport to be a complete description of its terms and is qualified in its entirety by reference to the amendment, which will be filed as an exhibit to Arcus’s Annual Report on Form 10-K for the year ending December 31, 2021.

On November 17, 2021 La Jolla Pharmaceutical Company (Nasdaq: LJPC) reported that it will commence a share repurchase plan for up to $10 million of the Company’s common stock. Repurchases may be made from time to time at the Company’s discretion (Press release, La Jolla Pharmaceutical, NOV 17, 2021, View Source [SID1234595790]). The plan has no time limit and can be discontinued at any time. There can be no assurance as to the timing or number of shares of any repurchases.

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"The decision to repurchase shares reflects our confidence in our team and the ability to execute against our strategic initiatives for growth, which is supported by the strength of our balance sheet," said Larry Edwards, President and Chief Executive Officer of La Jolla.

On November 17, 2021 Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) ("Atea"), a clinical-stage biopharmaceutical company, reported that the strategic collaboration pursuant to which it was jointly developing AT-527 for the treatment of COVID-19 with Roche will be terminating (Press release, Chugai, NOV 17, 2021, View Source [SID1234595725]). Upon termination, the rights and licenses granted by Atea to Roche under the strategic collaboration will be returned to Atea, and Atea will have full rights to continue the clinical development and future commercialization of AT-527 worldwide.

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"We believe strongly in the potential of AT-527 with its unique dual mechanism of action, antiviral activity against the major variants of concern and its market potential given the need for additional therapeutic options for COVID-19," said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals. "We have the financial resources and the talent to independently drive forward the Phase 3 MORNINGSKY clinical trial program, and we continue to expect data from this trial during the second half of 2022. We are energized by the opportunity to move forward with full ownership, providing us with autonomy to efficiently bring AT-527 to market."

The strategic collaboration with Roche, which included joint development, will be terminated on February 10, 2022.

"We are continuing to expedite efforts to submit the recently announced Phase 3 MORNINGSKY amendment to global health authorities," said Janet Hammond, MD, PhD, Chief Development Officer of Atea Pharmaceuticals. "We have an established development team at Atea with extensive global clinical trial experience, as well as outside resources we continue to leverage. We remain committed to developing and delivering AT-527 as an oral antiviral that will address treatment needs for patients as COVID-19 continues to evolve."

As of September 30, 2021, Atea reported cash and cash equivalents of $839.7 million with a cash runway through 2023.

About the AT-527 COVID-19 Clinical Development Program

Derived from Atea’s nucleos(t)ide prodrug platform, AT-527 is an oral direct-acting antiviral which is being studied to determine its potential to protect against disease progression and the development of long-COVID complications. Its unique mechanism of action, with dual targets including chain termination (RdRp) and NiRAN inhibition, has the potential to create a high barrier to resistance with broad antiviral coverage to different variants of SARS-CoV-2. Atea has completed a comprehensive nonclinical program to characterize the safety profile of AT-527. Results observed from these nonclinical studies demonstrated that AT-527 was non-mutagenic, had no effects on fertility or reproduction and was non-teratogenic.

Atea is evaluating AT-527 across multiple clinical trials that are advancing in parallel, including the global Phase 3 MORNINGSKY trial.

On November 17, 2021 DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, reported that Rick Pauls, President and CEO, will participate in a fireside chat at the upcoming Piper Sandler 33rd Annual Virtual Healthcare Conference. Management will also be available for one-on-one meetings (Press release, DiaMedica, NOV 17, 2021, View Source [SID1234595741]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A recording of the presentation will be available beginning on Monday, November 22, 2021, at 10:00a.m. Eastern Time. Interested parties may access the presentation in the "Investors" section of the company’s website at View Source