On November 17, 2021 CymaBay Therapeutics, Inc. (Nasdaq: CBAY), a clinical-stage biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases with high unmet medical need, reported that it has commenced an underwritten public offering of its common stock and pre-funded warrants (Press release, CymaBay Therapeutics, NOV 17, 2021, View Source [SID1234595759]). All shares of common stock and pre-funded warrants to be sold in the offering will be offered by CymaBay. CymaBay intends to grant the underwriters a 30-day option to purchase up to an aggregate of an additional 15% of the number of shares of its common stock offered in the public offering (including shares underlying the pre-funded warrants). The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. CymaBay anticipates using the net proceeds from the offering to fund ongoing development of seladelpar and for working capital and general corporate purposes.

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Piper Sandler and Raymond James are acting as the joint book-running managers for the offering.

The securities described above are being offered by CymaBay pursuant to a shelf registration statement previously filed with the Securities and Exchange Commission (the "SEC") on July 2, 2020, which became effective on July 13, 2020. A preliminary prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, from: Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at 800-747-3924, or by email at [email protected]; or Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, by telephone at (800) 248-8863, or by e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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 any such state or jurisdiction

On November 17, 2021 CymaBay Therapeutics, Inc. (Nasdaq: CBAY), a clinical-stage biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases with high unmet medical need, reported that it has commenced an underwritten public offering of its common stock and pre-funded warrants (Press release, CymaBay Therapeutics, NOV 17, 2021, View Source [SID1234595758]). All shares of common stock and pre-funded warrants to be sold in the offering will be offered by CymaBay. CymaBay intends to grant the underwriters a 30-day option to purchase up to an aggregate of an additional 15% of the number of shares of its common stock offered in the public offering (including shares underlying the pre-funded warrants). The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. CymaBay anticipates using the net proceeds from the offering to fund ongoing development of seladelpar and for working capital and general corporate purposes.

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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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Piper Sandler and Raymond James are acting as the joint book-running managers for the offering.

The securities described above are being offered by CymaBay pursuant to a shelf registration statement previously filed with the Securities and Exchange Commission (the "SEC") on July 2, 2020, which became effective on July 13, 2020. A preliminary prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, from: Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at 800-747-3924, or by email at [email protected]; or Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, by telephone at (800) 248-8863, or by e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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 any such state or jurisdiction.

On November 17, 2021 Ascendis Pharma A/S (Nasdaq: ASND) reported that the Company is scheduled to participate in the Evercore ISI 4th Annual HealthCONx Conference (Press release, Ascendis Pharma, NOV 17, 2021, https://ascendispharma.gcs-web.com/news-releases/news-release-details/ascendis-pharma-participate-evercore-isi-4th-annual-healthconx [SID1234595757]). Company executives will participate in a virtual fireside chat hosted by Evercore ISI.

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Details

Event Evercore ISI 4th Annual HealthCONx Conference
Location Virtual
Date Wednesday, December 1, 2021
Time 3:55-4:15 p.m. Eastern Time
A live audio webcast of the presentation will be available on the Investors & News section of the Company’s website at View Source A webcast replay will be available on the Company’s website shortly after conclusion of the event for 30 days.

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 Alpheus Medical, Inc, a privately held company developing a novel sonodynamic therapy (SDT) platform targeting solid body cancers, reported it has closed $16M in Series A financing (Press release, Alpheus Medical, NOV 17, 2021, View Source [SID1234595755]). Co-led by OrbiMed Advisors and Action Potential Venture Capital, the round included participation from the Medtech Convergence Fund, a SV Health Investors venture fund, the Brain Tumor Investment Fund, an affiliate of the National Brain Tumor Society, and BrightEdge, the American Cancer Society’s impact venture capital arm. The company’s investigational non-invasive sonodynamic therapy has the potential to offer whole hemisphere treatment that is designed to selectively target and kill cancer cells through an outpatient procedure that may be repeated, as needed, to treat the disease. The funds will support a FIH trial of the therapy for recurrent glioblastoma multiforme (rGBM), a fatal brain cancer with very limited treatment options.

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The multi-site first-in-human trial will evaluate the safety, feasibility, and molecular and clinical effects of the proprietary sonodynamic therapy treatment in patients with recurrent high-grade gliomas. Enrollment is expected to begin in the coming months.

"Alpheus’ unique drug-device combination is poised to overcome the challenges of rGDM tumors"

"Glioblastomas are located within the blood-brain barrier and are very difficult to treat due to their heterogenous and invasive nature. Treatment of these devastating tumors is currently limited by procedures that are highly invasive, may not be repeated, often result in complications, and in many situations lead to undesirable quality of life trade-offs for the patient," commented Klaus Veitinger, MD, Venture Partner at OrbiMed Advisors and Executive Chairman of Alpheus Medical’s board of directors. "Our team has followed the brain cancer market closely. Alpheus’ unique drug-device combination is poised to overcome the challenges this tumor poses and deliver the hope of better outcomes for these critically ill patients."

Alpheus Medical’s drug-device combination uses a sonodynamic approach, where a drug, or sonosensitizer, selectively accumulates in cancer cells and is activated under low intensity ultrasound to kill the tumor cells. After the drug is administered, Alpheus’ proprietary ultrasound delivery device provides SDT treatment to activate cell death in only the cancer cells that have absorbed the drug. Alpheus’ therapy aims to address the heterogenous and diffuse nature of the disease with its large field treatment of cells both at the primary tumor site and those throughout the diseased hemisphere. The innovative therapy also eliminates the requirement for concomitant imaging, such as magnetic resonance imaging (MRI). It can be performed as a convenient outpatient procedure and may be repeated to maximize treatment effect.

"The ability to selectively target cancer cells with Alpheus’ treatment is very exciting and has the potential to deliver a much-needed option for this challenging disease, where drug therapies alone have struggled," stated Imran Eba, Partner with Action Potential Venture Capital and newly appointed board member of Alpheus Medical. "We are pleased to co-lead this round and look forward to supporting the team as it moves the platform into clinical trials."