On Decmeber 23, 2022 Adaptimmune Therapeutics plc (NASDAQ: ADAP), a leader in cell therapy to treat cancer, today reports that it has initiated the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for afami-cel for use as a single-dose regimen for the treatment of advanced synovial sarcoma (Press release, Adaptimmune, DEC 23, 2022, View Source [SID1234625584]).

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"Adaptimmune’s goal is to design and deliver cell therapies to transform the lives of people with cancer," said Dennis Williams, PharmD, Senior VP of Late-Stage Development. "Initiation of this rolling BLA submission is an important milestone toward achieving this goal – bringing to market a new therapeutic option for people with advanced synovial sarcoma. This also marks an important milestone for the treatment of solid tumors with autologous T-cell products."

The BLA submission for afami-cel is supported by positive clinical data from Adaptimmune’s SPEARHEAD-1 clinical trial in patients with advanced synovial sarcoma. The Company plans to complete its rolling submission by mid-2023 and the application will be eligible for priority review under the FDA’s regenerative medicine advanced therapy (RMAT) program.

On December 20, 2022 Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology, obesity and non-alcoholic steatohepatitis (NASH), reported the pricing of its underwritten public offering of 10,350,000 shares of its common stock at a public offering price of $7.25 per share, before underwriting discounts and commissions (Press release, Terns Pharmaceuticals, DEC 23, 2022, View Source [SID1234625581]). The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Terns, are expected to be approximately $75.0 million, excluding any exercise of the underwriters’ option to purchase additional shares. In addition, Terns has granted the underwriters a 30-day option to purchase up to an additional 1,552,500 shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on December 23, 2022, subject to customary closing conditions. All of the securities are being offered by Terns.

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Jefferies and Cowen are acting as lead book-running managers for the proposed offering. UBS Investment Bank is also acting as a bookrunner for the proposed offering. Mizuho and JMP Securities, a Citizens Company, are acting as co-lead managers for the proposed offering.

Terns intends to use the net proceeds from the proposed offering, together with its existing cash and cash equivalents, to advance its clinical-stage development pipeline, including the TERN-501, TERN-701 and TERN-601 clinical programs and for working capital and general corporate purposes.

The public offering is being made pursuant to a registration statement on Form S-3 previously filed with the Securities and Exchange Commission ("SEC"), which became effective on March 14, 2022. A prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the prospectus supplement and accompanying prospectus relating to this offering, when available, may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at 877-821-7388 or by email at [email protected] or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at 1-833-297-2926 or by e-mail: [email protected].

On December 23, 2022 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported the grant of restricted stock unit (RSU) awards for an aggregate of 14,200 shares of Syros common stock to four newly hired employees in connection with their commencement of employment with Syros (Press release, Syros Pharmaceuticals, DEC 23, 2022, View Source [SID1234625580]). These RSUs were granted as material inducements to employment in accordance with Nasdaq Listing Rule 5635(c)(4).

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The awards were granted on December 22, 2022, and vest as to one-quarter of the shares on December 31, 2023 and as to an additional one-quarter of the shares at the end of each successive year thereafter, subject to the employee’s continued service with Syros. These awards are subject to the terms and conditions of a restricted stock unit agreement covering the award and Syros’ 2022 Inducement Stock Incentive Plan.

On December 23, 2022 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported that its Board of Directors declared a dividend of one one-thousandth of a share of newly designated Series D Preferred Stock, par value $0.001 per share, for each outstanding share of the Company’s common stock held of record as of 5:00 p.m. Eastern Standard Time on January 3, 2023 (Press release, Soligenix, DEC 23, 2022, View Source [SID1234625579]). The shares of Series D Preferred Stock will be distributed to such recipients at 5:00 p.m. Eastern Standard Time on January 4, 2023. The outstanding shares of Series D Preferred Stock will vote together with the outstanding shares of the Company’s common stock, as a single class, exclusively with respect to a reverse stock split, as well as any proposal to adjourn any meeting of stockholders called for the purpose of voting on the reverse stock split, and will not be entitled to vote on any other matter, except to the extent required under the Delaware General Corporation Law. Subject to certain limitations, each outstanding share of Series D Preferred Stock will have 1,000,000 votes per share (or 1,000 votes per one one-thousandth of a share of Series D Preferred Stock).

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"The current market conditions have been extremely difficult for many companies both large and small, and Soligenix is no exception," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "After receiving the Nasdaq deficiency letter stating that the Company no longer met the required $1.00 minimum bid price, we were hopeful that our important 2022 milestones such as the submission of the HyBryte new drug application (NDA), had the potential to put the Company back in compliance with Nasdaq requirements. Unfortunately, while achieving these major milestones, our stock price did not respond as we had hoped in these difficult global market conditions. Therefore, we are now faced with having to consider a reverse stock split in order to maintain our Nasdaq listing, which is very important for the Company’s future success as we move toward potential NDA approval and U.S. launch, and continue partnership discussions. It should also make our stock more attractive to larger institutional investors."

All shares of Series D Preferred Stock that are not present in person or by proxy at the meeting of stockholders held to vote on the reverse stock split as of immediately prior to the opening of the polls at such meeting will automatically be redeemed by the Company. Any outstanding shares of Series D Preferred Stock that have not been so redeemed will be redeemed if such redemption is ordered by the Company’s Board of Directors or automatically upon the approval by the Company’s stockholders of an amendment to the Company’s certificate of incorporation effecting the reverse stock split at such meeting.

The Series D Preferred Stock will be uncertificated, and no shares of Series D Preferred Stock will be transferable by any holder thereof except in connection with a transfer by such holder of any shares of the Company’s common stock held by such holder. In that case, a number of one one-thousandths of a share of Series D Preferred Stock equal to the number of shares of the Company’s common stock to be transferred by such holder would be transferred to the transferee of such shares of common stock.

Further details regarding the Series D Preferred Stock will be contained in a report on Form 8-K to be filed by the Company with the Securities and Exchange Commission.

On December 23, 2022, Sesen Bio, Inc. ("Sesen") and Viventia Bio, Inc., a wholly-owned subsidiary of Sesen ("Viventia," and together with Sesen, the "Company"), terminated the Exclusive License Agreement (the "License Agreement") dated July 30, 2020 by and between Sesen, Viventia, and Qilu Pharmaceutical Co., Ltd. ("Qilu"), as well as other related agreements between the Company and Qilu, consistent with the Company’s previously disclosed restructuring plan (Filing, 8-K, Sesen Bio, DEC 23, 2022, View Source [SID1234625578]). The terms of the License Agreement are more fully described in the Company’s Form 8-K filed with the Securities and Exchange Commission on July 31, 2020.

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In connection with the termination of the License Agreement, the Company shall make a one-time aggregate payment to Qilu of $1,400,000, which consists of a $1,200,000 termination fee payable upon the termination of the License Agreement and a $200,000 payment payable upon the Company’s receipt of certain clinical data and chemistry, manufacturing, and controls data from Qilu. As a result of the termination of the License Agreement, all rights to Vicineum in China, Hong Kong, Macau and Taiwan have reverted to the Company. The Company currently retains all global rights to Vicineum and is continuing to work with a financial advisor to explore strategic alternatives for Vicineum to maximize value for Sesen Bio stockholders.