On January 11, 2024 Xcell Biosciences, Inc. (Xcellbio), a platform technology company focused on cell and gene therapy applications, reported a collaboration with ElevateBio, LLC (ElevateBio), through which the companies aim to explore novel approaches to improving therapeutic potency of cell and gene therapies (Press release, Xcell Biosciences, JAN 11, 2024, View Source [SID1234639210]). As part of this collaboration, ElevateBio becomes the first member of Xcellbio’s beta program for its new AVATAR Foundry device. In addition, Michael Paglia, Chief Technology Officer at ElevateBio’s BaseCamp, has joined Xcellbio’s Scientific Advisory Board.

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ElevateBio is a technology-driven company commercializing its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate the development of genetic medicines. The company’s integrated ecosystem combines its BaseCamp process development and current Good Manufacturing Practice (cGMP) manufacturing business with its technology stack that includes gene editing, cell engineering technologies, and viral and non-viral delivery.

"At BaseCamp, we work with industry partners to design the best process for their product and recognize the importance of emerging technologies that will revolutionize how cell and gene therapies are manufactured," said Mr. Paglia. "I am excited to join the Xcellbio advisory board and look forward to joining Brian and the team on the collaboration with BaseCamp."

As part of this collaboration, ElevateBio BaseCamp scientists will have access to Xcellbio’s AVATAR incubator system for cell therapy research and development as well as two new platforms: the AVATAR Ai system for measuring the potency of cell therapies and the AVATAR Foundry system for cGMP cell therapy manufacturing. The AVATAR and AVATAR Foundry systems are used to metabolically reprogram therapeutic cells to improve their potency and persistence in the tumor microenvironment (TME), while the AVATAR Ai provides real-time analysis of tumor cytotoxicity under TME conditions. These collaborative efforts should streamline manufacturing protocols for cell and gene therapies.

Brian Feth, co-founder and CEO at Xcellbio, commented: "We are delighted to collaborate with ElevateBio, a true leader in the cell and gene therapy field, and we look forward to one day having a collective impact in how these important treatments are used to improve healthcare. We also welcome Mike to our advisory board and are eager for his contributions to our own R&D programs in that capacity."

The beta program for Xcellbio’s AVATAR Foundry system is now open. To learn more, meet with the Xcellbio team at Advanced Therapies Week taking place in Miami from January 16-19 or visit View Source

On January 11, 2024 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company (the "Company"), reported that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company on January 18, 2024 at the virtual B. Riley Securities 4th Annual Oncology Conference: Tumor-ow’s Titans – Finding Value in (Near-) Commercial Oncology Companies (Press release, Puma Biotechnology, JAN 11, 2024, View Source [SID1234639211]).

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For access to Mr. Auerbach’s live presentation at 2:00 p.m. ET on January 18, please contact your B. Riley representative. A replay of the presentation will be available on Puma’s website after 5:00 p.m. ET at View Source

On January 10, 2024 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, reported that the Compensation Committee of the company’s Board of Directors granted two employees nonqualified stock options to purchase an aggregate of 18,500 shares of its common stock with an exercise price of $2.10, which is equal to the closing price of Gritstone’s common stock on January 4, 2024, the date of the grant (Press release, Gritstone Bio, JAN 10, 2024, View Source [SID1234639185]). These stock options are part of an inducement material to the new employees becoming an employee of Gritstone, in accordance with Nasdaq Listing Rule 5635(c)(4).

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The stock options will vest over a four-year period, with 25% of the options vesting on the first anniversary of the employees’ date of hire, and 1/48th of the options vesting monthly thereafter, subject to the employees’ continued employment with Gritstone on such vesting dates. The stock options are subject to the terms and conditions of Gritstone’s 2021 Employment Inducement Incentive Award Plan and the stock option agreement covering the grant.

On January 10, 2024 Inventiva (Euronext Paris and Nasdaq: IVA) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of patients with non-alcoholic steatohepatitis ("NASH") and other diseases with significant unmet medical needs, reported the drawdown of the second tranche of €25 million of the unsecured loan agreement executed with the European Investment Bank ("EIB") on May 16, 2022 (the "Finance Contract") with a maturity date on or about January 18, 2027 (Press release, Inventiva Pharma, JAN 10, 2024, View Source [SID1234639186]). The disbursement of the second tranche is expected to occur on or about January 18, 2024. On January 4, 2024, and in accordance with the Finance Contract, the Company issued 3,144,654 warrants to EIB.

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Jean Volatier, Deputy Chief Executive Officer and Chief Financial Officer of Inventiva, stated: "The drawdown of this second tranche of €25 million was triggered by the accomplishment of key milestones by Inventiva, and allows us to further finance our pivotal Phase III clinical trial evaluating our lead compound, lanifibranor, in NASH. Inventiva is a leader in drug development for the treatment of NASH and the financial support provided by the EIB through a facility loan totaling €50 million is a testament to the important work of Inventiva in the field. We are truly thankful for the support provided by the EIB."

As previously announced, the Finance Contract provides funding in two tranches of €25 million, each subject to the completion of certain conditions precedent.

After the drawdown of the first tranche in December 20222, the Company was eligible to access the second tranche of €25 million if it met certain conditions precedent described below. Following the achievement of those conditions, the Company decided to draw on the second tranche to reinforce its financial position. The Company intends to use the proceeds to fund part of its pivotal NATiV3 Phase III clinical trial evaluating lanifibranor in patients with NASH and estimates that, including this second tranche of €25 million of the EIB loan, its cash, cash equivalents and deposits would allow the Company to fund its operations as currently planned until the beginning of the third quarter of 20241.

This second tranche carries a 7% interest capitalized annually, has a maturity of 3 years from the disbursement date and a repayment in fine. As a result, the Company expects to repay this tranche in early 20273, after the anticipated publication of the results of the NATiV3 Phase III trial evaluating lanifibranor in patients with NASH which is expected to take place in the first half of 2026. The disbursement of this second tranche was subject to, among other conditions, (i) the full drawdown of the first tranche, (ii) the receipt by the Company from the date of the Finance Contract of an aggregate amount of at least €70 million (inclusive of the €18 million that were a condition for the disbursement of the first tranche), paid either in exchange for shares of the Company, or through upfront or milestone payments, (iii) an out-licensing, partnership or royalty transaction with an upfront payment of at least €10 million, (iv) operational criteria based on patient enrollment and number of sites activated in the Company’s NATiV3 Phase III clinical trial of lanifibranor in patients with NASH and (v) the Company issuing warrants to EIB in accordance with the terms and conditions of the warrant agreement entered into on July 1, 2022.

On January 4, 2024, the Company issued 3,144,654 warrants to EIB, in accordance with the terms of the 6th resolution of the combined general meeting of shareholders of January 25, 2023, and Article L.225-138 of the French Commercial Code, as a condition to the drawdown of the second tranche. This represents approximately 6.08% of the Company’s current outstanding share capital4.

The exercise price of the warrants issued in connection with the second tranche is equal to €3.95 and corresponds to 95% of the volume-weighted average price of the Company’s shares on the regulated market of Euronext Paris during the last trading session preceding the decision to issue the warrants (i.e. January 3, 2024).

Pursuant to the previously disclosed warrant agreement, the warrants have a maturity of twelve years and shall be exercisable following the earliest to occur of (i) the maturity date of the first tranche (i.e. on December 8, 2026), (ii) a change of control event, (iii) an event of default under the Finance Contract, or (iv) a repayment demand by EIB under the Finance Contract. The warrants will automatically be deemed null and void if not exercised within the twelve-year period.

EIB has a put option which may require the Company to repurchase all or part of the unexercised warrants then exercisable at their intrinsic value (subject to a cap equal to the amount drawn under the Finance Contract) under certain circumstances (for example, in the event of a change of control of the Company or on the maturity date of the first tranche or in the event of default). The Company (or a substitute third party) has a call option to require EIB to sell all shares and other securities of the Company in certain circumstances, including the warrants, to the Company, subject to certain terms and conditions. In addition, the Company has a right of first refusal to buy-back all warrants offered for sale to a third party, subject to certain terms and conditions.

On the basis of the 3,144,654 new shares of the Company issuable upon exercise of the warrants issued in connection with the drawdown of the second tranche at an exercise price of €3.95 per new share, the Company could potentially receive gross proceeds of up to €12,421,383. There is no assurance that EIB will exercise any or all of the warrants or that the Company will receive any proceeds from the exercise of the warrants.

On January 10, 2024, Coherus BioSciences, Inc. (the "Company") reported that it had delivered a notice of termination of the TIGIT Program (as defined in the Collaboration Agreement) to Shanghai Junshi Biosciences, Co., Ltd ("Junshi Biosciences") pursuant to the Exclusive License and Commercialization Agreement (the "Collaboration Agreement") dated February 1, 2021, between the Company and Junshi Biosciences (Press release, Coherus Biosciences, JAN 10, 2024, View Source [SID1234651090]). The Company had previously notified Junshi Biosciences on January 9, 2022 of its election to exercise the license option for the TIGIT program CHS-006 described in the Collaboration Agreement (the "TIGIT Program").

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After its acquisition of Surface Oncology, Inc. in September 2023, the Company disclosed that it would conduct a portfolio prioritization process to allocate resources towards the most promising and/or competitively positioned product candidates in its pipeline. The Company believes it is in its best interests to terminate future work with Junshi Biosciences on the TIGIT Program. The Company plans to wind down work with Junshi Biosciences on the TIGIT Program over the coming months pursuant to the termination. Despite the termination of the work with Junshi BioSciences on the TIGIT Program, the Company will continue to support patients in its current studies involving CHS-006 (clinicaltrials.gov identifier# NCT05061628 and clinicaltrials.gov identifier# NCT05757492).

The Collaboration Agreement remains effective and active for all other purposes as the Company continues to work together with Junshi Biosciences on the development of LOQTORZI (toripalimab-tpzi).