On February 22, 2023 ARS Pharmaceuticals, Inc. (the "Company") reported that it has entered into a Termination Agreement (the "Termination Agreement") with Recordati Ireland, LTD. ("Recordati"), pursuant to which, among other things, the Company and Recordati agreed to terminate that certain License and Supply Agreement, dated September 21, 2020, by and between the Company and Recordati (the "License and Supply Agreement") (Filing, 8-K, ARS Pharmaceuticals, FEB 22, 2023, View Source [SID1234627548]).

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Pursuant to the Termination Agreement, the Company will reacquire from Recordati all of its rights in and to an exclusive, royalty-bearing, sublicensable license under its patents relating to neffy to (i) perform Recordati’s development activities on the epinephrine compositions ("Licensed Compositions") and related products ("Products") for commercialization in the E.U., United Kingdom, and certain countries in the Middle East, Africa and Eurasia (the "Territory"), (ii) manufacture (or have manufactured) the Products for commercialization in the Territory, (iii) file and hold regulatory approvals for the Products in the Territory, and (iv) commercialize the Products in the Territory.

Under the Termination Agreement, the Company agreed to pay Recordati a one-time upfront payment of €3.0 million and Recordati is eligible to receive (i) an European Medicines Agency regulatory milestone payment of €2.0 million, (ii) a milestone payment of €5.0 million upon first commercial sale of a Product in the Territory, and (iii) milestone payments of up to €5.0 million in the aggregate from sales of Product(s) in the Territory.

The foregoing summary of the Termination Agreement does not purport to be a complete description of the document and is qualified in its entirety by the Termination Amendment, which the Company intends to file as an exhibit to the Company’s Annual Report on Form 10-K for the year ended December 31, 2022.

Item 1.02
Termination of a Material Definitive Agreement.

On February 22, 2023, the Company entered into the Termination Agreement with Recordati, pursuant to which, among other things, the Company and Recordati agreed to terminate the License and Supply Agreement, effective immediately.

A description of the material terms of the License and Supply Agreement was included under the heading "License and Supply Agreement with Recordati Ireland" under Item 1.01 of the Current Report on Form 8-K filed by the Company on November 8, 2022 (the "2022 Form 8-K"), which is incorporated herein by reference. A description of the material terms of the Termination Agreement are included under Item 1.01 of this Current Report on Form 8-K and is incorporated herein by reference.

On February 22, 2023 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage cell and gene therapy company advancing a new class of treatments for patients with cancer and rare diseases, reported that the Company plans to highlight its clinical and preclinical pipeline progress during a virtual R&D Day to be held today at 10:00am ET / 7:00am PT (Press release, Poseida Therapeutics, FEB 22, 2023, View Source [SID1234627547]).

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"R&D Day is our annual showcase for the innovative and exciting science we are advancing at Poseida that continues to drive our leadership in the field of cell and gene therapies," said Mark Gergen, Chief Executive Officer of Poseida Therapeutics. "Today, we will announce our second liver-directed preclinical gene therapy program partnered with Takeda: P-PAH-101 for the in vivo treatment of Phenylketonuria, or PKU. We are excited to share the progress we have made with our site-specific Super piggyBac platform to enable highly targeted site-specific editing and insertion, one of the most sought-after characteristics of genetic engineering. Finally, in our cell therapy portfolio, we continue to differentiate ourselves, expanding our capabilities for our allogeneic T cell platform to deploy TCRs in combination with CARs in solid tumors. We are thankful for the continued dedication of our scientists, partners and collaborators as we work together to unlock the potential of our technologies to treat patients with cancer and rare genetic diseases."

The Company’s third-annual R&D Day will feature its executive leadership and scientists for a morning of presentations and fireside chats with special guest speakers exploring the future of cell and gene therapy. The program will highlight the Company’s proprietary genetic engineering platform technologies, differentiated allogeneic CAR-T programs, and novel approaches to gene therapy as well as ongoing collaborations with Roche and Takeda.

External speakers will include:

George M. Church, Ph.D., a pioneer in the fields of genetics and synthetic biology and Chair of the Company’s Gene Therapy Scientific Advisory Board;

Madhu Natarajan, Ph.D., Head of the Rare Diseases Drug Discovery Unit at Takeda;

Christine Brown, Ph.D., Professor, City of Hope, a CAR-T cell expert and member of the Company’s Immuno-Oncology Scientific Advisory Board.

Key R&D Day Topics and Highlights

In Vivo Gene Therapy Programs

The Company will present advancements in hybrid technology highlighting the potential for single treatment cures across multiple diseases.

P-OTC-101 is the Company’s liver-directed gene therapy program for the in vivo treatment of urea cycle disease caused by a deficiency in the ornithine transcarbamylase (OTC) enzyme, a defect that impairs the body’s ability to detoxify ammonia, a byproduct of protein metabolism. The Company will show data highlighting disease correction and evaluation in non-human primates, with the Company’s lead lipid nanoparticle formulation that has demonstrated favorable tolerability.

The Company will announce P-PAH-101, its second Takeda-partnered gene therapy program. P-PAH-101 is a liver-directed gene therapy to treat PKU, an inherited genetic disorder caused by mutations in the phenylalanine hydroxylase (PAH) gene resulting in buildup of phenylalanine in the body. If left untreated, PKU can affect a person’s cognitive development. P-PAH-101 utilizes Super piggyBac technology combined with a hybrid adeno-associated virus (AAV) and nanoparticle delivery system. Preclinical data has demonstrated the potential to resolve phenylalanine to normal levels following a single treatment in juvenile and adult mice.

Emerging Technologies in Gene Therapy

The Company will highlight its continuing focus on innovation in its emerging platform technologies at today’s event.

Site-specific Super piggyBac DNA Delivery, first unveiled at the Company’s R&D Day in February 2022, has continued to advance. The Company has made significant enhancements to efficiency and site-specific transposition, with up to 60% of haploid genomes modified.

The Company has made key enhancements to its non-viral gene delivery system resulting in nearly 10-fold improvements in DNA expression in the past 12 months on a pathway towards realizing the full potential of non-viral gene delivery.

Allogeneic Cell Therapy Programs

The Company will recap early clinical data presented at the European Society for Medical Oncology Immuno-Oncology Annual Congress in December 2022 (ESMO I-O) on both of its Phase 1 allogeneic cell therapy programs: P-MUC1C-ALLO1, a wholly-owned CAR-T product candidate targeting solid tumors derived from epithelial cells, including breast and ovarian cancers, and P-BCMA-ALLO1, a CAR-T product candidate partnered with Roche targeting relapsed/refractory multiple myeloma. The Company plans to present additional updates on both trials at a medical conference in 2023.

The Company will present preclinical data on additional emerging allogeneic CAR-T programs including P-CD19CD20-ALLO1, P-CD70-ALLO1 and P-ckit-ALLO1.

Emerging Technologies in Cell Therapy

The Company will share early preclinical data highlighting progress made towards developing dual-targeting CAR-TCR-T therapies capable of recognizing extracellular and intracellular solid tumor antigens for potential improved clinical outcomes.

R&D Day Webcast Information

Registration for this virtual event and access to the live webcast will be available on the Investors & Media section of the Company’s website, www.poseida.com. A replay of the webcast will be available for 90 days following the presentation.

On February 22, 2023 Jounce Therapeutics, Inc. (Nasdaq: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that it is reducing its workforce by approximately 57 percent (Press release, Jounce Therapeutics, FEB 22, 2023, View Source [SID1234627545]). The decision to reduce its workforce was made as Jounce believes advancement of its clinical programs, JTX-8064 and vopratelimab, requires funding and a scope that the Company cannot pursue on its own and will be seeking business development opportunities for both programs.

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"We believe data in both the SELECT and INNATE clinical trials is intriguing, but to date neither study has demonstrated clinical activity sufficient to create the value necessary for Jounce to independently advance these programs to the next stage of development. We believe a company with additional resources and a longer value creation timeline could potentially advance these programs, for the benefit of cancer patients," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "Although reducing our workforce was a difficult decision, we are incredibly proud of the work of the entire Jounce team and would like to thank our talented employees impacted today for their dedication and contributions in support of our mission to benefit cancer patients."

Jounce expects to incur a non-recurring charge of approximately $11.2i million in the first quarter of 2023 related to the restructuring announced today. The workforce reduction will be substantially completed by March 31, 2023.

On February 22, 2023 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported that it has entered into definitive agreements for the issuance and sale of an aggregate of 1,428,572 shares of its common stock (or common stock equivalents) at a purchase price of $5.25 per share of common stock (or common stock equivalent) in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Checkpoint Therapeutics, FEB 22, 2023, View Source [SID1234627543]).

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In addition, in a concurrent private placement, Checkpoint will issue and sell Series A warrants to purchase up to 1,428,572 shares of common stock and Series B warrants to purchase up to 1,428,572 shares of common stock. The Series A warrants will be exercisable immediately upon issuance and will expire five years following the issuance date and have an exercise price of $5.00 per share and the Series B warrants will be exercisable immediately upon issuance and will expire eighteen months following the issuance date and have an exercise price of $5.00 per share.

H.C. Wainwright & Co. is acting as exclusive placement agent for the offering.

The closing of the offering is expected to occur on or about February 23, 2023, subject to the satisfaction of customary closing conditions. The gross proceeds from the offering are expected to be approximately $7.5 million. Checkpoint intends to use the net proceeds of this offering for working capital and general corporate purposes, including the manufacturing of cosibelimab and certain pre-commercial activities in anticipation of potential approval and commercial launch.

The shares of common stock (or common stock equivalents) described above (but not the warrants issued in the concurrent private placement or the shares of common stock underlying such warrants) are being offered by Checkpoint pursuant to a shelf registration statement on Form S-3 (File No. 333-251005) that was previously filed with the Securities and Exchange Commission ("SEC") on November 27, 2020, and subsequently declared effective on December 17, 2020. The securities offered in the registered direct offering are being offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying base prospectus relating to, and describing the terms of, the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus relating to the offering, when available, may also be obtained by contacting H.C. Wainwright & Co., LLC, at 430 Park Ave., New York, New York 10022, by telephone at (212) 856-5711, or by email at [email protected].

The warrants described above are being made in a transaction not involving a public offering and have not been registered under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act") and/or Rule 506(b) of Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be reoffered or resold in the United States except pursuant to an effective registration statement with the Securities and Exchange Commission (the "SEC") or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On February 22, 2023 Eterna Therapeutics Inc., a Delaware corporation (the "Company"), reported that it has entered into an exclusive license agreement (the "Exclusive License Agreement") with Factor Bioscience Limited ("Factor"), pursuant to which Factor has granted to the Company an exclusive, sublicensable, worldwide license under certain patents owned by Factor (the "Factor Patents") for the purpose of, among other things, identifying and pursuing certain opportunities to develop products in respect of the Factor Patents and otherwise grant to third parties sublicenses to the Factor Patents (Filing, 8-K, Eterna Therapeutics, FEB 22, 2023, View Source [SID1234627542]).

The term of the Exclusive License Agreement expires on November 22, 2027 (the "Expiration Date"), but will be automatically extended for an additional two and a half years (such period, the "Renewal Term") if the Company receives at least $100 million in fees from sublicenses to the Factor Patents ("Sublicense Fees") granted by it pursuant to the Exclusive License Agreement. Pursuant to the Exclusive License Agreement, the Company will pay Factor 20% of any Sublicense Fees received by the Company before the Expiration Date and 30% of any Sublicense Fees received by the Company during the Renewal Term. The Company may terminate the Exclusive License Agreement upon 120 days’ written notice to Factor, and both parties otherwise have additional customary termination rights, including in connection with certain uncured material breaches of the Exclusive License Agreement and specified bankruptcy events.

Dr. Matthew Angel, the Company’s President and Chief Executive Officer, is the co-founder, President, CEO, and a director of Factor Bioscience Inc., which is the parent of Factor.

The foregoing description of the Exclusive License Agreement is only a summary and is qualified in its entirety by reference to the full text of the Exclusive License Agreement, which is filed as Exhibit 10.1 to this Current Report on Form 8-K and incorporated by reference in this Item 1.01.

Item 1.02
Termination of a Material Definitive Agreement.

As previously reported, on November 22, 2022, the Company entered into a First Amendment to that certain exclusive license agreement, dated as of April 26, 2021 (as amended, the "Amended Factor License Agreement"), by and among Eterna Therapeutics LLC (f/k/a Brooklyn ImmunoTherapeutics LLC), a wholly owned subsidiary of the Company ("Eterna LLC"), Novellus Therapeutics Limited, a wholly owned subsidiary of the Company, and Factor. Effective on February 20, 2023, the Exclusive License Agreement terminated and superseded the Amended Factor License Agreement. A description of the material terms of the Amended Factor License Agreement is contained in Item 1.01 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on November 22, 2022, which description is incorporated by reference in this Item 1.02.

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