BioInvent International AB: Interim report January–September 2023

On October 26, 2023 BioInvent reported Interim report January–September 2023 (Presentation, BioInvent, OCT 26, 2023, https://www.bioinvent.com/sites/bioinvent/files/pr/20231026-7e7c641f-ae2a-4798-b82c-755644c71a5a-1.pdf?ts=1698300010 [SID1234638115]).

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MaaT Pharma to Present Preclinical Data at SITC on MaaT034, an Artificial Intelligence-Generated Product Aimed at Improving Patients’ Responses to Immunotherapies

On October 26, 2023 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotech company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, reported the details of two poster presentations at the 38th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, the world-leading event in immunotherapy, scheduled to be held from November 1-5, 2023, in San Diego, California, U.S.A (Press release, MaaT Pharma, OCT 26, 2023, View Source [SID1234636538]). Presentations will include in vitro results for its new Artificial Intelligence (AI)-generated lead product, MaaT034, designed to improve responses to immunotherapy for patients with solid tumors. MaaT034 is the first member of the MET-C platform that can co-cultivate a healthy microbiota ecosystem. The first-in-human testing is planned for 2025, with the first clinical batches to be produced in 2024.

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Nathalie Corvaia, Chief Scientific Officer, states "we are very excited to present our first pre-clinical data at SITC (Free SITC Whitepaper) showing biological activity for MaaT034, our new generation of co-cultured products and the robustness of our proprietary AI-engine, gutPrint. MaaT034 is active in restoring the integrity of the gut barrier and stimulating immune cells leading to an improvement in the immune cell response to ICI therapy. This bolsters our confidence in our immuno-oncology approach driven by our AI engine. We are looking forward to moving to clinical evaluation in 2025."

Poster Presentation Details:

Poster 1 Title: Evaluation of a new co-cultured microbiome ecosystem therapy candidate (MaaT03X) for clinical testing as adjuvant/neoadjuvant to immune checkpoint inhibitors in solid tumors
Poster Number: 1321
Date & Location: November 3, 2023 – Exhibit Halls A & B1
Key findings for MaaT034:

replicates, at large industrial scale, the richness and diversity of healthy native-based microbiome ecosystems
restores the integrity of a damaged gut barrier
activates AhR[1] pathway involved in gut homeostasis
stimulates both myeloid and lymphoid immune cells
improves immune cell response to ICI therapy
Poster 2 Title: Robust Machine Learning (ML) approach for screening Microbiome Ecosystem Therapies (MET) drug candidates in combination with Immune Checkpoint Inhibitors
Poster Number: 1304
Date & Location: November 3, 2023 – Exhibit Halls A & B1
Key findings for gutPrint AI engine:

selection and training of models to grade samples as "Responder-like" according to the baseline stool metagenomics of ICI treated cancer patients
improvement of predictive performance compared to literature with more patient data, cross studies and indication
application of the best performing model (mean LODO AUC = 0.65) to MaaT Pharma’s healthy donor cohort or pooled samples (mixes of stools from 4 to 8 healthy donors) classified a large majority of those as "Responder-like" microbiota (especially pooled samples)

Takeda Quarterly Financial Report For the Quarter Ended September 30, 2023

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Merck Announces Third-Quarter 2023 Financial Results

On October 26, 2023 Merck reported its Third-Quarter 2023 Financial Results (Press release, Merck & Co, OCT 26, 2023, View Source [SID1234636447]).

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Mustang Bio Announces $4.4 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

On October 26, 2023 Mustang Bio, Inc. ("Mustang" or the "Company") (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, reported that it has entered into a definitive agreement for the issuance and sale of an aggregate of 2,588,236 of its shares of common stock (or common stock equivalents in lieu thereof) at a purchase price of $1.70 per share (or common stock equivalent in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Mustang Bio, OCT 26, 2023, View Source [SID1234636446]). In a concurrent private placement, Mustang has also agreed to issue and sell unregistered warrants to purchase up to an aggregate of 2,588,236 shares of its common stock. The offering is expected to close on or about October 30, 2023, subject to the satisfaction of customary closing conditions.

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

The unregistered warrants will have an exercise price $1.58 per share, will become exercisable immediately upon issuance and will expire five and one-half years from the date of issuance.

The gross proceeds to Mustang from the offering are expected to be approximately $4.4 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. Mustang currently intends to use the net proceeds from the offering for working capital and general corporate purposes.

The shares of common stock (or common stock equivalents) offered in the registered direct offering (but excluding the unregistered warrants offered in the concurrent private placement and the shares of common stock underlying such unregistered warrants) are being offered and sold by the Company pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-255476), including a base prospectus, previously filed with the Securities and Exchange Commission (SEC) on April 23, 2021 and declared effective by the SEC on May 24, 2021. The offering of the shares of common stock (or common stock equivalents) to be issued in the registered direct offering are being made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and an accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the final prospectus supplement and accompanying base prospectus may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The offer and sale of the unregistered warrants in the private placement 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 such unregistered warrants, have not been registered under the Securities Act or applicable state securities laws. Accordingly, the unregistered warrants offered in the private placement and the underlying shares of common stock may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, 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 the registration or qualification under the securities laws of any such state or jurisdiction