On January 3, 2024 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, reported that it will webcast its presentation at the 42nd Annual J.P. Morgan Healthcare Conference at 9:45 a.m. PT on Tuesday, January 9, 2024 (Press release, Sana Biotechnology, JAN 3, 2024, View Source [SID1234638926]). The presentation will feature a business overview and update by Steve Harr, Sana’s President and Chief Executive Officer.

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The webcast will be accessible on the Investor Relations page of Sana’s website at View Source A replay of the presentation will be available at the same location for 30 days following the conference.

On January 3, 2024 Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress" or "Company"), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, reported the closing of its previously announced registered direct offering (Press release, Fortress Biotech, JAN 3, 2024, View Source [SID1234638925]). The company issued 3,303,305 shares of its common stock and warrants to purchase up to 3,303,305 shares of common stock at a combined offering price of $3.33 per share of common stock and accompanying warrant priced at-the-market under Nasdaq rules. The warrants have an exercise price of $3.21 per share, are immediately exercisable, and will expire five years following the date of issuance.

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The gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, were approximately $11.0 million. The transaction closed on January 3, 2024.

Roth Capital Partners acted as exclusive placement agent for the offering.

The securities described above were offered in the registered direct offering pursuant to a registration statement on Form S-3 (File No. 333-258145), which was declared effective by the Securities and Exchange Commission (the "SEC") on July 30, 2021. The securities were offered in the registered direct offering only by means of a prospectus which is a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the registered direct offering were filed with the SEC and will be available on the SEC’s website at www.sec.gov. Additionally, electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained from Roth Capital Partners, LLC at 888 San Clemente Drive, Newport Beach, CA 92660, or by phone at (800) 678-9147 or email at [email protected].

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 by 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 January 3, 2024 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported that Bassil Dahiyat, Ph.D., president and chief executive officer, will present at the 42nd Annual J.P. Morgan Healthcare Conference on January 10, 2024 at 3:45 p.m. PST (Press release, Xencor, JAN 3, 2024, View Source [SID1234638923]).

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A live webcast of the presentation will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. After the webcast, a replay will be archived on the website for at least 30 days.

On January 3, 2024 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on developing novel therapies for a broad range of cancer indications, reported that it intends to offer and sell shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase shares of common stock in a public offering (Press release, Sellas Life Sciences, JAN 3, 2024, View Source [SID1234638922]). All of the securities to be sold in the offering are to be offered by SELLAS.

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The Company intends to use the net proceeds from the offering for funding of ongoing operations, including clinical development of existing product candidates, and for working capital and other general corporate purposes.

A.G.P./Alliance Global Partners is acting as sole placement agent for the offering on a best-efforts basis. The offering is subject to market 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.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-255318) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). The offering will be made only by means of a prospectus supplement and accompanying prospectus. The preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the preliminary prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected]. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that SELLAS has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about SELLAS and such offering.

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 January 3, 2024 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported a business update and will host a corporate webinar at 8:30 am ET (Press release, Sellas Life Sciences, JAN 3, 2024, View Source [SID1234638921]).

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"2023 was a very productive year for SELLAS," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "We advanced our clinical-stage programs for both galinpepimut-S (GPS) and SLS009, reported positive initial topline Phase 2a data of SLS009 which showed the first complete response achieved in an acute myeloid leukemia (AML) patient resistant to venetoclax combination therapies and significant antileukemic effect and apparent survival benefit, initiated a Phase 1b/2 trial of SLS009 in relapsed/refractory (r/r) peripheral T-cell lymphomas (PTCL) and held a successful FDA Type C meeting which solidified our GPS CMC program and commercial manufacturing and regulatory plans. We are pleased that the potential for SLS009 has been recognized by the FDA as evidenced by the granting of Fast Track Designation for PTCL and Orphan Drug Designations for AML and PTCL."

Dr. Stergiou continued: "We hope to build on this excellent progress and look forward to multiple clinical milestones that have the potential to create significant value for our shareholders. These include reporting interim data from the Phase 3 REGAL trial of GPS in AML as well as topline data from our Phase 2a SLS009 r/r AML trial this quarter and topline data from the Phase 1b/2 study of SLS009 in PTCL by the end of the second quarter. We believe that 2024 will be a pivotal year for SELLAS as we continue to advance our clinical-stage GPS and SLS009 programs that address a broad spectrum of hematologic malignancies and solid tumor indications. We welcome you to join us on our 8:30am call this morning where we will discuss further relevant corporate matters."

2024 Milestones:

Galinpepimut-S (GPS): Wilms Tumor-1 (WT1) targeting immunotherapeutic

Phase 3 REGAL study in AML: The interim analysis of the ongoing global Phase 3 registrational clinical trial (the REGAL study) of GPS in patients with AML who have achieved complete remission following second-line salvage therapy (CR2 patients) is expected in the first quarter of 2024. Because this analysis is event-driven, it may occur at a different time than currently expected.
SLS009: highly selective CDK9 inhibitor

Phase 2a clinical trial in AML: The Company expects to report data from the fully enrolled 45 mg (safety dose level) cohort and initial data from the 60 mg (recommended Phase 2 dose level) cohort in the first quarter of 2024 and expects the 60 mg cohort to be analyzed in the second quarter of 2024.
Phase 1b/2 clinical trial in r/r PTCL: Enrollment started in December 2023. Thirty-one sites are active for recruiting and approximately 10 more sites will be initiated. Interim analysis is planned after 20-25 patients are enrolled and have undergone initial follow-up which is projected to occur by June 2024. The interim efficacy data will be discussed with regulatory agencies to decide on continuation of the trial as a pivotal registrational study that would enroll approximately 70-75 additional patients. This study is fully funded by the Company’s partner for SLS009, GenFleet Therapeutics (Shanghai), Inc., and is being conducted in China.
2023 Highlights:

Galinpepimut-S (GPS): Wilms Tumor-1 (WT1) targeting immunotherapeutic

In the fourth quarter of 2023, the Company reached, and exceeded, its target enrollment of 105 patients in the ongoing Phase 3 REGAL trial of GPS, excluding the approximately 20 patients intended for enrollment in mainland China. Due to the uncertainty of timely participation of 3D Medicines in the REGAL study in mainland China, the Company is continuing to enroll patients in the United States, Europe and Asia to reach 126 patients, per the statistical analysis plan, for full enrollment in the first quarter of 2024. The number of patients needed for the pre-specified interim and final analyses are already enrolled.
Positive immunobiological and clinical data from the completed Phase 1/2 clinical trial of GPS in combination with Keytruda (pembrolizumab) in WT1+ platinum-resistant advanced ovarian cancer was presented at the International Gynecologic Cancer Society 2023 annual global meeting in November 2023.
The Company reported positive follow-up immune response and survival data in the fourth quarter of 2023 for the completed Phase 1 clinical trial of GPS combined with Opdivo (nivolumab) in advanced malignant pleural mesothelioma.
In the fourth quarter of 2023, the Company announced that it had concluded a Type C meeting with the U.S. Food and Drug Administration (FDA) regarding the Company’s Chemistry, Manufacturing, and Controls (CMC) sections in a potential biologics license application (BLA) for GPS. SELLAS had submitted a CMC Briefing Package to the FDA which provided an up-to-date overview of the extensive work completed for the GPS CMC program and commercial manufacturing and regulatory plans. The FDA reviewed this package of data and accompanying questions to the agency and responded with favorable guidance.
SLS009: highly selective CDK9 inhibitor

The Phase 1 clinical trial for patients with AML and lymphomas was completed in 2023. For patients with AML, SLS009 demonstrated a favorable tolerability profile with no dose limiting toxicities. Anti-tumor activity and clinical responses across dose levels were observed, indicating a broad therapeutic index. Meaningful cell killing activity, defined as ≥50% reduction in blasts in the bone marrow, was observed at several dose levels. A durable complete remission (CR) with no minimal residual disease (MRD) was observed in one patient with AML who had failed prior venetoclax plus azacytidine (aza/ven) therapy. The patient continues to be alive 11 months following commencement of treatment per last follow-up. The recommended Phase 2 dose for patients with AML was established at 60 mg. For the patients with lymphomas, no off-target safety issues were observed at any dose level and responses were observed across dose levels with a 14.7% clinical response rate overall, 35.3% overall disease control rate, and 36.4% clinical response rate for patients with PTCL. The recommended Phase 2 dose for patients with lymphomas was established at 100 mg administered as a once weekly infusion.
In the second quarter of 2023, the Company announced the dosing of the first patient (45 mg) in an open label, single arm, multi-center Phase 2a study that is designed to evaluate safety, tolerability, and efficacy at two dose levels of SLS009 (once weekly 45 mg or 60 mg) in combination with aza/ven in patients with AML. Enrollment in the 45 mg cohort was completed in the fourth quarter of 2023. Also in the fourth quarter of 2023, the Company announced the dosing of the first patients in the 60 mg dose cohort. The patients in the 60 mg dose cohort will be dosed with 60 mg once per week or 30 mg twice per week.
Early topline data from the Phase 2a study in patients with AML dosed at the 45 mg level (n=9) include one patient with a CR and significant anti-leukemic effects (≥50% decrease in bone marrow blasts) were observed in five out of six assessable patients with no significant safety issues to date.
In the fourth quarter of 2023, the Company announced the dosing of the first patient in a Phase Ib/II open-label, single arm trial in r/r PTCL which will enroll up to 95 patients to evaluate safety and efficacy and, based on results, may serve as a registrational study. This study is fully funded by the Company’s partner for SLS009, GenFleet Therapeutics (Shanghai), Inc. and is being conducted in China.
The Company received the following regulatory designations from the FDA for SLS009 in 2023:

Orphan Drug Designation (ODD) for the treatment of AML
ODD for the treatment of PTCL
Fast track designation for the treatment of r/r PTCL