On February 27, 2025 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported it has entered into securities purchase agreements with new and existing healthcare focused institutional investors as well as participation from certain directors of the Company, for the purchase and sale of 7,330,121 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to an aggregate of 7,330,121 shares of common stock in a registered direct offering priced at-the-market under Nasdaq rules (the "Offering") at a combined purchase price of $1.50 for the institutional investors and $1.66 for certain directors of the Company (Press release, PDS Biotechnology, FEB 27, 2025, View Source [SID1234650752]). The warrants will have an exercise price of $1.50 per share, will be immediately exercisable upon issuance and will expire 5 years from issuance. Approximately $11 million will be funded in full upon the closing of the Offering, and up to an additional $11 million may be funded upon full cash exercise of the warrants.

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The closing of the Offering is expected to occur on or about February 28, 2025, subject to the satisfaction of customary closing conditions. The gross proceeds from the Offering are expected to be approximately $11 million.

A.G.P./Alliance Global Partners is acting as sole placement agent for the Offering.

The Company intends to use the net proceeds from the Offering for research and development expenses and general corporate purposes.

The Offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333- 267041) which was declared effective by the Securities and Exchange Commission (the "SEC") on September 2, 2022. The offering is made only by means of a prospectus which is part of the effective registration statement. A final prospectus supplement and the accompanying 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 Additionally, when available, electronic copies of the final prospectus supplement and the accompanying prospectus 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].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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 27, 2025 Oncopeptides reported full year 2024 financial results (Presentation, Oncopeptides, FEB 27, 2025, View Source [SID1234654301]).

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On February 27, 2025 GENFIT (Nasdaq and Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, reported its cash position as of December 31, 2024 and revenues for 2024 (Press release, Genfit, FEB 27, 2025, https://ir.genfit.com/news-releases/news-release-details/genfit-announces-revenues-and-cash-position-december-31-2024 [SID1234650702]).

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Cash Position

As of December 31, 2024, the Company’s cash and cash equivalents amounted to €81.8 million compared with €77.8 million as of December 31, 2023 and €96.0 million as of September 30, 2024.

In 2024, cash utilization is mainly the result of our research and development efforts in our ACLF franchise (notably VS-01, NTZ, SRT-015, CLM-022, and VS-02 HE), as well as GNS561 in cholangiocarcinoma (CCA). Cash utilization is offset notably by the €48.7 million milestone received in August 2024 (invoiced in June 2024) upon first sale of Ipsen’s Iqirvo (elafibranor) in the U.S. for the treatment of PBC, as part of our long-term strategic partnership with Ipsen (the "Ipsen agreement") signed in December 2021.

As announced on January 30, 2025, Genfit has signed a royalty financing deal providing up to €185 million non-dilutive capital, enabling us to fund our operating expenses and capital expenditure requirements beyond the end of 2027. This is based on current assumptions and programs and does not include exceptional events. This estimation assumes i) our expectation to receive significant future milestone revenue in 2025, including the €26.55 million milestone pending a third pricing and reimbursement approval of Iqirvo (elafibranor) in a major European market and Ipsen meeting its sales-based thresholds, ii) the closing of the royalty financing and the drawing down all instalments thereunder, and iii) the repurchase of the OCEANEs following such closing or their reimbursement at maturity in October 2025. Note that the closing of the royalty financing remains subject to the approval of the OCEANE bondholders at a bondholders general meeting convened for March 10, 2025, as announced on February 21, 2025, and the satisfaction of other customary closing conditions.

Revenues

Revenues for 2024 amounted to €67.0 million compared to €28.6 million for the same period in 2023.

Of the €67.0 million, €48.7 million was attributable to a milestone payment invoiced to Ipsen in June 2024 and €2.7 million was attributable to royalty revenue from U.S. sales of Iqirvo/elafibranor which commenced mid-June in application of the Ipsen Agreement signed in December 2021. €15.3 million in revenue was attributable to the partial recognition of deferred income of €40 million accounted for in accordance with IFRS 15, in application of the aforementioned licensing agreement. €0.1 million in revenue was generated from the services rendered under the Transition Services Agreement and Part B Transition Services Agreement, signed in April 2022 and September 2023 respectively by GENFIT and Ipsen, in order to facilitate the transition of certain services related to the Phase 3 ELATIVE clinical trial until the complete transfer of the responsibility of the trial to Ipsen. €0.2 million was attributable to other ancillary activities.

Of the €28.6 million revenues in 2023, €13.3 million was attributable to a milestone payment invoiced to Ipsen in December 2023 in accordance with the Ipsen Agreement signed in December 2021. This milestone payment was earned following the New Drug Application filing acceptance by the U.S. Food and Drug Administration and Marketing Authorization Application filing acceptance by the European Medicines Agency for accelerated approval of elafibranor. €8.7 million in revenue was attributable to the partial recognition of the €40.0 million deferred income as described above. €6.5 million in revenue was generated from the services rendered under the Transition Services Agreement and Part B Transition Services Agreement, signed in April 2022 and September 2023 respectively by GENFIT and Ipsen as described above. €0.1 million was attributable to other ancillary activities.

Upcoming Financial Communications

The Company will release its full-year 2024 financial results on April 24, 2025. The 2024 Universal Registration Document, the 2024 Annual Financial Report (included in the 2024 Universal Registration Document), and the Annual Report on Form 20-F will be published by the end of April 2025.

On February 27, 2025 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers, reported that its abstract has been accepted for poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Spring Scientific 2025 Cell Therapy Meeting being held March 12 – 14, 2025 in San Diego, CA and virtually (Press release, Xenetic Biosciences, FEB 27, 2025, View Source [SID1234650720]). 

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Details for the presentation are as follows:  

Abstract Number:  123
Title: DNase I Intervention Enhances CAR-T Cell Therapy in Solid Tumors by Targeting Neutrophil Extracellular Traps in Metastatic Melanoma
Presenter:  Alexey Stepanov, PhD, Institute Investigator at The Scripps Research Institute
Date & Time:  Wednesday, March 12, 2025 at 5:10 p.m. – 6:45p.m. PT

On February 27, 2025 Alphamab Oncology (Stock Code: 9966.HK) and CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (Stock Code: 1093.HK) reported that the first patient has been successfully dosed in the Phase III clinical study (Study ID: JSKN003-301) of anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003. The study aims to compare the efficacy and safety of JSKN003 versus trastuzumab emtansine (T-DM1) for the treatment of HER2-positive advanced breast cancer.

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Breast cancer is one of the most common malignant tumors among women worldwide and the most prevalent cancer in women in China. HER2-positive breast cancer is the most aggressive and highly malignant subtype. In recent years, the diagnosis and treatment of HER2-positive breast cancer has significantly improved. However, recurrent and metastatic breast cancer still has significant unmet clinical needs. JSKN003 is an anti-HER2 biparatopic ADC developed inhouse with Alphamab’s proprietary Glycan-specific conjugation platform. Compared with its ADC counterparts, JSKN003 demonstrated better serum stability and stronger bystander effect, which effectively expands the therapeutic window. The Phase III clinical studies of JSKN003 for HER2 low-expressing breast cancer (JSKN003-302) and platinum-resistant ovarian cancer (JSKN003-306) are currently progressing smoothly.

JSKN003-301 is a randomized, controlled, open-label, multicenter, Phase III clinical study aimed at evaluating the efficacy and safety of JSKN003 compared to emtansine (T-DM1) in the treatment of patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who have previously received trastuzumab or taxane-based therapies. The primary endpoint of the study is progression-free survival (PFS) as assessed by the Blinded Independent Review Committee (BIRC). The expedited progression of this study is anticipated to offer a treatment option with improved efficacy and safety for this patient population, further improving prognosis and quality of life.

About JSKN003

JSKN003 is an anti-HER2 biparatopic antibody-drug conjugate (ADC), which is developed inhouse with Alphamab’s proprietary Glycan-specific conjugation platform. JSKN003 can bind HER2 on the surface of tumor cells and release topoisomerase I inhibitors (TOPIi) through cellular endocytosis, thereby exert anti-tumor effects. Compared with its ADC counterparts, JSKN003 demonstrated better serum stability and stronger bystander effect, which effectively expands the therapeutic window.

Multiple clinical studies at various stages of JSKN003 are currently being conducted in China and Australia. Clinical research results have demonstrated favorable tolerability and safety profile, with promising efficacy of JSKN003 in heavily pretreated patients with advanced solid tumors, especially in patients with HER2-expressing breast cancer, platinum-resistant ovarian cancer (PROC), or high HER2-expressing solid tumors.

In September 2024, the Company entered a licensing agreement with JMT-Bio Technology Co., Ltd. ("JMT-Bio"), a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (stock code: 1093.HK), pursuant to which, JMT-Bio was granted the exclusive license and sublicense rights to develop, sell, offer for sale and commercialize JSKN003, for the treatment of tumor-related indications (the "Field") in mainland China (excluding Hong Kong, Macau or Taiwan) (the "Territory") and become the sole marketing authorization holder for JSKN003 for the Field in the Territory. Alphamab retains the sole right to supply JSKN003.

(Press release, Alphamab, FEB 27, 2025, View Source [SID1234657004])