On October 10, 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 the pricing of an underwritten offering of 735,000 shares of common stock at a price to the public of $6.12 per share, for gross proceeds of approximately $4.5 million, before deducting underwriting discounts and commissions and other estimated offering expenses (Press release, Xenetic Biosciences, OCT 10, 2025, View Source [SID1234656556]). All shares of common stock are being offered by Xenetic. The offering is expected to close on or about October 14, 2025, subject to the satisfaction of customary closing conditions.

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Canaccord Genuity is acting as the sole bookrunner for the offering.

Xenetic intends to use the net proceeds from the offering for working capital and other general corporate purposes.

The offering is being made pursuant to a shelf registration statement on Form S-3 (File No. 333-282756) that was declared effective by the Securities and Exchange Commission ("SEC") on November 1, 2024. A preliminary prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and a final prospectus supplement with the final terms of the offering will be filed with the SEC and will be available for free on the SEC’s website, located at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from Canaccord Genuity LLC, Attention: Syndication Department, One Post Office Square, Suite 3000, Boston, Massachusetts 02109, or by telephone at (617) 371-3900, or by email at [email protected].

This press release does not constitute an offer to sell or the 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 registration or qualification under the securities laws of that state or jurisdiction.

On October 10, 2025 Bristol Myers Squibb (NYSE: BMY, "BMS") and Orbital Therapeutics ("Orbital") reported a definitive agreement under which BMS will acquire Orbital, a privately held biotechnology company pioneering a new generation of RNA medicines that reprogram the immune system in vivo, enabling treatments that provide the precision, control, and flexibility needed to address the underlying biology and unique complexities of each disease (Press release, Bristol-Myers Squibb, OCT 10, 2025, View Source [SID1234656554]).

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"In vivo CAR T represents a novel treatment approach that could redefine how we treat autoimmune diseases," said Robert Plenge, MD, PhD, executive vice president, Chief Research Officer, BMS. "This acquisition enhances our robust cell therapy research platform and provides an opportunity to advance a potential best-in-class therapy designed to deplete autoreactive B cells and reset the immune system. We are excited by the promise this holds for patients with autoimmune diseases who are waiting for better options."

The acquisition includes Orbital’s lead RNA immunotherapy preclinical candidate currently in IND-enabling studies, OTX-201, which comprises an optimized circular RNA encoding a CD19-targeted CAR for in vivo expression delivered via targeted lipid nanoparticles (LNPs). This in vivo approach, in which the patient’s own body serves as the manufacturer of CAR T-cells, has the potential to offer a reduced treatment burden and improved accessibility compared to ex vivo CAR T-cell therapies. Additionally, BMS will acquire Orbital’s proprietary RNA platform, which integrates circular and linear RNA engineering, advanced LNP delivery, and AI-driven design to enable durable, programmable RNA therapies tailored to the distinct biology of a broad spectrum of diseases.

"With the acquisition of Orbital Therapeutics and its next-generation RNA platform, we have an incredible opportunity to make CAR T-cell therapy more efficient and accessible to more patients," said Lynelle B. Hoch, president, Cell Therapy Organization, BMS. "As a leader in cell therapy, we are uniquely positioned to evaluate multiple different platform approaches to induce immune reset in autoimmune diseases and continue to optimize in vivo technology in clinical development."

"This agreement with Bristol Myers Squibb, a recognized leader in global medicine, marks a transformational moment for Orbital and the advancement of RNA medicine," said Ron Philip, Chief Executive Officer, Orbital Therapeutics. "Since inception, Orbital has made significant strides developing a differentiated RNA platform designed to enable a new generation of RNA medicines that reach more tissues, address more diseases, and benefit more patients. The promising early data from our lead program, OTX-201, underscore the strength of this approach and the potential of our integrated RNA technologies. Together, we aim to deliver RNA medicines that provide patients with treatments that are simpler, safer, and more accessible compared to today’s complex therapies."

Under the terms of the agreement, BMS will pay $1.5 billion in cash at closing to acquire Orbital, which is subject to the satisfaction of customary closing conditions, including expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and until then, BMS and Orbital will continue to operate as separate and independent companies. The accounting treatment as a business combination or asset acquisition will be determined upon the expected close of the transaction.

Advisors
Covington & Burling LLP is serving as legal counsel to Bristol Myers Squibb. Centerview Partners LLC is serving as exclusive financial advisor to Orbital Therapeutics, and Goodwin Proctor LLP is serving as legal counsel.

On October 10, 2025 Oncolytics biotech presented its corporate presentation (Presentation, Oncolytics Biotech, OCT 10, 2025, View Source [SID1234656555]).

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On October 9, 2025 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, reported the expansion of FLAMINGO-01 clinical trial to Austria (Press release, Greenwich LifeSciences, OCT 9, 2025, View Source [SID1234656534]).

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The Company’s application to European regulators has been formally approved, adding Austria as an approved country in FLAMINGO-01 in addition to Spain, France, Germany, Italy, Poland, Romania, Ireland, Portugal, Belgium, and the US.

According to the latest data collected by the European Cancer Information System (click here), a total of 6,070 new cases of breast cancer were diagnosed in Austria in 2022, which is the most common cancer diagnosed in women, representing approximately 28% of all cancers in women. Breast cancer is the leading cause of death from cancer in women in Austria with 1,789 deaths in 2022.

CEO Snehal Patel commented, "We are collaborating with principal investigators at the Ordensklinikum Linz in Upper Austria. The site approached the Company after patients asked about participating in FLAMINGO-01. We recently visited the site in Linz, where we started training activities. We hope to activate the site this year and plan to further develop the geographic strategy for Austria, where we are considering additional sites in Vienna and Salzburg."

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On October 9, 2025 Leap Therapeutics (Nasdaq: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported that it has closed its previously announced private placement led by Winklevoss Capital raising $58,888,888 in cash to initiate a digital asset treasury strategy. At the closing of the transaction, Leap issued (i) 15,212,311 shares of common stock (the "Shares"), (ii) pre-funded warrants (the "Pre-Funded Warrants") to purchase up to an aggregate of 80,768,504 shares of common stock, and (ii) warrants to purchase an additional 71,985,605 shares of common stock at an exercise price of $0.5335 per share (the "Warrants" and together with the Shares and the Pre-Funded Warrants, the "Units") (Press release, Leap Therapeutics, OCT 9, 2025, View Source [SID1234656536]).

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Winklevoss Capital will provide both capital and strategic support to help Leap structure and execute its digital asset treasury strategy. Leveraging the expertise of Winklevoss Capital, Leap aims to build long-term shareholder value through participation in digital assets. A portion of the capital will be used to continue development of Leap’s therapeutic programs, including FL-501 and sirexatamab, which has recently completed a randomized controlled Phase 2 trial in patients with colorectal cancer that is being presented in a Mini Oral Session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 on October 19 in Berlin, Germany.

Pursuant to a lead investor agreement, Leap has increased the size of its Board of Directors to 12 members, and Winklevoss Capital will have the right to nominate two individuals to Leap’s Board of Directors, one of whom shall also be the chairperson of the Board.

Leap expects to release additional updates regarding its treasury activities in the near-term.

Parcrest acted as the placement agent in connection with the financing.

Morgan, Lewis & Bockius LLP acted as legal advisor to Leap, and Cooley LLP acted as legal advisor to Winklevoss Capital.

The offer and sale of the foregoing securities is being made in a private placement in reliance on an exemption from the registration requirement of the Securities Act of 1933, as amended (the "Securities Act"), pursuant to Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder, and applicable state securities laws. Accordingly, the securities offered in the private placement may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirement of the Securities Act and such applicable state securities laws. Concurrently with the execution of the securities purchase agreements, the Company and the investors entered into a registration rights agreement pursuant to which the Company has agreed to file a registration statement with the Securities and Exchange Commission (the "SEC") registering the resale by the purchasers participating in the offering of the Shares and the shares of common stock underlying the Pre-Funded Warrants and the Warrants. Any offering of the Company’s common stock under the resale registration statement will only be made by means of a prospectus.

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 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.

The private placement was conducted in accordance with applicable Nasdaq rules and was priced to satisfy the "Minimum Price" requirement (as defined in the Nasdaq rules).