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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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).

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including triple-negative breast cancer (TNBC) and metastatic colorectal cancer (mCRC), reported that CFO Robert E. Hoffman will present a corporate overview at the LD Micro Main Event XIX Investor Conference from October 19 – 21, 2025 at the Hotel Del Coronado in San Diego, California (Press release, CytoDyn, OCT 9, 2025, View Source [SID1234656533]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Presentation Date: Tuesday, October 21, 2025

Time: 9 a.m. PDT

Register to view presentation: Webcast Link

Mr. Hoffman will be available for one-on-one meetings with conference attendees. To request a meeting to discuss the Company’s current development strategy and upcoming milestones, please contact [email protected].

On October 9, 2025 Bio-Techne Corporation (NASDAQ: TECH), a global provider of life science tools, reagents, and diagnostic products, reported a significant enhancement to its agreement with Oxford Nanopore Technologies (LSE: ONT) (Press release, Bio-Techne, OCT 9, 2025, View Source [SID1234656530]). The expanded agreement broadens Bio-Techne’s ability to develop a portfolio of genetic products on Oxford Nanopore Technologies platforms and extends the collaboration through 2032.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Building upon the successful launch of the AmplideX Nanopore Carrier Plus Kit in March 2025, the enhanced collaboration streamlines coordination on the development and commercialization of a broader portfolio of targeted enrichment sequencing kits for the screening and diagnosis of heritable genetic disorders.

"This expanded agreement underscores our commitment to advancing genetic testing solutions that simplify workflows and deliver richer insights for laboratories worldwide," said Matt McManus, President of the Diagnostics and Spatial Biology Segment of Bio-Techne. "By deepening our collaboration with Oxford Nanopore, we are accelerating innovation in diagnostics and creating a foundation for future portfolios."

"We’re pleased to expand our collaboration with Bio-Techne to bring new genetic testing solutions to laboratories worldwide. By combining Bio-Techne’s diagnostics expertise and innovations with our advanced molecular sensing platform, together we can make testing faster, simpler, and more accessible," said Rosemary Dokos, Chief Product and Marketing Officer of Oxford Nanopore Technologies.

On October 9, 2025 Amplia Therapeutics Limited (ASX: ATX), referred to as "Amplia" or "the Company", reported an update from the ongoing ACCENT clinical trial, which is investigating the company’s leading FAK inhibitor, narmafotinib, in combination with the chemotherapies gemcitabine and Abraxane for the treatment of advanced pancreatic cancer. The trial is being conducted across sites in Australia and Korea (Press release, Amplia Therapeutics, OCT 9, 2025, View Source [SID1234656519]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

LATEST TRIAL DATA AND KEY FINDINGS

An additional confirmed partial response and an unconfirmed partial response have been recorded as part of the data analysis from the ACCENT Trial following the data cut off on 25 Sept 2025. These new findings bring the Objective Response Rate (ORR) to 33%, a notable improvement over the 23% response rate previously observed with chemotherapy alone1. The objective response rate measures only the partial and complete responses that have been confirmed by an additional scan after 2 months. When all confirmed and unconfirmed responses are taken together, the response rate is 42%.

The mean duration on trial—a key indicator of the drug combination’s ability to halt cancer progression— is 219 days, which is substantially longer than the duration typically achieved with chemotherapy alone. Notably, seven patients have remained on the study for at least 12 months, and two patients have continued for more than 18 months. These results are consistent with previously reported data2 showing a median Progression Free Survival (mPFS) of 7.6 months, representing a two-month improvement compared to chemotherapy alone. There are currently nine (9) patients on study.