On April 14, 2026 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, reported additional updates on its financing strategy.

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The Company’s ATM financing vehicle allows the Company to sell its common stock directly into the trading market at market price. The amount raised through our ATM for Q1 2026 exceeded the Company’s Q1 2026 cash burn rate, leading to a Q1 2026 cash balance of approximately $10.5 million as of March 31, 2026. The above preliminary financial figures are unaudited and are subject to change following completion of the Company’s financial review for Q1 2026.

About FLAMINGO-01 Open Label Phase III Data

More than 1,000 patients have been screened with a current screen rate of approximately 800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.

In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 70-80% reduction in recurrence rate.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.

Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.

About GLSI-100 Phase IIb Study

In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:

80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
The PIS elicited a potent immune response as measured by local skin tests and immunological assays.

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated 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 are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to 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.

(Press release, Greenwich LifeSciences, APR 14, 2026, View Source [SID1234664357])

On April 17, 2026 Genmab A/S (Nasdaq: GMAB) reported that worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.), as reported by J&J were USD 3,964 million in the first quarter of 2026. Net trade sales were USD 2,208 million in the U.S. and USD 1,756 million in the rest of the world. Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC products, under the exclusive worldwide license to J&J to develop, manufacture and commercialize daratumumab.

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(Press release, Genmab, APR 14, 2026, View Source [SID1234664356])

On April 14, 2026 Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver disease and GI oncological therapeutics, reported a research collaboration agreement with Ramot at Tel Aviv University – Tel Aviv University’s technology transfer company – to evaluate Galmed’s brain-penetrating SCD1 inhibitor, Aramchol, as a targeted therapy for metastatic brain cancer. By combining the genomic expertise of the Ben-David Lab with the advanced 3D in vitro and in vivo modeling capabilities of the Satchi-Fainaro Lab (both TAU internationally renowned research labs), Galmed aims to validate Aramchol’s efficacy in treating p53-deficient brain metastases. The findings from the new research would also support Galmed’s clinical work underway at Virginia Commonwealth University’s Massey Comprehensive Cancer Center in colorectal cancers, where p53 mutations are highly prevalent.

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The published research by Prof. Ben-David and Prof. Satchi-Fainaro demonstrated that the loss of p53 induces profound metabolic adaptations of the tumor, facilitating metastatic colonization in the lipid-rich brain microenvironment. SCD1, an enzyme that converts saturated fatty acids into monounsaturated fatty acids, is essential for lipid synthesis and membrane production in proliferating cancer cells. Owing to SCD1 upregulation in p53-deficient tumors, its downregulation by Aramchol could potentially treat the metabolic-dependent brain tumor, as confirmed in preclinical models.

Allen Baharaff, Galmed’s Co-founder and CEO commented: "p53 is widely known as the ‘guardian of the genome’, playing a critical role in maintaining cellular integrity, with its mutations often leading to cancer and metastases. The findings that p53 inactivation drives metastasis to the brain through SCD1 upregulation and increased fatty acid metabolism open up a promising and innovative therapeutic option for Aramchol in metastatic cancers. Today’s announced collaboration with the esteemed researchers at TAU maps a potential development path for Aramchol as a novel and effective therapeutic solution for one of the most challenging clinical conditions."

Prof. Uri Ben-David commented: "A major hurdle in treating brain metastases is understanding how cancer cells adapt to survive in the brain’s unique environment. We recently established that p53 inactivation drives this adaptation through SCD1 upregulation and altered fatty acid metabolism. Collaborating with Galmed enables us to apply Aramchol against SCD1-expressing brain metastases, taking a critical step toward an innovative therapeutic solution for metastatic brain cancer."

Prof. Ronit Satchi-Fainaro commented:" I am very enthusiastic about this collaboration with Galmed Pharmaceuticals to evaluate Aramchol in our advanced preclinical systems. Following our recent findings published in Nature Genetics on the role of p53 and SCD1 in breast cancer brain metastasis, this partnership represents a valuable opportunity to translate mechanistic insights into therapeutic strategies. Our 3D tumor models and spontaneous brain metastasis models closely recapitulate tumor complexity and metastatic progression in the clinical setting, providing a robust, predictive platform to assess Aramchol’s efficacy and mechanism of action. I believe these models can significantly strengthen the preclinical validation of the drug and support its development in this challenging clinical setting".

The collaboration is managed by Ramot, Tel Aviv University’s technology transfer company. Ramot is dedicated to bringing the groundbreaking research of Prof. Uri Ben-David and Prof. Ronit Satchi-Fainaro to the clinic. Their work on the metabolic vulnerabilities of p53-deficient tumors represents a transformative approach to treating metastatic brain cancer, offering a new path for patients with high unmet needs.

(Press release, Galmed Pharmaceuticals, APR 14, 2026, View Source,-Aramchol,-as-a-Targeted-Therapy-for-Metastatic-Brain-Cancers [SID1234664355])

On April 14, 2026 Galera Therapeutics, Inc. ("Galera") (OTC: GRTX), a clinical-stage biopharmaceutical company focused on advancing a pan-NOS inhibitor through clinical development for patients with the hardest-to-treat forms of advanced breast cancer, and Obsidian Therapeutics, Inc. ("Obsidian"), a privately-held clinical-stage biopharmaceutical company harnessing novel protein-regulation technology to develop engineered tumor infiltrating lymphocyte, ("TIL"), cell therapies, reported that they have entered into a definitive merger agreement to combine in an all-stock transaction. The combination will be accomplished by both companies becoming wholly owned subsidiaries of a newly formed company. Upon completion of the transaction, the combined company plans to operate under the name Obsidian Therapeutics, Inc. and will apply to trade on Nasdaq under the ticker symbol "OBX."

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In support of the transaction, Galera and Obsidian have secured commitments for an oversubscribed private placement financing that is expected to result in total gross proceeds of $350 million from a syndicate of new investors, including Balyasny Asset Management, Caligan Partners LP, Eventide Asset Management, Nantahala Capital, Octagon Capital, Redmile, Spruce Street Capital and Trails Edge Capital Partners, and with participation from current Obsidian investors, including Atlas Venture, Deep Track Capital, Foresite Capital, Janus Henderson Investors, Logos Capital, Novo Holdings A/S, Paradigm BioCapital Advisors, Pivotal bioVenture Partners, RA Capital Management, RTW Investments, TCGX and Wellington Management, among other leading investment management firms.

The private placement financing is expected to close immediately prior to completion of the proposed merger transaction. The combined company’s cash and cash equivalents balance at closing, including the funds from the private placement financing, is anticipated to fund the combined company’s operations

into the second half of 2028 and provides runway through key clinical milestones for Obsidian’s lead product candidate, OBX-115. These include Phase 1 data from the ongoing NSCLC trial expected in the first half of 2027, and by year-end 2027, topline data from their melanoma registration-enabling trial. The combined company will also continue to support Galera’s pipeline.

"At Obsidian, we are striving to deliver a best-in-class TIL cell therapy developed using our proprietary protein-regulation technology," said Madan Jagasia, M.D., Chief Executive Officer of Obsidian. "We believe OBX-115 offers an opportunity to provide patients with an improved TIL product and patient experience. This transaction and the support from leading life sciences investors will allow us to advance our development plans for OBX-115 in melanoma and NSCLC."

Obsidian leverages their cytoDRIVE platform to develop engineered TIL cell therapies. OBX-115 is currently in a Phase 2 clinical trial for the treatment of advanced melanoma and a Phase 1 clinical trial for the treatment of NSCLC. OBX-115 is designed with regulatable membrane-bound IL15 (mbIL15), which drives TIL persistence, eliminates the need to dose toxic interleukin-2 (IL2), and enables outpatient administration of low-dose lymphodepletion. Furthermore, OBX-115 can be manufactured using tumor tissue procurement from an outpatient, minimally invasive core needle biopsy. OBX-115 has been granted Fast Track and Regenerative Medicine Advanced Therapy designations from the U.S. Food and Drug Administration for the treatment of patients with unresectable or metastatic melanoma that is resistant to immune checkpoint inhibitor therapy.

"We believe this transaction with Obsidian is the best path forward for Galera and look forward to the combined company’s success," said J. Mel Sorensen, M.D., Chief Executive Officer of Galera. "Obsidian’s pipeline of novel engineered TIL cell therapies and its promising lead product candidate, OBX-115, offer near-term, value creating milestones for Galera stockholders. In addition, Galera stockholders will retain a contingent value right for 95% of all future milestones for up to 10 years arising out of its October 2025 Asset Purchase Agreement with Biossil.ai for its dismutase mimetics."

About the Proposed Transaction

Under the terms of the merger agreement, as of the closing of the proposed transaction, the pre-closing Galera stockholders (other than those investors participating in the private placement financing) are expected to own approximately 1.8% of the combined company, the pre-closing Obsidian stockholders are expected to own approximately 53.2% of the combined company, and investors in the private placement financing are expected to own approximately 45.0% of the combined company. The percentage of the combined company that Galera’s stockholders will own as of the closing of the proposed transaction is subject to adjustment based on the estimated amount of Galera’s net cash immediately prior to the closing date.

The pre-closing Galera stockholders (other than those investors participating in the private placement financing) are expected to receive one contingent value right for each outstanding share of Galera common stock held by such stockholder, representing the right to receive contingent payments upon the occurrence of certain events (including receipt of milestone proceeds under the Biossil.ai agreement).

The transaction has received approval by the Board of Directors of both companies and is expected to close by the third quarter of 2026, subject to certain closing conditions, including, among others, approval by the stockholders of each company, the effectiveness of a registration statement to be filed with the U.S. Securities and Exchange Commission (the "SEC") to register the securities to be issued in connection with the proposed acquisitions of Obsidian and Galera and the satisfaction of other customary closing conditions.

The combined company plans to operate under the name Obsidian Therapeutics, Inc. and will be led by Madan Jagasia, M.D., Obsidian’s current Chief Executive Officer. Obsidian’s Board of Directors will become directors of the combined company, chaired by Maria Fardis, Ph.D., M.B.A., Chief Executive Officer of Lassen Therapeutics and AirNexis Therapeutics.

Leerink Partners is serving as exclusive financial advisor and Goodwin Procter LLP is serving as legal counsel to Obsidian. Leerink Partners, TD Cowen, Piper Sandler, William Blair and LifeSci Capital are acting as placement agents in connection with the concurrent private placement financing. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. is serving as legal counsel to the placement agents. Sidley Austin LLP is serving as legal counsel to Galera. Lucid Capital Markets is providing a fairness opinion to Galera’s Board of Directors.

(Press release, Galera Therapeutics, APR 14, 2026, View Source [SID1234664354])

On April 14, 2026 Renaissance Pharma Limited, an Essential Pharma company focused on development stage assets, reported that the US Food and Drug Administration (FDA) has granted Fast Track Designation for Daretabart (hu1418K322A), a novel anti-GD2 monoclonal antibody in development for the treatment of high-risk neuroblastoma (HRNB), a rare paediatric cancer. The designation recognises the significant unmet medical need in HRNB and will support more frequent interactions with the FDA throughout development, as well as eligibility for accelerated and rolling review.

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The company also confirms it has received IND clearance from the FDA, enabling initiation of the SHINE Phase II/III clinical trial in relapse or refractory children with HRNB in the United States. The first commercial-scale Good Manufacturing Practice (GMP) batch of Daretabart (hu1418K322A) has also been successfully manufactured for use in the SHINE trial.

Daretabart (hu1418K322A) is being developed by Renaissance Pharma under an exclusive license agreement with St. Jude Children’s Research Hospital, a global leader in pediatric cancer research and treatment. The antibody targets GD2, a cell surface antigen highly expressed on neuroblastoma cells. By binding to GD2, Daretabart (hu1418K322A) is designed to enhance immune-mediated tumour cell killing, while incorporating novel structural modifications intended to improve tolerability profile.

The programme builds on encouraging Phase II data evaluating Daretabart (hu1418K322A) as part of first-line therapy and in the post-consolidation setting for patients with HRNB. The study demonstrated a three-year event-free survival (EFS) rate of 73.7% and an overall survival (OS) rate of 86.0%. These results were published in the Journal of Clinical Oncology in December 2021.

The successful manufacture of the first commercial-scale GMP batch marks a key operational milestone and underscores Renaissance Pharma’s commitment to ensuring reliable, high-quality supply as the programme advances. This achievement supports ongoing clinical development and represents an important step towards future commercial readiness.

Simon Ball, Interim CEO of Essential Pharma and Director of Renaissance Pharma Limited said: "Daretabart has the potential to make a real difference for children with high-risk neuroblastoma, a disease where outcomes remain deeply inadequate despite intensive treatment. FDA Fast Track Designation is an important external validation of that potential, and together with IND clearance and our ability to manufacture at commercial scale, reflects the strength and maturity of this programme. Having worked exceptionally hard behind the scenes for a number of months, it is with great excitement that we announce this update today. We are executing at pace, and look forward to sharing data from the SHINE trial as it progresses. Today’s news brings us another step closer to delivering Daretabart as a meaningful new treatment option for children facing this aggressive cancer."

(Press release, Essential Pharma, APR 14, 2026, View Source [SID1234664353])

(Press release, Essential Pharma, APR 14, 2026, View Source [SID1234664353])