On July 9, 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 GLSI-100, an immunotherapy to prevent breast cancer recurrences, reported the following update on the use of commercially manufactured GP2 in FLAMINGO-01 in Europe.

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All European and US Sites to Treat Patients with Commercially Manufactured GP2

The Company previously announced that the first three commercial lots of GP2 active ingredient were manufactured in 2023 in an approved commercial facility, which could be used to prepare approximately 200,000 doses of GP2. In 2024, the first commercial lot filling GP2 into vials for commercial sale or for clinical use was manufactured in a commercial facility. In addition, drug stability programs were initiated for all four lots. Data on these commercial lots was submitted to the FDA, and after review, the first commercial lot of GP2 vials was approved for use in FLAMINGO-01 in the US in early 2026. All approximately 40-50 US sites have been supplied with commercially manufactured GP2 vials and have begun treating patients with these vials. We were able to efficiently distribute the GP2 vials and communicate with the US pharmacists working with our warehouse partners and through our clinical team, which we internalized in Q4 2025.

The European Medicines Agency (EMA) has completed their review and will also allow use of the same commercially manufactured GP2 lot in FLAMINGO-01 in Europe. Thus, all clinical sites in the US and Europe, which have increased from 160 sites to approximately 170-180 sites, are expected to be using the same lot with shipments to European pharmacies already under way. We are now seeking approval to use this lot in the UK and Canada in separate and independent regulatory processes.

About FLAMINGO-01 Open Label Phase III Data

More than 1,300 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.
The AACR (Free AACR Whitepaper) Meeting 2026 delayed-type-hypersensitivity (DTH) poster and the ASCO (Free ASCO Whitepaper) Meeting 2026 injection site reaction (ISR) poster can be seen and downloaded at the bottom of the Phase III clinical trial tab on the Company’s website here.
As shown in both posters the frequency of DTH and ISR reactions increased statistically significantly over time.
As reported in Table 1 of each poster, each HLA-A type exhibited more frequent immune reactivity after treatment with GLSI-100 than at baseline.
Baseline DTH reaction prior to any treatment suggests that GP2 may be a natural antigen and that GP2 specific T cells may exist in some patients prior to any treatment with GLSI-100. Baseline immune response to GP2 prior to any vaccination with GP2 was also observed in the Phase IIb trial and is being observed in the blinded randomized arms of FLAMINGO-01, where HLA-A*02 only patients are being vaccinated.

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 posters and results can be summarized as follows and can be seen here:

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 170-180 sites globally.

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, JUL 9, 2026, View Source [SID1234669122])

On July 9, 2026 Alchemab Therapeutics reported to have extended its series A financing with a £25 million (USD $34m) investment from the British Business Bank – the Bank’s largest investment in a life sciences company to date. The funding will enable the company to build its clinical pipeline and grow its proprietary unique antibody dataset to more than a billion sequences.

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Alchemab is discovering and developing first-in-class drugs from its unique Resiliome platform which uses complex AI derived algorithms to identify naturally occurring antibodies present in humans with unusual resistance to a range of hard-to-treat diseases.

This investment builds on the success of the company’s first asset, ATLX-1282 – a first-in-class antibody therapeutic in clinical development for amyotrophic lateral sclerosis (ALS) which was licensed to Eli Lilly and has provided robust validation of the potential of the Resiliome platform approach.

The additional funding brings Alchemab’s total Series A investment to date to £109 million and will enable the company to enhance its antibody database from 500 million to a billion antibody sequences and advance additional clinical candidates into development

Dr Jane Osbourn, CEO and Co-Founder of Alchemab, said "We are delighted that British Business Bank has recognised the importance of enabling Alchemab to grow and thrive here in the UK. This investment provides further validation of the sustainable, long-term potential of our drug discovery platform and will enable us to further accelerate our pipeline of first-in-class antibody therapeutics for conditions with significant unmet need."

Dame Kate Bingham, Managing Partner at SV Health Investors and Chair of Alchemab’s board of directors, said, "The UK life sciences sector has the expertise, creativity and commercial potential to build globally significant biotech companies, and Alchemab is determined to be one of them. This investment by the British Business Bank demonstrates the importance of providing capital to allow innovative biotechs to scale here, and we are proud to be building the company’s future in the UK."

Charlotte Lawrence, Managing Director of Direct Equity at British Business Bank said, "Alchemab sits at the cutting edge of UK scientific capability, integrating deep sequencing and lab-based validation to harness the body’s natural defences against disease. This landmark £25m investment demonstrates our commitment to providing the long-term capital necessary for the UK’s most innovative biotech firms to advance complex pipelines in the UK."

Dr Carmine Circelli, Senior Investment Director, Life Sciences at British Business Bank said, "Alchemab is yet another example of the UK’s strength in leveraging technology in life sciences. By combining one of the world’s largest proprietary antibody datasets with advanced AI, the company has developed a powerful platform with the potential to unlock new treatments. Our investment will help convert promising results into high value medical discoveries."

(Press release, Alchemab Therapeutics, JUL 9, 2026, View Source [SID1234669121])

On July 8, 2026 MAIA Biotechnology, Inc. (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, reported positive initial efficacy data from its Phase 2 THIO-101 clinical trial expansion, Part C, evaluating its lead candidate, ateganosine, a dual mechanism of action drug incorporating telomere targeting and immunogenicity, as a third-line (3L) therapy for patients with advanced non-small cell lung cancer (NSCLC).

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Initial data from the THIO-101 Part C 3L studies1 show a disease control rate (DCR) of 90.5% (19 out of 21 patients) in the efficacy evaluable population who had at least one tumor scan after starting treatment. Patients are treated with ateganosine followed by cemiplimab (Libtayo) in cycles of 21 days. Current chemotherapy treatments deliver an approximate 25-35% disease control rate.2

"The initial efficacy data from the Part C studies are consistent with the encouraging efficacy signals we previously reported for Parts A and B of THIO-101, including an 88% disease control rate in third-line NSCLC patients. This measure of efficacy is close to triple the reported outcome for standard-of-care chemotherapy treatment," said Vlad Vitoc, Founder and Chief Executive Officer of MAIA Biotechnology. "Importantly, patients enrolled in Part C of our trial represent a more heavily pre-treated population, with all patients having previously received docetaxel in addition to demonstrating resistance to both immunotherapy and other chemotherapies."

MAIA recently announced that it has completed international enrollment in Part C of the Phase 2 THIO-101 expansion trial. Treatment with ateganosine followed by cemiplimab has shown an acceptable safety profile to date in a heavily pre-treated population.

About Ateganosine
Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101 Phase 2 Clinical Trial
THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo) has shown an acceptable safety profile to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

(Press release, MAIA Biotechnology, JUL 8, 2026, View Source [SID1234669115])

On July 8, 2026 Allotera Therapeutics, Inc. (formerly Wugen, Inc.), a clinical-stage biotechnology company developing allogeneic, off-the-shelf cell therapies for hematological malignancies, reported the successful closing of a $35 million financing round comprising equity and venture debt. The company also introduced its new name, Allotera Therapeutics, reflecting its sharpened focus on advancing off-the-shelf CAR-T cell therapies for patients with T-cell cancers.

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The financing brings Allotera’s total capital raised to $150 million, building on the company’s $115 million Series C announced in late 2025. Proceeds will primarily support the ongoing global pivotal T-RRex clinical trial of Soficabtagene Geleucel, also known as Sofi-cel, in relapsed or refractory T-ALL/T-LBL, as well as advance platform capabilities, operational scale-up, and continued team growth.

"Allotera reflects who we are becoming as a company: a pivotal-stage cell therapy company focused on bringing off-the-shelf CAR-T therapies to patients with T-cell cancers," said Kumar Srinivasan, Ph.D., M.B.A., Chief Executive Officer of Allotera Therapeutics. "With Sofi-cel advancing in T-RRex, a global pivotal study, this financing strengthens our ability to execute across clinical development, manufacturing, and patient-community engagement as we work to address diseases where treatment options remain limited."

T-cell cancers are among the most difficult settings for CAR-T therapy development because many therapeutic targets are also present on the T cells used to manufacture the therapy. Allotera is developing Sofi-cel as an allogeneic, healthy donor-derived CAR-T cell therapy intended to address these challenges and provide an off-the-shelf treatment approach for patients with aggressive T-cell malignancies.

The Series C was led by Fidelity Management & Research Company, with participation from all existing investors. The current extension includes additional participation from Lightchain Capital and BioGenerator, as well as new investors, including Blood Cancer United’s Therapy Acceleration Program (TAP) and others. The venture debt was provided by Banc of California.

In connection with the financing, Allotera has also entered into a strategic partnership with Blood Cancer United, through which TAP will provide ongoing access to its scientific and drug development expertise, facilitate engagement with key opinion leaders, and connect Allotera to critical resources, including clinical trial support, patient education, and community engagement capabilities.

"Our partnership with Blood Cancer United reflects an important part of Allotera’s next chapter," said Srinivasan. "As we advance Sofi-cel through pivotal development, we are committed not only to building the clinical and manufacturing capabilities needed to bring off-the-shelf cell therapies forward, but also to engaging with the communities most affected by these diseases."

About Soficabtagene Geleucel (Sofi-cel)

Sofi-cel is an allogeneic, off-the-shelf, CD7-targeted CAR-T cell therapy being developed for T-cell cancers. Allotera uses CRISPR/Cas9 gene editing to delete CD7 and the T-cell receptor alpha constant (TRAC) genes, an approach intended to prevent CAR-T cell fratricide and mitigate the risk of graft-versus-host disease.

Sofi-cel is manufactured in the United States using healthy donor-derived T cells, which is intended to avoid malignant cell contamination that can occur in the autologous CAR-T setting. Sofi-cel is currently being evaluated in a global pivotal clinical trial for relapsed or refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma. More information on the pivotal trial is available at ClinicalTrials.gov, identifier NCT06514794.

Sofi-cel has received Breakthrough Therapy, Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. Food and Drug Administration for the treatment of relapsed or refractory T-ALL/T-LBL, as well as Priority Medicines, or PRIME, designation in the European Union. RMAT and PRIME designations provide increased agency support to expedite the development and review of promising therapies for patients with medical need. Sofi-cel was also selected to participate in the FDA’s Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program.

(Press release, Allotera Therapeutics, JUL 8, 2026, View Source [SID1234669114])

On July 8, 2026 GE HealthCare and Mayo Clinic reported the MI-BET (Molecular Imaging Biomarker-Based End of Therapy Trial) research collaboration, a novel theranostics study designed to explore a more personalized approach to radioligand therapy (RLT) for patients with advanced prostate cancer. This collaboration is a direct result of the 2023 Strategic Radiology Research Alliance between Mayo Clinic and GE HealthCare, aimed at transforming the experience of patients and clinicians in the practice of radiology and the delivery of novel therapies.

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Radioligand therapy is an emerging treatment approach within theranostics that combines targeted radiopharmaceutical diagnostics and therapies, allowing clinicians to identify and treat cancer with greater precision. Today, many patients receiving RLT follow a standardized preset number of treatment cycles. MI-BET is designed to evaluate whether imaging- and biomarker-informed insights can support a more personalized approach to each patient’s care. In this case, treatment may be adapted via a pause in RLT treatment. The decision to apply this pause is directly determined from the individual patient’s disease response over time.

"This collaboration is an example of how Mayo Clinic leads in discovery by integrating novel technologies into our practice and accelerating innovation across research and clinical care to advance the future of medicine," says Andrew Danielsen, chief business development officer at Mayo Clinic. "By bringing together complementary expertise and capabilities, we can enable our world-class researchers and physicians to develop new insights, expand treatment possibilities, and ultimately provide the best outcomes for our patients globally."

The MI-BET study will use GE HealthCare’s StarGuide SPECT/CT technology alongside MIM Software’s MIM LesionID Pro to track how tumors are responding to treatment throughout therapy. By integrating imaging data with clinical outcomes and blood-based biomarkers, the Mayo Clinic research team is exploring these combined insights, which may help inform treatment decisions and potentially support the development of predictive markers for patient response. Predictive marker insights could enable researchers and clinicians to anticipate how patients will respond before or early in treatment, further enabling physicians to make adaptive treatment decisions.

"Personalizing therapy is both a scientific pursuit and an opportunity to expand patient access," says Geoffrey Johnson, M.D., Ph.D., chair of the Radiopharmaceutical Trial Team at Mayo Clinic Comprehensive Cancer Center. "Theranostics, and studies such as MI-BET, give us an important opportunity to rethink how and when we treat cancer. By evaluating response earlier in their treatment, we can generate data to drive approaches that could help reduce unnecessary therapy while expanding access to care for wider populations."

This effort supports a broader goal of expanding access to advanced theranostic care so that scientific advances can benefit a wide range of patients. The study is designed to encourage broad participation through patient outreach, collaboration with community and advocacy organizations, and the use of approaches such as telemedicine that may help reduce barriers to enrollment and engagement.

Beyond evaluating treatment duration, MI-BET also seeks to contribute to the broader evolution of theranostics by exploring new imaging biomarkers and data-driven approaches designed to support clinical decision-making. These efforts reflect a growing shift in oncology toward more adaptive, patient-specific care models.

"Making theranostics truly adaptive and personalized requires strong clinical evidence and a deeper understanding of how patients respond to therapy," says Sergio Calvo, global general manager, Theranostics, at GE HealthCare. "Through our collaboration with Mayo Clinic, we are exploring how imaging and data-driven insights can help inform more individualized treatment decisions, support the broader adoption of these approaches and contribute to the continued growth of precision care in oncology."

MI-BET research and activities will be based at Mayo Clinic’s campus in Rochester, Minnesota, leveraging both organizations’ strengths in clinical practice, research and product development. Additionally, Mayo Clinic is the first U.S. site to investigate the benefits that could be achieved with GE HealthCare’s next-generation SPECT/CT StarGuide GX* technology. This includes exploring the potential for reduction in scan time and increasing the precision in tumor assessments.

(Press release, GE Healthcare, JUL 8, 2026, View Source [SID1234669113])