On June 9, 2026 GT Medical Technologies, Inc., a medical device company dedicated to improving the lives of patients with brain tumors, reported the closing of an oversubscribed $100 millon Series E equity financing. The financing was led by new investor Viking Global Investors with participation from key existing investors, including MVM Partners, Gilde Healthcare, Evidity Health Capital, Medtech Venture Partners and FemHealth Ventures.

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"This financing is validation of GammaTile’s potential to be a standard of care treatment for operable brain tumors and will accelerate our ability to bring this important therapy to even more patients," said Per Langoe, Chief Executive Officer at GT Medical Technologies.

The funds will be used to accelerate investments across commercial and operational initiatives following the release of the final data from the Company’s ROADS randomized controlled trial (RCT) last month. The ROADS RCT studied the use of GammaTile, the Company’s FDA-cleared bioresorbable radiotherapy implant, in patients with newly diagnosed brain metastases. The ROADS RCT data was selected for oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) conference and demonstrated statistical superiority for GammaTile relative to standard of care; GammaTile reduced the risk of tumor recurrence and death at 12 months by 93% and 41%, respectively.1

Proceeds from the financing will also support continued expansion of GT Medical Technologies’ recently initiated BRIDGES RCT in patients with newly diagnosed glioblastomas (GBMs).

"We are excited to lead this financing and to work with GT to unlock the potential of GammaTile therapy," said Jason Rostovsky, a Principal at Viking Global Investors. "GT Medical Technologies’ technology has demonstrated profound clinical impact, and we look forward to supporting the GT Medical Technologies team in improving the treatment algorithm for patients with resectable brain tumors."

"An oversubscribed financing of this magnitude and the strength of our syndicate provides significant optionality for the Company, allowing us to accelerate the next phase of our growth and make meaningful clinical and operational investments for the future," added James Leech, Chief Financial & Strategy Officer at GT Medical Technologies.

GammaTile is an innovative form of radiation therapy placed at the time of brain tumor removal surgery, delivering immediate, targeted radiation to the tumor resection site when cancer cells are at their lowest residual levels. Unlike conventional approaches that require delays between surgery and the initiation of radiation therapy to allow for wound healing, GammaTile eliminates this treatment gap by starting treatment immediately. By delivering immediate, concentrated radiation directly at the tumor site, GammaTile maximizes the treatment’s effectiveness against remaining cancer cells and reduces the risk of regrowth.

ROADS RCT data presented at the 2026 ASCO (Free ASCO Whitepaper) conference demonstrated that the 12-month rate of tumor surgical bed recurrence was dramatically lower with GammaTile at 1.3% compared with standard of care at 15.4% (HR:0.07, p=0.012).1 Surgical bed recurrence-free survival, defined as the time from surgery to either tumor recurrence or death from any cause, whichever occurred first, was significantly improved with GammaTile, with the median time to an event not reached compared with standard of care at 10.9 months (HR: 0.48, P=0.002).1 Additionally, 24-month overall survival was 61.7% for GammaTile compared with 35.7% for standard of care (HR: 0.59, p=0.032).

(Press release, GT Medical Technologies, JUN 9, 2026, View Source [SID1234666512])

On June 9, 2026 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has granted rare pediatric disease (RPD) designation to opaganib for treatment of neuroblastoma (NB).

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"Receiving a cancer diagnosis is always distressing, but when it involves your child, it becomes profoundly devastating. There is an ongoing necessity to explore new alternatives that can augment treatment and enhance results for neuroblastoma, the most prevalent cancer in infants. In data from models of high-risk NB (HRNB), presented at AACR (Free AACR Whitepaper) 2026, we saw positive effects of opaganib as a potential add-on to chemotherapy, showing an ability to directly destabilize a key oncogenic driver of neuroblastoma and other solid tumors, n-Myc, through increased ceremide production enhancing programmed cancer cell death (apoptosis)," said Dr. Mark Levitt, Chief Scientific Officer at RedHill. "This rare pediatric disease designation, supported by data from NB and other preclinical oncology models, along with a clinically demonstrated safety and tolerability profile adds to our belief that opaganib holds promise for improving outcomes in treating pediatric NB. We aim to further advance development following ongoing discussions with Penn State University and the Beat Childhood Cancer consortium."

The FDA grant of rare pediatric disease designation to opaganib provides for a Priority Review Voucher (PRV), subject to certain conditions, and with opaganib’s current neuroblastoma orphan drug designation also allows for the potential for seven years’ marketing exclusivity, if approved, accelerated development and review times, FDA Prescription Drug User Fee Act (PDUFA) application fee waivers and tax credits. The neuroblastoma market is expected to be valued at approximately $3.5 billion in 2032.

Opaganib is a novel, potentially broad acting, oral, small molecule sphingosine kinase-2 (SPHK2) selective inhibitor drug with demonstrated safety & efficacy profiles. It is in development for multiple oncology, viral (including Ebola virus disease (EVD), inflammatory and diabetes and obesity-related indications.

About Neuroblastoma

Neuroblastoma is a type of cancer most commonly affecting babies and young children. While rare, neuroblastoma is the most common infancy cancer with ~5,500 global pediatric cases per year in children aged 0–14. It accounts for 10% of childhood cancers and 15% of pediatric cancer-related deaths in the U.S.5,6. Around 750 children in the United States are diagnosed with neuroblastoma each year7. Approximately half of all neuroblastoma patients have high risk (HRNB) disease which has an overall five-year survival of ~50%8.

Neuroblastoma originates from immature nerve cells (neuroblasts), and most often forms in the adrenal glands – small organs that sit on top of the kidneys – but can also start in nerve cells in the abdomen, chest, neck, or pelvis. The exact cause of neuroblastoma is not well understood, but genetic mutations and abnormalities are known to play a role. Some cases may be linked to genetic syndromes or family history, although most occur sporadically without a clear inherited pattern.

About Opaganib (ABC294640)

Opaganib is a proprietary first-in-class investigational, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor drug. Potentially broad-acting, it is in development for multiple oncology, viral (including Ebola virus disease), inflammatory, metabolic (diabetes and obesity) and additional indications.

Opaganib’s suggested mechanism of action, published in the journal Drug Design, Development and Therapy, is host-directed and potentially broad-acting and is expected to maintain its effect against emerging viral variants. Opaganib is thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis, and disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS).

Opaganib has received Orphan Drug designation from the FDA for the treatment of neuroblastoma and cholangiocarcinoma. A Bayer-supported 80-patient placebo-controlled randomized Phase 2 study is ongoing to evaluate the efficacy of opaganib in combination with Bayer’s darolutamide in men with metastatic castrate-resistant prostate cancer (mCRPC), testing the potentially enhancing effect of opaganib in patients with a poor prognosis9. Opaganib also has a Phase 1 chemoradiotherapy study protocol ready for FDA-IND submission.

Opaganib has demonstrated its safety and tolerability profile in more than 470 participants in multiple clinical studies and expanded access use, including a large global Phase 2/3 study in hospitalized patients with moderate to severe COVID-19, published in Microorganisms.

(Press release, RedHill Biopharma, JUN 9, 2026, View Source [SID1234666513])

On June 9, 2026 Cellectis (the "Company") (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene editing platform to develop life-saving cell and gene therapies, reported that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to lasmecabtagene timgedleucel (lasme-cel), its CD22-targeting allogeneic CAR-T cell therapy product candidate, for the treatment of patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).

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The granting of RMAT designation reflects the FDA’s recognition of the potential for lasme-cel to address the unmet medical need faced by patients with r/r B-ALL.

The RMAT designation is supported by Phase 1 BALLI-01 data demonstrating promising efficacy and a manageable safety profile. Final Phase 1 data from the BALLI-01 trial of lasme-cel will be presented in an oral session at the 2026 Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) this Saturday, June 13 at 5:15 – 6:30pm CET by Nitin Jain, M.D., Professor of Medicine, Department of Leukemia at MD Anderson Cancer Center in Houston (TX).

"As the company that pioneered allogeneic CAR-T, we see the RMAT designation for lasme-cel as a meaningful recognition of the need for off-the-shelf CAR-T options for patients with relapsed or refractory B-ALL, patients who cannot wait. This designation strengthens our dialogue with the FDA as we advance lasme-cel through its pivotal program" said André Choulika, Ph.D., Co-founder and Chief Executive Officer of Cellectis.

The BALLI-01 trial Pivotal Phase 2 is open for enrollment. Information on participant eligibility and participating clinical centers can be found on clinicaltrials.gov: BALLI-01 (NCT04150497).

(Press release, Cellectis, JUN 9, 2026, View Source [SID1234666514])

On June 9, 2026 Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, reported the participation in a Virtual Investor KOL Connect segment featuring Ira S. Winer, MD, PhD, FACOG, Scientific Advisory Board Member at Ernexa Therapeutics, Professor in the Division of Gynecologic Oncology at Wayne State University School of Medicine and gynecologic oncologist at the Barbara Ann Karmanos Cancer Institute.

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During the discussion, Dr. Winer provided perspective on the significant unmet need that continues to exist in ovarian cancer, limitations associated with current treatment approaches and the growing focus on overcoming immunologically "cold" tumors that remain resistant to many immune-based therapies.

The segment also explored the broader evolution of immune and cell therapies in solid tumors and discussed how scalable, off-the-shelf engineered cell therapy approaches may potentially play an increasing role in future oncology treatment paradigms by improving manufacturing scalability, expanding accessibility and offering new hope for patients with difficult-to-treat cancers.

Additionally, Dr. Winer discussed Ernexa’s ERNA-101 program, including the potential importance of activating immune responses within the tumor microenvironment and the differentiated aspects of the Company’s engineered IL-7/IL-15 fusokine-iMSC platform. The discussion highlighted the potential advantages of ERNA-101’s dual mechanism approach, including tumor microenvironment remodeling, immune activation, off-the-shelf manufacturing scalability and the potential to support broader affordability and patient access compared to more complex personalized cell therapy approaches.

The discussion also highlights the potential advantages of Ernexa’s engineered allogeneic induced mesenchymal stem cell (iMSC) platform, including the opportunity to develop scalable, off-the-shelf cell therapies designed to improve accessibility and overcome manufacturing challenges associated with traditional autologous approaches.

"Ovarian cancer remains one of the most challenging solid tumors to treat, particularly as patients progress through later lines of therapy and face increasingly limited treatment options," said Dr. Ira Winer. "There continues to be a significant need for innovative approaches capable of addressing the immunosuppressive tumor microenvironment that characterizes many ovarian cancers. Emerging engineered cell therapy strategies designed to activate immune responses and potentially convert immunologically ‘cold’ tumors into more responsive tumors may not only create new treatment possibilities, but also potentially improve scalability and accessibility for patients in need."

The Virtual Investor KOL Connect segment featuring Ernexa Therapeutics is now available here.

(Press release, Ernexa Therapeutics, JUN 9, 2026, View Source [SID1234666515])

On June 9, 2026 Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of oral small molecule degrader medicines for immunological diseases, reported that the first participant has been dosed in the first-in-human Phase 1 clinical trial evaluating KT-485 (SAR447971), an oral, potent and selective IRAK4 degrader, in adult healthy volunteers and hidradenitis suppurativa (HS) patients. The Phase 1 trial (NCT07629336) is being conducted by the Company’s partner Sanofi. Under the terms of the collaboration, dosing of the first participant triggered a $20 million milestone payment to Kymera from Sanofi.

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Per the collaboration, Sanofi is leading development, regulatory, and commercial efforts for the program. Kymera is eligible to receive up to $975 million of potential clinical, regulatory and commercial milestones related to KT-485.

"Advancing KT-485, our second generation IRAK4 degrader, into the clinic is an important milestone for our collaboration with Sanofi and our efforts to ultimately bring this important oral therapy to patients," said Nello Mainolfi, PhD, Founder, President and CEO, Kymera Therapeutics. "There remains a significant need for novel oral options that can address key inflammatory pathways implicated in several immuno-inflammatory conditions, and we are excited to collaborate with Sanofi on this work."

The Phase 1 trial will evaluate the safety, tolerability, pharmacokinetics and additional exploratory endpoints of orally administered KT-485. The three-part study includes double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) cohorts, as well as an open-label MAD cohort.

About KT-485/SAR447971
KT-485 is a second generation, oral degrader of IRAK4, that demonstrated increased potency and specificity with a favorable safety profile in preclinical testing. IRAK4 is a scaffolding kinase and key protein of the myddosome complex that mediates signaling through IL-1 and toll-like receptors. IRAK4 acts at the interface of the innate and adaptive immune responses with a variety of functions depending on its kinase activity and scaffolding function. Eliminating IRAK4 completely through degradation impacts both the kinase and scaffolding functions, therefore having the potential to achieve a broad, well-tolerated, anti-inflammatory effect providing a novel oral therapeutic approach for a variety of immuno-inflammatory diseases. KT-485 is being developed under Kymera’s collaboration with Sanofi for IRAK4 degraders outside of oncology and immuno-oncology. Kymera has the option to participate in future development and commercialization, and 50/50 profit split, in the United States and double-digit tiered royalties in ROW.

(Press release, Kymera Therapeutics, JUN 9, 2026, View Source [SID1234666516])