On July 15, 2026 AdvanCell, a clinical-stage radiopharmaceutical company developing innovative targeted alpha therapies for cancer, reported the closing of an oversubscribed and upsized US $315 million Series D financing.

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The financing was led by Ally Bridge Group and co-led by Alpha Wave, alongside new investors Bain Capital Life Sciences, Fidelity Management & Research Company, funds and accounts advised by T. Rowe Price Associates, Inc., a leading sovereign wealth fund, Eventide Asset Management, and Velosity Capital. Existing investors Morningside, Eli Lilly and Company, SV Health Investors, Sanofi Ventures, Abingworth, SymBiosis, Tenmile, Brandon Capital, Piper Heartland, Catalio Capital Management, Proto Axiom, Time BioVentures and other shareholders also participated in the round.

Targeted alpha therapy is entering a new era in oncology, but until now, broader adoption has been limited by isotope supply and manufacturing challenges. AdvanCell has built a vertically integrated platform centered on proprietary Lead-212 technology that combines secure isotope supply, automated manufacturing and scalable production to accelerate the development and commercial delivery of next-generation targeted alpha therapies.

The financing will advance ADVC001 toward Phase 3 clinical development in metastatic prostate cancer, expand AdvanCell’s proprietary Lead-212 platform, strengthening isotope supply and expanding U.S. manufacturing infrastructure to support Phase 3 development and future commercial demand, and accelerate AdvanCell’s growing pipeline of targeted alpha therapies.

"This financing marks a transformational milestone for AdvanCell and reflects the conviction of an exceptional investor syndicate in the potential of ADVC001 and the innovation behind our vertically integrated Lead-212 platform," said Philina Lee, Ph.D., Chief Executive Officer, AdvanCell. "Building on our recent leadership appointments and U.S. expansion, this financing puts us in a strong position to enter our next stage of growth and execution, advancing our lead therapy ADVC001 toward registrational development, expanding isotope supply and manufacturing infrastructure to support Phase 3 and future commercial demand, and progressing our Lead-212 pipeline into the clinic. Together, these priorities establish a clear path towards a diversified clinical pipeline with the goal of bringing the promise of targeted alpha therapy to more patients with cancer."

"The companies poised to lead the next generation of targeted alpha therapies will be those that combine differentiated clinical assets with end-to-end control over supply and manufacturing," said Andrew Lam, PharmD, Managing Director, Head of Biotech Private Equity at Ally Bridge Group. "AdvanCell has assembled that foundation through its de-risked lead program, vertically integrated platform and experienced leadership team, uniquely positioning the company to execute at scale and emerge as a potential category leader."

"The most enduring healthcare companies combine breakthrough science with the infrastructure and expertise to repeatedly develop new medicines," said Nik Economopoulos, Director, Life Sciences Investments, Alpha Wave. "We believe AdvanCell is building that kind of generational company, with the platform, manufacturing capabilities and pipeline to unlock the full potential of targeted alpha therapies."

Concurrent with the financing round, Andrew Lam of Ally Bridge Group and Nik Economopoulos of Alpha Wave will join AdvanCell’s Board of Directors.

AdvanCell’s lead program, ADVC001, is an investigational Lead-212 PSMA-targeted alpha therapy for metastatic prostate cancer currently in Phase 2 clinical development (NCT05720130). Designed to selectively deliver potent alpha radiation to tumor cells while minimizing radiation exposure to healthy tissue, ADVC001 has the potential to address key limitations of PSMA radioligand therapy, including treatment resistance, tolerability challenges and the need for dose optimization. ADVC001 has demonstrated encouraging Phase 1b anti-tumor activity and favorable tolerability in patients with prostate cancer. These results support the continued advancement of ADVC001 while validating AdvanCell’s Lead-212 platform and its broader pipeline of next-generation targeted alpha therapies across additional cancer indications.

(Press release, Advancell, JUL 15, 2026, View Source [SID1234669239])

On July 15, 2026 Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, reported that new patients have been administered INT230-6 in the INVINCIBLE-4 Study in Switzerland. The trial (NCT06358573) analyzes INT230-6 given before administration of the standard-of-care neoadjuvant immuno-chemotherapy ("SOC") and the SOC alone by using a 2-cohort design. The study evaluates the pathological complete response ("pCR") rates of the two cohorts relative to a null hypothesis, which is a pCR rate of ≤ 0.6. The success of each cohort in rejecting the null hypotheses will be evaluated.

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The INVINCIBLE-4 Study is a randomized open-label, multicenter study to determine the clinical activity, safety, and tolerability of INT230-6 in patients with early-stage, operable triple-negative breast cancer ("TNBC") who undergo SOC treatment and SOC alone. The primary endpoint is pCR in the primary tumor and affected lymph nodes. In the amended protocol, patients will be randomized to receive a regimen of one dose of INT230-6 followed by SOC, which consists of pembrolizumab, anthracyclines, carboplatin, cyclophosphamide, and paclitaxel, or to SOC alone. The INVINCIBLE-4 Study reopens following a pause in patient accrual to evaluate skin irritation issues seen in some patients. In March 2026, a protocol amendment was submitted to Swissmedic and the Swiss Ethics Committee to resume enrollment using a slightly lower drug-to-tumor volume ratio and a single injection of INT230-6. Prior to the pause, fourteen (14) patients were treated, seven (7) with the combination and (7) received the SOC alone. Patients receiving INT230-6 prior to the SOC reported a favorable trend towards much fewer overall grade 3 or higher adverse events and immune-related adverse events compared to those patients receiving the SOC alone. The INVINCIBLE-4 Study is expected to enroll an additional 47 patients in Switzerland and France.

"Many TNBC patients undergoing SOC treatment alone fail to achieve a pathological complete response at the time of surgery, especially in larger tumor sizes. Early data indicates that INT230-6 has the potential to fill this unmet need for aggressive subtypes, such as TNBC, through its anti-cancer mechanisms of action that cause tumor cell necrosis and ignite an anti-cancer immune-based response," said Markus Joerger, MD-PhD from the Department of Medical Oncology and Hematology at Health Ostschweiz, Professor of Medicine at the University of Basel, Co-Chair of the SCI’s Project Group for Developmental Therapeutics and coordinating investigator of the trial. "The ability for INT230-6 to induce necrosis and activate immune effects before a patient’s surgery with reduction in toxicity would be a major advance for the treatment of breast cancer and potentially many other cancers."

"We are excited to have restarted our Phase 2 study in presurgical triple-negative breast cancer. Triple-negative is a deadly and aggressive form of breast cancer, and patients having local disease currently undergo a harsh six-month regimen whereby a small percentage can die from the SOC before their surgery," said Intensity Therapeutics’ Founder, Chairman, and CEO, Lewis H. Bender. "We believe that the new dosing regimen can continue to show favorable overall safety, a meaningful improvement in the percentage of patients who achieve pCR, and ultimately an improved event-free survival."

About INT230-6

INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that non-covalently conjugates to the two payload drugs, facilitating the dispersion of potent cytotoxic drugs throughout tumors and allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.

About Triple Negative Breast Cancer in the Presurgical Setting

Approximately 11-17% of breast cancers test negative for estrogen receptors (ER), progesterone receptors (PR), and excess human epidermal growth factor receptor 2 (HER2) protein, qualifying them as triple negative. TNBC is considered to be more aggressive and has a poorer prognosis than other types of breast cancer, mainly because there are fewer available targeted medicines. Most patients with local TNBC typically receive immune/chemotherapy before surgery. Since the publication of Keynote-522, standard neoadjuvant treatment for TNBC includes systemic chemotherapy (anthracyclines, cyclophosphamide, paclitaxel, carboplatin) and the anti-PD-1 monoclonal antibody pembrolizumab. pCR rates are only 63%, with rates generally lower in the larger-sized T2 to T4 tumors. The toxicity of the Keynote-522 regimen is high, with 80% of patients experiencing grade 3 or higher treatment-related AEs, including treatment-related adverse events that lead to death in 0.5% of patients.

(Press release, Intensity Therapeutics, JUL 15, 2026, View Source [SID1234669238])

On July 15, 2026 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for patent application no. 18/784,354 entitled "Treatment of Low-Grade Intermediate-Risk Non-Muscle-Invasive Bladder Cancer With a Thermally Gelling Pharmaceutical Composition Containing Mitomycin." The allowed claims cover methods of treating patients with recurrent, low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) without a transurethral resection of a bladder tumor (TURBT), supported by data from the ENVISION and ATLAS clinical trials. The U.S. patent, once issued, will have an expiration date in July 2044.

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"This patent allowance further strengthens the intellectual property foundation supporting ZUSDURI and our UGN-103 investigational medicine, if approved, and underscores the innovation behind our proprietary RTGel technology," said Liz Barrett, President and Chief Executive Officer of UroGen. "Supported by data from the ENVISION and ATLAS trials of ZUSDURI, these patent claims reflect the ability of our RTGel-based technology to deliver mitomycin as a primary, non-surgical treatment option for adults with recurrent LG-IR-NMIBC without a TURBT. We believe this approach helps patients achieve highly durable recurrence-free intervals while reducing the burden of repeat surgical interventions."

Building on the growing body of clinical evidence supporting ZUSDURI and UGN-103, UroGen remains focused on advancing its proprietary RTGel technology and developing innovative therapies that have the potential to expand non-surgical treatment options for patients with urothelial cancers and strengthen the company’s long-term growth opportunities.

About ZUSDURI
ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology (a sustained release, hydrogel-based formulation), ZUSDURI is delivered directly into the bladder by a trained healthcare professional using a urinary catheter in an outpatient setting, thereby enabling the treatment of tumors by non-surgical means.

About UGN-103
In January 2024, UroGen entered into a licensing and supply agreement with medac to develop UGN-103 for recurrent LG-IR-NMIBC. UGN-103 is designed to reinforce and extend the clinical and commercial profile of ZUSDURI, the first and only FDA-approved treatment for adults with recurrent LG-IR-NMIBC. The program maintains UroGen’s innovative and proven RTGel technology, enabling sustained mitomycin exposure in the bladder, while incorporating next-generation enhancements, including a more streamlined manufacturing process and simplified reconstitution to support improved ease of use in clinical practice. UroGen holds U.S. patents covering the combination of its proprietary RTGel technology with medac’s licensed lyophilized mitomycin formulation, as well as the use of UGN-103 in LG-IR-NMIBC, with intellectual property protection expected to extend into December 2041.

(Press release, UroGen Pharma, JUL 15, 2026, View Source [SID1234669237])

On July 15, 2026 Tempest Therapeutics, Inc. (Nasdaq: TPST) ("Tempest"), a clinical-stage biotechnology company developing a pipeline of advanced chimeric antigen receptor T-cell ("CAR-T") product candidates, reported details of its next-generation in vivo CAR-T platform. The company plans to advance TPST-4003, its lead in vivo CAR-T product candidate, into a first investigator-initiated clinical trial in patients with nervous system autoimmune diseases, initially focusing on myasthenia gravis ("MG") and multiple sclerosis ("MS"). The study is expected to enroll approximately 10 patients, with first patient dosing anticipated in the fourth quarter of 2026.

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TPST-4003 combines Tempest’s next-generation CD7-targeted mRNA lipid nanoparticle ("CD7-tLNP") delivery platform with the same dual-targeting CD19 B-cell maturation antigen ("CD19/BCMA") chimeric antigen receptor ("CAR") architecture used in TPST-2003, the company’s clinical-stage CAR-T program. Interim Phase 1/2a clinical data generated with TPST-2003 demonstrating the achievement of a 100% complete response rate, together with its successful U.S. manufacturing, provide important support of the underlying CAR construct, establishing a foundation for TPST-4003.

"We are excited to announce the strategic prioritization of our next-generation in vivo CAR-T pipeline and our plan to advance TPST-4003 toward an anticipated first patient dosing later this year," said Matt Angel, Ph.D., President and Chief Executive Officer of Tempest. "We believe our differentiated in vivo CAR-T platform may enable broader addressable T-cell coverage and support scalable repeat dosing once developed and commercialized, supporting future commercial attractiveness of in vivo CAR-T therapy. The lead product candidate in our pipeline, TPST-4003, is being designed to enable broad B-cell lineage depletion and reset with its dual CD19/BCMA targeting architecture, with the goal of potentially delivering improved efficacy and durability compared with single-target CAR approaches. We look forward to advancing TPST-4003 into clinical development later this year."

Planned Investigator-Initiated Trial of TPST-4003

The first planned investigator-initiated trial is expected to evaluate TPST-4003 in approximately 10 patients with nervous system autoimmune diseases, initially focusing on MG and MS. Initial study planning has involved discussions with six prospective clinical centers and principal investigators experienced in neurological autoimmune diseases. The company expects first patient enrollment and dosing to occur in the fourth quarter of 2026.

The study is expected to assess safety, cellular kinetics and pharmacodynamic activity following initial dosing. Key assessments are expected to include treatment-emergent adverse events and serious adverse events; the generation and expansion of peripheral blood CD4+ and CD8+ CAR-T cells and CD56+ CAR-NK cells; CAR transgene copy number; and the depth and kinetics of CD19+ B-cell depletion and B-cell subset reconstitution. Where clinically appropriate, exploratory assessments may also include the detection of CAR-positive immune cells in cerebrospinal fluid and the evaluation of B-cell depletion in lymphoid tissue.

Disease-specific clinical activity will be evaluated using established measures. Initial safety and pharmacodynamic data from the first patients are expected in the first half of 2027, followed by an interim clinical update including preliminary safety, pharmacodynamic and efficacy data in the second half of 2027.

Additional preclinical programs leverage advanced payloads and create a modular in vivo CAR-T portfolio. These include TPST-001 for non-B-cell hematologic malignancies and TPST-002 for solid tumors.

Tempest’s in vivo CAR-T platform, CD7-tLNP, is being designed to expand the potential of next-generation in vivo CAR-T therapy through three core differentiators:

Broader T-Cell Reach: The platform is being engineered to efficiently target both CD4+ and CD8+ T-cell populations, targeting broad CAR expression across the key cellular drivers of durable immunity. This comprehensive T-cell engagement is intended to support a more balanced and effective therapeutic response.
Better Delivery Logic: A differentiated targeting ligand, combined with rapid cellular internalization and a chemically optimized mRNA payload, is being designed to maximize intracellular delivery and CAR protein expression. Nucleoside-modified mRNA and optimized construct architecture together target a reduced innate immune sensing, extended functional mRNA activity, and robust yet transient CAR expression – enhancing delivery efficiency while preserving the advantages of an in vivo approach.
Scalable In Vivo CAR-T: By increasing CAR expression on a per-particle basis, the platform is being designed to achieve meaningful biological activity at lower doses, supporting improved manufacturing efficiency, reduced cost of goods, and the potential for scalable, repeatable treatment.

Together, we believe these capabilities may position the CD7-tLNP platform as a differentiated solution for the next generation of in vivo CAR-T therapies.

About TPST-4003

TPST-4003 is a preclinical, in vivo dual-targeting CD19/BCMA CAR-T product candidate that combines proprietary CD7-targeted mRNA/LNP delivery with a clinically validated dual-target CAR architecture utilized in the company’s TPST-2003 CAR-T program. Targeting broad B-cell lineage depletion and reset, TPST-4003 is being designed to address a range of autoimmune and oncology indications, initially including MG and MS.

(Press release, Tempest Therapeutics, JUL 15, 2026, View Source [SID1234669236])

On July 15, 2026 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer, reported significant progress in the protection of its proprietary innovations across key international markets. The company has received multiple favorable patent actions encompassing three notices of allowance and one grant decision to further strengthen Phio’s global intellectual property portfolio in the United States, Canada, and Japan, respectively. This reinforces the Company’s commitment to developing and safeguarding breakthrough technologies for the INTASYL compounds.

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"Strong patent protection is an important component of our strategy to advance innovative immuno-oncology therapies and maximize the long-term value of our INTASYL siRNA platform," said Robert Bitterman, President and Chief Executive Officer of Phio Pharmaceuticals. "These additional patent advancements across therapeutic areas and geographic regions will facilitate strategic partnerships, support R&D initiatives, and eventual commercialization."

The patent portfolio consists of 54 issued patents. The portfolio encompasses the INTASYL chemistry, specific gene targets, immuno-oncology compounds and therapeutic indications in key countries.

(Press release, Phio Pharmaceuticals, JUL 15, 2026, View Source [SID1234669235])