On May 29, 2026 Ratio Therapeutics Inc. (Ratio), a pharmaceutical company employing innovative technologies to develop best-in-class radiopharmaceuticals for cancer treatment, reported an expanded manufacturing collaboration with PharmaLogic Holdings Corp. (PharmaLogic), a leading contract development and manufacturing organization (CDMO) specialized in radiopharmaceuticals, to support the continued clinical development and future commercialization readiness of Ratio’s lead therapeutic candidate, [Ac-225]RTX-2358.

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Under the expanded agreement, PharmaLogic will increase manufacturing capacity for the clinical supply of Ratio’s fibroblast activation protein-alpha (FAP)-targeted therapeutic, [Ac-225]RTX-2358, by expanding manufacturing to PharmaLogic’s Idaho Falls therapeutics facility. The broadened collaboration will also include enhancements of production processes with the aim of providing larger scale multi-dose batch manufacturing. The partnership is designed to support ongoing and future clinical studies, including later-stage and potentially registrational trials evaluating [Ac-225]RTX-2358 in FAP-expressing tumors.

"This expanded collaboration with PharmaLogic represents an important step in advancing our manufacturing strategy as we continue to progress [Ac-225]RTX-2358 through clinical development," said Jack Hoppin, Chief Executive Officer of Ratio. "Reliable, redundant and scalable manufacturing infrastructure is critical to the successful development of radiopharmaceutical therapeutics, particularly Actinium-225-based therapies. PharmaLogic has been a strong and reliable partner in supporting our clinical programs, and this next phase of our collaboration is intended to support the progression of our clinical trials and achieve readiness for commercial supply."

"As a service provider to the radiopharmaceutical industry, PharmaLogic measures its success by the success of its partners," said Etienne Montagut, President and Chief Executive Officer of PharmaLogic. "The expansion of our collaboration with Ratio Therapeutics, including the addition of our Idaho Falls therapeutics facility and enhancements to enable larger multi-dose batch production will provide the capacity, redundancy, and scalability that the [Ac-225]-RTX-2358 program requires as it advances toward commercialization. Drawing on more than a decade of experience producing clinical and commercial radiopharmaceutical therapies, we are committed to supporting this program with the full depth of that capability. We thank the Ratio team for their continued trust and collaboration."

About [Ac-225]RTX-2358

[Ac-225]RTX-2358 is a FAP-targeted alpha particle emitting radiotherapeutic. [Ac-225]RTX-2358 is designed for high tumor uptake & long retention time: a trifunctional small molecule engineered for optimized plasma clearance, increased binding affinity, and prolonged tumor retention, radiolabeled with the potent alpha-emitting [Ac-225] radioactive payload. Ratio is currently evaluating [Ac-225]RTX-2358 to treat patients with relapsed or refractory soft tissue sarcomas in the ongoing Phase 1/2 ATLAS trial.

About the ATLAS Trial

Ratio is conducting the ATLAS, ‘Actinium Therapy for Late-stage Aggressive Sarcomas’, clinical study (clinicaltrials.gov: NCT07156565). ATLAS is an open-label, seamless, Phase 1/2 clinical trial to evaluate the safety, tolerability, dosimetry, biodistribution, pharmacokinetics (PK), and anti-tumor activity of [Ac-225]RTX-2358 to treat patients with relapsed or refractory soft tissue sarcoma.

The Phase 1 portion of the ATLAS trial uses a modified 3+3 with queue (IQ) dose escalation design with backfill. Cohorts of patients will assess increasing administered activity ‘dose’ levels and treatment schedules of [Ac-225]RTX-2358, to determine the maximum tolerated dose and establish a recommended dose and schedule for the Phase 2 Expansion. Backfill of Phase 1 cohorts will enable more patients to be treated and evaluated, to provide better characterization of safety and tolerability, as well as assessment of preliminary efficacy. The Phase 2 Expansion portion of the ATLAS study will evaluate the efficacy and safety of [Ac-225]RTX-2358 in up to 50 patients with soft tissue sarcoma.

(Press release, Ratio Therapeutics, MAY 29, 2026, View Source [SID1234666201])

On May 29, 2026 PanTher Therapeutics ("PanTher" or the "Company"), a clinical-stage company redefining early cancer treatment with therapeutic implants administered directly at the tumor site, reported that it has concluded the dose escalation portion of its Phase 1b clinical trial of PTM-101 in pancreatic ductal adenocarcinoma (PDAC). PanTher has identified the PTM-101 400mg paclitaxel-containing implant as the recommended Phase 2 dose (RP2D) in combination with neoadjuvant standard of care chemotherapy. In addition, PanTher announced the appointment of senior life sciences executive Dr. Tim Clackson to its Board of Directors. This news reflects a pivotal stage in the company’s development to achieve the promise of the PTM-101 technology.

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The ongoing Phase 1b study builds on PanTher’s first-in-human trial that demonstrated the safety of PTM-101 at 100 mg and reported promising tumor shrinkage, with reduction in overall tumor volume of up to 70%. The current trial is an open-label, multicenter, single-arm study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of PTM-101 in patients with newly diagnosed, treatment naïve, non-metastatic pancreatic cancer. In the dose-finding phase, subjects were treated at higher doses of paclitaxel (200 mg and 400 mg) with no systemic paclitaxel detected, no evidence of significant implant-related toxicities, and no additive toxicities with standard of care chemotherapy. Plasma pharmacokinetic data show no evidence of systemic exposure to paclitaxel with levels below quantifiable limits. Based on these data from a total of 12 patients, the Study Safety Committee endorsed the 400mg dose as the RP2D for further evaluation. This dose represents 4x the Maximum Tolerable Dose (MTD) of paclitaxel when delivered systemically, underscoring the potential benefit of localized therapy.

Approximately 50% of PDAC patients present with non-metastatic disease at diagnosis, when timely anti-tumor treatment and surgery still offer the potential for cure. Yet multi-agent systemic chemotherapy is often limited by toxicity. PTM-101 is a proprietary paclitaxel implant administered at the tumor surface during a standard tumor staging laparoscopy, immediately after diagnosis, providing ~6 weeks of sustained high-dose therapy directly to the tumor, with no systemic exposure. As an add-on therapy, PTM-101 integrates seamlessly with neoadjuvant standard of care FOLFIRINOX by adding a fourth chemotherapy agent while creating a new window for early intervention and improved outcomes.

The ongoing Phase 1b study (NCT06673017) is assessing safety, tolerability, and anti-tumor activity of PTM-101 when combined with standard of care neoadjuvant chemotherapy (FOLFIRINOX) in subjects with borderline resectable or locally advanced PDAC. PanTher is now enrolling patients in the dose expansion phase, which will enroll approximately 15 additional patients at sites across the United States to further characterize the safety and efficacy of PTM-101. For more information on the trial, please visit View Source

PanTher also announced today the appointment of Dr. Tim Clackson to its Board of Directors. Dr. Clackson brings more than three decades of experience building oncology companies to PanTher’s board, and his appointment reflects PanTher’s commitment to assembling a world-class team to support the advancement of PTM-101 and the Company’s broader pipeline.

"We are thrilled to welcome Tim to PanTher’s Board of Directors," said Laura Indolfi, Ph.D., Chief Executive Officer and Co-founder of PanTher Therapeutics. "His experience in developing and commercializing oncology therapies will be invaluable as we continue to build on the momentum of our Phase 1b clinical program and work to bring PTM-101 to patients in need."

Laura continued, "For patients with localized pancreatic cancer, every treatment decision made at diagnosis can impact the future of that patient and the development of their diagnosis. PTM-101 offers the potential to integrate directly into the neoadjuvant standard treatment paradigm from the outset, delivering additional anti-tumor activity without compounding systemic side effects. It is our aim with PTM-101 to meaningfully improve clinical outcomes for patients, alongside the current standard of care, to drive deeper and longer treatment responses before a tumor has the opportunity to become metastatic."

"PanTher is taking a highly differentiated and promising approach to tackling one of the most challenging cancers. By intervening right after diagnosis, with localized, high dose and sustained therapy, PTM-101 has the potential to transform PDAC outcomes before metastasis," said Tim Clackson, Ph.D. "As a simple add-on therapy that integrates seamlessly with existing workflows and therapies, it has the potential for wide adoption. I look forward to working with Laura and the PanTher team to help bring PTM-101, and a broader pipeline of localized medicines, to patients in need."

PTM-101 is the lead product candidate within PanTher’s pipeline of implantable medicines designed to directly address hard-to-treat solid tumors. PanTher is additionally developing polymeric drug formulations for the treatment of a range of other solid tumor types.

The company expects to share topline data from the Phase 1b study of PTM-101 in the first half of 2027.

About PTM-101

PanTher’s most advanced investigational product candidate, PTM-101, is an absorbable thin film formulation of paclitaxel for non-metastatic pancreatic cancer. PTM-101 is designed to deliver continuous, long-lasting, high-dose chemotherapy to the tumor with little to no systemic exposure. The product, laparoscopically implanted at the tumor site, easily integrates with common minimally invasive procedures used in staging pancreatic cancer. PTM-101 is currently being evaluated in a Phase 1b clinical trial (NCT06673017) with support from the Cancer Prevention & Research Institute of Texas (CPRIT) DP220066.

(Press release, PanTher Therapeutics, MAY 29, 2026, View Source [SID1234666232])

On May 29, 2026 Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported that following collaborative communications with the U.S. Food and Drug Administration (FDA), the Company and the FDA have aligned on a path forward for resubmission and reconsideration of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.

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The company will resubmit the RP1 BLA in the coming days. The FDA has indicated it will treat the BLA resubmission as an urgent matter upon receipt and will prioritize its review in recognition of the significant unmet need for patients in the advanced melanoma community. This constructive dialogue represents an important step forward for the thousands of patients living with advanced melanoma who have progressed on prior anti-PD-1 based therapy and have limited treatment options available to them.

"We are grateful to the FDA leadership for their willingness to engage in a collaborative dialogue towards finding a meaningful path forward for RP1," said Sushil Patel, Ph.D., Chief Executive Officer of Replimune. "We are encouraged by the agency’s commitment to supporting patients and U.S. innovation and look forward to working closely with the FDA to bring this important therapy to the advanced melanoma community as swiftly as possible."

The BLA is supported by data from the IGNYTE clinical trial, which evaluated RP1 combined with nivolumab in patients with confirmed progression on an anti-PD-1 containing regimen. Approximately 8,500 Americans with advanced melanoma die each year, and standard of care checkpoint inhibitor therapy fails approximately half of all patients who receive it, underscoring the urgent need for new treatment options.

About RP1
RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate, based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R⁻) and GM-CSF. RP1 is designed to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

About Advanced Melanoma
Melanoma is the fifth most common cancer in the United States, with approximately 112,000 new cases estimated in 2026 and the most lethal form of skin cancer, accounting for nearly 8,500 deaths annually. Melanoma is considered advanced when the cancer has spread beyond the primary tumor. Standard of care therapy includes immune checkpoint blockade, to which approximately half of patients will not respond or will progress after treatment, leaving a significant population in need of effective therapeutic alternatives.

(Press release, Replimune, MAY 29, 2026, View Source [SID1234666202])

On May 29, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported a new collaboration with Diakonos Oncology Corp., a clinical-stage biotechnology company developing immunotherapies to treat challenging and aggressive cancers. As part of the collaboration, Signatera will be used to longitudinally assess molecular response in patients with refractory melanoma enrolled in Diakonos’ DOC-RM Phase I/II investigational immunotherapy trial.

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The DOC-RM trial, which began enrollment in May, is evaluating DOC1021 (dubodencel), a first-in-class, personalized dendritic cell investigational therapy that recently received Fast Track designation by the U.S. Food and Drug Administration (FDA) in unresectable or metastatic cutaneous melanoma. With Signatera, Natera will conduct analyses of circulating tumor DNA (ctDNA) at multiple timepoints during and following treatment.

Refractory melanoma is an area of significant unmet need. Although immunotherapy has transformed the treatment landscape for advanced melanoma, many patients either do not respond or eventually develop resistance, underscoring the need for novel therapeutic approaches. Because radiographic response assessment can be challenging in immunotherapy-treated patients, serial ctDNA monitoring may provide earlier insight into molecular response and disease dynamics during treatment.1

"With an FDA Fast Track designation in hand, DOC1021’s path forward in refractory melanoma will benefit from early, high-quality evidence of activity," said Jay Hartenbach, president and COO of Diakonos Oncology. "Natera’s Signatera test is the most trusted tumor-informed MRD platform in oncology, making them a natural partner to help evaluate molecular response in a population where imaging often lags the biology."

"Signatera is uniquely positioned to help biopharma partners evaluate molecular response throughout the course of therapy, and we are thrilled to partner with Diakonos on this exciting program," said Eric Matthews, general manager, BioPharma, Natera. "By assessing MRD status across multiple timepoints, this collaboration has the potential to provide deep insight into treatment response dynamics and support future development efforts for patients with difficult-to-treat cancers."

(Press release, Diakonos Oncology, MAY 29, 2026, View Source [SID1234666233])

On May 29, 2026 Tempest Therapeutics, Inc. (Nasdaq: TPST) (the "Company"), a clinical-stage biotechnology company developing a pipeline of advanced CAR-T cell therapy product candidates to treat cancer, reported the entry a definitive agreement for the immediate exercise of certain outstanding warrants to purchase an aggregate of 1,172,414 shares of the Company’s common stock originally issued by the Company on November 26, 2025, having an original exercise price of $3.50 per share, at a reduced exercise price of $1.73 per share. The closing of the warrant exercise transaction is expected to occur on or about May 29, 2025, subject to satisfaction of customary closing conditions.

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H.C. Wainwright is acting as the exclusive placement agent for the transaction.

As consideration for the exercise of such existing warrants for cash, the Company will issue new unregistered short-term warrants to purchase up to an aggregate of 2,344,828 shares of common stock at an exercise price of $1.73 per share. The new short-term warrants will be exercisable on the effective date of stockholder approval of the issuance of the shares of common stock upon exercise of the new short-term warrants (the "Stockholder Approval") and will expire two years following the initial issuance date.

The aggregate gross proceeds from the exercise of the existing warrants are expected to be approximately $2 million, before deducting placement agent fees and other offering expenses payable by the Company. The additional potential gross proceeds from the new short-term warrants, if fully exercised on a cash basis, will be approximately $4 million. No assurance can be given that any of the new short-term warrants will be exercised. The Company expects to use the net proceeds from the transaction for working capital and general corporate purposes.

The resale of the shares of common stock issuable upon the exercise of the existing warrants has been registered pursuant to an effective registration statement on Form S-1 (File No. 333- 292026).

The offer and sale of the new short-term warrants and the shares of common stock issuable upon exercise of the new short-term warrants have not been registered under the Securities Act of 1933, as amended, or under applicable state securities laws. Accordingly, the new short-term warrants and the shares of common stock issuable upon the exercise of the new short-term warrants may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act of 1933, as amended, and such applicable state securities laws.

This press release does not constitute an offer to sell or the 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.

(Press release, Tempest Therapeutics, MAY 29, 2026, View Source [SID1234666203])