On June 2, 2026 Creatv Bio, a Division of Creatv MicroTech, Inc. ("Creatv"), a liquid biopsy company focused on innovative diagnostics for cancer, and Neovia Oncology LLC, a Delaware based pharmaceutical company dedicated to developing novel oncology therapies, reported the signing of a strategic partnership agreement to collaborate on Neovia’s upcoming studies treating patients with advanced multiple drug resistant solid tumors who are entering late lines of therapy.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The collaboration is expected to generate translational and biomarker data designed to improve patient stratification and deepen understanding of treatment response dynamics in advanced cancers.

In addition to its development as a systemic therapy, Neovia is also evaluating the broader platform potential of NEV-801 in next-generation oncology applications, including antibody-drug conjugate (ADC) strategies.

"We selected Creatv Bio because of their strong scientific capabilities and extensive experience supporting biomarker research across multiple solid tumor types," said Trevor Blake, Founder and CEO of Neovia Oncology. "By integrating advanced liquid biopsy technologies into our clinical development program, we hope to gain deeper insights into patient response patterns and resistance biology as we advance NEV-801."

Creatv’s LifeTracDx blood test isolates Cancer Associated Macrophage-Like Cells (CAMLs) and Circulating Tumor Cells (CTCs) using Creatv’s CellSieveTM microfilters to develop companion diagnostics to monitor drug targets and provide information on patient treatment response.

Dr. Cha-Mei Tang, President and CEO of Creatv Bio added, "Our partnership with Neovia Oncology LLC has the potential to advance the future of cancer diagnosis and treatment, thus saving and improving the lives of cancer patients."

(Press release, Neovia Oncology, JUN 2, 2026, View Source [SID1234666379])

On June 2, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL, BCTXZ) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported the closing of its best-efforts offering of 1,449,300 common shares. Each common share was sold at an offering price of $3.25 per share. All of the common shares in the offering were offered by the Company. Total gross proceeds from the offering, before deducting placement agent’s fees and other offering expenses, were approximately $4.7 million. The Company relied upon the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as Nasdaq.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company intends to use the net proceeds from the offering for working capital requirements, general corporate purposes, and the advancement of business objectives.

ThinkEquity acted as the sole placement agent for the offering.

The securities described above were offered and sold by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-276650), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on January 22, 2024 and declared effective on January 31, 2024. The offering was made only by means of a written prospectus. A final prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and can be accessed for free on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, BriaCell Therapeutics, JUN 2, 2026, View Source [SID1234666395])

On June 2, 2026 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications, reported detailed efficacy and safety results from the PIK3CA mutant ("MT") cohort of the Phase 3 VIKTORIA-1 clinical trial of gedatolisib, an investigational pan-PI3K/mTORC1/2 inhibitor, in adults with hormone receptor positive ("HR+"), human epidermal growth factor receptor 2 negative ("HER2-"), PIK3CA mutated, locally advanced or metastatic breast cancer ("ABC"), following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor. VIKTORIA-1 is the first Phase 3 clinical trial to compare the efficacy of two PI3K/AKT/mTOR ("PAM") inhibitors in this patient population.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The study results will be presented in a late-breaking abstract ("LBA") oral session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting today, Tuesday, June 2, 2026, 12:09 p.m. CDT.

The PAM pathway is a key oncogenic driver of HR+/HER2- breast cancer that requires inhibition of multiple molecular components to comprehensively blockade excessive PAM signaling in tumors with or without a PAM variant. Gedatolisib is the first multitarget PAM inhibitor to demonstrate superior efficacy relative to a single-target inhibitor of this pathway. In the PIK3CA MT cohort of the Phase 3 VIKTORIA-1 trial, the gedatolisib-triplet demonstrated a statistically significant and clinically meaningful improvement in median PFS among patients, increasing the likelihood of survival without disease progression or death by two times compared to alpelisib plus fulvestrant (based on a hazard ratio [HR] of 0.50; 95% CI: 0.37-0.68; p<0.0001). The median PFS, as assessed by blinded independent central review ("BICR"), was nearly two-times longer, 11.1 months versus 5.6 months, compared to alpelisib plus fulvestrant. The ORR of the gedatolisib-triplet was 48.9% compared to 26.0% with alpelisib plus fulvestrant and the median DOR for the gedatolisib triplet was 15.7 months compared to 7.5 months for alpelisib plus fulvestrant.

For the gedatolisib-doublet, the median PFS was more than two-times longer, 11.3 months versus 5.6 months, compared to alpelisib plus fulvestrant (HR=0.51; 95% CI: 0.33-0.79; descriptive p=0.0013). The ORR of the gedatolisib-doublet was 35.7% and the median DOR was 24.2 months.

The topline gedatolisib-triplet efficacy data from the VIKTORIA-1 PIK3CA MT cohort established several new milestones in the history of drug development for HR+/HER2- ABC:

● First Phase 3 trial to demonstrate superiority of one PAM inhibitor versus another.

● The median PFS of 11.1 months for the gedatolisib-triplet is the highest reported by any Phase 3 trial for patients with HR+/HER2- ABC receiving a regimen including endocrine therapy as second-line treatment.

● The objective response rate of 48.9% for the gedatolisib-triplet is the highest reported by any Phase 3 clinical trial for a regimen including endocrine therapy in second-line HR+/HER2- ABC.

"Therapies that target only PI3Kα or AKT typically offer modest benefit for patients with PIK3CA mutant HR+/HER2- advanced breast cancer whose disease has progressed while on or after treatment with a CDK4/6 inhibitor," said Sara Hurvitz, MD, Senior Vice President, Clinical Research Division, Fred Hutchinson Cancer Center, Smith Family Endowed Chair in Women’s Health and Professor and Head, Division of Hematology and Oncology, University of Washington, Department of Medicine and co-principal investigator for the trial. "By comprehensively blocking the PI3K/AKT/mTOR, or PAM, pathway, gedatolisib combined with fulvestrant, with or without palbociclib, showed it can offer these patients two times the likelihood of survival without disease progression or death relative to a single-target inhibitor of the PAM pathway. With these results, the gedatolisib regimens, if approved, represent a new potential standard of care for patients with HR+, HER2-negative, PIK3CA mutant advanced breast cancer whose disease progressed on or after treatment with a CDK4/6 inhibitor."

The gedatolisib-triplet and -doublet were generally well tolerated in the trial with mostly low-grade treatment-related adverse events ("TRAEs"). The most common Grade 3+ TRAEs for the gedatolisib-triplet, the gedatolisib-doublet, and alpelisib plus fulvestrant groups included neutropenia (58.8%, 0%, and 0.7% of patients, respectively); stomatitis (16.3%, 5.8%, and 5.3% of patients, respectively); rash (6.5%, 5.8%, and 15.1% of patients, respectively); and hyperglycemia (2.6%, 0%, and 14.5% of patients, respectively). TRAEs led to the discontinuation of study treatment in 2.6% of patients in the gedatolisib-triplet group, 3.8% in the gedatolisib-doublet group, and 7.1% in the alpelisib plus fulvestrant group. 1One Grade 5 TRAE in the gedatolisib-triplet group, which was related to palbociclib, was reported, no Grade 5 TRAE’s were reported in the gedatolisib-doublet group, and two Grade 5 TRAE’s were reported in the alpelisib plus fulvestrant group.

"Both gedatolisib regimens were well-tolerated with few VIKTORIA-1 patients discontinuing treatment due to an adverse event," said Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. "These safety results compare very favorably to those from the patient group treated with alpelisib and fulvestrant, which we believe reflects the benefit of gedatolisib’s multi-target mechanism of action, pharmacokinetic profile, and intravenous administration."

Overall survival, a key secondary endpoint in VIKTORIA-1, while immature at the time of the analysis, showed promising trends for both the gedatolisib-triplet and -doublet.

Celcuity intends to submit these data to the U.S. Food and Drug Administration ("FDA") as a supplemental New Drug Application ("sNDA") and to submit VIKTORIA-1 data to other regulatory authorities following the sNDA submission.

"It is rare in oncology for a targeted therapy to offer both improved efficacy and better safety results relative to another drug in its class," said Brian Sullivan, CEO and co-founder of Celcuity. "This second positive Phase 3 data readout further underscores the broad potential of multi-target PAM inhibition and increases our excitement about our two Phase 3 trials in the first-line setting for HR+/HER2- advanced breast cancer. We are on track to launch gedatolisib commercially, in anticipation of its potential FDA approval in the third quarter of 2026, and we look forward to the possibility of bringing this important therapy to physicians treating patients with advanced breast cancer."

The FDA has granted Priority Review of Celcuity’s New Drug Application ("NDA") for gedatolisib in patients with HR+/HER2-/PIK3CA wild-type ("WT") ABC and assigned a Prescription Drug User Fee Act ("PDUFA") goal date of July 17, 2026.

About HR+/HER2- Breast Cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 More than two million breast cancer cases were diagnosed globally in 2022.1 While survival rates are high for those diagnosed with early breast cancer, only approximately 30% of patients who are diagnosed with or who progress to metastatic disease are expected to live five years after their diagnosis.2 HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers.2

Three interconnected signaling pathways, estrogen, cyclin D1-CDK4/6, and the PAM pathway , are primary oncogenic drivers of HR+/HER2- ABC.3 Therapies inhibiting these pathways are approved and used in various combinations for ABC. Currently approved inhibitors of the PAM pathway for breast cancer target a single PAM pathway component, such as PI3Kα, AKT, or mTORC1.4,5,6,7 However, resistance to CDK4/6 inhibitors and current endocrine therapies develops in many patients with advanced disease.8 Optimizing the inhibition of the PAM pathway is an active area of focus for breast cancer research.

About the VIKTORIA-1 Phase 3 Trial

VIKTORIA-1 is a Phase 3 open-label, randomized clinical trial to evaluate the efficacy and safety of gedatolisib in combination with fulvestrant, with or without palbociclib, in adults with HR+/HER2- ABC whose disease progressed on or after prior CDK4/6 therapy in combination with an aromatase inhibitor. The trial enrolled 701 subjects regardless of PIK3CA status while enabling separate evaluation of subjects according to their PIK3CA status. Detailed results from the PIK3CA WT cohort of VIKTORIA-1 have been previously reported. For the PIK3CA MT cohort, 350 subjects who met eligibility criteria and had confirmed PIK3CA mutations were randomly assigned (3:3:1) to receive a regimen of either the gedatolisib-triplet, alpelisib and fulvestrant, or the gedatolisib-doublet.

About Gedatolisib

Gedatolisib is an investigational, multi-target PAM inhibitor that potently targets all four class I PI3K isoforms, mTORC1, and mTORC2 to induce comprehensive blockade of the PAM pathway.9,10,11 As a multi-target PAM inhibitor, gedatolisib’s mechanism of action is highly differentiated from currently approved single-target inhibitors of the PAM pathway.11 Inhibition of only a single PAM component gives tumors an escape mechanism through cross-activation of the uninhibited targets. Gedatolisib’s comprehensive PAM pathway inhibition ensures full suppression of PAM activity by eliminating adaptive resistance cross-activation that occurs with single-target inhibitors. Unlike single-target inhibitors of the PAM pathway, gedatolisib has demonstrated equal potency and comparable cytotoxicity in PIK3CA-mutant and -wild-type breast tumor cells in nonclinical studies and early clinical data.

(Press release, Celcuity, JUN 2, 2026, View Source [SID1234666364])

On June 2, 2026 Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company focused on developing new products for rare diseases, and Vanderbilt Health reported data from a Phase 2a clinical trial of ifetroban to prevent metastasis in high-risk solid tumors. The study’s primary safety endpoint was achieved, along with favorable trends in decreased metastasis recurrence and metastasis-free survival. A safe and effective medication that reduces distant metastatic recurrence could transform cancer management and improve the lives of millions of cancer survivors and their families.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The randomized, double-blind, placebo-controlled Phase 2a trial evaluated the safety of ifetroban, an investigational thromboxane A2 receptor antagonist, in patients with solid tumors at high risk of early metastatic recurrence. Cancer types included breast, lung, pancreatic, soft tissue, bladder, and renal cancers.

The study met its primary endpoint, demonstrating that ifetroban was safe and well-tolerated in this patient population. Rates for adverse events related to treatment were similar between placebo and ifetroban. No serious adverse events (> grade 3) in either group were identified as being related to study treatment. Treatment discontinuation rates were not statistically different between placebo and ifetroban.

Although primarily a safety study and intentionally not powered for efficacy, the study compared the percentage of patients with distant metastatic recurrence 12 months after completion of therapy in both groups (10 placebo-treated and 18 ifetroban-treated participants) as a prespecified secondary endpoint. While 50% of participants experienced distant metastatic recurrence in the placebo arm, only 17% of participants experienced distant metastatic recurrence in the ifetroban arm (p=0.091). Three deaths due to distant metastatic disease occurred in the placebo arm, and none occurred in the ifetroban arm (p=0.037).

Though metastasis is a primary driver of cancer lethality, most current therapies act on tumor cells directly. Approaches targeting the mechanisms underlying the metastatic process are lacking. Even during clinical remission, microscopic metastases can remain present, leaving many patients at serious risk for metastatic recurrence. The premise of this novel therapy is that antagonizing the thromboxane A2 receptor and blocking platelet activation and aggregation lessens tumor cells’ ability to migrate, spread, cluster, invade distal organs, and evade immune detection.

This was the first trial evaluating the effects of ifetroban in people with solid tumors with high risk for early recurrence, defined as ≥ 50% chance of recurrence within 5 years of diagnosis. The intervention was given after all cancer-related therapies and surgical procedures had been completed; participants received the intervention for 12 months and were then followed for an additional 12 months. Among 29 participants, 10 received placebo and 19 received ifetroban.

"A therapeutic intervention aimed at metastasis prevention for cancer patients with high risk of recurrence that is given during the period of "watchful waiting" could be groundbreaking if proven beneficial in larger scale investigations," said Dr. Ben Ho Park of the Vanderbilt-Ingram Cancer Center. "We look forward to pursuing those pivotal studies as we relentlessly look for treatments to benefit patients living with cancer."

This clinical trial translated robust in silico and preclinical data to humans, confirming safety of ifetroban in patients with solid tumors and preliminarily suggesting that ifetroban may target biologic mechanisms involved in distant metastatic recurrence. A phenome-wide association study (PheWAS) was conducted by Vanderbilt Health investigators using the BioVU biorepository, which linked a naturally occurring genetic variant in the thromboxane receptor gene (TBXA2R) to an increased risk of metastatic disease across multiple cancer types.

Preclinical studies subsequently published in Molecular Cancer Therapeutics demonstrated that ifetroban reduced metastasis in several animal models without affecting tumor growth, and that the drug’s effects appeared to involve strengthening of the vascular endothelial barrier and inhibiting the ability of tumor cells to migrate across blood vessel walls.

"The favorable safety profile of ifetroban in this patient population, combined with the efficacy signals observed in this study, supports continued investigation of ifetroban as a candidate for metastasis prevention," said A.J. Kazimi, chief executive officer of Cumberland Pharmaceuticals. "The contributions of the Vanderbilt Health team have been essential to advancing this program."

Results of this Phase 2a clinical trial will be used to guide the further clinical development verifying efficacy and further demonstrating safety.

About Ifetroban

Ifetroban is a potent and selective thromboxane-prostanoid receptor (TPr) antagonist. It exhibits high affinity for TPr on many cell types including platelets, cardiomyocytes, vascular and airway smooth muscle, and fibroblasts, and lacks agonistic activity. Cumberland is also evaluating ifetroban in Phase 2 clinical programs for patients with Duchenne Muscular Dystrophy, Systemic Sclerosis and Idiopathic Pulmonary Fibrosis. Ifetroban has a favorable safety profile as evidenced by multiple completed clinical trials collectively enrolling over 1,400 people.

(Press release, Cumberland Pharmaceuticals, JUN 2, 2026, View Source [SID1234666380])

On June 2, 2026 KORTUC Inc, a global oncology biotech company, reported that it has launched enrollment into its Phase 1/2 clinical study evaluating KRC-01, a proprietary intratumoral radiosensitizer, in patients with locally advanced cervical cancer. The study examines the impact of Kortuc’s compound in low-oxygen (hypoxic) tumors, which generally do not respond to therapeutic radiation doses. The announcement comes after its trial protocol was reviewed by the U.S. Food and Drug Administration and a $20 million funding round, led by Midas Capital.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Cervical cancer is the fourth most common cancer among women globally, with an estimated 604,000 new cases and 342,000 deaths in 2020. About 90 percent of new cases and deaths occur in low- and middle-income countries.

Hypoxia – low oxygen levels – inside a cancer cell undermines the efficacy of radiation therapy by making cells more resistant. KRC-01 has shown significant promise in creating a more oxygen-rich environment to improve radiotherapy efficacy. Led by the University of California San Diego, the trial will examine whether adding KRC-01 to standard treatment (chemotherapy combined with radiation) can improve overall survival. A total of 70 patients will be enrolled, with planned expansion to the United Kingdom and India.

"Radiation therapy is a proven curative treatment of cervical cancer," said Kazuyuki Matsuda, CEO of Kortuc. "But the unfortunate reality is about half of cervical cancer patients are unresponsive to this treatment due to hypoxic tumors. Our technology exists today, and it can lead to tangible positive impact on patients’ lives."

KRC-01 is based on a well-understood mechanism of action. Hydrogen peroxide (H₂O₂), a simple and well-known compound with an established safety profile, serves as the active ingredient in the KRC-01 radiosensitizer. As the only agent known to inactivate antioxidative enzymes within tumors, it increases tumor oxygenation and reduces hypoxia, thereby enhancing sensitivity to radiation therapy. Sodium hyaluronate delays the decomposition of H₂O₂, maintaining elevated oxygen partial pressure within the tumor for up to 48 hours following intratumoral injection of KRC-01.

Preliminary results and studies have shown that the newly oxygenated environment makes cancer cells more susceptible to radiation therapy.

The phase 1/2 clinical trial is designed to move efficiently from safety testing to early evaluation of effectiveness.

Phase 1 will include 10 patients and focus on determining the safest and most appropriate dosing schedule for KRC-01 when used alongside standard chemoradiotherapy. KRC-01 will be injected directly into the tumor shortly before radiation treatment.

Phase 2 will enroll 60 additional patients and compare standard treatment alone with standard treatment plus KRC-01. This phase will explore whether KRC-01 may help extend overall survival.
All participants will receive the current standard of care for locally advanced cervical cancer, which includes radiation therapy combined with weekly chemotherapy, followed by brachytherapy (internal radiation).

In addition to cervical cancer, Kortuc is studying the use of its technology for other solid tumor indications, including breast cancer.

(Press release, KORTUC, JUN 2, 2026, View Source [SID1234666396])