On June 2, 2026 Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, reported updated data from the RALLY-MF Phase 2 trial of DISC-0974 in anemia of MF at the ASCO (Free ASCO Whitepaper) Annual Meeting in Chicago, IL. In this updated data set, treatment with DISC-0974 shows substantial reductions in hepcidin and increases in iron levels translating to positive impact on clinically meaningful measures of anemia across a broad range of patient types.

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"We are excited to have solidified and strengthened the magnitude, durability, and consistency of responses as we have enrolled more patients and extended follow-up," said John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc Medicine. "The activity observed both with and without background JAK inhibitor therapy, together with improvements in transfusion burden and fatigue, continues to support the potential for DISC-0974 to serve a broad population of patients living with MF-associated anemia, an area where substantial unmet need remains."

This ongoing Phase 2 open-label study had enrolled 61 adult patients with MF and anemia as of the data cutoff date of April 27, including 50 patients with sufficient follow up to be included in the responder analysis (non-transfusion dependent receiving no transfusions (nTD, n=31), transfusion dependent with low transfusion burden (TD Low, n=11) and transfusion dependent with high transfusion burden (TD High, n=8)). The trial was comprised of both patients receiving concomitant JAK inhibitor therapy (n=25) and not receiving JAK inhibitor therapy (n=25). DISC-0974 was administered subcutaneously at 50 mg every 4 weeks for up to 6 treatments. The updated results demonstrated:

Consistent, substantial decreases in hepcidin reaching >75% reduction from baseline and corresponding increases in serum iron
55% (N=17 of 31) of baseline nTD patients achieved a hemoglobin increase of ≥1.5 g/dL for ≥12 weeks (major response) and 68% had an increase of ≥1 g/dL for ≥12 weeks (overall response)
64% (N=7 of 11) of TD Low patients achieved transfusion independence (TI, major response) over a 16-week period and 73% achieved a ≥50% reduction in transfusions (overall response)
50% (N=4 of 8) of TD High patients achieved transfusion independence (TI, major response) over a 12-week period and 88% achieved a ≥50% reduction in transfusion requirement (overall response)
56% of patients receiving concomitant JAK inhibitor therapy achieved a major hematologic response across transfusion groups and 72% achieved an overall response, with similar response rates regardless of which specific JAK inhibitor the patient received
Dosing with DISC-0974 was associated with improvements in patient-reported outcomes:
Clinically significant improvements in FACIT-Fatigue scores in nTD and TD Low participants that were correlated with hemoglobin change
MPN-SAF TSS50 at EOS was achieved by 50% of nTD and TD low major responders
DISC-0974 was generally well-tolerated. Diarrhea, not considered serious, was the only adverse event (AE) that was reported as related to DISC-0974 and reported in two or more subjects. The majority of AEs were not considered related to DISC-0974.

Additional data from the RALLY-MF study is to be shared in Q4 2026, with an end of Phase 2 meeting with the FDA expected to occur by end of year.

DISC-0974 is an investigational agent and is not approved for use as a therapy in any jurisdiction worldwide

(Press release, Disc Medicine, JUN 2, 2026, View Source [SID1234666398])

On June 2, 2026 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel cancer therapies, reported positive results from CRDF-004, a randomized, controlled, dose-finding Phase 2 clinical trial evaluating onvansertib in combination with SoC regimens (FOLFIRI/bevacizumab (bev) or FOLFOX/bev) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC). Results showed that the selected dose/regimen of the registrational program, onvansertib 30 mg + FOLFIRI/bev, demonstrated deep and durable tumor shrinkage, including clinically meaningful improvements in overall response rate (ORR) and progression-free survival (PFS) compared to SoC alone, with no additive adverse events. The data were presented today by Heinz-Josef Lenz, MD, associate director for clinical research and co-leader of the GI cancers program at the University of Southern California (USC) Norris Comprehensive Cancer Center, in a rapid oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago.

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Following the completion of the End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), the Company has aligned on the design of the registrational trial with onvansertib in mCRC. The randomized, controlled Phase 3 trial will evaluate the safety and efficacy of onvansertib 30 mg + FOLFIRI/bev as first-line therapy versus standard-of-care FOLFIRI/bev in patients with RAS-mutated mCRC.

"RAS-mutated metastatic colorectal cancer remains a significant clinical challenge, with limited therapeutic progress over the past two decades. Patients with RAS-mutated mCRC continue to face poor outcomes, and there are currently no treatment options specifically approved for patients with RAS-mutated mCRC—except for KRAS G12C mutations, which account for less than 4% of all colorectal cancers," said Dr. Lenz. "With its novel mechanism of action, onvansertib, when combined with FOLFIRI/bev, demonstrated deep and durable tumor shrinkage over time. A positive confirmatory Phase 3 study that builds on the Phase 2 data presented today could potentially establish onvansertib + FOLFIRI/bev as a new standard-of-care for these patients."

Data Highlights from the ongoing Phase 2 trial (Data cut: March 18, 2026):
In the intent-to-treat (ITT) population, the dose selected for the registrational program, 30 mg onvansertib arm in combination with FOLFIRI/ bev achieved:

Primary endpoint of confirmed objective response rate of 72.2% (13/18), compared with 42.1% (8/19) for FOLFIRI/bev alone, a 30% improvement over standard-of-care (SoC). The responses were deeper and more durable in the onvansertib arm.
Secondary endpoint of progression free survival (PFS) hazard ratio (HR) of 0.55 (95% CI: 0.15–2.09) and 0.57 (95% CI: 0.20–1.65) vs. FOLFIRI/bev by Blinded Independent Central Review (BICR) and investigator assessment (IA), respectively.
Median PFS not reached in 30 mg onvansertib + FOLFIRI/bev arm, but has been reached in both SoC arms. Four patients remain on onvansertib treatment beyond 15 months, including 2 beyond 20 months.

Notably, fourteen patients remain on trial, with nine patients in the onvansertib (20 or 30 mg) plus FOLFIRI/bev arms and one patient remaining on SoC.

No meaningful differences in efficacy were observed between the onvansertib + FOLFOX/bev arms and FOLFOX/bev alone.

Safety/Tolerability:
Onvansertib in combination with both chemotherapy (FOLFIRI or FOLFOX)/bev regimens was well-tolerated. There were no major or unexpected toxicities observed and no additive adverse events reported. Grade 3 or higher adverse events were infrequent, with neutropenia being the most common treatment-emergent adverse event across both the onvansertib combination and SoC arms.

"We are excited to share these updated results and are highly encouraged by the consistent efficacy seen with onvansertib in combination with FOLFIRI/bev across two clinical trials in patients with RAS-mutated mCRC," said Mani Mohindru, PhD, President and Chief Executive Officer. "The data generated to date continue to support the potential of onvansertib in combination with standard-of-care FOLFIRI/bev in RAS-mutated mCRC and reinforce our plans to advance the program into a global registrational study. We look forward to providing additional updates on those plans in the coming months."

The ASCO (Free ASCO Whitepaper) presentation will be made available on the Scientific Publications page of the Company’s website following the rapid oral presentation.

Conference Call and Webcast
The investor webcast will take place on June 3, 2026 at 8:30 am ET/5:30 am PT. To register for and access the live webcast, please visit the "Events" page of the Cardiff Oncology website. The slides from the conference call will be posted after the call has concluded.

CRDF-004 Trial Design
The CRDF-004 Phase 2 trial was designed to evaluate the safety, efficacy, and pharmacokinetics of two different doses of onvansertib in combination with FOLFIRI/bevacizumab or FOLFOX/bevacizumab in first-line patients with KRAS- or NRAS-mutated metastatic colorectal cancer (mCRC). The randomized, controlled trial was designed to enroll 110 patients across 6 different arms, and the trial’s endpoints include objective response rate (ORR), progression-free survival (PFS), duration of response, and safety.

For additional information about the trial, please visit www.clinicaltrials.gov (Trial ID: NCT06106308).

About Onvansertib
Onvansertib is a highly specific, oral PLK1 inhibitor advancing toward a registrational trial in first-line RAS-mutated metastatic colorectal cancer (mCRC). In a randomized Phase 2 trial, onvansertib in combination with FOLFIRI/bevacizumab (first-line standard-of-care) demonstrated dose-dependent improvements in overall response rate and progression-free survival compared to standard-of-care alone, building on findings from a prior Phase 2 trial in second-line RAS-mutated mCRC. Based on these results, the Company has selected the 30 mg dose of onvansertib in combination with FOLFIRI/bevacizumab for advancement into a registrational trial in first-line patients with RAS-mutated mCRC.

Onvansertib is also being evaluated in multiple other cancers through investigator-initiated studies, including metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), triple-negative breast cancer (TNBC), and chronic myelomonocytic leukemia (CMML).

(Press release, Cardiff Oncology, JUN 2, 2026, View Source [SID1234666397])

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.

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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])

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.

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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 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the "Company"), a late-clinical stage biotechnology company pioneering nanotherapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, reported an update on operational progress and reported financial results for the first quarter of 2026.

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"Nanobiotix continues to advance with focus, discipline, and ambition as we work to unlock the full potential of physics-based nanotherapeutics," said Laurent Levy, chief executive officer of Nanobiotix and chairman of the executive board. "During the first quarter of 2026, we strengthened our foundation by supporting the advancement of JNJ-1900 (NBTXR3), progressing our Nanoprimer platform, and reinforcing our financial position. We remain deeply grateful to the team members, patients, investigators, collaborators and shareholders who give us their trust, commitment and support as we pursue our mission of revolutionizing treatment outcomes for millions."

Operational Highlights

Part 1 data from Phase 2 JNJ-1900 (NBTXR3) Study in Unresectable Stage 3 NSCLC (CONVERGE) presented at ELCC 2026 and updated at ESTRO 2026
Initial investigator-reported efficacy responses observed in 7 patients following the full treatment regimen of concurrent chemoradiotherapy, JNJ-1900 (NBTXR3), and consolidation with durvalumab showed:
Overall response rate ("ORR") = 85.7% (6/7 patients) reported at ESTRO 2026
In the same cohort of 7 patients, ORR observed at earlier time point and reported at ELCC 2026 was 71.4% (5/7 patients)
Complete response rate ("CRR") = 57.1% (4/7 patients) reported at ESTRO 2026
With the current standard of care, concurrent chemoradiation therapy (cCRT) ± durvalumab, depth of response remains limited in Stage 3 Inoperable NSCLC with very low rates of complete response (<5%)1
Absence of progressive disease and deepening response over time suggests potential for long-term durability
The procedure demonstrated an acceptable safety profile without serious treatment-emergent adverse events (TEAEs)
Early results suggest that intratumoral/intranodal injection of JNJ-1900 (NBTXR3) is feasible and can be performed safely in patients with stage III unresectable NSCLC
Protocol amendment to global Phase 3 JNJ-1900 (NBTXR3) Study in Cisplatin-ineligible Head and Neck Cancer (NANORAY-312)
Interim analysis eliminated and final analysis modified to be conducted sooner with fewer events than originally planned
New preclinical data presented at 2026 AACR (Free AACR Whitepaper) Meeting:
Pre-treatment with Nanoprimer followed by administration of LNP-delivered recombinant DNA ("LNP-DNA") designed for anti-tumor immunotherapy showed increased systemic bioavailability, reduced hepatic toxicity, and reduced cGAS-STING related inflammation compared to LNP-DNA administered without the Nanoprimer

First Quarter Financial Updates

Cash and Cash Equivalents: The Company believes that the net proceeds from the recent follow-on offering, together with its cash and cash equivalents of €42.1 million as of March 31, 2026, will be sufficient to meet its working capital requirements for operations into 2029, consistent with the Company’s currently contemplated cash burn rate.

About JNJ-1900 (NBTXR3)

JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas through a successful randomized Phase 2/3 study in 2018. The product candidate’s mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that JNJ-1900 (NBTXR3) could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

Radiotherapy-activated JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. The program is led by NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of JNJ-1900 (NBTXR3) activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating JNJ-1900 (NBTXR3) across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson company.

(Press release, Nanobiotix, JUN 2, 2026, View Source [SID1234666394])