On April 1, 2026 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company, reported positive clinical results from its ongoing HT-001 program, including achievement of the primary efficacy endpoint in interim analysis, with patients reaching an ARIGA rash severity score of ≤1 by week six.

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In addition to the strong results in Ariga score, HT-001 demonstrated strong patient benefit across multiple clinically meaningful measures. Over 65% of patients reported meaningful reductions in pain and itching, supporting HT-001’s potential to significantly improve quality of life for patients suffering from dermatologic toxicities, including those associated with epidermal growth factor receptor inhibitor (EGFR) cancer therapies.

Importantly, zero patients required dose reduction or discontinuation of their EGFR inhibitor therapy while receiving HT-001, highlighting the potential for HT-001 to manage dermatologic side effects without interfering with life-saving cancer treatments.

HT-001 was also well tolerated, with no treatment discontinuations reported.

Pharmacokinetic (PK) analysis further demonstrated that HT-001 achieves approximately 99% lower systemic exposure compared to FDA-approved oral therapies, supporting a targeted delivery profile designed to maximize local efficacy while minimizing systemic side effects.

Building on these positive results, Hoth has received regulatory approval in Hungary, enabling expansion of the Phase 2 clinical trial into Europe. The Company anticipates additional regulatory approvals in Spain and Poland, with site activations expected in the near term. In the United States, an additional clinical site is expected to be activated, further accelerating patient enrollment and data generation.

"The achievement of these interim results, combined with strong patient-reported outcomes and the ability to maintain uninterrupted cancer therapy, represents a meaningful advancement for HT-001," said Robb Knie Chief Executive Officer of Hoth Therapeutics. "With over 65% of patients reporting reductions in pain and itching, along with a favorable safety profile and expanding global clinical footprint, we believe HT-001 is well positioned as a differentiated therapy addressing a critical unmet need in oncology supportive care."

Dermatologic toxicities remain a significant challenge for patients undergoing cancer treatment, often leading to discomfort, reduced quality of life, and in some cases treatment modification or discontinuation. HT-001’s ability to demonstrate primary endpoint achievement, meaningful symptom improvement, and zero disruption to EGFR inhibitor therapy may represent a compelling advancement over existing treatment options.

(Press release, Hoth Therapeutics, APR 1, 2026, View Source [SID1234664133])

On April 1, 2026 Celldex Therapeutics, Inc. ("Celldex" or the "Company") (Nasdaq: CLDX) reported the pricing of an underwritten public offering of 10,345,000 shares of its common stock at a public offering price of $29.00 per share. All of the shares to be sold in the offering are to be sold by Celldex. In connection with the offering, Celldex has also granted the underwriters a 30-day option to purchase up to an additional 1,551,750 shares of common stock at the public offering price, less the underwriting discounts and commissions. The Company expects to receive gross proceeds from the offering, excluding the exercise of the underwriters’ option, if any, of approximately $300 million, excluding the underwriting discounts and commissions and other offering-related expenses. The offering is expected to close on or about April 6, 2026, subject to customary closing conditions.

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Celldex intends to use the net proceeds of this offering, together with our existing cash, cash equivalents, and marketable securities, (i) to fund ongoing commercial readiness activities and the commercial launch of barzolvolimab, if approved, for the treatment of CSU in the United States, (ii) to continue the clinical and preclinical development of our product candidates, including current and future development of barzolvolimab, (iii) to grow our bispecific antibody platform and clinical candidates, (iv) to fund ongoing efforts to develop additional clinical pipeline product candidates and (v) for general corporate purposes.

Leerink Partners, TD Cowen, Guggenheim Securities and Cantor are acting as joint bookrunning managers for the offering. LifeSci Capital and H.C. Wainwright & Co. are acting as co-lead managers for the offering.

The offering is being made pursuant to a shelf registration statement on Form S-3 (File No. 333-275300), which was previously filed with the Securities and Exchange Commission ("SEC") and became automatically effective on November 3, 2023. This offering is being made only by means of a prospectus supplement and accompanying base prospectus that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. A final prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source When available, copies of the final prospectus supplement and the accompanying base prospectus may be obtained for free by contacting Leerink Partners LLC, Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525 ext. 6105 or by email at [email protected] or TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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, Celldex Therapeutics, APR 1, 2026, View Source [SID1234664132])

On April 1, 2026 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, reported that the first patient has been enrolled in the landmark global phase 3 BATTMAN (CO.33) trial (NCT07152821). This study is evaluating Agenus’ immunotherapy combination of botensilimab (BOT) plus balstilimab (BAL) versus best supportive care in patients with refractory, unresectable microsatellite stable (MSS)/mismatch repair proficient (pMMR) metastatic colorectal cancer (mCRC), a population long considered resistant to immunotherapy.

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This study is being conducted as a cooperative group trial led by the Canadian Cancer Trials Group (CCTG) from Canada and run across Canada, France, Australia and New Zealand. More than 100 sites will participate across the academic cooperative networks of CCTG, GI Cancer Trials in Australia and France’s Partenariat de Recherche en Oncologie Digestive (PRODIGE) consortium (including Unicancer, GERCOR and FFCD). The BATTMAN (CO.33) trial serves as the registrational-enabling study for BOT+BAL enrolling approximately 830 patients and is expected to complete global enrollment quickly, reflecting the unprecedented investigator and patient enthusiasm worldwide, including strong interest from sites and physicians engaged through Agenus’ paid named patient and French AAC access programs.

"Enrollment of the first patient in the BATTMAN study marks a key milestone for Agenus and the BOT+BAL program," said Dr. Steven O’Day, Chief Medical Officer, Agenus. "This study advances our goal of developing effective immunotherapies for patients who currently have few options. We’re grateful to our partners at CCTG, GI Cancer Trials in Australia, and PRODIGE and to the dedicated investigators, site staff, and patients driving this global effort."

"Our collaboration with Agenus builds on years of cooperative-group research aimed at bringing immunotherapy benefits to patients with microsatellite-stable colorectal cancer—those historically left without effective options," said Dr. Chris O’Callaghan, DVM, PhD, Senior Investigator, Canadian Cancer Trials Group. "Earlier CCTG studies suggested that doublet immunotherapy could extend survival even in cold tumors, and the magnitude and durability of responses seen with botensilimab and balstilimab in earlier studies warrant their investigation in a phase 3 trial."

"The enthusiasm among investigators has been remarkable—within days of Health Canada submission, leading centers across Canada moved to open the study. We’re eager to advance this global effort and potentially transform outcomes for patients who have exhausted all other treatments," said Dr. Jonathan Loree, MD, MSc, FRCPC, CO.33 Study Chair.

About the BATTMAN (CO.33) Trial

The BATTMAN (CCTG CO.33) (NCT07152821) trial is a global Phase 3, randomized, controlled study evaluating botensilimab (BOT) plus balstilimab (BAL) versus best supportive care in patients with refractory, unresectable microsatellite stable (MSS)/mismatch repair proficient (pMMR) colorectal cancer. Conducted as an international cooperative group study led by the Canadian Cancer Trials Group (CCTG), the trial will enroll approximately 830 patients across more than 100 sites in Canada, France, Australia, and New Zealand. Participating academic networks include CCTG, the GI Cancer Trials, and France’s Partenariat de Recherche en Oncologie Digestive (PRODIGE), sponsored by UNICANCER. This registrational-enabling study is designed to support potential regulatory submissions for BOT+BAL in this difficult-to-treat patient population. Patients interested in learning more about the study, including eligibility and enrollment information, can visit: View Source

(Press release, Agenus, APR 1, 2026, View Source [SID1234664131])

On April 1, 2026 Voro Therapeutics, a biotechnology company pioneering tumor-activated biologics to improve the safety and efficacy of cancer therapies, reported upcoming oral presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 and the Antibody Engineering & Therapeutics (AET) Europe conference.

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Voro Therapeutics will present new preclinical data showcasing the power of its proprietary PrimeBody biologics platform and the broad therapeutic index of its lead program, VOR-101. The presentations will demonstrate how PrimeBody’s novel protease-cleavable linkers and affinity-tuned masking domains drive tumor-selective activation, enabling the safe and effective deployment of highly potent warheads that are not achievable with conventional approaches. Voro will also highlight the platform’s broader potential through applications in T-cell engagers, antibody-drug conjugates and cytokines.

Presentation Details

American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026

San Diego Convention Center • San Diego, CA • April 17–22, 2026

Date: April 20th, 2026

Session: MS.IM01.02 – Advances in Therapeutic Antibodies

Title: Tumor-Activated PrimeBody Biologics Platform Enables More Potent CD47 Targeting and Superior Therapeutic Index in Preclinical Models

Presenter: Aaron Springer, PhD, Associate Director of Preclinical Biology, Voro Therapeutics

Conference Link: View Source

Antibody Engineering & Therapeutics (AET) Europe

Congress Center Basel • Basel, Switzerland • May 27–29, 2026

Date: May 29th, 2026

Session: Masked, Gated, Conditionally Activated Antibodies

Title: Tumor-Activated PrimeBody Platform Unlocks the Safe and Effective Delivery of Potent Biologics Beyond the Reach of Conventional Approaches

Presenter: Ugur Eskiocak, PhD, Co-Founder and CEO, Voro Therapeutics

Conference Link: https://informaconnect.com/antibody-engineering-europe/

(Press release, Voro Therapeutics, APR 1, 2026, View Source [SID1234664129])

On April 1, 2026 TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, reported financial results for the Company’s fourth quarter and full year ended December 31, 2025, and provided a corporate update.

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"2025 was a strong year of executing upon our goals, and we continue to move all our programs forward this year. As we progress our clinical development pipeline, we have strategically strengthened our clinical and drug development expertise with Craig Tendler, M.D., providing the strategic and operational services consistent with those of a Chief Medical Officer to oversee clinical development strategy and operations of the company’s pipeline, including our VISTA inhibiting antibody, TBS-2025," said Dr. James Bianco, President and CEO of TuHURA Biosciences. "Craig brings a depth of experience that is invaluable to us as we look forward to several targeted key milestones in our VISTA program this year. Our IFx-2.0 Phase 3 study in front-line Merkel Cell Carcinoma (MCC) continues to enroll, and we now anticipate completing enrollment in mid-2027. Additionally, we continue to make important advancements toward preclinical proof-of-concept in our first-in-class immune modulating antibody drug conjugates (ADC) program and anticipate presenting new data at a scientific conference later this year."

Dr. Bianco continued, "We are grateful to have the unwavering support of our shareholders, who are committed to supporting our programs and realizing the potentially meaningful opportunity each one addresses."

Corporate Highlights

•
Initiated a randomized Phase 3 Accelerated Approval Trial for IFx-2.0 in first line treatment of patients with advanced or metastatic Merkel Cell Carcinoma (MCC) as adjunctive therapy to Keytruda (pembrolizumab). Phase 3 study trial being conducted under a Special Protocol Assessment (SPA) agreement with U.S. Food and Drug Administration (FDA). Primary endpoint of Overall Response Rate (ORR) qualifies for accelerated approval process. Key secondary endpoint of Progression Free Survival (PFS) may satisfy the requirement for a post confirmatory trial, converting accelerated approval to regular approval.

•
Initiated Phase 1b/2a Study of IFx-2.0 as an adjunctive therapy to Keytruda (pembrolizumab) in first line treatment for metastatic Merkel Cell Carcinoma of Unknown Primary Origin (MCCUP). Trial designed to evaluate the safety and feasibility of IFx-Hu2.0 in combination with Keytruda when administered via Interventional Radiology (IR) in patients with deep- seated tumors without associated cutaneous tumors.

•
Closed acquisition of Kineta gaining rights to TBS-2025, a novel VISTA inhibiting antibody, for $10.5 million.

•
Raised gross proceeds of $21.2 million in registered direct offerings and private placements

•
Presented data demonstrating the Delta Opioid Receptor (DOR) as a new target in overcoming acquired resistance to immune checkpoint inhibitors at ASH (Free ASH Whitepaper). Selected for Oral Presentation by the Scientific Committee of American Society of Hematology (ASH) (Free ASH Whitepaper) new scientific evidence that DOR is expressed on tumor-associated Myeloid-Derived Suppressor Cells (MDSCs), and its inhibition decreases immune suppressing capabilities of MDSCs by downregulating expression of multiple genes associated with MDSC induced immunosuppression. Data also presented in the poster session demonstrated that the DOR is also expressed on tumor associated macrophages (TAMs) and DOR inhibition appears to reverse TAM mediated T cell suppression with the potential to overcome resistance to checkpoint inhibitors and other cancer immunotherapies.

Upcoming Targeted Milestones by Program

IFx-2.0 (Innate immune agonist)

•
1H 2026: Anticipate Orphan Drug Designation for IFx-2.0 in MCC
•
2H 2026: Anticipate preliminary data from the Phase1b/2a study of IFx-2.0 as an adjunctive therapy to Keytruda (pembrolizumab) in first line treatment for metastatic Merkel Cell Carcinoma of Unknown Primary Origin (MCCUP)
•
2H 2027: Anticipate topline results from the Phase 3 accelerated approval trial of IFx-2.0 as an adjunctive therapy to Keytruda (pembrolizumab) in first line treatment for advanced or metastatic MCC

TBS-2025 (VISTA inhibiting antibody)

•
June 2026: Meeting with the FDA to discuss the development plan for TBS-2025 in NPM1 mut r/r AML

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2H 2026: Anticipate initiation of Phase 1b/2 trial of VISTA in NPM1 mut r/r AML

Lead ADC Selection

•
1H 2026: Select lead ADC in AML
•
2H 2026: Expect to initiate ADC in vivo proof of concept (POC) studies
•
2H 2026: Anticipate POC data in humanized model of AML
•
2H 2026: Presentations at key scientific meetings

Summary of Financial Results for the Full Year 2025

Cash and cash equivalents of $3.6 million at December 31, 2025, with an additional $7.5 million received in Q1 2026 from the 2025 registered direct offering. As of December 31, 2025, TuHURA’s total shares outstanding were approximately 52.9 million.

Research and development expenses were $20.5 million and $13.3 million for the 12 months ended December 31, 2025, and 2024, respectively. On a pro forma basis, which includes a full year of Kineta research and development, these expenses were $22.1 million and $18.7 million for the 12 months ended December 31, 2025, and 2024, respectively.

General and administrative (G&A) expenses were $7.6 million and $3.9 million for the 12 months ended December 31, 2025, and 2024, respectively.

Net cash outflows from operating activities were ($27.7) million and ($14.7) million for the 12 months ended December 31, 2025, and 2024, respectively.

Net cash flows from financing activities were $19.9 million and $29.7 million for the 12 months ended December 31, 2025, and 2024, respectively.

(Press release, TuHURA Biosciences, APR 1, 2026, View Source [SID1234664128])