On May 15, 2025 Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, reported financial results for the quarter ended March 31, 2025, and provided recent business updates (Press release, Elevation Oncology, MAY 15, 2025, View Source;utm_medium=rss&utm_campaign=elevation-oncology-reports-first-quarter-2025-financial-results-and-provides-business-updates [SID1234653166]).

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"We recently presented preclinical proof-of-concept data for EO-1022, reaffirming its potential as a differentiated HER3 ADC, and supporting our goal of providing a safer and more effective option for patients with HER3-expressing solid tumors," said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. "In parallel, we are engaged in efforts to explore a range of strategic alternatives, with the objective of identifying and capitalizing on the opportunity that is in the best interest of our shareholders. We look forward to providing an update at the appropriate time."

Recent Business Updates

Pipeline

Elevation Oncology is developing EO-1022, a HER3 antibody-drug conjugate (ADC) for the treatment of patients with HER3-expressing solid tumors, including breast cancer and non-small cell lung cancer. The Company expects to file an Investigational New Drug (IND) application for EO-1022 in 2026.

In April 2025, Elevation Oncology presented new preclinical proof-of-concept data supporting the development of EO-1022 in a late-breaking poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The in vitro and in vivo data indicate EO-1022 may offer reduced payload-associated toxicity and an improved safety profile, as well as improved anti-tumor activity, for patients living with solid tumors that express HER3. Specifically, data show:
EO-1022 is highly stable in human serum, with a homogenous drug-to-antibody ratio (DAR) of 4 and minimal free payload compared to seribantumab-vcMMAE and patritumab-DXd, two benchmark HER3 ADCs, both of which use stochastic conjugation. These findings illustrate that a key feature of EO-1022 is minimal systemic exposure to free payload, potentially resulting in reduced payload-associated toxicity in patients and an improved safety profile.
EO-1022 exhibits potent in vitro cytotoxicity that is dependent on HER3 expression levels.
EO-1022 elicits anti-tumor activity in in vivo models of low, medium and high HER3 expression levels, including in a patient derived xenograft (PDX) model of low HER3-expressing EGFR-mutant lung cancer.
Corporate

In March 2025, Elevation Oncology elected to discontinue development of EO-3021. In parallel, the Company implemented a workforce reduction of approximately 70%. Elevation Oncology is in the process of evaluating strategic options with a commitment to maximizing shareholder value. There is currently no timetable set for completion of the strategic alternatives review process.
Financial Outlook

Elevation Oncology ended the first quarter of 2025 with $80.7 million in cash, cash equivalents and marketable securities. Subsequent to the first quarter, on May 2, 2025, Elevation Oncology voluntarily prepaid the $32.3 million aggregate principal, interest, fees and expenses due under its loan agreement with K2 HealthVentures LLC. Elevation Oncology expects that a significant majority of expenses incurred in relation to its workforce reduction and EO-3021 program closure will be paid in the second quarter of 2025.

Elevation Oncology estimates that it will have cash, cash equivalents and marketable securities in a range of approximately $30 million to $35 million as of June 30, 2025, which is expected to fund its current operations into the second half of 2026.

First Quarter 2025 Financial Results

Research and development expenses for the first quarter of 2025 were $6.9 million, compared to $6.0 million for the first quarter of 2024. The increase of $0.9 million was primarily due to $1.3 million of increased costs associated with the preclinical development of EO-1022 and a $0.6 million increase in clinical trial expenses for EO-3021, partially offset by a $1.0 million decrease in clinical trial expenses for seribantumab.

General and administrative expenses for the first quarter of 2025 were $4.0 million, compared to $3.9 million for the first quarter of 2024. The increase of $0.1 million was mainly due to increased personnel costs, including stock-based compensation.

Restructuring charges were $3.4 million for the first quarter of 2025 and consisted primarily of charges related to the workforce reduction in connection with the discontinuation of development of EO-3021. No such charges were incurred during the first quarter of 2024.

Net loss for the first quarter of 2025 was $14.2 million, compared to $10.7 million for the first quarter of 2024.

About EO-1022

Elevation Oncology is developing EO-1022, a potentially differentiated HER3 ADC for the treatment of HER3-expressing solid tumors, including breast cancer and non-small cell lung cancer. EO-1022 consists of seribantumab, a fully human IgG2 anti-HER3 antibody, site-specifically conjugated at glycan to the MMAE payload with a DAR of 4. It leverages seribantumab’s desirable internalization properties and advanced site-specific ADC technology which makes possible the use of the potent cytotoxic MMAE payload. Elevation Oncology expects to file an IND application in 2026.

On May 15, 2025 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a novel, FDA-cleared drug-delivery device, reported its financial results and business updates for the first quarter ended March 31, 2025 (Press release, Renovorx, MAY 15, 2025, View Source [SID1234653182]). RenovoCath powers RenovoRx’s patented Trans-Arterial Micro-Perfusion (TAMP) therapy platform.

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"I am pleased to report a milestone event for RenovoRx: Q1 was our first full quarter of RenovoCath commercial sales, generating approximately $200,000 in revenue. Moreover, this revenue exceeded our internal expectations, and we anticipate this positive trend to continue as we expect sequential quarterly growth for the foreseeable future," said Shaun Bagai, CEO of RenovoRx. "Additionally, we believe that the approximately twenty cancer centers that have used RenovoCath as part of our ongoing Phase III TIGeR-PaC trial could also become potential customers after the planned completion of trial enrollment later this year. Our enthusiasm about the value proposition of our company has never been higher as we dual track the growth of our commercial efforts and progress our clinical trial towards important milestones later this year."

RenovoCath Commercialization Update

The first quarter of 2025 represented RenovoRx’s first full quarter of generating revenue from commercial sales. This is the result of the important strategic decision in 2024 to focus on implementing a commercial strategy for RenovoCath in tandem with the ongoing Phase III TIGeR-PaC trial.

RenovoRx planned to launch its commercial efforts for RenovoCath during the first quarter of this year in response to anticipated strong demand for the patented RenovoCath device. However, the Company received purchase orders ahead of schedule, generating $43,000 in revenue in December alone. RenovoCath is gaining strong traction, with over ten non-TIGeR-PaC medical institutions including several esteemed, high-volume, academic and community, and National Cancer Institute-designated centers who have initiated purchase orders. RenovoRx believes that many of the twenty cancer centers that have used RenovoCath as part of the TIGeR-PaC trial could also be potential customers for RenovoCath after completion of TIGeR-PaC enrollment, anticipated for later this year. Additionally, early utilization of RenovoCath devices by initial customers has led to repeat purchase orders.

RenovoRx believes that the initial total addressable market for RenovoCath (TAM) represents an estimated $400 million peak annual U.S. sales opportunity. In calculating this sales opportunity, the Company is assuming an average of 8 procedures per patient and 7,000 initial target patients at peak market penetration in patient populations where RenovoRx already has clinical usage, with catheter pricing between $6,500-$8,500 per device.

Looking ahead, RenovoRx sees expansion opportunities across other cancer indications that could create the potential for a several-billion-dollar U.S. TAM for RenovoCath over time. The prospect of penetrating even a small portion of this market combined with the potential to help patients is driving the Company’s excitement about this opportunity.

Ongoing Pivotal Phase III TIGeR-PaC Trial Update

During the first quarter of 2025, RenovoRx announced that Johns Hopkins Medicine has now initiated enrollment in the ongoing Phase III TIGeR-PaC trial. This is a valuable addition to the distinguished network of clinical cancer sites across the U.S. participating in this important trial as RenovoRx works towards full enrollment. RenovoRx is continuing to evaluate additional sites and expects that Phase III TIGeR-PaC trial will achieve full enrollment during 2025.

The current protocol and statistical analysis plan for the Phase III TIGeR-PaC trial requires 114 randomized patients, with 86 events, or deaths, necessary to complete the final analysis. As of May 2, 2025, 91 patients have been randomized and 56 events have occurred, triggering the second interim analysis. RenovoRx anticipates the Phase III TIGeR-PaC Data Monitoring Committee will review trial data in the third quarter of 2025 and looks forward to receiving their recommendations and feedback.

First Quarter 2025 and Subsequent Key Highlights

During and subsequent to the first quarter, RenovoRx presented abstracts at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium 2025, the Society of Interventional Oncology 2025, and the Society of Surgical Oncology 2025 supporting the TAMP therapy platform via additional human pharmacokinetic (PK) data and pre-clinical data. Additionally, a publication supporting TAMP for targeted locoregional drug delivery was recognized in the Journal of Vascular and Interventional Radiology Award-Winning Paper Scientific Session during the Society of Interventional Radiology 2025 conference.

Subsequent to the first quarter of 2025, RenovoRx announced the issuance of a new U.S. patent for the Company’s TAMP therapy platform, further enhancing the Company’s intellectual property protection. RenovoRx now holds a robust portfolio of 19 patents in multiple countries across the globe, including 9 U.S. patents as well as 7 U.S. patents pending. RenovoRx’s strong and growing intellectual property portfolio provides key support to the Company’s continuing commercialization of RenovoCath. The issuance of this new patent highlights the innovation behind the TAMP therapy platform and strengthens the Company’s competitive position.

Finally, during the first quarter 2025, RenovoRx announced that in the most recent open trading window, members of the management team and Board purchased an aggregate of approximately 143,000 shares of the Company’s stock in multiple open market purchases.

Financial Highlights for the First Quarter Ended March 31, 2025:

● Revenue: RenovoRx reported revenues of approximately $200 thousand from commercial sales of the RenovoCath device.
● Cash Position: As of March 31, 2025, the Company had $14.6 million in cash and cash equivalents. The Company anticipates that the growing revenues from RenovoCath will reduce its burn rate, and that cash as of March 31, 2025, will fully fund both the RenovoCath scale-up and the continued progress towards completion in the Phase III TIGeR-PaC trial.
● R&D Expenses: Research and development expenses were $1.7 million, compared to $1.3 million in Q1 2024. The $0.4 million increase was due to an increase in employee compensation due to cost-of-living adjustments, an increase in manufacturing and non-recurring engineering costs to support commercial scale-up, an increase in conference and trade show activity, and an increase in other R&D activity.
● SG&A Expenses: Selling, general, and administrative expenses were approximately $1.6 million, up from $1.2 million for Q1 2024. The $0.4 million increase was due to an increase in personnel and benefits, an increase in professional and consulting fees to support commercialization, and an increase in other G&A activity.
● Net Loss: Net loss was $2.4 million, compared to $1.1 million in Q1 2024. The $1.3 million increase was due to an increase in loss from operations of $0.6 million and a $0.8 million decrease in the fair value of the common warrant liability.
● Shares Outstanding: As of May 9, 2025, shares of common stock outstanding totaled 36,572,232.

Conference Call Details

Event: RenovoRx First Quarter 2025 Financial Results Conference Call
Date: Thursday, May 15, 2025
Time: 4:30 p.m. ET
Live Call: 1-877-407-4018 (U.S. Toll Free) or 1-201-689-8471 (International)
Webcast: View Source

For interested individuals unable to join the conference call, a dial-in replay of the call will be available until May 29, 2025, and can be accessed by dialing 1-844-512-2921 (U.S. Toll Free) or 1-412-317-6671 (International) and entering replay pin number: 13753595.

A question-and-answer session will occur at the end of the call, and a link to the recording of this presentation will be available on RenovoRx’s Investor Relations website after the event.

On May 15, 2025 Agendia, Inc., reported that new data on its comprehensive genomic tests will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper), taking place May 30th – June 3rd, 2025, in Chicago, Illinois (Press release, Agendia, MAY 15, 2025, View Source [SID1234653200]).

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The selected abstracts draw upon data from the ongoing FLEX Study (NCT03053193), which recently reached a significant milestone of 20,000 enrolled patients, nearly 10,000 of which have reached 3-year follow-up and 4,000 have reached 5-year follow-up. This real-world evidence study is providing critical insights into how genomic testing can address disparities in early-stage breast cancer care and optimize treatment selection across diverse patient populations. Since its launch in April 2017, the FLEX Study has enrolled patients across 100 sites in the U.S. and around the world, including 12 NCI-designated cancer centers, and has conducted over 40 sub-studies in several topics.

"The 2025 ASCO (Free ASCO Whitepaper) Annual Meeting provides an important platform to share our latest findings from the FLEX Study, which now includes crucial survival metrics for a modern cohort of early-stage breast cancer patients," said William Audeh, MD, MS, Chief Medical Officer at Agendia. "The exceptional follow-up rates enable meaningful analysis of correlations between patient-reported genetic ancestry, molecular classifications, and treatment approaches, reinforcing the value of genomic testing in guiding equitable treatment decisions."

The following are details of the abstracts that have been accepted as poster presentations:

Association of MammaPrint and clinical outcomes by race among 5000 individuals with HR+HER2- early-stage breast cancer enrolled in FLEX
Author: Cobain, E., et al.
Presenter: Erin Cobain MD, Associate Professor in the Division of Hematology/Oncology at the University of Michigan Medical School, Ann Arbor and co-Principal Investigator of the SWOG S2206 Trial
Session: Quality Care/Health Services Research
Date / Time: Saturday, May 31, 2025 | 1:30 – 4:30 PM CDT

Real-World Evidence from FLEX: Utility of MammaPrint in guiding treatment planning for patients aged 70 and older with early-stage breast cancer
Author: Mahtani, R., et al.
Presenter: Reshma Mahtani, DO, Baptist Health Miami Cancer Institute, Chief of Breast Medical Oncology at Baptist Health Wellness and Medical Complex
Session: Quality Care/Health Services Research
Date / Time: Saturday, May 31, 2025 | 1:30 – 4:30 PM CDT

Association of ImPrintTN signature with survival outcomes by race in Basal-Type Triple Negative Breast Cancer (TNBC)
Author: Sharma, P., et al.
Presenter: Priyanka Sharma, MD, Professor, Medical Oncology, University of Kansas Medical Center
Session: Breast Cancer – Local/Regional/Adjuvant
Date / Time: Monday, June 2, 2025 | 9:00 AM – 12:00 PM CDT

Molecular Insights into HR+/HER2+ Early-Stage Breast Cancer: Neoadjuvant Therapy Responses by MammaPrint and BluePrint genomic subtypes
Author: Samijan, L., et al.
Presenter: Adam Brufsky, MD, PhD, Professor and Associate Chief of Hematology and Oncology at UPMC Hillman Cancer Center
Session: Breast Cancer – Local/Regional/Adjuvant
Date / Time: Monday, June 2, 2025 | 9:00 AM – 12:00 PM CDT
More information about the program can be found at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting website.

On May 15, 2025 Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue, reported financial results and recent corporate highlights for the first quarter ended March 31, 2025 (Press release, Fortress Biotech, MAY 15, 2025, View Source [SID1234653167]).

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Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, "Fortress entered 2025 with strong momentum following a transformational fourth quarter marked by the U.S. Food and Drug Administration ("FDA") approvals of Emrosi and UNLOXCYT, and the acceptance of the New Drug Application ("NDA") for CUTX-101. In the first quarter 2025, our Fortress-founded partner company, Checkpoint Therapeutics, Inc., ("Checkpoint"), signed a merger agreement with Sun Pharma providing for Checkpoint’s acquisition by Sun Pharma, which we believe will enable broader patient access for Checkpoint’s UNLOXCYT (cosibelimab-ipdl) product and trigger a significant monetization event for Fortress — including an expected ~$28 million at closing, future potential royalties, and a potential CVR payment. These outcomes continue to validate Fortress’ business model — identifying, developing, and advancing innovative therapies with strategic optionality for value creation."

Dr. Rosenwald continued, "Looking ahead, we are focused on key value drivers, including the September 30, 2025 Prescription Drug User Fee Act ("PDUFA") action date for CUTX-101, which may also result in a Priority Review Voucher for our subsidiary, Cyprium Therapeutics, upon approval. Commercial launch of Emrosi is also underway with initial prescriptions filled at the end of March. Fortress’ robust pipeline — including multiple late-stage programs and newly approved products — positions us for continued revenue growth, value-driving milestones, and additional monetization opportunities. We remain committed to delivering innovative therapies to patients while building long-term shareholder value."

Recent Corporate Highlights1:

Monetization Updates

● In March 2025, our subsidiary Checkpoint entered into an agreement to be acquired by Sun Pharmaceutical Industries Limited (together with its subsidiaries and/or associated companies, "Sun Pharma"). Fortress owns approximately 6.9 million shares (including Class A Common on an as-converted basis) of Checkpoint’s common stock and is eligible to receive a 2.5% royalty on future sales of UNLOXCYT, pursuant to a royalty agreement between Checkpoint, Sun Pharma and Fortress. Upon completion of the transaction, Sun Pharma will acquire all outstanding shares of Checkpoint, and Checkpoint stockholders will receive, for each share of common stock they hold, an upfront cash payment of $4.10, without interest, and a non-transferable contingent value right ("CVR") entitling the stockholder to receive up to an additional $0.70 in cash if cosibelimab is approved prior to certain deadlines in the European Union pursuant to the centralized approval procedure or in Germany, France, Italy, Spain or the United Kingdom, subject to the terms and conditions in the CVR agreement. The closing of the transaction is subject to various conditions including the approval by requisite majorities of holders of Checkpoint’s shares at a special meeting of Checkpoint’s stockholders on May 28, 2025. We expect the transaction to close shortly after the stockholder meeting, assuming the requisite votes are received, although there can be no assurance that the transaction closes in a timely manner, or at all.

Regulatory Updates

● In November 2024, the FDA approved Emrosi (Minocycline Hydrochloride Extended-Release Capsules, 40mg), also known as DFD-29. Emrosi has the potential to be the new treatment paradigm for the millions of patients suffering from inflammatory lesions of rosacea. In March 2025, we announced the launch of Emrosi by our partner company, Journey Medical Corporation ("Journey Medical") (Nasdaq: DERM).
● In December 2024, the FDA approved UNLOXCYT, also known as cosibelimab, our anti-PD-L1 antibody, as a treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma ("cSCC") who are not candidates for curative surgery or radiation. UNLOXCYT was developed at our partner company, Checkpoint (Nasdaq: CKPT).
● The FDA accepted the NDA submission for CUTX-101 (copper histidinate for Menkes disease) for priority review with a PDUFA goal date of September 30, 2025. In December 2023, we completed the asset transfer of CUTX-101 to Sentynl Therapeutics ("Sentynl"), a wholly owned subsidiary of Zydus Lifesciences Ltd. Sentynl completed the rolling submission of the NDA for CUTX-101 in the fourth quarter of 2024. Cyprium Therapeutics, our subsidiary company that developed CUTX-101, will retain 100% ownership over any FDA Priority Review Voucher that may be issued at NDA approval.

Commercial Product Updates

● Journey Medical’s net product revenues for the first quarter ended March 31, 2025, were $13.1 million, compared to net product revenues of $13.0 million for the first quarter ended March 31, 2024.
● At the end of March 2025, Journey Medical announced the launch of, and the first prescriptions filled for, Emrosi for the treatment of inflammatory lesions of rosacea in adults. Emrosi is available by prescription at specialty pharmacy chains.

Clinical Updates

● In March 2025, we announced that full results from two Phase 3 multicenter, randomized, double-blind, parallel-group, active-comparator and placebo-controlled clinical trials, Minocycline Versus Oracea in Rosacea-1 ("MVOR-1") and Minocycline Versus Oracea in Rosacea-2 ("MVOR-2"), evaluating Emrosi for the treatment of moderate-to-severe papulopustular rosacea in adults, were published in the Journal of the American Medical Association – Dermatology. The results demonstrated the efficacy, safety and tolerability of oral DFD-29 in rosacea. The full publication is available at View Source Information on such website is not a part of this release.
● In January 2025, we announced that the first patient was dosed in a multicenter, placebo-controlled and randomized Phase 2 clinical trial to evaluate Triplex, a cytomegalovirus ("CMV") vaccine, when administered to human leukocyte antigen matched related stem cell donors to reduce CMV events in patients undergoing hematopoietic stem cell transplantation. Triplex is currently in development at our subsidiary company, Helocyte, Inc.

General Corporate:

● In March 2025, Fortress entered into a strategic collaboration with Partex NV to identify and evaluate biopharmaceutical compounds using artificial intelligence for potential acquisition or licensing by Fortress.
● In February 2025, our partner company Mustang Bio, Inc. ("Mustang") raised net proceeds of $6.8 million in a public offering.
● Also in February 2025, Mustang announced the exit of the lease for its manufacturing facility in Worcester, Massachusetts and concurrent divestment of certain fixed assets including furniture and equipment to AbbVie Bioresearch Center Inc. for $1.0 million.

Financial Results:

● As of March 31, 2025, Fortress’ consolidated cash and cash equivalents totaled $91.3 million, compared to $57.3 million as of December 31, 2024, an increase of $34.0 million during the quarter.
● Fortress’ consolidated cash and cash equivalents totaling $91.3 million as of March 31, 2025, includes $19.5 million attributable to Fortress and the private subsidiaries, $3.5 million attributable to Avenue, $33.0 million attributable to Checkpoint, $14.2 million attributable to Mustang Bio and $21.1 million attributable to Journey Medical.
o Fortress’ consolidated cash and cash equivalents totaled $57.3 million as of December 31, 2024, and included $20.9 million attributable to Fortress and private subsidiaries, $2.6 million attributable to Avenue, $6.6 million attributable to Checkpoint, $6.8 million attributable to Mustang and $20.3 million attributable to Journey Medical.
● Fortress’ consolidated net product revenue totaled $13.1 million for the first quarter ended March 31, 2025, which is generated from Journey Medical’s marketed dermatology products. This compares to consolidated revenue totaling $13.0 million for the first quarter of 2024.
● Consolidated research and development expenses totaled $3.9 million for the first quarter ended March 31, 2025, compared to $24.8 million for the first quarter ended March 31, 2024.
● Consolidated selling, general and administrative costs were $25.7 million for the first quarter ended March 31, 2025, compared to $17.9 million for the first quarter ended March 31, 2024.
● Consolidated net loss attributable to common stockholders was $(12.7) million, or $(0.48) per share, for the first quarter ended March 31, 2025, compared to net loss attributable to common stockholders of $(17.9) million, or $(1.04) per share for the first quarter ended March 31, 2024.

On May 15, 2025 TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, reported financial results for the Company’s first quarter ended March 31, 2025, and provided a corporate update (Press release, TuHURA Biosciences, MAY 15, 2025, View Source [SID1234653183]).

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"TuHURA has had an impressive start to 2025, and we continue to execute our corporate strategy as we drive towards TuHURA’s four major clinical data readouts anticipated over the next 24 months. We recently initiated our Phase 1b/2a study of IFx-Hu2.0 in combination with pembrolizumab in checkpoint-naïve MCCUP patients. Evaluating IFx-Hu2.0 in MCCUP patients is an important component of our overall strategy for the program, as the Phase 1b/2a trial will include patients without skin lesions who present with metastatic deep-seated tumors in the liver, lungs or retroperitoneum (abdomen), who are not eligible to participate in our Phase 3 accelerated approval trial due to the trial’s primary lesion enrollment criteria. Approximately 30% of MCC patients have unknown primary lesions, and demonstrating safety and efficacy in the MCCUP patient population would allow us the opportunity to provide IFx-Hu2.0 to more patients with MCC," said James Bianco, M.D., President and Chief Executive Officer of TuHURA Biosciences. "We are also moving towards initiating our Phase 3 accelerated approval trial of IFx-Hu2.0 in first-line advanced and metastatic MCC and anticipate the lifting of the manufacturing-related partial clinical hold in the coming weeks. Our Phase 3 trial, for which we have an SPA agreement with the FDA, will be a single randomized placebo-controlled trial of IFx-Hu2.0 as adjunctive therapy with Keytruda (pembrolizumab) as a first-line therapy for advanced and metastatic Merkel cell carcinoma (MCC), and, if positive, may satisfy the requirement for a post-approval confirmatory trial, saving time, money and risk associated with a second trial."

"In addition to our IFx-Hu2.0 drug candidate, we continue to assemble an exciting late-stage pipeline through our pending acquisition of Kineta, Inc. and its VISTA inhibitor antibody, KVA12123. We are targeting to close the acquisition later this quarter subject to financing and other conditions and advance KVA12123 into a Phase 2 trial in relapsed or refractory NPM1-mutated AML where VISTA expression on leukemic blasts is believed to be responsible for how leukemic cells escape immune recognition contributing to poor responses to therapy and high rates of relapse," stated Dr. Bianco. "We are also developing tumor microenvironment modulators in the form of bi-specific immune modulating Antibody Peptide Conjugates (APCs) and Antibody Drug Conjugates (ADCs) targeting myeloid-derived suppressor cells (MDSCs). We plan to present data at a scientific conference this year on the discovery of high-expression delta opioid receptor (DOR) and the effect on MDSCs and M2 macrophages in the tumor environment. We believe that our DOR program has the potential to reprogram the function of MDSCs and M2 macrophages within the tumor microenvironment, which could have broad implications," concluded Dr. Bianco.

Corporate Highlights

Initiation of Phase 1b/2a Study of IFx-Hu2.0 as Adjunctive Therapy to Keytruda in 1L MCCUP. In May 2025, TuHURA announced that it initiated its Phase 1b/2a trial of IFx-Hu2.0 as an adjunctive therapy to pembrolizumab in MCCUP. This Phase 1b/2a trial is investigating safety and feasibility of IFx-Hu2.0 when administered via interventional radiology to patients with deep-seated tumors who would not be eligible for the Phase 3 trial.
Presentation of Two Posters at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. In April 2025, TuHURA presented a poster at the AACR (Free AACR Whitepaper) Annual Meeting outlining a greater than 90% VISTA receptor occupancy following treatment with Kineta’s VISTA inhibitor mAb as monotherapy and in combination with pembrolizumab in advanced solid tumors. Additionally, the Markowitz Lab at Moffitt Cancer Center presented a poster of IFx-Hu2.0, demonstrating increased T Cell and B Cell production in peripheral blood relative to tumor tissue following adjunctive administration of IFx-Hu2.0 in combination with pembrolizumab.
Appointment of Dr. Bertrand Le Bourdonnec as Head of Drug Discovery. In April 2025, TuHURA announced the appointment of Dr. Le Bourdonnec as the Company’s Executive Vice President, Head of Drug Discovery, Early Development and Program Management. Dr. Le Bourdonnec has extensive experience in the biology and molecular pharmacology of the DOR, TuHURA’s core target on MDSCs for the Company’s emerging suite of ADC and APC development candidates.
Appointment of Dr. Craig L. Tendler to Board of Directors. In March 2025, TuHURA announced the appointment of industry veteran Dr. Craig Tendler to its Board of Directors. Dr. Tendler brings to TuHURA decades of experience in cancer therapeutic development, and most recently served as Johnson & Johnson’s Vice President, Oncology Clinical Development. During his tenure at J&J, Dr. Tendler oversaw 30 major drug approvals, and led development planning from proof of concept through registration and life-cycle management, for J&J’s treatments in hematological malignancies and more prevalent solid tumor diseases.
Upcoming Anticipated Milestones by Program

IFx-Hu2.0

Q2 2025: TuHURA anticipates the FDA’s complete response letter lifting the partial clinical hold relating to completion of certain CMC requirements.
Q2 2025: Initiation of Phase 3 accelerated approval trial in first line Merkel cell carcinoma
VISTA Inhibiting Monoclonal Antibody

Q2 2025: TuHURA expects to close its acquisition of Kineta, Inc. and Kineta’s VISTA inhibiting mAb.
Q3 2025: Initiation of Phase 2 trial of VISTA inhibiting mAb in combination with a menin inhibitor for the treatment of NPM1-mutated AML.
ADC and APC Development Candidates

TuHURA continues to advance its bi-specific, bi-functional immune modulating ADCs and APCs that target the DOR on MDSCs, inhibiting their immune suppressing effects in the tumor microenvironment while localizing a checkpoint inhibitor like the VISTA inhibiting antibody.
In 2025, TuHURA anticipates presenting non-clinical data at relevant medical meetings.
Financial Results for the Three Months Ended March 31, 2025

Research and development expenses were $4.6 million and $3.6 million for the three months ended March 31, 2025, and 2024, respectively.

General and administrative expenses were $2.4 million and $1.0 million for the three months ended March 31, 2025, and 2024, respectively.

As of March 31, 2025, TuHURA’s total shares outstanding was approximately 43.7 million.

As previously announced, on December 11, 2024, TuHURA entered into a definitive agreement with Kineta, Inc. (OTC Pink: KANT) in which, as amended, TuHURA agreed to acquire Kineta, including the rights to Kineta’s novel KVA12123 antibody, for a combination of cash and shares of TuHURA common stock via a merger transaction upon the terms and conditions described in TuHURA’s Form 8-Ks filed on December 12, 2024 and May 7, 2025. The merger is currently targeted to close in Q2 2025 pending the satisfaction of certain financing and other closing conditions.