Financial Data and Key Metrics Changes - Research and development (R&D) expenses decreased to $12.4 million for Q1 2025 from $18.9 million in Q1 2024, a reduction of $6.5 million primarily due to lower clinical development expenses [12] - General and administrative (G&A) expenses were $5.3 million for Q1 2025, down from $5.6 million in Q1 2024, reflecting a decrease of $300,000 [13] - Net loss for Q1 2025 was $15.3 million compared to a net loss of $23.2 million in Q1 2024, indicating improved financial performance [13] - Cash and cash equivalents as of March 31, 2025, were $32.4 million, down from $49 million as of December 31, 2024 [13] Business Line Data and Key Metrics Changes - The Phase one dose escalation study for the dual conditionally binding EpCAM and CD3 T cell engager is progressing well, with multiple patients achieving tumor reduction [6] - The MACV ADC demonstrated a two-year landmark survival of 59% in MKRAS non-small cell lung cancer patients, significantly higher than the less than 20% reported for standard care [7] - The OSV ADC showed a 100% disease control rate and a 45% overall response rate in treatment-refractory HPV positive head and neck cancer patients [9] Market Data and Key Metrics Changes - The company is focusing on the HPV positive head and neck cancer segment, which is currently underserved by existing treatments [9] - The overall survival data for MACV across different solid tumor types, including soft tissue sarcomas, indicates a strong market potential for the product [8] Company Strategy and Development Direction - The company is committed to advancing its CAD platform and is focusing on two internal priority programs while seeking partnerships for others [14][42] - Ongoing discussions with potential collaborators aim to maximize the value of the company's assets, particularly in the context of pivotal trials and accelerated approval opportunities [26][44] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the progress of clinical programs and the potential impact of their therapies on patients with challenging solid tumors [15] - The company anticipates that cost reductions from recent restructuring will provide sufficient runway to fund operations and achieve key clinical readouts in the first half of 2026 [14] Other Important Information - The company has received Fast Track designation from the FDA for its OSV program, facilitating discussions regarding treatment options for metastatic HPV positive squamous cell carcinoma [10] - Management highlighted the importance of overall survival as a key metric in evaluating the effectiveness of their therapies compared to standard care [38] Q&A Session Summary Question: Will the poster presentation for the ROAR-two program at ASCO contain an updated data cut? - Yes, there will be an updated data cut including additional safety data and long-term outcomes [20] Question: Any thoughts on a pivotal design for the actual program and options for accelerated approval? - The pivotal trial would likely be randomized against docetaxel in second and third line patients, with FDA guidance supportive of this approach [25][26] Question: Can you provide details on tumor regressions and patient therapy duration for the EpCAM program? - Two patients with colorectal adenocarcinoma have shown extended progression-free intervals, with ongoing dose escalation and no concerning safety issues reported [33][34] Question: What is the ideal partnership structure for the company? - The company seeks multiple partnerships, aiming to maintain substantial value in North America while generating cash value through upfront and near-term milestones [41][44]

Financial Data and Key Metrics Changes - In Q1 2025, total revenues were approximately €183 million, a slight decrease from €188 million in Q1 2024, reflecting expected seasonality in the COVID-19 vaccine market [26] - Research and development expenses increased to €526 million from €508 million in the prior year, driven by late-stage clinical studies [26] - The net loss for Q1 2025 was €416 million, compared to a net loss of €350 million in the same period last year, with a basic and diluted loss per share of €1.73 versus €1.31 [27][28] Business Line Data and Key Metrics Changes - The oncology segment is advancing with multiple clinical trials, including BNT327, which is being developed for various cancer types, including triple-negative breast cancer and small cell lung cancer [14][15] - The COVID-19 vaccine franchise remains a significant revenue driver, with preparations for a variant-adapted vaccine for the upcoming season [8] Market Data and Key Metrics Changes - The addressable market for the second-line endometrial cancer treatment is estimated at around 10,000 patients in the US and Europe, indicating a sizable opportunity [41] - The company anticipates stable vaccination rates and market shares for its COVID-19 vaccine, with revenue guidance for 2025 expected to be between €1.7 billion and €2.2 billion [30][31] Company Strategy and Development Direction - The company aims to become a fully integrated biopharmaceutical company with a focus on oncology, particularly through the development of BNT327 and mRNA cancer immunotherapies [28][36] - There is a strong emphasis on combination therapies to improve treatment outcomes across various cancer types, with ongoing investments in clinical development and commercialization capabilities [12][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of their oncology pipeline to establish new standards of care and improve patient outcomes [12][25] - The company is closely monitoring regulatory changes and public sentiment regarding COVID-19 vaccines, which could impact future revenues [31][56] Other Important Information - The company announced a new Chief Financial Officer, Ramon Sapater, who will take over in July 2025, as current CFO Jens Holstein prepares for retirement [10][34] - The company is diversifying its manufacturing supply base for BNT323, currently reliant on a China-based CDMO, to mitigate risks associated with tariffs [41][44] Q&A Session Summary Question: What is the addressable population for endometrial cancer? - The estimated second-line market in endometrial cancer is about 10,000 patients in the US and Europe [41] Question: How do you see the NSCLC market evolving in five years? - Both bispecifics and ADCs will play a role in the NSCLC market, with the expectation that clinical benefit thresholds will evolve over time [50][72] Question: What impact do you anticipate from the CDC's upcoming vote on COVID boosters? - The company expects the market is already oriented towards a risk-based vaccination approach, with a base scenario of around 20% vaccination rates continuing [55] Question: Can you elaborate on the Phase II and Phase III trial timelines for BNT327? - The Phase II portion of the Rosetta trial will be completed later this year, with data to inform the Phase III portion [87] Question: How do you plan to manage toxicity observed in initial data for BNT327? - The stomatitis rate in combination with TROP-two ADC was comparable to that observed with BNT325 alone, indicating no additional additive toxicity [94]

Core Viewpoint - TuHURA Biosciences has initiated a Phase 1b/2a trial for IFx-Hu2.0 in combination with Keytruda® to evaluate safety and feasibility in patients with deep-seated tumors, expanding the potential patient population for this treatment [1][2][4]. Group 1: Trial Details - The Phase 1b/2a trial is designed to assess the safety and feasibility of IFx-Hu2.0 as an adjunctive therapy to Keytruda® in adult patients with non-cutaneous Merkel cell carcinoma (MCC) [4]. - The trial will enroll a total of nine patients with hepatic, pulmonary, or retroperitoneal lesions, administering IFx-Hu2.0 (0.1 mg) weekly for three weeks, followed by pembrolizumab [4]. - The primary endpoint is the safety and feasibility of IFx-Hu2.0 evaluated 28 days after the last dose, with secondary endpoints including efficacy assessed at three and six months [4]. Group 2: Future Plans - If the trial demonstrates safety and feasibility, TuHURA plans to extend enrollment to other non-MCC cancers that poorly respond to checkpoint inhibitors [3]. - The company is preparing to initiate a Phase 3 accelerated approval trial of IFx-Hu2.0 as an adjunctive therapy to Keytruda® for first-line treatment of advanced or metastatic MCC [5][9]. - The FDA has agreed to the trial's design under the accelerated approval pathway, with overall response rate (ORR) as the primary endpoint [6][7]. Group 3: Company Overview - TuHURA Biosciences is focused on developing novel technologies to overcome resistance to cancer immunotherapy, addressing a significant challenge in cancer treatment [8]. - The lead product candidate, IFx-Hu2.0, is designed to overcome primary resistance to checkpoint inhibitors, with prior trials showing promise in various skin cancers [9][10].

MARLBOROUGH, Mass., April 23, 2025 (GLOBE NEWSWIRE) -- Akoya Biosciences, Inc. (NASDAQ:AKYA) ("Akoya"), The Spatial Biology Company®, today announced a collaboration with the Singapore Translational Cancer Consortium (STCC) on the STCC Unified PD1/PDL1 Evaluation of Response (SUPER) study. This initiative aims to identify and validate key biomarkers predicting response or refractoriness to immune checkpoint inhibitors using Akoya's IO60 panel for spatial proteomic analysis. Advancing Precision Immunotherapy ...

Core Points - Anixa Biosciences has received a Notice of Allowance for a new patent related to its breast cancer vaccine technology, which broadens the scope of immunogenic compositions used in the vaccine [1][2] - The patent covers methods of immunizing patients against breast cancer using an immunogenic composition containing the human α-lactalbumin protein, which is expressed in certain breast cancers [2] - The CEO of Anixa highlighted that this patent enhances the company's intellectual property portfolio, which includes multiple issued and pending patents in the U.S. and internationally [3] Company Overview - Anixa Biosciences is a clinical-stage biotechnology company focused on cancer treatment and prevention, with a therapeutic portfolio that includes an ovarian cancer immunotherapy program developed in collaboration with Moffitt Cancer Center [3] - The company's vaccine portfolio includes vaccines for breast and ovarian cancer, as well as other cancer vaccines targeting high incidence malignancies such as lung, colon, and prostate cancers [3] - Anixa's business model involves partnerships with renowned research institutions, allowing the company to explore emerging technologies for further development and commercialization [3]

Core Insights - TuHURA Biosciences, Inc. has appointed Dr. Bertrand Le Bourdonnec as Executive Vice President, Head of Drug Discovery, Early Development, and Program Management, bringing extensive experience in drug discovery and development [1][3][4] Company Overview - TuHURA is a Phase 3 registration-stage immuno-oncology company focused on developing novel technologies to overcome resistance to cancer immunotherapy, addressing a significant challenge in cancer treatment [6][8] - The company is preparing to initiate a Phase 3 trial for its lead candidate, IFx-2.0, as an adjunctive therapy to Keytruda® for advanced or metastatic Merkel Cell Carcinoma [7] Leadership and Expertise - Dr. Le Bourdonnec has a proven track record in leading R&D programs across various therapeutic areas, including oncology and pain management, and is an expert in the biochemistry and pharmacology of the Delta Opioid Receptor (DOR) [2][4] - His previous roles include Chief Scientific Officer at HDAX Therapeutics and VP at Deciphera Pharmaceuticals, where he managed significant teams and contributed to the development of novel therapeutics [4][5] Technology and Innovation - TuHURA is leveraging its DOR technology to develop first-in-class bi-specific Antibody Drug Conjugates (ADCs) and Antibody Peptide Conjugates (APCs) targeting Myeloid Derived Suppressor Cells (MDSCs) to enhance the immune response in the tumor microenvironment [8] - The company aims to address unmet medical needs and transform treatment paradigms for cancer patients through innovative drug development [4][6]

Core Insights - Anixa Biosciences has received a Notice of Allowance from the USPTO for a key patent application related to its ovarian cancer vaccine technology, which targets Anti-Mullerian Hormone Receptor, Type II (AMHR2) [1][4] - The ovarian cancer vaccine is being developed in collaboration with Cleveland Clinic and the National Cancer Institute, focusing on high-risk populations such as those with BRCA mutations [2] - The allowed claims cover methods of administering an immunogenic composition that elicits an AMHR2-specific immune response [3] Company Overview - Anixa is a clinical-stage biotechnology company dedicated to cancer treatment and prevention, with a focus on ovarian cancer immunotherapy and a unique CAR-T technology [4] - The company collaborates with renowned research institutions to develop vaccines for various cancers, including breast, lung, colon, and prostate cancers, targeting "retired" proteins expressed in these malignancies [4] - Anixa's business model emphasizes partnerships at all stages of development, allowing for the exploration of emerging technologies for commercialization [4]