Core Viewpoint - Edesa Biotech, Inc. is advancing its clinical-stage biopharmaceutical development, particularly focusing on its vitiligo drug candidate EB06, while reporting financial results that reflect a strategic pivot in operational activities towards this program [1][4]. Financial Overview - For the three months ended March 31, 2025, total operating expenses decreased by $0.6 million to $1.6 million compared to $2.2 million for the same period in 2024 [7] - The company reported a net loss of $1.6 million, or $0.30 per common share, for the quarter, an improvement from a net loss of $1.9 million, or $0.58 per common share, for the same quarter last year [8] - For the six months ended March 31, 2025, total operating expenses decreased by $0.6 million to $3.5 million compared to $4.1 million for the same period in 2024 [9] - The net loss for the six months was $3.2 million, or $0.74 per common share, compared to a net loss of $3.5 million, or $1.12 per common share, for the same period last year [11] Business Development - The company completed a $15 million equity financing to support the development of EB06, an anti-CXCL10 monoclonal antibody for vitiligo [2] - Edesa has initiated outreach to potential investigators and manufacturing activities to support U.S. regulatory approval for a Phase 2 study in moderate-to-severe nonsegmental vitiligo patients [2][6] - The planned Phase 2 study for EB06 is already approved in Canada, with drug manufacturing data expected to be submitted to the FDA in the second half of 2025 [6] Research and Development - Research and development expenses decreased by $0.7 million to $0.5 million for the three months ended March 31, 2025, primarily due to decreased external research expenses related to the investigational drug paridiprubart [9][16] - General and administrative expenses increased by $0.2 million to $1.2 million for the three months ended March 31, 2025, mainly due to increased salaries and related costs [9] Cash Position - As of March 31, 2025, Edesa had cash and cash equivalents of $13.9 million and working capital of $13.5 million [12]

American Society of Clinical Oncology (ASCO) GI Symposium data underscores pelareorep's clinical benefit in anal and pancreatic cancersPelareorep featured in Key Opinion Leader event on oncolytic immunotherapies in breast and pancreatic cancersPoster on pelareorep's stimulation of adaptive and innate immunity to be shared at ASCO Annual MeetingConference call and webcast today at 4:30 p.m. ET to discuss Q1 results and clinical outlookSAN DIEGO, Calif. and CALGARY, AB, May 14, 2025 /PRNewswire/ -- Oncolytics ...

PDS Biotechnology (PDSB) Q1 2025 Earnings Call May 14, 2025 08:00 AM ET Company Participants Mike Moyer - Managing DirectorFrank Bedu-Addo - Chief Executive OfficerLars Boesgaard - Chief Financial OfficerMayank Mamtani - Senior Managing Director & Group Head of HealthcareKirk Shepard - Chief Medical Officer Conference Call Participants Joseph Pantginis - MD & Senior Healthcare AnalystJames Molloy - Managing Director, Senior Biotechnology & Specialty Pharmaceuticals Equity Analyst Operator Greetings, and wel ...

PDS Biotechnology (PDSB) Q1 2025 Earnings Call May 14, 2025 08:00 AM ET Speaker0 Greetings, and welcome to the PBS Biotech First Quarter and twenty twenty five Earnings Conference Call. At this time, all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mike Moyer, LifeSci Advisors. Thank you, sir. You may begin. Speaker1 Thank you, operator. Good mor ...

VERSATILE-003 Phase 3 Site Initiations Underway Multiple Abstracts Selected for Presentation at the 2025 American Society of Clinical Oncology Annual Meeting Conference call and webcast today at 8:00 a.m. Eastern Time PRINCETON, N.J., May 14, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today provided a clinical and corporate update and report ...

VERSATILE-003 Phase 3 Site Initiations Underway Multiple Abstracts Selected for Presentation at the 2025 American Society of Clinical Oncology Annual Meeting Conference call and webcast today at 8:00 a.m. Eastern Time PRINCETON, N.J., May 14, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today provided a clinical and corporate update and report ...

Core Insights - Checkpoint Therapeutics has received FDA approval for UNLOXCYT™ (cosibelimab-ipdl), the first and only anti-PD-L1 treatment for advanced cutaneous squamous cell carcinoma (cSCC) [7] - A special meeting of stockholders is scheduled for May 28, 2025, to vote on a merger with Sun Pharmaceutical Industries, with a total transaction value of up to approximately $416 million [7] - Financial results for Q1 2025 show a net loss of $11.2 million, with cash and cash equivalents increasing to $33.0 million from $6.6 million at the end of 2024 [7][31] Recent Corporate Updates - UNLOXCYT is indicated for adults with metastatic or locally advanced cSCC who are not candidates for curative surgery or radiation [5] - The merger agreement with Sun Pharma was announced in March 2025, with Checkpoint continuing as a wholly owned subsidiary [7] - The definitive proxy statement for the merger was filed in April 2025 [7] Financial Results - Cash and cash equivalents as of March 31, 2025, totaled $33.0 million, an increase of $26.4 million from $6.6 million at December 31, 2024 [7] - Research and development expenses for Q1 2025 were $3.8 million, down from $8.5 million in Q1 2024 [7] - General and administrative expenses rose to $7.4 million in Q1 2025 from $2.5 million in Q1 2024 [7] - The net loss for Q1 2025 was $11.2 million, or $0.19 per share, compared to a net loss of $10.9 million, or $0.33 per share, in Q1 2024 [7][31]

Core Insights - Elicio Therapeutics is progressing towards an interim analysis focused on disease-free survival in the Phase 2 AMPLIFY-7P clinical trial, expected in Q3 2025, which is a significant milestone for the company and patients with pancreatic ductal adenocarcinoma [1][2] - The company has aligned with the FDA on key design elements for a planned Phase 3 study of ELI-002, indicating regulatory support for its development [1][8] - Elicio's current cash position of $18.4 million is expected to support operations into Q4 2025, beyond the anticipated interim analysis [6][7] Financial Performance - Research and development expenses for Q1 2025 were $7.8 million, a slight increase from $7.6 million in Q1 2024, primarily due to clinical trial costs [4] - General and administrative expenses rose to $3.0 million in Q1 2025 from $2.7 million in Q1 2024, attributed to higher compensation and benefits [5] - The net loss for Q1 2025 was $11.2 million, compared to $11.8 million in Q1 2024, with a net loss per share of $0.87, down from $1.15 in the previous year [6][10] Clinical Development - ELI-002 is being studied as a potential treatment for mKRAS-driven tumors, with the upcoming interim data readout in PDAC seen as a critical validation opportunity for the AMP platform [2][8] - The company plans to finalize the pivotal Phase 3 trial protocol for ELI-002 in resected mKRAS PDAC in the second half of 2025 [8][19] - Elicio's AMP technology aims to enhance the immune response against cancer by delivering antigens directly to lymph nodes, which may lead to improved therapeutic outcomes [16][17] Corporate Updates - In March 2025, Elicio appointed Preetam Shah, Ph.D., MBA, as Chief Strategy and Financial Officer, indicating a strengthening of its leadership team [8] - The company raised $10 million through a registered direct offering of common stock and warrants in January 2025, bolstering its cash position [8]

CytomX Therapeutics (NASDAQ: CTMX ) is a biotech focused on development of novel immunotherapy approaches for different forms of cancer. In my first coverage of them, I expressed a bullish sentiment primarily onI have my PhD in biochemistry and have worked for years analyzing clinical trials and biotech companies. It is my passion to educate everyone possible on the science behind the businesses that we invest in, and it's my mission to help you do your due diligence and not get burned by the pitfalls of in ...

Core Viewpoint - Y-mAbs Therapeutics, Inc. is set to hold a virtual Radiopharmaceutical R&D update on May 28, 2025, focusing on its ongoing clinical trials and pipeline strategy for cancer treatment [1][2]. Group 1: Upcoming Event Details - The virtual update will cover Part A clinical data from the ongoing Phase 1 GD2-SADA clinical trial, including pharmacokinetic and dosimetry data [2]. - The update will also include information on nonclinical optimization studies for the GD2-SADA asset and plans for clinical implementation [2]. - The duration of the update is expected to be 90 minutes, with a live audio webcast available on the company's Investor Relations website [3]. Group 2: Company Overview - Y-mAbs is a commercial-stage biopharmaceutical company focused on developing novel radioimmunotherapy and antibody-based therapeutic products for cancer treatment [4]. - The company utilizes technologies such as the Self-Assembly DisAssembly (SADA) Pretargeted Radioimmunotherapy Platform (PRIT) and bispecific antibodies generated using the Y-BiClone platform [4]. - The product pipeline includes DANYELZA® (naxitamab-gqgk), the first FDA-approved treatment for relapsed or refractory high-risk neuroblastoma in specific patient populations [4].