Immutep Limited (IMMP, PRRUF) is an immunotherapy-focused biotech that I've covered recently, coming away with an optimistic take on their investment thesis built on pivoting fully into the development of a LAG3I 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 Insights - IMUNON, Inc. is advancing its lead candidate IMNN-001, a DNA-mediated immunotherapy, into Phase 3 trials for treating advanced ovarian cancer, marking a significant milestone in its development program [1][4] - IMNN-001 is the first immunotherapy to demonstrate a meaningful overall survival benefit in a Phase 2 trial for women with advanced ovarian cancer [1][2] - The Phase 3 OVATION 3 trial will compare IMNN-001 combined with chemotherapy against standard care, focusing on overall survival as the primary endpoint [2][5] Company Developments - The first trial site for the OVATION 3 study has been initiated at Washington University School of Medicine, with additional sites being established [1][4] - The OVATION 3 trial will include women with newly diagnosed advanced ovarian cancer, specifically those eligible for neoadjuvant therapy, and will assess various endpoints including surgical response and time to second-line treatment [2][5] - IMUNON plans to present new data from the Phase 2 OVATION 2 study at the upcoming ASCO Annual Meeting in May 2025 [3] Product Information - IMNN-001 is designed using IMUNON's TheraPlas platform, which allows for localized delivery of IL-12, a potent cytokine for inducing anticancer immunity [7][10] - The Phase 2 OVATION 2 study involved 112 patients and evaluated the safety and efficacy of IMNN-001 in combination with standard chemotherapy [5][6] - Epithelial ovarian cancer, the target of IMNN-001, has a high recurrence rate and poor five-year survival rates, highlighting the need for new treatment options [8] Industry Context - Approximately 20,000 new cases of ovarian cancer are diagnosed annually in the U.S., with a significant percentage presenting at advanced stages [8] - The development of IMNN-001 represents a potential breakthrough in a field where standard treatment options have not changed significantly in over 25 years [2][4]

Infectimune® studies funded by and performed by investigators at the National Institute of Allergy and Infectious Diseases (NIAID)’s Center for Influenza Vaccine Research for High-Risk Populations (CIVR-HRP)PRINCETON, N.J., May 08, 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 and infectious diseases, today provided updates on preclinical immune ...

PRINCETON, N.J., May 07, 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 announced that the Company will host a conference call to report financial results for the quarter ended March 31, 2025, and provide a clinical programs update on Wednesday, May 14, 2025 at 8:00 a.m. Eastern Time. Conference Call Details Date: May 14, 2025 Time: 8:00 a ...

Core Viewpoint - Y-mAbs Therapeutics, Inc. announced that naxitamab-gqgk (DANYELZA®) has been recommended as a Category 2A treatment option for high-risk neuroblastoma by the National Comprehensive Cancer Network (NCCN) [1][2] Company Overview - Y-mAbs is a commercial-stage biopharmaceutical company focused on developing and commercializing novel radioimmunotherapy and antibody-based therapeutic products for cancer treatment [8] - The company’s product pipeline includes DANYELZA (naxitamab-gqgk), which is the first FDA-approved treatment for relapsed or refractory high-risk neuroblastoma in patients who have shown a partial response, minor response, or stable disease to prior therapy [8] Product Information - Naxitamab-gqgk (DANYELZA) was granted accelerated approval by the FDA on November 25, 2020, for pediatric patients aged one year and older and adult patients with relapsed or refractory high-risk neuroblastoma [3] - The approval was based on efficacy results from two single-arm, open-label trials [3] - DANYELZA is indicated for use in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) [6] - The product includes a Boxed Warning for serious infusion-related reactions and neurotoxicity [6] NCCN Guidelines - The NCCN is a not-for-profit alliance of 33 leading cancer centers focused on advancing quality cancer care [4] - The inclusion of DANYELZA in the NCCN Guidelines reinforces its position as a leading anti-GD2 therapy for high-risk neuroblastoma [2]

Bioatla (BCAB) Q1 2025 Earnings Call May 06, 2025 04:30 PM ET Company Participants Bruce Mackle - Managing DirectorJay Short - Co-Founder, CEO & ChairmanRichard Waldron - Chief Financial OfficerEric Sievers - Chief Medical OfficerReni Benjamin - Managing DirectorYu He (Arthur) - Equity Research Vice President Conference Call Participants Jeet Mukherjee - Vice President & Biotechnology Analyst Operator Good day, everyone, and welcome to today's BioAtlas First Quarter twenty twenty five Earnings Call. At this ...

Core Insights - Genelux Corporation reported a productive first quarter of 2025, establishing a strong foundation for advancing its lead product, Olvi-Vec, in various cancer indications [2][3] Pipeline Highlights - The FDA provided encouraging feedback on the OnPrime Phase 3 trial for Olvi-Vec in resistant/refractory ovarian cancer, indicating potential for traditional approval if a meaningful progression-free survival advantage is demonstrated [3] - Preliminary data from the Phase 1b/2 trial of Olvi-Vec in small cell lung cancer showed a 71% disease control rate, with significant tumor reductions observed in participants [4] - Patient enrollment is increasing in the ongoing Phase 2 trial for recurrent non-small cell lung cancer, with interim results expected in the second half of 2025 [5] Business Updates - Matthew Pulisic was appointed as the new Chief Financial Officer, bringing over 19 years of experience in the biopharmaceutical industry [6] - The company completed an underwritten offering of 3,000,000 shares at $3.50 per share, raising approximately $10.5 million to strengthen its balance sheet and extend its operational runway [7] Financial Results - As of March 31, 2025, cash, cash equivalents, and short-term investments totaled $35.1 million, expected to provide runway into the third quarter of 2026 [8] - Research and development expenses increased to $4.7 million from $4.0 million year-over-year, primarily due to higher clinical trial costs [9] - General and administrative expenses decreased to $3.1 million from $4.1 million year-over-year [10] - The net loss for the first quarter of 2025 was $7.5 million, or $0.21 per share, compared to a net loss of $7.9 million, or $0.29 per share, in the same period of 2024 [11]

Data from OVATION 2 trial will also be reviewed in an oral presentation at ASCO Annual Meeting on June 3, 2025 LAWRENCEVILLE, N.J., May 06, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today announced that data from the company’s Phase 1/2 OVATION 2 trial evaluating intraperitoneal IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy in newly diagnosed patients with advanced epithelial ovarian canc ...

Core Insights - Y-mAbs Therapeutics, Inc. is set to report its first quarter 2025 results on May 13, 2025, before market opening [1] - A conference call and webcast will be held on the same day at 8:00 a.m. ET to discuss the results, with a live audio webcast available on the company's Investor Relations website [2] Company Overview - Y-mAbs is a commercial-stage biopharmaceutical company focused on developing and commercializing novel radioimmunotherapy and antibody-based therapeutic products for cancer treatment [3] - The company utilizes advanced technologies such as the Self-Assembly DisAssembly (SADA) Pretargeted Radioimmunotherapy Platform (PRIT) and bispecific antibodies from the Y-BiClone platform [3] - Y-mAbs has a broad product pipeline, including DANYELZA® (naxitamab-gqgk), which is the first FDA-approved treatment for relapsed or refractory high-risk neuroblastoma in specific patient conditions [3]

Châtillon, France, May 5, 2025 DBV Technologies to Participate in the Citizens JMP Life Sciences Conference DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced Daniel Tassé, Chief Executive Officer, will participate in a fireside chat at the Citizens JMP Life Sciences Conference on Wednesday, May 7, 2025, at 11:00am ET, in New York, NY. A live webcast of the fireside chat can be accessed here, and will also be availab ...