Workflow
Body
icon
Search documents
Veru(VERU) - 2025 Q2 - Earnings Call Transcript
2025-05-08 13:00
Veru (VERU) Q2 2025 Earnings Call May 08, 2025 08:00 AM ET Speaker0 After this morning's discussion, there will be an opportunity to ask questions. Please note that this event is being recorded. I would now like to turn the conference call over to Mr. Sam Fish, Veru Inc. Executive Director, Investor Relations and Corporate Communications. Please go ahead, sir. Speaker1 Statements made on this conference call may be forward looking statements. Forward looking statements may include, but are not necessarily l ...
Compass Therapeutics Reports 2025 First Quarter Financial Results and Provides Corporate Update
Globenewswire· 2025-05-08 12:00
Core Insights - Compass Therapeutics reported positive progress in its clinical trials, particularly achieving the primary endpoint in the COMPANION-002 trial for tovecimig in biliary tract cancer (BTC) [2][4][5] - The company has a strong financial position with $113 million in cash and marketable securities, providing a cash runway into 2027 [2][13] Clinical Development Updates - Tovecimig (DLL4 x VEGF-A bispecific antibody) achieved a 17.1% overall response rate (ORR) in the COMPANION-002 trial, significantly higher than the 5.3% ORR for paclitaxel alone [4][5] - The first patient has been dosed in an Investigator Sponsored Trial (IST) at The University of Texas MD Anderson Cancer Center for tovecimig in the first-line setting for BTC [2][4] - CTX-10726, a PD-1 x VEGF-A bispecific antibody, is on track for an IND filing expected in Q4 2025, with clinical data anticipated in 2026 [2][10] - CTX-8371, a PD-1 x PD-L1 bispecific antibody, has progressed to the fourth dosing cohort in a Phase 1 study, with data expected in the second half of 2025 [2][10] Financial Performance - The net loss for Q1 2025 was $16.6 million, or $0.12 per share, compared to a net loss of $10.8 million, or $0.08 per share, in Q1 2024 [9][18] - Research and Development (R&D) expenses increased by 37% to $13.1 million in Q1 2025, primarily due to additional spending on clinical trials [10][18] - General and Administrative (G&A) expenses rose by 51% to $4.9 million, largely due to increased personnel costs [12][18] Cash Position - As of March 31, 2025, the company had $113 million in cash and marketable securities, down from $127 million at the end of 2024, indicating a cash runway into 2027 [13][20]
ADC Therapeutics to Host First Quarter 2025 Financial Results Conference Call on May 14, 2025
Prnewswire· 2025-05-08 11:15
LAUSANNE, Switzerland, May 8, 2025 /PRNewswire/ -- ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), today announced that it will host a conference call and live webcast on Wednesday, May 14, 2025, at 8:30 a.m. EDT to report financial results for the first quarter 2025 and provide operational updates.To access the conference call, please register here. The participant toll-free dial-in number is 1-800-836-8184 for North America an ...
Merus Announces Financial Results for the First Quarter 2025 and Provides Business Update
Globenewswire· 2025-05-07 20:11
- Petosemtamab in combination with pembrolizumab in 1L PD-L1+ r/m HNSCC phase 2 trial ongoing with clinical data update at 2025 ASCO® Annual Meeting - Based on the Company’s current operating plan, existing cash, cash equivalents and marketable securities expected to fund Merus’ operations into 2028 UTRECHT, The Netherlands and CAMBRIDGE, Mass., May 07, 2025 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), an oncology company developing innovative, full-length multispecific an ...
Y-mAbs Announces Update to National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for Neuroblastoma to Include Naxitamab-gqgk (DANYELZA®)
Globenewswire· 2025-05-07 11:05
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]
Y-mAbs to Announce First Quarter 2025 Financial and Operating Results on May 13, 2025
Globenewswire· 2025-05-06 11:05
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]
Syndax(SNDX) - 2025 Q1 - Earnings Call Presentation
2025-05-05 20:29
First Quarter 2025 Financial Results Presentation / May 5, 2025 Forward-looking statements disclosure This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events, progress, timing or circumstances) are intended to identify forward-looking statements. All statements other than statements of hi ...
Spyre Therapeutics Announces Poster Presentations at Digestive Disease Week (DDW) 2025 Including Up to Eight months of Follow-up from an Ongoing Phase 1 Trial of SPY001
Prnewswire· 2025-05-05 12:00
Core Insights - SPY001 is a novel, half-life extended α4β7 antibody in development for the treatment of Inflammatory Bowel Disease (IBD) with a pharmacokinetic profile supporting a potential best-in-class status [1][3] - The company plans to initiate a Phase 2 trial in mid-2025, which will include SPY001 and other candidates, with initial data expected in 2026 [1][2] Group 1: SPY001 Development - SPY001 has shown a human half-life of approximately 80 days, which is more than three times that of vedolizumab, allowing for potential quarterly or biannual dosing [3][4] - Interim data from the Phase 1 trial indicates that SPY001 is well tolerated and maintains target engagement at expected Phase 2 trough concentrations [4] Group 2: Clinical Trials and Future Plans - The Phase 2 platform trial will test SPY001 as a monotherapy and in combination with other therapies for ulcerative colitis patients, expected to begin mid-2025 [2][3] - Initial monotherapy data from the Phase 2 trial is anticipated in 2026 [1] Group 3: Preclinical and Clinical Data - Preclinical studies indicate that combined inhibition of α4β7 integrin and TL1A cytokine is superior to either monotherapy in mouse models of colitis [4] - The pharmacodynamic data supports rapid and sustained saturation of α4β7 receptors with a single dose of SPY001 [1][4] Group 4: Company Overview - Spyre Therapeutics focuses on developing next-generation therapies for IBD and other immune-mediated diseases through advanced antibody engineering and therapeutic combinations [5] - The company's pipeline includes extended half-life antibodies targeting α4β7, TL1A, and IL-23 [5]
VERAXA Biotech Enters Co-discovery Alliance with OmniAb for a Novel Bispecific Antibody Drug Conjugate Program
GlobeNewswire News Room· 2025-05-05 05:00
Core Insights - VERAXA Biotech AG has announced a co-discovery alliance with OmniAb, Inc. to develop a novel bispecific antibody drug conjugate (bsADC) program targeting solid tumors, combining their respective technologies for enhanced therapeutic discovery [1][2] - The collaboration is part of VERAXA's strategy to drive innovation through strategic partnerships, marking its second major initiative in six months [2] - Under the agreement, VERAXA will utilize OmniAb's transgenic antibody discovery solutions to source high-quality human antibody leads and will be responsible for preclinical validation of the bsADC lead candidate [2] Company Overview - VERAXA is focused on the discovery and development of next-generation antibody-based therapeutics, including bispecific ADCs and other innovative formats, leveraging transformative technologies and quality-by-design principles [3] - The company was founded on scientific breakthroughs from the European Molecular Biology Laboratory, emphasizing its commitment to pioneering life science research [3] Business Combination - On April 22, 2025, VERAXA entered into a definitive business combination agreement with Voyager Acquisition Corp., which is expected to lead to VERAXA becoming a publicly traded company on NASDAQ [4] - Voyager Acquisition Corp. aims to revolutionize the healthcare sector through strategic mergers and business combinations, supported by a team with extensive expertise in investing and medical innovation [5]
Summit Therapeutics Q1 Loss Narrower Than Expected, Sales Nil
ZACKS· 2025-05-02 14:05
Core Viewpoint - Summit Therapeutics reported a narrower loss per share in Q1 2025 compared to estimates, but still lacks any marketed products, resulting in no quarterly revenues [1][2]. Financial Performance - The company reported a loss per share of 9 cents, which is better than the Zacks Consensus Estimate of a loss of 10 cents, but wider than the 6 cents loss from the previous year [1]. - Adjusted research and development expenses increased by 65% year over year to $47.1 million, primarily due to rising clinical costs [4]. - Adjusted general and administrative expenses surged 95% year over year to $8.6 million, attributed to higher headcount and commercial readiness efforts [4]. - As of March 31, 2025, the company had cash, cash equivalents, and short-term investments totaling $361.3 million, down from $412.3 million as of December 31, 2024 [5]. Pipeline Developments - Summit has one pipeline drug, ivonescimab, currently undergoing three late-stage studies for non-small cell lung cancer (NSCLC) [6]. - Positive results were reported from the Akeso-sponsored phase III HARMONi-6 study, showing significant improvement in progression-free survival compared to BeiGene's Tevimbra [7]. - The HARMONi-6 study is notable as the first late-stage study in NSCLC to demonstrate significant improvement over a PD-(L)1 inhibitor combined with chemotherapy [8]. - The company is also conducting the HARMONi-3 study, which compares ivonescimab plus chemotherapy against Merck's Keytruda [8]. - Akeso has secured approval for ivonescimab in a second indication based on HARMONi-2 results, although the interim overall survival analysis was not statistically significant [9]. - Summit is exploring partnerships for ivonescimab development across multiple disease areas, including a collaboration with Pfizer to evaluate the drug in combination with several of Pfizer's antibody-drug conjugates [10]. Stock Performance - SMMT's stock has surged 38% year to date, contrasting with a 2% decline in the industry [2].