PASADENA, CALIF, July 02, 2025 (GLOBE NEWSWIRE) -- Lixte Biotechnology Holdings, Inc. (NASDAQ: LIXT) (the “Company”), a clinical stage pharmaceutical company, today announced the closing of a private placement with accredited investors for the purchase and sale of approximately $5.0 million of shares of Common Stock (or Pre-Funded Warrants), Series B Convertible Preferred Stock and Common Warrants. The offering was priced at the market under Nasdaq rules. The offering consisted of the sale of an aggregate o ...

BOSTON, June 27, 2025 (GLOBE NEWSWIRE) -- Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering the next generation of precision cancer medicines, today announced that the first patient has been dosed in the Phase 1/2 trial of TNG462 and Revolution Medicines’ daraxonrasib (RAS(ON) multi-selective inhibitor) or zoldonrasib (RAS(ON) G12D-selective inhibitor) in patients with MTAP-deleted and RAS mutant metastatic pancreatic or lung cancer. “Almost all MTAP-de ...

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Summary of Tango Therapeutics Conference Call Company Overview - **Company**: Tango Therapeutics - **Industry**: Biotechnology, specifically focused on oncology and synthetic lethality Core Insights and Arguments - **Synthetic Lethality Platform**: Tango's discovery platform is based on synthetic lethality, which targets tumor suppressor gene loss that cannot be directly targeted due to their inactivation. This approach supplements existing therapies that focus on activated oncogenes [2][3] - **Pipeline Development**: Tango is advancing its lead asset, TNG-462, a PRMT5 inhibitor, which is synthetic lethal with MTAP deletions, common in lung and pancreatic cancers. The company is nearing the end of a Phase III study for this asset [8][9] - **Durability of Treatment**: The efficacy of TNG-462 is highlighted by its durability in patients, with some remaining on treatment for over a year, which is notable compared to standard chemotherapy options [10][11] - **Tolerability Profile**: TNG-462 is reported to have a best-in-class tolerability profile, making it suitable for patients with difficult-to-treat cancers [12] Pipeline Details - **TNG-462**: Focused on pancreatic and lung cancers, with plans to present data from over 20 patients in each category later this year [10] - **TNG-456**: A next-generation brain-penetrant asset aimed at glioblastoma, which has a high prevalence of MTAP deletions. This asset is expected to deliver more drug into the brain due to increased selectivity [13][15] - **TNG-260**: A coREST inhibitor targeting STK11 mutation patients, which represents a significant opportunity in non-small cell lung cancer. The program is currently in dose expansion [30][31] Competitive Landscape - **Key Competitors**: The primary competitors identified are Bristol Myers Squibb (BMS) and Amgen, with Tango believing it has a competitive edge in terms of pharmacokinetics (PK) and tolerability [21][22] - **Market Positioning**: Tango positions itself as a leader in the PRMT5 space, with a significant lead over other companies like AstraZeneca and BeiGene [22] Combination Strategies - **Combination with RAS Mutations**: Tango is initiating a study combining TNG-462 with RAS mutation-targeted therapies, which is expected to be transformative for pancreatic and lung cancer patients [27] - **Focus on Tolerability**: The company is monitoring overlapping toxicities in combination therapies but expects good tolerability based on existing safety profiles [29] Financial and Strategic Focus - **Capital Allocation**: Tango's capital allocation strategy is heavily focused on advancing the development of TNG-462 for pancreatic cancer, with plans to start a pivotal study next year [38] - **Investor Perception**: There is a belief that investors have underestimated the importance of PRMT5 as a target and Tango's position in the market. The company asserts it is well-resourced to compete effectively [36][37] Additional Insights - **Innovative Approach**: Tango's approach to synthetic lethality and its focus on specific genetic mutations (like STK11 and MTAP) are seen as innovative and potentially game-changing in oncology [30][31] - **Clinical Proof of Concept**: The company has demonstrated that its findings in animal models translate to human patients, reinforcing the validity of its therapeutic strategies [32][34]

Group 1 - IDEAYA Biosciences, Inc. is participating in two upcoming investor relations events: the 2025 Jefferies Global Healthcare Conference on June 4th and the Goldman Sachs 46th Annual Global Healthcare Conference on June 9th [1] - The CEO, Yujiro S. Hata, will be featured in fireside chats at both conferences, hosted by equity research analysts from Jefferies and Goldman Sachs [1] - A live audio webcast of the events will be available on the IDEAYA website, with replays accessible for 30 days post-event [1] Group 2 - IDEAYA is focused on precision medicine in oncology, developing targeted therapeutics based on molecular diagnostics [2] - The company integrates capabilities in identifying and validating translational biomarkers with drug discovery to optimize patient selection for its therapies [2] - IDEAYA is particularly focused on synthetic lethality, an emerging class of precision medicine targets [2]

Forward-Looking Statements Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events, Tango's future operating performance and goals, the anticipated benefits of therapies and combination therapies (that include a Tango pipeline product), as well as the expectations, beliefs and development objectives for Tango's product pipeline and clinical trials. In some cases, you can identify forward-looking statements by termino ...

Core Insights - IDEAYA Biosciences, Inc. provided a business update and announced financial results for Q1 2025, highlighting significant progress in its clinical programs and financial position [1][2]. Financial Overview - As of March 31, 2025, IDEAYA had approximately $1.05 billion in cash, cash equivalents, and marketable securities, down from $1.08 billion at the end of 2024, primarily due to operational cash usage [4][16]. - The company projects that its current cash balance will fund operations into 2029 based on its updated operating plan [17]. - The net loss for Q1 2025 was $72.2 million, a decrease from a net loss of $130.3 million in Q4 2024 [22]. Clinical Development Highlights - The darovasertib program received U.S. FDA breakthrough therapy designation, with over 300 patients enrolled in the registrational trial for HLA-A2-negative metastatic uveal melanoma (MUM) [2][4]. - The company is targeting a median progression-free survival (PFS) readout by the end of 2025 to enable a potential accelerated approval filing [4][5]. - IDEAYA is advancing multiple clinical programs, including IDE849 for lung cancer, IDE275 for MSI-high colorectal and endometrial cancer, and IDE397 for MTAP-deletion lung and urothelial cancer [2][4]. Research and Development Updates - The Phase 3 trial for darovasertib as neoadjuvant therapy for primary uveal melanoma is expected to enroll approximately 520 patients, with a focus on eye preservation and visual acuity outcomes [5][6]. - IDEAYA plans to present clinical data updates at medical conferences throughout 2025, including results from darovasertib and other pipeline candidates [4][5]. - The company has initiated a Phase 1 study for IDE849 in small cell lung cancer (SCLC) and is collaborating with Gilead to evaluate IDE397 in combination with Trodelvy® [12][19]. Corporate Developments - IDEAYA appointed Joshua Bleharski as Chief Financial Officer and Shanthakumar Tyavanagimatt as Senior Vice President of Technical Operations, enhancing its leadership team [21]. - The company formed a collaboration with ATTMOS to develop a computational platform for small molecule discovery, aiming to unlock oncology targets [21].

Financial Data and Key Metrics Changes - The company reported a strong cash position of $243 million as of December 2024, providing a cash runway into 2027 [42] Business Line Data and Key Metrics Changes - FHD-909 is highlighted as a highly selective oral inhibitor of SMARCA2, with multibillion-dollar potential, particularly targeting SMARCA4 mutated non-small cell lung cancer [5][6] - The collaboration with Eli Lilly, initiated in December 2021, is noted as one of the largest deals for preclinical programs in the industry, with significant upfront payment and downstream participation for the company [7] Market Data and Key Metrics Changes - SMARCA4 mutations are found in approximately 5% of all human cancers, with non-small cell lung cancer showing about 10% prevalence of these mutations [11] - The median overall survival for patients with SMARCA4 mutations in metastatic non-small cell lung cancer is reported at 8 months, compared to 15 months for wild-type counterparts [12] Company Strategy and Development Direction - The company aims to develop FHD-909 as a standard frontline therapy for patients with non-small cell lung cancer harboring SMARCA4 mutations, addressing a significant unmet medical need [28][29] - The strategy includes defining the potential added benefit of FHD-909 in combination with leading therapies such as pembrolizumab and platinum-based combinations [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of FHD-909 to change the treatment landscape for patients with SMARCA4 mutations, emphasizing the urgent need for novel agents in this area [29] - The company is focused on advancing its proprietary pipeline programs, including selective CBP and EP300 degraders, which are expected to enhance its position in oncology [31][32] Other Important Information - The company is currently enrolling patients in the monotherapy dose-finding portion of the FHD-909 study, with plans for combination studies in anticipation of successful dose escalation [29] - The proprietary pipeline includes three additional programs that are advancing toward the clinic, showcasing the company's commitment to innovative cancer therapies [31] Q&A Session Summary Question: Can you enrich the backfill cohorts for specific characteristics? - Yes, the company can select specific doses and backfill those levels with specific indications and SMARCA4 alterations [45] Question: How will trial progress be communicated? - The company intends to align with Eli Lilly on clinical data disclosure, aiming to communicate results at the end of dose escalation [46] Question: Are SMARCA4 alterations detectable through standard panels? - Yes, SMARCA4 alterations can be detected using conventional FDA-approved NGS panels and immunohistochemistry [61] Question: What is the therapeutic index for FHD-909? - The dosing holidays at the higher dose were due to accumulation in rodents, not a lack of tolerability, indicating a favorable therapeutic window [62] Question: What is the potential for the ARED1B degrader program? - The company is excited about the selective degradation of ARED1B and is waiting for a complete story before disclosing further updates [74] Question: Will there be partnerships for the proprietary pipeline? - The company is not in a rush to partner but anticipates that strategic partnerships will be beneficial as they progress their proprietary pipeline [76]

SOUTH SAN FRANCISCO, Calif., April 28, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced its participation in the upcoming investor relations events.Barclays Hosted: Peter Lawson's Catalyst & Key Debate Calls & Investor 1x1'sThursday, May 8th, 2025 at 11:00 AM ET Fireside chat with Yujiro S. Hata, President and Chief Executive Officer, hosted by Peter Lawson, D.Phil., Managing Dir ...

Core Insights - IDEAYA Biosciences has initiated a Phase 1/2 expansion clinical trial for IDE397, a potential first-in-class MAT2A inhibitor, in combination with Gilead's Trodelvy for treating MTAP-deletion urothelial cancer based on preliminary safety and efficacy data [1][10]. Company Overview - IDEAYA Biosciences is focused on precision medicine in oncology, aiming to discover and develop targeted therapeutics using molecular diagnostics to identify patient populations that would benefit most from its therapies [8]. Clinical Development - The combination of IDE397 and Trodelvy is being explored due to the high unmet medical need in MTAP-deletion urothelial cancer, where no approved therapies currently exist [3]. - The prevalence of MTAP-deletion in urothelial cancer is estimated to be around 26% [2][10]. - A clinical program update regarding the IDE397 and Trodelvy combination is expected in 2025, alongside other studies for IDE397 as a monotherapy in MTAP-deletion non-small cell lung cancer (NSCLC) and urothelial cancer [5]. Collaboration and Rights - IDEAYA and Gilead retain commercial rights to their respective compounds under a clinical study collaboration and supply agreement, with IDEAYA acting as the study sponsor [6].