Core Insights - Aura Biosciences, Inc. has initiated a multi-dose Phase 1b/2 trial of bel-sar for Non-Muscle-Invasive Bladder Cancer (NMIBC), with initial data expected by the end of 2025 [1][14] - The company has strengthened its leadership team by appointing Tony Gibney as Chief Financial and Business Officer [1][18] - Aura is making significant progress in its ocular and urologic oncology programs, particularly with the Phase 3 CoMpass trial for early-stage choroidal melanoma [2][3] Recent Pipeline Developments - The CoMpass trial is the first registration-enabling study for early-stage choroidal melanoma, actively enrolling patients globally [3][4] - Over 220 patients have been pre-screened for the CoMpass trial since June 2024, indicating a strong demand for vision-preserving therapies [4] - Bel-sar is also being explored for metastases to the choroid and cancers of the ocular surface, with a collective incidence of over 60,000 patients annually in the U.S. and Europe [6][10] Clinical Trials and Data - A Phase 2 trial for bel-sar in metastases to the choroid has been initiated, with plans to broaden inclusion criteria to include various solid tumors [7] - Positive results from a completed Phase 1 trial for NMIBC showed multiple clinical complete responses and a favorable safety profile [12] - The ongoing Phase 1b/2 trial for NMIBC will evaluate two approaches, with endpoints including complete response rates and recurrence-free survival [13][14] Financial Overview - As of March 31, 2025, Aura reported cash and cash equivalents totaling $128.0 million, sufficient to fund operations into the second half of 2026 [18] - Research and development expenses increased to $23.3 million in Q1 2025 from $17.1 million in Q1 2024, driven by clinical trial costs [19] - The net loss for Q1 2025 was $27.5 million, compared to $19.7 million in Q1 2024, reflecting increased operational expenses [24]

Eight Swiss sites are activated in the INVINCIBLE-4 Study, and several patients have been treated European Medicines Agency Authorization to initiate INVINCIBLE-4-Study in FranceSHELTON, Conn., May 13, 2025 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition ...

Survival observations in mTNBC patients correlated with increased PD-L1 expression Preliminary evidence suggests leronlimab has potential to turn “cold” tumors “hot” VANCOUVER, Washington, May 13, 2025 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced new data suggesting a novel mechanism of action of leronlimab for the treatment of solid tumors ...

Enrollment on track in Phase 2 pivotal portion of PYNNACLE clinical trial evaluating rezatapopt as monotherapy in patients with TP53 Y220C and KRAS wild-type advanced solid tumorsInterim analysis from Phase 2 PYNNACLE trial expected mid-2025; PMV plans to provide interim analysis data for approximately 50 patients with at least 18 weeks of follow-upCash, cash equivalents, and marketable securities of $165.8 million as of March 31, 2025, providing expected cash runway to end of 2026 PRINCETON, N.J., May 09, ...

Lisata Therapeutics (LSTA) Q1 2025 Earnings Call May 08, 2025 04:30 PM ET Company Participants John Menditto - Vice President of Investor Relations & Corporate CommunicationsDavid Mazzo - President and Chief Executive OfficerJames Nisco - SVP of Finance, Treasurer, CAO & Principal Financial & Accounting OfficerKristen Buck - EVP of R&D and Chief Medical OfficerSara Nik - Senior Associate - Equity ResearchPeter Enderlin - Portfolio Manager Conference Call Participants Kemp Dolliver - Director - Research & Se ...

Lisata Therapeutics (LSTA) Q1 2025 Earnings Call May 08, 2025 04:30 PM ET Speaker0 Welcome to the Losada Therapeutics First Quarter twenty twenty five Financial Results and Business Update Conference Call. Currently, participants are in listen only mode. Following management's prepared remarks, we will hold a Q and A session. As a reminder, this call is being recorded today, Thursday, 05/08/2025. I will now turn the call over to John Mendito, Vice President of Investor Relations and Corporate Communications ...

Encouraging results of Cohort A data from the ASCEND trial presented at ASCO-GI 2025;Cohort B results from the ASCEND trial accepted for an oral presentation at ESMO-GI 2025 Cash runway extending into the third quarter of 2026 with no debt Conference call scheduled for today at 4:30 p.m. Eastern Time BASKING RIDGE, N.J., May 08, 2025 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatm ...

1Q25 Total Product Revenue of $49.3M FY25 Total Product Revenue Guidance Revised to $250M-$300M FY25 Operating Expenses Reduced and 2H26 Cash Runway Guidance Maintained 2025 Regulatory Approvals for Amtagvi® Expected in the UK, EU, and Canada On Track to Report Updated Clinical Data for Registrational Trialin Previously Treated Advanced NSCLC in 2H25 SAN CARLOS, Calif., May 08, 2025 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, ...

SAN CARLOS, Calif., May 02, 2025 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, will report its first quarter 2025 financial results and corporate updates on Thursday, May 8, 2025. Management will host a conference call and live audio webcast to discuss these results and provide a corporate update on May 8, 2025 at 4:30 p.m. ET. ...

PRINCETON, N.J., May 01, 2025 (GLOBE NEWSWIRE) -- Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) (the "Company" or "Sonnet"), a clinical-stage company developing immunotherapeutic drugs targeting the tumor microenvironment (TME), today announced it will present at the 6th Annual Cytokine-Based Drug Development Summit being held May 15-16, 2025 in Boston, MA. Details of the presentation are as follows: Title: Managing Toxicity Caused by The Over Expression of Cytokines to Widen the Therapeutic WindowSes ...