SAN FRANCISCO, May 12, 2025 (GLOBE NEWSWIRE) -- In a dramatic turn for Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), investors watched the company's shares plunge nearly 44% on May 9, 2025, after the San Carlos-based cell therapy pioneer reported a first-quarter revenue miss that sharply contradicted earlier upbeat assurances from management. Hagens Berman is now investigating whether Iovance violated U.S. securities laws and urges Iovance investors who suffered substantial losses to submit your losses now. ...

Core Insights - Century Therapeutics, Inc. is set to present at the ASGCT 28th Annual Meeting, showcasing its preclinical cell therapy pipeline targeting autoimmune diseases and cancer [1][2] Presentation Details - The first presentation will focus on enhancing solid tumor elimination using a TGF-b neutralizing synthetic receptor in iPSC-derived allogeneic therapies, scheduled for May 13, 2025 [2] - The second presentation will discuss the generation of iPSC-derived CD4+ and CD8+ CD19 CAR ab T cells, demonstrating in vivo tumor control and cell expansion comparable to healthy donor T cells, set for May 17, 2025 [2] Company Overview - Century Therapeutics is a clinical-stage biotechnology company specializing in iPSC-derived cell therapies, aiming to provide significant advantages over existing therapies [3] - The company is committed to developing off-the-shelf cell therapies to enhance patient access and improve treatment outcomes for autoimmune diseases and cancers [3]

Financial Data and Key Metrics Changes - The base business, excluding Veclury, grew 4% year over year, primarily driven by growth in the HIV business [6][50] - Total product sales, including Veclury, were down by 1% from last year, reflecting fewer COVID-19 related hospitalizations [8][50] - Non-GAAP diluted EPS was $1.81, with a product gross margin flat year over year at 85% [52][54] Business Line Data and Key Metrics Changes - HIV sales were up 6% year over year, with Biktarvy sales increasing by 7% [7][22] - Livedelzi achieved first-quarter sales of $40 million, reflecting early momentum in its launch [27] - Veclury sales were down 45% year over year, reflecting lower rates of COVID-19 related hospitalizations [28] - Trodelvy sales were down 5% year over year, impacted by inventory dynamics and lower average realized price [29][98] - Cell therapy sales were down 3% year over year, with Yescarta sales up 2% year over year [31] Market Data and Key Metrics Changes - The HIV treatment market continues to grow at an expected rate of 23% annually [22] - Descovy sales increased by 38% year over year, driven by higher average realized price and demand [23][78] - The liver disease segment saw sales of $758 million, up 3% year over year [26] Company Strategy and Development Direction - The company is focused on multiple upcoming launches, including lenacapavir, anetocel, and Trodelvy [13][34] - Gilead Sciences, Inc. has no major loss of exclusivity (LOE) until the end of 2033, positioning itself for top-line growth across therapeutic areas [14] - The company is increasing investment in US manufacturing and R&D infrastructure [15][89] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming FDA decision on lenacapavir for PrEP, with a potential launch immediately following [9][38] - The company remains well-positioned to adapt to potential policy outcomes in the US [14] - Management noted that the first quarter was lighter than expected but emphasized the variability of the business [54][93] Other Important Information - Gilead Sciences, Inc. received an upgrade in its long-term debt rating from BBB+ to A- [58] - The company returned $1.7 billion to shareholders in the first quarter of 2025 through dividends and share repurchases [58] Q&A Session Summary Question: Expectations for lenacapavir for PrEP and reimbursement dynamics - Management is excited about the upcoming PDUFA date and expects around 75% access within the first six months post-launch, reaching about 90% at the twelve-month mark [62] Question: Impact of HHS and CDC cuts on launch dynamics - Management has not seen anything that would alter plans for the lenacapavir launch and is actively engaging with policymakers [68] Question: Implications of COVID-19 on Descovy and lenacapavir - Descovy saw a 38% growth year over year, driven by market development initiatives, which supports the opportunity for lenacapavir [78] Question: Tariff risks and US market supply - Management indicated that the majority of Gilead's IP is in the US, which suggests lower value for pharmaceutical imports, and they have invested significantly in US manufacturing [86][89] Question: Cannibalization of Descovy by lenacapavir - Management believes lenacapavir will attract both switch patients from daily orals and naive patients, potentially accelerating market growth [124]

Financial Data and Key Metrics Changes - The base business, excluding Veclury, grew by 4% year-over-year, primarily driven by growth in the HIV business [6][50] - Total product sales, including Veclury, decreased by 1% year-over-year, reflecting fewer COVID-19 related hospitalizations [8][50] - Non-GAAP diluted EPS was reported at $1.81 [56] Business Line Data and Key Metrics Changes - HIV sales increased by 6% year-over-year, with Biktarvy sales up by 7% [7][19] - Livedelzi achieved first-quarter sales of $40 million, reflecting early momentum in its launch [27] - Veclury sales were down 45% year-over-year, totaling $302 million [28] - Trodelvy sales decreased by 5% year-over-year, totaling $293 million [29] - Cell therapy sales were down 3% year-over-year, totaling $464 million [31] Market Data and Key Metrics Changes - The HIV treatment market is expected to grow at an annual rate of 23% [22] - Descovy sales increased by 38% year-over-year, driven by higher average realized price and demand [23] - The liver disease segment saw sales of $758 million, up 3% year-over-year [26] Company Strategy and Development Direction - The company plans to launch multiple products, including lenacapavir and anetocel, to drive growth in HIV and oncology [14][34] - Gilead Sciences, Inc. has no major loss of exclusivity (LOE) until the end of 2033, positioning it well for sustained growth [14] - The company is increasing investments in US manufacturing and R&D infrastructure [15][89] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming FDA decision on lenacapavir for PrEP, with a potential launch immediately following [9][38] - The company remains focused on expense management and expects to adapt to macroeconomic changes [56][57] - Management noted that the average corporate tax rate is approximately 20%, reflecting a strong US investment [14] Other Important Information - Gilead Sciences, Inc. received an upgrade in its long-term debt rating from BBB+ to A- [58] - The company has returned $1.7 billion to shareholders in the first quarter of 2025 through dividends and share repurchases [58] Q&A Session Summary Question: Expectations for lenacapavir for PrEP - Management is excited about the upcoming PDUFA date and anticipates building access to about 75% within the first six months post-launch [62] Question: Impact of HHS and CDC cuts on launch - Management has not seen any changes that would affect the launch plans for lenacapavir for PrEP [68] Question: Implications of COVID-19 on Descovy sales - Descovy saw a 38% year-over-year growth, driven by higher average realized price and demand, which supports the opportunity for lenacapavir [77] Question: Tariff risks and US market supply - Management indicated that the majority of Gilead's profits are recognized in the US, which mitigates tariff risks [86] Question: Impact of lenacapavir on Descovy sales - Management believes lenacapavir will provide a switch strategy for patients currently on daily oral medications, potentially accelerating market growth [124]

Core Viewpoint - Protara Therapeutics is set to present updated safety and efficacy data from the Phase 2 ADVANCED-2 trial of TARA-002 for non-muscle invasive bladder cancer (NMIBC) on April 28, 2025, with data showcased at the American Urological Association 2025 Annual Meeting on April 26, 2025 [1][2] Group 1: Company Overview - Protara Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing transformative therapies for cancer and rare diseases [7] - The company's lead candidate, TARA-002, is an investigational cell-based therapy aimed at treating NMIBC and lymphatic malformations (LMs) [7] - Protara is also developing IV Choline Chloride for patients on parenteral nutrition [7] Group 2: Clinical Trial Details - The ADVANCED-2 trial (NCT05951179) is a Phase 2 open-label study assessing TARA-002 in NMIBC patients who are BCG-unresponsive or BCG-naïve [3] - The trial includes approximately 100 BCG-unresponsive patients and 31 BCG-naïve patients, with the BCG-unresponsive cohort designed to be registrational [3] Group 3: Product Information - TARA-002 is derived from a master cell bank of genetically distinct group A Streptococcus pyogenes, similar to OK-432, which is marketed in Japan [4] - The therapy is hypothesized to activate immune cells and induce a pro-inflammatory response, enhancing the antitumor immune response [5] Group 4: Disease Context - NMIBC accounts for about 80% of bladder cancer diagnoses, with approximately 65,000 new cases diagnosed annually in the United States [6]

Core Insights - Ernexa Therapeutics is presenting new data on its lead cell therapy product, ERNA-101, at the AACR Annual Meeting 2025, focusing on advanced cancer and autoimmune disease treatment [1][2] Company Overview - Ernexa Therapeutics specializes in innovative cell therapies targeting advanced solid tumors and autoimmune diseases, utilizing engineered induced pluripotent stem cells (iPSCs) to create allogeneic synthetic induced mesenchymal stem cells (iMSCs) [4] - The company is developing two main cell therapy products: ERNA-101 for ovarian cancer and ERNA-102 for autoimmune diseases, both currently in preclinical stages [5] Product Details - ERNA-101 employs specially engineered cells to deliver treatment directly to ovarian tumors by secreting immune-stimulating cytokines, aiming to enhance anti-tumor immune responses [2][5] - The study on ERNA-101 is led by Dr. Michael Andreeff from The University of Texas MD Anderson Cancer Center, highlighting its potential to reshape the tumor microenvironment [2] Presentation Information - The poster presentation for the study will take place on April 28, 2025, from 2:00–5:00 pm CDT, under the session category of Immunology, with details available for conference attendees [3]

Core Insights - FibroBiologics, Inc. is a clinical-stage biotechnology company focused on developing therapeutics for chronic diseases using fibroblast cells and materials [1][3] - The company holds over 240 patents issued and pending, covering various clinical pathways including wound healing, multiple sclerosis, and cancer [3] - Hamid Khoja, Ph.D., the Chief Scientific Officer, will present at The Cell & Gene Meeting On The Mediterranean, highlighting a fibroblast cell-based therapeutic approach [1][2] Company Overview - FibroBiologics is based in Houston and is engaged in the development of a pipeline of treatments aimed at chronic diseases [3] - The company represents advancements in cell therapy and tissue regeneration, with a focus on innovative medical solutions [3] Conference Details - The presentation titled "Restoring Immune system homeostasis using a fibroblast cell-based therapeutic targeting three chronic inflammation-mediated diseases" will take place on April 16, 2025, at 9:00 AM CEST [2] - The event is a significant gathering for the Advanced Therapy Medicinal Products community in Europe [1][2]

Company Overview - MaxCyte, Inc. is a leading company focused on cell engineering, providing platform technologies to advance the discovery, development, and commercialization of next-generation cell therapeutics [1][3] - The company has over 25 years of expertise in building best-in-class platforms and innovating solutions for the cell therapy market [3] Financial Results Announcement - MaxCyte will release its financial results for the first quarter of 2025 after the U.S. market closes on May 7, 2025 [1] - A conference call to discuss these financial results will be hosted by company management at 4:30 p.m. Eastern Time on the same day [1] Conference Call Registration - Investors interested in the conference call must register online, with a recommendation to do so at least a day in advance [2] - A live and archived webcast of the event will be available on the MaxCyte website [2]

Core Insights - Ernexa Therapeutics is advancing its strategic focus on innovative cell therapies for cancer and autoimmune diseases, particularly ovarian cancer [1][2][3] - The company has entered into a securities purchase agreement for a private placement of approximately 69.3 million shares at a price of $0.1046 per share, totaling around $7.25 million, pending stockholder approval [1][2] - The first closing of this transaction occurred on April 2, 2025, raising approximately $1.1 million from the issuance of about 10.4 million shares [2] Company Overview - Ernexa Therapeutics specializes in developing cell therapies targeting advanced solid tumors and autoimmune diseases, utilizing induced pluripotent stem cells (iPSCs) to create allogeneic synthetic mesenchymal stem cells (iMSCs) [4] - The company is currently focused on two preclinical cell therapy products: ERNA-101, aimed at treating ovarian cancer, and ERNA-102, designed to address inflammation in autoimmune diseases [5] Recent Developments - The recent fundraising follows a previous private investment in public equity (PIPE) round in 2024, which secured $5 million in financing [3] - Ernexa has undergone a rebranding to reflect its new strategic direction, emphasizing its commitment to advancing therapeutic innovation [2][3]

Core Insights - Ernexa Therapeutics has shifted its strategic focus from a cell therapy platform to prioritizing product development, emphasizing its commitment to patient impact with the new tagline "Breaking Through Defenses, Delivering Hope" [1][2] Company Overview - Ernexa Therapeutics, formerly Eterna Therapeutics, is a leader in cell therapies targeting advanced cancer and autoimmune diseases, with a focus on engineering induced pluripotent stem cells (iPSCs) into induced mesenchymal stem cells (iMSCs) [1][6] - The company aims to provide scalable, off-the-shelf treatment solutions through its allogeneic synthetic iMSCs, addressing challenges such as immune rejection and donor shortages [2][6] Product Development - Ernexa is developing two cell therapy products currently in preclinical trials: ERNA-101, aimed at enhancing the immune system's response to cancer, and ERNA-102, designed to treat inflammation and autoimmune diseases [3][7] - ERNA-101 is specifically being developed for ovarian cancer, a field with significant unmet medical needs due to the lack of effective targeted therapies [4][5] Market Potential - The company highlights the potential of ERNA-101 and ERNA-102 to significantly impact the treatment landscape for ovarian cancer and autoimmune diseases, respectively [5][7]