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Iovance Biotherapeutics (IOVA) Faces Investor Lawsuit Over Growth Projections Following Stock Plunge – Hagens Berman
GlobeNewswire News Room· 2025-05-22 20:30
Core Viewpoint - Iovance Biotherapeutics, Inc. is facing a securities class action lawsuit for allegedly misleading investors about its growth potential and ability to meet demand for its cancer treatments [1][2]. Group 1: Lawsuit Details - The lawsuit, Farberov v. Iovance Biotherapeutics, Inc., claims that the company made overwhelmingly positive statements while concealing material adverse facts regarding its operational readiness [2][5]. - The class period for the lawsuit is from May 9, 2024, to May 8, 2025, with a lead plaintiff deadline set for July 14, 2025 [2]. Group 2: Stock Performance - On May 9, 2025, Iovance's stock price dropped approximately 44.8%, falling from $3.17 to $1.75, following the announcement of disappointing financial results and a downward revision of revenue guidance [3]. Group 3: Financial Performance - In its July 2024 announcement, Iovance attributed the lower revenue guidance to a month-long reduction in manufacturing capacity due to maintenance, lower-than-expected sales of Proleukin, and a variable pace in the treatment of patients with newer therapies [4]. Group 4: Investor Claims - Investors argue that the disclosures revealed previously concealed issues that negatively impacted the company's growth prospects, contradicting earlier positive statements about its operational readiness [5].
Senti Bio to Present at LIVE! with Webull Corporate Connect: Virtual Biotech Investment Webinar
Globenewswire· 2025-05-22 20:05
Company Overview - Senti Biosciences, Inc. is a clinical-stage biotechnology company focused on developing next-generation cell and gene therapies using its proprietary Gene Circuit platform [3] - The company aims to create new medicines that can precisely target and kill cancer cells while sparing healthy cells, enhancing specificity to target tissues, and allowing for control even after administration [3] Upcoming Event - Timothy Lu, M.D., Ph.D., Co-Founder and CEO of Senti Bio, will present at the LIVE! with Webull Corporate Connect: Virtual Biotech Investment Webinar on May 29, 2025, at 2:40 PM ET [1][2] Technology and Pipeline - Senti Bio's pipeline includes cell therapies engineered with Gene Circuits targeting challenging liquid and solid tumor indications [3] - The Gene Circuits have shown preclinical efficacy in both NK and T cells, with potential applications extending beyond oncology [3]
Evaxion Biotech (EVAX) Conference Transcript
2025-05-22 17:15
Summary of Evaxion Biotech (EVAX) Conference Call - May 22, 2025 Company Overview - **Company**: Evaxion Biotech (EVAX) - **Industry**: Biotechnology, specifically focused on AI-powered drug development and vaccine creation Key Points and Arguments 1. **Funding and Financial Position**: - Raised significant cash early in the year, extending runway into mid-2026 [3] - Merck participated in the latest public offering, holding approximately 20% of the company [3][12] - Potential for an additional $10 million if Merck exercises options on vaccine candidates [4][12] 2. **AI Immunology Platform**: - Evaxion is a pioneer in AI-driven medicine development, founded in 2008 [5] - The platform has been clinically validated and is a key differentiator from newer AI companies [6] - Capable of rapid target discovery, reducing the number of targets tested by 80% compared to conventional methods [16] 3. **Pipeline and Partnerships**: - Focus on both platform and pipeline, allowing for high-value partnerships in vaccine development [7][10] - Collaboration with Merck on developing novel vaccine candidates for infectious diseases with no current vaccines [8][11] - Pipeline includes proprietary candidates for gonorrhea and staph aureus, both addressing significant unmet medical needs [23][28] 4. **Market Opportunities**: - Cancer immunotherapy market projected to reach $280 billion by the end of the decade; infectious disease market expected to be $70 billion [14] - Significant unmet needs in both cancer (10 million deaths annually) and infectious diseases (8 million deaths annually) [13] 5. **Clinical Data and Product Development**: - Lead candidate EVX-one shows a 69% overall response rate in metastatic melanoma, significantly higher than the 33% response rate of the current gold standard [25] - 80% of neoantigens in the vaccine candidates elicited an immune response, indicating strong efficacy [26] 6. **Strategic Ambitions**: - Aim to remain a leading AI-powered biotech company and drive best-in-class drug discovery [29] - Plans to enter at least two new partnerships and select a lead candidate for a precision-based cancer vaccine [32] 7. **Future Outlook**: - Anticipated milestones include Merck's decision on option exercise and upcoming phase two data for EVX-one [31][33] - Strong focus on generating new partnerships and maintaining a robust business development pipeline [30] Additional Important Content - **Partnership Development**: - Merck's involvement has been crucial, participating in multiple financing rounds and showing long-term commitment [45][46] - The partnership allows Evaxion to focus on R&D without incurring further costs for the development of partnered candidates [44] - **Market Perception**: - Despite a strong fundamental position, the market has not fully appreciated the company's potential, as reflected in share price trends [48][49] - The company emphasizes execution of its strategy over short-term market fluctuations [49] - **Technological Advancements**: - Continuous improvement of the AI platform is expected, with potential future applications in quantum computing [40][41] This summary encapsulates the key insights from the conference call, highlighting Evaxion's strategic positioning, financial health, and innovative capabilities in the biotechnology sector.
5月22日晚间新闻精选
news flash· 2025-05-22 13:46
Group 1 - The central bank announced a 500 billion MLF operation with a fixed amount and interest rate bidding, with a term of one year [1] - The Financial Regulatory Bureau stated that the first batch of pilot reforms for long-term investment of insurance funds is 50 billion, the second batch is 112 billion, and a third batch of 60 billion is pending approval, totaling 222 billion [2] - The CSRC's Chief Risk Officer emphasized the continuous optimization of the domestic listing environment for technology companies, supporting high-quality red-chip tech firms to return to domestic listings [3] Group 2 - Xiaomi launched the Xiaomi 15S Pro, Pad 7 Ultra, and Watch S4, all equipped with the self-developed Xuanjie chip; the Xiaomi YU 7 was officially released, positioned as a "luxury high-performance SUV" [4] - Three Life Health reached a cooperation with Pfizer on project 707, with uncertainties regarding the sales milestone payments and royalties [5] - Nanjing Port saw an 8-day cumulative increase of 102.4%, with individual investors accounting for 88.47% of purchases [5]
Akari Therapeutics to Present at LIVE! with Webull Corporate Connect: Virtual Biotech Investment Webinar
Globenewswire· 2025-05-22 13:00
Company Overview - Akari Therapeutics is an oncology biotechnology company focused on developing next-generation spliceosome payload antibody drug conjugates (ADCs) [3] - The company utilizes an innovative ADC discovery platform to generate and optimize ADC candidates for various targets [3] Lead Product Candidate - Akari's lead candidate, AKTX-101, targets the Trop2 receptor on cancer cells and delivers a novel PH1 payload directly into tumors [3] - PH1 is a spliceosome inhibitor designed to disrupt RNA splicing within cancer cells, leading to cancer cell death and activation of immune cells [3] - Preclinical studies indicate that AKTX-101 has significant activity and prolonged survival compared to traditional ADCs [3] Synergistic Potential - AKTX-101 has shown potential for synergy with checkpoint inhibitors, demonstrating prolonged survival both as a single agent and in combination with these inhibitors [3] Upcoming Presentation - Abizer Gaslightwala, President and CEO of Akari, will present recent corporate events at the Virtual Biotech Investment Webinar on May 29, 2025 [1][2]
Senti Bio Receives Additional $1.0 Million Tranche from California Institute for Regenerative Medicines (CIRM) Grant for Advancing Clinical Development of SENTI-202
GlobeNewswire News Room· 2025-05-22 12:30
Core Insights - Senti Biosciences, Inc. has received an additional $1.0 million from the California Institute of Regenerative Medicine (CIRM) for achieving clinical study enrollment milestones, bringing the total received from an $8 million grant to $7.4 million [1] - The company is developing SENTI-202, a first-in-class Logic Gated off-the-shelf CAR-NK cell therapy aimed at treating relapsed/refractory hematologic malignancies, including acute myeloid leukemia (AML) [1][3] - Preliminary results from the ongoing Phase 1 trial of SENTI-202 indicate it is well-tolerated, with no dose-limiting toxicities reported and a recommended Phase 2 dose identified as 1.5 x 10^9 CAR NK cells [4] Company Overview - Senti Bio is focused on developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, which aims to enhance precision and control in targeting cancer cells while sparing healthy cells [5] - The company's pipeline includes cell therapies engineered with Gene Circuits to address challenging liquid and solid tumor indications, demonstrating preclinical efficacy in both NK and T cells [5] Clinical Development - SENTI-202 is currently in a Phase 1 clinical trial (NCT06325748) and has shown promising preliminary results, with two out of three patients in the recommended Phase 2 dose cohort achieving a composite Complete Remission (cCR) [4] - The trial data presented at the American Association for Cancer Research (AACR) Annual Meeting 2025 supports the Logic Gate mechanism of action, with four out of four cCR patients being Measurable Residual Disease Negative (MRD-) [4]
NorthStrive Biosciences Announces Completion of Phase I Strategic Review for EL-22 Targeting Muscle Loss Associated with GLP-1 Weight Loss Drugs and Age-Related Sarcopenia
Globenewswire· 2025-05-22 12:16
Core Insights - Northstrive Biosciences Inc. has completed a Phase I strategic research and literature synthesis for its first-in-class oral myostatin-engineered probiotic, EL-22, aimed at addressing muscle-wasting conditions [1][7] - The analysis, conducted with Yuva Biosciences, provided insights into EL-22's mechanism of action and its potential to meet critical needs in muscle-wasting conditions such as GLP-1-associated atrophy and age-related sarcopenia [1][7] Company Overview - Northstrive Biosciences Inc. is a biopharmaceutical company under PMGC Holdings Inc., focusing on developing innovative aesthetic medicines [4] - The lead asset, EL-22, utilizes a myostatin-engineered probiotic approach to help preserve muscle during weight loss treatments, particularly with GLP-1 receptor agonists [4] Product Highlights - EL-22 employs a myostatin-engineered probiotic strategy to combat obesity-related muscle loss during weight loss treatments, offering a patient-friendly oral delivery method [2][4] - The product is designed to induce an immune response against myostatin, a key regulator of muscle growth, using genetically engineered Lactobacillus casei [2] Research Findings - The report highlights significant effects of EL-22 in mdx mice, including improvements in antibody production, serum creatine kinase levels, body weight, motor function, and muscle histology [7] - EL-22's unique oral vaccine approach distinguishes it from traditional systemic antibody or gene therapy methods, aiming to stimulate both mucosal and systemic immunity against myostatin [7] Market Positioning - With the rise of GLP-1 receptor agonists in obesity and diabetes treatment, EL-22 is strategically positioned to address the associated muscle loss concerns [7] - Northstrive plans to initiate a Phase 2 proof-of-concept trial targeting GLP-1 users and engage in regulatory discussions to advance EL-22 towards an IND filing in the U.S. [7]
BetterLife Provides Comments on CEO’s Share Position Ownership and Recent BCSC Press Release
Globenewswire· 2025-05-22 12:00
VANCOUVER, British Columbia, May 22, 2025 (GLOBE NEWSWIRE) -- BetterLife Pharma Inc. (“BetterLife” or the “Company”) (CSE: BETR / OTCQB : BETRF / FRA: NPAU), an emerging biotech company focused on the development of BETR-001, a non-hallucinogenic neuroplastogen in the treatment of psychiatric and neurological disorders, is issuing the following press release in response to British Columbia Securities Commission’s (“BCSC”) May 21, 2025 news release. BetterLife announced on July 16, 2024, that it had amended ...
Unicycive Therapeutics to Present at Upcoming Investor Conferences
Globenewswire· 2025-05-22 11:00
LOS ALTOS, Calif., May 22, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that Shalabh Gupta, M.D., Chief Executive Officer will present at two upcoming virtual investment conferences. Event: Lytham Partners Spring 2025 Investor Conference Type: Fireside ChatDate/Time: Thursday, May 29, 2025, at 12:30 p.m. ET Event: Noble Capital Markets 2025 Emerging Growth Virtual Equity Con ...
PCI Biotech: Minutes of Annual General Meeting 2025
Globenewswire· 2025-05-22 09:45
Oslo, 22 May 2025. The Annual General Meeting in PCI Biotech Holding ASA took place today, 22 May 2025. All the matters on the agenda were approved and the minutes of the Annual General Meeting are attached to this release and are available on www.pcibiotech.com. Contact information: PCI Biotech Holding ASA, Ullernchausséen 64, N-0379 Oslo Ronny Skuggedal, CEO / CFO, rs@pcibiotech.no, Mobile: +47 9400 5757 This information is subject to a duty of disclosure pursuant to Section 5-12 of the Norwegian Securit ...