BOSTON, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Block & Leviton is investigating Rezolute, Inc. (Nasdaq: RZLT) for potential securities law violations. Investors who have lost money in their Rezolute, Inc. investment should contact the firm to learn more about how they might recover those losses. For more details, visit https://blockleviton.com/cases/rzlt. What is this all about? Shares of Rezolute fell over 85 percent on December 11, after the company announced that its Phase 3 sunRIZE study in congenital hyperi ...

Summary of Precision BioSciences Conference Call Company Overview - **Company**: Precision BioSciences (NasdaqCM:DTIL) - **Industry**: In-vivo gene editing - **Location**: Durham, North Carolina - **Focus**: Developing gene editing therapies for chronic hepatitis B and Duchenne muscular dystrophy (DMD) [2][3][4] Key Programs PBGene-HBV (Hepatitis B) - **Target Population**: 300 million people globally with chronic hepatitis B [2] - **Current Status**: Program initiated in the clinic late 2024, with ongoing data generation throughout 2025 and into 2026 [3][4] - **Mechanism**: Aims to eliminate cccDNA, the root cause of hepatitis B, rather than just reducing S antigen levels [9][10][12] - **Clinical Trial**: Phase 1 trial named "Eliminate B" with three cohorts, focusing on safety and efficacy [13][14] - **Safety Profile**: Well-tolerated across all doses, with manageable side effects [15][20] - **Data Trends**: Early cohorts show promising reductions in S antigen levels, with cohort three demonstrating sustained reductions [16][18] - **Future Plans**: Completion of cohort three dosing, potential to stop nucleoside analogs, and test for a cure [20][21] PBGene-DMD (Duchenne Muscular Dystrophy) - **Target Population**: Affects boys with a genetic disease leading to muscle loss and early mortality [21][22] - **Current Status**: IND filing expected by the end of 2025, with clinical trials anticipated to start in early 2026 [25][26] - **Mechanism**: Gene editing approach targeting mutations in exons 45 to 55, potentially benefiting up to 60% of DMD patients [22][24] - **Clinical Trial Design**: Phase 1, 2, 3 study design with a focus on safety and efficacy [25][26] Financials - **Recent Financing**: Raised $75 million from existing and new investors, providing a cash runway through 2028 [4] - **Investment Strategy**: Focused on two key programs to maximize capital efficiency and create value inflection points [35] Market Context - **Unmet Needs**: Both hepatitis B and DMD represent significant unmet medical needs, with current treatments lacking effectiveness [21][22][27] - **Competitive Landscape**: Current standard of care for hepatitis B involves nucleoside analogs, which do not address cccDNA, resulting in low functional cure rates (1%-3%) [29][30][31] Strategic Partnerships - **PBGene-HBV**: Potential for strategic partnerships for commercialization, especially for larger phase three trials [32] - **PBGene-DMD**: Opportunities for partnerships exist, but the company is capable of advancing this program independently [33] Future Outlook - **Data Readouts**: Anticipated data readouts for both programs in 2026, with potential for a Biologics License Application (BLA) for DMD by the end of 2028 [26][27] - **Investor Engagement**: Emphasis on demonstrating the effectiveness of gene editing to attract further investment and partnerships [35]

GENERATIVE AI DRUG CREATION ABS-201 KOL SEMINAR ABSCI CORPORATION 2025 ALL RIGHTS RESERVED Disclaimers Forward-Looking Statements Certain statements in this presentation that are not historical facts are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements containing the words "will," "may," "anticipates," "plans," "believes," "forecast," "estimates," "expects," "predic ...

Core Insights - Pomerantz LLP is investigating claims on behalf of investors of Bicycle Therapeutics plc regarding potential securities fraud or unlawful business practices [1] - RBC Capital Markets analyst downgraded Bicycle to Sector Perform from Outperform due to delays in the development of zelenectide pevedotin for metastatic urothelial cancer, which is now pushed to the first quarter of 2026 [2] - Following the downgrade, Bicycle's ADR price fell by $0.69, or 7.88%, closing at $8.07 on October 31, 2025 [3] Company Developments - The investigation by Pomerantz LLP focuses on whether Bicycle and its officers/directors have engaged in any fraudulent activities [1] - The delay in the development of zelenectide pevedotin is significant as the urothelial cancer treatment market is becoming increasingly competitive, with potential advantages for competing products, particularly from Pfizer [2] - The recent downgrade and subsequent price drop indicate investor concerns regarding Bicycle's market position and product development timeline [3]

Core Viewpoint - Johnson Fistel, PLLP is investigating potential derivative claims on behalf of aTyr Pharma, Inc. related to alleged fiduciary breaches concerning the Phase 3 EFZO-FIT clinical trial disclosures [1][2] Investigation Background - The investigation covers the period from November 7, 2024, to September 12, 2025, focusing on allegations that aTyr and certain executives made false and/or misleading statements regarding the Phase 3 trial results [2][3] - Following the negative results from the Phase 3 trial, aTyr's stock price experienced a significant decline [2] Board Oversight - The investigation is examining whether aTyr's board failed to adequately oversee clinical disclosure controls and allowed overly optimistic representations that could expose the company to litigation and reputational risks [3] Shareholder Guidance - Current aTyr shareholders who held their shares continuously before November 7, 2024, may have the standing to pursue derivative claims on behalf of the company [2]

Core Insights - Tivic Health® Systems, Inc. has acquired the strategic manufacturing and development assets of Scorpius Holdings, Inc. and is launching a new subsidiary, Velocity Bioworks™, to provide contract development and manufacturing services [1] Group 1: Acquisition Details - The acquisition is financed by 3i, LP, which includes $16 million in debt financing for asset purchase and up to $75 million in preferred convertible equity for therapeutics commercialization and corporate growth initiatives [1] - The formation of Velocity Bioworks™ secures a robust US-based manufacturing site for Tivic's lead drug candidate, Entolimod™, as the company prepares for a Biologics License Application (BLA) with the U.S. Food & Drug Administration [1]

Hemostemix CEO Introduces Conformal Consciousness Hypothesis A = E/(hv)Thomas Smeenk, BA, unveils a proposed conformal invariant, A = E/(hv), explored as a potential bridge between General Relativity, Quantum Mechanics, cosmology, and string theory.December 11, 2025 9:40 AM EST | Source: Hemostemix Inc.Calgary, Alberta--(Newsfile Corp. - December 11, 2025) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0) the leading autologous (patient's own) stem cell therapy company offering VesCell™ ...

Summary of Evaxion Biotech A/S Conference Call Company Overview - **Company**: Evaxion Biotech A/S (Ticker: EVAX) - **Industry**: Biotechnology, specifically focusing on AI-powered vaccine development - **Founded**: 17 years ago as an AI company aimed at decoding the human immune system [2][3] Core Business and Strategy - **AI Immunology Platform**: A clinically validated platform for target discovery in vaccine development, significantly faster and more cost-effective than traditional methods [3][5][6] - **Partnerships**: Multi-partner approach with a focus on outlicensing programs by phase two of development, with Merck as a key collaborator and investor holding a 15% stake [4][10] - **Pipeline**: Strong pipeline in both cancer vaccines (e.g., EVX-01 for melanoma) and infectious disease vaccines (e.g., EVX-B2 for gonorrhea) [16][21] Financial Highlights - **Recent Deal**: Historic outlicensing deal with Merck for the EVX-B3 program, providing an immediate cash inflow of $7.5 million and potential milestone payments of up to $592 million [10][11] - **Cash Runway**: Extended cash runway until the second half of 2027, supported by various financial strategies including public offerings and agreements with the European Investment Bank [13][22] Market Potential - **Market Size**: The global market for cancer immunology and infectious disease vaccines is projected to grow significantly, with the infectious disease vaccine market expected to reach $68 billion by 2031 [7][8] - **Unmet Needs**: Focus on diseases with no approved vaccines, such as Staph aureus, gonorrhea, and CMV virus, indicating strong potential for future growth [9] Key Achievements - **Clinical Trials**: EVX-01 showed a 75% overall response rate in a two-year phase two trial, significantly outperforming Merck's Keytruda [18][19] - **Innovative Development**: Introduction of an automated vaccine design module to enhance efficiency and quality in vaccine development [12] Leadership and Team - **New CEO**: Helen Tayton-Martin appointed as CEO, bringing extensive experience from previous roles in the biotech industry [9] - **Experienced Team**: Strong leadership with backgrounds in major pharmaceutical companies, enhancing the company's credibility and operational capability [9] Future Outlook - **Resource Allocation**: Focus on developing infectious disease vaccines to the clinic stage while maintaining a higher investment in oncology programs [26] - **Partnership Opportunities**: Open to collaborations with various pharmaceutical companies, including potential expansions with Merck [27] Investor Insights - **Stock Performance**: The stock has increased by 110% over the last six months, driven by successful milestones and partnerships [29] - **Recognition**: Collaboration with the Gates Foundation for target discovery, highlighting the company's growing reputation in the industry [30] Conclusion - **Investment Case**: Evaxion presents a compelling investment opportunity with its pioneering AI platform, strong pipeline, and strategic partnerships, aiming for continued growth and value creation in the biotech sector [24][30]

Summary of Sunrise Pipeline Data Conference Call Company and Industry - **Company**: Rezolute - **Industry**: Pharmaceutical/Biotechnology, specifically focusing on treatments for congenital hyperinsulinism (HI) and tumor hyperinsulinism (HI) Core Points and Arguments 1. **Study Results**: The Phase 3 Sunrise study for ersodetug in patients with congenital HI did not achieve statistical significance for primary and secondary endpoints, which was unexpected and disappointing for the company [2][8][14] 2. **Patient Population**: The study involved an ultra-rare pediatric population, which presents unique challenges in clinical trials, including the management of glucose levels by families [3][4] 3. **Regulatory Engagement**: The FDA has shown a willingness to reconsider study designs for ultra-rare diseases, which may provide a pathway for future studies [4][5][6] 4. **Financial Position**: As of September 30, 2025, the company reported having $150 million in cash, allowing it to pursue its objectives despite the study setback [6][45] 5. **Operational Adjustments**: The company plans to decrease operating expenses, which may include a reduction in workforce [6][7] 6. **Open-Label Extension**: More than 50 children from the Sunrise study are now on ersodetug as part of an open-label extension, with some weaned off other therapies, indicating potential efficacy [3][9][67] 7. **Safety Observations**: The safety profile of ersodetug was generally favorable, with a low incidence of serious allergic reactions [12][13] 8. **Placebo Effect**: The study observed a significant placebo response, complicating the interpretation of the results [14][33][39] 9. **Future Studies**: The company is committed to engaging with the FDA to explore alternative study designs for congenital HI and is optimistic about the tumor HI study, which has a different endpoint [5][21][63] Other Important Content 1. **Study Demographics**: The study enrolled 63 participants, with a high retention rate, indicating strong family commitment despite the challenges of frequent visits for treatment [9][10] 2. **Background Therapies**: Many participants were on standard care therapies, which may have influenced baseline hypoglycemia rates [10][11] 3. **Adverse Events**: Hypertrichosis was noted as a common adverse event associated with the study drug, but it was generally mild and less concerning than similar effects from other treatments [13][55][56] 4. **Continuous Glucose Monitoring (CGM)**: The variability in CGM data was noted as a potential limitation in measuring drug performance, suggesting a need for further investigation [51][52] 5. **Future Engagements**: The company plans to meet with advocacy groups and key opinion leaders to discuss the study outcomes and next steps [54][68] This summary encapsulates the key points discussed during the conference call, highlighting the challenges faced by the company and its commitment to addressing the needs of patients with congenital HI.

Core Insights - Arquitos Capital Management reported a net return of 29.6% for Q3 2025, with year-to-date gains reaching 66.8% [1] - The firm focuses on a select group of companies and is willing to hold investments for extended periods [1] Company Highlights - Finch Therapeutics Group, Inc. (OTC:FNCH) is highlighted as a key investment, with a one-month return of -3.59% and a 52-week gain of 16.50% [2] - As of December 10, 2025, Finch Therapeutics' stock closed at $13.98, with a market capitalization of $22.449 million [2] - Finch's share price increased from $11.30 at the beginning of the year to $12.28 at the end of Q3 2025 [3] - The company won a jury trial against Ferring Pharmaceuticals in August 2024, resulting in a $30 million award and potential for enhanced damages due to willful infringement [3] Investment Perspective - Finch Therapeutics is not among the 30 most popular stocks among hedge funds, with the firm suggesting that certain AI stocks may offer better upside potential and lower downside risk [4]