Core Insights - Biotech shares experienced significant movements in after-hours trading, with Sarepta Therapeutics leading due to anticipated trial data and other companies benefiting from recent clinical and regulatory updates [1] Company Summaries - Sarepta Therapeutics Inc. (SRPT) saw a surge of 9.65% to $23.17, driven by anticipation for a webcast on January 26, 2026, where three-year topline results from its Phase 3 trial of ELEVIDYS for Duchenne muscular dystrophy will be presented, potentially pivotal for its gene therapy program [2] - Fractyl Health, Inc. (GUTS) increased by 7.66% to $2.25, indicating speculative interest despite no new company news, suggesting momentum-driven trading [3] - Greenwich LifeSciences, Inc. (GLSI) advanced 2.08% to $26.00 following FDA approval of the first commercial lot of GP2 vials for the FLAMINGO-01 trial, marking a significant step in its commercialization efforts with the potential to prepare approximately 200,000 doses [4] - Anebulo Pharmaceuticals, Inc. (ANEB) rose 8.41% to $1.16, attracting buyers despite no new updates, reflecting investor interest [5] - OmniAb, Inc. (OABI) gained 4.59% to $2.05, similar to Anebulo, indicating broader investor interest in the biotech sector without fresh news [6] - Trevi Therapeutics, Inc. (TRVI) added 3.40% to $10.33 after publishing results from its Phase 2b CORAL trial in a peer-reviewed journal, enhancing credibility and investor enthusiasm [7] - AEON Biopharma, Inc. (AEON) edged up 1.80% to $1.13, confirming a meeting with the FDA and securing shareholder approval for financing transactions, simplifying its capital structure ahead of a second PIPE financing closing expected around January 27, 2026 [8]

Core Insights - Fractyl Health, Inc. has appointed Lara Smith Weber as Chief Financial Officer, effective January 12, 2026, to oversee finance, accounting, and investor relations, and to support the executive leadership team and Board of Directors [1][3] Company Overview - Fractyl Health is a metabolic therapeutics company focused on innovative treatments for obesity and type 2 diabetes (T2D), aiming to shift from chronic management to durable disease-modifying therapies [5] - The company has a strong intellectual property portfolio, with 35 granted U.S. patents and approximately 45 pending U.S. applications, alongside numerous foreign patents [5] Leadership Transition - Lara Smith Weber brings over 20 years of financial leadership experience in medtech and biotech, with a proven track record in building financial organizations and guiding companies through operational scaling [2][3] - Ms. Smith Weber's previous roles include CFO at Inari and ONWARD Medical, where she strengthened capital structures and financial systems [3] - Lisa Davidson, the former CFO, resigned effective December 31, 2025, after ten years with the company, during which she played a key role in its growth and IPO [4][5]

Financial Position - As of December 31, 2025, the company's preliminary unaudited cash and cash equivalents were approximately $81.5 million, which increased to $85.6 million after receiving an additional $4.1 million from Tranche A warrants[9]. - The company anticipates that its current cash position will fund operations through early 2027, supporting planned clinical and regulatory milestones for 2026[9]. - The company had 153,372,044 shares of common stock outstanding as of December 31, 2025, with no Tranche A warrants remaining[10]. - The company’s financial information is preliminary and unaudited, subject to completion of financial closing procedures for the fiscal year ended December 31, 2025[17]. Clinical and Regulatory Milestones - The company plans to advance its Revita program through key clinical and regulatory milestones in 2026, focusing on validation in post-GLP-1 weight maintenance[11]. - The anticipated milestones for the Revita program include 6-month randomized data from the REMAIN-1 Midpoint Cohort in late January 2026 and a potential PMA filing in H2 2026[14]. - The Rejuva gene therapy platform is expected to progress toward clinical validation in 2026, with first-in-human dosing of RJVA-001 anticipated in H2 2026, subject to regulatory authorization[12]. - The company is aligning its clinical development with regulatory strategy and real-world implementation considerations for Revita as it moves through a registrational year[11]. - The company has completed Clinical Trial Applications for RJVA-001 in the EU and Australia, setting the stage for expected dosing of first patients in 2026[12]. - The company’s strategic outlook for 2026 includes anticipated clinical and regulatory milestones across its Revita and Rejuva programs[8].

Core Insights - Fractyl Health is positioned for a significant year in 2026, focusing on clinical and regulatory milestones for its Revita and Rejuva programs [2][3] Financial Overview - As of December 31, 2025, Fractyl had approximately $81.5 million in cash and cash equivalents, which increased to $85.6 million following the exercise of Tranche A warrants [6][8] - The current cash runway is expected to support operations through early 2027 [8] Revita Program - The Revita program aims to address post-GLP-1 weight maintenance, with pivotal data and potential PMA filing expected in H2 2026 [2][3] - Key milestones for Revita in 2026 include: - Late January: 6-month randomized data from the REMAIN-1 Midpoint Cohort - Early 2026: Completion of randomizations for the REMAIN-1 Pivotal Cohort - Q2 2026: 1-year REVEAL-1 Cohort data - Q3 2026: 1-year REMAIN-1 Midpoint Cohort data - H2 2026: Topline 6-month randomized data from the REMAIN-1 Pivotal Cohort and potential PMA filing [6][10] Rejuva Program - The Rejuva gene therapy platform is advancing towards clinical validation, with the first-in-human evaluation of RJVA-001 expected in 2026, pending regulatory authorization [5][11] - Key milestones for Rejuva in 2026 include: - Q2 2026: Regulatory feedback on the Clinical Trial Application (CTA) for RJVA-001 - H2 2026: First-in-human dosing of RJVA-001 and preliminary data [7][11] Company Overview - Fractyl Health focuses on innovative treatments for metabolic diseases, particularly obesity and type 2 diabetes (T2D), aiming to transform treatment from chronic management to disease-modifying therapies [9][10] - The company has a robust intellectual property portfolio, with 35 granted U.S. patents and approximately 45 pending applications [9]

Core Insights - Fractyl Health, Inc. (NASDAQ:GUTS) is recognized as one of the 10 Best New Penny Stocks to Invest In, with a Buy rating and a price target of $8 reiterated by Canaccord Genuity [1][3] Business Overview - Fractyl Health, Inc. is a metabolic therapeutics company focused on innovative approaches to treat serious metabolic diseases such as obesity and type 2 diabetes (T2D) [6] Clinical Developments - The company discussed the Revita procedure and its clinical profile during meetings with analysts, highlighting the positive clinical data shared so far [2][3] - Positive six-month results from the open-label REVEAL-1 Cohort were announced, showing that patients who underwent the Revita procedure maintained stable body weight and glycemic control after stopping GLP-1 therapy [4][5] Commercial Opportunities - The discussions emphasized the commercial opportunities for Fractyl Health, supported by the positive clinical outcomes, which have instilled confidence among analysts [2][3]

Market Overview - U.S. stock futures are lower, with Dow futures down approximately 0.2% [1] Company-Specific Movements - Lightwave Logic Inc (NASDAQ:LWLG) shares fell 14.5% to $3.22 in pre-market trading following the announcement of a $35 million public offering of common stock [1] - Ascent Solar Technologies, Inc. (NASDAQ:ASTI) shares decreased by 15.1% to $3.54 after a previous increase of 34% on Monday [2] - Fractyl Health Inc (NASDAQ:GUTS) shares dropped 10.4% to $2.00 in pre-market trading [2] - Ready Capital Corp (NYSE:RC) shares fell 9% to $2.12, despite declaring a quarterly cash dividend of $0.01 per share for the quarter ended December 31, 2025 [2] - Cellectis SA (NASDAQ:CLLS) shares declined 8.4% to $4.39 following arbitration results with Servier [2] - Destiny Tech100 Inc (NYSE:DXYZ) shares decreased by 7.4% to $31.59 [2] - Kyverna Therapeutics Inc (NASDAQ:KYTX) shares fell 7.2% to $10.04 after announcing a $100 million offering [2] - Maase Inc (NASDAQ:MAAS) shares dropped 6.3% to $4.16 [2] - Argo Blockchain PLC – ADR (NASDAQ:ARBK) shares fell 6% to $5.32 after an 18% decline on Monday [2] - Canopy Growth Corp (NASDAQ:CGC) shares decreased by 5.4% to $1.57 [2] - Neogen Corp (NASDAQ:NEOG) shares fell 4.5% to $6.54 [2]

Market Overview - U.S. stock futures are lower, with Dow futures down approximately 0.2% [1] Company-Specific Movements - Lightwave Logic Inc (NASDAQ:LWLG) shares fell 14.5% to $3.22 in pre-market trading following the announcement of a $35 million public offering of common stock [1] - Ascent Solar Technologies, Inc. (NASDAQ:ASTI) shares decreased 15.1% to $3.54 after a previous jump of 34% on Monday [2] - Fractyl Health Inc (NASDAQ:GUTS) shares fell 10.4% to $2.00 in pre-market trading [2] - Ready Capital Corp (NYSE:RC) shares dipped 9% to $2.12, despite declaring a quarterly cash dividend of $0.01 per share for the quarter ended December 31, 2025 [2] - Cellectis SA (NASDAQ:CLLS) shares declined 8.4% to $4.39 following arbitration results with Servier [2] - Destiny Tech100 Inc (NYSE:DXYZ) shares decreased 7.4% to $31.59 [2] - Kyverna Therapeutics Inc (NASDAQ:KYTX) shares fell 7.2% to $10.04 after announcing a $100 million offering [2] - Maase Inc (NASDAQ:MAAS) shares dropped 6.3% to $4.16 [2] - Argo Blockchain PLC – ADR (NASDAQ:ARBK) shares fell 6% to $5.32 after an 18% decline on Monday [2] - Canopy Growth Corp (NASDAQ:CGC) shares decreased 5.4% to $1.57 [2] - Neogen Corp (NASDAQ:NEOG) shares fell 4.5% to $6.54 [2]

Core Viewpoint - Fractyl Health, Inc. is calling all outstanding Tranche A Warrants for cancellation or exercise, with a deadline of December 30, 2025, potentially raising up to $17.9 million in gross proceeds if all warrants are exercised [1][6]. Group 1: Tranche A Warrants Details - Holders of Tranche A Warrants can exercise them at an exercise price of $1.05 per share until the Cancellation Date [2]. - As of the announcement, there are approximately 17,063,073 Tranche A Warrants outstanding, with the last reported sale price of the Common Stock at $2.24 per share, indicating a premium of $1.19 over the exercise price [3]. - Any unexercised Tranche A Warrants after the Cancellation Date will be void and holders will receive $0.00001 per share [5]. Group 2: Conditions for Calling Warrants - The call of the Tranche A Warrants was enabled after the company met clinical and market performance conditions, including positive data from the REMAIN-1 study and trading conditions where the Common Stock exceeded an average closing price of $1.37 for 15 consecutive trading days [4]. Group 3: Financial Implications - If all outstanding Tranche A Warrants are exercised, Fractyl will receive approximately $17.9 million in additional gross proceeds, which will strengthen the company's balance sheet as it advances its clinical programs [6]. Group 4: Company Overview - Fractyl Health is focused on pioneering new approaches to treat metabolic diseases, including obesity and type 2 diabetes, aiming to transform treatment from chronic management to disease-modifying therapies [10][11]. - The company has a robust intellectual property portfolio with 35 granted U.S. patents and around 45 pending applications [11].

Summary of Fractyl Health FY Conference Call (December 03, 2025) Company Overview - **Company**: Fractyl Health (NasdaqGM:GUTS) - **Focus**: Development of Revita, a treatment targeting obesity and type 2 diabetes through an outpatient endoscopic procedure Key Industry Insights - **Obesity and GLP-1 Drugs**: There are approximately 10 million people using GLP-1 medications for weight loss, with an estimated 6 million expected to stop treatment this year, leading to significant weight regain risks for many patients [1][2] - **Market Opportunity**: The potential market for Revita includes nearly 1 million patients annually who are already undergoing endoscopies for other reasons, making it easier to integrate the Revita procedure into existing healthcare practices [8] Core Findings from Clinical Studies - **Reveal-1 Study**: - Patients who lost an average of 24% body weight (over 50 pounds) on GLP-1s and then underwent Revita maintained a weight regain of only 1.5% over six months, compared to an expected regain of over 10% [4][5] - The study demonstrated that 40% of patients continued to lose weight after the procedure, indicating a stable weight maintenance profile [14] - Hemoglobin A1c levels remained stable, with only a 0.04% change, suggesting effective glucose control alongside weight maintenance [15][16] - **Remain-1 Study**: - In a pilot study with 45 subjects, those who received Revita lost an average of 2 kg after stopping tirzepatide, while the sham group regained approximately 8 kg, highlighting a significant treatment difference of about 10 kg [21] - The pivotal Remain-1 study, which includes 315 patients, is expected to provide further data in the second half of 2026, with a focus on post-GLP-1 weight maintenance [24][23] Important Data Points - **Endoscopy Statistics**: Approximately 20 million endoscopies are performed annually in the U.S., with 800,000 of those being patients on GLP-1s [7] - **Patient Cohorts**: Fractyl is studying three patient cohorts: Reveal-1 (open-label), Remain Midpoint (pilot randomized), and Remain pivotal [13][20] - **FDA Designation**: The company has received Breakthrough Device Designation from the FDA, which may expedite the approval process for Revita [25] Additional Considerations - **Market Expectations**: A 50% reduction in weight regain is considered a significant win for the market, with stability in weight maintenance being a critical factor for patient outcomes [30][32] - **Clinical Consistency**: The data from both Reveal-1 and Remain-1 studies show a consistent signal of stability in weight maintenance, which is crucial for the therapeutic potential of Revita [33] This summary encapsulates the key points discussed during the Fractyl Health FY Conference Call, highlighting the company's innovative approach to addressing obesity and the promising clinical data supporting its treatment.

Core Insights - Fractyl Health, Inc. announced positive results from the REVEAL-1 Cohort, showing that participants who lost 24% of total body weight on GLP-1 drugs maintained stable weight and glycemic control six months after a single Revita treatment [1][3][6] - Revita demonstrated a mean weight change of 1.5% after six months, significantly lower than the ~10% weight regain observed in third-party studies following GLP-1 withdrawal [1][6] - The company anticipates key clinical data releases in 2026, including the REMAIN-1 Midpoint Cohort data in January and potential PMA filing in H2 2026 [1][13] Company Overview - Fractyl Health focuses on innovative treatments for obesity and type 2 diabetes, aiming to transform metabolic disease management from chronic symptomatic treatment to durable, disease-modifying therapies [11] - The company has a robust intellectual property portfolio with 35 granted U.S. patents and approximately 45 pending applications [11] - Revita, the company's lead product, is designed to remodel the duodenal lining to reverse damage caused by unhealthy diets, and has received FDA Breakthrough Device designation for weight maintenance after GLP-1 drug discontinuation [12] Study Details - The REVEAL-1 Cohort included 22 participants who had lost at least 15% of their body weight on GLP-1 medications and chose to discontinue therapy [9][10] - Participants maintained stable weight and minimal change in HbA1c levels after the Revita procedure, indicating potential for long-term metabolic health [6][8] - The study reported excellent tolerability, with no serious adverse events and mild, transient treatment-emergent adverse events in 36% of participants [6][8] Future Outlook - Fractyl Health is preparing for multiple clinical readouts in 2026, including 1-year data from the REVEAL-1 Cohort and the REMAIN-1 Pivotal Cohort [13] - The company is experiencing rapid clinical enrollment in its pivotal studies, reflecting a strong demand for non-drug alternatives in obesity treatment [8]