Buttressed by a significant amount of fresh capital, the company is showing progress in the early development of its top investigational drug.A recommendation upgrade from an analyst at the beginning of December set the tone for Shattuck Labs (STTK +4.85%) stock in 2025's final month. The clinical-stage biotech's share price rose by almost 74% as a result.Good for what ails you The person responsible for that influential move was H.C. Wainwright's Joseph Pantginis, who on Dec. 1 shifted his recommendation o ...

AUSTIN, TX and DURHAM, NC, Dec. 15, 2025 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (“Shattuck” or the “Company”) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of novel therapeutics targeting tumor necrosis factor (TNF) superfamily receptors for the treatment of patients with inflammatory and immune-mediated diseases, today announced that it has granted inducement equity awards on December 10, 2025 (the “Grant Date”) to a newly-hired non-executive officer. The inducement awa ...

Summary of Shattuck Labs FY Conference Call (December 04, 2025) Company Overview - **Company**: Shattuck Labs (NasdaqGS:STTK) - **Focus**: Development of a novel mechanism targeting the TL1A axis, specifically through receptor-blocking antibodies Key Points and Arguments Target Mechanism - **TL1A**: An inflammatory ligand that signals through the DR3 receptor, with a unique characteristic of only signaling through a single receptor [2][10] - **Receptor vs. Ligand Targeting**: The company is focusing on receptor-blocking antibodies due to engineering challenges and potential safety liabilities associated with ligand-blocking antibodies [2][3] Confidence in Receptor-Blocking Approach - **Safety Concerns**: Addressed concerns about potential agonist properties of receptor-blocking antibodies, emphasizing that their lead antibody showed no evidence of receptor agonism in non-human primate studies [4][5] - **Phase 1 Study**: Currently halfway through a Phase 1 study with positive early indicators regarding safety and immunogenicity [5][17] Immunogenicity Profile - **Immunogenicity Advantages**: The receptor-blocking approach is expected to have a better immunogenicity profile compared to ligand-blocking antibodies, which often lead to the formation of anti-drug antibodies (ADAs) [6][27] - **ADA Formation**: Over 65% of patients treated with TL1A antibodies develop ADAs, which can accelerate clearance of the therapeutic antibody [8][25] Efficacy Differentiation - **Stable Target**: The receptor is consistently expressed by lymphocytes, providing a stable target compared to the ligand, which is induced in a pulsatile manner [18][20] - **Potential for Better Efficacy**: The receptor-blocking strategy may lead to more effective treatment outcomes in inflammatory diseases due to stable receptor occupancy [22][26] Development Pipeline - **Half-Life Extension and Bispecifics**: The company is actively developing half-life extended versions of their antibodies and exploring bispecific antibodies targeting DR3 [28][29] - **Clinical Studies**: Plans to conduct a healthy volunteer Phase 1 study with the half-life extended version while running a Phase 2 study in inflammatory bowel disease (IBD) with the non-half-life extended version [29] Market Context and Competition - **Competitive Landscape**: Other companies, such as Teva and Novartis, are also developing TL1A-targeting therapies, but Shattuck Labs believes their receptor-focused approach offers distinct advantages [12][30] - **Potential Collaborations**: Discussion of possible combinations with biosimilar IL-23 therapies, indicating a strategic approach to enhance treatment efficacy [32][34] Additional Important Insights - **Regulatory and Market Readiness**: The company is preparing for multiple indications and potential platform trials, indicating a proactive approach to market entry and competition [33][34] - **Focus on Safety and Efficacy**: Emphasis on the importance of demonstrating a superior safety profile and efficacy in upcoming clinical trials to differentiate from existing therapies [27][28] This summary encapsulates the critical insights from the Shattuck Labs FY Conference Call, highlighting the company's innovative approach to targeting the TL1A axis and its strategic positioning in the competitive landscape of inflammatory disease therapies.

Summary of Shattuck Labs FY Conference Call Company Overview - **Company**: Shattuck Labs (NasdaqGS:STTK) - **Event**: FY Conference on December 02, 2025 Industry Focus - **Industry**: Biotechnology, specifically focusing on antibody therapies for inflammatory bowel diseases (IBD) such as ulcerative colitis and Crohn's disease Key Points and Arguments 1. **Lead Antibody**: The primary focus is on SL325, a DR3 blocking antibody, with a half-life extended version called SL425 mentioned but not discussed in detail [2][19] 2. **Biological Mechanism**: The presentation emphasizes the TL1A-DR3 axis, where TL1A is the ligand and DR3 is the receptor. The company believes that targeting DR3 may offer advantages over TL1A blocking antibodies, particularly in terms of safety and efficacy [3][4] 3. **Efficacy Comparison**: Emerging data suggests that TL1A blocking antibodies show efficacy similar to JAK inhibitors but with fewer toxicities. Shattuck Labs posits that DR3 blocking could provide more durable inhibition and a better safety profile [3][11] 4. **Immunogenicity Concerns**: TL1A antibodies have shown high rates of anti-drug antibodies (ADA), leading to accelerated clearance and reduced efficacy. In contrast, DR3 targeting is expected to minimize immune complex formation, potentially improving the immunogenicity profile [11][12] 5. **Preclinical Data**: SL325 has demonstrated high affinity (1-picomolar binding) and specificity, with preclinical studies indicating no residual agonism and effective inhibition of TL1A-mediated cytokine production [5][14] 6. **Phase 1 Study**: The company is currently conducting a Phase 1 study in healthy volunteers, aiming to assess safety, receptor occupancy, and immunogenicity. Results are expected in the first half of 2026 [17][18] 7. **Funding and Future Trials**: Shattuck Labs is funded through Phase 2 trials, with cash reserves projected to last until 2029 due to recent financing [19] Additional Important Information - **Competitive Landscape**: The company acknowledges a competitive landscape for both TL1A and DR3 targeting but believes it has a unique position with its DR3 blocking approach [18] - **Dosing Interval**: While the dosing interval has not been disclosed, the target for maintenance is approximately every 8 weeks, pending Phase 1 data [19]

Core Viewpoint - HC Wainwright upgraded Shattuck Labs Inc. from Neutral to Buy, forecasting a price of $6, driven by the potential of its lead product candidate SL-325 for inflammatory bowel disease (IBD) [1] Group 1: Product Development - Shattuck Labs has initiated dosing of the first healthy participants in the Phase 1 clinical trial for SL-325, with the single-ascending dose (SAD) portion expected to be completed by Q3 2025 [1] - Enrollment for both SAD and multiple-ascending dose (MAD) portions is anticipated to conclude in Q2 2026 [1] Group 2: Market Opportunity - Analyst Joseph Pantginis highlighted the opportunity for SL-325 to capture significant market share despite competition from later-stage programs that have established clinical proof-of-concept with the TL1A approach [2] - The TL1A/DR3 development landscape for IBD, including ulcerative colitis and Crohn's Disease, has attracted attention from major pharmaceutical companies, focusing primarily on the TL1A side [3] Group 3: Competitive Landscape - Leading late-stage TL1A programs include Merck & Co.'s tulisokibart and Roche Holdings' afimkibart, which have shown promising data, but concerns regarding durability of response and immunogenicity persist across the class [4] - Shattuck Labs aims to differentiate itself by targeting the DR3 receptor, which is expected to provide more durable inflammatory control compared to ligand-level inhibition [5][6] Group 4: Stock Performance - Following the upgrade, Shattuck Labs' stock (STTK) rose by 13.3%, reaching $2.38 [6]

Core Viewpoint - Shattuck Labs, Inc. (NASDAQ:STTK) is recognized for its strong performance and potential upside, making it a notable investment opportunity among penny stocks [1]. Financial Performance - For Q3 2025, Shattuck Labs reported a net loss of $10.1 million, equating to $0.14 per basic and diluted share [3]. - Research and Development (R&D) expenses decreased to $7.60 million, while General and Administrative (G&A) expenses totaled $4.10 million [3]. - The company maintains a solid financial position with cash and investments amounting to $86.10 million [2]. Drug Development Progress - The Phase 1 readout for the SL-325 drug is anticipated in Q2 2026, which is viewed as a significant growth catalyst [2]. - The company is advancing the SL-325 trial and is making progress towards selecting a bispecific candidate for development in 2026 [3]. - The SL-325 drug targets the DR3/TL1A pathway, aiming for a complete blockade, indicating its potential in treating autoimmune and inflammatory diseases [4]. Analyst Sentiment - Analyst Joseph Pantginis from H.C. Wainwright has reiterated a "Hold" rating on Shattuck Labs, citing the drug's clinical potential and the company's balanced risk profile [2].

Core Insights - Shattuck Labs, Inc. is a clinical-stage biotechnology company focused on developing novel therapeutics targeting tumor necrosis factor (TNF) superfamily receptors for inflammatory and immune-mediated diseases [1][4] - The company will participate in multiple investor conferences in December 2025, including the Piper Sandler 37 Annual Healthcare Conference and the Evercore ISI 8 Annual HealthCONx Conference [1][2] Conference Details - The Piper Sandler 37 Annual Healthcare Conference will feature a presentation by CEO Taylor Schreiber on December 2, 2025, at 10:10 AM EST in New York, NY [2] - The Evercore ISI 8 Annual HealthCONx Conference will include a fireside chat with CEO Taylor Schreiber on December 4, 2025, at 8:20 AM EST in Coral Gables, FL [2] - Replays of the presentations will be available on the company's website for up to 30 days following the events [2] Product Development - SL-325 is a potential first-in-class Death Receptor 3 (DR3) blocking antibody designed to block the DR3/TL1A pathway, showing high affinity binding and superior activity compared to TL1A antibodies [3] - SL-325 is currently in a Phase 1 clinical trial and has demonstrated a favorable safety profile in non-human primates [3][4] - The company aims to develop SL-325 as a treatment for inflammatory bowel disease (IBD) and other inflammatory and immune-mediated diseases [4]

Financial Performance - License and collaboration revenue for Q3 2025 was $1,000,000, a decrease of 66.7% compared to $2,997,000 in Q3 2024[20] - Net loss for Q3 2025 was $10,056,000, compared to a net loss of $16,675,000 in Q3 2024, indicating a 39.5% improvement[20] - The company reported a comprehensive loss of $10,054,000 for Q3 2025, compared to a comprehensive loss of $16,618,000 in Q3 2024, showing a 39.5% reduction[20] - For the nine months ended September 30, 2025, the net loss was $36.2 million, a decrease from a net loss of $56.7 million in the same period of 2024, representing a 36% improvement[26] - Net loss for the three months ended September 30, 2025, was $10.1 million, a decrease of $6.6 million or 39.7% compared to a net loss of $16.7 million for the same period in 2024[150] - For the nine months ended September 30, 2025, the net loss was $36.2 million compared to $56.7 million for the same period in 2024, indicating a reduction in losses[133] Revenue and Expenses - Research and development expenses for the nine months ended September 30, 2025, were $26,218,000, down 49.5% from $51,816,000 in the same period of 2024[20] - Research and development expenses for the three months ended September 30, 2025, totaled $7,618 million, a decrease of 53.3% from $16,313 million in the same period of 2024[119] - General and administrative expenses decreased by $0.5 million, or 11.0%, to $4.1 million for the three months ended September 30, 2025, from $4.6 million for the same period in 2024[153] - General and administrative expenses for the nine months ended September 30, 2025, decreased by $1.9 million, or 12.9%, to $12.9 million from $14.8 million for the same period in 2024[158] - For the nine months ended September 30, 2025, license and collaboration revenue decreased by $4.7 million, or 82.5%, to $1.0 million from $5.7 million for the same period in 2024[156] Assets and Liabilities - Total assets increased to $100,333,000 as of September 30, 2025, up from $91,049,000 at December 31, 2024, representing a 10.3% growth[18] - Total stockholders' equity increased to $93,240,000 as of September 30, 2025, up from $79,626,000 at December 31, 2024, reflecting a 17.1% increase[18] - The company’s total liabilities decreased to $7,093,000 as of September 30, 2025, down from $11,423,000 at December 31, 2024, a reduction of 38.1%[18] - Cash and cash equivalents decreased to $42,548,000 as of September 30, 2025, down from $57,387,000 at December 31, 2024, a decline of 25.8%[18] - The company reported cash and cash equivalents of $42.5 million as of September 30, 2025, down from $43.8 million at the end of 2024[26] - The company has an accumulated deficit of $417.9 million as of September 30, 2025, highlighting ongoing financial challenges[28] Cash Flow - Cash flows from operating activities resulted in a net cash used of $31.4 million for the nine months ended September 30, 2025, compared to $43.1 million in 2024, indicating a 27% reduction in cash outflow[26] - Net cash used in operating activities for the nine months ended September 30, 2025, was $31.4 million, reflecting a net loss of $36.2 million[168] - Net cash provided by financing activities for the nine months ended September 30, 2025, was $44.4 million, primarily from the sale of common stock and warrants[171] Stock and Equity - Weighted-average shares outstanding increased to 72,184,818 for Q3 2025, compared to 50,833,538 for Q3 2024, representing a 42.0% increase[20] - The Company issued 15,225,158 shares of common stock at a price of $0.8677 per share in August 2025[106] - The Company completed a public offering in December 2023, selling 4,651,163 shares of common stock at a price of $6.45 per share[105] - As of September 30, 2025, the company has 52,635,346 common stock warrants outstanding[108] - The Company recorded total stock-based compensation of $1.778 million for the three months ended September 30, 2025, a decrease of 30.5% from $2.556 million in the same period of 2024[112] Future Outlook - The company anticipates additional losses and negative cash flows until it can generate significant sales from its product candidates currently in development[28] - The company does not expect to generate significant product revenue until successful development and regulatory approval of its product candidates, which may take several years[134] - The company estimates that existing cash and cash equivalents, short-term investments, and potential future proceeds from the exercise of all outstanding common stock warrants will fund operating expenses into 2029[188] Regulatory and Compliance - The company is classified as an emerging growth company and a smaller reporting company, allowing it to take advantage of reduced reporting requirements and exemptions from certain accounting standards[179][181] - The company has identified risks related to potential disruptions at the FDA, which could negatively impact the review of regulatory submissions and overall business operations[190] - The company regained compliance with Nasdaq Listing Rule 5450(a)(1) after meeting the minimum bid price requirement of $1.00 per share[135] Miscellaneous - The global macroeconomic environment remains uncertain, potentially impacting the company's future operations due to inflation and other economic factors[29] - The One Big Beautiful Bill Act (OBBBA) was enacted, with provisions effective in 2025 and 2027, but the immediate impact is not material[79] - The company has not reported any legal proceedings or defaults upon senior securities during the reporting period[186][197] - Shattuck Labs, Inc. filed its Quarterly Report on Form 10-Q on November 6, 2025[204]

Core Viewpoint - Shattuck Labs, Inc. has initiated a Phase 1 clinical trial for its lead product candidate SL-325, a DR3 blocking antibody, and has reported financial results for Q3 2025, highlighting its strong capital position to advance clinical development [1][2][3]. Business Highlights - SL-325 is the first DR3 blocking antibody to enter clinical development, with the Phase 1 trial proceeding as planned [2]. - The company closed a private placement of approximately $103 million in August 2025, which is expected to fund operations into 2029 and support multiple clinical milestones for SL-325 [3][6]. - Recent appointments to the Board of Directors include Dan Baker, M.D., and Mona Ashiya, Ph.D., enhancing the company's leadership [4][6]. Clinical Development - The Phase 1 trial for SL-325 began with the first participants dosed in Q3 2025, focusing on safety, tolerability, immunogenicity, and pharmacokinetics [7]. - Enrollment for the single-ascending dose (SAD) and multiple-ascending dose (MAD) portions is expected to be completed by Q2 2026, with initial results anticipated by the same timeframe [7]. - The company is also developing preclinical DR3-based bispecific antibodies aimed at treating inflammatory bowel disease (IBD) [7]. Financial Results - As of September 30, 2025, cash and cash equivalents were approximately $86.1 million, down from $90.1 million a year earlier [10][14]. - Research and Development (R&D) expenses for Q3 2025 were $7.6 million, a decrease from $16.3 million in Q3 2024 [14]. - The net loss for Q3 2025 was $10.1 million, or $0.14 per share, compared to a net loss of $16.6 million, or $0.33 per share, in the same quarter of the previous year [14][21].

Company Overview - Shattuck Labs is a clinical-stage biotechnology company focused on developing novel therapeutics for inflammatory and immune-mediated diseases[5] - The lead program, SL-325, is a potential first-in-class blocking antibody targeting DR3 for the treatment of inflammatory bowel disease (IBD)[5] - The company had $86.1 million in cash and cash equivalents as of September 30, 2025, with a cash runway expected to last into 2029[5] SL-325 Program and TL1A/DR3 Pathway - SL-325 has picomolar binding affinity (1.3 pM) to DR3 and overlaps the TL1A binding site[44] - SL-325 is designed for potent DR3 blockade and does not bind to DcR3[44] - Preclinical data suggests SL-325 blocks TL1A binding at lower concentrations than benchmark anti-TL1As, with approximately 10-fold greater potency in vitro[52] - In non-human primate studies, SL-325 achieved full and durable receptor occupancy (RO) at all dose levels for at least four weeks post-dose[60] Market and Milestones - Worldwide inflammatory bowel disease (IBD) sales are expected to reach $33.3 billion by 2030[22, 76] - Enrollment is ongoing in a Phase 1 clinical trial evaluating SL-325 in healthy volunteers, with completion expected in Q2 2026[5, 76]