Financial Performance - The company incurred a net loss of $13.7 million for the three months ended March 31, 2025, compared to a net loss of $18.5 million for the same period in 2024, representing a 26.5% improvement[20]. - The accumulated deficit as of March 31, 2025, was $395.4 million, up from $381.7 million at the end of 2024, indicating ongoing financial challenges[26]. - The net loss for the three months ended March 31, 2025, was $13.702 million, compared to a net loss of $18.504 million for the same period in 2024, indicating a 26.0% improvement[109]. - The company anticipates continued significant expenses and operating losses in the near term as it advances SL-325 and other product candidates[121][122]. - The company anticipates incurring additional net losses and negative cash flows from operations in the near future until significant sales of product candidates can be generated[144]. Revenue and Collaboration - The company reported collaboration revenue of $0 for Q1 2025, down from $1.1 million in Q1 2024, reflecting a significant decline in revenue generation[20]. - The Company derived all of its revenue in 2024 from collaborations with Ono Pharmaceutical Co., Ltd. and ImmunoGen, with all services required under these agreements completed by December 31, 2024[35]. - The Company recognized revenue of $5.4 million for preclinical research activities under the Ono Agreement for the three months ended March 31, 2024[88]. - The Company has not recognized any revenue from the ImmunoGen Agreement for the three months ended March 31, 2025[91]. - Collaboration revenue decreased by $1.1 million, or 100.0%, to $0.0 million for the three months ended March 31, 2025, due to the completion of obligations under previous agreements[124][138]. Research and Development - Research and development expenses decreased to $9.9 million in Q1 2025 from $16.3 million in Q1 2024, a reduction of 39.5%[20]. - Research and development expenses totaled $9.9 million for the three months ended March 31, 2025, down 39.0% from $16.3 million in the same period in 2024[121][137]. - Research and development costs are expensed as incurred, including salaries, stock-based compensation, and clinical trial expenses, reflecting the Company's ongoing investment in innovation[65]. - The Company is developing a first-in-class antibody for inflammatory bowel disease, with a focus on the SL-325 program targeting the TL1A/DR3 pathway[25]. - SL-325, the Company's lead program, is a high-affinity DR3 blocking monoclonal antibody aimed at treating inflammatory bowel disease (IBD)[111]. Cash and Liquidity - Cash and cash equivalents increased to $60.9 million as of March 31, 2025, up from $57.4 million at the end of 2024, marking a 4.4% increase[24]. - As of March 31, 2025, the company believes that cash and cash equivalents are sufficient to fund projected operations into 2027[146]. - The company has the ability to offer and sell up to $24.5 million of shares under the ATM Facility as of March 31, 2025[143]. - The company estimates that its existing cash and cash equivalents will fund operating expenses into 2027, but may require additional funding sooner than expected[170]. - Minimal cash was provided by financing activities during the three months ended March 31, 2025[151]. Economic and Market Conditions - The global macroeconomic environment remains uncertain, potentially impacting future operations[123]. - The United States imposed a 25% tariff on imports from Canada and Mexico, and a 10% additional tariff on imports from China, which may adversely affect global economic conditions[167]. - The Federal Reserve has raised interest rates multiple times, which may increase economic uncertainty and affect consumer spending[168]. - Increased inflation rates could adversely affect the company by increasing costs, including labor and employee benefit costs[168]. - The ongoing military conflicts and rising geopolitical tensions have created extreme volatility in global capital markets, potentially disrupting the global supply chain[168]. Operational Risks - The Company is highly dependent on a limited number of contract development and manufacturing organizations (CDMOs) for drug product supply, which poses a risk to its research and development activities[36]. - The ability to raise additional funds will depend on financial, economic, and market conditions, which may be beyond the company's control[171]. - The company may face delays or difficulties in initiating or expanding clinical trials and manufacturing sufficient quantities of materials due to macroeconomic conditions[169]. - The company is evaluating options related to the advancement of its mRNA/LNP administered multifunctional GLP-1 constructs and TRIM7 program, which may include independent financing[145]. Stock and Equity - The Company has 3,100,823 pre-funded warrants outstanding, which are included in the calculation of basic loss per share[72]. - The Company’s stock options outstanding increased from 6,468,859 as of March 31, 2024, to 8,458,834 as of March 31, 2025[73]. - The Company has 8,458,834 stock options outstanding as of March 31, 2025, with a weighted average exercise price of $5.52[100]. - The share reserve under the 2020 Equity Incentive Plan increased by 1,908,588 shares on January 1, 2025, with 3,721,751 shares available for future grants as of March 31, 2025[96].

Financial Performance - Cash balance as of March 31, 2025, was approximately $60.9 million, expected to fund operations into 2027[5] - Net loss for Q1 2025 was $13.7 million, or $0.27 per share, compared to a net loss of $18.5 million, or $0.37 per share, in Q1 2024, indicating an improvement of 26.5%[10] - Collaboration revenue for Q1 2025 was $0, down from $1.1 million in Q1 2024[10] - Total assets as of March 31, 2025, were $77.2 million, a decrease from $91.0 million as of December 31, 2024[16] Expenses - Research and Development (R&D) expenses for Q1 2025 were $9.9 million, down from $16.3 million in Q1 2024, representing a decrease of 39.1%[10] - General and Administrative (G&A) expenses for Q1 2025 were $4.5 million, compared to $4.9 million in Q1 2024, a decrease of 8.2%[10] Clinical Development - The company plans to initiate a Phase 1 clinical trial for SL-325 in Q3 2025, with the first patient expected to be enrolled in the same quarter[6] - Phase 1 enrollment completion for SL-325 is expected in Q2 2026[6] - The company is developing multiple preclinical DR3-based bispecific antibodies, with a lead candidate nomination planned for 2025[6] - Shattuck Labs reported no infusion-related reactions in preclinical studies of SL-325, with a No Observed Adverse Effect Level determined to be 100 mg/kg[6]

Core Insights - Shattuck Labs, Inc. is advancing its SL-325 program with an IND filing expected in the third quarter of 2025, targeting inflammatory bowel disease (IBD) and other immune-mediated diseases [1][5][9] - The company reported a cash balance of approximately $60.9 million as of March 31, 2025, which is expected to fund operations into 2027 [1][8] Company Developments - SL-325 is a potentially first-in-class DR3 antagonist antibody designed to block the DR3/TL1A pathway, with the Phase 1 clinical trial set to evaluate safety, tolerability, and pharmacokinetics [5][9] - The first patient for the SAD portion of the Phase 1 trial is expected to be enrolled in the third quarter of 2025, with completion of enrollment anticipated by the second quarter of 2026 [5][9] - The company has completed wind-down activities related to discontinued oncology programs and is well-positioned to fund operations beyond the Phase 1 trial results [2][5] Financial Performance - For the first quarter of 2025, Shattuck Labs reported R&D expenses of $9.9 million, down from $16.3 million in the same quarter of 2024, and G&A expenses of $4.5 million, slightly down from $4.9 million [12][19] - The net loss for the quarter was $13.7 million, or $0.27 per share, compared to a net loss of $18.5 million, or $0.37 per share, in the first quarter of 2024 [12][19] - Cash and cash equivalents decreased from $114.6 million as of March 31, 2024, to $60.9 million as of March 31, 2025 [12][19] Upcoming Events - Shattuck Labs participated in the 24th Annual Needham Virtual Healthcare Conference and presented at the ECCO in February 2025 [5][12] - The company is scheduled to present at the PEGS Boston Summit on May 12, 2025, and will participate in the Leerink Partners Therapeutics Forum on July 8-9, 2025 [12]

Core Insights - Shattuck Labs, Inc. is participating in the 24th Annual Needham Virtual Healthcare Conference from April 7–10, 2025, with a presentation scheduled for April 9, 2025, at 3:00 PM EDT [1][2] Company Overview - Shattuck Labs, Inc. is a biotechnology company focused on developing novel therapeutics for inflammatory and immune-related diseases, with a lead program SL-325 targeting the DR3/TL1A pathway [4] - The company has expertise in protein engineering and aims to create first-in-class treatments for conditions such as inflammatory bowel disease (IBD) [4] Product Development - SL-325 is a potential first-in-class Death Receptor 3 (DR3) blocking antibody, showing high affinity binding and superior activity compared to TL1A antibodies, with an IND filing expected in Q3 2025 [3]

Drug Development and Clinical Trials - SL-325 is a high-affinity DR3 blocking monoclonal antibody designed for the treatment of inflammatory bowel disease (IBD) and has shown superior blocking of TL1A binding compared to leading TL1A blocking antibodies[21]. - The company plans to file an Investigational New Drug (IND) application for SL-325 in Q3 2025 and complete enrollment in the Phase 1 clinical trial by Q2 2026[24][26]. - SL-325 demonstrated a No Observed Adverse Effect Level of 100 mg/kg in a GLP toxicology study, with full and durable DR3 receptor occupancy observed at doses of 1 mg/kg or higher[42]. - SL-325's pharmacokinetic profile suggests extended dosing intervals, which will be further characterized in the upcoming Phase 1 clinical trial[22]. - The clinical success of existing TL1A blocking antibodies indicates that SL-325 may have monotherapy disease-modifying activity early in clinical development[24]. - SL-325 is expected to enter Phase 1 clinical trials in the second half of 2025, with the potential to become a best-in-class inhibitor of the DR3/TL1A axis[41]. - The company must submit an IND to the FDA before beginning any clinical trial in the United States[86]. - Human clinical trials typically involve three phases, with Phase 3 aimed at establishing the overall risk/benefit ratio of the investigational product[97]. - The FDA may require additional clinical trials post-approval to gather more information about the product[92]. - The process of obtaining regulatory approvals requires substantial time and financial resources, with potential sanctions for non-compliance[85]. Market Potential and Competitive Landscape - The IBD market is projected to grow from $23 billion in 2023 to $34 billion by 2030, indicating significant commercial potential for SL-325[32]. - The competitive landscape includes major pharmaceutical companies such as AbbVie, Johnson & Johnson, and Merck, which may pose challenges in market positioning[70]. - The company is also developing SL-425, a half-life extended version of SL-325, and multiple preclinical DR3-based bispecific antibodies for IBD treatment[27]. - The company is developing bispecific antibodies targeting DR3 and other validated targets, with a lead bispecific candidate expected to be nominated in 2025[61]. Regulatory and Approval Processes - The FDA reviews a BLA to determine if a product is safe, pure, and potent, and if manufacturing facilities meet compliance standards[99]. - Approval may be granted with limitations on indicated uses, including a Risk Evaluation and Mitigation Strategy (REMS) to manage safety risks[101]. - The FDA offers expedited development and review programs, including fast track designation for products intended to treat serious diseases, allowing for more frequent interactions with the review team[102]. - Products may receive accelerated approval if they show effects on surrogate endpoints likely to predict clinical benefits, with post-marketing studies required to verify these effects[103]. - The RMAT designation facilitates efficient development and expedited review for regenerative medicine therapies, providing benefits similar to breakthrough therapy designation[105]. - Breakthrough therapy designation allows for intensive FDA interaction and guidance, expediting development for products showing substantial improvement over existing therapies[106]. - Priority review designation aims for FDA action on marketing applications within six months, compared to ten months under standard review, for products showing significant improvement potential[107]. - The FDA requires compliance with regulatory standards post-approval, including record-keeping and reporting of adverse experiences, with potential consequences for non-compliance[113]. - The FDA closely regulates marketing and promotion of biologics, with strict limitations on claims related to safety and efficacy[115]. Intellectual Property and Compliance - The company owns one pending international patent application and six pending provisional applications related to DR3 as of March 1, 2025[82]. - The company may apply for Patent Term Extension for currently owned or licensed patents depending on clinical trial lengths[81]. - The company may apply for a patent term extension of up to five years after a BLA approval, with a maximum total patent term of 14 years[123]. - The company is subject to various healthcare regulations, including the Anti-Kickback Statute and the False Claims Act, which impose strict compliance requirements[124][126]. - Compliance with data privacy laws, such as HIPAA and state-specific regulations, is critical and violations can lead to significant penalties[134][140]. Financial and Market Access Challenges - Significant uncertainty exists regarding the coverage and reimbursement status of pharmaceutical products, which can vary significantly among payors[142]. - Third-party payors are increasingly scrutinizing the prices of medical products and may challenge the medical necessity and cost-effectiveness of pharmaceutical products[143]. - The IRA provides CMS with new authorities to curb drug costs, impacting the pricing and reimbursement landscape[145]. - The Inflation Reduction Act of 2022 aims to foster generic and biosimilar competition and lower drug costs[122]. - The U.S. federal Physician Payments Sunshine Act requires manufacturers to report payments to healthcare professionals annually[129]. Employment and Organizational Structure - As of December 31, 2024, the company employed 44 full-time employees across two locations in the United States, Austin, TX and Durham, NC[215]. - The company plans to hire additional employees in 2025 and beyond, focusing on clinical research and development, in-house process development, and manufacturing to support later-stage clinical trials[216]. - A large majority of the company's employees hold advanced degrees, and the company supports further development through individualized plans, mentoring, and training[218]. International Regulations and Compliance - The UK government has adopted the Medicines and Medical Devices Act 2021 to update regulatory frameworks post-Brexit, impacting the company's operations in the UK market[211]. - The EMA grants orphan drug designation for products intended for conditions affecting no more than five in 10,000 persons in the EU[190]. - The centralized procedure grants a single Marketing Authorization (MA) valid for all EU Member States, with a typical evaluation timeframe of 210 days, which can be reduced to 150 days for accelerated assessments[174]. - The new Clinical Trials Regulation (CTR) allows a single application for clinical trial approval through the centralized EU clinical trials portal (CTIS), with a transition period of three years[166]. - The UK has retained the benefit of market exclusivity for orphan medicines post-Brexit, with similar requirements to the EU[195].

Core Insights - Shattuck Labs, Inc. is advancing its lead product candidate SL-325, a potentially first-in-class DR3 blocking antibody, towards Phase 1 clinical trials with an IND filing expected in Q3 2025 [1][5][9] Financial Overview - As of December 31, 2024, Shattuck Labs reported a cash balance of approximately $73.0 million, which is expected to fund operations into 2027 [1][8] - Research and Development (R&D) expenses for Q4 2024 were $15.4 million, slightly up from $15.2 million in Q4 2023, while total R&D expenses for the year decreased to $67.2 million from $74.3 million in 2023 [12][17] - General and Administrative (G&A) expenses for Q4 2024 were $4.2 million, down from $4.4 million in Q4 2023, with total G&A expenses for the year at $19.1 million compared to $19.3 million in 2023 [12][17] - The net loss for Q4 2024 was $18.7 million, or $0.37 per share, compared to a net loss of $17.7 million, or $0.41 per share, in Q4 2023 [12][17] Product Development - SL-325 has demonstrated a favorable safety profile in preclinical studies, with no infusion-related reactions and full receptor occupancy at doses of 1 mg/kg or greater [5][9] - The Phase 1 clinical trial will assess safety, tolerability, and pharmacokinetics, with complete enrollment expected by Q2 2026 [5][9] - Shattuck Labs is also developing multiple preclinical DR3-based bispecific antibodies aimed at treating IBD, with plans to nominate a lead bispecific candidate in 2025 [5][9] Recent Developments - The company presented preclinical data for SL-325 at the 20th Congress of ECCO, highlighting its potential for achieving best-in-class clinical remission rates for IBD patients [1][2] - The decision to terminate the SL-172154 program in 2024 was made to focus resources on the development of SL-325 [2]

Core Insights - Shattuck Labs, Inc. announced positive preclinical data for SL-325, a high-affinity DR3 blocking antibody aimed at treating inflammatory bowel disease (IBD) [1][2] - The company plans to file an Investigational New Drug (IND) application in the third quarter of 2025 [1][4] Preclinical Data - SL-325 demonstrated no evidence of toxicity or residual agonism in a GLP toxicology study conducted in non-human primates [1][5] - The study showed full and durable DR3 receptor occupancy at low doses, indicating potential for extended dosing intervals in humans [2][5] - No adverse effects were observed at the highest dose of 100 mg/kg, and no infusion-related reactions were noted [5][6] Mechanism and Efficacy - Inhibition of the TL1A/DR3 signaling axis by SL-325 has shown complete remission rates that match or exceed those of existing treatments like IL-23 or α4β7 blocking antibodies [2][4] - The preclinical studies suggest that targeting DR3 may provide a more comprehensive blockade compared to TL1A [2][4] Future Development - SL-325 is expected to enter Phase 1 clinical trials later in 2025, with projected dosing schedules of 1 mg/kg every two weeks for induction and 3 mg/kg every two weeks for maintenance [5][6] - The company is leveraging its expertise in protein engineering to develop SL-325 as a first-in-class treatment for autoimmune and inflammatory diseases [6]

Core Insights - Shattuck Labs, Inc. is developing SL-325, a high-affinity DR3 blocking antibody for the treatment of inflammatory bowel disease (IBD), with positive preclinical data indicating no toxicity or residual agonism in non-human primates [1][4][5] - The company plans to file an Investigational New Drug (IND) application in the third quarter of 2025, with Phase 1 clinical trials expected to commence later this year [1][4][5] Preclinical Data - SL-325 demonstrated complete and durable DR3 receptor occupancy at low doses in non-human primates, with no observed adverse effects or organ dysfunction [5][6] - The pharmacokinetic profile suggests extended dosing intervals in humans, with projected dosing of 1 mg/kg every two weeks for induction and 3 mg/kg every two weeks for maintenance [5][6] Mechanism of Action - Inhibition of the TL1A/DR3 signaling axis by SL-325 shows complete remission rates that match or exceed those of existing therapies, indicating a potentially more effective treatment option for IBD [2][4] - The antibody's design aims for a more complete blockade of the DR3/TL1A pathway compared to TL1A blocking antibodies, leveraging the higher expression of DR3 in IBD patients [2][4] Company Overview - Shattuck Labs specializes in developing treatments for autoimmune and inflammatory diseases, with a focus on novel therapeutics targeting TNF superfamily receptors [5][6] - The company operates from Austin, Texas, and Durham, North Carolina, and emphasizes its expertise in protein engineering [6]

AUSTIN, TX & DURHAM, NC, Feb. 13, 2025 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a biotechnology company pioneering the development of novel therapeutics targeting tumor necrosis factor (TNF) superfamily receptors for the treatment of patients with inflammatory and immune-related diseases, today announced an upcoming oral presentation at the 20th Congress of ECCO in Inflammatory Bowel Diseases 2025 being held in Berlin, Germany from February 19–22, 2025. This presentation will featu ...

AUSTIN, TX & DURHAM, NC, Feb. 13, 2025 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck) (NASDAQ:STTK), a biotechnology company pioneering the development of novel therapeutics targeting tumor necrosis factor (TNF) superfamily receptors for the treatment of patients with inflammatory and immune-related diseases, today announced an upcoming oral presentation at the 20th Congress of ECCO in Inflammatory Bowel Diseases 2025 being held in Berlin, Germany from February 19–22, 2025. This presentation will featur ...