Core Insights - Shattuck Labs, Inc. has entered into a securities purchase agreement for a private placement financing expected to yield total gross proceeds of approximately $103 million, which will fund the development of SL-325 through multiple Phase 2 clinical trials [1][5] Group 1: Financing Details - The private placement is led by OrbiMed and includes participation from both new and existing investors such as Coastlands Capital, Prosight Capital, Adage Capital, Redmile Group, and NextBio Capital [2] - The financing will involve the issuance of 15,225,158 shares of common stock and pre-funded warrants for an aggregate of 37,410,188 shares, along with warrants for an additional 52,635,346 shares [3] - The purchase price for each share of common stock is set at $0.8677, with accompanying warrants having an exercise price of $1.0846 [3] Group 2: Clinical Development Plans - SL-325 is a potentially first-in-class DR3 blocking antibody aimed at treating Crohn's disease, ulcerative colitis, and other autoimmune diseases, with Phase 1 clinical trial enrollment expected to begin in the current quarter [4][9] - The anticipated net proceeds from the private placement will be used for the clinical development of SL-325, including multiple Phase 2 trials in inflammatory bowel disease (IBD) and another autoimmune disease [5] - The total proceeds from the private placement, combined with current cash and equivalents, are expected to fund operations into 2029 [1][5] Group 3: Company Overview - Shattuck Labs, Inc. specializes in developing treatments for autoimmune and inflammatory diseases, with a focus on novel therapeutics targeting TNF superfamily receptors [10] - The company is headquartered in Austin, Texas, and Durham, North Carolina, and is recognized for its expertise in protein engineering and the development of TNF receptor agonist and antagonist therapeutics [10]

Company Overview - Shattuck Labs is a clinical-stage biotechnology company focused on bi-functional fusion proteins [10] - The company has $114.6 million in cash and cash equivalents and investments as of March 31, 2024, expected to fund operations into 2026 [10] SL-172154 Clinical Trials (AML/HR-MDS) - In a Phase 1A/B trial, 14 frontline TP53m AML patients were enrolled [77] - In the same trial, 22 frontline HR-MDS patients were enrolled [77] - In TP53m AML patients, 3 out of 11 evaluable patients achieved a CR/CRi [54] - In HR-MDS patients, 9 out of 14 evaluable patients achieved a CR/mCR [70] - 81% of HR-MDS patients in the trial had TP53 mutation or deletion [65] SL-172154 Clinical Trials (PROC) - Enrollment was completed in Q4'23 in the Phase 1B dose expansion cohort for PROC [110] - Initial data showed a 27% Objective Response Rate (ORR) for SL-172154 in combination with PLD [110] - 50% of PROC patients had received one prior line of systemic therapy, and 50% had received two or more [106]

Company Overview - Shattuck Labs, Inc. is a biotechnology company focused on developing novel therapeutics targeting tumor necrosis factor (TNF) superfamily receptors for inflammatory and immune-related diseases [1][3] - The company is headquartered in Austin, Texas, and Durham, North Carolina [3] Product Development - Shattuck is developing SL-325, a potential first-in-class Death Receptor 3 (DR3) blocking antibody aimed at achieving a complete and durable blockade of the DR3/TL1A pathway [2][3] - Preclinical studies of SL-325 show high affinity binding and superior activity compared to TL1A antibodies, supporting the rationale for targeting the TNF receptor DR3 [2] - SL-325 has completed a GLP toxicology study in non-human primates, with an Investigational New Drug (IND) filing anticipated in the third quarter of 2025 [2] Upcoming Events - Company management will participate in a panel discussion and one-on-one meetings at the Leerink Partners Therapeutics Forum on July 8-9, 2025, in Boston, MA [1][2] - The session titled "TL1A: Pioneering a New MOA in IBD and Beyond" will be moderated by analysts from Leerink, with Shattuck's CEO, Taylor Schreiber, presenting [2]

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]