Core Insights - The discussion focuses on the UEGW conference in Berlin, highlighting significant updates in the Inflammatory Bowel Disease (IBD) sector [1]. Group 1: Conference Overview - The UEGW conference was described as exciting, with numerous updates relevant to the IBD space [1]. - The session is part of the Wedbush Rewind series, aimed at reviewing key highlights from industry conferences [1]. Group 2: Participants - Key participants include David Nierengarten, Managing Director of the Healthcare Equity Research team at Wedbush, Dr. Marla Dubinsky from Mount Sinai, David De Vries M. Phil, CEO of Tr1X Bio, and Taylor Schreiber, MD, PhD, CEO of Shattuck Labs [2]. - The format encourages audience participation through a Q&A session, enhancing engagement during the discussion [3].

Core Insights - Momentum investing focuses on following a stock's recent price trends, aiming to buy high and sell higher, with the expectation that established trends will continue [1] - The Zacks Momentum Style Score helps investors identify stocks with strong momentum, addressing the challenges of defining momentum [2] Company Overview: Shattuck Labs, Inc. (STTK) - Shattuck Labs, Inc. currently holds a Momentum Style Score of B, indicating a favorable momentum outlook [3] - The company has a Zacks Rank of 2 (Buy), suggesting strong potential for outperformance in the market [4] Performance Metrics - Over the past week, STTK shares increased by 3.07%, while the Zacks Medical - Biomedical and Genetics industry rose by 3.61% [6] - In a longer timeframe, STTK shares have surged by 209.66% over the past quarter and 94.44% over the last year, significantly outperforming the S&P 500, which increased by 8.11% and 19.22% respectively [7] Trading Volume - The average 20-day trading volume for STTK is 426,895 shares, which serves as a bullish indicator when combined with rising stock prices [8] Earnings Outlook - Recent earnings estimate revisions for STTK show positive momentum, with three estimates moving higher for the full year, raising the consensus estimate from -$0.96 to -$0.71 [10] - For the next fiscal year, three estimates have also increased, with no downward revisions noted [10] Conclusion - Considering the positive performance metrics and earnings outlook, STTK is positioned as a 2 (Buy) stock with a Momentum Score of B, making it a potential candidate for near-term investment [12]

Summary of Shattuck Labs Conference Call Company Overview - **Company**: Shattuck Labs (NasdaqGS:STTK) - **Focus**: Development of the first in-class death receptor three (DR3) blocking antibody for inflammatory bowel disease (IBD) targeting TL1A [1][2] Core Industry Insights - **Target Mechanism**: DR3 is the sole signaling receptor for TL1A, a well-known target in IBD [2] - **Efficacy Comparison**: Targeting DR3 may provide superior efficacy compared to existing TL1A blocking antibodies due to differences in expression patterns and stability [3][10] Key Points on DR3 vs. TL1A - **Expression Levels**: - TL1A is expressed in about 8-10% of cells in actively inflamed tissue of Crohn's disease patients, while DR3 is expressed in 18-20% of those cells [5][6] - DR3 shows broader and more stable expression, making it a more reliable target [6][10] - **Immunogenicity**: - TL1A blocking antibodies have shown high rates of anti-drug antibody formation (over 65% in some cases), leading to accelerated clearance and loss of response [18][19] - DR3 does not generate immune complexes, potentially reducing immunogenicity [20] Development of SL-325 - **Antibody Characteristics**: SL-325 is a high-affinity human DR3 blocking antibody with no Fc gamma receptor binding activity, minimizing the risk of residual agonism [22][24] - **Clinical Development Timeline**: Phase one study is expected to complete in the first half of next year, with plans to move into multiple placebo-controlled phase two trials [31] Potential Indications and Market Opportunities - **Indications for Development**: - Initial focus on IBD (Crohn's disease and ulcerative colitis) with potential expansion into other autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, and asthma [32][34] - The presence of specific single nucleotide polymorphisms (SNPs) in TL1A may drive pathology in various diseases [33] - **Market Need**: There is a high unmet medical need in diseases associated with TL1A signaling, making the development of DR3 blocking antibodies potentially lucrative [35] Competitive Landscape - **Current Competitors**: No disclosed programs for DR3 antagonists are known, although other companies have attempted development but faced challenges with agonist activity [29][30] Conclusion - Shattuck Labs is positioned to advance its DR3 blocking antibody, SL-325, with a focus on addressing the limitations of existing TL1A therapies and exploring a range of autoimmune diseases where there is significant unmet medical need [39]

Core Insights - Shattuck Labs, Inc. is participating in a panel discussion at the United European Gastroenterology Week (UEGW) Conference 2025, focusing on key takeaways from the event [1] - The panel will be moderated by analysts Martin Fan, Ph.D. and David Nierengarten, Ph.D., featuring KOL Marla Dubinsky, M.D. [1] Conference Details - The panel discussion titled "Wedbush UEGW Conference 2025 Rewind" will take place on October 8, 2025, from 10:00 am to 12:00 pm EST [2] - Shattuck's CEO, Taylor Schreiber, M.D., Ph.D., will represent the company during the session [2] Product Information - SL-325 is 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] - Preclinical studies of SL-325 show high affinity binding and superior activity compared to TL1A antibodies, indicating potential for higher efficacy and lower immunogenicity [2] - SL-325 is currently undergoing a Phase 1 clinical trial [2] Company Overview - Shattuck Labs, Inc. specializes in developing treatments for inflammatory and immune-mediated diseases, with a focus on inflammatory bowel disease (IBD) [3] - The company leverages its expertise in protein engineering to develop novel TNF receptor therapeutics, with SL-325 being its lead program [3] - Shattuck Labs operates offices in Austin, Texas, and Durham, North Carolina [3]

Core Viewpoint - Shattuck Labs, Inc. (STTK) is showing potential for a bullish breakout due to a recent "golden cross" in its moving averages, indicating a key technical support level has been reached [1][3]. Technical Analysis - STTK's 50-day simple moving average has crossed above its 200-day simple moving average, forming a "golden cross," which is a bullish signal for traders [1]. - The golden cross pattern typically follows a downtrend, indicating a reversal to an upward trend, and is considered a stronger breakout signal due to the longer time periods involved [2]. Performance Metrics - Over the past four weeks, STTK has experienced a significant rally of 149.3%, suggesting strong upward momentum [3]. - Currently, STTK holds a 2 (Buy) rating on the Zacks Rank, further supporting the bullish outlook for the stock [3]. Earnings Outlook - The earnings outlook for STTK is positive, with no earnings estimates cut and three revisions higher in the past 60 days, indicating confidence among analysts [3]. - The Zacks Consensus Estimate for STTK has also increased, reinforcing the potential for continued gains [5].

Core Viewpoint - Shattuck Labs, Inc. (STTK) has received an upgrade to Zacks Rank 2 (Buy), indicating a positive outlook based on rising earnings estimates, which significantly influence stock prices [1][2]. Earnings Estimates and Stock Price Movement - The Zacks rating system emphasizes the importance of changes in earnings estimates, which are strongly correlated with near-term stock price movements [3][5]. - Institutional investors utilize earnings estimates to determine the fair value of stocks, leading to significant price movements based on their trading activities [3]. Business Improvement Indicators - The upgrade in earnings estimates for Shattuck Labs suggests an improvement in the company's underlying business, which is expected to drive the stock price higher [4][9]. - Over the past three months, the Zacks Consensus Estimate for Shattuck Labs has increased by 22.5%, reflecting analysts' growing confidence in the company's performance [7]. Zacks Rank System Overview - The Zacks Rank system categorizes stocks into five groups based on earnings estimates, with a proven track record of Zacks Rank 1 stocks generating an average annual return of +25% since 1988 [6][8]. - Shattuck Labs' upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating strong potential for market-beating returns in the near term [9].

Core Insights - Shattuck Labs, Inc. has successfully closed a private placement of approximately $103 million, which is expected to fund operations into 2029 and advance SL-325 through multiple Phase 2 clinical trials, including those for Inflammatory Bowel Disease (IBD) [1][3] - The company has appointed two new members to its Board of Directors: Dr. Daniel Baker and Dr. Mona Ashiya, while several outgoing directors have stepped down [2][3] - SL-325 is positioned as a potentially first-in-class DR3 blocking antibody, with expectations for superior efficacy and reduced immunogenicity compared to existing TL1A-blocking antibodies [3][7] Financial Overview - The aggregate net proceeds from the private placement are expected to support Shattuck's planned operations and clinical trials through 2029, assuming full exercise of common stock warrants [1] - The financing is led by OrbiMed, indicating strong investor confidence in the company's future prospects [1] Leadership Changes - Dr. Daniel Baker brings over 20 years of drug development experience, having previously contributed to the development of major drugs like Remicade, Simponi, and Stelara [4] - Dr. Mona Ashiya has extensive experience in the biotechnology sector and serves on the boards of several companies, enhancing the strategic direction of Shattuck [6] Product Development - SL-325 is designed to achieve a complete blockade of the DR3/TL1A pathway, with preclinical studies showing high affinity binding and superior activity over TL1A antibodies [7][8] - The company plans to commence a Phase 1 clinical trial for SL-325 in healthy volunteers in the third quarter of 2025, with multiple data readouts anticipated [3][7]

Core Insights - Shattuck Labs, Inc. is developing SL-325, a potentially first-in-class DR3 antagonist antibody aimed at treating Inflammatory Bowel Disease (IBD) and other inflammatory and immune-mediated diseases [1][5] - The company plans to dose the first participant in its Phase 1 clinical trial in healthy volunteers in Q3 2025, with enrollment expected to be completed by Q2 2026 [2][4] - Current cash and cash equivalents, along with anticipated proceeds of up to $103 million from a recent private placement, are expected to fund operations into 2029 [1] Company Overview - Shattuck Labs, Inc. specializes in developing treatments for autoimmune and inflammatory diseases, focusing on novel therapeutics targeting TNF superfamily receptors [5] - The company has offices in Austin, Texas, and Durham, North Carolina [5] Clinical Development - SL-325 is designed to achieve a complete and durable blockade of the DR3/TL1A pathway, with preclinical studies showing high-affinity binding and superior activity compared to TL1A antibodies [4] - The Phase 1 clinical trial will evaluate safety, tolerability, and pharmacokinetics through a randomized, double-blind, placebo-controlled design [2]

PART I FINANCIAL INFORMATION [Item 1. Condensed Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Condensed%20Financial%20Statements%20(Unaudited)) Unaudited **H1 2025** financials reflect a reduced net loss and decreased assets, primarily due to lower **R&D** expenses and the conclusion of collaboration agreements [Condensed Balance Sheets](index=5&type=section&id=Condensed%20Balance%20Sheets) Condensed Balance Sheet Summary (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $50,467 | $57,387 | | Total current assets | $54,675 | $79,215 | | **Total assets** | **$64,371** | **$91,049** | | **Liabilities & Equity** | | | | Total current liabilities | $5,336 | $8,917 | | **Total liabilities** | **$7,352** | **$11,423** | | **Total stockholders' equity** | **$57,019** | **$79,626** | - Total assets decreased from **$91.0 million** at the end of **2024** to **$64.4 million** as of **June 30, 2025**, primarily due to a reduction in cash, cash equivalents, and investments[18](index=18&type=chunk) [Condensed Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenue | $0 | $1,609 | $0 | $2,724 | | Research and development | $8,680 | $19,239 | $18,599 | $35,503 | | General and administrative | $4,352 | $5,332 | $8,822 | $10,227 | | Loss from operations | $(13,032) | $(22,962) | $(27,421) | $(43,006) | | **Net loss** | **$(12,458)** | **$(21,552)** | **$(26,160)** | **$(40,056)** | | Net loss per share | $(0.24) | $(0.42) | $(0.51) | $(0.79) | - Net loss for the second quarter of **2025** was **$12.5 million**, a significant reduction from **$21.6 million** in the same period of **2024**, mainly due to a **55%** decrease in **R&D** expenses[21](index=21&type=chunk) [Condensed Statements of Changes in Stockholders' Equity](index=7&type=section&id=Condensed%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) - Total stockholders' equity decreased from **$79.6 million** at **December 31, 2024**, to **$57.0 million** at **June 30, 2025**, primarily driven by the net loss of **$26.2 million** for the six-month period[23](index=23&type=chunk) [Condensed Statements of Cash Flows](index=8&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Cash Flow Summary for Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(22,463) | $(27,079) | | Net cash provided by (used in) investing activities | $15,600 | $(38,690) | | Net cash (used in) provided by financing activities | $(57) | $836 | | **Net decrease in cash and cash equivalents** | **$(6,920)** | **$(64,933)** | - Cash and cash equivalents decreased by **$6.9 million** during the first six months of **2025**, ending at **$50.5 million**, compared to a much larger decrease of **$64.9 million** in the same period of **2024**, which included significant purchases of investments[25](index=25&type=chunk) [Notes to the Unaudited Interim Condensed Financial Statements](index=9&type=section&id=Notes%20to%20the%20Unaudited%20Interim%20Condensed%20Financial%20Statements) - The company has incurred losses since inception, with an accumulated deficit of **$407.9 million** as of **June 30, 2025**, but management believes current cash of **$50.5 million** is sufficient to fund operations for at least the next twelve months[27](index=27&type=chunk) - All collaboration revenue in **2024** was derived from agreements with **Ono Pharmaceutical** and **ImmunoGen**, both completed by **December 31, 2024**, with no revenue recognized from these agreements in **2025**[36](index=36&type=chunk)[86](index=86&type=chunk)[91](index=91&type=chunk) - On **August 4, 2025**, the company entered into a securities purchase agreement for a private placement expected to provide upfront gross proceeds of approximately **$46 million**, including common stock, pre-funded warrants, and common stock warrants[110](index=110&type=chunk)[113](index=113&type=chunk) R&D Expenses by Program for Six Months Ended June 30 (in thousands) | Program | 2025 | 2024 | | :--- | :--- | :--- | | SL-325 | $4,833 | $363 | | SL-172154 (discontinued) | $2,625 | $16,270 | | Other research and development | $4,859 | $8,204 | | **Total R&D** | **$18,599** | **$35,503** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the strategic pivot to developing **SL-325**, reduced operating expenses, and liquidity, with a private placement extending funding into **2029** [Overview](index=25&type=section&id=Overview) - The company is now focused on developing **SL-325**, a potentially first-in-class death receptor **3** (**DR3**) antagonist antibody for treating inflammatory bowel disease (**IBD**) and other immune-mediated diseases[116](index=116&type=chunk) - **Shattuck Labs** plans to initiate a **Phase 1** clinical trial for **SL-325** in the third quarter of **2025** and expects to complete enrollment in the full **Phase 1** trial in the second quarter of **2026**[121](index=121&type=chunk) - The company is also developing a series of bispecific antibodies targeting **DR3** and other clinically validated targets, with a lead candidate nomination expected in **2025**[124](index=124&type=chunk)[125](index=125&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) Comparison of Operating Results for Q2 (in thousands) | Metric | Q2 2025 | Q2 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Collaboration Revenue | $0 | $1,609 | $(1,609) | (100.0)% | | R&D Expense | $8,680 | $19,239 | $(10,559) | (54.9)% | | G&A Expense | $4,352 | $5,332 | $(980) | (18.4)% | | **Net Loss** | **$(12,458)** | **$(21,552)** | **$9,094** | **(42.2)%** | Comparison of Operating Results for H1 (in thousands) | Metric | H1 2025 | H1 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Collaboration Revenue | $0 | $2,724 | $(2,724) | (100.0)% | | R&D Expense | $18,599 | $35,503 | $(16,904) | (47.6)% | | G&A Expense | $8,822 | $10,227 | $(1,405) | (13.7)% | | **Net Loss** | **$(26,160)** | **$(40,056)** | **$13,896** | **(34.7)%** | - The decrease in **R&D** expenses for **H1 2025** was primarily due to a **$13.6 million** reduction from the discontinuation of **SL-172154** and a **$4.4 million** decrease in compensation from workforce reductions, offset by a **$4.5 million** increase in spending on **SL-325**[154](index=154&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) - The company believes its cash and cash equivalents of **$50.5 million** as of **June 30, 2025**, are sufficient to fund operations into **2027**[162](index=162&type=chunk) - The anticipated proceeds from the **August 2025** Private Placement, combined with current cash, are expected to extend the company's operational funding into **2029**[162](index=162&type=chunk) - The company's Registration Statement on **Form S-3** expired on **July 29, 2025**, halting sales under its **ATM Facility**, and due to its public float, sales are limited to one-third of the market value of its common stock held by non-affiliates until its public float exceeds **$75.0 million**[158](index=158&type=chunk)[159](index=159&type=chunk) [Critical Accounting Policies](index=33&type=section&id=Critical%20Accounting%20Policies) - There have been no material changes to the company's critical accounting policies, including revenue recognition, accrual for **R&D** expenses, and valuation of stock-based awards, compared to those disclosed in the **2024** Annual Report on **Form 10-K**[171](index=171&type=chunk)[174](index=174&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is not required to provide market risk disclosures - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[179](index=179&type=chunk) [Item 4. Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls were effective as of **June 30, 2025**, with no material changes in internal control over financial reporting during **Q2 2025** - Management concluded that as of **June 30, 2025**, the company's disclosure controls and procedures were effective at the reasonable assurance level[180](index=180&type=chunk) - No changes in internal control over financial reporting occurred during the second quarter of **2025** that have materially affected, or are reasonably likely to materially affect, these controls[181](index=181&type=chunk) PART II OTHER INFORMATION [Item 1. Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) The company reported no legal proceedings as of the reporting date - As of the reporting date, there were no legal proceedings to disclose[183](index=183&type=chunk) [Item 1A. Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) Key risks include the need for additional funding, potential non-completion of the private placement, and **Nasdaq** minimum bid price non-compliance - The company requires additional funding to complete development of its product candidates, and the **August 2025** Private Placement is subject to closing conditions and may not be completed as expected[185](index=185&type=chunk)[187](index=187&type=chunk) - On **August 8, 2025**, the company received a notice from **Nasdaq** for non-compliance with the minimum bid price rule (**$1.00** per share), with a deadline of **February 4, 2026**, to regain compliance[191](index=191&type=chunk)[192](index=192&type=chunk) - The company is subject to limitations on its ability to sell stock under **Form S-3**, which may restrict sales to no more than one-third of the market value of its common stock held by non-affiliates until its public float exceeds **$75.0 million**[186](index=186&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=37&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds were reported - None reported[194](index=194&type=chunk) [Item 3. Defaults Upon Senior Securities](index=37&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities were reported - None reported[194](index=194&type=chunk) [Item 4. Mine Safety Disclosures](index=37&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) No mine safety disclosures were reported - None reported[195](index=195&type=chunk) [Item 5. Other Information](index=37&type=section&id=Item%205.%20Other%20Information) The company received a **Nasdaq** notice for non-compliance with the **$1.00** minimum bid price rule, with a compliance deadline of **February 4, 2026** - On **August 8, 2025**, the company received a notice from **Nasdaq** for failing to meet the minimum bid price requirement of **$1.00** per share for **30** consecutive business days[196](index=196&type=chunk) - The company has a **180-day** compliance period, ending **February 4, 2026**, to regain compliance by having its closing bid price be at least **$1.00** for a minimum of **10** consecutive business days[196](index=196&type=chunk) [Item 6. Exhibits](index=38&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the **Form 10-Q**, including certifications and **Inline XBRL** data files - The exhibits filed with the report include certifications from the **CEO** and **CFO**, and **Inline XBRL** documents[202](index=202&type=chunk)

Core Insights - Shattuck Labs, Inc. has submitted an Investigational New Drug (IND) application for SL-325, with clearance expected in Q3 2025, and plans to begin dosing the first participant in a Phase 1 clinical trial in the same quarter [1][6][10] - The company reported a cash balance of approximately $50.5 million at the end of Q2 2025, with additional funding from a recent oversubscribed private placement expected to support operations into 2029 [1][9] - SL-325 is a first-in-class DR3 blocking antibody aimed at treating inflammatory bowel disease (IBD) and other immune-mediated diseases, with multiple preclinical bispecific antibodies also in development [6][10][11] Recent Developments - The second quarter of 2025 was marked by the successful submission of the IND application to the FDA, with expectations to start enrollment in the Phase 1 trial later this quarter and complete it by Q2 2026 [2][6] - The Phase 1 trial will assess safety, tolerability, immunogenicity, and pharmacokinetics in healthy volunteers, with the first participant expected to be dosed in Q3 2025 [6][10] - Shattuck is also developing multiple preclinical DR3-based bispecific antibodies targeting IBD and plans to nominate a lead candidate from this pipeline in 2025 [6][10] Financial Performance - As of June 30, 2025, cash and cash equivalents were approximately $50.5 million, down from $105.3 million a year earlier [13] - Research and Development (R&D) expenses for Q2 2025 were $8.7 million, a decrease from $19.2 million in Q2 2024 [13] - The net loss for Q2 2025 was $12.5 million, or $0.24 per share, compared to a net loss of $21.6 million, or $0.42 per share, in the same quarter of the previous year [13][19]