AUSTIN, TX and DURHAM, NC, Oct. 02, 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 that Company management will participate in a panel discussion focused on key takeaways from the United European Gastroenterology Week (UEGW) Conference 2025. The session will be ...

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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]

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]