Core Insights - Shattuck Labs has announced the discontinuation of its clinical program SL-172154 due to modest improvements in median overall survival in TP53 mutant acute myeloid leukemia (AML) and higher-risk myelodysplastic syndromes (HR-MDS) compared to azacitidine monotherapy benchmarks [1][6] - The company will shift its focus to SL-325, a first-in-class DR3 antagonist antibody intended for clinical development in inflammatory bowel disease (IBD), with an IND filing expected in Q3 2025 [1][8] - A restructuring plan is in place, which will reduce the workforce by approximately 40%, allowing the company to extend its cash runway into 2027 [1][11][10] Clinical Data Summary - For HR-MDS, the current median overall survival (OS) is 15.6 months, with TP53m HR-MDS patients showing a median OS of 10.6 months, which is not expected to improve beyond 13.1 months [4] - Benchmark data indicates a median OS of approximately 9–12 months for TP53m HR-MDS patients treated with azacitidine alone [4] - For TP53m AML, the current median OS is 10.5 months, with an expected maximum improvement to 11.7 months [5] - Benchmark data shows a median OS of approximately 5-8 months for TP53m AML patients treated with azacitidine alone [5] Corporate Developments - Shattuck has mutually agreed with Ono Pharmaceutical Co., Ltd. to terminate their collaboration and license agreement, relieving the company of any remaining performance obligations [7] - The company has implemented a restructuring plan to optimize its cost structure following the discontinuation of SL-172154, with a significant workforce reduction expected to be completed in Q4 2024 [10] - As of June 30, 2024, Shattuck reported cash and cash equivalents of $105.3 million, which is projected to fund operations into 2027 [9][11]

Group 1: Earnings Performance - Shattuck Labs reported a quarterly loss of $0.42 per share, slightly worse than the Zacks Consensus Estimate of a loss of $0.41, but an improvement from a loss of $0.50 per share a year ago, indicating a -2.44% earnings surprise [1] - The company posted revenues of $1.61 million for the quarter ended June 2024, exceeding the Zacks Consensus Estimate by 82.84%, compared to revenues of $0.2 million in the same quarter last year [2] - Over the last four quarters, Shattuck Labs has surpassed consensus EPS estimates two times and topped consensus revenue estimates four times [2] Group 2: Stock Performance and Outlook - Shattuck Labs shares have declined approximately 44.2% since the beginning of the year, contrasting with the S&P 500's gain of 15.8% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.43 on revenues of $1.1 million, and for the current fiscal year, it is -$1.56 on revenues of $4.3 million [7] - The estimate revisions trend for Shattuck Labs is mixed, resulting in a Zacks Rank 3 (Hold), suggesting the stock is expected to perform in line with the market in the near future [6] Group 3: Industry Context - The Medical - Biomedical and Genetics industry, to which Shattuck Labs belongs, is currently in the top 35% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% of industries [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Financial Performance - Collaboration revenue for the three months ended June 30, 2024, was $1,609,000, compared to $200,000 for the same period in 2023, representing a significant increase[7]. - The net loss for the three months ended June 30, 2024, was $21,552,000, compared to a net loss of $21,346,000 for the same period in 2023, reflecting a slight increase in losses[7]. - The company reported a comprehensive loss of $21,543,000 for the three months ended June 30, 2024, compared to a comprehensive loss of $21,081,000 for the same period in 2023[7]. - The net loss for the six months ended June 30, 2024, was $40,056 thousand, compared to a net loss of $42,070 thousand for the same period in 2023, representing a decrease of approximately 4.8%[11]. - The company reported cash and cash equivalents of $60,693 thousand as of June 30, 2024, down from $71,893 thousand at the end of 2023, reflecting a decrease of about 15.5%[11]. - The accumulated deficit as of June 30, 2024, was $346.4 million, highlighting the ongoing financial challenges faced by the company since its inception[14]. Expenses - Research and development expenses for the six months ended June 30, 2024, totaled $35,503,000, up from $34,872,000 in the same period of 2023, indicating a year-over-year increase of approximately 1.8%[7]. - The company incurred general and administrative expenses of $5,332,000 for the three months ended June 30, 2024, compared to $4,742,000 for the same period in 2023, reflecting an increase of approximately 12.4%[7]. - The company’s operating expenses for the three months ended June 30, 2024, were $24,571,000, compared to $22,947,000 for the same period in 2023, representing an increase of approximately 7.1%[7]. - Stock-based compensation for the six months ended June 30, 2024, was $5,140 thousand, an increase from $3,535 thousand in the same period of 2023, representing a rise of approximately 45.5%[11]. - The Company recorded total stock-based compensation expense of $2.7 million for the three months ended June 30, 2024, compared to $1.9 million for the same period in 2023[57]. Equity and Shares - The weighted-average shares outstanding for the three months ended June 30, 2024, were 50,791,241, compared to 42,467,664 for the same period in 2023, indicating an increase of approximately 19.7%[7]. - The total stockholders' equity as of June 30, 2024, was $110,616,000, down from $144,705,000 as of December 31, 2023, showing a decrease of about 23.5%[9]. - The Company’s stock options outstanding increased from 5,379,211 in 2023 to 6,443,892 in 2024[38]. - As of June 30, 2024, there were 3,468,550 shares available for future grants under the 2020 Equity Incentive Plan[54]. - The Company has no current plans to issue any shares of preferred stock, with none outstanding as of June 30, 2024[53]. Cash Flow - Cash used in operating activities for the six months ended June 30, 2024, was $27,079 thousand, a significant improvement from $45,077 thousand in the prior year, indicating a reduction of approximately 40%[11]. - The company incurred a net cash used in investing activities of $38,690 thousand for the six months ended June 30, 2024, compared to a net cash provided by investing activities of $69,558 thousand in the prior year[11]. Revenue Sources - Revenue in 2024 has been derived from collaborations with Ono Pharmaceutical Co., Ltd and ImmunoGen, Inc., with the latter being acquired by AbbVie, Inc. in February 2024[22]. - The Company has not recognized any revenue related to sales-based royalties or milestone payments based on the level of sales to date[34]. - The Company entered into a collaboration agreement with Ono Pharmaceutical, potentially receiving up to $217.5 million in milestone payments and tiered royalties ranging from mid-single digit to low-double digit percentages[48][50]. - The Company recognized revenue of $1.5 million and $2.4 million from the Ono Agreement for the three and six months ended June 30, 2024, respectively, with no revenue recognized in 2023[50]. - The Company has completed all obligations under the ImmunoGen Agreement and recognized revenue of $0.3 million for the six months ended June 30, 2024[51]. Investments and Liabilities - The Company’s investments in U.S. government securities had a total fair value of $44,651,000 as of June 30, 2024[40]. - The Company has a liability of up to $20.5 million under the Kopfkino License Agreement, contingent upon achieving specified milestones[44]. - The Company has a cash, cash equivalents, and investments total of $105.3 million, which is expected to fund operations for at least the next twelve months[14]. Clinical Development - The Company has one clinical-stage product candidate, SL-172154, and several compounds in preclinical development, focusing on oncology and autoimmune diseases[13]. - The company is highly dependent on a limited number of contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs) for its clinical trials, which poses a risk to its operations[22]. Stock Options and Valuation - The expected term of employee stock options with service-based vesting is approximately 6.02 years for 2024, slightly down from 6.08 years in 2023[61]. - The expected stock price volatility for options under the 2020 Plan increased to 96.1% in 2024 from 84.8% in 2023[61]. - The risk-free interest rate for options under the 2020 Plan rose to 4.1% in 2024, compared to 3.6% in 2023[61]. - The expected term for options calculated using the Monte Carlo pricing model is 0 years for 2024, down from 4.00 years in 2023[63]. - The expected volatility for shares issued under the 2020 ESPP increased significantly to 158.6% in 2024 from 84.8% in 2023[64]. - The risk-free interest rate for shares issued under the 2020 ESPP is 5.1% for 2024, up from 3.5% in 2023[64]. - The expected dividend yield remains at 0% as the company does not plan to pay dividends in the foreseeable future[61]. - The company utilizes the Black-Scholes option pricing model for estimating the fair value of employee stock options and restricted stock awards[60]. - The fair value of stock options is determined using various management estimates including expected term, volatility, risk-free interest rate, and dividend yield[60]. Regulatory and Reporting - The Company evaluates the measure of progress for revenue recognition each reporting period and adjusts as necessary[33]. - The Company’s collaboration revenue arrangements may include up-front license fees, milestone payments, and royalties[33]. - The Company has not granted a development and commercialization license as of the reporting date[34]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures[105].

Presentation Details Conference: BTIG Virtual Biotechnology Conference Format: Fireside chat with covering analyst, Kaveri Pohlman, Ph.D. Presenter: Dr. Taylor Schreiber, M.D., Ph.D., Shattuck's Chief Executive Officer Date: August 5, 2024 Time: 2:00 p.m. ET Shattuck Labs, Inc. (Nasdaq: STTK) is a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease. Compounds deri ...

AUSTIN, TX & DURHAM, NC, July 01, 2024 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck) (Nasdaq: STTK), a clinical-stage biotechnology company pioneering the development of bifunctional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, today announced its addition to the Russell 2000® and Russell 3000® Indexes at the conclusion of the 2024 Russell U.S. Indexes annual reconstitution. Shattuck's addition will be effective today when the U.S ...

AUSTIN, TX & DURHAM, NC, July 01, 2024 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck) (Nasdaq: STTK), a clinical-stage biotechnology company pioneering the development of bifunctional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, today announced its addition to the Russell 2000® and Russell 3000® Indexes at the conclusion of the 2024 Russell U.S. Indexes annual reconstitution. Shattuck's addition will be effective today when the U.S ...

Shattuck Labs, Inc. (STTK) announced updated interim data from the phase IB dose expansion study of lead candidate SL-172154, in combination with azacitidine, in frontline higher-risk myelodysplastic syndromes (HRMDS) and TP53 mutant (TP53m) acute myeloid leukemia (AML) patients. SL-172154 is an investigational agonist redirected checkpoint fusion protein, designed to simultaneously inhibit the CD47/SIRPα checkpoint interaction and activate the CD40 costimulatory receptor to bolster an anti-tumor immune res ...

AUSTIN, TX and DURHAM, NC, June 10, 2024 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck) (Nasdaq: STTK), a clinical-stage biotechnology company pioneering the development of bifunctional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, today announced that the U.S. FDA has granted orphan drug designation (ODD) to lead clinical candidate SL172154 for the treatment of AML. "AML patients have few options for treatment and a poor prognosis. ...

"AML patients have few options for treatment and a poor prognosis. FDA's decision to grant orphan drug designation to SL-172154 highlights the urgent need for new treatment options," said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. "This is an important first step in our progression to later-stage clinical studies, and we look forward to presenting additional data from the Phase 1B dose expansion clinical trial of SL-172154 with azacitidine in frontline higher-risk myelodysplastic sy ...

Shattuck Labs, Inc. (STTK) has been on a downward spiral lately with significant selling pressure. After declining 19.9% over the past four weeks, the stock looks well positioned for a trend reversal as it is now in oversold territory and there is strong agreement among Wall Street analysts that the company will report better earnings than they predicted earlier. Here is How to Spot Oversold Stocks We use Relative Strength Index (RSI), one of the most commonly used technical indicators, for spotting whether ...