TRIM7

- Completed additional enrollment in Phase 1B dose-expansion cohorts for TP53 mutant (TP53m) Acute Myeloid Leukemia (AML) patients in the first quarter of 2024; updated combination data expected at the European Society of Hematology (EHA) 2024 Annual Meeting in June – - Randomized, controlled Phase 1B dose-expansion cohort in frontline Higher-Risk Myelodysplastic Syndromes (HR-MDS) patients expected to initiate enrollment in the second quarter of 2024 – - Presented preclinical data at the 2024 American Association for Cancer Research (AACR) Annual Meeting, demonstrating the potential therapeutic utility of TRIM7 inhibition to prevent or reverse acquired resistance to immune checkpoint therapy – AUSTIN, TX and DURHAM, NC., May 02, 2024 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck) (Nasdaq: STTK), 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, today reported financial results for the quarter ended March 31, 2024 and provided recent business highlights. "We were pleased to see rapid enrollment to the expanded TP53m AML cohort in January. We also expect to see similarly rapid enrollment through the remainder of 2024 into the randomized and controlled expansion cohort in frontline HR-MDS patients,” said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. “We remain excited about the profile of SL-172154 in frontline AML and HR-MDS and are looking forward to sharing additional response and initial survival data in June. In addition to our clinical momentum, we have continued to advance our pre-clinical pipeline to create additional opportunities for growth and value alongside SL-172154. Our collaboration with Ono Pharma on compounds outside of oncology, and our recent oral presentation on a novel small molecule inhibitor of TRIM7 as a potential means to prevent and address acquired resistance to checkpoint inhibitors, are the first two examples of that strategy.” Clinical Milestones Expected in 2024 SL-172154 (SIRPα-Fc-CD40L) Objective response rates and duration of response based on the then-available data from the Phase 1B expansion cohorts of SL-172154 in combination with azacitidine (AZA) in frontline HR-MDS and frontline TP53m AML expected at the EHA 2024 Annual Meeting in June.Randomized, controlled Phase 1B dose-expansion cohort in frontline HR-MDS patients is expected to initiate enrollment in the second quarter of 2024. Approximately 60 patients will be randomized in a 1:1:1 ratio to receive SL-17254 at 3mg/kg in combination with AZA, SL-17254 at 1mg/kg in combination with AZA, or AZA as a monotherapy.Objective response rate and duration of response data based on the then-available data from the Phase 1B clinical trial of SL-172154 in combination with pegylated liposomal doxorubicin (PLD) in Platinum-Resistant Ovarian Cancer (PROC) expected mid-year 2024.Phase 1B clinical trial of SL-172154 in combination with mirvetuximab soravtansine in PROC expected to complete enrollment in the second quarter of 2024, followed by initial data expected mid-year 2024. First Quarter 2024 Business Highlights and Other Recent DevelopmentsPreclinical Presented preclinical data at the 2024 AACR Annual Meeting: Demonstrated the potential therapeutic utility of TRIM7 inhibition to prevent or reverse acquired resistance to immune checkpoint therapy. These data were featured in an oral presentation during the 2024 AACR Annual Meeting. Results build on a recent publication in the journal Cancer Cell, where Shattuck’s preclinical anti-PD1 acquired resistance mouse model helped to elucidate the underlying biology of acquired resistance and identify a novel target, TRIM7. Shattuck expects that these efforts will support expansion of its oncology pipeline alongside lead program, SL-172154. Shattuck and Ono Enter into Collaboration Agreement: On February 13, 2024, Shattuck announced a strategic collaboration and license agreement with Ono Pharmaceutical Co., Ltd. (Ono) in which Shattuck will lead the research and preclinical development of certain compounds selected by Ono from its pipeline of bifunctional fusion proteins to a pair of prespecified targets for potential treatment of autoimmune and inflammatory diseases. Corporate Updates Shattuck Appoints Clay Siegall, Ph.D., and Kate Sasser, Ph.D., to its Board of Directors: On March 4, 2024, Shattuck announced the appointment of Clay Siegall, Ph.D. and Kate Sasser, Ph.D. to its Board of Directors, effective March 1, 2024. Both Dr. Siegall and Dr. Sasser are highly successful executives and scientific pioneers who bring valuable industry experience to Shattuck. First Quarter 2024 Financial Results Cash and Cash Equivalents and Investments: As of March 31, 2024, cash and cash equivalents and investments were $114.6 million, as compared to $135.5 million as of March 31, 2023.Research and Development (R&D) Expenses: R&D expenses were $16.3 million for the quarter ended March 31, 2024, as compared to $16.7 million for the quarter ended March 31, 2023.General and Administrative (G&A) Expenses: G&A expenses were $4.9 million for the quarter ended March 31, 2024, as compared to $5.1 million for the quarter ended March 31, 2023.Net Loss: Net loss was $18.5 million for the quarter ended March 31, 2024, or $0.37 per basic and diluted share, as compared to a net loss of $20.7 million for the quarter ended March 31, 2023, or $0.49 per basic and diluted share. Financial Guidance Shattuck believes its cash and cash equivalents and investments will be sufficient to fund its operations into 2026, beyond results from its Phase 1 clinical trials of SL-172154. This cash runway guidance is based on the Company’s current operational plans and excludes any additional capital that may be received, proceeds from business development transactions, and/or additional costs associated with clinical development activities that may be undertaken. About SL-172154 SL-172154 (SIRPα-Fc-CD40L) is an investigational ARC® fusion protein designed to simultaneously inhibit the CD47/SIRPα checkpoint interaction and activate the CD40 costimulatory receptor to bolster an anti-tumor immune response in patients with advanced cancer. Multiple Phase 1 clinical trials are ongoing for patients with PROC and patients with AML and HR-MDS: Ongoing Phase 1A/B Clinical Trial of SL-172154 in Frontline HR-MDS and Frontline TP53m AML Patients: This trial is evaluating the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-172154 in combination with AZA in both frontline HR-MDS patients and frontline TP53m AML patients. A randomized cohort in frontline HR-MDS patients is expected to initiate enrollment in the second quarter of 2024. Approximately 60 patients will be randomized in a 1:1:1 ratio to receive SL-172154 at 3mg/kg in combination with AZA, SL-172154 at 1mg/kg in combination with AZA, or AZA as a monotherapy.Ongoing Phase 1B Clinical Trial of SL-172154 in Combination with PLD in PROC Patients: This trial is evaluating the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-172154 at 3.0 mg/kg in combination with PLD in patients with PROC. The initial data from this Phase 1B clinical trial in PROC patients was presented in November 2023. Initial data suggest that SL-172154 improved the response rate relative to what would be expected from PLD alone, and SL-172154 had an acceptable safety profile in combination with PLD. Objective response rate and duration of response based on the then-available data from the Phase 1B clinical trial of SL-172154 in combination with PLD in PROC are expected mid-year 2024.Ongoing Phase 1B Clinical Trial of SL-172154 in Combination with Mirvetuximab Soravtansine in PROC Patients: This trial is evaluating the safety, pharmacokinetics, pharmacodynamic effects, and preliminary anti-tumor activity of SL-172154 administered in combination with mirvetuximab soravtansine in patients with PROC. Mirvetuximab soravtansine is an antibody-drug conjugate targeting folate receptor alpha (FRα), which provides for both direct tumor cell killing as well as enhanced macrophage phagocytosis through binding with Fc gamma receptors and has received accelerated approval in the United States for PROC patients whose tumors are shown to be FRα positive, defined as ≥75%, as determined by the VENTANA FOLR1 (FOLR1-2.1) Assay. Enrollment completion for the Phase 1B clinical trial of SL-172154 in combination with mirvetuximab soravtansine in PROC is expected in the second quarter of 2024, followed by initial data expected mid-year 2024. About Shattuck Labs, Inc. 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 derived from Shattuck’s proprietary Agonist Redirected Checkpoint, (ARC®), platform are designed to simultaneously inhibit checkpoint molecules and activate costimulatory molecules with a single therapeutic. The company’s lead SL-172154 (SIRPα-Fc-CD40L) program, which is designed to block the CD47 immune checkpoint and simultaneously agonize the CD40 pathway, is being evaluated in multiple Phase 1 trials. Shattuck has offices in both Austin, Texas and Durham, North Carolina. For more information, please visit: www.ShattuckLabs.com. Forward-Looking Statements Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, our expectations regarding: plans for our preclinical studies, clinical trials and research and development programs; plans for expansion of clinical trials; the anticipated timing of the results from our clinical trials; the anticipated timing and pace of enrollment in our clinical trials; the clinical benefit, safety and tolerability of SL-172154; the potential therapeutic utility of TRIM7 inhibition to prevent or reverse acquired resistance to immune checkpoint therapy; and expectations regarding the time period over which our capital resources will be sufficient to fund our anticipated operations. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While we believe these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in our filings with the U.S. Securities and Exchange Commission (SEC)), many of which are beyond our control and subject to change. Actual results could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility, expectations regarding the initiation, progress, and expected results of our preclinical studies, clinical trials and research and development programs; expectations regarding the timing, completion and outcome of our clinical trials; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; liquidity and capital resources; and other risks and uncertainties identified in our Annual Report on Form 10-K for the year ended December 31, 2023, and subsequent disclosure documents filed with the SEC. We claim the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We expressly disclaim any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law. The Company intends to use the investor relations portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD. Investor & Media Contact: Conor RichardsonVice President of Investor RelationsShattuck Labs, Inc.InvestorRelations@shattucklabs.com SHATTUCK LABS, INC. CONDENSED BALANCE SHEETS (In thousands) March 31, 2024December 31,2023 (unaudited)Assets Current assets: Cash and cash equivalents $76,005 $125,626 Investments 38,628 4,999 Prepaid expenses and other current assets 16,443 12,595 Total current assets 131,076 143,220 Property and equipment, net 12,830 13,804 Other assets 2,429 2,540 Total assets $146,335 $159,564 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $2,154 $1,587 Accrued expenses and other current liabilities 7,569 9,523 Deferred revenue 4,606 343 Total current liabilities 14,329 11,453 Non-current operating lease liabilities 3,193 3,406 Total liabilities 17,522 14,859 Stockholders’ equity: Common stock 5 5 Additional paid-in capital 453,636 451,006 Accumulated other comprehensive (loss) income (14) 4 Accumulated deficit (324,814) (306,310)Total stockholders’ equity 128,813 144,705 Total liabilities and stockholders’ equity $146,335 $159,564 SHATTUCK LABS, INC. CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) (In thousands, except share and per share amounts) Three Months Ended March 31, 2024 2023 Collaboration revenue$1,115 $57 Operating expenses: Research and development 16,264 16,667 General and administrative 4,895 5,051 Expense from operations 21,159 21,718 Loss from operations (20,044) (21,661) Other income 1,540 937 Net loss$(18,504) $(20,724)Unrealized (loss) gain on investments (18) 538 Comprehensive loss$(18,522) $(20,724) Net loss per share – basic and diluted$(0.37) $(0.49)Weighted-average shares outstanding – basic and diluted 50,566,394 42,439,204

– Aberrant TRIM7 expression identified as a key driver of immune checkpoint blockade (ICB) acquired resistance; inhibition of TRIM7 with small molecule inhibitors may prevent or reverse acquired resistance to PD-1/L1 blockade – AUSTIN, TX and DURHAM, NC, April 09, 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 preclinical data demonstrating the therapeutic utility of TRIM7 inhibition to prevent or reverse acquired resistance to immune checkpoint therapy. These data were featured in an oral presentation during the AACR Annual Meeting 2024, being held from April 5-10, 2024, in San Diego, California. “One of the largest areas of unmet medical need in oncology is in the setting of acquired resistance to checkpoint inhibitors, and we expect this to continue to grow because of the broad application of anti-PD1/PD-L1 inhibitors across multiple tumor types. Our efforts in helping to define the underlying biology of acquired resistance were recently revealed with a publication in Cancer Cell,” said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. “I am very pleased to share how our team has leveraged those biological insights to identify a novel target, TRIM7, which appears to be a mediator of the acquired resistant phenotype in mouse and human tumors, and, importantly, this has led to a development compound that reverses PD-1 acquired resistance in pre-clinical studies through specific inhibition of TRIM7. We expect that these efforts will support expansion of our oncology pipeline alongside our lead program, SL-172154.” Presentation DetailsAbstract title: Aberrant TRIM7 Expression Potentiates RACO-1 Mediated Proliferation and Dysregulated Interferon Responsiveness in the Setting of anti-PD-1 Acquired Resistance in CancerLocation: San Diego Convention Center, San Diego, CaliforniaPresenter: Dr. George Fromm, Ph.D., Chief Scientific Officer, Shattuck LabsSession Category: Experimental and Molecular TherapeuticsSession Title: Drug Discovery 2: New Therapies Date/Time: Tuesday, April 9, 2024, 4:05 PM - 4:20 PM (PT)Abstract Presentation Number: 6584 Key Takeaways TRIM7 is an E3 ligase which supports tumor cell proliferation downstream of KRAS signaling through ubiquitination and stabilization of RACO-1. TRIM7 also contributes to PD-1 acquired resistance through ubiquitination and degradation of STING and MAVS.Shattuck developed a series of small-molecule inhibitors of TRIM7 that specifically disrupt KRAS-mediated tumor cell proliferation, reverse the transcriptional phenotype of PD-1 acquired resistance, and restore sensitivity to anti-PD1 antibodies to PD-1 acquired resistant tumors in pre-clinical models. Additional meeting information can be found on the AACR website. A copy of the AACR presentation will be available on the Investors section of the Company’s website shortly after the event. About Shattuck Labs, Inc.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 derived from Shattuck’s proprietary Agonist Redirected Checkpoint (ARC®) platform are designed to simultaneously inhibit checkpoint molecules and activate costimulatory molecules with a single therapeutic. The company’s lead SL-172154 (SIRPα-Fc-CD40L) program, which is designed to block the CD47 immune checkpoint and simultaneously agonize the CD40 pathway, is being evaluated in multiple Phase 1 trials. Shattuck has offices in both Austin, Texas and Durham, North Carolina. For more information, please visit: www.ShattuckLabs.com. Forward-Looking StatementsCertain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, statements regarding: the potential benefit of TRIM7 inhibition alone or in combination with KRAS pathway inhibition and/or blockage of PD-L1, clinical development plans and strategies for SL-172154, future plans for Shattuck’s pipeline and Shattuck’s strategies. Words such as “anticipate,” “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Shattuck’s filings with the U.S. Securities and Exchange Commission (SEC)), many of which are beyond the company’s control and subject to change. Actual results could be materially different. Risks and uncertainties which could cause such outcomes to change include: global macroeconomic conditions and related volatility; expectations regarding the initiation, progress, and expected results of Shattuck’s preclinical studies, clinical trials and research and development programs; expectations regarding the timing, completion and outcome of the company’s clinical trials; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; liquidity and capital resources and other risks and uncertainties identified in Shattuck’s Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent disclosure documents filed with the SEC. Shattuck claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Shattuck expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law. The Company intends to use the investor relations portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD. Investor & Media Contact: Conor RichardsonVice President of Investor RelationsShattuck Labs, Inc.InvestorRelations@shattucklabs.com

HAMILTON, Ontario, Oct. 17, 2023 (GLOBE NEWSWIRE) -- Exerkine Corporation (the "Company" or "Exerkine") is pleased to announce that it has successfully transitioned from its pre-revenue development phase into commercial operations. Importantly, Exerkine’s R&D pipeline is maturing and generating patented nutrition-based therapies that are supported by strong clinical results. These therapies are particularly impactful at a time when North American obesity rates and age-related disorders are at pandemic levels. The biggest threats to North American health are obesity and age-related disorders (i.e. muscle loss, cardiovascular disease, type 2 diabetes, dementia). Current nutritional strategies to combat these health issues have been shown to be ineffective in the long term. Exerkine is poised to change this paradigm through proprietary products that are built and backed by science. Founded by Dr. Mark Tarnopolsky, and in partnership with McMaster University, Exerkine is a Canadian nutritional supplements company built upon decades of research. Utilizing advances in mitochondrial sciences, exercise physiology, and nutrition, Exerkine leverages pharmaceutical-industry R&D standards to create novel nutrition-based products. This rigorous development pipeline sets Exerkine apart by ensuring that its nutritional products are supported by high quality preclinical and clinical research, supported by proven health claims, and meet safety and regulatory standards, which, when combined, deliver superior products to consumers. Exerkine is led by internationally renowned physician-scientist, Dr. Mark Tarnopolsky, PhD, MD, FRCP(C). As the founder, CEO and CSO of Exerkine, Dr. Tarnopolsky is applying his clinical and scientific expertise to lead Exerkine’s commercial and research development. Having successfully co-founded and acted as CSO for Life Science Nutritionals, he has expanded his business acumen as the co-founder and Vice President of Business Development for Systemic Therapeutics, and CSO for SoftTabs. Additionally, he has forged a career studying the impact of exercise and nutritional therapies in the treatment of aging-acquired and genetic disorders. He holds an endowed chair in, and is division head of, Neuromuscular and Neurometabolic Diseases Clinic at the McMaster University Children’s Hospital and is an advisor on numerous medical advisory boards. Dr. Tarnopolsky’s extensive research and medical knowledge is exemplified by over 500 published scientific and medical manuscripts (h index = 141) and has received high-profile attention from media outlets such as CBC News, ABC News, Wall Street Journal, New York Times, and Time magazine. “Exerkine is at the forefront of a new phase in its development. Having been supported by McMaster University as a start-up company, we are looking to expand our operations by fostering new partnerships, expanding our research program, and by bring our game-changing evidence-backed products to market.” Dr. Tarnopolsky continued to say “we are thrilled to see what the future holds for Exerkine - a company that’s truly built and backed by science.” Core to its R&D strategy, Exerkine is actively engaged in developing a diverse patent portfolio. The corporation’s initial filing outlined the novel use of interleukin-15, a cytokine known to be involved in a variety of biological pathways, to promote mitochondrial biogenesis and drive improvements in skin health. This patent has been awarded in both Canada (CA2917944C) and the United States (US10064919B2) and has garnered attention from companies in the skincare and beauty industry. Exerkine has since gone on to develop and submit over two dozen patent applications and the company will be making several exciting announcements as its portfolio matures. As part of its evolving commercial strategy, Exerkine launched its nutrition subdivision, StayAbove Nutrition. Through StayAbove Nutrition, Exerkine is marketing several novel nutrition-based products to the consumer. These products are designed to target a health disorder from multiple pathways to yield a combined therapeutic benefit. Clinical results have shown that these products not only provide preventative options to combat obesity and aging-related disorders, but also show treatment options for those already suffering from these conditions. Exerkine is excited to present its two flagship products: Muscle 5 (Muscle Enhancement Supplement) and Trim 7 (Weight Management Supplement) under StayAbove Nutrition. Muscle 5 is a nutritional supplement containing 5 carefully selected ingredients shown to enhance muscle mass and strength in younger and older adults. Unlike single ingredient protein powders, Muscle 5’s patented design is proven to build muscle and strength, and has been shown to impact blood cholesterol levels, as well as cognition (Nilsson et al, 2020; Bell et al, 2017; Bell et al, 2019). Trim 7 is a weight management supplement containing 7 specific ingredients shown to reduce fat mass but preserve lean mass. Trim7’s patented design focuses on the mitochondria, the cell’s powerhouse, to drive weight loss by turning on the body’s natural fat burning pathways. A significant amount of research and development has already been done on this product, including pre-clinical (Nederveen et al, 2021) work, and the company will be announcing its clinical trial results in a press release shortly. About ExerkineExerkine Corporation is a nutra-pharmaceutical company that is developing a new class of therapies to treat obesity and age-related disorders . Advances in mitochondrial sciences, cell metabolism, exercise physiology and nutrition are fueling innovation in nutrition-based therapies. Exerkine is seeking opportunities to expand its commercial operations, leverage its IP portfolio, and raise capital investment. Additionally, Exerkine provides R&D and consultation services to the nutritional and pharmaceutical industries. Contact us if you wish to learn more and how Exerkine can support your business. A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/28b3b26b-4cb8-4c38-a7c7-a493359842bd