– Initiated enrollment in Phase 1B clinical trial of SL-172154 in combination with mirvetuximab soravtansine in platinum-resistant ovarian cancer –
– Dosed patients in first combination cohort with azacitidine in ongoing Phase 1A/B clinical trial of SL-172154 in acute myeloid leukemia (AML) and higher-risk myelodysplastic syndromes (HR-MDS) –
– Announced two potential lead product candidates, currently in preclinical development, from the Gamma Delta T Cell Engager (GADLEN) platform –
– Appointed Dr. George Fromm and Dr. Suresh de Silva as Chief Scientific Officers (CSO) of the ARC and GADLEN platforms, respectively –
– Completed Phase 1 dose-escalation trial of SL-279252 and announces discontinuation of the SL-279252 program –
AUSTIN, TX and DURHAM, NC, Feb. 23, 2023 (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 fourth quarter and full year ended December 31, 2022 and provided recent business highlights.
“During the fourth quarter of 2022, we continued to focus on clinical execution to position ourselves for key clinical data readouts for SL-172154 in 2023. Enrollment in our AML/HR-MDS clinical trial of SL-172154 is moving along nicely, and, in the fourth quarter, we advanced into the first combination cohort with azacitidine. This keeps us on track to share initial data from the dose-escalation portion of this trial from relapsed/refractory AML/HR-MDS patients both as monotherapy and in combination with azacitidine in the first half of 2023. As it relates to our trials in platinum-resistant ovarian cancer, in early 2022 we established a collaboration with ImmunoGen to combine SL-172154 with mirvetuximab soravtansine and, in the fourth quarter, we initiated enrollment in this Phase 1B clinical trial. We expect initial data from the combination trial with SL-172154 and liposomal doxorubicin midyear 2023, and we expect initial data from the combination trial of SL-172154 and mirvetuximab soravtansine in the second half of 2023,” said Taylor Schreiber, M.D., Ph.D., and Chief Executive Officer of Shattuck. “I am also very pleased to announce the promotion of Dr. George Fromm to CSO of the ARC platform and Dr. Suresh de Silva to CSO of the GADLEN platform. We look forward to benefiting from the expertise of these scientific program leaders as we continue our momentum in 2023. Drs. Fromm and de Silva have been invaluable to Shattuck from the time they each joined the company in 2017, and they will continue to play a critical role as we build-out our pipeline over the coming years. 2023 is an important year for Shattuck, with multiple data readouts, which we believe will establish SL-172154 as both a differentiated CD47 inhibitor and a CD40 agonist capable of activating the CD40 pathway in human cancer patients. We expect that these data will position Shattuck well for continued growth in the years ahead.”
“After enrolling patients in the final dose levels of 12 and 24 mg/kg with the SL-279252 clinical program, and not meeting a stringent efficacy threshold required to justify further development, we have decided to discontinue development of SL-279252. The development program for SL-279252 has yielded tremendously important preclinical, translational, and clinical data for the ARC platform, and we thank the patients and their families for participating in our clinical trial. We remain focused on delivering novel therapeutics that benefit patients with cancer with high unmet need and look forward to the combination data in both of our ongoing clinical trials with SL-172154 in the coming quarters,” continued Dr. Schreiber.
Clinical Milestones Expected in 2023
ARC Platform
SL-172154 (SIRPα-Fc-CD40L)
GADLEN Platform
GADLEN Preclinical Compounds
Fourth Quarter 2022 Recent Business Highlights and Other Recent Developments
ARC Clinical-Stage Pipeline
SL-172154 (SIRPα-Fc-CD40L)
SL-279252 (PD1-Fc-OX40L)
Gamma Delta T Cell Engager (GADLEN) Preclinical Pipeline
Preclinical Pipeline Development
Corporate Update
Upcoming Events
Fourth-Quarter and Full-Year 2022 Financial Results
2023 Financial Guidance
Shattuck believes its cash and cash equivalents and investments will be sufficient to fund its operations into the second half of 2024, 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 advanced platinum-resistant ovarian cancer (NCT05483933) and patients with AML and HR-MDS (NCT05275439).
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 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. Additionally, the company is advancing a proprietary Gamma Delta T Cell Engager, GADLEN™, platform, which is designed to bridge gamma delta T cells to tumor antigens for the treatment of patients with cancer. 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 clinical trial design, the anticipated timing of the results from our preclinical studies and clinical trials, anticipated timing for preclinical development updates, potential clinical benefit of our product candidates, 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 (the “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, 2022, 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 Richardson
Vice President of Investor Relations
Shattuck Labs, Inc.
InvestorRelations@shattucklabs.com
FINANCIAL INFORMATION
SHATTUCK LABS, INC.
BALANCE SHEETS
(In thousands)
December 31, | |||||||
2022 | 2021 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 47,379 | $ | 92,268 | |||
Investments | 113,901 | 176,536 | |||||
Prepaid expenses and other current assets | 23,304 | 19,462 | |||||
Total current assets | 184,584 | 288,266 | |||||
Property and equipment, net | 17,671 | 9,938 | |||||
Other assets | 3,069 | 381 | |||||
Total assets | $ | 205,324 | $ | 298,585 | |||
Liabilities and Stockholders’ Equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 7,170 | $ | 10,012 | |||
Accrued expenses and other current liabilities | 17,795 | 14,574 | |||||
Total current liabilities | 24,965 | 24,586 | |||||
Non-current operating lease liabilities | 4,202 | — | |||||
Deferred rent | — | 2,213 | |||||
Total liabilities | 29,167 | 26,799 | |||||
Stockholders’ equity: | |||||||
Common stock | 5 | 5 | |||||
Additional paid-in capital | 396,041 | 389,408 | |||||
Accumulated other comprehensive loss | (877 | ) | (560 | ) | |||
Accumulated deficit | (219,012 | ) | (117,067 | ) | |||
Total stockholders’ equity | 176,157 | 271,786 | |||||
Total liabilities and stockholders’ equity | $ | 205,324 | $ | 298,585 |
SHATTUCK LABS, INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
Three Months Ended December 31, (Unaudited) |
Year Ended December 31, | ||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
Collaboration revenue | $ | 390 | $ | 30,078 | $ | 652 | $ | 30,017 | |||||||
Operating expenses: | |||||||||||||||
Research and development | 21,887 | 16,207 | 82,899 | 56,563 | |||||||||||
General and administrative | 4,779 | 4,624 | 21,082 | 18,723 | |||||||||||
Expense from operations | 26,666 | 20,831 | 103,981 | 75,286 | |||||||||||
Gain (loss) from operations | (26,276 | ) | 9,247 | (103,329 | ) | (45,269 | ) | ||||||||
Other income (expense): | |||||||||||||||
Interest income (expense) | 908 | (1,321 | ) | 1,592 | 625 | ||||||||||
Other | (43 | ) | (79 | ) | (208 | ) | (330 | ) | |||||||
Total other income (expense) | 865 | (1,400 | ) | 1,384 | 295 | ||||||||||
Net income (loss) | $ | (25,411 | ) | $ | 7,847 | $ | (101,945 | ) | $ | (44,974 | ) | ||||
Unrealized gain (loss) on investments | 457 | 1,267 | (317 | ) | (497 | ) | |||||||||
Comprehensive gain (loss) | $ | (24,954 | ) | $ | 9,114 | $ | (102,262 | ) | $ | (45,471 | ) | ||||
Basic and Diluted Per Common Share Data: | |||||||||||||||
Net earnings (loss) per share – basic | $ | (0.60 | ) | $ | 0.19 | $ | (2.41 | ) | $ | (1.07 | ) | ||||
Weighted-average shares outstanding – basic | 42,390,586 | 42,286,190 | 42,378,895 | 42,032,384 | |||||||||||
Net earnings (loss) per share – diluted | $ | (0.60 | ) | $ | 0.18 | $ | (2.41 | ) | $ | (1.07 | ) | ||||
Weighted-average shares outstanding – diluted | 42,390,586 | 44,734,866 | 42,378,895 | 42,032,384 |
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