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– Completed enrollment in Phase 1 dose-escalation clinical trial of SL-172154 as monotherapy in platinum-resistant ovarian cancer; complete data expected midyear 2023 –
– Dosed first patient in ongoing Phase 1B clinical trial of SL-172154 in combination with liposomal doxorubicin in platinum-resistant ovarian cancer; initial combination data expected midyear 2023 –
– Announced plans to present updated preclinical data from Gamma Delta T Cell Engager (GADLEN) platform preclinical product candidates at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in November –
AUSTIN, TX and DURHAM, NC, Nov. 08, 2022 (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 September 30, 2022 and provided recent business highlights.
“We are pleased to have completed the monotherapy dose-escalation trial with SL-172154 in platinum-resistant ovarian cancer and to have advanced to the combination phase of clinical development for SL-172154 in both platinum-resistant ovarian cancer and AML and HR-MDS,” said Taylor Schreiber, M.D., Ph.D., and Chief Executive Officer of Shattuck. “This year we have significantly expanded our clinical trial footprint to enable steady execution of our clinical studies and are looking forward to the opportunity for SL-172154 to differentiate from other CD47 inhibitors over the course of a data-rich 2023. Beyond our clinical-stage product candidates, we have progressed our gamma delta T cell engager (GADLEN) platform and published key preclinical data which will guide our clinical strategy. We expect to provide additional updates later this month at the SITC annual meeting.”
Third Quarter 2022 Recent Business Highlights and Other Recent Developments
ARC Clinical-Stage Pipeline and Preclinical Pipeline
SL-172154 (SIRPα-Fc-CD40L) Program Update
Third Quarter 2022 Financial Results
2022 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 and SL-279252. This cash runway guidance is based on the Company’s current operational plans and excludes any addition funding that may be received, proceeds from business development transactions, or additional costs associated with clinical development activities that may be undertaken.
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. Phase 1 clinical trials are ongoing for patients with advanced platinum-resistant ovarian cancer (NCT05483933) and patients with AML and HR-MDS (NCT05275439).
SL-279252 (PD1-Fc-OX40L) is an investigational ARC® fusion protein designed to simultaneously inhibit the PD-1/PD-L1 interaction and activate the OX40 receptor in patients with advanced cancers. A Phase 1 trial in patients with solid tumors and lymphoma is ongoing (NCT03894618).
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 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. A second product candidate, SL-279252 (PD1-Fc-OX40L), is being evaluated in a Phase 1 trial in solid tumors or lymphomas. 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.
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, the anticipated timing for enrollment of our clinical trials, 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: the recent and ongoing COVID-19 pandemic; 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, 2021, 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:
Senior Director, Finance & Investor Relations
Shattuck Labs, Inc.
PART I – FINANCIAL INFORMATION
Item 1. Financial Statements
SHATTUCK LABS, INC.
|September 30, 2022||December 31,
|Cash and cash equivalents||$||39,758||$||92,268|
|Prepaid expenses and other current assets||16,402||19,462|
|Total current assets||201,516||288,266|
|Property and equipment, net||18,242||9,938|
|Liabilities and Stockholders’ Equity|
|Accrued expenses and other current liabilities||16,103||14,574|
|Total current liabilities||19,139||24,586|
|Non-current operating lease liabilities||4,386||—|
|Additional paid-in capital||394,348||389,408|
|Accumulated other comprehensive loss||(1,334||)||(560||)|
|Total stockholders’ equity||199,418||271,786|
|Total liabilities and stockholders’ equity||$||222,943||$||298,585|
SHATTUCK LABS, INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Research and development||18,862||15,137||61,012||40,356|
|General and administrative||6,579||4,343||16,303||14,098|
|Expense from operations||25,441||19,480||77,315||54,454|
|Loss from operations||(25,229||)||(17,580||)||(77,053||)||(54,515||)|
|Unrealized loss on investments||(226||)||(207||)||(774||)||(1,764||)|
|Net loss per share – basic and diluted||$||(0.58||)||$||(0.41||)||$||(1.81||)||$||(1.26||)|
|Weighted-average shares outstanding – basic and diluted||42,386,470||42,155,981||42,374,955||41,946,852|