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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Shattuck Labs Inc | NASDAQ:STTK | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.02 | -0.45% | 4.41 | 4.31 | 4.96 | 4.59 | 4.37 | 4.54 | 165,948 | 01:00:00 |
“We designed the ARC platform to simultaneously block immune checkpoint targets and activate immune costimulatory receptors in the TNF superfamily. The clinical data presented this week at SITC demonstrate evidence of anti-tumor activity, target receptor binding, and dose-dependent immune activation specific to each of CD40 and OX40,” said Taylor Schreiber, M.D., Ph.D., and Chief Executive Officer of Shattuck. “Both compounds have been well tolerated and are demonstrating predictable dose-response relationships in humans. The doses we have explored to date remain below the recommended Phase 2 doses of benchmark CD47 inhibitors and PD-L1 inhibitors, and we look forward to continuing dose escalation of both SL-172154 and SL-279252 into dose levels that we believe will maximize the pharmacodynamic activity and anti-tumor activity of each compound.”
“We are very encouraged by the initial data from the Phase 1 trial of SL-172154. The data show an excellent safety profile, high CD47 receptor occupancy and clear evidence of CD40 engagement, which collectively differentiate SL-172154 from other CD47 inhibitors,” said Nehal Lakhani, M.D., Ph.D., South Texas Accelerated Research Therapeutics (START) Midwest, Grand Rapids, MI. “We desperately need new therapies for late-stage ovarian cancer patients, particularly in the platinum resistant setting. The combined actions of CD47 inhibition and CD40 activation provided by SL-172154 represents a strategy that has not yet been examined in this disease and may initiate anti-tumor immune responses that could provide lasting benefits in late-stage ovarian cancer.”
“SL-172154 is emerging as a highly differentiated CD47 inhibitor. The clinical data indicate that this compound can safely engage CD40 in a manner that has evaded other CD40-targeted biologics for over twenty years. At the same time, we can compare and contrast the relative potency of CD40 versus OX40 activation, and the clinical data indicate that CD40 targeting provides substantially more immunologic activity than OX40 activation. There are some parallels to these observations in the checkpoint space, where blockade of targets like LAG3, TIM3, and TIGIT has been far more subtle than blockade of CTLA-4 or PD-1,” continued Dr. Schreiber. “The current data suggests that we may be coming close to a recommended Phase 2 dose selection for SL-172154 as monotherapy. We are excited to transition to the combination with liposomal doxorubicin in ovarian cancer, and with azacitidine and venetoclax in AML, and azacitidine in higher-risk MDS and TP53 mutant AML. More importantly, these data help to establish the ARC platform more broadly as a novel class of biologic medicine, which opens opportunities for the rest of our vast pipeline of candidates developed internally at Shattuck.”
Third Quarter 2021 Recent Business Highlights and Other Recent Developments
Agonist Redirected Checkpoint (ARC) Platform Clinical-Stage Pipeline
Corporate Updates
Third Quarter 2021 Financial Results
2021 Financial Guidance
Shattuck believes its cash and cash equivalents and short-term investments will be sufficient to fund its operations into the second half of 2024, which is beyond results from its Phase 1 clinical trials of SL-172154 and SL-279252. The reduction in cash runway guidance from our last issued guidance is primarily attributable to increased clinical activities for SL-172154 and ongoing process development and manufacturing to support our ongoing and future clinical trials, including the development of a manufacturing process suitable for registrational trials. This cash runway guidance is based on the Company’s current operational plans and excludes any additional funding that may be received or business development or additional 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 cancers. Two Phase 1 clinical trials are ongoing, the first for patients with advanced and platinum resistant ovarian cancer (NCT04406623) and the second for patients with advanced squamous cell carcinoma of the head, neck or skin (NCT04502888).
About SL-279252
SL-279252 (PD1-Fc-OX40L) is an investigational ARC® fusion protein designed to simultaneously inhibit the PD-1/PD-L1 checkpoint interaction and activate the OX40 costimulatory receptor to bolster an anti-tumor immune response receptor in patients with advanced solid tumors. 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, with three ongoing Phase 1 clinical trials. Compounds derived from Shattuck’s proprietary Agonist Redirected Checkpoint, ARC®, platform simultaneously inhibit checkpoint molecules and activate costimulatory molecules within 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 two 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.
Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws. 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 the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, filed with the U.S. Securities and Exchange Commission (“SEC”) and other subsequent documents we file with the SEC, many of which are beyond our control and subject to change. Actual results could be materially different. 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 Contact: Conor RichardsonSenior Director, Finance & Investor RelationsShattuck Labs, Inc.InvestorRelations@shattucklabs.com
Media Contact:Stephanie Ascher Managing DirectorStern Investor Relations, Inc.Stephanie.ascher@sternir.com
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
SHATTUCK LABS, INC.
BALANCE SHEETS
(In thousands)
September 30,2021 | December 31,2020 | |||||
(unaudited) | ||||||
Assets | ||||||
Current assets: | ||||||
Cash and cash equivalents | $ | 85,094 | $ | 157,898 | ||
Short-term investments | 205,121 | 177,551 | ||||
Prepaid expenses and other current assets | 11,429 | 10,190 | ||||
Total current assets | 301,644 | 345,639 | ||||
Property and equipment, net | 8,651 | 3,000 | ||||
Other assets | 273 | 349 | ||||
Total assets | $ | 310,568 | $ | 348,988 | ||
Liabilities and Stockholders’ Equity | ||||||
Current liabilities: | ||||||
Accounts payable | $ | 3,251 | $ | 1,754 | ||
Accrued expenses | 13,783 | 7,352 | ||||
Deferred revenue | 2,801 | 7,728 | ||||
Total current liabilities | 19,835 | 16,834 | ||||
Deferred revenue, net of current portion | 27,277 | 21,306 | ||||
Deferred rent | 2,290 | 987 | ||||
Total liabilities | 49,402 | 39,127 | ||||
Stockholders’ equity: | ||||||
Common stock | 5 | 5 | ||||
Additional paid-in capital | 387,902 | 382,012 | ||||
Accumulated other comprehensive loss | (1,827 | ) | (63 | ) | ||
Accumulated deficit | (124,914 | ) | (72,093 | ) | ||
Total stockholders’ equity | 261,166 | 309,861 | ||||
Total liabilities and stockholders’ equity | $ | 310,568 | $ | 348,988 |
SHATTUCK LABS, INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(In thousands, except share and per share amounts)
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||
Collaboration revenue - related party | $ | 1,900 | $ | 2,435 | $ | (61 | ) | $ | 8,592 | ||||||
Operating expenses: | |||||||||||||||
Research and development | 15,137 | 11,804 | 40,356 | 27,696 | |||||||||||
General and administrative | 4,343 | 2,470 | 14,098 | 5,816 | |||||||||||
Expense from operations | 19,480 | 14,274 | 54,454 | 33,512 | |||||||||||
Loss from operations | (17,580 | ) | (11,839 | ) | (54,515 | ) | (24,920 | ) | |||||||
Other income (expense): | |||||||||||||||
Interest income | 251 | 86 | 1,947 | 474 | |||||||||||
Other | (81 | ) | (76 | ) | (253 | ) | (145 | ) | |||||||
Total other income | 170 | 10 | 1,694 | 329 | |||||||||||
Net loss | $ | (17,410 | ) | $ | (11,829 | ) | $ | (52,821 | ) | $ | (24,591 | ) | |||
Unrealized loss on short-term investments | (207 | ) | (28 | ) | (1,764 | ) | (64 | ) | |||||||
Comprehensive loss | $ | (17,617 | ) | $ | (11,857 | ) | $ | (54,585 | ) | $ | (24,655 | ) | |||
Net loss per share – basic and diluted | $ | (0.41 | ) | $ | (1.54 | ) | $ | (1.26 | ) | $ | (3.21 | ) | |||
Weighted-average shares outstanding – basic and diluted | 42,155,981 | 7,700,371 | 41,946,852 | 7,656,077 |
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