SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 15, 2021
Shattuck Labs, Inc.
(Exact name of registrant as specified in its charter)
|(State or other jurisdiction of|
incorporation or organization)
|(Commission File Number)||(I.R.S. Employer|
1018 W. 11th Street, Suite 100
Austin, TX 78703
|(Address of principal executive offices including zip code)|
(Registrant’s telephone number, including area code)
(Former name or former address, if changed since last report)
|Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:|
|Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)|
|Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)|
|Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))|
|Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))|
Securities registered pursuance to Section 12(b) of the Act:
|Title of each class||Trading Symbol(s)||Name of each exchange on which registered|
|Common Stock, par value $0.0001 per share||STTK||The Nasdaq Global Select Market|
|Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).|
|Emerging Growth Company|
|If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act|
Item 2.02 Results of Operations and Financial Condition
On March 15, 2021, Shattuck Labs, Inc. issued a press release announcing its financial results for the three months and year ended December 31, 2020. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
As provided in General Instruction B.2 of Form 8-K, the information in this Item 2.02 and Exhibit 99.1 incorporated herein shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall such information or Exhibit 99.1 be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|Shattuck Labs, Inc.|
|Date: March 15, 2021||By:|
/s/ Dr. Taylor Schreiber
Dr. Taylor Schreiber
Chief Executive Officer
(principal executive officer)
Shattuck Labs Reports Fourth Quarter and Full Year 2020 Financial Results and Recent Business Highlights
– Initial dose-escalation data from Phase 1 clinical trial for lead wholly owned CD47 checkpoint inhibitor, SL-172154 (SIRPα-Fc-CD40L), expected in the second half of 2021 –
– Dose-escalation data from Phase 1 clinical trial for lead partnered PD-1 checkpoint inhibitor, SL-279252 (PD1-Fc-OX40L), expected in the second half of 2021 –
AUSTIN, TX and DURHAM, NC, March 15, 2021 -- 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, 2020 and provided recent business highlights.
“2020 was a transformative year for Shattuck, and as we look ahead to 2021, we are excited to reveal the unique biology unlocked by the Agonist Redirected Checkpoint (ARC) technology in patients with cancer,” said Taylor Schreiber, M.D., Ph.D., and Chief Executive Officer of Shattuck. “We look forward to the Phase 1 data releases in the second half of this year for SL-172154 in patients with ovarian cancer and for SL-279252 in patients with advanced solid tumors. In addition, we are on-track to file an Investigational New Drug application in 2021 and to announce the lead candidate from our Gamma Delta T Cell Engager (GADLEN) platform. This is an exciting time for Shattuck and all of our stakeholders, and we believe that we are poised for years of clinical progress and expansion.”
Fourth Quarter 2020 Recent Business Highlights and Other Recent Developments
•Continued Enrollment of Phase 1 Clinical Trial of SL-172154 in Ovarian Cancer: Shattuck continues to enroll patients in its Phase 1 clinical trial for its lead wholly owned asset SL-172154, a CD47/SIRPα inhibitor and CD40 agonist, and the second clinical program to advance from its proprietary ARC platform. The Phase 1 trial is an open label, multi-center dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-172154 in patients with ovarian cancer. Initial Phase 1 dose-escalation data from the trial are expected in the second half of 2021.
•Initiated Enrollment of Phase 1 Clinical Trial of SL-172154 in Head and Neck or Skin Squamous Cell Carcinoma: Shattuck also initiated a Phase 1 clinical trial for its lead wholly owned asset SL-172154, administered intratumorally. The Phase 1 trial will evaluate the safety, tolerability, and anti-tumor effects of SL-172154 in patients with squamous cell carcinoma of the head and neck or skin. Initial Phase 1 dose-escalation data from the trial are expected in the first half of 2022.
•Continued Enrollment of Phase 1 Clinical Trial of SL-279252: Shattuck continues to enroll patients in its Phase 1 clinical trial evaluating SL-279252, a PD-1/PD-L1 inhibitor and OX40 receptor agonist. The Phase 1 trial is an open label, multi-center, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamics effects of SL-279252 in patients with advanced solid tumors or lymphomas. SL-279252 is currently being developed in collaboration with Takeda Pharmaceuticals. Phase 1 dose-escalation data from the trial are expected in the second half of 2021.
•Presented Preclinical Development of SL-9258: Preclinical data for SL-9258 (TIGIT-Fc-LIGHT), a dual TIGIT inhibitor and HVEM/LTβR agonist, was released at the TIGIT Therapies Summit in October 2020. These data provided preclinical evidence for anti-tumor activity of the murine equivalent of SL-9258 in PD-1 resistant tumors and increased tumor rejection in comparison to TIGIT blocking antibodies.
•Presented Preclinical Introduction of GADLEN Platform: Preclinical proof of concept data on Shattuck’s proprietary GADLEN platform was presented at the Society for Immunotherapy of Cancer (SITC) Meeting in November 2020. GADLEN compounds were shown to stimulate proliferation and activation of gamma delta T cells in vivo and to target those expanded cells to a selected tumor antigen.
•Completed Initial Public Offering (IPO): In October 2020, Shattuck completed an upsized IPO of common stock at $17.00 per share, raising gross proceeds of approximately $232.3 million and extending its cash runway through 2024.
•In April 2021, Shattuck will present an update on preclinical development of an in vivo model of checkpoint acquired resistance and updated information on its GADLEN platform at the American Association for Cancer Research (AACR) annual meeting.
•Shattuck will attend the following investor conferences. Details of the presentations and webcasts will be announced prior to the events.
•31st Annual Oppenheimer Healthcare Conference, March 16-18
•20th Annual Needham Healthcare Conference, April 12-15
•7th Annual Truist Securities Life Sciences Summit, May 4-5
Fourth Quarter and Full Year 2020 Financial Results
•Cash Position: As of December 31, 2020, cash and cash equivalents and short-term investments were $335.4 million, as compared to $39.1 million as of December 31, 2019. Net cash provided by financing activities for the year ended December 31, 2020 was $330.9 million, primarily comprised of approximately $117.0 million in net proceeds from Shattuck’s Series B and B-1 financings and $213.5 million in net proceeds from Shattuck’s IPO, completed in October 2020, partially offset by cash used in operating and investing activities.
•Research and Development (R&D) Expenses: R&D expenses for the fourth quarter ended December 31, 2020 were $9.8 million, as compared to $8.8 million for the fourth quarter ended December 31, 2019. R&D expenses for the year ended December 31, 2020 were $37.5 million, as compared to $29.2 million for the year ended December 31, 2019.
•General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter ended December 31, 2020 were $3.6 million, as compared to $1.7 million for the fourth quarter ended December 31, 2019. General and administrative expenses for the year ended December 31, 2020 were $9.4 million, as compared to $5.7 million for the year ended December 31, 2019.
•Net Loss: Net loss was $12.0 million for the fourth quarter ended December 31, 2020, or $0.31 per basic and diluted share, as compared to a net loss of $7.4 million for the fourth quarter ended December 31, 2019, or $0.97 per basic and diluted share. Net loss for the year ended December 31, 2020 was $36.6 million, or $2.36 per basic and diluted share, as compared to $24.0 million, or $3.17 per basic and diluted share, for the year ended December 31, 2019.
2021 Financial Guidance
Shattuck believes its cash and cash equivalents and short-term investments will be sufficient to fund its operations through 2024, which is 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 additional funding that may be received or business development or additional clinical development activities that may be undertaken.
About Shattuck Labs, Inc.
Shattuck 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 within a single therapeutic. The company’s lead wholly owned program, SL-172154 (SIRPα-Fc-CD40L), which is designed to block the CD47 immune checkpoint and simultaneously agonize the CD40 pathway, is being evaluated in a Phase 1 trial. A second compound, SL-279252 (PD1-Fc-OX40L), is being evaluated in a Phase 1 trial in collaboration with Takeda Pharmaceuticals. 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 of the results from those studies and trials, anticipated timing for preclinical development updates, additional uses for our proprietary ARC technology and GADLEN platform, potential new uses for 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 and associated shelter-in-place orders; 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 Phase 1 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, 2020, to be filed on March 16, 2021 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.
Senior Director, Finance & Investor Relations
Shattuck Labs, Inc.
Stern Investor Relations, Inc.
SHATTUCK LABS, INC.
|Cash and cash equivalents||$||157,898 ||$||7,013 |
|Short-term investments||177,551 ||32,074 |
|Prepaid expenses and other current assets||10,190 ||3,355 |
|Total current assets||345,639 ||42,442 |
|Property and equipment, net||3,000 ||2,437 |
|Other assets||349 ||90 |
|Total assets||$||348,988 ||$||44,969 |
|Liabilities, Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)|
|Accounts payable||$||1,754 ||$||3,051 |
|Accrued expenses||7,352 ||4,039 |
|Deferred revenue - related party||7,728 ||12,894 |
|Total current liabilities||16,834 ||19,984 |
|Deferred revenue - related party net of current portion||21,306 ||9,571 |
|Deferred rent||987 ||898 |
|Total liabilities||39,127 ||30,453 |
|Series A redeemable convertible preferred stock||— ||49,064 |
|Series B redeemable convertible preferred stock||— ||— |
|Series B-1 redeemable convertible preferred stock||— ||— |
|Stockholders’ equity (deficit):|
|Common stock||5 ||1 |
|Additional paid-in capital||382,012 ||887 |
|Accumulated other comprehensive income (loss)||(63)||54 |
|Total stockholders’ equity (deficit)||309,861 ||(34,548)|
|Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit)||$||348,988 ||$||44,969 |
SHATTUCK LABS, INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
|Three Months Ended December 31,|
|Twelve Months Ended December 31,|
|Collaboration revenue - related party||$||1,342 ||$||2,821 ||$||9,934 ||$||9,887 |
|Research and development||9,786 ||8,771 ||37,483 ||29,218 |
|General and administrative||3,567 ||1,674 ||9,382 ||5,736 |
|Expense from operations||13,353 ||10,445 ||46,865 ||34,954 |
|Loss from operations||(12,011)||(7,624)||(36,931)||(25,067)|
|Other income (expense):|
|Interest income||75 ||282 ||549 ||1,184 |
|Total other income||(2)||255 ||328 ||1,085 |
|Other comprehensive income (loss):|
|Unrealized gain (loss) on investments||(52)||(65)||(117)||54 |
|Net loss per share—basic and diluted||$||(0.31)||$||(0.97)||$||(2.36)||$||(3.17)|
Weighted-average shares outstanding—basic and diluted
|38,800,057 ||7,595,332 ||15,506,067 ||7,556,812 |