On 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, reported financial results for the fourth quarter and full year ended December 31, 2020 and provided recent business highlights.

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"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) (Free SITC Whitepaper) 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.
Upcoming Events

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) (Free AACR Whitepaper) 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. (Press release, Shattuck Labs, MAR 15, 2021, View Source [SID1234576694])