On May 7, 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 first quarter ended March 31, 2021 and provided recent business highlights (Press release, Shattuck Labs, MAY 7, 2021, View Source [SID1234579568]).
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"We have made steady progress across the organization this quarter and remain on-track to present clinical data from both SL-172154 and SL-279252 in the second half of this year," said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. "In addition, we accelerated our expansion of SL-172154 into hematologic malignancies, and we plan to announce our strategy to bridge an immunologically active dose identified in our ovarian cancer study into multiple hematologic indications in the second half of 2021."
First Quarter 2021 Recent Business Highlights and Other Recent Developments
Continued Enrollment of SL-172154 Phase 1 Clinical Trial in Ovarian Cancer: Shattuck continues to enroll patients in a Phase 1 clinical trial for its lead wholly owned asset SL-172154, a dual CD47/SIRPα inhibitor and CD40 agonist. 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 administered intravenously in patients with ovarian cancer. Initial dose-escalation data from the trial are expected in the second half of 2021.
Continued Enrollment of SL-172154 Phase 1 Clinical Trial in Squamous Cell Carcinoma of the Head and Neck or Skin: Shattuck continues to enroll patients in a Phase 1 clinical trial for SL-172154, administered intratumorally. The Phase 1 trial will evaluate the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-172154 in patients with squamous cell carcinoma of the head and neck or skin. Initial dose-escalation data from the trial are expected in the first half of 2022.
Continued Enrollment of SL-279252 Phase 1 Clinical Trial: Shattuck continues to enroll patients in a Phase 1 clinical trial evaluating SL-279252, a dual 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 pharmacodynamic effects of SL-279252 in patients with advanced solid tumors or lymphomas. SL-279252 is currently being developed in collaboration with Takeda Pharmaceuticals. Dose-escalation data from the trial are expected in the second half of 2021.
Presented Preclinical Data for SL-9258: Preclinical data for SL-9258 (TIGIT-Fc-LIGHT), a dual TIGIT inhibitor and HVEM/LTβR agonist, was presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April 2021. These data demonstrated that SL-9258 (TIGIT-Fc-LIGHT) was highly active in a PD1 acquired resistance model and outperformed dual checkpoint blockade with anti-PD1 antibodies and anti-TIGIT antibodies.
Presented Continued Preclinical Development of GADLEN Platform: Preclinical proof of concept data on Shattuck’s proprietary Gamma Delta T Cell Engager (GADLEN) platform were presented at the AACR (Free AACR Whitepaper) annual meeting in April 2021. These data demonstrated a multi-layer analysis to uncover the gamma and delta TCR usage in tumors and the butyrophilin expression pattern guiding the design of GADLEN therapeutics, which are intended to target both hematologic malignancies and solid tumor indications.
First Quarter 2021 Financial Results
Cash Position: As of March 31, 2021, cash and cash equivalents and short-term investments were $321.2 million, as compared to $335.4 million as of December 31, 2020.
Research and Development (R&D) Expenses: R&D expenses for the first quarter ended March 31, 2021 were $10.3 million, as compared to $8.1 million for the first quarter ended March 31, 2020. The increase was primarily driven by an increase in our personnel related costs, expanded clinical development, and laboratory capabilities.
General and Administrative (G&A) Expenses: G&A expenses for the first quarter ended March 31, 2021 were $4.4 million, as compared to $1.6 million for the first quarter ended March 31, 2020. The increase was primarily driven by an increase in personnel related costs to support our activities associated with being a public company and operational expansion.
Net Loss: Net loss was $11.8 million for the first quarter ended March 31, 2021, or $0.28 per basic and diluted share, as compared to a net loss of $6.6 million for the first quarter ended March 31, 2020, or $0.86 per basic and diluted share.
Expected 2021 Milestones
Shattuck anticipates achieving the following milestones during 2021:
SL-172154
Initial dose-escalation data from Phase 1 clinical trial in ovarian cancer expected in the second half of 2021
IND filings for SL-172154 in hematologic malignancies anticipated in the second half of 2021
SL-279252
Dose-escalation data from Phase 1 clinical trial expected in the second half of 2021
Initiation of one or more dose-expansion cohorts expected in the second half of 2021
Pipeline Advancements
Nomination of third ARC compound to clinical stage pipeline anticipated in the second half of 2021
Nomination of GADLEN lead compound anticipated in the second half of 2021
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 SL-172154
SL-172154 is an investigational bi-functional fusion protein designed to block the CD47 immune checkpoint and simultaneously agonize the CD40 pathway. SL-172154 is currently being evaluated in Phase 1 clinical trials for the treatment of patients with ovarian and head and neck or skin squamous cell carcinoma.
In preclinical studies, SL-172154, demonstrated evidence of bridging the innate and adaptive immunity, antigen cross-priming to CD8+ T cells, and durable receptor occupancy, leading to superior anti-tumor activity over anti-CD47 antibodies, and anti-CD40 antibodies, both alone or in combination. Additionally, SL-172154 preclinically demonstrated a favorable safety profile with no evidence of hematologic toxicities observed with other CD47 inhibitors.
About SL-279252
SL-279252 is an investigational bi-functional fusion protein designed to block the PD-1 immune checkpoint and simultaneously agonize the OX40 pathway. SL-279252 is currently being evaluated in a Phase 1 clinical trial for the treatment of patients with advanced solid tumors and lymphoma. SL-279252 is part of a collaboration with Takeda Pharmaceuticals.
In preclinical studies, SL-279252, demonstrated evidence of high monotherapy activity, potent stimulation of OX40+ T Cells and superior anti-tumor activity over anti-PD1/L-1 antibodies and anti-OX40 antibodies, both alone or in combination.