On November 8, 2022 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 quarter ended September 30, 2022 and provided recent business highlights (Press release, Shattuck Labs, NOV 8, 2022, View Source [SID1234623419]).
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"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 (Free SITC Whitepaper) 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
Completed Enrollment and Study Objectives in Phase 1 Monotherapy Dose-Escalation Clinical Trial of SL-172154 in Platinum-Resistant Ovarian Cancer: This open-label, multi-center, dose-escalation clinical trial evaluated the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-172154 administered intravenously in patients with advanced platinum-resistant ovarian cancer. We reached a maximum administered dose of 10.0 mg/kg and completed enrollment of additional patients at 3.0 mg/kg with an extended infusion time. We expect to present complete dose-escalation data from the trial midyear 2023.
First Patient Dosed in Combination Trial of SL-172154 with Liposomal Doxorubicin in Advanced Platinum-Resistant Ovarian Cancer: Enrollment is continuing in this trial, which is evaluating the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-172154, starting at 3.0 mg/kg, in combination with liposomal doxorubicin in patients with advanced platinum-resistant ovarian cancer. We expect to present initial data from the trial midyear 2023.
Enrollment Progressing in Phase 1A/B Clinical Trial of in SL-172154 in AML and HR-MDS: This trial is evaluating the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-172154 as both monotherapy and in combination with azacitidine in a parallel staggered dose escalation. Patients have been dosed in the initial monotherapy cohorts of this trial and enrollment in the azacitidine combination cohorts is expected to begin in the fourth quarter of 2022. Initial dose-escalation data from both monotherapy and azacitidine combination cohorts are expected in the first half of 2023.
SL-279252 (PD1-Fc-OX40L)
Continued Enrollment of SL-279252 Phase 1 Dose-Escalation Clinical Trial in Advanced Solid Tumors: Enrollment of patients with primarily PD-L1 selected tumors continues in the Phase 1 open-label, multi-center, dose-escalation clinical trial to evaluate the safety, tolerability, pharmacokinetics, anti-tumor activity and pharmacodynamic effects of SL-279252 in patients with advanced solid tumors and lymphoma. Top-line data from the Phase 1 trial are anticipated in the first quarter of 2023.
GADLEN
Preclinical Candidates from GADLEN Platform Continue to Advance: We have developed both CD20-directed and B7H3-directed GADLEN product candidates. Additional preclinical data on both programs will be presented at the annual SITC (Free SITC Whitepaper) conference in November. We plan to provide additional clinical development detail and further program guidance in 2023.
Upcoming Events
37th Annual SITC (Free SITC Whitepaper) Annual Meeting: Updated preclinical data on Gamma Delta T Cell Engager (GADLEN) platform candidates to be presented at Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting taking place in Boston on November 8-12, 2022.
Cowen’s 6th Annual IO Next Summit: Management will participate in a fireside chat with covering analyst Marc Frahm at Cowen’s Annual IO Next Conference taking place virtually on November 11, 2022.
5th Annual Evercore ISI HealthCONx Conference: Management will participate in investor one-on-one meetings and a fireside chat with covering analyst Jonathan Miller at the Evercore ISI HealthCONx Conference taking place virtually on November 30 – December 1, 2022.
34th Annual Piper Sandler Healthcare Conference: Management will participate in investor one-on-one meetings and present a corporate update at the Annual Piper Sandler Healthcare Conference taking place in New York City on November 29 – December 1, 2022.
Live and archived audio webcasts of the fireside chats and presentation will be available on the Events & Presentations section of the Company’s website.
Third Quarter 2022 Financial Results
Cash Position: As of September 30, 2022, cash and cash equivalents and investments were $185.1 million, as compared to $268.8 million as of December 31, 2021.
Research and Development (R&D) Expenses: R&D expenses for the quarter ended September 30, 2022 were $18.9 million, as compared to $15.1 million for the quarter ended September 30, 2021. This increase was primarily driven by increases in clinical costs, including clinical site and contract research organization costs, to support clinical development of SL-172154, lab supplies, and personnel-related costs.
General and Administrative (G&A) Expenses: G&A expenses for the quarter ended September 30, 2022 were $6.6 million, as compared to $4.3 million for the quarter ended September 30, 2021. This increase was primarily driven by a litigation settlement of $1.4 million and increases in personnel-related and other operating costs.
Net Loss: Net loss was $24.6 million for the quarter ended September 30, 2022, or $0.58 per basic and diluted share, as compared to a net loss of $17.4 million for the quarter ended September 30, 2021, or $0.41 per basic and diluted share.
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.
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 cancer. Phase 1 clinical trials are ongoing for patients with advanced platinum-resistant ovarian cancer (NCT05483933) and patients with AML and HR-MDS (NCT05275439).
About SL-279252
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).