Shattuck Labs, Inc. Q3 FY2023 earnings call

Clinical Trials

• Lead product candidate SL-172154 (154) has clinical data from hematologic and solid tumor programs. In the Phase 1B trial in platinum-resistant ovarian cancer with SL-172154 + pegylated liposomal doxorubicin (PLD), as of Oct 31, 2023, overall response rate was 27%.
• Phase 1A/B trial in AML/high-risk MDS: Dose escalation completed in Q2 2023, data presented at ASH. Frontline dose expansion cohorts initiated, enrolling quickly due to unmet need. SL-172154 has acceptable safety profile, no destructive anemia. CD40 agonist domain differentiates it.

Financials

• As of Sep 30, 2023, cash and cash equivalents and investments were $101.1 million.
• Q3 2023 R&D expenses: $24.2 million vs $18.9 million in Q3 2022.
• Q3 2023 general and administrative expenses: $5.1 million vs $6.6 million in Q3 2022.
• Q3 2023 net loss: $27.5 million or $0.65 per basic and diluted share.

No specific product segment financial performance detailed; focus on clinical trial updates. The company's lead product candidate SL-172154 is in clinical trials, with updates on ovarian cancer and AML/high-risk MDS programs.

Financial Runway

• Cash and cash equivalents and investments are sufficient to fund operations through year-end 2024, excluding capital from business development transactions or additional clinical costs.

Milestones

• Expect to present complete data from dose escalation of Phase 1A/B trial at ASH. Initial data from frontline TP53 mutant AML and higher-risk MDS dose expansion cohorts to be presented post-ASH. Complete enrollment in frontline higher-risk MDS cohort in Q4 2023 and Phase 1B PLD combo cohort in Q4 2023.

Uncertainties

• Forward-looking statements involve risks and uncertainties. Actual results may differ from those expressed. Refer to SEC filings, including the most recent quarterly report on Form 10-Q for details on risks and uncertainties.

Q: Jonathan Miller of Evercore ISI asked about baseline characteristics of PROC patients and comparison to other CD47 programs.

A: Taylor Schreiber and Lini Pandite responded, discussing patient characteristics similar to JAVELIN study and how SL-172154's CD40 domain may impact efficacy.

Q: Joe Pantginis of H.C. Wainwright inquired about scenario analysis for AML/MDS study and targeted approval paths.

A: Taylor Schreiber responded, talking about potential targeted approval for TP53 mutant patients and rapid response kinetics observed.

Q: Marc Frahm of TD Cowen asked about patient status in PROC trial and efficacy in PARP-experienced vs non-experienced patients.

A: Lini Pandite responded, stating 5 patients in PROC trial are still on study waiting for first scan, and it's too early to draw conclusions on efficacy differences by PARP exposure.

Q: Yigal Nochomovitz of Citi asked about correlation between platinum-free interval and response in PROC and biologic hypotheses for TP53 mutant AML vs higher-risk MDS.

A: Taylor Schreiber responded, discussing platinum-free interval in PROC and hypotheses on TP53 mutant AML vs higher-risk MDS based on immunogenicity and CD40 agonist potential.

Q: Gil Blum of Needham & Company asked about go/no-go decision for PLD + SL-172154 and behavior of non-responding patients in PROC.

A: Taylor Schreiber responded, discussing enrollment challenges and potential regulatory path based on data maturation, and stating it's too early to assert behavior of non-responding patients.