Shattuck Labs Q2 2024 Financial Results and Business Highlights

Shattuck Labs, Inc., a clinical-stage biotech company specializing in bi-functional fusion proteins for cancer and autoimmune diseases, has shared its financial results for the second quarter of 2024 and several recent business developments. Noteworthy achievements include promising interim data from a Phase 1B clinical trial for their lead asset SL-172154, targeting Higher-Risk Myelodysplastic Syndromes (HR-MDS) and TP53 mutant Acute Myeloid Leukemia (AML), as well as an Orphan Drug Designation granted by the U.S. FDA for SL-172154 for AML treatment.

Chief Executive Officer Taylor Schreiber highlighted the promising complete remission rates for HR-MDS and TP53m AML patients treated with SL-172154 in combination with Azacitidine (AZA), which surpassed those expected for AZA alone. Schreiber expressed optimism about future data on overall survival benefits, anticipated later in the year. Furthermore, enrollment has begun in a randomized, controlled Phase 1B dose-expansion cohort for frontline HR-MDS patients.

Key Business Highlights:
1. SL-172154 (SIRPα-Fc-CD40L) in Frontline HR-MDS and TP53m AML:
- Updated interim data from the Phase 1B trial showed a 67% Objective Response Rate (ORR) in frontline HR-MDS patients, with a 58% complete remission/marrow complete remission rate. The median overall survival had not been reached by the data cutoff on April 23, 2024.
- The treatment demonstrated a manageable safety profile, with infusion-related reactions as the predominant adverse event.
- Enrollment for the randomized, controlled Phase 1B dose-expansion cohort in frontline HR-MDS patients is ongoing. This cohort will include approximately 60 patients randomized to receive different doses of SL-172154 combined with AZA or AZA alone.

2. TP53m AML:
- The trial observed a 43% ORR in frontline TP53m AML patients, with a 33% complete remission rate (with incomplete hematologic recovery). Median overall survival had not been achieved by the cutoff date of June 4, 2024.
- SL-172154 also demonstrated a manageable safety profile in combination with AZA.

3. SL-172154 in Platinum-Resistant Ovarian Cancer (PROC):
- Phase 1B clinical trial data indicated an acceptable safety profile when combined with pegylated liposomal doxorubicin (PLD) or mirvetuximab soravtansine (Elahere). As of April 23, 2024, partial responses were observed in 19% of treated patients. Two additional patients with stable disease showed significant tumor reductions.
- Completed enrollment for the cohort combining SL-172154 with Elahere, though no added ORR benefit beyond Elahere alone was observed by the data cutoff.

Corporate Developments:
- Shattuck Labs was added to the Russell 2000® and Russell 3000® indexes as of July 1, 2024.
- Upcoming events include participation in several investor conferences scheduled for August and September 2024.

Financial Overview for Q2 2024:
- Cash and cash equivalents and investments were $105.3 million as of June 30, 2024, down from $117.2 million a year prior.
- Research and Development expenses rose to $19.2 million, while General and Administrative expenses increased to $5.3 million compared to the same quarter in 2023.
- The net loss for the quarter was $21.5 million, or $0.42 per share, slightly higher than the $21.3 million loss (or $0.50 per share) in Q2 2023.

Shattuck Labs anticipates that its current cash reserves will support operations into 2026, covering the continuation of its Phase 1 clinical trials for SL-172154. This projection excludes any potential additional capital or costs from future clinical developments.

SL-172154 is an investigational ARC® fusion protein designed to inhibit the CD47/SIRPα checkpoint interaction while activating the CD40 receptor, aimed to strengthen anti-tumor immune responses. Shattuck Labs continues to evaluate this molecule in multiple Phase 1 trials.

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