Shattuck Labs Q1 2024 Financial Results and Business Highlights

Shattuck Labs, Inc., a clinical-stage biotechnology company focusing on the development of bi-functional fusion proteins for cancer and autoimmune disease treatments, has released its financial outcomes for the quarter ending March 31, 2024, alongside significant business updates.

In the first quarter of 2024, Shattuck successfully expanded the enrollment in the Phase 1B dose-expansion cohorts targeting TP53 mutant Acute Myeloid Leukemia (AML) patients. Updated data from this combination study is anticipated at the European Society of Hematology (EHA) Annual Meeting in June 2024. Furthermore, Shattuck plans to initiate enrollment for a randomized, controlled Phase 1B dose-expansion cohort in frontline Higher-Risk Myelodysplastic Syndromes (HR-MDS) patients in Q2 2024.

Shattuck also presented promising preclinical data at the 2024 American Association for Cancer Research (AACR) Annual Meeting, illustrating the therapeutic benefits of inhibiting TRIM7 to counter acquired resistance to immune checkpoint therapies. This preclinical progress represents one of the multiple growth avenues Shattuck is exploring apart from its leading SL-172154 program.

Key clinical milestones expected in 2024 for SL-172154 (SIRPα-Fc-CD40L) include:

- Objective response rates and duration of response data from Phase 1B expansion cohorts of SL-172154 combined with azacitidine in frontline HR-MDS and TP53m AML patients, expected at the EHA Annual Meeting in June 2024.
- Initiation of a randomized, controlled Phase 1B dose-expansion cohort in frontline HR-MDS patients in Q2 2024, involving approximately 60 patients treated in a 1:1:1 ratio with different doses of SL-172154 and azacitidine or azacitidine alone.
- Mid-year 2024 data from the Phase 1B trial of SL-172154 combined with pegylated liposomal doxorubicin (PLD) in Platinum-Resistant Ovarian Cancer (PROC) patients.
- Completion of enrollment and initial data release for the Phase 1B trial of SL-172154 with mirvetuximab soravtansine in PROC patients by mid-2024.

In terms of recent preclinical achievements, Shattuck's presentation at AACR 2024 underscored the potential of TRIM7 inhibition in overcoming immune checkpoint resistance. The preclinical results were strengthened by prior findings published in Cancer Cell, which identified TRIM7 as a novel target through an anti-PD1 resistance mouse model.

Additionally, Shattuck entered into a strategic collaboration with Ono Pharmaceutical Co., Ltd. (Ono) on February 13, 2024. This agreement allows Shattuck to spearhead research and preclinical development of selected compounds from Ono's bifunctional fusion proteins pipeline targeting autoimmune and inflammatory diseases.

Corporate developments also included the appointment of Clay Siegall, Ph.D., and Kate Sasser, Ph.D., to Shattuck's Board of Directors as of March 1, 2024. Both leaders bring extensive experience and industry knowledge to Shattuck.

Financially, as of March 31, 2024, Shattuck reported cash, cash equivalents, and investments totaling $114.6 million, compared to $135.5 million on March 31, 2023. The company's research and development (R&D) expenses for Q1 2024 stood at $16.3 million, slightly down from $16.7 million in Q1 2023. General and administrative (G&A) expenses were $4.9 million, compared to $5.1 million in the previous year. The net loss decreased to $18.5 million ($0.37 per share) from $20.7 million ($0.49 per share) year-over-year.

Shattuck projects that its current cash and investments will sustain operations into 2026, covering the ongoing Phase 1 clinical trials of its lead candidate, SL-172154. This financial outlook excludes any additional capital from new business development deals or clinical development costs that might arise.

SL-172154 (SIRPα-Fc-CD40L) is an investigational fusion protein designed to inhibit the CD47/SIRPα checkpoint and activate the CD40 receptor, hence enhancing the anti-tumor immune response. It is currently under multiple Phase 1 trials targeting AML, HR-MDS, and PROC patients in various combinations to assess its safety, efficacy, and pharmacodynamics.