Shattuck Labs, Inc. - STTK STOCK NEWS

Shattuck Labs (NASDAQ: STTK) reported Q3 2024 financial results and announced a strategic shift to focus on SL-325, a first-in-class DR3 blocking antibody. The company ended Q3 with $90.1 million in cash and investments, compared to $101.1 million year-over-year. Q3 net loss was $16.7 million ($0.33 per share), improved from $27.5 million ($0.65 per share) in Q3 2023. R&D expenses decreased to $16.3 million from $24.2 million, while G&A expenses reduced to $4.6 million from $5.1 million. The company completed restructuring plans and expects current cash to fund operations into 2027, beyond SL-325's Phase 1 trial results.

Shattuck Labs (Nasdaq: STTK) announced a strategic pipeline prioritization, discontinuing its SL-172154 clinical program due to modest improvements in overall survival for TP53 mutant AML and HR-MDS patients. The company will focus on SL-325, a first-in-class DR3 antagonist antibody for inflammatory bowel disease (IBD), with an IND filing expected in Q3 2025.

Key points:

• SL-172154 showed only modest improvement in median overall survival compared to azacitidine monotherapy benchmarks
• Approximately 40% workforce reduction as part of restructuring
• Cash runway extended into 2027
• Mutual termination of collaboration agreement with Ono Pharmaceutical
• SL-325 demonstrates high affinity binding and superior efficacy over TL1A antibodies in preclinical studies

Shattuck Labs (Nasdaq: STTK) reported Q2 2024 financial results and business highlights. Key points include:

1. Updated positive interim data from Phase 1B trial of SL-172154 with Azacitidine in HR-MDS and TP53m AML patients.

2. Enrollment ongoing in randomized Phase 1B dose-expansion cohort for frontline HR-MDS.

3. FDA granted Orphan Drug Designation for SL-172154 in AML treatment.

4. Q2 2024 financials: $105.3M cash and investments, $19.2M R&D expenses, $5.3M G&A expenses, $21.5M net loss ($0.42 per share).

5. Cash runway expected into 2026, beyond Phase 1 trial results for SL-172154.

Shattuck Labs (NASDAQ: STTK), a clinical-stage biotech company developing bi-functional fusion proteins for cancer and autoimmune disease treatment, announced its participation in the upcoming BTIG Virtual Biotechnology Conference. The event is scheduled for August 5-6, 2024. Dr. Taylor Schreiber, Shattuck's CEO, will engage in a fireside chat with BTIG analyst Kaveri Pohlman on August 5 at 2:00 p.m. ET. The company will also be available for one-on-one meetings during the conference. A live webcast of the fireside chat will be accessible to conference participants.

Shattuck Labs (Nasdaq: STTK), a clinical-stage biotechnology company focusing on bifunctional fusion proteins for cancer and autoimmune diseases, announced its inclusion in the Russell 2000® and Russell 3000® Indexes, effective July 1, 2024. This addition reflects the company's progress in advancing its lead candidate, SL-172154, in high-risk myelodysplastic syndromes (HR-MDS) and TP53-mutated acute myeloid leukemia (TP53m AML). The annual Russell U.S. Indexes reconstitution includes the 4,000 largest U.S. stocks, ranking them by market capitalization. The Russell Indexes are widely used by investment managers and institutional investors for index funds and benchmarking active investment strategies.

Shattuck Labs has revealed updated positive interim data from the Phase 1B clinical trial of SL-172154 combined with Azacitidine (AZA) for treating frontline higher-risk myelodysplastic syndromes (HR-MDS) and TP53 mutant acute myeloid leukemia (AML).

The trial showed a 67% objective response rate (ORR) in HR-MDS patients, with a 58% complete remission rate, while frontline TP53m AML patients exhibited a 43% ORR and 33% complete remission with incomplete hematologic recovery.

SL-172154 demonstrated a manageable safety profile, with the most common adverse events being infusion-related reactions. The median overall survival for both patient groups has not yet been reached.

Shattuck is focusing on HR-MDS and TP53m AML due to competition and potential for accelerated approval pathways. The company will host a conference call on June 14, 2024, to discuss these findings further.

Shattuck Labs announced that its lead clinical candidate, SL-172154, has been granted Orphan Drug Designation (ODD) by the U.S. FDA for the treatment of Acute Myeloid Leukemia (AML). This designation is awarded to drugs that address rare diseases affecting fewer than 200,000 people in the U.S. and provides benefits such as market exclusivity for seven years, tax credits for clinical trials, and waived application fees. The company plans to present additional data from the Phase 1B dose expansion clinical trial of SL-172154 at the European Hematology Association 2024 Congress.

Shattuck Labs will host an investor call and webcast on June 14, 2024, at 7:30 a.m. ET to discuss additional interim data from their Phase 1B dose expansion clinical trial of SL-172154 combined with Azacitidine (AZA) in treating frontline higher-risk myelodysplastic syndromes (HR-MDS) and TP53 mutant acute myeloid leukemia (AML) patients. The event, held during the European Hematology Association (EHA) 2024 Congress, will feature lead investigator Dr. Naval G. Daver from The University of Texas MD Anderson Cancer Center. The webcast will provide updates on safety and efficacy from the ongoing trial. Participants must register in advance to join the webcast, and a replay will be available for those unable to attend the live session.

Shattuck Labs (Nasdaq: STTK) will present new data from its Phase 1B trial of SL-172154 at the European Hematology Association (EHA) 2024 Congress. The trial, which combines SL-172154 with azacitidine (AZA), targets frontline higher-risk myelodysplastic syndromes (HR-MDS) and TP53 mutant (TP53m) acute myeloid leukemia (AML). As of February 1, 2024, the combination therapy showed promising complete response (CR) rates and an acceptable safety profile. The HR-MDS cohort had a 65% objective response rate (ORR), while TP53m AML had a 36% ORR. The next data update is expected in the second quarter of 2024. Key safety concerns include infusion-related reactions and some severe treatment-emergent adverse events (TEAEs).