8-K: Shattuck Labs Announces Positive Clinical Trial Data and Second Quarter 2024 Financial Results

Shattuck Labs reported encouraging interim data from its SL-172154 clinical trials, along with its second quarter 2024 financial results.

Summary

• Shattuck Labs announced updated positive interim data from the Phase 1B trial of SL-172154 in combination with Azacitidine for patients with Higher-Risk Myelodysplastic Syndromes and TP53 mutant Acute Myeloid Leukemia.
• The company observed a 67% Objective Response Rate in frontline HR-MDS patients and a 43% ORR in frontline TP53m AML patients.
• The company also reported a 58% complete remission rate in HR-MDS and a 33% complete remission rate in TP53m AML.
• Enrollment is ongoing in a randomized, controlled Phase 1B dose-expansion cohort in frontline HR-MDS patients.
• The U.S. FDA granted Orphan Drug Designation to SL-172154 for the treatment of AML.
• Shattuck Labs reported second quarter 2024 cash and cash equivalents and investments of $105.3 million, compared to $117.2 million in the same period last year.
• Research and development expenses were $19.2 million for the quarter, compared to $18.2 million in the same quarter of 2023.
• The company's net loss for the quarter was $21.5 million, or $0.42 per share, compared to a net loss of $21.3 million, or $0.50 per share, in the second quarter of 2023.
• Shattuck believes its current cash will fund operations into 2026.

Sentiment

Score: 7

Explanation: The document presents positive clinical trial data and a sufficient cash runway, but also includes a net loss and some mixed results in other trials. The overall sentiment is positive but with some caution.

Positives

• The clinical trial data for SL-172154 in HR-MDS and TP53m AML showed promising objective response and complete remission rates.
• The granting of Orphan Drug Designation by the FDA for SL-172154 in AML could provide regulatory and commercial benefits.
• The company has a cash runway that is expected to fund operations into 2026.
• Enrollment has begun in a randomized, controlled expansion cohort in frontline HR-MDS patients.

Negatives

• The company experienced a net loss of $21.5 million for the quarter.
• Cash and cash equivalents decreased from $117.2 million in June 2023 to $105.3 million in June 2024.
• The Phase 1B trial of SL-172154 in Platinum-Resistant Ovarian Cancer did not show an ORR benefit beyond Elahere alone.

Risks

• The company's clinical trials are subject to risks and uncertainties, and results may not translate to an overall survival benefit.
• The company's cash runway is based on current operational plans and excludes potential additional costs or capital raises.
• The company's financial results are subject to various risks and uncertainties, including those related to clinical trials and regulatory approvals.
• The company's research and development programs are subject to risks and uncertainties, and results may not be successful.

Future Outlook

Shattuck believes its cash and cash equivalents and investments will be sufficient to fund its operations into 2026, beyond results from its Phase 1 clinical trials of SL-172154. This guidance excludes any additional capital that may be received, proceeds from business development transactions, and/or additional costs associated with clinical development activities that may be undertaken.

Management Comments

• Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck, stated that the complete remission rate improved as the number of patients in each cohort increased since the initial data presented at ASH in December of 2023.
• The CEO also mentioned that the next milestone is to see how these response rates translate to an overall survival benefit, with data expected to mature over the second half of the year.

Industry Context

Shattuck Labs is operating in the competitive biotechnology sector, focusing on developing novel bi-functional fusion proteins for cancer and autoimmune diseases. The positive clinical data for SL-172154 in HR-MDS and AML positions the company as a potential player in the oncology space, particularly in areas with high unmet medical needs. The company's approach of combining checkpoint inhibition and costimulatory activation is a growing area of interest in immuno-oncology.

Comparison to Industry Standards

• The 67% Objective Response Rate in HR-MDS patients is promising when compared to standard treatments like Azacitidine alone, which typically show lower response rates.
• The complete remission rates of 58% in HR-MDS and 33% in TP53m AML are also encouraging, although direct comparisons are difficult without detailed data from other trials using similar patient populations and treatment combinations.
• Companies like Agios Pharmaceuticals and Celgene (now part of Bristol Myers Squibb) have developed treatments for MDS and AML, but Shattuck's approach with a bi-functional fusion protein is novel and could offer a different mechanism of action.
• The Phase 1B trial design, including the randomized controlled expansion cohort, is consistent with industry best practices for evaluating new cancer therapies.

Stakeholder Impact

• Shareholders may react positively to the promising clinical trial data and the extended cash runway.
• Employees may be encouraged by the progress of the company's lead program.
• Patients with HR-MDS and AML may benefit from the development of new treatment options.
• The company's suppliers and partners may see continued business opportunities.

Next Steps

• Shattuck will continue to enroll patients in the randomized, controlled Phase 1B dose-expansion cohort in frontline HR-MDS patients.
• The company will monitor the overall survival data from the SL-172154 trials, which is expected to mature in the second half of the year.
• Shattuck plans to attend several investor conferences in August and September 2024.
• The company will continue to follow patients in the PROC trial for progression free survival and overall survival.

Key Dates

Keywords

SL-172154, HR-MDS, AML, Orphan Drug Designation, Clinical Trial, Biotechnology, Cancer, Azacitidine, Phase 1B, Objective Response Rate, Complete Remission, Financial Results