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STTK Discontinues Cancer Program, Plans Workforce Cut, Stock Falls
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Shattuck Labs (STTK - Free Report) announced its decision to discontinue the development of its pipeline candidate SL-172154, which was being developed for acute myeloid leukemia (AML) and higher-risk myelodysplastic syndromes (HR-MDS), types of blood cancer, as part of its strategic pipeline prioritization efforts. This disappointed investors as SL-172154 was the only clinical-stage candidate in Shattuck’s pipeline. Following the news, the stock plummeted 45% on Tuesday and lost another 3.7% during the after-market hours.
STTK's Phase IB SL-172154 Study Shows Limited Efficacy
Shattuck’s phase IB study evaluated SL-172154, combined with Bristol Myers’ (BMY - Free Report) Vidaza/Onureg (azacitidine), to treat patients with TP53 mutant (TP53m) AML and HR-MDS. Per the interim analysis results, treatment with the combo therapy in the MDS arm showed a median OS of 10.6 months, which will not improve beyond 13.1 months with subsequent data cuts. The benchmark median OS for TP53m HR-MDS patients treated with Vidaza/Onureg monotherapy is approximately 9-12 months.
Additionally, in the AML arm, it was observed that treatment with SL-172154 and Bristol Myers’ Vidaza/Onureg resulted in a median OS is 10.5 months, which will not improve beyond 11.7 months with subsequent data cuts. The benchmark median OS for TP53m AML patients treated with Vidaza/Onureg monotherapy is approximately five to eight months.
Per Shattuck, approval of SL-172154 for AML and HR-MDS would need significant improvement in overall survival (OS) in large, randomized studies. However, in contrast to previously observed early-stage data, the company observed only modest OS gains in the phase IB study. Given the company’s current cash position and the limited OS benefit, STTK discontinued the SL-172154 clinical program.
Year to date, shares of Shattuck have plunged 73.1% compared with the industry’s 1.2% decline.
Image Source: Zacks Investment Research
In both treatment arms, SL-172154 was overall well-tolerated and demonstrated a manageable safety profile. The most common treatment-related adverse events were infusion-related reactions.
Bristol Myers markets azacitidine as a subcutaneous or intravenous injection under the brand name Vidaza to treat intermediate-2, HR-MDS and AML. An oral formulation of azacitidine is also marketed by BMY under the brand name Onureg for treating AML. Please note that Vidaza/Onureg was added to Bristol Myers’ oncology portfolio following the acquisition of Celgene in 2019.
STTK Terminates Collaboration Deal With Ono Pharmaceutical
In the same press release, Shattuck announced that on Sept. 30, 2024, it mutually agreed with Ono Pharmaceutical to terminate their Feb. 13, 2024, collaboration and license agreement, which involved preclinical compound development. Consequently, Shattuck no longer has any obligations under the agreement and will not receive future payments or reimbursements from Ono.
This has also likely contributed to the stock price drop, as the deal’s termination limits the company’s income potential. With no marketed products, Shattuck lacks a steady revenue source.
STTK's Strategic Prioritization Plans for Future Development
Following the discontinuation of the SL-172154 clinical program, Shattuck has crowned its preclinical candidate, SL-325, a DR3 antagonist antibody, as the lead candidate for initial clinical development in patients with inflammatory bowel disease. Management believes that SL-325 has first-in-class potential as TL1A/DR3 blocking antibodies have demonstrated compelling monotherapy efficacy in treating inflammatory autoimmune disease indications.
In preclinical studies, SL-325 has shown strong binding affinity and better efficacy compared to TL1A antibodies, supporting management’s decision to target the TNF receptor DR3 instead of its ligand, TL1A. Shattuck plans to file an investigational new drug application with the FDA to begin clinical development of SL-325 in the third quarter of 2025.
As part of its strategic prioritization and organizational realignment, Shattuck will also reduce its workforce by about 40%, with the process expected to be completed in the fourth quarter of 2024. This move will enable the company to concentrate its resources on developing SL-325.
As of June 30, 2024, Shattuck had cash and cash equivalents and investments worth $105.3 million. Taking into account the changes to its operations and cost structure, the company believes that its current cash position will fund operations through 2027, extending beyond the expected results of its phase I study for SL-325. This projection is based on current plans and does not account for potential new funding, business development deals, or additional development costs.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.53 to $4.81. Earnings per share estimates for 2025 have improved from $5.38 to $5.86. Year to date, shares of ANIP have gained 7.9%.
ANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from 46 cents to 28 cents. The consensus estimate for 2025 loss per share has narrowed from $1.67 to $1.14. Year to date, shares of FULC have plunged 46.7%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.
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STTK Discontinues Cancer Program, Plans Workforce Cut, Stock Falls
Shattuck Labs (STTK - Free Report) announced its decision to discontinue the development of its pipeline candidate SL-172154, which was being developed for acute myeloid leukemia (AML) and higher-risk myelodysplastic syndromes (HR-MDS), types of blood cancer, as part of its strategic pipeline prioritization efforts. This disappointed investors as SL-172154 was the only clinical-stage candidate in Shattuck’s pipeline. Following the news, the stock plummeted 45% on Tuesday and lost another 3.7% during the after-market hours.
STTK's Phase IB SL-172154 Study Shows Limited Efficacy
Shattuck’s phase IB study evaluated SL-172154, combined with Bristol Myers’ (BMY - Free Report) Vidaza/Onureg (azacitidine), to treat patients with TP53 mutant (TP53m) AML and HR-MDS. Per the interim analysis results, treatment with the combo therapy in the MDS arm showed a median OS of 10.6 months, which will not improve beyond 13.1 months with subsequent data cuts. The benchmark median OS for TP53m HR-MDS patients treated with Vidaza/Onureg monotherapy is approximately 9-12 months.
Additionally, in the AML arm, it was observed that treatment with SL-172154 and Bristol Myers’ Vidaza/Onureg resulted in a median OS is 10.5 months, which will not improve beyond 11.7 months with subsequent data cuts. The benchmark median OS for TP53m AML patients treated with Vidaza/Onureg monotherapy is approximately five to eight months.
Per Shattuck, approval of SL-172154 for AML and HR-MDS would need significant improvement in overall survival (OS) in large, randomized studies. However, in contrast to previously observed early-stage data, the company observed only modest OS gains in the phase IB study. Given the company’s current cash position and the limited OS benefit, STTK discontinued the SL-172154 clinical program.
Year to date, shares of Shattuck have plunged 73.1% compared with the industry’s 1.2% decline.
Image Source: Zacks Investment Research
In both treatment arms, SL-172154 was overall well-tolerated and demonstrated a manageable safety profile. The most common treatment-related adverse events were infusion-related reactions.
Bristol Myers markets azacitidine as a subcutaneous or intravenous injection under the brand name Vidaza to treat intermediate-2, HR-MDS and AML. An oral formulation of azacitidine is also marketed by BMY under the brand name Onureg for treating AML. Please note that Vidaza/Onureg was added to Bristol Myers’ oncology portfolio following the acquisition of Celgene in 2019.
STTK Terminates Collaboration Deal With Ono Pharmaceutical
In the same press release, Shattuck announced that on Sept. 30, 2024, it mutually agreed with Ono Pharmaceutical to terminate their Feb. 13, 2024, collaboration and license agreement, which involved preclinical compound development. Consequently, Shattuck no longer has any obligations under the agreement and will not receive future payments or reimbursements from Ono.
This has also likely contributed to the stock price drop, as the deal’s termination limits the company’s income potential. With no marketed products, Shattuck lacks a steady revenue source.
STTK's Strategic Prioritization Plans for Future Development
Following the discontinuation of the SL-172154 clinical program, Shattuck has crowned its preclinical candidate, SL-325, a DR3 antagonist antibody, as the lead candidate for initial clinical development in patients with inflammatory bowel disease. Management believes that SL-325 has first-in-class potential as TL1A/DR3 blocking antibodies have demonstrated compelling monotherapy efficacy in treating inflammatory autoimmune disease indications.
In preclinical studies, SL-325 has shown strong binding affinity and better efficacy compared to TL1A antibodies, supporting management’s decision to target the TNF receptor DR3 instead of its ligand, TL1A. Shattuck plans to file an investigational new drug application with the FDA to begin clinical development of SL-325 in the third quarter of 2025.
As part of its strategic prioritization and organizational realignment, Shattuck will also reduce its workforce by about 40%, with the process expected to be completed in the fourth quarter of 2024. This move will enable the company to concentrate its resources on developing SL-325.
As of June 30, 2024, Shattuck had cash and cash equivalents and investments worth $105.3 million. Taking into account the changes to its operations and cost structure, the company believes that its current cash position will fund operations through 2027, extending beyond the expected results of its phase I study for SL-325. This projection is based on current plans and does not account for potential new funding, business development deals, or additional development costs.
Shattuck Labs, Inc. Price and Consensus
Shattuck Labs, Inc. price-consensus-chart | Shattuck Labs, Inc. Quote
Zacks Rank & Stocks to Consider
Shattuck currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals (ANIP - Free Report) and Fulcrum Therapeutics (FULC - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.53 to $4.81. Earnings per share estimates for 2025 have improved from $5.38 to $5.86. Year to date, shares of ANIP have gained 7.9%.
ANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from 46 cents to 28 cents. The consensus estimate for 2025 loss per share has narrowed from $1.67 to $1.14. Year to date, shares of FULC have plunged 46.7%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.