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Syros Pharmaceuticals Inc (SYRS) (Q1 2024) Earnings Call Transcript Highlights: Strategic ...

  • Revenue: $0 in Q1 2024 compared to $3 million in Q1 2023.

  • R&D Expenses: $24.7 million in Q1 2024, down from $28.8 million in Q1 2023.

  • G&A Expenses: $6.3 million in Q1 2024, decreased from $7.4 million in Q1 2023.

  • Net Loss: $3.7 million in Q1 2024, or $0.1 per share; significantly lower than $23.8 million, or $0.85 per share in Q1 2023.

  • Cash, Cash Equivalents, and Marketable Securities: $108.3 million as of March 31, 2024, down from $139.5 million at the end of 2023.

Release Date: May 14, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

  • Syros Pharmaceuticals Inc (NASDAQ:SYRS) reported passing the prespecified interim futility analysis for the Phase 3 SELECT-MDS-1 trial, indicating continued potential for Tamibarotene as a treatment for hematologic malignancies.

  • The FDA granted Fast Track designation for Tamibarotene in combination with venetoclax and azacitidine for the treatment of newly diagnosed unfit AML, reflecting the unmet medical need and strength of initial data.

  • Syros Pharmaceuticals Inc (NASDAQ:SYRS) has successfully completed enrollment for the necessary patient count in the SELECT-MDS-1 trial, staying on track for pivotal data readout by mid Q4.

  • The company has demonstrated a well-tolerated safety profile for Tamibarotene, which is crucial for its target demographic of elderly patients with high-risk MDS.

  • Syros Pharmaceuticals Inc (NASDAQ:SYRS) has a strong cash position, with sufficient funds to cover anticipated operating expenses and capital expenditure requirements into the third quarter of 2025.

Negative Points

  • Syros Pharmaceuticals Inc (NASDAQ:SYRS) did not recognize any revenue in the first quarter of 2024, reflecting a decrease from the previous year due to the termination of a collaboration agreement with Pfizer.

  • Research and Development (R&D) expenses, although reduced from the previous year, remain high at $24.7 million, focusing primarily on the advancement of Tamibarotene.

  • General and Administrative (G&A) expenses, while reduced, still amounted to $6.3 million in the first quarter of 2024.

  • The company reported a net loss of $3.7 million for the first quarter of 2024, indicating ongoing financial challenges despite reduced losses compared to the previous year.

  • The competitive landscape for higher risk MDS treatments is narrowing, with several compounds failing due to efficacy or safety issues, which could pose risks for Syros Pharmaceuticals Inc (NASDAQ:SYRS)'s ongoing trials.

Q & A Highlights

Q: Can you provide any additional information on the statistical bar for the futility analysis in the SELECT-MDS-1 trial? A: David Roth, Chief Medical Officer - The futility analysis was prespecified and triggered when 50% of the patients contributing to the final primary analysis had sufficient time on study. The data were reviewed in a blinded fashion by an independent data monitoring committee, which looked at the complete response rates across the two arms. We remain blinded to the specific results but were informed that the trial passed without any new safety concerns and should continue without modification.

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Q: Do you think you have enough information post the Q3 update to make a go/no-go decision on pivotal development in AML? A: David Roth, Chief Medical Officer - We anticipate reporting another prespecified analysis from the SELECT-AML-1 trial in the third quarter, which will include outcomes from at least half of the trial's patients. The actual data from this analysis has not yet been seen, so it's premature to project a go/no-go decision. We will provide updates on this in the future.

Q: What are the upcoming milestones for Tamibarotene in clinical trials? A: David Roth, Chief Medical Officer - We are on track to report pivotal complete response data from the SELECT-MDS-1 trial by mid-Q4 this year. Additionally, we expect to share clinical activity and tolerability data from a prespecified analysis of over 40 patients from the randomized portion of the SELECT-AML-1 trial in the third quarter of this year.

Q: What does the FDA's Fast Track designation for Tamibarotene signify for its development? A: Conley Chee, CEO - The Fast Track designation for Tamibarotene in combination with venetoclax and azacitidine for treating newly diagnosed unfit AML patients reflects the urgent need for effective therapies in this area and supports the strength of our initial data from the SELECT-AML-1 trial.

Q: How does the financial performance in Q1 2024 compare to Q1 2023? A: Jason Haas, CFO - In Q1 2024, we did not recognize any revenue compared to $3 million in Q1 2023, reflecting the termination of our collaboration with Pfizer. R&D expenses decreased due to reduced external consulting, contract manufacturing, and headcount expenses. Our net loss improved to $3.7 million from $23.8 million in the same period last year.

Q: What are the financial projections post-Q1 2024, especially considering the amended loan agreement with Oxford? A: Jason Haas, CFO - The amendment with Oxford extends the interest-only period and increases the available term loans, enhancing our financial flexibility. We believe our current cash position will fund our operations into Q3 2025, beyond the pivotal Phase 3 data from SELECT-MDS-1 and additional data from SELECT-AML-1.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

This article first appeared on GuruFocus.