Analyst Conference Summary

biotechnology

conference date: July 31, 2024 @ 5:30 AM Pacific Time
for quarter ending: June 30, 2024 (second quarter, Q2)

Forward-looking statements

Overview: Continues to advance pipeline of therapies, crucial results by end of 2024.

Basic data (GAAP):

Revenue was $0 million, down sequentially from $0 million, and down from $3 million year-earlier. Revenue is from collaborations with GBT and Incyte, not product sales.

Net income was negative $23 million, down sequentially from negative $3.7 million, and up from negative $36 million year-earlier.

Earnings per Share (EPS), diluted, were negative $0.59, down sequentially from negative $0.10, and up from negative $1.30 year-earlier.

Guidance:

Has a cash runway into Q3 2025.

Conference Highlights:

Conley Chee, CEO said "Syros is well-positioned heading into key clinical data readouts expected in the second half of 2024, including pivotal complete response (CR) data from the Phase 3 SELECT-MDS-1 trial by mid-fourth quarter. In addition, we will present clinical activity and tolerability data from over 40 patients from the SELECT-AML-1 Phase 2 trial at the SOHO 2024 annual meeting in September. As we approach two critical data readouts, we are working diligently to prepare for our first New Drug Application (NDA) filing and launch, so that we can effectively deliver tamibarotene to the thousands of HR-MDS patients in need of new treatment options."

In May 2024 the Oxford Financial loan agreement was increased to potentially $100 million from the prior $40 million, upon reaching certain milestones.

Data from the pivotal Tamibarotene (+ standard of care) Phase 3 SELECT-MDS-1, with overall survival (OS) as a key secondary endpoint, and CR as the primary endpoint, is expected in mid Q4 2024. If accelerated approval is achieved, the OS portion of the trial would allow for full approval. The FDA granted Fast Track for MDS in February 2023. Completed enrollment of 190 patients necessary to support complete response (CR) primary endpoint in Q1 2024 in the SELECT-MDS-1 Phase 3 trial in newly diagnosed HR-MDS patients with RARA gene overexpression. The trial will enroll up to 550 patients with overall survival (OS) as a key secondary endpoint.

Tamibarotene, in combination with standard of care, for RARA positive AML additional Phase 2 SELECT-AML-1 data will be reported at the Society of Hematologic Oncology (SOHO) meeting in September 2024. Was last reported in December 2023. In April,2024 the FDA granted Fast Track Designation to tamibarotene in combination with venetoclax and azacitidine for the treatment of newly diagnosed AML with RARA overexpression, in adults who are over age 75 and who have comorbidities that preclude the use of intensive induction chemotherapy.

Syros has halted work on SY-2101 (arsenic trioxide formulation for APL (acute promyelocytic leukemia))to focus on Tamibarotene.

Cash and equivalents ended the quarter at $79 million, down sequentially from $108 million.

Operating expenses were $27 million, comprised of $22 million for R&D and $5 million for administration. Loss from operations $27 million. Interest net $0 million. Change in warrant fair value up $4 million.

Q&A selective summary:

AML pivotal study decision timing? Planning data update on prespecified data. Should include at least 40 patients, probably a few more. No decision before we see the data. Earlier data had CR/CRI of 100%, which was very exciting, but also we need to see the differences between the two arms. So we will interpret the data when we release it in September.

EU path for MDS? EU is a fragmented market, so we hope to license there.

Expenses are down due to reprioritization. So we are at a new run rate.

SELECT-MDS criteria, powering? CR rate is primary endpoint. Powered to over 90% to show differences between the two arms, which required 190 patients. We have assumed the standard performance for the control arm.

SELECT-MDS-1 result presentation? Will first share topline results. No plan yet for fuller data release. We believe we are making good progress towards enrolling the full 550 patients.

MDS high-risk v. low-risk? That is based on prognosis, based on published standards. Anemia is typically low-risk. High-risk looks more like AML, like bone marrow blasts and higher white blood cell counts. In high-risk the complete response rate is more important, corresponds to overall survival.

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