Analyst Conference Summary

biotechnology

conference date: November 5, 2020 @ 1:30 PM Pacific Time
for quarter ending: September 30, 2020 (third quarter, Q3)

Forward-looking statements

Overview: Continues to progress pipeline.

Basic data (GAAP):

Revenue was $3.8 million, up sequentially from $3.2 million, and up from $0.6 million year-earlier.

Net income was negative $19.5 million, down sequentially from negative $17.2 million, and nearly flat from negative $19.8 million year-earlier.

Earnings per Share (EPS), diluted, were negative $0.43, down sequentially from negative $0.38, and up from negative $0.47 year-earlier.

Guidance:

Believes cash sufficient into 2022.

Conference Highlights:

Nancy Simonian, M.D., CEO said "We are making great progress on the three pillars underlying our corporate strategy: advancing SY-1425 in RARA-positive patients, building on our leadership in CDK7 inhibition, and continuing to invest in our gene control platform to fuel a robust pipeline in oncology and monogenic diseases. We recently presented initial clinical data for SY-5609, our oral CDK7 inhibitor, demonstrating proof-of-mechanism and supporting our ongoing development strategy. While early, these data reinforce our conviction in CDK7 inhibition as a potentially transformative targeted approach for difficult-to-treat cancers. Looking ahead, we are eager to share new data for SY-1425 at ASH, including clinical data in two AML patient populations, which will guide next steps for the program and mark important progress toward our goal of delivering SY-1425 as a foundational therapy for all RARA-positive patients."

Syros specializes in using small molecules to control gene regulation.

All Q3 revenue were from the Incyte collaboration.

Lab based functions had been suspended due to the pandemic, but were restarted by the end of Q2.

SY-1425 completed enrollment in May 2020 in the ongoing Phase 2 trial cohort evaluating SY-1425 in combination with azacitidine in RARA-positive relapsed or refractory acute myeloid leukemia patients. Also same combination for newly diagnosed AML in patients who are not candidates for chemo. Syros will present new clinical data for SY-1425 at the 62nd American Society of Hematology (ASH) Annual Meeting in December 2020. In separate oral presentations, Syros will present data from the ongoing Phase 2 trial cohort of SY-1425 in combination with azacitidine in RARA-positive relapsed or refractory AML patients plus mature data from the cohort evaluating SY-1425 in combination with azacitidine in newly diagnosed unfit AML patients. There is still high unmet medical need in AML. SY-1425 is an oral agent.

SY-5609, a oral CDK7 agent, reported Phase 1 safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) data in October 2020. More data in mid 2021 from the dose-escalation portion of Phase 1 trial evaluating SY-5609 in patients with breast, colorectal, lung and ovarian cancers, and in patients with solid tumors of any histology that harbor Rb pathway alterations. A second Phase 1 study started in June 2020, in combination with fulvestrant, for HR-positive metastatic breast cancer patients who progressed after CDK4/6 inhibitor treatment. Believes showed proof of mechanism and importance of polr2a biomarker.

Expects to move one candidate from preclinical to clinical in 2021.

Cash and equivalents ended the quarter at $93 million, down sequentially from $109 million.

Operating expenses were $23 million, comprised of $18 million for R&D and $5 million for administration. Loss from operations $19 million. Other expense $0.5 million.

Q&A summary:

Frontline unfit AML, durability needed? We have to look at the total data, not just duration. We see a great opportunity, we will provide context at ASH. We are seeing roughly 10 month duration when combined with azacitidine.

SY-5609 intermittent dosing? These are early data, but exciting. Continuous 3 mg is maximum tolerated daily dose. We are seeing sustained biomarkers and clinical responses at that level. Intermittant dosing at 4mg could also work, we are testing to see what to move forward with. We might be able to get the full activity without continuous dosing.

Vanetaclax refractory patients? Van/Azacitidine has become the standard of care, but about one third of patients never respond and have overall survival of less than 3 months. The phenotype of those resistant tumors are RARA enriched. We want to be able to treat patients upfront with a therapy that produces complete remission.

5609 polr2a biomarker? Guiding to mid next year for more mature dose escalation and activity data. The biomarker is important. It codes for RNA polymerase 2. The marker goes up when CDK7 is inhibited.

Transfusion dependence? AML results in anemia as a side effect. A complete response normalizes your blood count. So it is an objective parameter of clinical benefit.

Cash runway? We will talk more about our go forward plans at ASH.

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