Analyst Conference Summary

biotechnology

conference date: August 9, 2022 @ 5:30 AM Pacific Time
for quarter ending: June 30, 2022 (second quarter, Q2)

Forward-looking statements

Overview: Continues trials of therapies. Merger with Tyme Technologies and capital raise announced.

Basic data (GAAP):

Revenue was $6.3 million, up sequentially from $5 million, and up from $5.2 million year-earlier. Revenue is from collaborations, not product sales.

Net income was negative $34.5 million, down sequentially from negative $25 million, and down from negative $22.5 million year-earlier.

Earnings per Share (EPS), diluted, were negative $0.54, down sequentially from negative $0.40, and down from negative $0.36 year-earlier.

Guidance:

Believes cash sufficient into Q2 2023. If merger and capital raise are success should have cash to operate into 2025.

Conference Highlights:

Nancy Simonian, M.D., CEO said "We are entering the second half of the year in a position of strength with multiple data readouts expected over the next 18 months and, following the anticipated closing of our previously announced merger with Tyme Technologies and concurrent PIPE financing, we expect to have a robust balance sheet. The gross proceeds of approximately $190 million from these transactions, together with the amendment to our existing loan facility, are expected to extend our cash runway into 2025, at least one year beyond expected pivotal data from our ongoing SELECT-MDS-1 trial."

In July, Syros announced that it plans to raise approximately $190 million through a merger with Tyme Technologies. This follows an oversubscribed private investment in public equity (PIPE) financing of $130 million. The transactions are expected to close concurrently with each other in the second half of 2022, subject to approval by the stockholders of Syros and Tyme and the satisfaction of other customary closing conditions.

All revenue was from the Incyte or the GBT collaborations.

On track to report preliminary SY-5609 Phase 1 data by end of 2022. In Q3 2021 presented encouraging Phase 1 clinical data for SY-5609 at ESMO for a variety of solid cancers. 5609 is an oral CDK7 agent with polr2a as a biomarker. Based on those outcomes, initiated an expansion cohort in pancreatic cancer in Q4 2021 with safety portion data in late 2022. In August 2021 announced an agreement with Roche to explore SY-5609 in combination with atezolizumab (Tecentriq) in Kras mutant second-line colorectal cancer patients. This will be part of the ongoing Phase 1 trying multiple therapy combinations. No rights are being sold, Roche will pay for the study and share the data with Syros. Roche began actively enrolling patients in the Phase 1b colorectal cancer arm in Q2 2022. Use for hematological is deprioritized as of Q2 2022.

On August 8, 2022 reported positive prelimary data for its novel oral form of arsenic trioxide. Based on the pharmacokinetic data available to date, SY-2101 achieved exposures comparable to IV arsenic trioxide and demonstrated high oral bioavailability. In Q3 2021 had initiated SY-2101 for APL in a Phase 2 trial. Has agreed with FDA on endpoints for Phase 3. Based on recent (Q2 2022) feedback received from the EMA, Syros plans to conduct a singular registration trial for SY-2101 that could support approval in both the US and the EU.

In July, 2022, the EMA issued a positive opinion on the application for orphan drug designation for tamibarotene for the treatment of MDS. A Phase 3 trial of tamibarotene (SY-1425) combined with azacitidine in RARA positive high risk MDS continued. Data is expected in late 2023 or early 2024. Potential NDA in 2024. In Q1 2022 received orphan drug designation from the FDA. In 2H 2022 expects to report clinical activity data from safety lead-in portion of ongoing SELECT-AML-1 Phase 2 trial, combined with azacitidien and venetoclax, in newly diagnosed unfit RARA-positive AML patients. In March 2022 agreed with Qiagen for RARA biomarker. Now increased estimate of RARA+ MDS patients to 50%. Believes tamibarotene has the potential to become the standard of care for its patient set.

In July, 2022 the CDK12 inhibitor, SY-12882, advanced to development candidate status. Preclinical data presented at the American Association for Cancer Research (AACR) annual meeting in April 2022 demonstrated that selective CDK12 inhibition resulted in strong anti-tumor activity as a single agent as well as in combination with a DNA damaging agent and in combination with a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor in models of breast, lung, and ovarian cancer.

Cash and equivalents ended the quarter at $86 million, down sequentially from $112 million.

Operating expenses were $40 million, comprised of $33 million for R&D and $7 million for administration. Loss from operations $34 million. Interest expense $1 million. Gain from change in warrant liability was $0.2 million.

Q&A summary:

SYS-2101 consistency across patients, tolerability? We are encouraged by what we are seeing. Believe will have a dose level for the Phase 3 trial. Adverse events minimal. The currently approved drug is IV and weight based. We are looking at the weights of our trial patients.

Select-AML early data? Safety lead in prior to randomized portion of trial. The safety cohort is being tested for activity, CR, CRi, etc.

Partnership discussions? Excited about our gene control discovery engine. Inhibitors of regulatory targets. Looking for partners, in discussions, to provide capital for these early programs.

GBT acquisition by Pfizer? Collaboration is ongoing for sickle cell disease. There is a real interest in sickle cell disease, but no known impact on our collaboration at this time.

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