Analyst Conference Summary

biotechnology

conference date: August 5, 2021 @ 5:30 AM Pacific Time
for quarter ending: June 30, 2021 (second quarter, Q2)

Forward-looking statements

Overview: Continues trials of therapies. Announced agreement with Roche for SY-5609.

Basic data (GAAP):

Revenue was $5 million, flat sequentially from $5 million, and up from $3 million year-earlier.

Net income was negative $22.5 million, down sequentially from negative $14.2 million, and down from negative $17.2 million year-earlier.

Earnings per Share (EPS), diluted, were negative $0.36, down sequentially from negative $0.23, and up from negative $0.38 year-earlier. The share count increased sustantially y/y.

Guidance:

Believes cash sufficient into 2023.

Conference Highlights:

Nancy Simonian, M.D., CEO said "As Syros advances toward becoming a commercial-stage company, we are focused on execution across our growing portfolios in targeted hematology and selective CDK inhibition and made great strides in the second quarter. We continued to progress our targeted hematology portfolio with the ongoing SELECT-MDS-1 Phase 3 trial of tamibarotene in RARA-positive higher-risk MDS patients, as well as the SELECT-AML-1 randomized Phase 2 study of tamibarotene in RARA-positive unfit AML patients and our dose confirmation study of SY-2101 in APL patients, both of which are on track to start in the second half of this year. As we advance these programs through the clinic, we are engaging more deeply with the clinical community to realize the potential of tamibarotene and SY-2101 to address high unmet needs and set new standards of care in these targeted patient populations."

On August 5, 2021 announced an agreement with Roche to explore SY-5609 in combination with atezolizumab (Tecentriq) in 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.

Syros specializes in using small molecules to control gene regulation.

All revenue was from the Incyte or the GBT collaborations.

In February 2021 started a Phase 3 trail of SY-1425 (now tamibarotene) combined with azacitidine in RARA positive high risk MDS. An NDA in MDS could be filed in 2024. 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 presented data for SY-1425 ASH in December 2020 showing a 67% overall response rate and composite CR of 61%. There is still high unmet medical need in AML. SY-1425 is an oral agent. Syros plans, in 2021, to initiate another SY-1425 trial in combination with venetoclax and azacitidine for RARA+ AML patients not suitable for standard chemo. Data is expected in 2022. Potential NDA in 2024.

SY-5609, a oral CDK7 agent, reported Phase 1 safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) data in October 2020. More Phase 1 data to be released in Q3 2021 at ESMO 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. Believes showed proof of mechanism and importance of polr2a biomarker. Expects to start the expansion portion of the Phase 1 trial later in 2021.

In December 2020, Syros acquired from Orsenix all assets related to SY-2101, a novel oral form of ATO (arsenic trioxide, oral). SY-2101 is a targeted clinical-stage drug candidate that has the potential to dramatically reduce the treatment burden of a standard-of-care regimen for newly diagnosed APL or acute promyelocytic leukemia. A dose confirmation study will start later in 2021, and a Phase 3 trial in 2022. An NDA could be filed in 2024.

Expects to move one candidate from preclinical to clinical in 2022. Also working on nucleotide repeat disorders.

Cash and equivalents ended the quarter at $195 million, down sequentially from $222 million.

Operating expenses were $31 million, comprised of $26 million for R&D and $6 million for administration. Loss from operations $26 million. Other expense $1 million. Gain from change in warrant liability ws $5 million.

Q&A summary:

5609 at ESMO, therapeutic window? Look at the totality of the data. We have a broad data set now, compared to the previous data release, which showed some efficacy at tolerable doses. So we hope to see a dose we can take forward, with signs of biological activity. From the outset we have planned for drug combinations with different doses and schedules.

Choice of 5609 cohorts? Believe it can work on difficult to treat cancers. We look at preclinical data, data from dose escalation, and unmet medical need.

PDL1 study? CDK7 inhibition disrupts the cell cycle, inducing replication stress. Inducing immune signaling. That helped a PD1 inhibitor in a mouse model. Colorectal cancer has been shown to have replication distress and immune involvement.

Number of patients in data? Was 17 in August 2020, ESMO will be larger, not releasing specifics yet.

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