Analyst Conference Summary

biotechnology

conference date: March 4, 2021 @ 5:30 AM Pacific Time
for quarter ending: March 31, 2021 (first quarter, Q1)

Forward-looking statements

Overview: Continues trials of therapies.

Basic data (GAAP):

Revenue was $4.8 million, down sequentially from $5.7 million, and up from $2.4 million year-earlier.

Net income was negative $14.2 million, up sequentially from negative $30.1 million, and up from negative $17.2 million year-earlier.

Earnings per Share (EPS), diluted, were negative $0.23, up sequentially from negative $0.62, and up from negative $0.39 year-earlier.

Guidance:

Believes cash sufficient into 2023.

Conference Highlights:

Nancy Simonian, M.D., CEO said "We began enrolling patients in our Phase 3 clinical trial of SY-1425 in RARA-positive higher-risk MDS, marking the start of our first registration-enabling trial and an important step toward our goal of setting new standards of care in the treatment of hematologic malignancies. Looking ahead, we are poised to continue building on this momentum. We look forward to initiating additional clinical trials with SY-1425 and SY-2101 in the second half of the year and reporting new dose-escalation data, including clinical activity, from our Phase 1 trial of SY-5609 in the third quarter, while continuing to invest in our earlier-stage programs in cancer and monogenic diseases."

Syros specializes in using small molecules to control gene regulation.

All revenue was from the Incyte or the GBT collaborations.

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.

In February 2021 started a Phase 3 trail of SY-1425 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.

SY-5609, a oral CDK7 agent, reported Phase 1 safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) data in October 2020. More data in Q3 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 2022. Also working on nucleotide repeat disorders.

Cash and equivalents ended the quarter at $222 million, up sequentially from $174 million. In January 2021 rasied $76 million in a public share offering.

Operating expenses were $25.8 million, comprised of $20.0 million for R&D and $5.7 million for administration. Loss from operations $20.9 million. Other expense $1 million. Gain from change in warrant liability ws $7.7 million.

Q&A summary:

Phase 3 HR MDS sites? We are actively dosing patients. No guidance on sites and patients. Managing through Covid.

5609 updated data? Q3 2021 data will include safety, tolerability, PK, PD, clinical activity. No specific number of patients. We generally report at medical meetings.

2101 discussions with regulators? We have had discussions with KOLs, showing interest and enthusiasm for an oral therapy. One will speak at our July event. Orsenix had had discussions with the FDA, we are following their plan.

1425 triple combo patient types? Focus is on rara positive newly diagnosed unfit AML. We are not looking for monocytic type, though there is a known correspondence, with most in the group being monocytic.

Oral, targetted SY-1425 is attracting patients and investigators.

Platform value? We have gained tremendous insight. CDK12 is looking like a really interesting target, especially given the potential to combine with PARP inhibitors. Turning genes up or down with small molecules. We are thinking about brand new programs in the gene control space.

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