Analyst Conference Summary

biotechnology

conference date: November 14, 2022 @ 5:30 AM Pacific Time
for quarter ending: September 30, 2022 (third quarter, Q3)

Forward-looking statements

Overview: Continues trials of therapies, increased cash to $245 million.

Basic data (GAAP):

Revenue was $3.9 million, down sequentially from $6.3 million, and down from $5.7 million year-earlier. Revenue is from collaborations with GBT and Incyte, not product sales.

Net income was negative $30.3 million, up sequentially from negative $34.5 million, and down from negative $26.0 million year-earlier.

Earnings per Share (EPS), diluted, were negative $3.21, down sequentially from negative $0.54, and up from negative $4.14 year-earlier.

Guidance:

Now has a cash runway into 2025.

Conference Highlights:

Nancy Simonian, M.D., CEO said "In September, we announced the closing of our merger with TYME Technologies and concurrent oversubscribed PIPE, with combined gross proceeds of approximately $190 million. With this additional capital, we believe we are well-positioned to build Syros into a commercial-stage company. We are now focused on advancing our late-stage hematology programs toward important clinical milestones, beginning with the presentation of initial results, including clinical activity, from the safety lead-in portion of the SELECT-AML-1 Phase 2 trial at the ASH Annual Meeting in December. In addition, we remain on track to report data from the pivotal SELECT-MDS-1 trial in late 2023 or early 2024 and, based on the preliminary data from our dose confirmation study of SY-2101 that we announced in August, expect to initiate a Phase 3 trial in patients with APL in the second half of next year. Today, we are excited to announce initial data from the safety lead-in portion of our Phase 1 trial evaluating SY-5609 in combination with chemotherapy in patients with relapsed/refractory metastatic pancreatic cancer as well as an update from the single agent portion in advanced solid tumor patients. Importantly, the data reinforce our belief in the promise of selective CDK7 inhibition to benefit many difficult to treat cancers. To maximize the potential of SY-5609, we made the strategic decision to seek partnership opportunities for this program while we continue dose escalation in the ongoing trial, and to focus our internal resources on advancing our late-stage hematology portfolio for the frontline treatment of MDS, AML and APL."

In September 2022 closed the merger with Tyme Technologies. In July, Syros had 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. This gave the company $244 million in cash at the end of Q3 2022.

The share count ended Q3 at 9,417,069, up 50% from 6,292,830 year-earlier. That results from, following the September 10 to 1 reverse stock split and the transactions, having 28 million shares of common stock and pre-funded warrants to purchase common stock.

All revenue was from the Incyte or the GBT collaborations.

Initial data from the safety portion of the Phase 2 trial of tamibarotene for AML will be reported at ASH 2022 in December. In July, 2022, the EMA issued a positive opinion on the application for orphan drug designation for tamibarotene (was SY-1425) for the treatment of MDS. A Phase 3 trial of tamibarotene 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 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.

Syros reported preliminary encouraging SY-5609 data from the safety lead-in portion of the Phase 1 trial in pancreatic cancer patients in Q3 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. The FDA granted SY-5609 orphan drug designation in September 2022. But as of November 2022 is exploring partnerships for further developoment.

Based on preliminary data from the dose confirmation study of SY-2101 announced in August, expects to initiate a SY-2101 Phase 3 trial in patients with APL in the second half of next year. On August 8, 2022 reported positive prelimary data for its novel oral form of arsenic trioxide. Based on the pharmacokinetic data available to date, achieved exposures comparable to IV arsenic trioxide and demonstrated high oral bioavailability. 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 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 $244 million, up sequentially from $86 million.

Operating expenses were $43 million, comprised of $26 million for R&D, $8 million for administration, and $10 million transaction-related. Loss from operations $39 million. Interest expense $1 million. Gain from change in warrant liability was $9 million.

Q&A summary:

More on ASH presentation? Updated data, will take questions at the meeting.

Phase 2 randomized portion timeline? Will also update that at ASH.

5609 goals at maximum tolerated dose? Combined with gemcitabine, with relatively low doses of 5609, we have generated exciting efficacy in the pancreatic cancer type. There is an emerging exposure-response relationship. So we hope a higher dose will be more effective, including in combinations. Saw greatly lowered tumor market in one patient, still below maximum dose.

Partners potential? We are looking at a variety of strategic opportunities. Believe CDK7 inhibition could be effective in a broad variety of tumors. Currently we have no plan to move beyond the safety lead in portion of the trial without a partner.

5609 triplet, why did you stop that? We were excited with the data across all arms, including 4 triplet arms. The single-agent arm defines the MTD. Then you can undestand the contribution to the doublet. The doublet enables the triplet to move forward. We may resume the triplet program in the future.

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