Syros Reports First Quarter 2024 Financial Results and Provides a Corporate Update
– Passed Interim Futility Analysis of the Primary Endpoint in Phase 3 SELECT-MDS-1 Trial of Tamibarotene; Pivotal CR Data Expected by Mid-4Q 2024; Company to Host HR-MDS-focused Webcast Event with Medical Experts on
– Received FDA Fast Track Designation for Tamibarotene for the Treatment of Unfit AML; Additional Data from SELECT-AML-1 Phase 2 Trial Expected in 3Q24 –
-- Management to Host Conference Call at
“In 2024, we are acutely focused on execution across clinical and pre-commercial activities as we advance tamibarotene toward critical milestones, including additional data from the Phase 2 SELECT-AML-1 trial in the third quarter and pivotal CR data from the Phase 3 SELECT-MDS-1 trial in the fourth quarter,” said
Syros today announced plans to host a webcast event on
UPCOMING MILESTONES
- Report pivotal complete response (CR) data from the SELECT-MDS-1 Phase 3 trial in newly diagnosed HR-MDS patients with RARA gene overexpression by the middle of the fourth quarter of 2024.
- Report clinical activity and tolerability data from a prespecified analysis of over 40 patients from the SELECT-AML-1 Phase 2 trial in unfit AML patients with RARA overexpression in the third quarter of 2024.
RECENT PIPELINE HIGHLIGHTS
- In March, the Phase 3 SELECT-MDS-1 clinical trial of tamibarotene passed a pre-specified interim futility analysis based on the CR rate, which was conducted by an Independent Data Monitoring Committee (IDMC). There were no concerning safety signals noted in the analysis and the IDMC recommended SELECT-MDS-1 continue without modification. Syros remains blinded to the data.
-
In April, the
U.S. Food and Drug Administration (FDA) granted Fast Track Designation to tamibarotene in combination with venetoclax and azacitidine for the treatment of newly diagnosed AML with RARA overexpression, as detected by an FDA approved test in adults who are over age 75 and who have comorbidities that preclude the use of intensive induction chemotherapy. The FDA previously granted this designation to tamibarotene in combination with azacitidine for the treatment of adults with HR-MDS and RARA overexpression inJanuary 2023 .
First Quarter 2024 Financial Results
-
The Company did not recognize any revenue in the first quarter of 2024, as compared to
$3.0 million for the first quarter of 2023. The decrease reflects the termination of Syros’ collaboration agreement with Pfizer. -
Research and development (R&D) expenses were
$24.7 million for the first quarter of 2024, as compared to$28.8 million for the first quarter of 2023. The decrease was primarily due to the reduction in external R&D consulting, contract manufacturing, and a reduction in headcount and related expenses. -
General and administrative (G&A) expenses were
$6.3 million for the first quarter of 2024, as compared to$7.4 million for the first quarter of 2023. The decrease was primarily due to a reduction of headcount and related expenses, consulting fees, and facilities expenses. -
For the first quarter of 2024, Syros reported a net loss of
$3.7 million , or$0.10 per share, compared to a net loss of$23.8 million , or$0.85 per share, for the same period in 2023.
Cash and Financial Guidance
On
Cash, cash equivalents and marketable securities as of
Based on its current plans and the recently executed amendment with Oxford, Syros believes that its existing cash, cash equivalents and marketable securities will be sufficient to fund its anticipated operating expenses and capital expenditure requirements into the third quarter of 2025, beyond pivotal Phase 3 data from the SELECT-MDS-1 trial and additional data from the randomized portion of the SELECT-AML-1 trial.
Conference Call and Webcast
Syros will host a conference call today at
To access the live conference call, please dial (800) 549-8228 (domestic) or (289) 819-1520 (international) and refer to conference ID 16518. A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.
About
Syros is committed to developing new standards of care for the frontline treatment of patients with hematologic malignancies. Driven by the motivation to help patients with blood disorders that have largely eluded other targeted approaches, Syros is developing tamibarotene, an oral selective RARα agonist in frontline patients with higher-risk myelodysplastic syndrome and acute myeloid leukemia with RARA gene overexpression. For more information, visit www.syros.com and follow us on Twitter (@SyrosPharma) and LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including without limitation statements regarding Syros’ clinical development plans, the progression of its clinical trials, the timing to report clinical data, the ability to commercialize tamibarotene and deliver benefit to patients, and the sufficiency of Syros’ capital resources to fund its operating expenses and capital expenditure requirements into the second quarter of 2025. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hope,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “target,” “should,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including Syros’ ability to: advance the development of its programs under the timelines it projects in current and future clinical trials; demonstrate in any current and future clinical trials the requisite safety, efficacy and combinability of its drug candidates; sustain the response rates and durability of response seen to date with its drug candidates; successfully develop a companion diagnostic test to identify patients with the RARA biomarker; obtain and maintain patent protection for its drug candidates and the freedom to operate under third party intellectual property; obtain and maintain necessary regulatory approvals; identify, enter into and maintain collaboration agreements with third parties; manage competition; manage expenses; raise the substantial additional capital needed to achieve its business objectives; attract and retain qualified personnel; and successfully execute on its business strategies; risks described under the caption “Risk Factors” in Syros’ Annual Report on Form 10-K for the year ended
Financial Tables
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Selected Condensed Consolidated Balance Sheet Data |
||||||
(in thousands) |
||||||
(unaudited) |
||||||
|
|
|
||||
Cash, cash equivalents and marketable securities (current and noncurrent) |
$ |
108,304 |
$ |
139,526 |
||
Working capital1 |
|
74,899 |
|
108,299 |
||
Total assets |
|
134,728 |
|
168,174 |
||
Total stockholders’ equity |
|
15,057 |
|
16,662 |
||
(1) The Company defines working capital as current assets less current liabilities. See the Company’s condensed consolidated financial statements for further details regarding its current assets and current liabilities. |
|
||||||
Condensed Consolidated Statement of Operations |
||||||
(in thousands, except share and per share data) |
||||||
(unaudited) |
||||||
|
Three Months Ended |
|
||||
|
|
|
||||
|
2024 |
|
2023 |
|
||
Revenue |
$ |
— |
|
$ |
2,954 |
|
Operating expenses: |
|
|
|
|
||
Research and development |
|
24,655 |
|
|
28,761 |
|
General and administrative |
|
6,266 |
|
|
7,405 |
|
Total operating expenses |
|
30,921 |
|
|
36,166 |
|
Loss from operations |
|
(30,921 |
) |
|
(33,212 |
) |
Interest income |
|
1,546 |
|
|
1,775 |
|
Interest expense |
|
(1,307 |
) |
|
(1,217 |
) |
Change in fair value of warrant liabilities |
|
26,974 |
|
|
8,865 |
|
Net loss applicable to common stockholders |
$ |
(3,708 |
) |
$ |
(23,789 |
) |
Net loss per share applicable to common stockholders - basic and diluted |
$ |
(0.10 |
) |
$ |
(0.85 |
) |
Weighted-average number of common shares used in net loss per share
|
38,978,046 |
|
27,842,218 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20240514351941/en/
Syros Contact
Director of
1-857-327-7321
khunady@syros.com
Investor Contact
Stern Investor Relations, Inc.
212-362-1200
amanda.isacoff@sternir.com
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