Syros Reports First Quarter 2024 Financial Results and Provides a Corporate Update
Syros Pharmaceuticals (SYRS) reported its first-quarter 2024 financial results and provided a corporate update. The company highlighted passing an interim futility analysis in the Phase 3 SELECT-MDS-1 trial, with pivotal CR data expected by mid-Q4 2024. Additionally, the FDA granted Fast Track designation for Tamibarotene in unfit AML. Financially, Syros recorded no revenue compared to $3 million in Q1 2023, and a net loss of $3.7 million, significantly reduced from $23.8 million the previous year. R&D expenses were $24.7 million, down from $28.8 million, while G&A expenses also decreased from $7.4 million to $6.3 million. The company’s cash position was $108.3 million as of March 31, 2024, sufficient to fund operations into Q3 2025.
- Passed interim futility analysis in Phase 3 SELECT-MDS-1 trial.
- FDA granted Fast Track designation for Tamibarotene in unfit AML.
- Net loss reduced to $3.7 million from $23.8 million.
- R&D expenses decreased from $28.8 million to $24.7 million.
- G&A expenses decreased from $7.4 million to $6.3 million.
- Company has $108.3 million in cash, sufficient to fund operations into Q3 2025.
- No revenue recognized in Q1 2024, down from $3 million in Q1 2023.
- Termination of collaboration agreement with Pfizer.
- Cash and equivalents decreased from $139.5 million to $108.3 million.
Insights
Syros' financial results for Q1 2024 present a mixed picture for investors. Revenue for the quarter was zero, down from
Notably, this reduction in costs has significantly decreased the net loss for Q1 2024 to
Additionally, the amendment to the loan agreement with Oxford Finance LLC offers the company increased access to capital, raising the available term loans from
Overall, while the lack of revenue is a concern, the company's reduced expenses and improved liquidity position via the Oxford loan amendment are positive steps. Investors should monitor the upcoming clinical trial data and FDA milestones, which could significantly impact the company's future financial health.
The passing of the interim futility analysis in the Phase 3 SELECT-MDS-1 trial is a promising development for Syros. A futility analysis assesses whether a clinical trial is unlikely to achieve its primary endpoint, guiding whether to continue, modify, or stop the study based on early data. The Independent Data Monitoring Committee's recommendation to continue the trial without any modifications indicates that tamibarotene has shown enough potential efficacy and safety signals in treating HR-MDS to justify further study.
Additionally, the granting of Fast Track Designation by the FDA for tamibarotene in treating unfit AML patients is a significant regulatory advance. Fast Track is a process designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need. This designation often leads to more frequent interactions with the FDA and can ultimately result in faster drug approval timelines, important for a biopharmaceutical company aiming to bring new therapies to market swiftly.
These clinical and regulatory milestones suggest that tamibarotene has a viable path forward, particularly in areas with high unmet medical needs like HR-MDS and AML. Investors should closely watch the upcoming data releases, as positive results could significantly enhance the drug's market potential and Syros' valuation.
From a market perspective, Syros' advances with tamibarotene could position the company strongly within the hematologic malignancies sector. The ongoing Phase 3 SELECT-MDS-1 trial and the Phase 2 SELECT-AML-1 trial target high-risk myelodysplastic syndrome (HR-MDS) and acute myeloid leukemia (AML), respectively. These are areas with limited effective treatments and substantial unmet medical needs. Successful trials and regulatory approvals could allow Syros to capture a significant share of these markets.
Syros' strategic focus on companion diagnostics for identifying RARA gene overexpression also sets it apart. Personalized medicine, where treatments are tailored based on individual genetic markers, is a growing trend in oncology. By developing a diagnostic tool alongside tamibarotene, Syros aims to better identify patients who would benefit most from the treatment, potentially improving clinical outcomes and market adoption.
However, investors should be cautious about the competitive landscape. Established players and other emerging therapies will vie for market share in HR-MDS and AML. The results from the upcoming clinical trials and the ability to effectively market the companion diagnostic will be key determinants of Syros' success in this space.
– 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 June 25, 2024 –
– 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 8:30 AM ET Today –
“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 Conley Chee, Chief Executive Officer of Syros. “We are particularly pleased to share today that an independent data monitoring committee recently completed a pre-specified interim futility analysis on
Mr. Chee continued, “In addition, following the completion of enrollment in the first quarter of 2024 of the 190 patients necessary for our primary endpoint analysis in the Phase 3 SELECT-MDS-1 trial, we have begun preparing for our first New Drug Application filing and subsequent launch in
Syros today announced plans to host a webcast event on June 25, 2024 to discuss disease biology and the current treatment landscape in HR-MDS, as well as the design of the ongoing pivotal Phase 3 SELECT-MDS-1 trial and opportunity for tamibarotene. The event will feature presentations from medical experts, in addition to Syros management. The event will be webcast live on the Investors & Media section of Syros’ website, www.syros.com. More details for the event are forthcoming.
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 in January 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 -
Research and development (R&D) expenses were
$24.7 million $28.8 million -
General and administrative (G&A) expenses were
$6.3 million $7.4 million -
For the first quarter of 2024, Syros reported a net loss of
$3.7 million $0.10 $23.8 million $0.85
Cash and Financial Guidance
On May 9, 2024, the Company agreed to amend its Loan Agreement with Oxford Finance LLC. The amendment will increase the amount of term loans available to Syros from
Cash, cash equivalents and marketable securities as of March 31, 2024, were
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 8:30 a.m. ET to discuss the first quarter 2024 financial results and provide a corporate update.
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 Pharmaceuticals
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 December 31, 2023 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, each of which is on file with the Securities and Exchange Commission; and risks described in other filings that Syros makes with the Securities and Exchange Commission in the future.
Financial Tables
Syros Pharmaceuticals, Inc. |
||||||
Selected Condensed Consolidated Balance Sheet Data |
||||||
(in thousands) |
||||||
(unaudited) |
||||||
|
March 31,
|
December 31,
|
||||
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. |
||||||
Syros Pharmaceuticals, Inc. |
||||||
Condensed Consolidated Statement of Operations |
||||||
(in thousands, except share and per share data) |
||||||
(unaudited) |
||||||
|
Three Months Ended |
|
||||
|
March 31, |
|
||||
|
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
Karen Hunady
Director of Corporate Communications & Investor Relations
1-857-327-7321
khunady@syros.com
Investor Contact
Amanda Isacoff
Stern Investor Relations, Inc.
212-362-1200
amanda.isacoff@sternir.com
Source: Syros Pharmaceuticals
FAQ
What were Syros Pharmaceuticals' (SYRS) financial results for Q1 2024?
What is the status of Syros' SELECT-MDS-1 trial?
What is Tamibarotene's FDA status?
What is Syros' cash position as of March 31, 2024?
What upcoming milestones has Syros Pharmaceuticals announced?
