Syros Reports Fourth Quarter and Full Year 2023 Financial Results and Provides a Corporate Update
- Completion of patient enrollment for a crucial Phase 3 trial showcases progress in drug development.
- Anticipation of pivotal data release by the end of 2024 adds to investor confidence.
- Successful equity offering secures financial stability and extends operational runway.
- Management's positive outlook and transformative plans for 2024 indicate strategic growth.
- None.
Insights
The completion of enrollment for the SELECT-MDS-1 Phase 3 trial and the progress of the SELECT-AML-1 Phase 2 trial by Syros Pharmaceuticals are significant milestones that could potentially lead to value inflection points for the company's stock. The $45.0 million equity offering that extends the company's cash runway into the second quarter of 2025 is a strategic financial move, as it provides the necessary capital to support operations and reduces the immediate risk of liquidity issues. Investors should note that while such offerings can dilute existing shares, they are often necessary for biopharmaceutical companies to fund expensive clinical trials.
From a financial perspective, the pivotal CR data expected by mid-4Q 2024 is an event that could significantly influence the company's valuation. Positive results could lead to an increase in the stock price due to heightened investor confidence in the company's pipeline and future revenue potential. Conversely, negative results could have an adverse effect. Investors should monitor these developments closely as they can impact the company's financial health and investment attractiveness.
For stakeholders in the biopharmaceutical sector, the successful completion of patient enrollment for a Phase 3 trial is an indicator of a company's progress toward regulatory approval and market entry. The SELECT-MDS-1 trial's focus on hematologic malignancies, a therapeutic area with significant unmet medical needs, could position Syros Pharmaceuticals to capture market share in a specialized, high-value domain should their treatment prove effective.
It is important to understand that 'pivotal CR data' refers to critical response data that will determine the efficacy of the treatment. The data from this trial will be scrutinized by regulatory bodies like the FDA and positive results could lead to expedited approvals. Long-term, if the treatment is approved, it could improve the standard of care for patients, which in turn can translate into substantial revenues for the company.
The biopharmaceutical industry is highly competitive and the success of clinical trials plays a pivotal role in a company's ability to stay ahead. The anticipation of trial results can create volatility in a company's stock as investors speculate on the outcome. Syros Pharmaceuticals' announcement of expected data in 2024 will likely keep investor attention focused on these dates. It is also noteworthy that extending the cash runway into 2Q 2025 may reassure investors about the company's short-term operational stability, which could be reflected in the stock's performance.
Market analysts typically look at the broader implications of such developments, including potential partnerships, merger and acquisition opportunities and competition from other drugs in the pipeline. Companies that are first to market with a new treatment for a particular condition often gain a competitive edge. However, it is critical to assess the market size and penetration rates, as well as payer reimbursement policies, to fully understand the potential commercial impact of Syros' treatments should they receive approval.
-- Completed Enrollment of 190 Patients for Primary Endpoint Analysis in SELECT-MDS-1 Phase 3 Trial; Pivotal CR Data Expected by Mid-4Q 2024 --
-- Additional Data from SELECT-AML-1 Phase 2 Trial Also Expected in 2024 --
-- Completed a
-- Management to Host Conference Call at 8:30 AM ET Today --
“We are entering 2024 poised for a major transformation,” said Conley Chee, Chief Executive Officer of Syros. “We recently completed enrollment of the 190 patients necessary for our primary endpoint analysis in the SELECT-MDS-1 Phase 3 trial, and we remain on track to report pivotal CR data by the middle of the fourth quarter of this year. We are optimistic about this data, which we believe will further reinforce tamibarotene’s potential as a differentiated, biologically targeted approach for the approximately
Mr. Chee continued, “In addition, we expect to report additional data from SELECT-AML-1 this year. In December, we shared initial results from a prespecified analysis of randomized patients, and we were highly encouraged by the
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 mid-Q4 2024.
- Report additional data from SELECT-AML-1 Phase 2 trial in unfit AML patients with RARA gene overexpression in 2024.
RECENT PIPELINE HIGHLIGHTS
-
On March 25, 2024, Syros announced the completion of enrollment for the 190 patients in the SELECT-MDS-1 Phase 3 clinical trial necessary to support the CR primary endpoint analysis and subsequent NDA filing in
the United States . The trial will continue to enroll up to 550 patients to evaluate overall survival (OS) as a key secondary endpoint. -
In December 2023, Syros announced encouraging initial data from the randomized SELECT-AML-1 Phase 2 clinical trial evaluating tamibarotene in combination with venetoclax and azacitidine. Data demonstrated a
100% CR/CRi (complete response/complete response with incomplete hematologic recovery) rate in response-evaluable patients (nine of nine) treated with the triplet regimen of tamibarotene, venetoclax and azacitidine, as compared to70% among patients (seven of ten) treated with venetoclax and azacitidine alone. The median time to CR/CRi response was rapid; all patients treated with the triplet regimen achieved a CR/CRi by the end of cycle one. Consistent with prior clinical experience, tamibarotene in combination with approved doses of venetoclax and azacitidine was generally well tolerated, and the overall safety profile demonstrated no additive toxicities or new safety signals, and no evidence of increased myelosuppression compared to treatment with the doublet combination of venetoclax and azacitidine. Read more here.
CORPORATE
-
In December 2023, Syros priced an equity offering of 4,939,591 shares of common stock at an offering price of
$4.42 $4.41 9$45.0 million
Fourth Quarter and Full Year 2023 Financial Results
-
Revenues were
$0.4 million $9.9 million $0.8 million $14.9 million -
Research and development expenses were
$21.5 million $108.2 million $27.9 million $111.9 million -
General and administrative (G&A) expenses were
$5.9 million $28.3 million $7.3 million $29.3 million -
For the fourth quarter of 2023, Syros reported a net loss of
$64.4 million $2.18 $4.8 million $0.17 $164.6 million $5.81 $94.7 million $7.49
Cash and Financial Guidance
Cash, cash equivalents and marketable securities as of December 31, 2023, were
Based on its current plans, 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 second 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 fourth quarter and full-year 2023 financial results and provide a corporate update.
To access the live conference call, please dial (888) 259 6580 (domestic) or (416) 764 8624 (international) and refer to conference ID 21905455. 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, 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) |
||||||
|
September 30,
|
|
December 31,
|
|||
Cash, cash equivalents and marketable securities (current and noncurrent) |
|
$ |
139,526 |
|
$ |
202,304 |
Working capital1 |
|
|
108,229 |
|
|
180,614 |
Total assets |
|
|
168,174 |
|
|
244,486 |
Total stockholders’ equity |
|
|
16,662 |
|
|
127,736 |
(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 |
|
|
Years Ended |
|||||||||||
|
|
December 31, |
|
|
December 31, |
|||||||||||
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
||||
Revenue |
|
$ |
387 |
|
|
$ |
(754 |
) |
|
$ |
|
|
|
$ |
14,880 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
21,503 |
|
|
|
27,914 |
|
|
|
108,153 |
|
|
|
111,944 |
|
General and administrative |
|
|
5,893 |
|
|
|
7,329 |
|
|
|
28,282 |
|
|
|
29,299 |
|
Transaction related expenses |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
9,510 |
|
Restructuring cost |
|
|
132 |
|
|
|
— |
|
|
|
2,489 |
|
|
|
— |
|
Total operating expenses |
|
|
27,528 |
|
|
|
35,243 |
|
|
|
138,924 |
|
|
|
150,753 |
|
Loss from operations |
|
|
(27,141 |
) |
|
|
(35,977 |
) |
|
|
(128,288 |
) |
|
|
(135,873 |
) |
Interest income |
|
|
1,283 |
|
|
|
1,594 |
|
|
|
6,816 |
|
|
|
2,132 |
|
Interest expense |
|
|
(1,328 |
) |
|
|
(1,126 |
) |
|
|
(5,127 |
) |
|
|
(4,134 |
) |
Change in fair value of warrant liabilities |
|
|
(37,198 |
) |
|
|
30,756 |
|
|
|
(37,275 |
) |
|
|
43,221 |
|
Net loss applicable to common stockholders |
|
$ |
(64,384 |
) |
|
$ |
(4,773 |
) |
|
$ |
(164,574 |
) |
|
$ |
(94,654 |
) |
Net loss per share applicable to common stockholders - basic and diluted |
|
$ |
(2.18 |
) |
|
$ |
(0.17 |
) |
|
$ |
(5.81 |
) |
|
$ |
(7.49 |
) |
Weighted-average number of common shares used in net loss per share applicable to common stockholders - basic and diluted |
|
|
29,541,899 |
|
|
|
27,753,257 |
|
|
|
28,325,779 |
|
|
|
12,631,968 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20240327550024/en/
Syros Contact
Karen Hunady
Director of Corporate Communications & Investor Relations
1-857-327-7321
khunady@syros.com
Investor Relations
Hannah Deresiewicz
Stern Investor Relations, Inc.
212-362-1200
hannah.deresiewicz@sternir.com
Source: Syros Pharmaceuticals
FAQ
When is the pivotal CR data expected for the SELECT-MDS-1 Phase 3 Trial?
How many patients were enrolled for the primary endpoint analysis in the SELECT-MDS-1 Phase 3 Trial?
What is the purpose of the $45.0 million equity offering completed by Syros Pharmaceuticals?
When is the management conference call scheduled for Syros Pharmaceuticals?
