Syros Reports Second Quarter 2024 Financial Results and Provides a Business Update

Rhea-AI Summary

Syros Pharmaceuticals (NASDAQ: SYRS) reported Q2 2024 financial results and provided a business update. Key highlights include:

1. Pivotal Complete Response (CR) data from SELECT-MDS-1 Phase 3 trial expected by mid-Q4 2024.

2. Additional data from SELECT-AML-1 Phase 2 trial expected in September 2024.

3. Q2 2024 net loss of $23.3 million, or $0.59 per share, compared to $36.3 million, or $1.30 per share, in Q2 2023.

4. Cash, cash equivalents, and marketable securities of $79.0 million as of June 30, 2024.

5. Current funds expected to support operations into Q3 2025, beyond pivotal Phase 3 data readouts.

Positive

• Pivotal Complete Response data from SELECT-MDS-1 Phase 3 trial expected by mid-Q4 2024
• Additional data from SELECT-AML-1 Phase 2 trial to be presented in September 2024
• Net loss decreased from $36.3 million in Q2 2023 to $23.3 million in Q2 2024
• R&D expenses reduced from $29.6 million in Q2 2023 to $22.0 million in Q2 2024
• G&A expenses decreased from $7.2 million in Q2 2023 to $5.5 million in Q2 2024
• Cash runway extended into Q3 2025, beyond key clinical data readouts

Negative

• No revenue recognized in Q2 2024 compared to $2.8 million in Q2 2023
• Cash position decreased from $108.3 million in Q1 2024 to $79.0 million in Q2 2024

Financial Analyst

Syros Pharmaceuticals' Q2 2024 financial results reveal a company in transition, focusing on late-stage clinical development while managing its cash runway. The absence of revenue this quarter, compared to $2.8 million in Q2 2023, reflects the termination of their Pfizer collaboration. This shift emphasizes Syros' pivot towards becoming a fully independent, product-focused company.

R&D expenses decreased from $29.6 million to $22.0 million year-over-year, primarily due to reductions in external consulting and contract manufacturing. This 25.7% decrease suggests a more focused approach to development, likely concentrating resources on their lead candidate, tamibarotene. Similarly, G&A expenses dropped from $7.2 million to $5.5 million, indicating ongoing efforts to streamline operations.

The net loss for Q2 2024 was $23.3 million, or $0.59 per share, an improvement from the $36.3 million loss ($1.30 per share) in Q2 2023. This 35.8% reduction in net loss, despite the absence of collaboration revenue, underscores the effectiveness of Syros' cost-cutting measures.

With $79.0 million in cash and equivalents as of June 30, 2024, Syros projects runway into Q3 2025. This timeline strategically aligns with anticipated clinical milestones, including pivotal Phase 3 data from the SELECT-MDS-1 trial. However, investors should note the 27.1% decrease in cash position from $108.3 million at the end of Q1 2024, which may raise questions about future financing needs, especially if commercialization efforts ramp up.

Oncology Researcher

Syros' focus on RARA overexpression in higher-risk MDS and AML represents a targeted approach in hematologic malignancies. The company's lead candidate, tamibarotene, is positioned to potentially address an unmet need in approximately 50% of higher-risk MDS and 30% of AML patients exhibiting this genetic profile.

The upcoming pivotal complete response (CR) data from the SELECT-MDS-1 Phase 3 trial, expected by mid-Q4 2024, is a critical milestone. CR rates are a key efficacy measure in MDS and AML trials, directly correlating with improved survival outcomes. A strong CR rate could position tamibarotene as a compelling frontline treatment option.

Additionally, the SELECT-AML-1 Phase 2 trial data, expected in September 2024, will provide insights into tamibarotene's efficacy in unfit AML patients. This population often has treatment options due to the intensity of standard chemotherapy regimens. If tamibarotene demonstrates good tolerability and efficacy in this group, it could fill a significant therapeutic gap.

The emphasis on convenience and quality of life in Syros' approach aligns with current trends in oncology care, where oral therapies that maintain efficacy while reducing hospital visits are increasingly valued. However, it's important to see how the complete data set balances efficacy, safety and quality of life measures to fully assess tamibarotene's potential impact on the treatment landscape.

Market Research Analyst

Syros Pharmaceuticals is positioning itself in a niche but potentially lucrative market within hematologic malignancies. The focus on RARA overexpression in higher-risk MDS and AML represents a targeted approach that could differentiate Syros in a competitive landscape.

The addressable market is significant, with the company estimating that 50% of higher-risk MDS and 30% of AML patients exhibit RARA overexpression. Given the high unmet need in these indications, a successful therapy could capture substantial market share. However, the actual market penetration will depend on the strength of the upcoming clinical data and the ability to effectively commercialize the product.

Syros' preparation for a potential New Drug Application (NDA) filing and launch indicates confidence in their clinical program. This proactive approach could accelerate time-to-market if the data is positive, potentially giving Syros a first-mover advantage in this specific patient population.

The company's focus on convenience and quality of life aligns with broader trends in oncology care, where oral therapies are increasingly preferred. This could be a key differentiator in the market, especially if efficacy is comparable to or better than existing treatments.

However, investors should be aware of potential challenges. The transition from a collaboration-based model to an independent, product-focused company carries execution risks. Additionally, the competitive landscape in hematologic malignancies is intense, with several large pharmaceutical companies and biotechs vying for market share. Syros will need to demonstrate clear clinical and commercial advantages to successfully compete in this space.

-- Pivotal Complete Response (CR) Data from SELECT-MDS-1 Phase 3 Trial Expected by Mid-4Q24 --

-- Additional Data from SELECT-AML-1 Phase 2 Trial Expected in September 2024--

-- Management to Host Conference Call at 8:30 AM ET Today --

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company committed to advancing new standards of care for the frontline treatment of hematologic malignancies, today reported financial results for the quarter ended June 30, 2024 and provided a corporate update.

“Syros is well-positioned heading into key clinical data readouts expected in the second half of 2024, including pivotal complete response (CR) data from the Phase 3 SELECT-MDS-1 trial by mid-fourth quarter. In addition, we will present clinical activity and tolerability data from over 40 patients from the SELECT-AML-1 Phase 2 trial at the SOHO 2024 annual meeting in September,” said Conley Chee, Chief Executive Officer of Syros. “We are keenly focused on execution across our late-stage clinical development programs and pre-commercial activities in support of our mission to provide tamibarotene as a new frontline standard-of-care for patients with RARA overexpression.

“Supported by compelling, consistent clinical data generated to-date across multiple trials, we believe our differentiated and biologically-targeted approach with tamibarotene provides a meaningful opportunity to address the approximately 50% of higher-risk MDS and 30% of AML patients with RARA overexpression. There is a significant unmet need in these two closely related diseases, with patients and physicians looking for new, convenient, and well-tolerated options that enhance clinical outcomes while maintaining quality of life. As we approach two critical data readouts, we are working diligently to prepare for our first New Drug Application (NDA) filing and launch, so that we can effectively deliver tamibarotene to the thousands of HR-MDS patients in need of new treatment options. We look forward to an exciting second half of the year and remain committed in our pursuit to provide profound benefit to patients in need,” Mr. Chee continued.

UPCOMING MILESTONES

• Report pivotal 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 more than 40 patients from the SELECT-AML-1 Phase 2 trial in unfit AML patients with RARA overexpression at the 12^th Annual Meeting of the Society of Hematologic Oncology (SOHO) meeting in September 2024.

RECENT HIGHLIGHTS

• In June, Syros hosted a webinar event to discuss disease biology and the current treatment landscape in HR-MDS, as well as to highlight the design of the ongoing pivotal Phase 3 SELECT-MDS-1 trial and the opportunity for tamibarotene. In addition to Syros management, the event featured presentations from medical experts in MDS. An archived replay of the event is available on the Investors & Media section of Syros’ website, www.syros.com.

Second Quarter 2024 Financial Results

• Syros did not recognize revenue in the second quarter of 2024, as compared to $2.8 million for the second quarter of 2023. The decrease reflects last year’s termination of Syros’ collaboration agreement with Pfizer.
• Research and development (R&D) expenses were $22.0 million for the second quarter of 2024, as compared to $29.6 million for the second 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 $5.5 million for the second quarter of 2024, as compared to $7.2 million for the second quarter of 2023. The decrease was primarily due to a reduction of headcount and related expenses, consulting fees, and facilities expenses.
• For the second quarter of 2024, Syros reported a net loss of $23.3 million, or $0.59 per share, compared to a net loss of $36.3 million, or $1.30 per share, for the same period in 2023.

Cash and Financial Guidance

Cash, cash equivalents and marketable securities as of June 30, 2024, were $79.0 million, as compared with $108.3 million as of March 31, 2024.

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 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 second 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 64947. 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 X (@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 third 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 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 June 30, 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)
		June 30, 2024			December 31, 2023
Cash, cash equivalents and marketable securities (current and noncurrent)		$	78,964		$	139,526
Working capital1			60,400			108,299
Total assets			106,722			168,174
Total stockholders’ (deficit) equity			(6,352)			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								Six Months Ended
	June 30,								June 30,
	2024				2023				2024				2023
Revenue	$	—			$	2,833			$	—			$	5,787
Operating expenses:
Research and development		21,953				29,608				46,608				58,369
General and administrative		5,463				7,225				11,729				14,630
Total operating expenses		27,416				36,833				58,337				72,999
Loss from operations		(27,416	)			(34,000	)			(58,337	)			(67,212	)
Interest income		1,085				2,125				2,631				3,900
Interest expense		(1,382	)			(1,278	)			(2,689	)			(2,495	)
Change in fair value of warrant liabilities		4,386				(3,105	)			31,360				5,760
Net loss applicable to common stockholders	$	(23,327	)		$	(36,258	)		$	(27,035	)		$	(60,047	)
Net loss per share applicable to common stockholders - basic and diluted	$	(0.59	)		$	(1.30	)		$	(0.69	)		$	(2.15	)
Weighted-average number of common shares used in net loss per share applicable to common stockholders - basic and diluted		39,269,434				27,913,448				39,123,740				27,878,030

 

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Syros Contact

Karen Hunady

Director of Corporate Communications & Investor Relations

1-857-327-7321

khunady@syros.com

Investor Relations

Amanda Isacoff

Precision AQ

1-212-362-1200

amanda.isacoff@precisionaq.com

Source: Syros Pharmaceuticals

FAQ

When will Syros Pharmaceuticals (SYRS) report pivotal data from the SELECT-MDS-1 Phase 3 trial?

Syros Pharmaceuticals expects to 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.

What was Syros Pharmaceuticals' (SYRS) net loss per share in Q2 2024?

Syros Pharmaceuticals reported a net loss of $0.59 per share for the second quarter of 2024.

How much cash does Syros Pharmaceuticals (SYRS) have as of June 30, 2024?

Syros Pharmaceuticals reported cash, cash equivalents, and marketable securities of $79.0 million as of June 30, 2024.

When does Syros Pharmaceuticals (SYRS) expect to present data from the SELECT-AML-1 Phase 2 trial?

Syros Pharmaceuticals plans to report clinical activity and tolerability data from over 40 patients in the SELECT-AML-1 Phase 2 trial at the SOHO 2024 annual meeting in September 2024.

How long does Syros Pharmaceuticals (SYRS) expect its current cash to fund operations?

Syros Pharmaceuticals believes its existing cash, cash equivalents, and marketable securities will fund operations into the third quarter of 2025, beyond pivotal Phase 3 data readouts.