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Subject: EARNINGS

Syros Reports Second Quarter 2022 Financial Results and Provides a Corporate Update


Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, today reported financial results for the quarter ended June 30, 2022 and provided a corporate update.

"We are entering the second half of the year in a position of strength with multiple data readouts expected over the next 18 months and, following the anticipated closing of our previously announced merger with TYME Technologies and concurrent PIPE financing, we expect to have a robust balance sheet," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "The gross proceeds of approximately $190 million from these transactions, together with the amendment to our existing loan facility, are expected to extend our cash runway into 2025, at least one year beyond expected pivotal data from our ongoing SELECT-MDS-1 trial."

Dr. Simonian continued, "Today, we reported promising preliminary data from our ongoing dose confirmation trial of SY-2101, our novel oral form of arsenic trioxide. Based on the pharmacokinetic data available to date, SY-2101 achieved exposures comparable to IV arsenic trioxide and demonstrated high oral bioavailability. The totality of data with our oral arsenic trioxide continues to support a favorable safety and tolerability profile, giving us further confidence that SY-2101 has the potential to replace the standard-of-care for acute promyelocytic leukemia patients. Based on recent feedback received from the EMA, Syros plans to conduct a singular registration trial for SY-2101 that could support approval in both the United States and the European Union."

UPCOMING MILESTONES

Tamibarotene: Oral RAR? agonist

Higher-Risk Myelodysplastic Syndrome (HR-MDS)

Acute Myelodysplastic Syndrome (AML)

SY-2101: Oral arsenic trioxide (ATO)

SY-5609: Oral selective CDK7 inhibitor

RECENT PIPELINE HIGHLIGHTS

CORPORATE

Second Quarter 2022 Financial Results

Cash and Financial Guidance

Cash, cash equivalents and marketable securities as of June 30, 2022 were $86.3 million, as compared with $143.4 million on December 31, 2021. Based on Syros's current operating plan and without giving effect to the merger with TYME, the PIPE financing and the loan amendment with Oxford, the completion of which cannot be assured, Syros anticipates that its cash, cash equivalents and marketable securities of $86.3 million as of June 30, 2022 will allow it to meet its liquidity requirements into the second quarter of 2023.

If Syros completes the merger with TYME and the PIPE financing and gives effect to certain provisions of the loan amendment with Oxford related to such closings (which is expected to occur in the second half of 2022), Syros anticipates having approximately $240 million in cash and other capital resources (after transaction expenses), which it believes will be sufficient to fund its planned operating expenses and capital expenditure requirements into 2025.

Conference Call and Webcast

Syros will host a conference call today at 8:30 a.m. ET to discuss these second quarter 2022 financial results and provide a corporate update.

To access the live conference call, please dial (833) 636-1323 (domestic) or (412) 902-4279 (international) and refer to the "Syros Pharmaceuticals Conference Call." 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 redefining the power of small molecules to control the expression of genes. Based on its unique ability to elucidate regulatory regions of the genome, Syros aims to develop medicines that provide a profound benefit for patients with diseases that have eluded other genomics-based approaches. Syros is advancing a robust clinical-stage pipeline, including: tamibarotene, a first-in-class oral selective RAR? agonist in RARA-positive patients with higher-risk myelodysplastic syndrome and acute myeloid leukemia; SY-2101, a novel oral form of arsenic trioxide in patients with acute promyelocytic leukemia; and SY-5609, a highly selective and potent oral CDK7 inhibitor in patients with select solid tumors. Syros also has multiple preclinical and discovery programs in oncology and monogenic diseases. 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 (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended (the Securities Act) concerning Syros, TYME Technologies, the proposed transactions and other matters, such as Syros' clinical development plans, including with respect to tamibarotene, SY-2101 and SY-5609, Syros' ability to deliver benefit to patients and value to stockholders, the timing and impact of upcoming clinical and preclinical data readouts, the timing for submitting a new drug application to the Food and Drug Administration, the ability to secure additional capital, and the sufficiency of Syros' capital resources to fund its operating expenses and capital expenditure requirements into the second quarter of 2023 or into 2025 upon the completion of the merger, PIPE and after giving effect to certain provision of the loan agreement amendment. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Syros and TYME Technologies, as well as assumptions made by, and information currently available to, management of Syros and TYME Technologies. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "anticipate," "plan," "likely," "believe," "estimate," "project," "intend," and other similar expressions. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation, Syros' ability to: advance the development of its programs, including tamibarotene, SY-2101 and SY-5609, 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. Additional factors that could cause actual results to differ materially from those contained in any forward-looking statement include, without limitation, the risk that the conditions to the closing of the proposed transactions are not satisfied, including the failure to obtain stockholder approval for the transactions or to complete the PIPE financing in a timely manner or at all; uncertainties as to the timing of the consummation of the transactions and the ability of each of Syros and TYME Technologies to consummate the transaction, including the PIPE financing; risks related to TYME Technologies' continued listing on the Nasdaq Stock Market until closing of the proposed transactions; risks related to Syros' and TYME Technologies' ability to correctly estimate their respective operating expenses and expenses associated with the transactions, as well as uncertainties regarding the impact any delay in the closing would have on the anticipated cash resources of the combined company upon closing and other events and unanticipated spending and costs that could reduce the combined company's cash resources; the ability of Syros or TYME Technologies to protect their respective intellectual property rights; competitive responses to the transaction; unexpected costs, charges or expenses resulting from the transaction; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the transaction; and legislative, regulatory, political and economic developments. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in Syros' Annual Report on Form 10-K for the year ended December 31, 2021, Syros' Quarterly Report on Form 10-Q for the quarter ended June 30, 2022 and TYME Technologies' Annual Report on Form 10-K for the year ended March 31, 2022, each of which is on file with the Securities and Exchange Commission (SEC). In addition, the extent to which the COVID-19 pandemic continues to impact the proposed transactions will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration and severity of the pandemic, additional or modified government actions, and the actions that may be required to contain the virus or treat its impact. Syros and TYME Technologies can give no assurance that the conditions to the transactions will be satisfied. Except as required by applicable law, Syros and TYME Technologies undertake no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release.

No Offer or Solicitation

This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed business combination and shall not constitute an offer to sell or a solicitation of an offer to buy any securities nor shall there be any sale of securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of the Securities Act.

Important Additional Information and Where to Find It

In connection with the transactions, Syros filed a Registration Statement on Form S?4 (Registration Statement) with the SEC on July 18, 2022, which was subsequently amended on August 1, 2022. The Registration Statement was declared effective by the SEC on August 8, 2022, and Syros and TYME Technologies intend to commence mailing of the joint proxy statement/prospectus contained in the Registration Statement to their respective stockholders on or about August 10, 2022. Syros may also file other relevant documents with the SEC regarding the proposed transactions. Investors and security holders are urged to read the Registration Statement and the joint proxy statement/prospectus carefully before making any voting or investment decision with respect to the proposed transactions. The Registration Statement and the joint proxy statement/prospectus contain important information about Syros, TYME Technologies, the transactions and related matters. Investors and security holders may obtain free copies of the Registration Statement and the joint proxy statement/prospectus and other documents filed with the SEC by Syros and TYME Technologies through the web site maintained by the SEC at www.sec.gov. In addition, investors and security holders may obtain free copies of the Registration Statement and the joint proxy statement/prospectus from Syros by contacting [email protected] or from TYME Technologies by contacting [email protected].

Participants in the Solicitation

Syros and TYME Technologies, and their respective directors and executive officers, may be deemed to be participants in the solicitation of proxies in respect of the transactions contemplated by the merger agreement. Information regarding Syros' directors and executive officers and TYME Technologies' directors and executive officers, including their interests in the transactions, is contained in the Registration Statement on file with the SEC. These documents can be obtained free of charge from the sources indicated above.

Syros Pharmaceuticals, Inc.

Selected Condensed Consolidated Balance Sheet Data

(in thousands)

(unaudited)

 

 

 

June 30,

2022

 

December 31,

2021

Cash, cash equivalents and marketable securities (current and noncurrent)

 

$

86,284

 

$

143,407

Working capital1

 

 

53,018

 

 

105,077

Total assets

 

 

126,234

 

 

182,935

Total stockholders' equity

 

 

31,019

 

 

85,218

 

(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,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenue

 

$

6,276

 

 

$

5,162

 

 

$

11,743

 

 

$

9,989

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

33,100

 

 

 

25,786

 

 

 

58,271

 

 

 

45,815

 

General and administrative

 

 

6,945

 

 

 

5,520

 

 

 

13,894

 

 

 

11,260

 

Total operating expenses

 

 

40,045

 

 

 

31,306

 

 

 

72,165

 

 

 

57,075

 

Loss from operations

 

 

(33,769

)

 

 

(26,144

)

 

 

(60,422

)

 

 

(47,086

)

Interest income

 

 

112

 

 

 

12

 

 

 

147

 

 

 

24

 

Interest expense

 

 

(981

)

 

 

(969

)

 

 

(1,956

)

 

 

(1,937

)

Change in fair value of warrant liability

 

 

157

 

 

 

4,611

 

 

 

2,604

 

 

 

12,281

 

Net loss applicable to common stockholders

 

$

(34,481

)

 

$

(22,490

)

 

$

(59,627

)

 

$

(36,718

)

Net loss per share applicable to common stockholders - basic and diluted

 

$

(0.54

)

 

$

(0.36

)

 

$

(0.94

)

 

$

(0.59

)

Weighted-average number of common shares used in net loss per share applicable to common stockholders - basic and diluted

 

 

63,823,789

 

 

 

62,859,500

 

 

 

63,441,918

 

 

 

62,123,658

 

 


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