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– Two praliciguat Phase 2 studies for diabetic nephropathy and heart failure with preserved ejection fraction (HFpEF) on track for data readouts in Q4 2019 –
– Phase 2 study of olinciguat in sickle cell disease on track for data readout in mid-2020 –
– Phase 1 study of central nervous system penetrant sGC stimulator, IW-6463, on track for data readout in Q4 2019 –
– Webcast investor event focused on praliciguat cardiometabolic programs to be held on September 17 in New York City ahead of anticipated clinical results –
CAMBRIDGE, Mass., Aug. 12, 2019 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company focused on the development of soluble guanylate cyclase (sGC) stimulators for the treatment of serious and orphan diseases, today provided general corporate and pipeline updates and reported financial results for the second quarter of 2019.
“Since Cyclerion launched as an independent public company in April, we have made excellent progress advancing our five programs targeting the soluble guanylate cyclase pathway. We look forward to an exciting and data-rich year ahead with four anticipated clinical readouts,” said Peter Hecht, Ph.D., chief executive officer of Cyclerion. “Each of our programs has the potential to provide a differentiated treatment option for serious diseases that are not well managed today, and each is supported by compelling science.”
Development Stage Programs and Recent Business Highlights
Upcoming Investor Event
Second Quarter 2019 Financial Results
About Cyclerion Therapeutics
Cyclerion Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of soluble guanylate cyclase (sGC) pharmacology to discover, develop and commercialize breakthrough treatments for serious and orphan diseases. Cyclerion is advancing its portfolio of five differentiated sGC stimulator programs with distinct pharmacologic and biodistribution properties that are uniquely designed to target tissues of greatest relevance to the diseases they are intended to treat. These programs include olinciguat in Phase 2 development for sickle cell disease, praliciguat in Phase 2 trials for heart failure with preserved ejection fraction (HFpEF) and for diabetic nephropathy, IW-6463 in Phase 1 development for serious and orphan central nervous system diseases, and two late-stage discovery programs targeting serious liver and lung diseases, respectively.
For more information about Cyclerion, please visit https://www.cyclerion.com/ and follow us on Twitter (@Cyclerion) and LinkedIn (www.linkedin.com/company/cyclerion).
Forward Looking Statement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Our forward-looking statements are based on current beliefs and expectations of our management team that involve risks, potential changes in circumstances, assumptions, and uncertainties, including statements about the anticipated timing of release of data from our clinical trials; the progression of our clinical programs into commercial products; the business and operations of Cyclerion; and our future financial performance and expense levels. We may, in some cases use terms such as “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include those related to the possibility that we may not achieve the expected benefits of the separation from Ironwood, and that this separation could harm our business, results of operations and financial condition; the risk that we may be unable to make, on a timely or cost-effective basis, the changes necessary to operate as an independent company; the risk of cessation or delay of any of the ongoing or planned clinical studies and/or our development of our product candidates; the risk of a delay in the enrollment of patients in our clinical studies; the risk that any one or more of our product candidates will not be successfully developed, approved or commercialized; our lack of independent operating history and the risk that our accounting and other management systems may not be prepared to meet the financial reporting and other requirements of operating as an independent public company; the risk that the separation from Ironwood may adversely impact our ability to attract or retain key personnel; and the other risks and uncertainties listed under the “Risk Factors” section and elsewhere in our Registration Statement on Form S-1 filed on April 18, 2019, with the Securities and Exchange Commission (SEC), and in subsequent reports that we file with the SEC. Investors are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and we undertake no obligation to update these forward-looking statements, except as required by law.
Cyclerion Therapeutics, Inc.
Condensed Consolidated and Combined Statements of Operations
(In thousands)
(Unaudited)
Three Months Ended
June 30, |
Six Months Ended
June 30, |
|||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
Revenue from related party | $ | 1,628 | $ | - | $ | 1,628 | $ | - | ||||||||
Cost and expenses: | ||||||||||||||||
Research and development | 25,759 | 22,251 | 52,163 | 43,765 | ||||||||||||
General and administrative | 8,923 | 7,530 | 19,900 | 11,299 | ||||||||||||
Total cost and expenses | 34,682 | 29,781 | 72,063 | 55,064 | ||||||||||||
Loss from operations | (33,054 | ) | (29,781 | ) | (70,435 | ) | (55,064 | ) | ||||||||
Interest and investment income | 800 | - | 800 | - | ||||||||||||
Net loss | $ | (32,254 | ) | $ | (29,781 | ) | $ | (69,635 | ) | $ | (55,064 | ) | ||||
Net loss per share: | ||||||||||||||||
Basic and diluted net loss per share | $ | (1.18 | ) | $ | (1.09 | ) | $ | (2.54 | ) | $ | (2.01 | ) | ||||
Weighted average shares used in calculating: | ||||||||||||||||
Basic and diluted net loss per share | 27,393 | 27,380 | 27,380 | 27,380 |
Cyclerion Therapeutics, Inc.
Condensed Consolidated and Combined Balance Sheets
(In thousands)
(Unaudited)
June 30,
2019 |
December 31,
2018 |
|||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 141,030 | $ | - | ||||
Related party accounts receivable | 1,857 | - | ||||||
Prepaid expenses | 1,778 | 867 | ||||||
Other current assets | 28 | 12 | ||||||
Total current assets | 144,693 | 879 | ||||||
Restricted cash | 7,726 | - | ||||||
Property and equipment, net | 12,754 | 6,497 | ||||||
Operating lease right-of-use asset | 70,330 | - | ||||||
Other assets | - | 25 | ||||||
Total assets | $ | 235,503 | $ | 7,401 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 6,863 | $ | 2,781 | ||||
Related party accounts payable | 1,920 | $ | - | |||||
Accrued research and development costs | 5,250 | 5,261 | ||||||
Accrued expenses and other current liabilities | 7,017 | 9,804 | ||||||
Current portion of operating lease liabilities | 866 | - | ||||||
Total current liabilities | 21,916 | 17,846 | ||||||
Operating lease liabilities, net of current portion | 72,397 | - | ||||||
Stockholders' equity (deficit) | ||||||||
Common stock, $0.0 par value, 400,000,000 shares authorized and 27,411,189 issued and outstanding at June 30, 2019 and no shares issued or outstanding at December 31, 2018 | - | - | ||||||
Accumulated deficit | (32,254 | ) | - | |||||
Net parent investment | - | (10,445 | ) | |||||
Paid-in capital | 173,448 | - | ||||||
Accumulated other comprehensive income (loss) | (4 | ) | - | |||||
Total stockholders' equity (deficit) | 141,190 | (10,445 | ) | |||||
Total liabilities and stockholders' equity (deficit) | $ | 235,503 | $ | 7,401 |
Investors
Brian Cali, (857) 338-3262
bcali@cyclerion.com
Media
Jessi Rennekamp, (857) 338-3319
jrennekamp@cyclerion.com