Conference call and webcast today at 4:30p.m. ET
NEWARK, Calif., Aug. 09, 2018 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY) a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced financial results and a corporate update for the quarter and six months ended June 30, 2018.
“Having completed a significant capital raise to start the year, we are now laser focused on high quality execution as we continue to advance novel treatment alternatives to patients suffering from liver diseases with significant unmet needs,” said Sujal Shah, President and Chief Executive Officer of CymaBay. “We have collected feedback from regulatory agencies and finalized our design for our planned Phase 3 study of seladelpar in primary biliary cholangitis (PBC) and we are on track to initiate this study in the second half of the year. Data from the ongoing Phase 2 study of seladelpar in patients with PBC were presented in a late-breaking presentation at The International Liver CongressTM in April, and we believe these data support the potential of seladelpar to provide improved efficacy and better tolerability over existing second-line therapy. We are also excited to expand development of seladelpar into non-alcoholic steatohepatitis (NASH) with the recent initiation of a Phase 2b proof-of-concept study. We believe seladelpar’s PPAR-delta mechanism of action may be particularly well suited to treat NASH given its beneficial impacts on lipid, glucose, and sterol metabolism, as well as its effects on inflammation and fibrogenesis.”
Second Quarter 2018 Business Highlights
Second Quarter 2018 Financial Results
First Half 2018 Financial Results
Conference Call Details
CymaBay management will host a conference call today at 4:30 p.m. ET to discuss second quarter 2018 financial results and provide a business update. To access the live conference call, please dial 877-407-0784 from the U.S. and Canada, or 201-689-8560 internationally, Conference ID# 13680965. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company's website at http://ir.cymabay.com/events.
About CymaBay
CymaBay Therapeutics, Inc. (CBAY) is a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet medical need. Seladelpar is a potent, selective, orally active PPARδ agonist, currently in development for the treatment of patients with primary biliary cholangitis (PBC), an autoimmune liver disease, and with non-alcoholic steatohepatitis (NASH).
Cautionary Statements
The statements in this press release regarding the potential for seladelpar to treat PBC and NASH, the potential benefits to patients, CymaBay’s expectations and plans regarding ongoing and future clinical trials, including timing in regard thereto, and CymaBay’s ability to fund current and planned clinical trials are forward looking statements that are subject to risks and uncertainties. Actual results and the timing of events regarding the further development of seladelpar could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, which include, without limitation, risks related to: the success, cost and timing of any of CymaBay's product development activities, including clinical trials; effects observed in trials to date that may not be repeated in the future; any delays or inability to obtain or maintain regulatory approval of CymaBay's product candidates in the United States or worldwide; and the ability of CymaBay to obtain sufficient financing to complete development, regulatory approval and commercialization of its product candidates in the United States and worldwide. Additional risks relating to CymaBay are contained in CymaBay's filings with the Securities and Exchange Commission, including without limitation its most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. CymaBay disclaims any obligation to update these forward-looking statements except as required by law.
For additional information about CymaBay visit www.cymabay.com.
Contact:
Hans Vitzthum
LifeSci Advisors, LLC
212-915-2568
[email protected]
CymaBay Therapeutics, Inc. | ||||||||||||||||
Financial Results | ||||||||||||||||
(In thousands, except share and per share information) | ||||||||||||||||
(unaudited) | ||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||
Collaboration revenue | $ | - | $ | - | $ | - | $ | 4,793 | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 14,397 | 4,044 | 23,874 | 8,085 | ||||||||||||
General and administrative | 3,574 | 3,582 | 6,947 | 7,283 | ||||||||||||
Total operating expenses | 17,971 | 7,626 | 30,821 | 15,368 | ||||||||||||
Loss from operations | (17,971 | ) | (7,626 | ) | (30,821 | ) | (10,575 | ) | ||||||||
Other income (expense): | ||||||||||||||||
Interest income | 1,061 | 44 | 1,769 | 81 | ||||||||||||
Interest expense | (128 | ) | (283 | ) | (336 | ) | (588 | ) | ||||||||
Loss on extinguishment of debt | (407 | ) | - | (407 | ) | - | ||||||||||
Other income (expense), net | (86 | ) | (1,064 | ) | (4,741 | ) | (3,198 | ) | ||||||||
Net loss | $ | (17,531 | ) | $ | (8,929 | ) | $ | (34,536 | ) | $ | (14,280 | ) | ||||
Basic net loss per common share | $ | (0.30 | ) | $ | (0.31 | ) | $ | (0.61 | ) | $ | (0.52 | ) | ||||
Diluted net loss per common share | $ | (0.30 | ) | $ | (0.31 | ) | $ | (0.61 | ) | $ | (0.52 | ) | ||||
Weighted average common shares outstanding used to calculate basic net loss per common share | 58,833,647 | 28,752,451 | 56,307,236 | 27,687,110 | ||||||||||||
Weighted average common shares outstanding used to calculate diluted net loss per common share | 58,905,898 | 28,752,451 | 56,307,236 | 27,687,110 | ||||||||||||
CymaBay Therapeutics, Inc. | ||||||
Balance Sheet Data | ||||||
(In thousands) | ||||||
June 30, | December 31, | |||||
2018 | 2017 | |||||
(unaudited) | ||||||
Cash, cash equivalents and short-term investments | $ | 212,079 | $ | 97,210 | ||
Working capital | 199,799 | 87,234 | ||||
Total assets | 218,168 | 104,247 | ||||
Facility loan | - | 6,098 | ||||
Warrant liability | 5,632 | 6,091 | ||||
Total liabilities | 18,955 | 19,300 | ||||
Common stock and additional paid-in capital | 684,332 | 535,507 | ||||
Total stockholders’ equity | 199,213 | 84,947 |
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