Gilead Sciences, Inc. has proposed to acquire CymaBay for $32.50 per share in cash or a total equity value of $4.3 billion.
U.S. FDA accepted seladelpar NDA for priority review, and seladelpar marketing applications were submitted to the EMA and MHRA for review in Europe and the U.K.
Due to the pending transaction with Gilead, CymaBay will not be hosting a conference call to review the financial results for the fourth quarter ended December 31, 2023 or commenting on its financial guidance for the future quarters.
NEWARK, Calif., Feb. 28, 2024 (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 corporate updates and financial results for the year and fourth quarter ended December 31, 2023.
“2023 was a seminal year for CymaBay with critical achievements in the development of our investigational therapeutic, seladelpar. The Phase 3 RESPONSE data presented in 2023 and recently published in the New England Journal of Medicine, indicate that seladelpar has the potential to raise the bar in PBC second-line treatment and improve quality of life for people living with this debilitating condition,” said Sujal Shah, President and CEO of CymaBay. “Our team moved at speed to submit seladelpar to regulatory agencies and with an updated breakthrough therapy designation were able to secure FDA priority review. These accomplishments were recognized with the recent announcement of the pending acquisition of CymaBay by Gilead. I am incredibly proud of the team and everything that has been achieved in 2023 to help bring seladelpar to people living with PBC, and believe that through Gilead, seladelpar can reach a broad range of people that may benefit in 2024 and beyond.”
2023 and Recent Corporate Highlights
Pending Acquisition by Gilead:
Regulatory Updates and Launch Readiness:
Clinical Development:
Presentations and Publications:
Financial Updates:
Held $416.2 million in cash, cash equivalents and investments as of December 31, 2023.
Fourth Quarter and Year Ended December 31, 2023, Financial Results:
About CymaBay
CymaBay Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on improving the lives of people with liver and other chronic diseases that have high unmet medical need. Our deep understanding of the underlying mechanisms of liver inflammation and fibrosis, and the unique targets that play a role in their progression, have helped us receive breakthrough therapy designation (U.S. Food and Drug Administration), Priority Medicines status (European Medicines Agency) and orphan drug status (U.S. and Europe) for seladelpar, a first-in-class investigational treatment for people with PBC. A new drug application for seladelpar was submitted to the FDA in December 2023. Our evidence-based decision-making and commitment to the highest quality standards reflect our relentless dedication to the people, families, and communities we serve. To learn more, visit www.cymabay.com and follow us on X (formerly Twitter) and Linkedin.
Additional Information and Where to Find It
This communication is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell securities. On February 23, 2024, Gilead Sciences, Inc. (“Gilead”) and Pacific Merger Sub, Inc., a wholly owned subsidiary of Gilead, filed a Tender Offer Statement on Schedule TO with the U.S. Securities and Exchange Commission (the “SEC”) in connection with Gilead’s pending acquisition of CymaBay Therapeutics, Inc. (“CymaBay”), and, on February 23, 2024, CymaBay filed a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. CYMABAY’S STOCKHOLDERS AND OTHER INVESTORS ARE URGED TO READ THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION THAT SHOULD BE READ CAREFULLY BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER OFFER. The Tender Offer Statement on Schedule TO, the Solicitation/Recommendation Statement on Schedule 14D-9 and other related documents are available for free at the SEC’s website at www.sec.gov. Investors and securityholders may also obtain, free of charge, the Solicitation/Recommendation Statement on Schedule 14D-9 and other related documents that CymaBay has filed with or furnished to the SEC under the “Investors & Media” section of CymaBay’s website at www.cymabay.com
Forward-Looking Statements
This communication contains “forward-looking statements.” These statements relate to future events and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of CymaBay to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “could,” “expects,” “plans,” “anticipates,” “believes,” and similar expressions intended to identify forward-looking statements. These statements reflect CymaBay’s current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Forward-looking statements include, without limitation, statements regarding Gilead’s pending acquisition of CymaBay and other related matters, prospective performance and opportunities, the ability of Gilead to advance CymaBay’s product pipeline and successfully commercialize seladelpar; the possibility of unfavorable results from clinical trials; regulatory applications and related timelines; and any assumptions underlying any of the foregoing. The following are some of the factors that could cause actual future results to differ materially from those expressed in any forward-looking statements: (i) uncertainties as to the timing of the tender offer and the subsequent merger; (ii) the risk that the tender offer or the subsequent merger may not be completed in a timely manner or at all; (iii) uncertainties as to the percentage of CymaBay’s stockholders tendering their shares in the tender offer; (iv) the possibility that competing offers or acquisition proposals for CymaBay will be made; (v) the possibility that any or all of the various conditions to the consummation of the tender offer or the subsequent merger may not be satisfied or waived, including the failure to receive any required regulatory approvals from any applicable governmental entities (or any conditions, limitations or restrictions placed on such approvals); (vi) the occurrence of any event, change or other circumstance that could give rise to the termination of the merger agreement related to the tender offer and the subsequent merger, including in circumstances which would require CymaBay to pay a termination fee or other expenses; (vii) the effect of the announcement or pendency of the transactions contemplated by such merger agreement on CymaBay’s ability to retain and hire key personnel, its ability to maintain relationships with its suppliers and others with whom it does business, or its operating results and business generally; (viii) risks related to diverting management’s attention from CymaBay’s ongoing business operations; (ix) the risk that stockholder litigation in connection with the transactions contemplated by such merger agreement may result in significant costs of defense, indemnification and liability and (x) other factors as set forth from time to time in CymaBay’s filings with the SEC, including its Form 10-K for the fiscal year ended December 31, 2023 and any subsequent Form 10-Qs. Any forward-looking statements set forth in this communication speak only as of the date of this communication. CymaBay does not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof other than as required by law. You are cautioned not to place undue reliance on any forward-looking statements.
Public Relations Contact:
Theresa Dolge
Evoke Kyne
(609) 915-2156
[email protected]
Arran Attridge
CymaBay Therapeutics
[email protected]
Investor Relations Contact:
PJ Kelleher
LifeSci Advisors, LLC
(617) 430-7579
[email protected]
CymaBay Therapeutics, Inc. | ||||||||||||||||
Financial Results | ||||||||||||||||
(In thousands, except share and per share information) | ||||||||||||||||
Quarter Ended | Year Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
(unaudited) | (unaudited) | |||||||||||||||
Collaboration revenue | 57 | - | 31,073 | - | ||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 22,749 | 16,230 | 80,799 | 67,995 | ||||||||||||
General and administrative | 19,806 | 7,247 | 51,953 | 25,116 | ||||||||||||
Total operating expenses | 42,555 | 23,477 | 132,752 | 93,111 | ||||||||||||
Loss from operations | (42,498 | ) | (23,477 | ) | (101,679 | ) | (93,111 | ) | ||||||||
Other income (expense), net: | ||||||||||||||||
Interest income | 5,680 | 921 | 13,490 | 2,017 | ||||||||||||
Interest expense | (5,081 | ) | (4,075 | ) | (18,945 | ) | (14,907 | ) | ||||||||
Other income | (3 | ) | (2 | ) | 1,764 | - | ||||||||||
Total other income (expense), net | 596 | (3,156 | ) | (3,691 | ) | (12,890 | ) | |||||||||
Net loss | (41,902 | ) | (26,633 | ) | (105,370 | ) | (106,001 | ) | ||||||||
Basic and diluted net loss per common share | $ | (0.35 | ) | $ | (0.30 | ) | $ | (0.99 | ) | $ | (1.21 | ) | ||||
Weighted average common shares outstanding used to calculate basic and diluted net loss per common share | 118,754,578 | 87,806,063 | 106,204,273 | 87,804,063 | ||||||||||||
CymaBay Therapeutics, Inc. | ||||||||||||||||
Balance Sheet Data | ||||||||||||||||
(in thousands) | ||||||||||||||||
December 31, | December 31, | |||||||||||||||
2023 | 2022 | |||||||||||||||
Cash, cash equivalents and marketable securities | $ | 416,187 | $ | 135,485 | ||||||||||||
Working capital | 366,959 | 122,632 | ||||||||||||||
Total assets | 434,686 | 141,852 | ||||||||||||||
Total liabilities | 142,430 | 105,698 | ||||||||||||||
Common stock and additional paid-in capital | 1,270,339 | 909,337 | ||||||||||||||
Total stockholders’ equity | 292,256 | 36,154 |
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