UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 2.02 | Results of Operations and Financial Condition. |
On January 29, 2020, CymaBay released a letter to stockholders (the “Letter”), updating stockholders on several issues including progress towards closing down its clinical studies, estimated 2019 year-end cash and estimated cash burn in the first half of 2020. The audit of CymaBay’s financial statements for the year ended December 31, 2019 is ongoing and 2019 year-end cash could change from the information in the Letter.
A copy of the Letter is furnished herewith as Exhibit 99.1 and is incorporated herein by reference. The information in this Item 2.02, and in Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this report and in the accompanying exhibit shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by CymaBay, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
| Item 5.02 | Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. |
On January 23, 2020, Carl Goldfischer, M.D. and Evan Stein, M.D., Ph.D. resigned as directors of CymaBay Therapeutics, Inc., effective immediately. In addition, on January 24, 2020, Robert Booth, Ph. D. and Robert Weiland resigned as directors of CymaBay, effective immediately. In conjunction with these resignations and in order to reduce the costs of operating a larger Board of Directors, on January 27, 2020 CymaBay reduced the size of its Board of Directors to five members. CymaBay believes this reduced Board size is appropriate given its current circumstances but still permits robust, independent and effective oversight of CymaBay. CymaBay’s Board of Directors continues to reflect a diverse and independent set of individuals with broad backgrounds. Their experience as public market investors, experienced biotech CEOs, heads of scientific and clinical research, and financial experts encompasses the types of skills needed to ensure a broad shareholder perspective and to assess all opportunities for shareholder value creation at CymaBay.
| Item 7.01 | Regulation FD Disclosure. |
The information set forth in Item 2.02 above is incorporated by reference here.
Statements in this filing, including Exhibit 99.1 hereof, regarding future events, results or expectations are forward-looking statements that involve risks and uncertainties. Forward-looking statements include, but are not limited to, expectations regarding the expected actions and timing for winding down and terminating existing studies, timing and expectations regarding future interactions with the FDA, estimated 2019 year-end cash and estimated cash burn in the first half of 2020. Actual results may differ from these expectations as a result of a number of factors, including expected cash is preliminary, and subject to adjustment during the audit process, and those set forth under the caption “Risk Factors” in CymaBay’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, filed with the Securities and Exchange Commission on November 5, 2019. CymaBay undertakes no obligation to update these statements as a result of future events, except as required by law.
| Item 9.01 | Financial Statements and Exhibits. |
| Exhibit |
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| 99.1 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) | |||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| CymaBay Therapeutics, Inc. | ||
| By: |
/s/ Sujal Shah | |
| Name: |
Sujal Shah | |
| Title: |
Chief Executive Officer | |
Dated: January 29, 2020
Exhibit 99.1
To Our Shareholders,
We intend to provide financial and business updates in our Annual Report later in the first quarter, as we have done regularly since becoming a public company in 2013. However, given the decision to suspend development of seladelpar in November 2019 - a decision made with the safety and care of patients at the forefront of our minds - and the progress that we have made since then, we felt it was important to provide you with an interim update on the ongoing activities at CymaBay.
As noted in our November announcement, the decision to halt development of seladelpar across all indications was based on initial histological findings observed in end of treatment biopsies from the Phase 2b study of seladelpar in nonalcoholic steatohepatitis (NASH). Planned, blinded histological assessments of the first tranche of liver biopsies in the trial revealed atypical histological findings in some patients. Although these patients had stable or improving biochemical markers of liver disease, the decision to halt development was based on a need to understand the significance of the findings, and possible impact on patients, before dosing additional patients with seladelpar. This decision was made in discussion with the FDA.
Since that decision, we have been working to close down clinical studies in an effort to reduce expenses, while ensuring the highest quality analysis of the safety findings from the Phase 2b NASH clinical study. For our primary biliary cholangitis (PBC) studies, which enrolled more than 350 patients across over 20 countries, termination activities, including end-of-treatment and follow-up visits, are expected to largely conclude in the second quarter of 2020. For the Phase 2b NASH clinical study, to better understand the atypical findings in some patients and respond to various FDA requests, patients are in the process of completing end-of-treatment biopsies and final study visits. While we have made substantial progress to close down this study, the termination activities will extend beyond mid-year, as patients with atypical histologic findings will have an additional follow-up biopsy conducted six months post end-of-treatment.
In addition to study close out activities, we are preparing for an independent, expert review of the NASH biopsies and an analysis of additional biomarkers that may further elucidate the nature and significance of the atypical findings. The primary objective of this effort is to meet our ethical and regulatory requirements for patients. As part of this effort we have scheduled a meeting with the FDA for the first quarter. We plan to discuss study close-out and patient follow-up activities with the FDA, respond to their information requests and engage with them on possible next steps for seladelpar.
Despite these ongoing activities, our Board of Directors and management team have undertaken (and continue to evaluate) additional cost cutting measures while our on-going study close-out activities continue. In December 2019, we announced a reduction in workforce of approximately 60%, and today, we announced that we have decreased the size of the Board of Directors from nine to five seats. We believe a reduced Board size is appropriate given our current circumstances while maintaining strong, independent, and effective oversight of CymaBay during this period.
Our estimated 2019 year-end cash, cash equivalents and marketable securities was $191 million. Based on our projections for obligations related to clinical study close-out and patient follow-up costs, severance related to additional headcount reductions, and other operating expenses, we estimate a total cash burn of between $30 - $50 million in the first half of 2020, approximately $20 -$35 million of which is for the required clinical study close-out and patient follow-up activities.
Finally, in parallel with these activities, our Board and management team have been working to assess all potential ways to maximize value for our shareholders, including liquidation, sale, merger, asset acquisitions, and/or continuing development of our internal programs. In recent weeks and at the JP Morgan Healthcare Conference in San Francisco earlier this month we had the opportunity to speak with a number of our shareholders. I am pleased by their continued support for our process as we explore all potential alternatives for CymaBay’s future. We appreciate the input we have received from all of our investors, and their robust engagement in our process. We are also aware of the condensed timeframe in which decisions must be made to maximize our financial and human capital and are therefore acting expeditiously.
I, along with the Board of Directors, understand the value of our financial and human capital and will continue to explore all options to retain and expand that value to the benefit of all shareholders. Our Board of Directors continues to reflect a diverse and independent set of individuals with broad backgrounds. Their experience as public market investors, experienced biotech CEOs, heads of scientific and clinical research, and financial experts encompasses the types of skills needed to ensure a broad shareholder perspective and to assess all opportunities for shareholder value creation at CymaBay. The Board of Directors, the management team, and I fully understand and appreciate the challenge ahead and the responsibility to our shareholders. We will continue to make decisions as we have always done, in the best interest of patients and in the best interest of our shareholders.
Sincerely,
Sujal Shah
President and Chief Executive Officer
CymaBay Therapeutics, Inc.
Statements in this letter regarding future events, results or expectations are forward-looking statements that involve risks and uncertainties. Forward-looking statements include, but are not limited to, our expectations regarding the expected actions and timing for winding down and terminating existing studies, timing and expectations regarding future interactions with the FDA, estimated 2019 year-end cash and estimated cash burn in the first half of 2020. Actual results may differ from these expectations as a result of a number of factors, including expected cash is preliminary, and subject to adjustment during the audit process, and those set forth under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, filed with the Securities and Exchange Commission on November 5, 2019. CymaBay undertakes no obligation to update these statements as a result of future events, except as required by law.
Document and Entity Information |
Jan. 23, 2020 |
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| Cover [Abstract] | |
| Amendment Flag | false |
| Entity Central Index Key | 0001042074 |
| Document Type | 8-K |
| Document Period End Date | Jan. 23, 2020 |
| Entity Registrant Name | CymaBay Therapeutics, Inc. |
| Entity Incorporation State Country Code | DE |
| Entity File Number | 001-36500 |
| Entity Tax Identification Number | 94-3103561 |
| Entity Address, Address Line One | 7575 Gateway Blvd. |
| Entity Address, Address Line Two | Suite 110 |
| Entity Address, City or Town | Newark |
| Entity Address, State or Province | CA |
| Entity Address, Postal Zip Code | 94560 |
| City Area Code | (510) |
| Local Phone Number | 293-8800 |
| Written Communications | false |
| Soliciting Material | false |
| Pre Commencement Tender Offer | false |
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| Security 12b Title | Common stock, $0.0001 par value per share |
| Trading Symbol | CBAY |
| Security Exchange Name | NASDAQ |
| Entity Emerging Growth Company | false |