CymaBay Reports Fourth Quarter and Year Ended December 31, 2021 Financial Results and Provides Corporate Update

Rhea-AI Summary

CymaBay Therapeutics (CBAY) reported its financial results for Q4 and FY 2021, highlighting a net loss of $26.5 million for Q4 and $90 million for the year. The company has secured significant funding, including a $100 million risk-sharing agreement and a $75 million public equity offering, to support its Phase 3 clinical trials for the liver disease treatment seladelpar. With over 120 sites activated globally for the RESPONSE study, CymaBay is focused on improving outcomes for patients with primary biliary cholangitis (PBC). As of December 31, 2021, cash and investments totaled $194.6 million, expected to fund operations through 2023.

Positive

• Secured $100 million in risk-sharing development financing with Abingworth to support seladelpar development.
• Raised $75 million from a public equity offering, enhancing financial stability.
• Activated over 120 clinical trial sites in over 20 countries for the RESPONSE study.

Negative

• Net loss increased to $90 million for FY 2021, up from $51 million in FY 2020.
• Research and development expenses rose significantly to $64.5 million for FY 2021, indicating higher operational costs.

Conference call and webcast today at 4:30 p.m. ET

NEWARK, Calif., March 17, 2022 (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 fourth quarter and fiscal year ended December 31, 2021.

Sujal Shah, President and CEO of CymaBay, stated, “2021 was a year of growth for CymaBay and included accomplishments that position CymaBay for long-term success. A non-dilutive, risk-sharing development financing agreement of up to $100 million signed with Abingworth in July, together with a $75 million public equity offering in November support the completion of our ongoing Phase 3 program for seladelpar in PBC. We now have over 120 sites activated across over 20 countries in our global registration study, RESPONSE, and expect these efforts to continue and ultimately drive the completion of enrollment in the first half of 2022. We have seen a high level of interest in our long-term safety study, ASSURE, where we have enrolled more than 120 patients from our prior studies of seladelpar in PBC. We were also excited to share additional data at The Liver Meeting® 2021 that we believe demonstrate improved benefit of seladelpar between one to two years of treatment, and differentiation from other existing treatments in a population of PBC patients with more advanced disease.”

“Heading into 2022, we are well positioned to deliver on our laser focus of improving the lives of patients with PBC. Although the pandemic and recent global unrest have presented our entire industry with evolving challenges, I am confident we have assembled talent across the organization that will allow us to achieve both our near-term goals and our longer-term vision of establishing a pipeline of opportunities for patients with unmet need. Despite these challenges, we have seen steady progress since re-initiating our development program in PBC in 2021. I’m also proud of the relationships we have established with patient communities, the medical community, and high-quality investors that all support the work we are dedicated to day-in and day-out.”

Recent Corporate Highlights

• Continued enrollment in RESPONSE, a 52-week, placebo-controlled, randomized, global, Phase 3 registrational study evaluating the safety and efficacy of seladelpar in patients with PBC. This study is targeting enrollment of 180 patients who have an inadequate response to, or intolerance to, ursodeoxycholic acid, in a 2:1 randomization to oral, once daily seladelpar 10 mg or placebo. The primary outcome measure is the responder rate at 52 weeks. A responder is defined as a patient who achieves an alkaline phosphatase level < 1.67 times the upper limit of normal with at least a 15% decrease from baseline and has a normal level of total bilirubin. Additional key outcomes of efficacy will compare the rate of normalization of alkaline phosphatase at 52 weeks and the level of pruritus at 6-months for patients with moderate to severe pruritus at baseline assessed by a numerical rating scale recorded with an electronic diary. To date we have over 120 sites activated across more than 20 countries.
• Continued enrollment in ASSURE, an open-label, long-term study of seladelpar in patients with PBC intended to collect additional long-term safety data to support registration. To date we have enrolled over 120 patients in the study, building our already extensive safety database for seladelpar treated PBC patients.
• Supported enrollment efforts in a Phase 2a proof-of-pharmacology study to evaluate the potential for MBX-2982, a GPR119 agonist, to prevent hypoglycemia in patients with type 1 diabetes. The study is being conducted by the AdventHealth Translational Research Institute in Orlando, Florida and fully funded by The Leona M. and Harry B. Helmsley Charitable Trust with CymaBay retaining full rights to MBX-2982.
  
• Announced that results of analyses from two clinical studies of seladelpar were delivered during The Liver Meeting Digital Experience™ 2021 (TLMdX) of the American Association for the Study of Liver Diseases (AASLD), as follows:
  
  • Oral presentation titled “Long-Term Safety and Efficacy of Seladelpar in Patients with Primary Biliary Cholangitis” delivered by Dr. Marlyn J. Mayo, MD, highlighting the efficacy and safety of seladelpar during 2 years of treatment in patients with primary biliary cholangitis (PBC).
  • A clinical presentation titled “Efficacy and Safety of Seladelpar in Patients with Compensated Cirrhosis and Evidence of Portal Hypertension due to Primary Biliary Cholangitis” delivered by Dr. Cynthia Levy, MD, highlighting the treatment effects of seladelpar in compensated cirrhotic patients with portal hypertension after 3 months, which led to ALP changes of -30% in the 5 mg and -45% in the 10 mg groups.
    
• Continued to grow our team from 40 to 59 employees during the year, including the hiring of two executive officers; Dr. Dennis Kim as Chief Medical Officer, a physician-scientist trained in endocrinology who brings significant clinical development and executive experience and Lewis Stuart as Chief Commercial Officer, an executive who brings a diverse set of experiences launching products in both the pharmaceutical and molecular diagnostics healthcare sectors.
  
• Expanded the Board of Directors composition by appointing Thomas Wiggans a biopharma industry veteran and Janet Dorling a senior commercial executive at Gilead. Recently appointed Dr. Éric Lefebvre, the Chief Medical Officer of Pliant Therapeutics, to the Board.
• Executed a non-dilutive financing transaction with Abingworth LLP for the development of seladelpar in PBC. CymaBay will receive up to $100 million of funding for seladelpar development costs, of which $75 million has been received to date. CymaBay has an option to receive an additional $25 million after the completion of enrollment of CymaBay’s Phase 3 RESPONSE clinical trial.
• Completed public equity offering in November 2021, CymaBay sold 15,625,000 shares of common stock at $4.00 per share and pre-funded warrants to purchase 3,125,000 shares of common stock at $3.9999 per share. After deducting underwriting commissions and other estimated offering expenses, net proceeds of the offering were $70.5 million.
• Held $194.6 million in cash, cash equivalents and short-term investments as of December 31, 2021. We believe that cash and investments on hand, together with committed capital available through the development financing agreement with Abingworth, is sufficient to fund CymaBay’s operating plan through 2023.
  
  

Fourth Quarter and Year Ended December 31, 2021 Financial Results

• Research and development expenses for the three months ended December 31, 2021 and 2020 were $18.4 million and $10.7 million, respectively. Research and development expenses for the twelve months ended December 31, 2021 and 2020 were $64.5 million and $35.9 million, respectively. Research and development expenses in the three and twelve months ended December 31, 2021 were higher than the corresponding periods in 2020 primarily due to an increase in clinical trial activities associated with the development of seladelpar in PBC. In particular, cost increases were primarily driven by an expansion of our site activation, patient enrollment, and other clinical trial activities associated with RESPONSE and ASSURE, our two active global late-stage clinical trials in PBC.
  
• General and administrative expenses for the three months ended December 31, 2021 and 2020 were $6.1 million and $5.2 million, respectively. General and administrative expenses for the twelve months ended December 31, 2021 and 2020 were $23.0 million and $16.7 million, respectively. General and administrative expenses in the three and twelve months ended December 31, 2021 were higher than the corresponding periods in 2020 due to higher employee compensation associated with the hiring of additional personnel and an increase in consulting and other expenses upon resumption of development of seladelpar in the second half of 2020.
  
• Net loss for the three months ended December 31, 2021 and 2020 was $26.5 million and $15.8 million, or ($0.34) and ($0.23) per diluted share, respectively. Net loss for the twelve months ended December 31, 2021 and 2020 was $90.0 million and $51.0 million, or ($1.27) and ($0.74) per diluted share, respectively. Net loss was higher largely due to increases in clinical operating expenses, which were incurred following the resumption of our clinical development of seladelpar in PBC during the second half of 2020. We expect our operating expenses to increase in the future as we continue to execute on our clinical development plans.
  

Conference Call Details

CymaBay will host a conference call today at 4:30 p.m. ET to discuss fourth quarter and fiscal year end 2021 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# 13726915. 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. 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 through a pipeline of innovative therapies. 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 treatment for people with primary biliary cholangitis (PBC). 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 Twitter and Linkedin.

Cautionary Statements
Any statements made in this press release and accompanying conference call regarding the potential for seladelpar to treat PBC and potentially improve clinical symptoms of the disease, the potential benefits to patients, CymaBay’s expectations and plans regarding its current and future clinical trials, including the timing of enrollment in RESPONSE, the impact of the COVID pandemic on the enrollment timeline for CymaBay’s clinical trials, CymaBay’s ability to fund current and planned clinical trials, the funding expected to be provided by Abingworth and payment schedule, as well as CymaBay’s anticipated cash runway 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; the potential termination of the agreement with Abingworth; the ability of CymaBay to meet its obligations under the agreement with Abingworth; the potential emergence of other COVID variants 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, its Quarterly Reports on Form 10-Q 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.

Public Relations Contact:            

Glenn Silver
Lazar-FINN Partners
(973) 818-8198
Glenn.silver@finnpartners.com

Investor Relations Contact:

Hans Vitzthum
LifeSci Advisors, LLC
(617) 430-7578
Hans@LifeSciAdvisors.com

CymaBay Therapeutics, Inc.
Financial Results
(In thousands, except share and per share information)
		Quarter Ended								Year Ended
		December 31,								December 31,
			2021				2020				2021				2020
		(unaudited)				(unaudited)
Operating expenses:
Research and development		$	18,405			$	10,688			$	64,542			$	35,882
General and administrative			6,104				5,185				23,040				16,720
Total operating expenses			24,509				15,873				87,582				52,602
Loss from operations			(24,509	)			(15,873	)			(87,582	)			(52,602	)
Other income (expense), net:
Interest income			27				122				167				1,616
Interest expense			(2,061	)			-				(2,583	)			-
Total other income (expense), net			(2,034	)			122				(2,416	)			1,616
Net loss		$	(26,543	)		$	(15,751	)		$	(89,998	)		$	(50,986	)
Basic and diluted net loss per common share		$	(0.34	)		$	(0.23	)		$	(1.27	)		$	(0.74	)
Weighted average common shares
outstanding used to calculate
basic and diluted net loss per common share			77,198,483				68,917,646				71,055,331				68,893,127
CymaBay Therapeutics, Inc.
Balance Sheet Data
(in thousands)
						December 31,				December 31,
							2021				2020
Cash, cash equivalents and marketable securities						$	194,602		*	$	146,323
Working capital							172,733				141,728
Total assets							202,318				153,825
Total liabilities							69,381				11,119
Common stock and additional paid-in capital							899,806				819,556
Total stockholders’ equity							132,937				142,706
* Does not include $25 million received from Abingworth on January 28, 2022.

FAQ

What were CymaBay's financial results for Q4 2021?

CymaBay reported a net loss of $26.5 million for Q4 2021, compared to $15.8 million in Q4 2020.

How much cash did CymaBay have at the end of 2021?

As of December 31, 2021, CymaBay held $194.6 million in cash and investments.

What is the status of the RESPONSE clinical trial for seladelpar?

The RESPONSE study has over 120 activated sites globally and aims to enroll 180 patients with PBC.

What are the key financial challenges for CymaBay in 2022?

CymaBay faces increased operational costs with a net loss projected to grow as clinical development progresses.