Secured up to
- Funds the Phase 3 development program for seladelpar in primary biliary cholangitis (PBC), including the Phase 3 RESPONSE clinical trial
Actively recruiting patients in two global, clinical studies evaluating seladelpar in PBC
- RESPONSE, a 52-week, randomized, placebo-controlled, Phase 3 registrational study
- ASSURE, an open-label, long-term study
Conference call and webcast today at
In
CymaBay also continued to make progress conducting the development program for seladelpar in primary biliary cholangitis (PBC). Additional clinical sites were activated in
Recent Corporate Highlights
- Executed a non-dilutive financing transaction with Abingworth for the development of seladelpar in PBC. Under the terms of the agreement, CymaBay will receive up to
$100 million of funding for seladelpar development costs, of which$75 million will be received in three installments over approximately six months. CymaBay has an option to receive an additional$25 million within approximately two months of the completion of enrollment of CymaBay’s Phase 3 RESPONSE clinical trial. - Conducted enrollment activities for 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.
- Conducted enrollment activities for ASSURE, an open-label, long-term study of seladelpar in patients with PBC intended to collect additional long-term safety data to support registration.
- Initiated enrollment 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 (T1D). The study is being conducted by the
AdventHealth Translational Research Institute inOrlando, Florida and fully funded byThe Leona M. and Harry B. Helmsley Charitable Trust with CymaBay retaining full rights to MBX-2982.
- Completed a Phase 1 single ascending dose and multiple asending dose study of CB-0406, a non-agonist ligand of PPARg that attenuates the expression of inflammatory genes. While the study showed CB-0406 had improved pharmacokinetics versus those historically achieved with the pro-drug arhalofenate, CB-0406’s safety profile did not support continued development as a result of the occurrence of a small number of reversible cases of thrombocytopenia at higher doses.
- Held
$106.1 million in cash, cash equivalents and short-term investments as ofJune 30, 2021 . We believe that cash and investments, along with the initial$75 million funding raised through the development funding agreement with Abingworth inJuly 2021 are sufficient to fund CymaBay’s current operating plan into 2023. - Due to the ongoing effects of the global coronavirus pandemic, CymaBay continues to conduct its operations remotely for all employees, which has allowed business activities to continue as seamlessly as possible. The recent emergence of the Delta variant has led to uncertainty regarding the duration and effects that the pandemic will have on future operating milestones. CymaBay continues to closely monitor pandemic developments and their associated risks to the business, including the conduct of its clinical development of seladelpar, and will continue to take actions to mitigate them where possible. Further, all CymaBay’s actions will continue to be guided by a commitment to ensuring the health and safety of its employees as well as patients enrolled in its clinical studies.
Second Quarter and Six Months Ended
- Research and development expenses for the three months ended
June 30, 2021 and 2020 were$16.7 million and$7.9 million , respectively. Research and development expenses for the six months endedJune 30, 2021 and 2020 were$29.1 million and$17.5 million , respectively. Research and development expenses in the three and six months endedJune 30, 2021 were higher than the corresponding periods in 2020 primarily due to an increase in clinical trial activities following our resumption of clinical development of seladelpar in PBC in late 2020. In particular, cost increases were primarily driven by the enrollment activities associated with RESPONSE and ASSURE, our two active global late-stage clinical trials in PBC. In the three and six months endedJune 30, 2020 , costs incurred were primarily associated with the termination and shutdown of our Phase 3 PBC, Phase 2b NASH, and Phase 2 PSC clinical trials, and other studies, after the seladelpar development program was placed on hold fromNovember 2019 throughJuly 2020 . - General and administrative expenses for the three months ended
June 30, 2021 and 2020 were$6.5 million and$3.2 million , respectively. General and administrative expenses for the six months endedJune 30, 2021 and 2020 were$11.8 million and$7.6 million , respectively. General and administrative expenses in the three and six months endedJune 30, 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
June 30, 2021 and 2020 was$23.2 million and$10.7 million , or ($0.34 ) and ($0.16 ) per diluted share, respectively. Net loss for the six months endedJune 30, 2021 and 2020 was$40.8 million and$23.8 million , or ($0.59 ) and ($0.35 ) 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 2021 as we continue to execute on our clinical development plans.
Conference Call Details
CymaBay will host a conference call today at
About CymaBay
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
Public Relations Contact:
(973) 818-8198
Glenn.silver@finnpartners.com
Investor Relations Contact:
(617) 430-7578
Hans@LifeSciAdvisors.com
Financial Results | ||||||||||||||||
(In thousands, except share and per share information) | ||||||||||||||||
Quarter Ended | Six Months Ended | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
(unaudited) | (unaudited) | (unaudited) | (unaudited) | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 16,745 | $ | 7,942 | $ | 29,127 | $ | 17,451 | ||||||||
General and administrative | 6,521 | 3,210 | 11,757 | 7,628 | ||||||||||||
Total operating expenses | 23,266 | 11,152 | 40,884 | 25,079 | ||||||||||||
Loss from operations | (23,266 | ) | (11,152 | ) | (40,884 | ) | (25,079 | ) | ||||||||
Interest income | 44 | 426 | 111 | 1,265 | ||||||||||||
Net loss | $ | (23,222 | ) | $ | (10,726 | ) | $ | (40,773 | ) | $ | (23,814 | ) | ||||
Basic and diluted net loss per common share | $ | (0.34 | ) | $ | (0.16 | ) | $ | (0.59 | ) | $ | (0.35 | ) | ||||
Weighted average common shares | ||||||||||||||||
outstanding used to calculate | ||||||||||||||||
basic and diluted net loss per common share | 68,985,461 | 68,885,108 | 68,965,885 | 68,883,783 | ||||||||||||
Balance Sheet Data | ||||||||||||||||
(in thousands) | ||||||||||||||||
2021 | 2020 | |||||||||||||||
(unaudited) | ||||||||||||||||
Cash, cash equivalents and marketable securities | $ | 106,134 | $ | 146,323 | ||||||||||||
Working capital | 104,854 | 141,728 | ||||||||||||||
Total assets | 117,041 | 153,825 | ||||||||||||||
Total liabilities | 9,947 | 11,119 | ||||||||||||||
Common stock and additional paid-in capital | 824,724 | 819,556 | ||||||||||||||
Total stockholders’ equity | 107,094 | 142,706 |
Source:
2021 GlobeNewswire, Inc., source