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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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94-3103561
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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7575 Gateway Blvd, Suite 110
Newark, CA
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94560
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(Address of principal executive offices)
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(Zip Code)
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Title of each class
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Trading
symbol(s)
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Name of each exchange
on which registered
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Common stock, $0.0001 par value per share
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CBAY
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Nasdaq Global Select Market
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Large accelerated filer
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☐
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Accelerated filer
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☒
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Non-accelerated
filer
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☐
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Smaller reporting company
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Emerging Growth Company
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• | primary biliary cholangitis (PBC), an autoimmune disease that causes progressive destruction of the bile ducts in the liver resulting in impaired bile flow (cholestasis) and inflammation; |
• | nonalcoholic steatohepatitis (NASH), a prevalent and serious chronic liver disease caused by excessive fat accumulation in the liver that results in inflammation and cellular injury that can progress to fibrosis and cirrhosis, and potentially liver failure and death; and |
• | primary sclerosing cholangitis (PSC), a rare, chronic cholestatic liver disease characterized by diffuse inflammation and fibrosis of the intrahepatic and extrahepatic bile ducts. |
Product
Candidates
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Disease/condition
|
Status
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Description
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|||
Seladelpar
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Primary Biliary
Cholangitis (PBC)
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Phase 3 (terminated)
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52-week
study to evaluate seladelpar in PBC patients with inadequate response or intolerance to ursodeoxycholic acid (UDCA) (NCT03602560)
†
|
|||
Seladelpar
|
Nonalcoholic
Steatohepatitis (NASH)
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Phase 2 (terminated)
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52-week
study to evaluate safety, tolerability, and effect of seladelpar in patients with NASH (NCT03551522)
†
|
|||
Seladelpar
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Primary Sclerosing
Cholangitis (PSC)
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Phase 2 (terminated)
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A
24-week
study to evaluate the safety, tolerability, and efficacy of Seladelpar in patients with PSC
(NCT04024813)
†
|
|||
MBX-2982*
(GPR 119 agonist)
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Gut/Liver
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Pre-IND
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Undisclosed indication(s)
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|||
CB-001
(GPR 120 agonist)
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Gut/Liver
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Preclinical
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Undisclosed indication(s)
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* | Phase 2 (discontinued) in type 2 diabetes supported safety and pharmacokinetic profile, currently being explored for other indication(s). |
• | Significant reductions in markers of cholestasis, such as alkaline phosphatase (ALP) and gamma-glutamyl transferase (GGT), |
• |
Decreases in high-sensitivity
C-reactive
protein (hs-CRP), a marker of inflammation,
|
• | Lowered LDL-C and raised high-density-lipoprotein (HDL-C), and |
• | Decreased triglycerides and free fatty acids. |
• | Completion of preclinical laboratory tests, animal studies and formulation studies according to Good Laboratory Practices (GLP) or other applicable regulations; |
• | Submission to the FDA of an Investigational New Drug (IND) application, which must become effective before human clinical studies may begin; |
• | Performance of adequate and well-controlled human clinical studies according to the FDA’s current Good Clinical Practices (GCP), to establish the safety and efficacy of the proposed pharmaceutical product for its intended use; |
• | Submission to the FDA of a New Drug Application (NDA) for a new pharmaceutical product; |
• | Satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the pharmaceutical product is produced to assess compliance with the FDA’s current Good Manufacturing Practice standards (cGMP), to assure that the facilities, methods and controls are adequate to preserve the pharmaceutical product’s identity, strength, quality and purity; |
• | Potential FDA audit of selected preclinical and clinical study sites that generated the data in support of the NDA; and |
• | FDA review and approval of the NDA. |
• | Phase 1. The pharmaceutical product is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion. |
• | Phase 2. The pharmaceutical product is evaluated in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases, to determine dosage tolerance, optimal dosage and dosing schedule and to identify patient populations with specific characteristics where the pharmaceutical product may be more effective. |
• | Phase 3. Clinical studies are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical study sites. These clinical studies are intended to establish the overall risk/benefit ratio of the product and provide an adequate basis for product labeling. The studies must be well-controlled and usually include a control arm for comparison. One or two Phase 3 studies are required by the FDA for an NDA approval, depending on the disease severity and other available treatment options. |
• | Post-approval studies, or Phase 4 clinical studies, may be conducted after initial marketing approval. These studies are used to gain additional experience from the treatment of patients in the intended therapeutic indication. |
• | an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain government healthcare programs; |
• | an increase in the rebates a manufacturer must pay under the Medicaid Drug Rebate Program to 23.1% and 13% of the average manufacturer price for branded and generic drugs, respectively; |
• |
a new Medicare Part D coverage gap discount program, in which manufacturers must now agree to offer 70%
point-of-sale
discounts to negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D;
|
• | extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations; |
• | expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for certain individuals with income at or below 133% of the Federal Poverty Level, thereby potentially increasing manufacturers’ Medicaid rebate liability; |
• | expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program; |
• | new transparency reporting requirements under the federal Physician Payments Sunshine Act, created under Section 6002 of the PPACA; |
• | a requirement to annually report drug samples that manufacturers and distributors provide to physicians; |
• | expansion of health care fraud and abuse laws, including the False Claims Act and the Anti-Kickback Statute, new government investigative powers, and enhanced penalties for noncompliance; |
• |
a licensure framework for
follow-on
biologic products;
|
• | a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research; and |
• | establishment of a Center for Medicare & Medicaid Innovation at the Centers for Medicare & Medicaid Services (CMS) to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending. |
Name
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Age
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Position Held With CymaBay
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|||
Executive Officers
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Sujal Shah
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46
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President & Chief Executive Officer
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Charles A. McWherter, Ph.D.
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64
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Chief Scientific Officer
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||||
Klara Dickinson
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52
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Chief Regulatory and Compliance Officer
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Daniel Menold
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50
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Vice President, Finance
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||||
Key Other Officers
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||||
Robert L. Martin, Ph D
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57
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Senior Vice President, Manufacturing and Nonclinical Development
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||||
Patrick J. O’Mara
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58
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Senior Vice President, Business Development
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• | the rate of progress and cost of our clinical studies; |
• | the need for additional or expanded clinical studies; |
• | the rate of progress and cost of our Chemistry, Manufacturing and Control development, registration, validation and commercial programs; |
• | the timing, economic and other terms of any licensing, collaboration or other similar arrangement into which we may enter; |
• | the costs and timing of seeking and obtaining U.S. Food and Drug Administration (FDA) and other regulatory approvals; |
• | the extent of our other development activities; |
• | the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; and |
• | the effect of competing products and market developments. |
• | successful enrollment and completion of clinical trials; |
• | receipt of marketing approvals from the FDA and regulatory authorities outside the United States for the product candidate; |
• | establishing commercial manufacturing capabilities by making arrangements with third-party manufacturers; |
• | launching commercial sales of the product, whether alone or in collaboration with others; |
• | acceptance of the product by patients, the medical community and third-party payors; |
• | effectively competing with other therapies; |
• | a continued acceptable safety profile of the product following marketing approval; and |
• | obtaining, maintaining, enforcing and defending intellectual property rights and claims. |
• | regulators or institutional review boards may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; |
• | the clinical study protocol may require one or more amendments delaying study completion; |
• | clinical trials of our product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs; |
• | the number of subjects required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be insufficient or slower than we anticipate, we may have to compete with other clinical trials to enroll eligible subjects, or subjects may drop out of these clinical trials at a higher rate than we anticipate; |
• | clinical investigators or study subjects fail to comply with clinical study protocols; |
• | trial conduct and data analysis errors may occur, including, but not limited to, data entry and/or labeling errors; |
• | our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all; |
• | we might have to suspend or terminate clinical trials of our product candidates for various reasons, including a finding that the subjects are being exposed to unacceptable health risks; |
• | regulators or institutional review boards may require that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements; |
• | the cost of clinical trials of our product candidates may be greater than we anticipate; |
• | the supply or quality of our clinical trial materials or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate; and |
• | our product candidates may have undesirable side effects or other unexpected characteristics, causing us or our investigators to suspend or terminate the trials. |
• | inability to raise funding necessary to initiate or continue a trial; |
• | delays in obtaining regulatory approval to commence a trial; |
• | delays in reaching agreement with the FDA or other regulatory authorities on final trial design; |
• | imposition of a clinical hold following a reported safety event; |
• | an inspection of our clinical trial operations or trial sites by the FDA or other regulatory authorities; |
• | delays in reaching agreement on acceptable terms with prospective contract research organizations (CROs) and clinical trial sites; |
• | delays in obtaining required institutional review board (IRB) approval at each site; |
• | delays in recruiting suitable patients to participate in a trial; |
• |
delays in having subjects complete participation in a trial or return for post-treatment
follow-up;
|
• | delays caused by subjects dropping out of a trial due to side effects or otherwise; |
• | changes to treatment guidelines or the introduction of a new standard of care; |
• | delays caused by clinical sites dropping out of a trial; |
• | time required to add new clinical sites; |
• | delays by our contract manufacturers to produce and deliver sufficient supply of clinical trial materials; and |
• | delays in importing clinical trial materials into foreign countries where our clinical trials are being conducted. |
• | regulatory authorities may withdraw their approval of the product or impose restrictions on its distribution in a form of a risk evaluation and mitigation strategy (REMS) plan; |
• | regulatory authorities may require the addition of labeling statements, such as black box or other warnings or contraindications that could diminish the usage of the product or otherwise limit the commercial success of the affected product; |
• | we may be required to change the way the product is administered or to conduct additional clinical studies; |
• | we may choose to discontinue sale of the product; |
• | we could be sued and held liable for harm caused to patients; or |
• | our reputation may suffer. |
• | the efficacy and safety, as demonstrated in clinical studies; |
• | the risk/benefit profile of our product candidates; |
• | the prevalence and severity of any side effects; |
• | the clinical indications for which the product is approved; |
• | acceptance of the product by physicians, other health care providers and patients as a safe and effective treatment; |
• | the potential and perceived advantages of product candidates over alternative treatments; |
• | the safety of product candidates seen in a broader patient group, including if physicians prescribe our products for uses outside the approved indications; |
• | the cost of treatment in relation to alternative treatments; |
• | the timing of market introduction of competitive products; |
• | the availability of coverage and adequate reimbursement by third party payors and government authorities; |
• | relative convenience and ease of administration; and |
• | the effectiveness of our or our partners’ sales, marketing and distribution efforts. |
• | we may be unable to demonstrate to the satisfaction of regulatory authorities that a product candidate is safe and effective for any indication; |
• | regulatory authorities may not find the data from nonclinical studies and clinical studies sufficient or may differ in the interpretation of the data; |
• | regulatory authorities may require additional nonclinical or clinical studies; |
• | the FDA or foreign regulatory authority might not approve our third party manufacturers’ processes or facilities for clinical or commercial product; |
• | the FDA or foreign regulatory authority may change its approval policies or adopt new regulations; |
• | the FDA or foreign regulatory authority may disagree with the design or implementation of our clinical studies; |
• | the FDA or foreign regulatory authority may not accept clinical data from studies that are conducted in countries where the standard of care is potentially different from that in the United States; |
• | the results of clinical studies may not meet the level of statistical significance required by the FDA or foreign regulatory authorities for approval; |
• | we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks; and |
• | the data collection from clinical studies of our product candidates may not be sufficient to support the submission of a new drug application (NDA), marketing authorization or other equivalent submission, or to obtain regulatory approval in the United States or elsewhere. |
• | issue an untitled or warning letter asserting violation of the law; |
• | seek an injunction or impose civil or criminal penalties up to and including imprisonment or monetary fines; |
• | suspend or withdraw regulatory approval; |
• | suspend any ongoing clinical trials; |
• | refuse to approve a pending NDA or supplements to an NDA; or |
• | request recall and/or seize product. |
• | the inability to meet our product specifications, including product formulation, and quality requirements consistently; |
• | a delay or inability to procure or expand sufficient manufacturing capacity; |
• |
manufacturing and product quality issues, including those related to
scale-up
of manufacturing;
|
• |
costs and validation of new equipment and facilities required for
scale-up;
|
• | a failure to comply with cGMP and similar quality standards; |
• | the inability to negotiate manufacturing agreements with third parties under commercially reasonable terms; |
• | termination or nonrenewal of manufacturing agreements with third parties in a manner or at a time that is costly or damaging to us; |
• | the reliance on a limited number of sources, and in some cases, single sources for key materials, such that if we are unable to secure a sufficient supply of these key materials, we will be unable to manufacture and sell our product candidates in a timely fashion, in sufficient quantities or under acceptable terms; |
• | the lack of qualified backup suppliers for those materials that are currently purchased from a sole or single source supplier; |
• | operations of our third-party manufacturers or suppliers could be disrupted by conditions unrelated to our business or operations, including the bankruptcy of the manufacturer or supplier; |
• | disruption of the distribution of chemical supplies between the U.K. and E.U. due to Brexit; |
• | carrier disruptions or increased costs that are beyond our control; and |
• | the failure to deliver our products under specified storage conditions and in a timely manner. |
• | demonstration of clinical safety and efficacy in our clinical trials; |
• | the risk/benefit profile of our product candidates; |
• | the relative convenience, ease of administration and acceptance by physicians, patients and health care payors; |
• | the prevalence and severity of any side effects; |
• | the safety of product candidates seen in a broader patient group, including its use outside the approved indications; |
• | limitations or warnings contained in the FDA and other regulatory authorities approved label for the relevant product candidate; |
• | acceptance of the product by physicians, other health care providers and patients as a safe and effective treatment; |
• | the potential and perceived advantages of product candidates over alternative treatments; |
• | the timing of market introduction of competitive products; |
• | pricing and cost-effectiveness; |
• | the effectiveness of our or any future collaborators’ sales and marketing strategies; |
• | our ability to obtain formulary approval; |
• | our ability to obtain and maintain sufficient third-party coverage or reimbursement, which may vary from country to country; and |
• | the effectiveness of our or any future collaborators’ sales, marketing and distribution efforts. |
• | different regulatory requirements for drug approvals in foreign countries; |
• | reduced protection for intellectual property rights; |
• | unexpected changes in tariffs, trade barriers and regulatory requirements; |
• |
differing payor reimbursement regimes, governmental payors or patient
self-pay
systems and price controls;
|
• | economic weakness, including inflation, or political instability in particular foreign economies and markets; |
• | compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; |
• | foreign taxes, including withholding of payroll taxes; |
• | foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country; |
• | workforce uncertainty in countries where labor unrest is more common than in the United States; |
• | production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and |
• | business interruptions resulting from geopolitical actions, including war and terrorism, pandemics, or natural disasters including earthquakes, typhoons, volcanic eruptions, floods and fires. |
• | research and development resources, including personnel and technology; |
• | regulatory experience; |
• | experience in pharmaceutical development and commercialization; |
• | ability to negotiate competitive pricing and reimbursement with third-party payors; |
• | experience and expertise in the exploitation of intellectual property rights; and |
• | capital resources. |
• | decreased demand for our product candidates; |
• | impairment to our business reputation; |
• | withdrawal of clinical study participants; |
• | distraction of management’s attention from our primary business; |
• | substantial monetary awards to patients or other claimants; |
• | the inability to commercialize our product candidates; and |
• | loss of revenues. |
• | adverse or inconclusive results or delays in preclinical testing or clinical trials; |
• | inability to obtain additional funding; |
• | any delay in filing an Investigational New Drug (IND) application or NDA for any of our future product candidates and any adverse development or perceived adverse development with respect to the FDA’s review of an IND or NDA; |
• | failure to maintain our existing collaborations or enter into new collaborations; |
• | failure of our collaboration partners to elect to develop or commercialize product candidates under our collaboration agreements or the termination of any programs under our collaboration agreements; |
• | failure by us or our licensors and collaboration partners to prosecute, maintain or enforce our intellectual property rights; |
• | failure to successfully develop and commercialize our future product candidates; |
• | changes in laws or regulations applicable to future products; |
• | changes in the structure of payment systems; |
• | inability to obtain adequate product supply for our future product candidates or the inability to do so at acceptable prices; |
• | adverse regulatory decisions; |
• | introduction of new products, services or technologies by our competitors; |
• | failure to meet or exceed financial projections we may provide to the public; |
• | failure to meet or exceed the estimates and projections of the investment community; |
• | the perception of the pharmaceutical industry by the public, legislatures, regulators and the investment community; |
• | announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us, our collaboration partners or our competitors; |
• | announcements of significant or potential equity or debt sales by us; |
• | announcements of clinical trial plans or results by us; |
• | disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies; |
• | additions or departures of key scientific or management personnel; |
• | significant lawsuits, including patent or stockholder litigation; |
• | changes in the market valuations of similar companies; |
• | sales of our common stock by us or our stockholders in the future; and |
• | trading volume of our common stock. |
• | primary biliary cholangitis (PBC), an autoimmune disease that causes progressive destruction of the bile ducts in the liver resulting in impaired bile flow (cholestasis) and inflammation |
• | nonalcoholic steatohepatitis (NASH), a prevalent and serious chronic liver disease caused by excessive fat accumulation in the liver that results in inflammation and cellular injury that can progress to fibrosis and cirrhosis, and potentially liver failure and death |
• | primary sclerosing cholangitis (PSC), a rare, chronic cholestatic liver disease characterized by diffuse inflammation and fibrosis of the intrahepatic and extrahepatic bile ducts. |
• | contract research organizations and other service providers in connection with clinical studies; |
• | contract manufacturers in connection with the production of clinical trial materials; and |
• | vendors in connection with preclinical development activities. |
|
Year Ended
|
|
|
|||||||||
|
December 31,
|
Change
|
|
|||||||||
|
2019
|
|
2018
|
|
2019 vs. 2018
|
|
||||||
Operating expenses:
|
|
|
|
|||||||||
Research and development
|
$ |
83,837
|
$ |
58,124
|
25,713
|
|||||||
General and administrative
|
19,238
|
14,381
|
4,857
|
|||||||||
Restructuring charges
|
5,075
|
—
|
5,075
|
|||||||||
Total operating expenses
|
108,150
|
72,505
|
35,645
|
|||||||||
Loss from operations
|
(108,150
|
) |
(72,505
|
) |
(35,645
|
) | ||||||
Other income (expense):
|
|
|
|
|||||||||
Interest income, net
|
5,342
|
3,652
|
1,690
|
|||||||||
Loss on extinguishment of debt
|
—
|
(407
|
) |
407
|
||||||||
Other expense, net
|
—
|
(3,288
|
) |
3,288
|
||||||||
Net loss
|
$ |
(102,808
|
) | $ |
(72,548
|
) |
(30,260
|
) | ||||
|
Year Ended
|
|
|
|||||||||
|
December 31,
|
Change
|
|
|||||||||
|
2019
|
|
2018
|
|
2019 vs. 2018
|
|
||||||
Operating expenses:
|
|
|
|
|||||||||
Research and development
|
$ |
83,837
|
$ |
58,124
|
25,713
|
|||||||
General and administrative
|
19,238
|
14,381
|
4,857
|
|||||||||
Restructuring charges
|
5,075
|
—
|
5,075
|
|||||||||
Total operating expenses
|
$ |
108,150
|
$ |
72,505
|
35,645
|
|||||||
|
Year Ended
December 31,
|
Change
|
|
|||||||||
|
2019
|
|
2018
|
|
2019 vs. 2018
|
|
||||||
Project costs:
|
|
|
|
|||||||||
Seladelpar PBC clinical studies
|
$ |
37,907
|
$ |
21,009
|
16,898
|
|||||||
Seladelpar NASH clinical studies
|
10,445
|
15,614
|
(5,169
|
) | ||||||||
Seladelpar PSC clinical studies
|
4,189
|
—
|
4,189
|
|||||||||
Seladelpar drug manufacturing & development
|
9,235
|
5,759
|
3,476
|
|||||||||
Seladelpar other studies
|
2,442
|
1,181
|
1,261
|
|||||||||
Non-seladelpar studies
|
361
|
184
|
177
|
|||||||||
Total project costs
|
64,579
|
43,747
|
20,832
|
|||||||||
Internal research and development costs
|
19,258
|
14,377
|
4,881
|
|||||||||
Total research and development
|
$ |
83,837
|
$ |
58,124
|
25,713
|
|||||||
• | expenses incurred under agreements with contract research organizations, investigative sites and consultants that conduct our clinical trials and a substantial portion of our preclinical activities; |
• | the cost of acquiring and manufacturing clinical trial and other materials; and |
• | other costs associated with development activities, including additional studies. |
|
Year Ended
|
|
|
|||||||||
|
December 31,
|
Change
|
|
|||||||||
|
2019
|
|
2018
|
|
2019 vs. 2018
|
|
||||||
Other income (expense):
|
|
|
|
|||||||||
Interest income, net
|
$ |
5,342
|
$ |
3,652
|
1,690
|
|||||||
Loss on extinguishment of debt
|
—
|
(407
|
) |
407
|
||||||||
Other expense, net
|
—
|
(3,288
|
) |
3,288
|
||||||||
Total other income (expense)
|
$ |
5,342
|
$ |
(43
|
) |
5,385
|
||||||
|
Year Ended
December 31,
|
|||||||
|
2019
|
|
2018
|
|
||||
Net cash used in operating activities
|
$ |
(97,911
|
) | $ |
(54,936
|
) | ||
Net cash used in investing activities
|
(34,347
|
) |
(54,111
|
) | ||||
Net cash provided by financing activities
|
108,132
|
134,988
|
||||||
Net (decrease) increase in cash and cash equivalents
|
$ |
(24,126
|
) | $ |
25,941
|
|||
(a) | Documents filed as part of this report |
|
Page
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70
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||||
71
|
||||
72
|
||||
73
|
||||
74
|
||||
75
|
Exhibit
No.
|
|
Description of Document
|
||
3.1
|
||||
3.2
|
||||
4.1
|
||||
4.2
|
||||
10.1*
|
||||
10.2*
|
||||
10.3*
|
||||
10.4*
|
Exhibit
No.
|
|
Description of Document
|
||
24.1
|
||||
31.1
|
||||
31.2
|
||||
32.1
|
||||
101.INS
|
Inline XBRL Instance Document
|
|||
101.SCH
|
Inline XBRL Taxonomy Extension Schema Document
|
|||
101.CAL
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document
|
|||
101.DEF
|
Inline XBRL Taxonomy Extension Definition Linkbase Document
|
|||
101.LAB
|
Inline XBRL Taxonomy Extension Label Linkbase Document
|
|||
101.PRE
|
Inline XBRL Taxonomy Extension Presentation Document
|
|||
104
|
Cover Page Interactive Data File (formatted as inline XBRL and contained in exhibit 101)
|
* | Indicates management contract or compensatory plan. |
# | Portions of this exhibit have been omitted pursuant to a grant of confidential treatment, which portions were omitted and filed separately with the Securities and Exchange Commission. |
|
Page
|
|
||
70
|
||||
71
|
||||
72
|
||||
73
|
||||
74
|
||||
75
|
|
December 31,
|
|||||||
|
2019
|
|
2018
|
|
||||
Assets
|
|
|
|
|
|
|
||
Current assets:
|
|
|
||||||
Cash and cash equivalents
|
$ |
24,869
|
$ |
48,995
|
||||
Marketable securities
|
166,076
|
129,669
|
||||||
Accrued interest receivable
|
687
|
304
|
||||||
Prepaid research and development expenses
|
9,910
|
1,670
|
||||||
Other prepaid expenses
|
1,381
|
924
|
||||||
Total current assets
|
202,923
|
181,562
|
||||||
Property and equipment, net
|
2,409
|
2,905
|
||||||
Operating lease right-of-use assets
|
235
|
—
|
||||||
Other assets
|
160
|
2,280
|
||||||
Total assets
|
$ |
205,727
|
$ |
186,747
|
||||
Liabilities and stockholders’ equity
|
|
|
|
|
|
|
||
Current liabilities:
|
|
|
||||||
Accounts payable
|
$ |
2,503
|
$ |
1,973
|
||||
Accrued research and development expenses
|
9,218
|
8,588
|
||||||
Accrued restructuring
|
|
|
3,193
|
|
|
|
—
|
|
Other accrued liabilities
|
2,722
|
3,854
|
||||||
Total current liabilities
|
17,636
|
14,415
|
||||||
Long-term portion of operating lease liability
|
1,743
|
—
|
||||||
Other liabilities
|
—
|
1,914
|
||||||
Total liabilities
|
19,379
|
16,329
|
||||||
Commitments and contingencies
|
|
|
||||||
Stockholders’ equity:
|
|
|
||||||
Preferred stock, $0.0001 par value: 10,000,000 shares authorized; no shares issued and outstanding
|
—
|
—
|
||||||
Common stock, $0.0001 par value: 100,000,000 shares authorized; 68,882,459 and 59,456,493 shares issued and outstanding as of December 31, 2019 and 2018, respectively
|
7
|
6
|
||||||
Additional
paid-in
capital
|
812,133
|
693,534
|
||||||
Accumulated other comprehensive income (loss)
|
80
|
(58
|
) | |||||
Accumulated deficit
|
(625,872
|
) |
(523,064
|
) | ||||
Total stockholders’ equity
|
186,348
|
170,418
|
||||||
Total liabilities and stockholders’ equity
|
$ |
205,727
|
$ |
186,747
|
||||
|
Year Ended
|
|||||||
|
December 31,
|
|||||||
|
2019
|
|
2018
|
|
||||
Operating expenses:
|
|
|
||||||
Research and development
|
$
|
83,837
|
$
|
58,124
|
||||
General and administrative
|
19,238
|
14,381
|
||||||
Restructuring charges
|
5,075
|
—
|
||||||
Total operating expenses
|
108,150
|
72,505
|
||||||
Loss from operations
|
(108,150
|
) |
(72,505
|
) | ||||
Other income (expense):
|
|
|
||||||
Interest income
|
5,342
|
3,988
|
||||||
Interest expense
|
—
|
(336
|
) | |||||
Loss on extinguishment of debt
|
—
|
(407
|
) | |||||
Other expense, net
|
—
|
(3,288
|
) | |||||
Total other income (expense)
|
5,342
|
(43
|
) | |||||
Net loss
|
$ |
(102,808
|
) | $ |
(72,548
|
) | ||
Other comprehensive income (loss):
|
|
|
||||||
Unrealized gain (loss) on marketable securities
|
138
|
(14
|
) | |||||
Other comprehensive income (loss)
|
138
|
(14
|
) | |||||
Comprehensive loss
|
$ |
(102,670
|
) | $ |
(72,562
|
) | ||
Basic net loss per common share
|
$ |
(1.53
|
) | $ |
(1.25
|
) | ||
Diluted net loss per common share
|
$
|
(1.53
|
) | $ |
(1.26
|
) | ||
Weighted average common shares outstanding used to calculate basic net loss per common share
|
67,033,046
|
57,808,254
|
||||||
Weighted average common shares outstanding used to calculate diluted net loss per common share
|
67,033,046
|
57,838,299
|
|
|
|
Additional
Paid-in
Capital
|
Accumulated
Other
Comprehensive
Income (Loss)
|
Accumulated
Deficit
|
Total
Stockholders’
Equity
|
||||||||||||||||||
|
|
|
||||||||||||||||||||||
|
Common Stock
|
|||||||||||||||||||||||
|
Shares
|
Amount
|
||||||||||||||||||||||
Balances as of December 31, 2017
|
44,408,796
|
$
|
4
|
$
|
535,503
|
$
|
(44
|
) |
$
|
(450,516
|
) |
$
|
84,947
|
|||||||||||
Issuance of common stock upon exercise of warrants
|
956,845
|
—
|
11,929
|
—
|
—
|
11,929
|
||||||||||||||||||
Issuance of common stock upon exercise of stock options
|
750,852
|
—
|
3,571
|
—
|
—
|
3,571
|
||||||||||||||||||
Stock-based compensation expense
|
—
|
—
|
7,013
|
—
|
—
|
7,013
|
||||||||||||||||||
Issuance of common stock, net of $8,553
issuance costs |
13,340,000
|
2
|
135,518
|
—
|
—
|
135,520
|
||||||||||||||||||
Net loss
|
—
|
—
|
—
|
—
|
(72,548
|
) |
(72,548
|
) | ||||||||||||||||
Net unrealized loss on marketable securities
|
—
|
—
|
—
|
(14
|
) |
—
|
(14
|
) | ||||||||||||||||
Balances as of December 31, 2018
|
59,456,493
|
$ |
6
|
$ |
693,534
|
$ |
(58
|
) | $ |
(523,064
|
) | $ |
170,418
|
|||||||||||
Issuance of common stock upon exercise of stock options
|
225,966
|
—
|
386
|
—
|
—
|
386
|
||||||||||||||||||
Stock-based compensation expense
|
—
|
—
|
10,468
|
—
|
—
|
10,468
|
||||||||||||||||||
Issuance of common stock, net of $7,254
issuance costs |
9,200,000
|
1
|
107,745
|
—
|
—
|
107,746
|
||||||||||||||||||
Net loss
|
—
|
—
|
—
|
—
|
(102,808
|
) |
(102,808
|
) | ||||||||||||||||
Net unrealized gain on marketable securities
|
—
|
—
|
—
|
138
|
—
|
138
|
||||||||||||||||||
Balances as of December 31, 2019
|
68,882,459
|
$ |
7
|
$ |
812,133
|
$ |
80
|
$ |
(625,872
|
) | $ |
186,348
|
||||||||||||
|
Year Ended December 31,
|
|||||||
|
2019
|
|
2018
|
|
||||
Operating activities
|
|
|
|
|
|
|
||
Net loss
|
$
|
(102,808
|
) |
$
|
(72,548
|
) | ||
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
||||||
Depreciation and amortization
|
572
|
105
|
||||||
Stock-based compensation expense
|
9,558
|
7,013
|
||||||
Accelerated vesting of stock-based compensation expense due to restructuring
|
910
|
—
|
||||||
Net accretion and amortization of investments in marketable securities
|
(2,237
|
) |
(1,945
|
) | ||||
Non-cash
interest associated with debt discount accretion
|
—
|
148
|
||||||
Loss on extinguishment of debt
|
—
|
407
|
||||||
Change in fair value of warrant liability
|
—
|
3,710
|
||||||
Gain on extinguishment of warrant liability
|
—
|
(422
|
) | |||||
Accretion of tenant improvement allowance
|
—
|
(263
|
) | |||||
Changes in assets and liabilities:
|
|
|
||||||
Receivable from collaboration
|
—
|
5,000
|
||||||
Interest receivable and other current assets
|
(383
|
) |
(178
|
) | ||||
Prepaid research and development and other prepaid expenses
|
(8,697
|
) |
(1,386
|
) | ||||
Other assets
|
2,120
|
(1,646
|
) | |||||
Accounts payable
|
530
|
662
|
||||||
Accrued restructuring
|
|
|
3,193
|
|
|
|
—
|
|
Accrued liabilities
|
(669
|
) |
6,450
|
|||||
Accrued interest payable
|
—
|
(43
|
) | |||||
Net cash used in operating activities
|
(97,911
|
) |
(54,936
|
) | ||||
|
|
|
|
|
|
|
|
|
Investing activities
|
|
|
|
|
|
|
||
Purchases of property and equipment
|
(315
|
) |
(529
|
) | ||||
Purchases of marketable securities
|
(290,893
|
) |
(276,382
|
) | ||||
Proceeds from maturities of marketable securities
|
252,881
|
222,800
|
||||||
Proceeds from sale of marketable securities
|
3,980
|
—
|
||||||
Net cash used in investing activities
|
(34,347
|
) |
(54,111
|
) | ||||
|
|
|
|
|
|
|
|
|
Financing activities
|
|
|
|
|
|
|
||
Proceeds from issuance of common stock, net of issuance costs
|
107,746
|
135,520
|
||||||
Proceeds from issuance of common stock pursuant to equity award plans
|
386
|
3,571
|
||||||
Proceeds from issuance of common stock upon exercise of warrants
|
—
|
2,550
|
||||||
Repayment of facility loan principal
|
—
|
(6,527
|
) | |||||
Payment of fees to extinguish facility loan
|
—
|
(126
|
) | |||||
Net cash provided by financing activities
|
108,132
|
134,988
|
||||||
Net (decrease) increase in cash and cash equivalents
|
(24,126
|
) |
25,941
|
|||||
Cash and cash equivalents at beginning of period
|
48,995
|
23,054
|
||||||
Cash and cash equivalents at end of period
|
$ |
24,869
|
$ |
48,995
|
||||
|
|
|
|
|
|
|
|
|
Supplemental
disclosures
|
|
|
|
|
|
|
||
Cash paid for amounts included in the measurement of lease liabilities
|
$ |
628
|
$ |
—
|
||||
Cash paid for interest
|
—
|
231
|
||||||
|
|
|
|
|
|
|
|
|
Supplemental
non-cash
investing and financing activities
|
|
|
|
|
|
|
||
Issuance of common stock upon warrant exercises
|
$ |
—
|
$ |
9,379
|
||||
Operating lease right-of-use assets obtained in exchange for lease liabilities
|
|
|
152
|
|
|
|
—
|
|
Lessor funded lease incentives included in property and equipment
|
—
|
2,256
|
||||||
Accrued property and equipment
|
—
|
156
|
|
As of December 31, 2018
|
|||||||||||||||
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
|
||||||||
Cash equivalents:
|
|
|
|
|
||||||||||||
Money market funds
|
$
|
39,481
|
$
|
—
|
$
|
—
|
$
|
39,481
|
||||||||
U.S. and foreign commercial paper
|
—
|
6,469
|
—
|
6,469
|
||||||||||||
Total cash equivalents
|
39,481
|
6,469
|
—
|
45,950
|
||||||||||||
Short-term investments:
|
|
|
|
|
||||||||||||
U.S. and foreign commercial paper
|
—
|
51,627
|
—
|
51,627
|
||||||||||||
U.S. and foreign corporate debt securities
|
—
|
34,634
|
—
|
34,634
|
||||||||||||
Asset-backed securities
|
—
|
25,472
|
—
|
25,472
|
||||||||||||
U.S. treasury securities
|
—
|
17,936
|
—
|
17,936
|
||||||||||||
Total short-term investments
|
—
|
129,669
|
—
|
129,669
|
||||||||||||
Total assets measured at fair value
|
$ |
39,481
|
$ |
136,138
|
$ |
—
|
$ |
175,619
|
||||||||
|
Year Ended
December 31, |
|||||||
|
2019
|
|
2018
|
|
||||
Balance, beginning of period
|
$ |
—
|
$ |
6,091
|
||||
Change in fair value
|
—
|
3,710
|
||||||
Settlement of financial instruments
|
—
|
(9,379
|
) | |||||
Extinguishment of financial instruments
|
—
|
(422
|
) | |||||
Balance, end of period
|
$ |
—
|
$ |
—
|
||||
|
|
Year Ended December 31,
|
|
|||||
|
|
2019
|
|
|
2018
|
|
||
Numerator:
|
|
|
|
|
|
|
|
|
Net loss allocated to common stock—basic
|
|
$
|
(102,808
|
)
|
|
$
|
(72,548
|
)
|
Adjustment for revaluation and extinguishment of common stock warrants
|
|
|
—
|
|
|
|
(422
|
)
|
|
|
|
|
|
|
|
|
|
Net loss allocated to common stock—diluted
|
|
$
|
(102,808
|
)
|
|
$
|
(72,970
|
)
|
|
|
|
|
|
|
|
|
|
Denominator:
|
|
|
|
|
|
|
|
|
Weighted average number of common stock shares outstanding—basic
|
|
|
67,033,046
|
|
|
|
57,808,254
|
|
Dilutive securities:
|
|
|
|
|
|
|
|
|
Common stock warrants
|
|
|
—
|
|
|
|
30,045
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common stock shares outstanding—diluted
|
|
|
67,033,046
|
|
|
|
57,838,299
|
|
Net loss per share—basic
|
|
$
|
(1.53
|
)
|
|
$
|
(1.25
|
)
|
Net loss per share—diluted
|
|
$
|
(1.53
|
)
|
|
$
|
(1.26
|
)
|
|
|
Year Ended
December 31, |
|
|||||
|
|
2019
|
|
|
2018
|
|
||
Common stock options
|
6,727
|
5,593
|
||||||
Incentive awards
|
101
|
130
|
||||||
Total
|
6,828
|
5,723
|
||||||
|
Amortized
Cost |
|
Gross
Unrealized Gains |
|
Gross
Unrealized Losses |
|
Estimated
Fair Value |
|
||||||||
As of December 31, 2019:
|
|
|
|
|
||||||||||||
Cash equivalents:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds
|
|
$
|
18,597
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
18,597
|
|
U.S. and foreign commercial paper
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
Total cash equivalents
|
|
|
18,597
|
|
|
|
—
|
|
|
|
—
|
|
|
|
18,597
|
|
Short-term investments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. and foreign commercial paper
|
51,102
|
—
|
—
|
51,102
|
||||||||||||
U.S. and foreign corporate debt securities
|
56,691
|
38
|
—
|
56,729
|
||||||||||||
Asset-backed securities
|
39,756
|
33
|
—
|
39,789
|
||||||||||||
U.S. treasury securities
|
18,447
|
9
|
—
|
18,456
|
||||||||||||
Total short-term investments
|
|
|
165,996
|
|
|
|
80
|
|
|
|
—
|
|
|
|
166,076
|
|
Total marketable securities
|
$ |
184,593
|
$ |
80
|
$ |
—
|
$ |
184,673
|
||||||||
|
Amortized
Cost |
|
Gross
Unrealized Gains |
|
Gross
Unrealized Losses |
|
Estimated
Fair Value |
|
||||||||
As of December 31, 2018:
|
|
|
|
|
||||||||||||
Cash equivalents:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds
|
|
$
|
39,481
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
39,481
|
|
U.S. and foreign commercial paper
|
|
|
6,469
|
|
|
|
—
|
|
|
|
—
|
|
|
|
6,469
|
|
Total cash equivalents
|
|
|
45,950
|
|
|
|
—
|
|
|
|
—
|
|
|
|
45,950
|
|
Short-term investments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. and foreign commercial paper
|
51,627
|
—
|
—
|
51,627
|
||||||||||||
U.S. and foreign corporate debt securities
|
34,668
|
—
|
(34
|
) |
34,634
|
|||||||||||
Asset-backed securities
|
25,494
|
—
|
(22
|
) |
25,472
|
|||||||||||
U.S. treasury securities
|
17,938
|
—
|
(2
|
) |
17,936
|
|||||||||||
Total short-term investments
|
|
|
129,727
|
|
|
|
—
|
|
|
|
(58
|
)
|
|
|
129,669
|
|
Total marketable securities
|
$ |
179,677
|
$ |
—
|
$ |
(58
|
) | $ |
175,619
|
|||||||
|
December 31,
|
|||||||
|
2019
|
|
2018
|
|
||||
Leasehold improvements
|
$ |
2,430
|
$ |
2,417
|
||||
Office and computer equipment
|
290
|
214
|
||||||
Purchased software
|
44
|
44
|
||||||
Furniture and fixtures
|
430
|
360
|
||||||
Total
|
3,194
|
3,035
|
||||||
Less accumulated depreciation and amortization
|
(785
|
) |
(130
|
) | ||||
Property and equipment, net
|
$ |
2,409
|
$ |
2,905
|
||||
|
December 31,
|
|||||||
|
2019
|
|
2018
|
|
||||
Accrued compensation
|
$ |
2,013
|
$ |
2,759
|
||||
Operating lease liability
|
407
|
—
|
||||||
Accrued professional fees and other
|
302
|
670
|
||||||
Deferred rent
|
—
|
425
|
||||||
Other accr
u
ed liabilit
i
e
s
|
$ |
2,722
|
$ |
3,854
|
||||
|
Operating
Leases |
|
||
Year ending December 31,
|
|
|||
2020
|
647
|
|||
2021
|
667
|
|||
2022
|
686
|
|||
2023
|
707
|
|||
2024
|
30
|
|||
Total undiscounted future minimum lease payments
|
$ |
2,737
|
||
Less: Imputed interest
|
587
|
|||
Total operating lease liability
|
$ |
2,150
|
||
Less: Current portion of operating lease liability (included in other accrued liabilities)
|
407
|
|||
Long-term portion of operating lease liability
|
$ |
1,743
|
||
|
|
December 31,
|
|
|||||
|
|
2019
|
|
|
2018
|
|
||
Equity incentive plan
|
|
|
9,143,863
|
|
|
|
6,991,570
|
|
|
|
|
|
|
|
|
|
|
Total reserved shares of common stock
|
|
|
9,143,863
|
|
|
|
6,991,570
|
|
|
|
|
|
|
|
|
|
|
|
Shares
Subject to
Outstanding
Options
|
|
Weighted
Average
Exercise
Price of
Options
|
|
Weighted
Average
Remaining
Contractual
Term
(Years)
|
|
Aggregate
Intrinsic
Value (in
thousands) |
|
||||||||
Outstanding as of December 31, 2018
|
5,593,132
|
$ |
7.68
|
|
|
|||||||||||
Options granted
|
2,775,360
|
8.25
|
|
|
||||||||||||
Options exercised
|
(223,631
|
) |
1.67
|
|
|
|||||||||||
Options forfeited
|
(1,127,078
|
) |
8.63
|
|
|
|||||||||||
Options expired
|
(291,088
|
) |
9.42
|
|
|
|||||||||||
Outstanding as of December 31, 2019
|
6,726,695
|
$ |
7.88
|
$ |
7.39
|
$ |
369
|
|||||||||
Vested and expected to vest as of December 31, 2019
|
6,726,695
|
7.88
|
7.39
|
$ |
369
|
|||||||||||
Exercisable as of December 31, 2019
|
3,769,835
|
$ |
6.87
|
$ |
6.47
|
$ |
328
|
|||||||||
|
Year Ended
|
|||||||
|
December 31,
|
|||||||
|
2019
|
|
2018
|
|
||||
Research and development
|
$ |
4,361
|
$ |
2,760
|
||||
General and administrative
|
5,197
|
4,253
|
||||||
Restructuring charges
|
910
|
—
|
||||||
Total stock-based compensation expense
|
$ |
10,468
|
$ |
7,013
|
||||
|
Year Ended
December 31,
|
|||||||
|
2019
|
|
2018
|
|
||||
Expected term (in years)
|
6.2
|
6.2
|
||||||
Expected volatility
|
76
|
% |
77
|
% | ||||
Risk-free interest rate
|
2.13
|
% |
2.62
|
% | ||||
Expected dividend yield
|
—
|
%
|
—
|
%
|
||||
Weighted-average grant date fair value per share
|
$ |
5.60
|
$ |
8.14
|
|
Total
|
|
||
Balances as of December 31, 2017
|
$ |
3,295
|
||
Increases related to prior year tax positions
|
6
|
|||
Increases related to 2018 tax positions
|
1,283
|
|||
Balances as of December 31, 2018
|
$ |
4,584
|
||
Increases related to prior year tax positions
|
83
|
|||
Increases related to 2019 tax positions
|
1,719
|
|||
Balances as of December 31, 2019
|
$ |
6,386
|
||
|
Termination
Benefits |
|
Contract
Termination Costs |
|
|
Total
|
|
||||||
Balances as of January 1, 2019
|
$ |
—
|
$ |
—
|
$ |
—
|
|||||||
Restructuring charges
|
2,912
|
413
|
3,325
|
||||||||||
Reductions for cash payments
|
(132
|
) |
—
|
(132
|
) | ||||||||
Balances as of December 31, 2019
|
$ |
2,780
|
$ |
413
|
$ |
3,193
|
|||||||
|
|
|
CymaBay Therapeutics, Inc.
|
|||
|
|
|
Registrant
|
|||
March 16, 2020
|
|
|
/s/ Sujal Shah
|
|||
Date
|
|
|
Sujal Shah
President and Chief Executive Officer
|
Name and Signature
|
Title
|
Date
|
||
/s/ Sujal Shah
Sujal Shah
|
President, Chief Executive Officer and Director
(Principal Executive Officer)
|
March 16, 2020
|
||
/s/ Daniel Menold
Daniel Menold
|
Vice President, Finance
(Principal Financial Officer)
|
March 16, 2020
|
||
/s/ Robert J. Wills
Robert J. Wills, Ph.D.
|
Director
|
March 16, 2020
|
||
/s/ Kurt von Emster
Kurt von Emster, CFA
|
Director
|
March 16, 2020
|
||
/s/ Caroline Loewy
Caroline Loewy
|
Director
|
March 16, 2020
|
||
/s/ Paul F. Truex
Paul F. Truex
|
Director
|
March 16, 2020
|
Exhibit 4.2
DESCRIPTION OF COMMON STOCK
Our authorized capital stock consists of 100,000,000 shares of common stock, $0.0001 par value per share, and 10,000,000 shares of preferred stock, $0.0001 par value per share. A description of material terms and provisions of our certificate of incorporation and bylaws affecting the rights of holders of our capital stock is set forth below. The description is intended as a summary, and is qualified in its entirety by reference to our certificate of incorporation and the bylaws.
Common stock
Voting Rights. Each holder of common stock is entitled to one vote for each share of common stock held on all matters submitted to a vote of the stockholders, including the election of directors. The certificate of incorporation and by-laws do not provide for cumulative voting rights in connection with election of directors unless, at the time of such election, we are subject to Section 2115(b) of the California General Corporation Law. The affirmative vote of holders of 66 2/3% of the voting power of all of the then-outstanding shares of capital stock, voting as a single class, will be required to amend certain provisions of our amended and restated certificate of incorporation, including provisions relating to amending our amended and restated bylaws, and removal of directors.
Dividends. Subject to preferences that may be applicable to any then outstanding preferred stock, the holders of outstanding shares of common stock may receive dividends, if any, as may be declared from time to time by the Board of Directors out of legally available funds. We have never issued a dividend on shares of its common stock and has no intention to do so in the future.
Liquidation. In the event we of liquidate, dissolve or wind up, the assets legally available for distribution shall be distributed ratably to the holders of shares of common stock and preferred stock, subject to the satisfaction of any liquidation preference granted to the holders of any outstanding shares of preferred stock.
Rights and Preferences. Holders of common stock have no preemptive, conversion or subscription rights, and there are no redemption or sinking fund provisions applicable to the common stock. The rights, preferences and privileges of the holders of common stock are subject to, and may be adversely affected by, the rights of the holders of shares of any series of preferred stock that we may designate and issue in the future.
Fully Paid and Nonassessable. All outstanding shares of common stock are fully paid and nonassessable.
Anti-takeover effects of provisions of our certificate of incorporation and bylaws and Delaware law
Certificate of incorporation and bylaws. Our amended and restated certificate of incorporation and amended and restated bylaws, include a number of provisions that may deter or impede hostile takeovers or changes of control or management. These provisions include:
Issuance of undesignated preferred stock. Our Board of Directors has the authority, without further action by the stockholders, to issue up to 10,000,000 shares of undesignated preferred stock with rights and preferences, including voting rights, designated from time to time by our Board of Directors. The existence of authorized but unissued shares of preferred stock enables our Board of Directors to make it more difficult or to discourage an attempt to obtain control of us by means of a merger, tender offer, proxy contest or otherwise.
Board of Directors vacancies. Our amended and restated certificate of incorporation and amended and restated bylaws authorize only our Board of Directors to fill vacant directorships. In addition, the number of directors constituting our Board of Directors may be set only by resolution adopted by a majority vote of our entire Board of Directors. These provisions prevent a stockholder from increasing the size of our Board of Directors and gaining control of our Board of Directors by filling the resulting vacancies with its own nominees.
Stockholder action; special meetings of stockholders. Our amended and restated certificate of incorporation provides that our stockholders may not take action by written consent, but may only take action at annual or special meetings of our stockholders. Stockholders will not be permitted to cumulate their votes for the election of directors unless required by applicable law. Our amended and restated bylaws provide that only the chairman of our Board of Directors, chief executive officer or a majority of our Board of Directors may call special meetings of our stockholders.
Advance notice requirements for stockholder proposals and director nominations. Our amended and restated bylaws provide advance notice procedures for stockholders seeking to bring business before our annual meeting of stockholders, or to nominate candidates for election as directors at our annual meeting of stockholders. Our amended and restated bylaws also specify certain requirements as to the form and content of a stockholders notice. These provisions may make it more difficult for our stockholders to bring matters before our annual meeting of stockholders or to nominate directors at annual meetings of stockholders.
We designed these provisions to enhance the likelihood of continued stability in the composition of our Board of Directors and its policies, to discourage certain types of transactions that may involve an actual or threatened acquisition of us, and to reduce our vulnerability to an unsolicited acquisition proposal. We also designed these provisions to discourage certain tactics that may be used in proxy fights. However, these provisions could have the effect of discouraging others from making tender offers for our shares and, as a consequence, they may also reduce fluctuations in the market price of our shares that could result from actual or rumored takeover attempts.
Section 203 of the Delaware General Corporation Law
We are subject to Section 203 of the DGCL, which prohibits a Delaware corporation from engaging in a business combination with any interested stockholder for a period of three years following the date the person became an interested stockholder, with the following exceptions:
|
before such date, the Board of Directors of the corporation approved either the business combination or the transaction that resulted in the stockholder becoming an interested holder; |
|
upon completion of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction began, excluding for purposes of determining the voting stock outstanding (but not the outstanding voting stock owned by the interested stockholder) those shares owned (a) by persons who are directors and also officers and (b) pursuant to employee stock plans in which employee participants do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer; and |
|
on or after such date, the business combination is approved by the Board of Directors and authorized at an annual or special meeting of the stockholders, and not by written consent, by the affirmative vote of at least 66 2/3% of the outstanding voting stock that is not owned by the interested stockholder. |
In general, Section 203 of the DGCL defines business combination to include the following:
|
any merger or consolidation involving the corporation and the interested stockholder; |
|
any sale, transfer, pledge or other disposition of 10% or more of the assets of the corporation involving the interested stockholder; |
|
subject to certain exceptions, any transaction that results in the issuance or transfer by the corporation of any stock of the corporation to the interested stockholder; |
|
any transaction involving the corporation that has the effect of increasing the proportionate share of the stock or any class or series of the corporation beneficially owned by the interested stockholder; and |
|
the receipt by the interested stockholder of the benefit of any loans, advances, guarantees, pledges or other financial benefits by or through the corporation. |
Section 203 of the DGCL defines an interested stockholder as an entity or person who, together with the entitys or persons affiliates and associates, beneficially owns, or is an affiliate of the corporation and within three years prior to the time of determination of interested stockholder status did own, 15% or more of the outstanding voting stock of the corporation. A Delaware corporation may opt out of these provisions with an express provision in its certificate of incorporation. We have not opted out of these provisions, which may as a result, discourage or prevent mergers or other takeover or change of control attempts of us.
Exhibit 21.1
List of Subsidiaries
Name of Subsidiary |
State or Jurisdiction in
Which Incorporated or Organized |
|||
CymaBay UK, Ltd. | ||||
CymaBay Ireland, Limited | ||||
CymaBay Canada, Ltd. |
Exhibit 23.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the incorporation by reference in the following Registration Statements:
(1) |
Registration Statement (Form S-3 No. 333-229082) of CymaBay Therapeutics, Inc., and |
(2) |
Registration Statements (Form S-8 Nos. 333-195211, 333-198289, 333-202941, 333-210453, 333-216905, 333-223687, 333-226741, and 333-229953) pertaining to the Metabolex, Inc. 2003 Equity Incentive Plan, and the CymaBay Therapeutics, Inc. 2013 Equity Incentive Plan; |
of our reports dated March 16, 2020, with respect to the consolidated financial statements of CymaBay Therapeutics, Inc. and the effectiveness of internal control over financial reporting of CymaBay Therapeutics, Inc. included in this Annual Report (Form 10-K) of CymaBay Therapeutics, Inc. for the year ended December 31, 2019.
/s/ Ernst & Young LLP
Redwood City, California
March 16, 2020
Exhibit 31.1
CERTIFICATIONS
I, Sujal Shah, certify that:
1. |
I have reviewed this Form 10-K of CymaBay Therapeutics, Inc.; |
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. |
The registrants other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
a) |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
b) |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
c) |
Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
d) |
Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and |
5. |
The registrants other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions): |
a) |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and |
b) |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting. |
Date: March 16, 2020
/s/ Sujal Shah |
Sujal Shah |
President and Chief Executive Officer |
(Principal Executive Officer) |
Exhibit 31.2
CERTIFICATIONS
I, Daniel Menold, certify that:
1. |
I have reviewed this Form 10-K of CymaBay Therapeutics, Inc.; |
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. |
The registrants other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
a) |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
b) |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
c) |
Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
d) |
Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and |
5. |
The registrants other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions): |
a) |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and |
b) |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting. |
Date: March 16, 2020
/s/ Daniel Menold |
Daniel Menold |
Vice President, Finance |
(Principal Accounting Officer) |
Exhibit 32.1
CERTIFICATION
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the Exchange Act), and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Sujal Shah., President and Chief Executive Officer and Daniel Menold, Vice President, Finance of CymaBay Therapeutics, Inc. (the Company), hereby certifies that, to the best of his knowledge:
1. |
The Companys Annual Report on Form 10-K for the period ended December 31, 2019, to which this Certification is attached as Exhibit 32.1 (the Annual Report) fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act, and |
2. |
The information contained in the Annual Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
In Witness Whereof, the undersigned have set their hands hereto as of the 16th day of March, 2020.
/s/ Sujal Shah |
Sujal Shah |
President and Chief Executive Officer |
(Principal Executive Officer) |
/s/ Daniel Menold |
Daniel Menold |
Vice President, Finance |
(Principal Financial Officer) |
This certification accompanies the Form 10-K to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of CymaBay Therapeutics, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-K), irrespective of any general incorporation language contained in such filing.