Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)

Inclusion Criteria:

1. Must have given written informed consent (signed and dated)

2. Participated in a PBC study with seladelpar

3. Females of reproductive potential must use at least one barrier contraceptive and asecond effective birth control method during the study and for at least 90 daysafter the last dose. Male subjects who are sexually active with female partners ofreproductive potential must use barrier contraception and their female partners mustuse a second effective birth control method during the study and for at least 90days after the last dose

Exclusion Criteria:

Exclusion criteria are only applicable for subjects with a seladelpar interruption greater than 4 weeks prior to Day 1 of this study and for subjects who participated in CB8025-21838 irrespective of seladelpar interruption.

1. Treatment-related adverse event (AE) leading to study drug discontinuation in aprevious PBC study with seladelpar

2. A medical condition, other than PBC, that in the Investigator's opinion wouldpreclude full participation in the study or confound its results (e.g., cancer, anyactive infection)

3. AST or ALT above 3 × the upper limit of normal (ULN)

4. Total bilirubin above 2 × ULN

5. MELD score ≥ 12. For subjects on anticoagulation medication, evaluation of thebaseline INR, in concert with any current dose adjustments in anti-coagulantmedications, will be taken into account when calculating this score. This will bedone in consultation with the medical monitor.

6. Evidence of advanced PBC as defined by the Rotterdam criteria: albumin below 1× thelower limit of normal (LLN) AND total bilirubin above 1 × ULN)

7. eGFR ≤45 mL/min/1.73 m2 (calculated by MDRD formula)

8. Auto-immune hepatitis

9. Primary sclerosing cholangitis

10. Known history of alpha-1-antitrypsin deficiency

11. Known history of chronic viral hepatitis

12. For females, pregnancy or breast-feeding

13. Use of colchicine, methotrexate, azathioprine, or long-term use of systemic steroids (e.g. prednisone, prednisolone, budesonide) (>2 weeks) within 2 months prior toScreening

14. Current use of fibrates or use of fibrates within 3 months prior to Screening

15. Current use of obeticholic acid or use of obeticholic acid within 3 months prior toScreening

16. Use of an experimental or unapproved treatment for PBC within 3 months prior toScreening

17. History of malignancy diagnosed or treated, actively or within 2 years, or activeevaluation for malignancy; localized treatment of squamous or non-invasive basalcell skin cancers and cervical carcinoma in-situ is allowed if appropriately treatedprior to Screening

18. Treatment with any other investigational therapy or medical device within 30 days orwithin 5 half-lives, whatever is longer, prior to Screening

19. Any other condition(s) that would compromise the safety of the subject or compromisethe quality of the clinical study, as judged by the Investigator

20. Immunosuppressant therapies (e.g., cyclosporine, tacrolimus, anti-TNF or otherimmunosuppressive biologics)

21. Other medications that effect liver or GI functions such as absorption ofmedications or the roux-en-y gastric bypass procedure may be prohibited and shouldbe discussed with the medical monitor on a case-by-case basis

22. Positive for:

23. Hepatitis B, defined as the presence of hepatitis B surface antigen

24. Hepatitis C, defined as the presence of hepatitis C virus ribonucleic acid (RNA)

25. Human immunodeficiency virus (HIV) antibody

26. Active COVID-19 infection during screening