• LianBio’s partner, Bristol Myers Squibb, has received U.S. FDA approval of mavacamten for the treatment of patients with obstructive hypertrophic cardiomyopathy (oHCM) • Registrational Phase 3 EXPLORER-CN clinical trial of mavacamten in Chinese patients with symptomatic oHCM ongoing • LianBio’s partner, Tarsus, announced positive topline data from the Phase 3 Saturn-2 clinical trial of TP-03 in patients with Demodex blepharitis • LianBio’s partner, ReViral, entered into definitive agreement to be acquired by Pfizer • Three additional pipeline programs expected to enter into registrational Phase 3 clinical trials in China by year-end 2022 • Cash balance of $389.1 million at the end of first quarter 2022 with runway through mid- 2024
Shanghai and Princeton, NJ - May 12, 2022 – LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, today reported financial results for the first quarter ended March 31, 2022 and provided a corporate update. “LianBio continues to solidify our standing as the partner of choice to bring clinically validated therapeutic candidates to Greater China and other Asian markets,” said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. “Several of our partners have recently reached significant global milestones, including a U.S. FDA approval, positive pivotal trial results, and an acquisition. We congratulate our development partners on these important achievements. In China, we are committed to accelerating patient access to potentially transformative therapeutics, and we remain on track to complete enrollment in our ongoing Phase 3 EXPLORER-CN trial of mavacamten and to initiate three additional pivotal studies this year.” Recent Business Highlights and Clinical Development Updates BMS receives FDA approval for mavacamten and presents additional positive Phase 3 clinical trial results
- In April 2022, LianBio’s partner Bristol Myers Squibb (BMS) presented data from two clinical trials of mavacamten at the American College of Cardiology 71st Annual Scientific Session. Data from the EXPLORER-LTE clinical trial demonstrated sustained improvements in clinically meaningful cardiovascular outcomes at weeks 48 and 84 in patients with symptomatic oHCM receiving mavacamten. Data from the Phase 3 VALOR-HCM clinical trial demonstrated the addition of mavacamten significantly reduced the need for septal reduction therapy (SRT) in patients with severely symptomatic oHCM who had been appropriate for SRT at baseline.
- In April 2022, BMS announced the U.S. Food and Drug Administration (FDA) approval of mavacamten for the treatment of adults with symptomatic New York Heart Association Class II-III oHCM to improve functional capacity and symptoms.
- In January 2022, LianBio initiated the Phase 3 EXPLORER-CN clinical trial of mavacamten in Chinese patients with symptomatic oHCM. Patient enrollment is ongoing.
- In February 2022, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation in China for mavacamten for the treatment of patients with oHCM.
- In May 2022, LianBio announced topline results from the Phase 1 pharmacokinetic (PK) study of mavacamten in healthy Chinese volunteers. A single oral administration of mavacamten in Chinese healthy adult subjects showed no new safety signals. The data demonstrated a favorable PK, safety and tolerability profile comparable to that observed in the Phase 1 pharmacokinetic study of mavacamten conducted by LianBio’s partner, MyoKardia, now a wholly owned subsidiary of BMS, in healthy volunteers in the United States.
- In May 2022, Tarsus announced positive topline data from the Phase 3 Saturn-2 clinical trial of TP-03 in Demodex blepharitis (DB) patients. The clinical trial met all primary and secondary endpoints and TP-03 was well-tolerated.
- Based on these data, Tarsus announced that it will submit a New Drug Application to the U.S. FDA in the second half of 2022.
- In April 2022, Pfizer and ReViral entered into a definitive agreement under which Pfizer will acquire ReViral and its respiratory syncytial virus therapeutic candidates, including sisunatovir.
- In April 2022, LianBio formed a Scientific Advisory Board (SAB). The LianBio SAB is comprised of industry leaders in global drug development who are serving as strategic advisors to the Company.
- In April 2022, LianBio appointed Wei Wei Chen to the Board of Directors. Ms. Chen brings over 17 years of experience serving as chief financial officer of companies in the consumer, retail and healthcare sectors.
- Current cash runway is projected to extend through mid-2024.
- Enrollment is ongoing in the EXPLORER-CN Phase 3 clinical trial of mavacamten in Chinese patients with oHCM. LianBio expects to complete enrollment in the second half of 2022.
- LianBio remains on track to initiate a Phase 3 clinical trial of TP-03 in Chinese patients with DB in the second half of 2022 to support regulatory approval in China.
- LianBio expects to begin dosing Chinese patients in Nanobiotix’s ongoing global pivotal Phase 3 NANORAY-312 clinical trial of NBTXR3 for the treatment of locally advanced head and neck squamous cell carcinoma in elderly patients ineligible for cisplatin in the second half of 2022.
- Enrollment is ongoing in LianBio’s Phase 2a clinical trial of infigratinib in locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with fibroblast growth factor receptor-2 (FGFR2) gene amplification and other advanced solid tumors with FGFR genomic alterations.
- LianBio expects to begin dosing Chinese patients in QED’s ongoing global pivotal Phase 3 PROOF-301 clinical trial of infigratinib in first-line cholangiocarcinoma (CCA) patients with FGFR2 gene fusions/translocations in the second half of 2022.
