On May 12, 2022 LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, reported financial results for the first quarter ended March 31, 2022 and provided a corporate update (Press release, LianBio, MAY 12, 2022, View Source [SID1234614312]).
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"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.
Mavacamten development progress continues in China
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.
TP-03 met all primary and secondary endpoints in Tarsus’s second U.S. pivotal trial
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.
Development partner ReViral Ltd. entered into definitive agreement to be acquired by Pfizer Inc.
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.
Formation of Scientific Advisory Board
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.
Appointment to the Board of Directors
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.
Business is well-positioned to achieve anticipated milestones
Current cash runway is projected to extend through mid-2024.
Key Milestones Anticipated in 2022
Mavacamten
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.
TP-03
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.
NBTXR3
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.
Infigratinib
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.
First Quarter 2022 Financial Results
Research & Development Expenses
Research and development expenses were $12.3 million for the first quarter of 2022 compared to $53.4 million for the first quarter of 2021. The decrease was primarily attributable to increased milestone payments in 2021, and was offset by higher development activities to support clinical trials and personnel-related expenses in 2022.
General & Administrative Expenses
General and administrative expenses were $16.1 million for the first quarter of 2022 compared to $7.1 million for the first quarter of 2021. The increase was primarily attributable to increases in payroll and personnel-related expenses (including share-based compensation expense) for increased employee headcount and higher expense for legal, consulting and accounting services.
Net Loss
Net loss was $27.7 million for the first quarter of 2022 compared to net loss of $61.6 million for the first quarter of 2021.
Cash Balance
Cash, cash equivalents, marketable securities and restricted cash at March 31, 2022 totaled $389.1 million compared to $403.2 million as of December 31, 2021. LianBio projects its current cash, cash equivalents, marketable securities, and restricted cash will be sufficient to fund its current operating plan through mid-2024.