On May 11, 2023 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, 2023 (Press release, LianBio, MAY 11, 2023, View Source [SID1234631518]).

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"We continue to achieve multiple significant milestones, propelling the company towards the anticipated commercial launch of mavacamten in China," said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. "Our team’s demonstrated proficiency in navigating the Chinese regulatory landscape instills confidence in our cross-border model. With the recent progress we’ve made, we believe we are on track to bring our first drug to market in China next year, while we continue to advance our other key programs through the clinic."
Recent Business Highlights and Clinical Development Updates

Mavacamten late-stage clinical development and launch readiness activities on track in China with NDA on file; mavacamten approved in Macau; NDAs under review in Singapore and Hong Kong
•In January 2023, mavacamten was added to The Joint Committee of Cardiomyopathy Specialty Alliance, National Center for Cardiovascular Diseases/Cardiovascular Precision Medicine Branch of China International Exchange and Promotive Association for Medical and Health Care’s 2023 Guidelines for the Diagnosis and Treatment of Patients with Hypertrophic Cardiomyopathy.
•In April 2023, the China NMPA accepted with priority review the NDA for mavacamten for the treatment of adults with symptomatic oHCM.
•In April 2023, LianBio announced topline results from the Phase 3 EXPLORER-CN trial evaluating mavacamten in Chinese patients with oHCM. EXPLORER-CN met the primary endpoint, demonstrating statistically significant and clinically meaningful improvement in Valsalva left ventricular outflow tract gradient from baseline to week 30 compared to placebo, and a safety profile consistent with previous studies.
•In May 2023, mavacamten was approved for the treatment of adults with symptomatic New York Heart Association Class II-III oHCM in the Macau Special Administrative Region.

Commercial infrastructure build continues in preparation for anticipated 2024 mavacamten launch
•In April 2023, Pascal Qian was promoted to Chief Commercial Officer to oversee the continued growth of the company’s commercial capabilities in preparation for the anticipated mavacamten commercial launch in China. He will continue to also serve as the company’s China General Manager.
Business is well-positioned to achieve anticipated milestones
•Current cash runway is projected to extend through the end of 2024.
Key Anticipated Milestones
Mavacamten
•LianBio plans to present detailed results from EXPLORER-CN at an upcoming medical meeting.
TP-03
•LianBio expects to report topline data from the Phase 3 LIBRA trial of TP-03 in Chinese patients with Demodex blepharitis in the fourth quarter of 2023.
Infigratinib
•LianBio expects to report topline data from the ongoing Phase 2a clinical trial of infigratinib in locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 gene amplification and other advanced solid tumors with FGFR genomic alterations in the second half of 2023.
•LianBio expects to initiate a pivotal Phase 2 trial of infigratinib in locally advanced or metastatic gastric cancer patients with FGFR2 gene amplification in the first half of 2024 to support regulatory approval in China.
BBP-398
•LianBio expects to initiate a Phase 1 clinical trial of BBP-398 in combination with an EGFR-inhibitor in non-small cell lung cancer in the second half of 2023.

First Quarter 2023 Financial Results

Research & Development Expenses

Research and development expenses were $10.8 million for the first quarter of 2023 compared to $12.3 million for the first quarter of 2022. The decrease was primarily attributable to increased milestone payments in 2022, and was offset by higher development activities to support clinical trials in 2023.
General & Administrative Expenses
General and administrative expenses were $15.1 million for the first quarter of 2023 compared to $16.1 million for the first quarter of 2022. The decrease was primarily attributable to decreases in expenses for legal, consulting and accounting services.

Net Loss

Net loss was $24.0 million for the first quarter of 2023 compared to net loss of $27.7 million for the first quarter of 2022.

Cash Balance
Cash, cash equivalents, marketable securities and restricted cash at March 31, 2023 totaled $286.6 million compared to $302.4 million as of December 31, 2022. LianBio projects its current cash, cash equivalents, marketable securities, and restricted cash will be sufficient to fund its current operating plan through the end of 2024.