On August 14, 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 second quarter ended June 30, 2023 (Press release, LianBio, AUG 14, 2023, View Source [SID1234634365]).

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"During the first half of 2023, we achieved multiple clinical development milestones and advanced our pipeline closer to patients in need of new treatment options," said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. "Over the next twelve months, we are looking forward to our first anticipated approval in China, building and developing our cardiovascular sales force, filing an NDA to support approval of TP-03 in China, and initiating a pivotal trial of infigratinib in gastric cancer. We believe we are well positioned for LianBio’s first launches in our territories later this year when we begin to commercialize mavacamten in Singapore and Macau."

Recent Business Highlights and Clinical Development Updates

Mavacamten commercial preparation ongoing in China with NDA under priority review; Asia Pacific regulatory milestones achieved with Singapore and Macau approvals granted and additional NDA under review in Hong Kong

•In the second quarter of 2023, LianBio continued to progress the Company’s collaboration with the Chinese Cardiovascular Association (CCA) to develop HCM centers of excellence (COE), with 17 key hospitals now taking part in the CCA’s HCM COE pilot program.
•In July 2023, LianBio announced data from the Phase 3 EXPLORER-CN trial of mavacamten in Chinese symptomatic oHCM patients were accepted for a late-breaking presentation at the European Society of Cardiology (ESC) Congress 2023.
•In June 2023, mavacamten was approved for the treatment of adults with symptomatic oHCM in Singapore.
•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.
•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. Mavacamten also demonstrated improvement across all secondary endpoints. Mavacamten demonstrated a safety profile consistent with previous studies.

•In April 2023, the China NMPA accepted with priority review the NDA for mavacamten for the treatment of adults with symptomatic oHCM.
Registrational Phase 3 LIBRA clinical trial of TP-03 for the treatment of Chinese Demodex blepharitis patients completed enrollment; TP-03 approved in the United States
•In July 2023, LianBio partner Tarsus Pharmaceuticals announced the U.S. Food and Drug Administration’s approval of TP-03 for the treatment of adults with Demodex blepharitis.
•In June 2023, LianBio announced completion of enrollment in the Phase 3 LIBRA clinical trial of TP-03 in Chinese Demodex blepharitis patients. LianBio expects the LIBRA trial to support TP-03 registration in China.
Positive topline data announced from Phase 2a trial of infigratinib in Chinese patients with gastric cancer and receipt of Breakthrough Therapy Designation in China
•In June 2023, LianBio announced topline results from the Company’s Phase 2a proof of concept trial evaluating infigratinib in patients with third-line or later gastric cancer or gastroesophageal junction adenocarcinoma with fibroblast growth factor receptor-2 (FGFR2) gene amplification. The trial demonstrated a confirmed objective response rate (ORR) of 25.0% (n=20). The observed mediation duration of response was 3.8 months.
•Based on these data, the NMPA granted Breakthrough Therapy Designation to infigratinib for the treatment of gastric cancer.
Phase 1 clinical trial of SHP2 inhibitor BBP-398 in combination with osimertinib in Chinese non-small cell lung cancer (NSCLC) patients with EGFR mutations initiated
•In August 2023, LianBio announced the initiation of a Phase 1 trial of BBP-398 in combination with osimertinib in Chinese NSCLC patients with EGFR mutations.
•In July 2023, LianBio entered into a clinical supply agreement with AstraZeneca in China to procure osimertinib for this clinical trial.
Commercial infrastructure build continues with Chief Commercial Officer appointment
•In April 2023, Pascal Qian was promoted to Chief Commercial Officer to oversee the continued growth of the company’s commercial capabilities. 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 into the first half of 2025.
Key Anticipated Milestones
Mavacamten
•LianBio expects to begin enrolling patients in BMS’s ongoing Phase 3 ODYSSEY-HCM trial of mavacamten in non-obstructive HCM (nHCM) in China in mid-2024.
•LianBio anticipates NDA approval in China in mid-2024, and commercial launch in China in the second half of 2024.
•LianBio expects to launch mavacamten in Singapore and Macau in the fourth quarter of 2023.
•LianBio plans to file NDAs to support mavacamten approval in Taiwan and Thailand in the fourth quarter of 2023.
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
•Data from the Phase 2a clinical trial of infigratinib in locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 gene amplification were accepted for a poster presentation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023, to be held October 20-24 in Madrid.
•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 a PD-1 inhibitor in advanced solid tumors in the first half of 2024.

Second Quarter 2023 Financial Results

Research & Development Expenses

Research and development expenses were $9.5 million for the second quarter of 2023 compared to $28.6 million for the second quarter of 2022, and $20.3 million for the six month period ended June 30, 2023 compared to $40.9 million for the six month period ended June 30, 2022. The decrease was primarily attributable to increased milestone payments in 2022 and was partially offset by higher development activities to support clinical trials in 2023.

General & Administrative Expenses

General and administrative expenses were $15.6 million for the second quarter of 2023 compared to $14.6 million for the second quarter of 2022, and $30.7 million for the six month period ended June 30, 2023 compared to $30.6 million for the six month period ended June 30, 2022. The increase was primarily attributable to increases in payroll and personnel-related expenses (including share-based compensation expense) for increased employee headcount and was partially offset by lower expenses for legal, consulting and accounting services.

Net Loss

Net loss was $21.6 million for the second quarter of 2023 compared to net loss of $42.4 million for the second quarter of 2022, and $45.7 million for the six month period ended June 30, 2023 compared to $70.1 million for the six month period ended June 30, 2022.

Cash Balance

Cash, cash equivalents, marketable securities and restricted cash at June 30, 2023 totaled $267.3 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 into the first half of 2025.