UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
________________________
FORM 8-K
________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 11, 2023
________________________
(Exact name of registrant as specified in its charter)
________________________
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||
| (Address of principal executive offices) | (Zip Code) | |||||||
(Registrant’s telephone number, including area code): (609 ) 486-2308
Not Applicable
(Former name or former address, if changed since last report)
________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company x
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. x
Item 2.02 Results of Operations and Financial Condition.
On May 11, 2023, LianBio (the “Company”) issued a press release announcing its financial results for the fiscal quarter ended March 31, 2023. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
Item 9.01 Financial Statements and Exhibits.
(d)Exhibits
| Exhibit No. | Description | |||||||
| 99.1 | ||||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| LIANBIO | |||||
| By: | /s/ Yizhe Wang | ||||
| Yizhe Wang | |||||
| Chief Executive Officer | |||||
Date: May 11, 2023
LianBio Reports First Quarter 2023 Financial Results and Provides Corporate Update
• Phase 3 trial of mavacamten in Chinese patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) met primary endpoint
•China National Medical Products Administration (NMPA) accepted mavacamten New Drug Application (NDA) with priority review
•Mavacamten commercial launch preparations continue in China, supported by the promotion of Pascal Qian to Chief Commercial Official
•Cash, cash equivalents and marketable securities of $286.5 million with runway through the end of 2024
Shanghai and Princeton, N.J., May 11, 2023 – 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, 2023.
“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.
+++
About LianBio
LianBio is a cross-border biotechnology company on a mission to bring transformative medicines to historically underserved patients in China and other Asian markets. Through partnerships with highly innovative biopharmaceutical companies around the world, LianBio is advancing a diversified portfolio of clinically validated product candidates with the potential to drive new standards of care across cardiovascular, oncology, ophthalmology, and inflammatory disease indications. LianBio is establishing an international infrastructure to position the company as a partner of choice with a platform to provide access to China and other Asian markets. For more information, please visit www.lianbio.com.
Cautionary Note Regarding Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements. The words “anticipate,” "plan," " believe," “continue,” "estimate," “expect,” “potential,” "may," “project,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include, but are not limited to, statements concerning the Company’s plans and expectations with respect to the initiation and completion of its clinical trials, including the Phase 2 clinical trial of infigratinib in patients with FGFR2 gene amplification and a Phase 1 clinical trial of BBP-398 in combination with an EGFR-inhibitor in non-small cell lung cancer; the Company’s plans to present and report results and data from EXPLORER-CN, the Phase 3 LIBRA trial of TP-03 and the ongoing Phase 2a clinical trial of infigratinib; the advancement of its pipeline of therapeutic candidates; the continued growth of its organization; its ability to bring transformative medicines to patients in China and across Asia; its ability to navigate complex regulatory environments in Greater China and Asia; the Company's plans and expectations with respect to preparation for potential commercialization and product launch, including the anticipated commercial launch of mavacamten in China; and the timeline through which it expects to be able to fund its operating expenses and capital expenditure requirements, as well as statements regarding its partners’ announced plans and expectations with respect to their planned product development activities, preclinical studies and clinical trials. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the Company’s ability to successfully initiate and conduct its planned clinical trials and complete such clinical trials and obtain results on its expected timelines, or at all; the Company’s plans to leverage data generated in its partners’ global registrational trials and clinical development programs to obtain regulatory approval and maximize patient reach for its product candidates; the Company’s ability to identify new product candidates and successfully acquire such product candidates from third parties; competition from other biotechnology and pharmaceutical companies; general market
conditions; the impact of changing laws and regulations and those risks and uncertainties described in LianBio’s filings with the U.S. Securities and Exchange Commission (SEC), including LianBio’s Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and LianBio specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon this information as current or accurate after its publication date.
For investor inquiries, please contact:
Elizabeth Anderson, VP Communications and Investor Relations
E: elizabeth.anderson@lianbio.com
T: (646) 655-8390
For media inquiries, please contact:
Josh Xu, Director of Communications
E: josh.xu@lianbio.com
T: +86 136 6140 8315
Katherine Smith, Evoke Canale
E: katherine.smith@evokegroup.com
T: (619) 849-5378
LianBio
Consolidated Balance Sheets
(In thousands, except share and per share amounts) (Unaudited)
| March 31, 2023 | December 31, 2022 | ||||||||||
| Assets | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 102,334 | $ | 79,221 | |||||||
| Marketable securities | 184,203 | 223,142 | |||||||||
| Prepaid expenses and other current assets | 8,500 | 8,640 | |||||||||
| Other receivable | 1,013 | 1,770 | |||||||||
| Total current assets | 296,050 | 312,773 | |||||||||
| Restricted cash, non-current | 73 | 73 | |||||||||
| Property and equipment, net | 2,836 | 3,116 | |||||||||
| Operating lease right-of-use assets | 3,604 | 3,978 | |||||||||
| Other non-current assets | 20 | 20 | |||||||||
| Total assets | $ | 302,583 | $ | 319,960 | |||||||
| Liabilities and Shareholders’ Equity | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | $ | 5,431 | $ | 1,453 | |||||||
| Accrued expenses | 16,627 | 19,826 | |||||||||
| Current portion of operating lease liabilities | 1,906 | 1,851 | |||||||||
| Other current liabilities | 1,961 | 485 | |||||||||
| Total current liabilities | 25,925 | 23,615 | |||||||||
| Operating lease liabilities | 2,014 | 2,488 | |||||||||
| Other liabilities | 217 | 210 | |||||||||
| Nonrefundable research deposit | — | — | |||||||||
| Total liabilities | $ | 28,156 | $ | 26,313 | |||||||
| Commitments and contingencies (Note 8) | |||||||||||
| Ordinary shares, $0.000017100448 par value. Authorized 2,923,900,005 shares as of March 31, 2023; 107,164,175 shares issued and outstanding at March 31, 2023; Authorized 2,923,900,005 shares as of December 31, 2022; 107,043,924 shares issued and outstanding at December 31, 2022 | 2 | 2 | |||||||||
| Additional paid-in capital | 736,752 | 732,476 | |||||||||
| Accumulated other comprehensive loss | (1,531) | (2,080) | |||||||||
| Accumulated deficit | (494,570) | (470,525) | |||||||||
| Total LianBio shareholders’ equity | 240,653 | 259,873 | |||||||||
| Non-controlling interest | 33,774 | 33,774 | |||||||||
| Total shareholders’ equity | 274,427 | 293,647 | |||||||||
| Total liabilities and shareholders’ equity | $ | 302,583 | $ | 319,960 | |||||||
LianBio
Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts) (Unaudited)
| Three Months Ended March 31, | |||||||||||
| 2023 | 2022 | ||||||||||
| Operating expenses: | |||||||||||
| Research and development | $ | 10,831 | $ | 12,329 | |||||||
| General and administrative | 15,138 | 16,088 | |||||||||
| Total operating expenses | 25,969 | 28,417 | |||||||||
| Loss from operations | (25,969) | (28,417) | |||||||||
| Other income (expense): | |||||||||||
| Interest income, net | 2,406 | 280 | |||||||||
| Other (expense) income, net | (44) | 417 | |||||||||
| Net loss before income taxes | (23,607) | (27,720) | |||||||||
| Income taxes | 438 | 6 | |||||||||
| Net loss | (24,045) | (27,726) | |||||||||
| Other comprehensive income (loss): | |||||||||||
| Foreign currency translation income (loss), net of tax | 104 | (393) | |||||||||
| Unrealized gain (loss) on marketable securities, net of tax | 445 | (823) | |||||||||
| Comprehensive loss | $ | (23,496) | $ | (28,942) | |||||||
| Net loss per share attributable to ordinary shareholders, basic and diluted | $ | (0.22) | $ | (0.26) | |||||||
| Weighted-average shares outstanding used in computing net loss per share attributable to ordinary shareholders, basic and diluted | 107,162,025 | 107,275,458 | |||||||||