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ArriVent BioPharma Reports First Quarter 2024 Financial Results Presented preclinical firmonertinib (formerly furmonertinib) data at the 2024 American Association for Cancer Research ("AACR") Annual Meeting Dosed first p

Key Takeaway: ArriVent BioPharma has reported its financial results for Q1 2024, demonstrating significant progress in its clinical studies. The company completed enrollment for its Phase 1b trial focusing on NSCLC patients and initiated a combination study involving firmonertinib. Recent data presented at the AACR Annual Meeting showcased firmonertinib's effectiveness against a variety of EGFR mutations. Additionally, the company aims to leverage its strong pipeline to address existing gaps in cancer therapeutics.

Market Sentiment Analysis

POSITIVE FACTORS

  • ArriVent successfully fully enrolled its Phase 1b cohort for NSCLC patients.
  • Positive preclinical data for firmonertinib were presented at the AACR Annual Meeting.
  • Firmonertinib demonstrates broad activity across various EGFR mutations, addressing unmet medical needs.

Full Press Release Details

ArriVent BioPharma Reports First Quarter 2024 Financial Results
NEWTOWN SQUARE, PA, May 8, 2024 (GLOBE NEWSWIRE) -- ArriVent BioPharma, Inc. ("Company" or "ArriVent") (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today reported financial results for the first quarter ended March 31, 2024, and highlighted recent Company progress.
"In the first quarter of this year, we continued our strong progress as we fully enrolled our NSCLC EGFR PACC mutation Phase 1b cohort in our FURTHER study and initiated a Phase 1b combination study of firmonertinib and ICP-189, a SHP2 inhibitor, in NSCLC patients with EGFR classical mutations. This underscores our comprehensive development plan to maximize the potential of firmonertinib across EGFR mutant NSCLC," said Bing Yao, Chairman and Chief Executive Officer of ArriVent. "We were also proud to present data at the AACR annual meeting, which further demonstrated that firmonertinib was observed to be broadly active preclinically across a wide range of EGFR uncommon mutations in NSCLC, including PACC and exon 20 insertion mutations. We look forward to continuing building upon these milestones as we work to give cancer patients important new treatment options."
First Quarter 2024 and Recent Highlights
First Quarter 2024 Financial Results
ArriVent is a clinical-stage biopharmaceutical company dedicated to the identification, development, and commercialization of differentiated medicines to address the unmet medical needs of patients with cancers. ArriVent seeks to utilize its team's deep drug development experience to maximize the potential of its lead development candidate, firmonertinib, and advance a pipeline of novel therapeutics, such as next-generation antibody drug conjugates, through approval and commercialization.
Firmonertinib (formerly furmonertinib) is an oral, highly brain-penetrant, and broadly active mutation-selective epidermal growth factor receptor (EGFR) inhibitor active against both classical and uncommon EGFR mutations, including PACC and exon 20 insertion mutations. In March 2021, firmonertinib was approved in China for first-line advanced non-small-cell lung cancer (NSCLC) with EGFR exon 19 deletion or L858R mutations and for patients with previously treated locally advanced or metastatic NSCLC with EGFR T790M mutation, otherwise known as EGFR classical mutations.
In October 2023, firmonertinib was granted U.S. Food and Drug Administration Breakthrough Therapy Designation for the treatment of patients with previously untreated locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations.
Firmonertinib is currently being studied in a global Phase 3 trial for first-line NSCLC patients with EGFR exon 20 insertion mutations (FURVENT; NCT05607550) and in a global Phase 1b study evaluating firmonertinib in patients EGFR PACC mutations (FURTHER; NCT05364043). In addition, firmonertinib is also being studied in a clinical combination study targeting advanced or metastatic NSCLC patients with EGFR classical mutations, in partnership with InnoCare Pharma.
About EGFR mutant NSCLC
Globally, lung cancer is the leading cause of cancer-related deaths among men and women. NSCLC is the predominant subtype of lung cancer, accounting for approximately 85% of all cases. Mutational activation of the EGFR is a frequent and early event in the development of NSCLC. EGFR mutations are divided into classical and uncommon. EGFR exon 20 insertion mutations are a group of uncommon EGFR mutations and constitute approximately 9% of all EGFR mutations. PACC mutations are another group of uncommon EGFR mutations and represent approximately 12% of all EGFR mutations. Patients with NSCLC whose tumors harbor uncommon EGFR mutations have significantly lower life expectancy with available therapies and represent an area of unmet medical need.
Forward-Looking Statements
This press release includes certain disclosures that contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations or financial condition, business strategy and plans, cash runway, estimates of our addressable market, activity of firmonertinib compared to available therapies, anticipated clinical milestones, including proof of concept data for firmonertinib in patients with NSCLC EGFR PACC mutations and the selection of an ADC development candidate, and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," or "would" or the negative of these words or other similar terms or expressions. Forward-looking statements are based on ArriVent's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not
limited to, risks and uncertainties that are described more fully in the section titled "Risk Factors" in our annual report on Form 10-K for the fiscal year ended December 31, 2023, filed with the Securities and Exchange Commission on March 28, 2024 and our other filings with the Securities and Exchange Commission. Forward-looking statements contained in this press release are made as of this date, and ArriVent undertakes no duty to update such information except as required under applicable law.
ARRIVENT BIOPHARMA, INC.
(in thousands, except share and per share data)
March 31, December 31,
2024 2023
Assets
Current assets:
Cash and cash equivalents $ 317,393 $ 150,389
Prepaid expenses and other current assets 10,087 9,579
Total current assets 327,480 159,968
Right of use assets - operating leases 250 291
Deferred offering costs - 2,732
Other assets 108 107
Total assets $ 327,838 $ 163,098
Liabilities, Convertible Preferred Stock and Stockholders' Equity (Deficit)
Current liabilities:
Accounts payable $ 4,098 $ 4,532
Accrued expenses 5,732 6,952
Operating lease liabilities 147 140
Total current liabilities 9,977 11,624
Operating lease liabilities 138 177
Total liabilities 10,115 11,801
Series A convertible preferred stock $0.0001 par value, 150,000,000 shares authorized; 150,000,000 shares issued and outstanding at December 31, 2023 - 149,865
Series B convertible preferred stock $0.0001 par value, 147,619,034 shares authorized; 147,619,034 shares issued and outstanding at December 31, 2023 - 154,625
Stockholders' equity (deficit):
Preferred stock $0.0001 par value, 10,000,000 shares authorized; no shares issued and outstanding - -
Common stock $0.0001 par value, 200,000,000 shares authorized; 33,493,750 and 2,745,480 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively 3 -
Additional paid-in capital 492,982 4,652
Accumulated deficit (175,262) (157,845)
Total stockholders' equity (deficit) 317,723 (153,193)
Total liabilities, convertible preferred stock and stockholders' equity (deficit) $ 327,838 $ 163,098
ARRIVENT BIOPHARMA, INC.
STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
Three Months Ended
March 31,
2024 2023
Operating expenses:
Research and development $ 16,975 $ 10,236
General and administrative 3,699 1,936
Total operating expenses 20,674 12,172
Operating loss (20,674) (12,172)
Interest income 3,257 -
Net loss $ (17,417) $ (12,172)
Share information:
Net loss per share of common stock, basic and diluted $ (0.70) $ (9.45)
Weighted-average shares of common stock outstanding, basic and diluted 25,046,531 1,287,574
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Frequently Asked Questions

What are the recent highlights for ArriVent BioPharma?

ArriVent fully enrolled its NSCLC EGFR PACC mutation Phase 1b cohort and initiated a Phase 1b combination study of firmonertinib and ICP-189.

What is firmonertinib used for?

Firmonertinib is an EGFR inhibitor for treating non-small-cell lung cancer with specific mutations.

What is the financial loss for Q1 2024?

ArriVent reported a net loss of $17,417,000 for the first quarter of 2024.

When was firmonertinib approved in China?

Firmonertinib was approved in China in March 2021 for advanced non-small-cell lung cancer.

What designation was granted to firmonertinib in October 2023?

Firmonertinib received U.S. FDA Breakthrough Therapy Designation for specific NSCLC patients.

Last updated: May 8, 2024