ArriVent BioPharma Reports Full Year 2023 Financial Results
- ArriVent secured Breakthrough Therapy Designation from the FDA for furmonertinib, enhancing its development prospects.
- Successful completion of a $201 million IPO in January 2024 provides the company with a strong financial position.
- The company's Phase 3 FURVENT trial for furmonertinib is currently enrolling patients globally, showing progress in clinical development.
- ArriVent's collaboration with InnoCare Pharma for a clinical combination study with furmonertinib and ICP-189 demonstrates strategic partnerships.
- Presentation of preclinical data at the 2024 AACR Annual Meeting showcases the potential of furmonertinib in treating NSCLC with EGFR exon 20 insertion mutations and PACC mutations.
- Net loss increased from $37.0 million in 2022 to $69.3 million in 2023, indicating growing financial challenges.
- Research and development expenses surged from $30.4 million in 2022 to $64.9 million in 2023, reflecting increased clinical spending.
- General and administrative expenses rose from $6.5 million in 2022 to $9.7 million in 2023, impacting overall financial performance.
- Selection of an ADC development candidate is expected to be completed in late 2024 or early 2025, potentially delaying progress.
- Increased external costs related to operating as a public company may strain financial resources in the long run.
Insights
The Breakthrough Therapy Designation granted by the FDA to furmonertinib for first-line treatment of NSCLC with EGFR exon 20 insertion mutations is a significant milestone. This status is accorded to drugs that demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. The designation can lead to expedited development and review processes, potentially accelerating time to market and providing a competitive advantage.
From a clinical perspective, the focus on EGFR exon 20 insertion mutations is noteworthy. These mutations are associated with a subset of NSCLC and have historically been difficult to target effectively with current EGFR inhibitors. The development of furmonertinib may represent an advance in precision medicine, offering a new therapeutic option for patients with limited treatments available.
The upcoming proof-of-concept data in 2024 will be critical in validating the efficacy and safety profile of furmonertinib. Positive results could not only solidify the drug's clinical prospects but also enhance investor confidence in ArriVent's pipeline and its potential for revenue generation in a market with unmet medical needs.
ArriVent's successful IPO in January 2024, raising $201 million, is a robust indicator of investor confidence and provides substantial capital to fund ongoing and future clinical trials. The cash runway into 2026 suggests that the company has a secure financial position in the near to mid-term, reducing the immediate need for further financing and dilution of shares.
However, investors should be aware of the inherent risks in biotech investing, particularly in clinical-stage companies. The costs associated with the development of furmonertinib are reflected in the increased R&D expenses year-over-year and the net loss has also widened. While these are expected trends in the biotech industry, they underscore the importance of successful clinical trial outcomes for future profitability and sustainability.
It is important to monitor the enrollment and progression of the pivotal Phase 3 FURVENT trial, as any delays or negative outcomes could impact the stock price and investor sentiment. Conversely, positive trial results and subsequent regulatory approvals could significantly enhance the company's valuation.
The landscape of NSCLC treatments is evolving, with a shift towards targeted therapies for specific genetic mutations. Furmonertinib's focus on EGFR exon 20 insertion mutations places ArriVent in a niche but growing segment of the oncology market. The potential market size for this treatment could be substantial, considering the global incidence of lung cancer and the percentage of NSCLC patients with this mutation.
ArriVent's collaboration with InnoCare Pharma for the combination study using ICP-189, a SHP2 inhibitor, indicates a strategic approach to combination therapies, which are becoming an industry norm due to their potential for improved patient outcomes. The success of this combination strategy could position ArriVent favorably within the competitive landscape.
Investors should consider the broader implications of ArriVent's pipeline developments, such as the selection of an ADC development candidate, on the company's long-term growth prospects. Diversification of the pipeline can mitigate risks associated with the development of a single lead candidate and provide multiple avenues for revenue generation.
- Company progresses the development of furmonertinib with a data readout planned for 2024
- Furmonertinib granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration
- Completed
$201 million initial public offering (“IPO”) in January 2024
NEWTOWN SQUARE, Pa., March 28, 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 full year ended December 31, 2023, and highlighted recent company progress.
“The fourth quarter was transformational for ArriVent, as we positioned our company for the successful IPO that we executed in January of this year and continued our strong progress with furmonertinib, which received Breakthrough Therapy Designation from the FDA,” said Bing Yao, Chairman and Chief Executive Officer of ArriVent. “Our company is well capitalized, with cash runway into 2026, and we have an experienced management team dedicated to strong pipeline execution. This year we look forward to providing an update on our Phase 1b FURTHER trial that includes EGFR mutant NSCLC patients with PACC mutations and advancing our Phase 3 FURVENT trial in frontline NSCLC with EGFR exon 20 insertion mutations as we continue our mission to identify and develop potentially transformative medicines to address the unmet medical needs of patients with cancer.”
2023 Highlights
Furmonertinib
- Announced clinical development collaboration with InnoCare Pharma. In July 2023, ArriVent and Beijing InnoCare Pharma Tech Co., Ltd. (“InnoCare Pharma”) announced a clinical development collaboration investigating a novel Src Homology 2 domain containing protein tyrosine phosphatase (“SHP2”) allosteric inhibitor, ICP-189, in combination with furmonertinib in patients with advanced non-small cell lung cancer (“NSCLC”).
- Presented interim results from the Phase 1b, randomized, open-label, multi-center clinical study (FAVOUR), evaluating the efficacy and safety of furmonertinib in patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (“EGFR”) exon 20 insertion mutations. In September 2023, ArriVent and its partner, Shanghai Allist Pharmaceuticals Company, Ltd. ("Allist”), presented interim Phase 1b results at the World Conference on Lung Cancer.
- U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for furmonertinib for first-line treatment of advanced or metastatic NSCLC with EGFR exon 20 insertion mutations. In October 2023, ArriVent announced that the FDA granted Breakthrough Therapy Designation for furmonertinib for the treatment of patients with previously untreated, locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations. The pivotal Phase 3 FURVENT trial (NCT05607550) of furmonertinib for the treatment of first-line NSCLC with EGFR exon 20 insertion mutations is currently enrolling patients globally.
Upcoming Milestones
- Proof-of-concept data expected in 2024. Furmonertinib is currently being studied in the Phase 1b FURTHER (NCT05364073) study in patients with NSCLC EGFR P-loop alpha-c helix compressing (“PACC”) mutations, which has been fully enrolled, with proof-of-concept data expected in 2024.
- Presentation of preclinical data for furmonertinib at the 2024 American Association for Cancer Research (“AACR”) Annual Meeting. ArriVent will present preclinical data evaluating furmonertinib in NSCLC with EGFR exon 20 insertion mutations and PACC mutations at the AACR Annual Meeting, being held April 5-10. The preclinical study found furmonertinib is similarly active against both PACC and exon 20 insertion mutations.
- Initiation of the clinical combination study with furmonertinib and ICP-189, a SHP2 inhibitor. ArriVent and its partner, InnoCare Pharma, dosed its first patient of this clinical combination study targeting EGFR classical mutations in March 2024.
- Selection of antibody drug conjugate (ADC) development candidate. ArriVent and its partner, Aarvik Therapeutics, Inc (“Aarvik”), continue to make progress on selecting an ADC development candidate, and expect to complete selection in late 2024 or early 2025.
Corporate Updates
- Completed a successful IPO. In January 2024, ArriVent successfully raised
$201 million in gross proceeds before deducting underwriting discounts, commissions, and offering expenses. - Strengthened board and executive team leadership. In September 2023, ArriVent appointed Chris Nolet to its Board of Directors. Mr. Nolet has extensive leadership experience as an audit partner, business advisor and independent board director in the life sciences industry, and serves on the boards of public companies Revance Therapeutics and Jasper Therapeutics. In January 2024, ArriVent appointed Winston Kung as Chief Financial Officer and Treasurer, bringing over 20 years of extensive leadership experience, most recently as Chief Financial Officer and Chief Operating Officer at PMV Pharmaceuticals.
Fiscal Year 2023 Financial Results
- Research and development expenses were
$64.9 million and$30.4 million for the years ended December 31, 2023 and 2022, respectively. The increase in expense was primarily due to increased clinical spending on trials related to furmonertinib. - General and administrative expenses were
$9.7 million and$6.5 million for the years ended December 31, 2023 and 2022, respectively. The increase was primarily due to increased external costs related to preparing for and operating as a public company, as well as increased personnel costs to support these activities. - Net loss was
$69.3 million and$37.0 million for the years ended December 31, 2023 and 2022, respectively. - As of December 31, 2023, the company had cash, cash equivalents and marketable securities of
$150.4 million , which, with the proceeds from our IPO in January 2024, is expected to fund operations into 2026.
About ArriVent
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, furmonertinib, and advance a pipeline of novel therapeutics, such as next-generation antibody drug conjugates, through approval and commercialization in patients suffering from cancer, with an initial focus on solid tumors.
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, anticipated clinical milestones 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, to be filed with the Securities and Exchange Commission 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. BALANCE SHEETS (in thousands, except share and per share data) | ||||||||
| December 31, | ||||||||
| 2023 | 2022 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 150,389 | $ | 163,372 | ||||
| Prepaid expenses and other current assets | 9,579 | 19,250 | ||||||
| Total current assets | 159,968 | 182,622 | ||||||
| Right of use assets – operating leases | 291 | 139 | ||||||
| Deferred offering costs | 2,732 | — | ||||||
| Other assets | 107 | 72 | ||||||
| Total assets | $ | 163,098 | $ | 182,833 | ||||
| Liabilities, Convertible Preferred Stock and Stockholders’ Deficit | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,532 | $ | 3,094 | ||||
| Accrued expenses | 6,952 | 5,138 | ||||||
| Operating lease liabilities | 140 | 128 | ||||||
| Total current liabilities | 11,624 | 8,360 | ||||||
| Operating lease liabilities | 177 | 11 | ||||||
| Total liabilities | 11,801 | 8,371 | ||||||
| Commitments and contingencies (Note 7) | ||||||||
| Series A convertible preferred stock | 149,865 | 149,865 | ||||||
| Series B convertible preferred stock | 154,625 | 109,706 | ||||||
| Stockholders’ (deficit): | ||||||||
| Common stock | — | — | ||||||
| Additional paid-in capital | 4,652 | 3,403 | ||||||
| Accumulated deficit | (157,845 | ) | (88,512 | ) | ||||
| Total stockholders’ (deficit) | (153,193 | ) | (85,109 | ) | ||||
| Total liabilities, convertible preferred stock and stockholders’ deficit | $ | 163,098 | $ | 182,833 | ||||
| ARRIVENT BIOPHARMA, INC. STATEMENTS OF OPERATIONS (in thousands, except share and per share data) | ||||||||
| Year Ended December 31, | ||||||||
| 2023 | 2022 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 64,884 | $ | 30,433 | ||||
| General and administrative | 9,706 | 6,473 | ||||||
| Total operating expenses | 74,590 | 36,906 | ||||||
| Operating loss | (74,590 | ) | (36,906 | ) | ||||
| Interest income | 5,257 | — | ||||||
| Net loss | $ | (69,333 | ) | $ | (36,906 | ) | ||
| Share information: | ||||||||
| Net loss per share of common stock, basic and diluted | $ | (32.38 | ) | $ | (28.90 | ) | ||
| Weighted-average shares of common stock outstanding, basic and diluted | 2,140,951 | 1,277,079 | ||||||
Contact for Investors & Media
Argot Partners
212.600.1902
ArriVent@argotpartners.com
FAQ
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