ArriVent BioPharma Reports Second Quarter 2025 Financial Results

Rhea-AI Summary

ArriVent BioPharma (NASDAQ:AVBP) reported Q2 2025 financial results and pipeline updates. The company highlighted positive interim Phase 1b data for firmonertinib in EGFR PACC mutant NSCLC, with plans to initiate the global Phase 3 ALPACCA study in 2H 2025. The company also dosed the first patient in a Phase 1 study of ARR-217, their CDH17-targeted ADC for gastrointestinal tumors.

Financially, ArriVent reported $254.5 million in cash and investments as of June 30, 2025, plus an additional $81.1 million raised in July 2025, extending their runway to mid-2027. The company's net loss increased to $95.8 million for H1 2025, compared to $39.3 million in H1 2024, primarily due to a $40 million upfront payment to Lepu Biopharma.

Positive

• None.

Negative

• Increased net loss to $95.8M in H1 2025 from $39.3M in H1 2024
• Higher R&D expenses at $89.0M vs $38.8M year-over-year
• Increased cash burn with net cash used in operations of $94.1M vs $37.7M year-over-year

Insights

Biotechnology Analyst

ArriVent shows strong clinical progress with firmonertinib in EGFR mutations and advances ADC pipeline despite increased R&D expenses.

ArriVent's Q2 2025 results show meaningful clinical advances across multiple oncology programs, balancing promising data with increased expenses. The interim Phase 1b data for firmonertinib in EGFR PACC mutant NSCLC patients demonstrates clinically meaningful progression-free survival and CNS complete responses - particularly significant as this appears to be the first clinical dataset testing an EGFR inhibitor in a prospectively defined PACC mutation population.

The company's pipeline diversification strategy is materializing with the dosing of the first patient in their CDH17-targeted ADC (ARR-217) program for gastrointestinal tumors. This marks ArriVent's first clinical entry in the highly competitive ADC space, an area attracting substantial investor interest.

From a financial perspective, their $254.5 million cash position (plus $81.1 million from July's offering) provides runway until mid-2027, offering sufficient capital through multiple value-inflection points. However, R&D expenses have more than doubled year-over-year to $89 million for H1 2025, largely due to the $40 million upfront payment to Lepu Biopharma and increased clinical activity.

The company faces critical upcoming catalysts, particularly the pivotal FURVENT Phase 3 study results for first-line EGFR Exon 20 insertions expected in early 2026. These results will be crucial for validating firmonertinib's commercial potential in this difficult-to-treat patient population. Additionally, final PACC cohort data at the WCLC in September 2025 and initiation of the pivotal ALPACCA Phase 3 study will provide important near-term readouts on their PACC mutation strategy.

Financial Analyst

ArriVent's financial position demonstrates careful capital management amidst accelerating R&D investment. The current $335.6 million in cash and investments (including July's offering) against a burn rate that reached $94.1 million for H1 2025 validates their mid-2027 runway projection. The 149.7% year-over-year increase in net cash used from operations ($94.1 million vs $37.7 million) is substantial but explainable - primarily driven by the one-time $40 million upfront payment to Lepu Biopharma for their ADC collaboration.

R&D expenses more than doubled to $89.0 million from $38.8 million in the comparable period, reflecting both the Lepu payment and increased clinical activity. The 50% increase in G&A expenses ($11.4 million vs $7.6 million) indicates organizational growth to support expanding clinical programs.

The net loss of $95.8 million for H1 2025 represents a 143.8% increase year-over-year, though approximately $40 million of this was the one-time payment. Excluding this non-recurring item, the underlying burn rate appears consistent with a clinical-stage oncology company advancing multiple programs.

The recently completed $81.1 million public offering in July strengthens their negotiating position for potential future partnerships and provides flexibility to withstand potential clinical setbacks. With multiple clinical readouts expected before mid-2027, including the pivotal firmonertinib data in early 2026, the company appears adequately capitalized to reach several value-inflection milestones without immediate financing pressure. This positions them to potentially negotiate from strength if additional capital is needed to support commercialization activities following positive clinical results.

• Positive interim Phase 1b update underscores firmonertinib’s potential in EGFR PACC mutant NSCLC; global pivotal Phase 3 ALPACCA study expected to enroll first patient in 2H 2025
• Dosed the first patient in the Phase 1 Study for ARR-217 (MRG007), a CDH17 targeted ADC, in gastrointestinal tumors
• Top-line firmonertinib monotherapy data from global pivotal FURVENT Phase 3 study for first-line EGFR exon20 insertion mutant NSCLC projected to be in early 2026
• Cash and investments of $254.5 million as of June 30, 2025, in addition to $81.1 million raised in the public offering in July 2025, expected to fund our operating plan to mid-2027

NEWTOWN SQUARE, Pa., Aug. 11, 2025 (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 second quarter ended June 30, 2025, and highlighted recent Company progress.

“Firmonertinib continues to advance with strong momentum toward registration, demonstrating promise across all key EGFR-mutant NSCLC populations including underrepresented and difficult to treat patient types,” said Bing Yao, CEO of ArriVent. “The positive interim PACC Phase 1b data build on our clinical progress in Exon 20 insertion mutations and further validate the therapeutic potential of firmonertinib across EGFR mutations. We look forward to presenting final PACC Phase 1b data at the World Conference on Lung Cancer in September, and we anticipate enrolling the first patient in our global pivotal Phase 3 PACC study in the second half of 2025. Following completion of enrollment in our registrational Exon 20 insertion trial in Q1 2025, topline pivotal data is projected to be in early 2026.”

Dr. Yao continued, “We believe our antibody-drug conjugate (ADC) pipeline is also making meaningful progress, led by ARR-217, a CDH17-targeted ADC with best-in-class potential for the treatment of gastrointestinal cancers. The first patient has been dosed, marking the first clinical entry from our ADC portfolio. Following our strengthened balance sheet and extended cash runway, we are well positioned to deliver on a series of important catalysts over the next twelve months.”

Second Quarter 2025 and Recent Highlights

Firmonertinib

• Positive interim update in EGFR PACC mutant NSCLC. In June 2025, ArriVent presented updated interim Phase 1b data for first-line firmonertinib monotherapy in NSCLC patients with EGFR PACC mutations (FURTHER; NCT05364043). Firmonertinib demonstrated clinically meaningful progression free survival, CNS complete responses, and a manageable safety profile consistent with previous trials in what we believe to be the first clinical dataset testing an EGFR inhibitor in a prospectively defined population of EGFR PACC mutant NSCLC.
• PACC clinical development plans. In June 2025, ArriVent announced the design of ALPACCA (FURMO-006), a randomized global Phase 3 study designed to evaluate first-line firmonertinib monotherapy for the treatment of PACC mutant NSCLC with potential for both accelerated and full approval.

Pipeline

• Clinical advancement of ADC lead ARR-217 (MRG007). Dosed the first patient in the Phase 1 study for ARR-217, a CDH17 targeted ADC, in gastrointestinal tumors by our partner, Lepu Biopharma Co., Ltd. (“Lepu BioPharma”).
  

Upcoming Milestones

• Final EGFR PACC Phase 1b data. Final EGFR PACC cohort data to be presented at the WCLC in September 2025.
• First-line EGFR PACC registrational study. Enrollment of first patient in the randomized, global pivotal ALPACCA Phase 3 study for first-line firmonertinib monotherapy in EGFR PACC mutant NSCLC expected in 2H 2025.
• Firmonertinib Pivotal EGFR Exon 20 insertions data. Top-line firmonertinib monotherapy data from the global pivotal FURVENT Phase 3 (NCT05607550) study for first-line EGFR Exon 20 insertions mutant NSCLC is projected to be in early 2026.
  

2025 Financial Results

• As of June 30, 2025, the Company had cash and investments of $254.5 million. The cash balance as of June 30, 2025 does not include the net proceeds of $81.1 million raised in the recently completed public offering in July 2025.   With the recent net proceeds in addition to our cash and investments, we expect to fund operations to mid-2027.
• Net cash used in operations was $94.1 million and $37.7 million for the six months ended June 30, 2025 and 2024, respectively. The increase in net cash used in operations in the first six months of 2025 was primarily driven by the one-time upfront payment of $40 million made to Lepu Biopharma.
• Research and development expenses were $89.0 million and $38.8 million for the six months ended June 30, 2025 and 2024, respectively. The increase in expense was primarily due to a one-time upfront payment made to Lepu Biopharma for our collaboration that began in January 2025, along with increased headcount and clinical expense related to firmonertinib.
• General and administrative expenses were $11.4 million and $7.6 million for the six months ended June 30, 2025 and 2024, respectively.
• Net loss was $95.8 million and $39.3 million for the six months ended June 30, 2025 and 2024, respectively.
  

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, firmonertinib, and advance a pipeline of novel therapeutics, such as next-generation antibody drug conjugates, through approval and commercialization.

About Firmonertinib

Firmonertinib 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.

Firmonertinib was granted U.S. Food and Drug Administration (FDA) 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 was also granted U.S. FDA Orphan Drug Designation for the treatment of NSCLC with EGFR mutations or human epidermal growth factor receptor 2 (HER2) mutations or HER4 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 3 study in first line NSCLC patients with EGFR PACC mutations (ALPACCA). 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 Beijing InnoCare Pharma Tech Co., Ltd.

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.

About EGFR PACC mutations

P-loop and αC-helix compressing (PACC) EGFR mutations are a distinct set of approximately 70 mostly missense activating mutations within the kinase domain of EGFR. They are similar to Exon 20 insertion mutations in narrowing the drug binding pocket to affect tyrosine kinase inhibitor activity. PACC mutations are diagnosed through commercially available NGS and most PCR tests. Patients with PACC mutations have limited treatment options, and there is no broadly utilized standard of care treatment for first-line PACC mutant patients.

About FURVENT

FURVENT is a global, pivotal 3 arm Phase 3 clinical trial of firmonertinib in first-line non-squamous locally advanced or metastatic NSCLC patients with exon 20 insertion mutations being conducted jointly with our partner Allist. The FURVENT clinical trial is designed to assess the safety and efficacy of firmonertinib administered at either 160 mg or 240 mg, once-daily with each dose being compared to platinum-based chemotherapy with pemetrexed, the current first-line standard of care. The primary endpoint of this study is PFS by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Seconday endpoints in patients with brain metastases at baseline include brain-specific CNS overall response rate (CNS-ORR) and CNS-PFS by modified RECIST (mRECIST). The study enrolled 398 patients globally, including from sites in the United States, Europe and certain Asian countries including Japan and China.

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, the timing of, and results of, top-line pivotal Phase 3 data for firmonertinib in previously untreated NSCLC patients whose tumors contain EGFR exon 20 insertion mutations, the timing of potential enrollment of the first patient in the global pivotal Phase 3 study of firmonertinib in previously untreated NSCLC patients whose tumors contain EGFR PACC mutations, 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, 2024, to be filed with the Securities and Exchange Commission on March 3, 2025 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) (Unaudited)
		June 30,				December 31,
		2025				2024
Assets
Current assets:
Cash and cash equivalents		$	112,765			$	74,293
Short-term investments			122,922				144,570
Prepaid expenses and other current assets			14,462				8,116
Total current assets			250,149				226,979
Long-term investments			18,793				47,683
Right of use assets – operating leases			85				154
Other assets			479				126
Total assets		$	269,506			$	274,942
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable		$	4,060			$	3,782
Accrued expenses			15,478				13,330
Operating lease liabilities			98				162
Total current liabilities			19,636				17,274
Operating lease liabilities, net of current amount			—				14
Total liabilities			19,636				17,288
Stockholders’ equity:
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; 37,490,439 and 33,706,765 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively			4				3
Additional paid-in capital			584,003				496,195
Accumulated deficit			(334,119	)			(238,333	)
Accumulated other comprehensive loss			(18	)			(211	)
Total stockholders’ equity			249,870				257,654
Total liabilities and stockholders’ equity		$	269,506			$	274,942

ARRIVENT BIOPHARMA, INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except share and per share data) (Unaudited)
		Three Months Ended									Six Months Ended
		June 30,								June 30,
		2025				2024				2025				2024
Operating expenses:
Research and development		$	27,720			$	21,778			$	89,009			$	38,753
General and administrative			5,903				3,919				11,386				7,618
Total operating expenses			33,623				25,697				100,395				46,371
Operating loss			(33,623	)			(25,697	)			(100,395	)			(46,371	)
Interest and investment income			2,224				3,823				4,609				7,080
Net loss			(31,399	)			(21,874	)			(95,786	)			(39,291	)
Unrealized gain (loss) on marketable securities			(1	)			—				193				—
Total other comprehensive gain (loss)			(1	)			—				193				—
Total comprehensive loss		$	(31,400	)		$	(21,874	)		$	(95,593	)		$	(39,291	)
Share information:
Net loss per share attributable to common stockholders, basic and diluted		$	(0.90	)		$	(0.65	)		$	(2.78	)		$	(1.34	)
Weighted-average shares of common stock outstanding, basic and diluted			35,006,114				33,502,347				34,455,585				29,274,441

Contact:
Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com

FAQ

What were ArriVent BioPharma's (AVBP) key financial results for Q2 2025?

ArriVent reported cash and investments of $254.5M as of June 30, 2025, plus $81.1M raised in July 2025. Net loss was $95.8M for H1 2025, with R&D expenses of $89.0M.

What are the upcoming milestones for ArriVent's firmonertinib drug?

Key milestones include final EGFR PACC Phase 1b data presentation at WCLC in September 2025, first patient enrollment in Phase 3 ALPACCA study in H2 2025, and top-line Phase 3 FURVENT data in early 2026.

How long will ArriVent's (AVBP) current cash runway last?

With current cash and investments of $254.5M plus $81.1M from the July 2025 offering, ArriVent expects to fund operations until mid-2027.

What progress has ArriVent made with their ADC program?

ArriVent dosed the first patient in the Phase 1 study of ARR-217, their CDH17-targeted ADC for gastrointestinal tumors, in partnership with Lepu Biopharma.

What were the Phase 1b results for firmonertinib in EGFR PACC mutant NSCLC?

The interim Phase 1b data showed clinically meaningful progression-free survival, CNS complete responses, and a manageable safety profile in EGFR PACC mutant NSCLC patients.