Gossamer Bio Announces Fourth Quarter and Full-Year 2024 Financial Results and Provides Business Update

Rhea-AI Summary

Gossamer Bio (NASDAQ: GOSS) has reported its Q4 and full-year 2024 financial results, highlighting significant progress in its pulmonary hypertension drug development programs. The company's lead candidate, seralutinib, is advancing with the PROSERA Phase 3 trial in PAH, with topline data expected in Q4 2025.

Key developments include seralutinib receiving Orphan Drug Designation in Japan for PAH treatment and plans to initiate a registrational Phase 3 trial for PH-ILD in H2 2025. The company ended 2024 with $294.5 million in cash and equivalents, expected to fund operations into H1 2027.

Financial highlights for 2024 include: R&D expenses of $138.5 million (vs $135.3M in 2023), G&A expenses of $36.1 million (vs $38.5M in 2023), and a significantly reduced net loss of $56.5 million or $0.25 per share (compared to $179.8M or $1.18 per share in 2023).

Positive

• Significant reduction in net loss from $179.8M in 2023 to $56.5M in 2024
• Strong cash position of $294.5M providing runway into H1 2027
• Seralutinib received Orphan Drug Designation in Japan for PAH
• Decreased G&A expenses from $38.5M in 2023 to $36.1M in 2024

Negative

• R&D expenses increased to $138.5M in 2024 from $135.3M in 2023
• Still operating at a loss with -$56.5M net loss in 2024

Insights

Biotechnology Financial Analyst

Gossamer Bio's Q4 and full-year 2024 results demonstrate significant financial improvement alongside steady advancement of its lead candidate. The 68.6% reduction in annual net loss to $56.5 million from $179.8 million in 2023 represents substantial progress toward operational efficiency, despite slightly increased R&D expenses.

The company's cash position of $294.5 million provides runway into H1 2027, comfortably covering the critical PROSERA Phase 3 readout expected in Q4 2025. This positions Gossamer to reach its pivotal clinical milestone without immediate financing pressure.

Seralutinib's development strategy is focused on two high-value indications: pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The Orphan Drug Designation in Japan enhances the global commercial potential and could facilitate market access in this important territory.

The company's mechanism-driven approach targeting PDGFR, CSF1R, and c-KIT pathways addresses underlying disease drivers beyond mere vasodilation, potentially offering disease-modifying benefits in these progressive conditions with high mortality rates. However, investors should recognize that while timelines appear on track, Phase 3 trials inherently carry execution risks, and commercial success remains dependent on positive efficacy data.

Clinical Development Specialist

Gossamer's seralutinib represents an innovative approach in pulmonary hypertension through its multi-pathway inhibition mechanism targeting cellular proliferation, inflammation, and fibrosis - addressing fundamental disease processes rather than just symptoms. The inhaled delivery method potentially maximizes lung tissue exposure while limiting systemic effects.

The PROSERA Phase 3 study employs the gold-standard six-minute walk distance (6MWD) as its primary endpoint, a clinically meaningful measure directly related to functional capacity and quality of life. This choice aligns with regulatory expectations and facilitates comparison with existing therapies.

The expansion into PH-ILD is particularly notable as this represents a severely underserved patient population with treatment options and poor prognosis. The dual-indication strategy leverages overlapping pathophysiology while addressing distinct patient needs.

The supporting biomarker data and preclinical models presented at PVRI suggest potential synergy with sotatercept (recently approved for PAH), which could position seralutinib favorably in combination regimens. The TORREY open-label extension data indicating sustained benefits strengthens the drug's profile, though the Phase 3 PROSERA results in late 2025 remain the definitive hurdle for regulatory consideration. The carefully structured clinical program demonstrates prudent development strategy, though success remains contingent on Phase 3 outcomes.

- PROSERA Phase 3 in PAH on Track for Topline Data Readout in Fourth Quarter of 2025 -

- Registrational Phase 3 in PH-ILD Expected to Commence in Second Half of 2025 -

- Seralutinib Receives Orphan Drug Designation for PAH in Japan -

- Cash, cash equivalents and marketable securities totaled $295 million at year-end 2024 -

SAN DIEGO--(BUSINESS WIRE)-- Gossamer Bio, Inc. (Nasdaq: GOSS), a late-stage, clinical biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), today announced its financial results for the fourth quarter and year ended December 31, 2024, and provided a business update.

“As we close the book on 2024 and embrace the promise of 2025, I am both humbled and energized by the remarkable progress that Gossamer has made in its mission to improve the lives of pulmonary hypertension patients,” said Faheem Hasnain, Chairman, Co-Founder and CEO of Gossamer Bio.

“Rationally designed to target pathways of abnormal cellular proliferation, inflammation and fibrosis in pulmonary hypertension, we believe that seralutinib, which is currently being studied in the registrational PROSERA Study in PAH, has the potential to reshape the treatment paradigm."

“Our confidence in seralutinib is such that we expect to activate clinical sites for our second registrational Phase 3 study, in PH-ILD patients, in the second half of this year. And beyond PAH and PH-ILD, there are additional indications of high unmet need for which we believe seralutinib holds the potential to improve patients’ lives. But despite the opportunities that lie ahead of seralutinib, the Gossamer team remains intensely focused on execution of the PROSERA Study to ensure topline results by end of the year.”

Seralutinib (GB002): Inhaled PDGFR, CSF1R and c-KIT Inhibitor

• Enrollment is ongoing in the PROSERA Study, a global registrational Phase 3 clinical trial in patients with WHO Functional Class II and III PAH. The primary endpoint is change in six-minute walk distance (6MWD) from baseline at week 24. Topline results from the PROSERA Study are expected in the fourth quarter of 2025.
• We expect to activate clinical sites for a registrational Phase 3 PH-ILD clinical trial in the second half of 2025. The planned Phase 3 study will be a randomized, double-blind, placebo-controlled, global clinical trial in PH-ILD patients.
• On January 31st, Japan’s Ministry of Health, Labour and Welfare (MHLW), granted seralutinib Orphan Drug Designation for the treatment of PAH. Previously, the Pharmaceuticals and Medical Devices Agency of Japan (PMDA), allowed inclusion of Japanese clinical trial sites in the ongoing Phase 3 PROSERA Study. Subject to final clinical trial results, PROSERA could form the basis of a marketing application in Japan.
• One oral presentation and three posters related to seralutinib were presented at the Pulmonary Vascular Research Institute (PVRI) 2025 Annual Congress that took place January 29th through February 1st in Rio de Janeiro, Brazil. Posters linked below:
  • Preclinical Models Support the Synergistic Potential of Seralutinib and Sotatercept in Treating Pulmonary Arterial Hypertension | Link: https://goss.bio/4h0uBJi
  • Sustained Benefit with Seralutinib Treatment: A Post-Hoc Analysis of the TORREY Open-Label Extension | Link: https://goss.bio/3CmVuYu
  • Sustained Effect of Seralutinib on Circulating Biomarkers in the TORREY Phase 2 Open-Label Extension Study | Link: https://goss.bio/42aKKqQ

Financial Results for Quarter and Full Year Ended December 31, 2024

• Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of December 31, 2024, were $294.5 million. As a result, we expect our current cash, cash equivalents and marketable securities will be sufficient to fund operating and capital expenditures into the first half of 2027.
• Research and Development (R&D) Expenses: For the quarter ended December 31, 2024, R&D expenses were $36.1 million compared to R&D expenses of $30.0 million for the same period in 2023. R&D expenses for the full year ended December 31, 2024, were $138.5 million compared to $135.3 million for the full year ended December 31, 2023.
• General and Administrative (G&A) Expenses: For the quarter ended December 31, 2024, G&A expenses were $9.4 million compared to $9.1 million for the same period in 2023. G&A expenses for the full year ended December 31, 2024, were $36.1 million compared to $38.5 million for the full year ended December 31, 2023.
• Net Loss: Net loss for the three months ended December 31, 2024, was $33.0 million, or $0.15 per share, compared to a net loss of $48.1 million, or $0.21 per share, for the same period in 2023. Net loss for the full year ended December 31, 2024, was $56.5 million, or $0.25 per share compared to a net loss of $179.8 million, or $1.18 per share, for the full year ended December 31, 2023.

About Gossamer Bio

Gossamer Bio is a late-stage, clinical biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. Its goal is to be an industry leader in, and to enhance the lives of patients living with, pulmonary hypertension.

Forward-Looking Statements

Gossamer cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: the anticipated timing of a data readout from our Phase 3 PROSERA Study; the development and market potential of seralutinib; the anticipated timing on commencing a Phase 3 clinical trial in PH-ILD; expectations on developing seralutinib for additional indications; the ability to file a commercial marketing application in Japan pending clinical data; and the expected timeframe for funding our operating plan with current cash, cash equivalents and marketable securities. The inclusion of forward-looking statements should not be regarded as a representation by Gossamer that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Gossamer’s business, including, without limitation: potential delays in the commencement, enrollment and completion of clinical trials; disruption to our operations from unexpected events, including clinical trial delays; the Company’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the results of preclinical studies and early clinical trials are not necessarily predictive of future results; the success of Gossamer’s clinical trials and preclinical studies for seralutinib; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of seralutinib that may limit its development, regulatory approval and/or commercialization, or may result in clinical holds, recalls or product liability claims; Gossamer’s ability to obtain and maintain intellectual property protection for seralutinib; Gossamer’s ability to comply with its obligations in collaboration agreements with third parties or the agreements under which it licenses intellectual property rights from third parties; unstable market and economic conditions and adverse developments with respect to financial institutions and associated liquidity risk may adversely affect our business and financial condition and the broader economy and biotechnology industry; Gossamer may use its capital resources sooner than it expects; and other risks described in the Company’s prior press releases and the Company’s filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in the Company’s annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Gossamer undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

GOSSAMER BIO, INC. CONDENSED CONSOLIDATED FINANCIAL STATEMENT DATA (UNAUDITED; IN THOUSANDS, EXCEPT SHARE AND PER SHARE DATA)
	Three months ended December 31,								Year ended December 31,
STATEMENTS OF OPERATIONS DATA:		2024				2023				2024				2023
Revenue:
Revenue from sale of licenses	$	1,931			$	—			$	90,682			$	—
Revenue from contracts with collaborators		7,448				—				24,019				—
Total revenue		9,379				—				114,701				—
Operating expenses:
Research and development	$	36,112			$	29,970			$	138,487			$	135,304
In process research and development		—				10,000				—				10,000
General and administrative		9,395				9,057				36,133				38,455
Total operating expenses		45,507				49,027				174,620				183,759
Loss from operations		(36,128	)			(49,027	)			(59,919	)			(183,759	)
Other income (expense)
Interest income		(744	)			310				1,779				1,997
Interest expense		(2,738	)			(3,239	)			(11,517	)			(13,511	)
Other income, net		4,171				3,808				14,022				15,456
Total other income, net		689				879				4,284				3,942
Loss before provision (benefit) for income taxes		(35,439	)			(48,148	)			(55,635	)			(179,817	)
Provision (benefit) for income taxes		(2,410	)			—				893				—
Net loss	$	(33,029	)		$	(48,148	)		$	(56,528	)		$	(179,817	)
Net loss per share, basic and diluted	$	(0.15	)		$	(0.21	)		$	(0.25	)		$	(1.18	)
Weighted average common shares outstanding, basic and diluted		226,604,138				225,409,315				226,228,016				152,621,669

BALANCE SHEET DATA:	December 31, 2024				December 31, 2023
Cash, cash equivalents, and marketable securities	$	294,518			$	296,425
Working capital		264,878				254,921
Total assets		315,292				311,916
Total liabilities		285,800				249,147
Accumulated deficit		(1,268,568	)			(1,212,040	)
Total stockholders' equity		29,492				62,769

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20250313732742/en/

For Investors and Media:

Bryan Giraudo, Chief Financial Officer & Chief Operating Officer

Gossamer Bio Investor Relations

ir@gossamerbio.com

Source: Gossamer Bio, Inc.

FAQ

When will Gossamer Bio (GOSS) release PROSERA Phase 3 trial results for seralutinib in PAH?

Gossamer Bio expects to release topline results from the PROSERA Phase 3 trial in PAH during the fourth quarter of 2025.

What is the cash runway for Gossamer Bio (GOSS) as of Q4 2024?

With $294.5 million in cash and equivalents at the end of 2024, Gossamer Bio expects to fund operations into the first half of 2027.

How did Gossamer Bio's (GOSS) net loss change in 2024 compared to 2023?

Net loss improved significantly to $56.5 million ($0.25 per share) in 2024, down from $179.8 million ($1.18 per share) in 2023.

What regulatory milestone did seralutinib achieve in Japan for GOSS in 2024?

Seralutinib received Orphan Drug Designation for PAH treatment from Japan's Ministry of Health, Labour and Welfare on January 31st.

When will Gossamer Bio (GOSS) begin its Phase 3 trial for seralutinib in PH-ILD?

Gossamer Bio plans to activate clinical sites for the registrational Phase 3 PH-ILD trial in the second half of 2025.