Gossamer Bio Announces Third Quarter 2024 Financial Results and Provides Business Update

Rhea-AI Summary

Gossamer Bio (GOSS) reported Q3 2024 financial results with $327.0 million in cash and equivalents as of September 30, 2024. The company posted revenue of $9.5 million from collaborator contracts, R&D expenses of $34.9 million, and a net loss of $30.8 million ($0.14 per share). The company expects current funds to sustain operations into H1 2027.

The company continues enrollment in the PROSERA Study, a Phase 3 trial for seralutinib in PAH patients, with topline results expected in Q4 2025. Additionally, Gossamer plans to initiate a Phase 3 trial for PH-ILD treatment in mid-2025.

Positive

• Strong cash position of $327.0 million, providing runway into H1 2027
• Revenue generation of $9.5 million from Chiesi collaboration
• Reduced net loss per share to $0.14 from $0.21 year-over-year
• Decreased G&A expenses to $8.5 million from $9.3 million year-over-year

Negative

• Increased R&D expenses to $34.9 million from $31.2 million year-over-year
• Continued net loss of $30.8 million in Q3 2024

Insights

Financial Analyst

The Q3 results show mixed signals for Gossamer Bio. The $327M cash position provides a healthy runway into H1 2027, important for completing their Phase 3 PROSERA study and launching the PH-ILD trial. Revenue from Chiesi collaboration at $9.5M provides some offset to operational costs.

Notable is the 11.9% increase in R&D expenses to $34.9M, reflecting intensified clinical trial activities. However, G&A expenses decreased by 8.6% to $8.5M, showing good cost control. The reduced net loss of $30.8M versus $40M YoY and improved EPS ($0.14 vs $0.21) indicate better operational efficiency.

The company's focus on seralutinib's development in both PAH and PH-ILD markets represents significant commercial potential if approved, though investors should monitor cash burn rate and trial progression closely.

Medical Research Analyst

The clinical development strategy for seralutinib shows promising potential in two distinct markets. The PROSERA Phase 3 study targeting PAH patients with WHO Functional Class II and III is particularly well-positioned, using the industry-standard 6-minute walk distance (6MWD) as the primary endpoint. The planned expansion into PH-ILD represents a strategic move to build a comprehensive pulmonary hypertension franchise.

The dual-indication approach with an inhaled PDGFR, CSF1R and c-KIT inhibitor could address significant unmet needs in both PAH and PH-ILD patient populations. The Q4 2025 timeline for PROSERA results and mid-2025 initiation of PH-ILD Phase 3 trial creates multiple potential value-driving catalysts.

- $327 Million in Cash, Cash Equivalents & Marketable Securities, as of September 30, 2024 -

SAN DIEGO--(BUSINESS WIRE)-- Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage 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 third quarter ended September 30, 2024 and provided a business update.

“Looking forward, we expect 2025 to be an exceptionally important year for Gossamer, as we both anticipate Phase 3 PROSERA Study results in PAH and commence our PH-ILD Phase 3 study,” said Faheem Hasnain, Co-Founder, CEO, and Chairman of Gossamer Bio.

“Proper clinical trial execution right now, including enrolling the targeted PAH patients, not only greatly increases the probability of a successful trial, but it also lays the groundwork for what we see as a potential blockbuster pulmonary hypertension franchise. To that end, as we come into the home stretch for 2024, our team remains hard at work, diligently focused on completing PROSERA Study enrollment and designing the registrational Phase 3 PH-ILD clinical trial.”

Seralutinib (GB002): Inhaled PDGFR, CSF1R and c-KIT Inhibitor for PAH and PH-ILD

• 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.
• In mid-2025, after engaging and discussing with global regulatory authorities, we expect to commence a global registrational Phase 3 clinical trial of seralutinib for the treatment of patients with PH-ILD.

Financial Results for Quarter Ended September 30, 2024

• Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of September 30, 2024, were $327.0 million. The Company expects the combination of current cash, cash equivalents and marketable securities will be sufficient to fund its operating and capital expenditures into the first half of 2027.
• Revenue from Sale of Licenses and from Contracts with Collaborators: For the quarter ended September 30, 2024, revenue from contracts with collaborators was $9.5 million. Our revenue consists of ongoing payments for research and development services related to the collaboration with Chiesi.
• Research and Development (R&D) Expenses: For the quarter ended September 30, 2024, R&D expenses were $34.9 million, compared to $31.2 million for the same period in 2023.
• General and Administrative (G&A) Expenses: For the quarter ended September 30, 2024, G&A expenses were $8.5 million, compared to $9.3 million for the same period in 2023.
• Net Loss: Net loss for the quarter ended September 30, 2024, was $30.8 million, or $0.14 basic net loss per share, compared to a net loss of $40.0 million, or $0.21 basic net loss per share, for the same period in 2023.

About Gossamer Bio

Gossamer Bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary hypertension. 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 development and market potential of seralutinib; the anticipated timing of commencing a Phase 3 registrational study in PH-ILD; the anticipated timing of a data readout from our Phase 3 PROSERA Study; 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 the COVID-19 pandemic, 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 their 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, including Chiesi, 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 Statement of Operations
Condensed Consolidated Statement of Operations
(in thousands, except share and per share amounts)
(unaudited)
	Three months ended September 30,								Nine months ended September 30,
	2024				2023				2024				2023
Revenue:
Revenue from sale of licenses	$	—			$	—			$	88,751			$	—
Revenue from contracts with collaborators		9,480				—				16,571				—
Total revenue		9,480				—				105,322				—
Operating expenses:
Research and development		34,897				31,200				102,375				105,334
General and administrative		8,502				9,290				26,738				29,398
Total operating expenses		43,399				40,490				129,113				134,732
Loss from operations		(33,919	)			(40,490	)			(23,791	)			(134,732	)
Other income (expense)
Interest income		430				405				2,523				1,687
Interest expense		(2,734	)			(3,343	)			(8,779	)			(10,272	)
Other income, net		4,288				3,420				9,851				11,648
Total other income, net		1,984				482				3,595				3,063
Loss before provision (benefit) for income taxes		(31,935	)			(40,008	)			(20,196	)			(131,669	)
Provision (benefit) for income taxes		(1,132	)			—				3,303				—
Net loss	$	(30,803	)		$	(40,008	)		$	(23,499	)		$	(131,669	)
Net loss per share, basic and diluted	$	(0.14	)		$	(0.21	)		$	(0.10	)		$	(1.03	)
Weighted average common shares outstanding, basic and diluted		226,346,058				192,883,209				226,101,727				128,092,499

Condensed Consolidated Balance Sheet
(in thousands)
BALANCE SHEET DATA:	September 30, 2024				December 31, 2023
	(unaudited)
Cash, cash equivalents, and marketable securities	$	327,034			$	296,425
Working capital		293,183				254,921
Total assets		350,879				311,916
Total liabilities		296,743				249,147
Accumulated deficit		(1,235,539	)			(1,212,040	)
Total stockholders' equity		54,136				62,769

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20241107455321/en/

For Investors and Media:

Bryan Giraudo, Chief Operating Officer and Chief Financial Officer

Gossamer Bio Investor Relations

ir@gossamerbio.com

Source: Gossamer Bio, Inc.

FAQ

What were Gossamer Bio's (GOSS) Q3 2024 financial results?

Gossamer Bio reported Q3 2024 revenue of $9.5 million, R&D expenses of $34.9 million, and a net loss of $30.8 million ($0.14 per share), with $327.0 million in cash and equivalents as of September 30, 2024.

When will Gossamer Bio (GOSS) release PROSERA Study results?

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

How long can Gossamer Bio (GOSS) fund its operations with current cash?

Gossamer Bio expects its current cash, cash equivalents and marketable securities of $327.0 million will fund operations into the first half of 2027.