Cardiovascular Complications of Systemic Sclerosis: What to Look For
Gossamer Bio Announces Fourth Quarter And Full-Year 2024 Financial Results And Provides Business Update
- 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, March 13, 2025--(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 HypertensionLink: https://goss.Bio/4h0uBJi
Sustained Benefit with Seralutinib Treatment: A Post-Hoc Analysis of the TORREY Open-Label ExtensionLink: https://goss.Bio/3CmVuYu
Sustained Effect of Seralutinib on Circulating Biomarkers in the TORREY Phase 2 Open-Label Extension StudyLink: https://goss.Bio/42aKKqQ
Story Continues
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/
Contacts
For Investors and Media:Bryan Giraudo, Chief Financial Officer & Chief Operating OfficerGossamer Bio Investor Relationsir@gossamerbio.Com
Understanding NCCN Guidelines: Gavreto In First-Line RET Fusion NSCLC
Gavreto is recommended as a first-line treatment for metastatic RET fusion-positive, metastatic non-small cell lung cancer, with potential severe side effects.
Gavreto is a preferred first-line treatment for metastatic RET fusion-positive NSCLC, with FDA approval based on the ARROW study and potential severe side effects.
For patients diagnosed with RET fusion-positive, metastatic non-small cell lung cancer (NSCLC), understanding treatment options is crucial.
Part of the decision-making process may include considerations from the National Comprehensive Cancer Network (NCCN), which provides expert-developed guidelines that doctors use to determine the best course of action for treatment.
For first-line treatment, the NCCN guidelines strongly recommend targeted therapies aimed at the RET fusion, which is the genetic change driving a patient's cancer growth.
These medications, such as Retevmo (selpercatinib) and Gavreto (pralsetinib), are taken orally and have shown significant promise in shrinking tumors and improving patient outcomes compared to traditional chemotherapy among patients with metastatic RET fusion-positive NSCLC.
Gavreto in the First LineGavreto is recommended as a category 2A preferred first-line treatment for metastatic RET fusion-positive NSCLC in the NCCN guidelines. This recommendation is based on evidence supporting its use in patients with a RET fusion-positive mutation.
Glossary:Complete response: disappearance of all cancer signs after treatment.
Interstitial lung disease: a group of lung disorders causing scarring and difficulty breathing.
Pneumonitis: Inflammation of lung tissue, causing symptoms like cough, shortness of breath and chest pain.
Hepatotoxicity: Liver damage from chemicals or drugs, leading to abnormal liver function and potential failure.
AST (Aspartate aminotransferase): an enzyme in the liver and other tissues, elevated levels suggest liver damage.
ALT (Alanine aminotransferase): a liver enzyme, elevated levels indicate liver damage.
Tumor lysis syndrome (TLS): rapid tumor cell destruction, causing kidney failure and other complications.
The Food and Drug Administration (FDA) approval of Gavreto was based on results from the phase 1/2 ARROW study, which demonstrated a 57% overall response rate in patients with RET fusion-positive NSCLC, regardless of prior therapy or central nervous system involvement. Among 87 patients previously treated with platinum-based chemotherapy, 5.7% had a complete response, and 70% of 27 patients who were treatment-naive responded, with 11% achieving a complete response.
Side Effects and DosingGavreto may cause severe, life-threatening interstitial lung disease or pneumonitis, with 12% of patients experiencing pneumonitis, including 3.3% with grade 3 (severe) to 4 (life-threatening) reactions and 0.2% with fatal cases. According to the agent's manufacturer, Rigel Pharmaceuticals, patients should be monitored for pulmonary symptoms, and Gavreto should be withheld for investigation if symptoms worsen.
Hypertension occurred in 35% of patients, with 18% experiencing grade 3 hypertension. Dose interruptions and reductions due to hypertension occurred in 8% and 4.8% of patients, respectively. Hepatotoxicity occurred in 1.5% of patients, with increased aspartate aminotransferase (AST) in 49% and alanine aminotransferase (ALT) in 37%. Grade 3 to 4 AST was observed in 7%, and grade 3 to 4 ALT in 4.8% of patients.
Hemorrhagic events, including fatal cases, were observed in 4.1% of patients, with one fatal case. Tumor lysis syndrome (TLS) was reported in patients with medullary thyroid carcinoma. Common adverse reactions (25% or more) included musculoskeletal pain, constipation, hypertension, diarrhea, fatigue, edema, pyrexia and cough. Grade 3 to 4 laboratory abnormalities (2% or more) included decreased lymphocytes, neutrophils, hemoglobin and phosphate, along with increased AST, ALT, alkaline phosphatase and bilirubin.
The recommended starting dose of Gavreto is 400 milligrams (mg) once daily. Treatment should continue until disease progression or unacceptable toxicity occurs. If a dose is missed, patients can take it on the same day, resuming their regular schedule the next day. If vomiting occurs, patients should not take an additional dose but continue with the next scheduled dose. Treatment should continue until disease progression or unacceptable toxicity occurs, with patients selected for Gavreto based on the presence of a RET gene fusion.
Gavreto and RET Fusion NSCLCGavreto works by selectively inhibiting the RET fusion protein, which drives tumor growth in RET fusion-positive NSCLC.
RET fusion-positive NSCLC is characterized by a fusion in the RET gene, present in 1% to 2% of NSCLC cases, according to Rigel Pharmaceuticals. The mutation leads to abnormal cell signaling, contributing to tumor growth. It is most commonly seen in patients with adenocarcinoma histology. Prior to Gavreto's approval, treatment options for these patients were limited.
Testing for RET fusion is necessary before initiating treatment with Gavreto.
For more news on cancer updates, research and education, don't forget to subscribe to CURE®'s newsletters here.
Lung Ultrasound Shows Promise For ILD-RA Detection
Photo Credit: iStock.Com/Inside Creative House
Lung ultrasound outperformed symptom-based screening questionnaires for ILD-RA detection, according to a recent study published in RMD Open.
Lung ultrasound outperformed symptom-based screening tools for the detection of interstitial lung disease associated with rheumatoid arthritis (ILD-RA), according to a study published in RMD Open.
The findings are based on a cross-sectional analysis conducted by Marie Vermant, MD, and colleagues that assessed the role of lung ultrasound, using a 72-zone approach, compared with symptom-based questionnaires to detect ILD in patients with RA.
The study included 116 adult patients diagnosed with RA. All patients underwent high-resolution CT, pulmonary function tests, and lung ultrasound. They also completed questionnaires about their pulmonary and rheumatologic symptoms. The questionnaires examined the presence of dyspnea and cough, and they included the modified Medical Research Council (mMRC) dyspnea scale and the Visual Analogue Scale for Cough (VAS Cough).
Kruskal-Wallis (KW) tests evaluated the correlation between clinical–radiological high-resolution CT score (no ILD, non-specific abnormalities, subclinical ILD or ILD) and the B-lines on lung ultrasound, predicated diffusion capacity (DLCO%pred), predicted forced vital capacity (FVC%pred), VAS Cough, and mMRC.
Most patients were women, seropositive, and ever-smokers. The majority were in remission, as shown by a median disease activity score 28-C-reactive protein of 2.2.
The researchers detected clinically relevant ILD in 11.8% and subclinical interstitial lung changes in 5.5% of patients. The researchers found B-lines (KW c2=41.2; P=<0.001) and DLCO%pred (KW χ2=27.4; P=<0.001) were significantly associated with the clinical–radiological score, in contrast to FVC%pred, mMRC, and VAS cough. When using the purely radiologic score, this correlation remained significant for B-lines (KW c2=24.16; P=<0.001) and DLCO%pred (KW χ2=19.7; P=<0.001).
Cough and dyspnea only weakly predicted the ILD score in the sensitivity–specificity analyses. The sensitivity and specificity for the presence of dyspnea to detect the clinical–radiological score 3 were 62% and 50%, respectively. For the presence of cough, the sensitivity and specificity to detect score 3 were 54% and 66%, respectively.
"While further collaborative research is necessary to define consensus protocols to identify subjects for screening, determine appropriate cut-offs for the number of B-lines, and define optimal screening intervals, our findings suggest that [lung ultrasound] could have a transformative role in the early detection of RA-ILD," the investigators concluded.
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