– Received FDA feedback on seralutinib phase three clinical trial It is anticipated to commence in the second half of 2023.
– Heat information from the TORREI Open-Label Extension study is anticipated in mid-2023 –
– Enrollment in GB5121 phase 1b/two clinical trial in PCNSL paused –
– Money, money equivalents and marketable securities totaled $256 million at the finish of 2022.
SAN DIEGO, March 17, 2023—(Business enterprise WIRE)–Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical corporation focused on the discovery, acquisition, improvement and commercialization of therapies in illness locations such as immunology, inflammation and oncology, nowadays announced its economic outcomes for the fourth quarter and year ended December 31, 2022. and supplied company updates.
Clinical Phase Solution Candidate Updates
Seralutinib (GB002): Inhaled PDGFR, CSF1R, and c-KIT Inhibitor for Pulmonary Arterial Hypertension (PAH)
Upon completion of the 24-week blinded portion of the TORREI phase two study, individuals have been eligible to enroll in an open-label extension trial. We count on to report the outcomes of this ongoing open-label extension trial in mid-2023.
We count on to initiate a Phase three PAH clinical trial in the second half of 2023. The planned Phase three clinical trial will be a randomized, double-blind, placebo-controlled, worldwide clinical trial in individuals with PAH. Individuals will be randomized to get either seralutinib or placebo, in addition to their major PAH therapies.
Primarily based on FDA feedback, we count on to test a single dose of 90 mg twice everyday in a planned Phase three PAH clinical trial, and we count on the major endpoint of the trial to be modify in six-minute stroll distance from baseline. Having said that, the final trial style is topic to additional feedback from worldwide regulatory authorities.
GB5121: Oral, CNS-Penetrating BTK Inhibitor for Main CNS Lymphoma (PCNSL)
Primarily based on the advantage/threat profile observed to date and resource priorities to assistance the seralutinib system, Gossamer has decided to pause enrollment in the Phase 1b/two STAR CNS study.
Gossamer plans to talk about the out there information with the study’s Information Overview Board to identify subsequent actions.
The story continues
Monetary outcomes for the quarter and complete year ended December 31, 2022
Money, money equivalents and marketable securities: Money, money equivalents and marketable securities at December 31, 2022 have been $255.7 million. As a outcome, we count on our present money, money equivalents and marketable securities to be enough to fund operating and capital expenditures in the second half of 2024.
Analysis and improvement (R&D) expenses: For the quarter ended December 31, 2022, study and improvement costs have been $41.five million compared to study and improvement costs of $40.9 million for the very same period in 2021. Analysis and improvement costs for the complete year ended 31 .December 2022 have been $170.9 million compared to $170.three million for the complete year. year that ended on December 31, 2021.
Basic and administrative (G&A) costs: For the quarter ended December 31, 2022, basic and administrative costs have been $12.eight million compared to $ten.7 million for the very same period in 2021. Basic and administrative costs for the complete year ended December 31, 2022 . have been $47.six million compared to $45.eight million for the complete year ended December 31, 2022.
Net loss: Net loss for the 3 months ended December 31, 2022 was $55.eight million, or $.59 per share, compared to a net loss of $56.three million, or $.74 per share, for the very same period 2021 Net loss for the complete year ended December 31, 2022 was $229.four million, or $two.71 per share, compared to a net loss of $234. million, or $three.13 per share action, for the complete year ended on December 31, 2021.
About Gossamer Bio
Gossamer Bio is a clinical biopharmaceutical corporation focused on the discovery, acquisition, improvement and commercialization of therapies in illness locations such as immunology, inflammation and oncology. Its aim is to be an sector leader in every single of these therapeutic locations and to enhance and prolong the lives of individuals suffering from such illnesses.
Gossamer cautions you that statements contained in this press release concerning matters that are not historical information are forward-hunting statements. These statements are primarily based on the Company’s present beliefs and expectations. Such forward-hunting statements consist of, but are not restricted to, statements concerning: the anticipated timing of initiation and enrollment in clinical trials for our item candidates, like the anticipated initiation timing of the Phase three clinical trial of seralutinib in PAH the study style of such a Phase three clinical trial of seralutinib primarily based on regulatory feedback plans to talk about our advantage/threat profile for GB5121 with our information critique committee, plans to advance our item candidates expectations concerning the timing of information readouts from our clinical research, like our open-label extension phase two trial of seralutinib and the anticipated timeframe for funding our operating program with present money, money equivalents and marketable securities. The inclusion of forward-hunting statements must not be deemed a representation by Gossamer that any of its plans will be realized. Actual outcomes may perhaps differ from these stated in this press release due to dangers and uncertainties inherent in Gossamer’s company, like, devoid of limitation: prospective delays in initiation, enrollment and completion of clinical trials subsequent developments and/or feedback from worldwide regulatory authorities or the FDA that may perhaps differ from preceding feedback that may perhaps modify our planned Phase three clinical trial style and timing of its initiation disruption to our company due to the COVID-19 pandemic, like delays in clinical trials the Company’s dependence on third parties in connection with item manufacturing, study and preclinical and clinical testing the outcomes of preclinical research and early clinical trials are not necessarily predictive of future outcomes the good results of Gossamer’s clinical trials and preclinical research for its item candidates regulatory developments in the United States and foreign nations unexpected adverse side effects or inadequate efficacy of our item candidates that may perhaps limit their improvement, regulatory approval and/or commercialization, or may perhaps outcome in clinical holds, recalls or item liability claims Gossamer’s capacity to receive and sustain intellectual house protection for its item candidates Gossamer’s capacity to comply with its obligations below collaboration agreements with third parties or agreements below which it licenses the intellectual house rights of third parties unstable market place and financial circumstances and adverse developments with respect to economic institutions and connected liquidity threat may perhaps adversely have an effect on our company and economic situation and the broader economy and biotechnology sector Gossamer may perhaps use its capital sources earlier than it expects and other dangers described in the Company’s preceding press releases and the Company’s filings with the Securities and Exchange Commission (SEC), like below the heading “Danger Aspects” in the Company’s Annual Report on Kind ten-K and all subsequent filings with the SEC. You are cautioned not to spot undue reliance on these forward-hunting statements, which speak only as of the date hereof, and Gossamer undertakes no obligation to update such statements to reflect events that take place or situations that exist just after the date of this statement. All forward-hunting statements are certified in their entirety by this cautionary statement, which is produced pursuant to the provisions of the Private Securities Litigation Reform Act of 1995.
GOSSAMER BIO, INC.
SUMMARY OF CONSOLIDATED Monetary STATEMENTS
(UNREVISED IN THOUSANDS, EXCEPT Information ON ACTION AND BY ACTION)
3 months ended December 31
Year ended December 31
Information OPERATING STATEMENTS:
Analysis & Improvement
In the approach of study and improvement
Basic and administrative
Total operating expenses
Loss from operations
Other earnings (costs)
Other earnings (costs)
Total other costs, net
Net loss per share, standard and diluted
Weighted typical popular shares outstanding, standard and diluted
BALANCE SHEET Information:
December 31, 2022
December 31, 2021
Money, money equivalents and marketable securities
Total shareholders’ equity
See the original version on businessvire.com: https://vvv.businessvire.com/nevs/house/20230317005063/en/
For investors and media:
Brian Giraudo, Chief Monetary Officer and Chief Operating Officer
Gossamer Bio Investor Relations
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