Gossamer Bio Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Updates

– Received FDA Feedback on Seralutinib Phase 3 Clinical Trial; Expected start in the second half of 2023 –

– Top-line data from open-label extension of TORREY study expected in mid-2023 –

– Enrollment in Phase 1b/2 GB5121 clinical trial in PCNSL halted –

– Cash, cash equivalents and marketable securities totaled $256 million at year-end 2022 –

SAN DIEGO, March 17, 2023–(BUSINESS WIRE)–Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the discovery, acquisition, development and commercialization of therapeutics in the disease areas of immunology, inflammation and… Oncology, today announced its financial results for the fourth quarter and year ended December 31, 2022 and provided a business update.

Updates from clinical stage product candidates

Seralutinib (GB002): Inhaled PDGFR, CSF1R, and c-KIT Inhibitor for Pulmonary Arterial Hypertension (PAH)

• Upon completion of the 24-week blinded portion of the Phase 2 TORREY study, patients were eligible to enroll in an open-label extension study. We expect reporting of the results of this ongoing open-label extension study in mid-2023.

• We expect to start a phase 3 PAH clinical trial in the second half of 2023. The planned phase 3 clinical trial will be a randomized, double-blind, placebo-controlled, global clinical trial in PAH patients. Patients will be randomized to receive either seralutinib or placebo in addition to their background PAH therapies.

• Based on FDA feedback, we anticipate testing a single dose of 90 mg twice daily in the planned Phase 3 clinical trial in PAH, and expect the trial’s primary endpoint to be a change in distance from six minutes walk from baseline will be. However, the final study design is subject to further feedback from global regulatory authorities.

GB5121: Oral CNS Penetrant BTK Inhibitor for Primary CNS Lymphoma (PCNSL)

• Based on the benefit-risk profile observed to date and a prioritization of resources to support the seralutinib program, Gossamer has decided to suspend enrollment in the Phase 1b/2 STAR-CNS trial.

• Gossamer plans to discuss the available data with the study’s Data Review Committee to determine next steps.

The story goes on

Financial results for the quarter and full year ended December 31, 2022

• Cash, cash equivalents and marketable securities: Cash, cash equivalents and marketable securities were $255.7 million as of December 31, 2022. As a result, we anticipate that our current cash, cash equivalents and marketable securities will be sufficient to fund operating and capital expenditures into the second half of 2024.

• Research and development (R&D) expenses: For the quarter ended December 31, 2022, R&D expenses were $41.5 million compared to R&D expenses of $40.9 million for the same period in 2021. R&D expenses for the am Full year ended December 31, 2022 was $170.9 million compared to $170.3 million for the full year ended December 31, 2021.

• General and Administrative Expenses (G&A): For the quarter ended December 31, 2022, G&A expenses were $12.8 million compared to $10.7 million for the same period in 2021. G&A expenses for the year ended December 31, 2022 The full year ended December 31, 2022 totaled $47.6 million compared to $45.8 million for the full year ended December 31, 2021.

• net loss: Net loss for the three months ended December 31, 2022 was $55.8 million, or $0.59 per share, compared to a net loss of $56.3 million, or $0.74 per share for the same period in 2021. Net loss for the full year ended December 2022 was $229.4 million, or $2.71 per share, compared to a net loss of $234.0 million, or 3, $13 per share for the full year ended December 31, 2021.

About Gossamer Bio

Gossamer Bio is a clinical-stage biopharmaceutical company focused on the discovery, acquisition, development and commercialization of therapeutics in the disease areas of immunology, inflammation and oncology. Its goal is to be an industry leader in each of these therapeutic areas and to improve and prolong the lives of patients suffering from such diseases.

Forward-Looking Statements

Gossamer cautions you that statements 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 initiating and initiating clinical trials for our product candidates, including the anticipated timing of initiating the Phase 3 clinical trial of seralutinib in PAH; the study design of any such phase 3 clinical trial of seralutinib based on regulatory feedback; plans to discuss our benefit-risk profile for GB5121 with our Data Review Committee, plans to advance our product candidates; expectations at the time of data read-out from our clinical studies, including our Phase 2 open-label extension study of seralutinib; and the expected timeframe for funding our plan of operations using current cash, cash equivalents and marketable securities. The inclusion of any forward-looking statements should not be taken as a representation by Gossamer that any of its plans will be achieved. Actual results could differ from those set forth in this press release due to the risks and uncertainties associated with Gossamer’s business, including but not limited to: potential delays in the initiation, registration and completion of clinical trials; subsequent developments with and/or feedback from global regulators or the FDA, which may differ from previous feedback, which may alter our planned Phase 3 clinical trial design and timing of its initiation; disruption to our operations due to the COVID-19 pandemic, including clinical trial delays; the Company’s dependence on third parties in connection with product manufacturing, research and pre-clinical and clinical testing; the results of pre-clinical studies and early clinical studies are not necessarily predictive of future results; the success of Gossamer’s clinical trials and pre-clinical studies for its product candidates; regulatory developments in the United States and other countries; unexpected undesirable side effects or insufficient efficacy of our product candidates, which may limit their development, regulatory approval and/or commercialization or result in clinical suspensions, recalls or product liability claims; Gossamer’s ability to obtain and maintain intellectual property protection for its product candidates; Gossamer’s ability to comply with its obligations under 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 relating to financial institutions and the associated liquidity risk may adversely affect our business and financial condition, the economy and the biotechnology industry generally; Gossamer may use its capital resources sooner than expected; 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 all 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 of this release, and Gossamer undertakes no obligation to update any such statements to reflect events or circumstances after the date of this release. All forward-looking statements are qualified in their entirety by this cautionary statement which is governed by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230317005063/en/

contacts

For investors and media:
Bryan Giraudo, Chief Financial Officer and Chief Operating Officer
Gossamer Bio Investor Relations
ir@gossamerbio.com