Seralutinib

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 two oral presentations and a poster presentation with data relevant to seralutinib at the European Respiratory Society (ERS) Congress 2024, which takes place from September 7 th through 11 th online and onsite in Vienna, Austria. “ We are thrilled to present additional findings from our Phase 2 TORREY open-label extension study at the European Respiratory Society Conference in Vienna which highlight the sustained effect of seralutinib beyond 24 weeks of treatment,” said Faheem Hasnain, Co-Founder, CEO, and Chairman of Gossamer Bio. “ With the continued improvement in clinical outcome measures and the sustained effect on circulating biomarkers of proteins and pathways relevant to PAH pathogenesis, these data demonstrate the potential of seralutinib to make a meaningful difference in the lives of people living with pulmonary hypertension. These findings reinforce our commitment to advancing the development of seralutinib for the treatment of patients with PAH and PH-ILD,” added Mr. Hasnain. Presentations related to Seralutinib, an Inhaled PDGFR, CSF1R and c-KIT Inhibitor Session Type: Oral Presentation Session Title: Novel Aspects in Pulmonary Hypertension Session Date & Time: September 8 th , 2:15pm – 3:30pm CEST Presentation Time: 2:25pm CEST Location: Lehar 3 Abstract Number: 1871 Presentation Title: Sustained benefit with seralutinib treatment: a post-hoc analysis of the TORREY open-label extension Presenter: Dr. Vallerie V. McLaughlin Session Type: Oral Presentation Session Title: Novel Aspects in Pulmonary Hypertension Session Date & Time: September 8 th , 2:15pm – 3:30pm CEST Presentation Time: 2:30pm CEST Location: Lehar 3 Abstract Number: 1872 Presentation Title: Sustained effect of seralutinib on circulating biomarkers in the TORREY phase 2 open-label extension study Presenter: Prof. Hossein-Ardeschir Ghofrani Session Type: Poster Presentation Session Title: Novel aspects in pulmonary hypertension pathobiology Session Date & Time: September 8 th , 12:30pm – 2:20pm CEST Location: PS-30 in Poster Area Abstract Number: 1613 Presentation Title: Reverse remodeling and anti-proliferative effects of seralutinib in PAH precision-cut lung slices and pulmonary artery smooth muscle cells Presenter: Prof. Soni S. Pullamsetti 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 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.

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 second quarter ended June 30, 2024 and provided a business update. “ Between the continued progress made in the enrollment of the Phase 3 PROSERA Study and the transformational collaboration agreement with the Chiesi Group, Gossamer has made great strides in the second quarter to advance the clinical development and strengthen the market potential of seralutinib,” said Faheem Hasnain, Co-Founder, CEO, and Chairman of Gossamer Bio. “ Additionally, we look forward to announcing seralutinib presentations and posters at major medical meetings in the coming months, which continue to support the potential of seralutinib as a novel agent in the treatment of patients with PAH and PH-ILD.” 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. On May 6, Gossamer Bio and the Chiesi Group announced a development and co-commercialization collaboration for seralutinib. Gossamer and Chiesi will split global development costs for seralutinib, except for the PROSERA Study, for which Gossamer will remain solely responsible. In the United States, Gossamer and Chiesi will split profits and losses, and Chiesi will be solely responsible for commercialization of seralutinib outside of the United States, for which Gossamer will receive mid-to-high teens royalties. Financial Results for Quarter Ended June 30, 2024 Cash, Cash Equivalents and Marketable Securities : Cash, cash equivalents and marketable securities as of June 30, 2024, were $354.5 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 June 30, 2024, revenue from the sale of licenses was $88.8 million and revenue from contracts with collaborators was $7.1 million. Our revenue consists of a one-time development cost reimbursement payment for licenses related to the collaboration with Chiesi and ongoing payments for research and development services related to the collaboration with Chiesi. Research and Development (R&D) Expenses : For the quarter ended June 30, 2024, R&D expenses were $35.1 million, compared to $36.3 million for the same period in 2023. General and Administrative (G&A) Expenses : For the quarter ended June 30, 2024, G&A expenses were $8.7 million, compared to $10.0 million for the same period in 2023. Net Income (Loss) : Net income for the quarter ended June 30, 2024, was $49.2 million, or $0.22 basic net income per share, compared to a net loss of $42.5 million, or $0.45 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; the timing of presentations and posters related to seralutinib; each of Gossamer’s and Chiesi’s respective obligations under the collaboration and license agreement to lead commercialization efforts and split development costs; 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 June 30, Six months ended June 30, 2024 2023 2024 2023 Revenue: Revenue from sale of licenses $ 88,751 $ — $ 88,751 $ — Revenue from contracts with collaborators 7,091 — 7,091 — Total revenue 95,842 — 95,842 — Operating expenses: Research and development 35,086 36,309 67,478 74,104 In process research and development — 15 — 30 General and administrative 8,669 9,976 18,236 20,108 Total operating expenses 43,755 46,300 85,714 94,242 Income (loss) from operations 52,087 (46,300 ) 10,128 (94,242 ) Other income (expense) Interest income 1,749 695 2,093 1,282 Interest expense (2,916 ) (3,429 ) (6,045 ) (6,929 ) Other income, net 2,747 6,538 5,563 8,228 Total other income, net 1,580 3,804 1,611 2,581 Income (loss) before provision for income taxes 53,667 (42,496 ) 11,739 (91,661 ) Provision for income taxes 4,435 — 4,435 — Net income (loss) $ 49,232 $ (42,496 ) $ 7,304 $ (91,661 ) Net income (loss) per share, basic $ 0.22 $ (0.45 ) $ 0.03 $ (0.96 ) Net income (loss) per share, diluted $ 0.22 $ (0.45 ) $ 0.03 $ (0.96 ) Weighted average common shares outstanding, basic 226,221,202 95,446,929 225,978,219 95,160,204 Weighted average common shares outstanding, diluted 238,543,102 95,446,929 225,978,219 95,160,204 Condensed Consolidated Balance Sheet (in thousands) BALANCE SHEET DATA: June 30, 2024 December 31, 2023 (unaudited) Cash, cash equivalents, and marketable securities $ 354,488 $ 296,425 Working capital 325,718 254,921 Total assets 373,448 311,916 Total liabilities 291,919 249,147 Accumulated deficit (1,204,736 ) (1,212,040 ) Total stockholders' equity 81,529 62,769