– 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.

Forward-hunting statements

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:

in 2022

in 2021

in 2022

in 2021

Operating costs:

Analysis & Improvement

$

41,508

$

40,932

$

170,919

$

170,267

In the approach of study and improvement

15

15

65

75

Basic and administrative

12,834

ten,714

47,609

45,782

Total operating expenses

54,357

51,661

218,593

216,124

Loss from operations

(54,357

)

(51,661

)

(218,593

)

(216.124

)

Other earnings (costs)

Interest earnings

594

236

1,583

761

Interest costs

(three.457

)

(four.937

)

(13,880

)

(19,440

)

Other earnings (costs)

1,456

78

1,512

799

Total other costs, net

(1.407

)

(four.623

)

(ten,785

)

(17,880

)

Net loss

$

(55,764

)

$

(56,284

)

$

(229,378

)

$

(234.004

)

Net loss per share, standard and diluted

$

(.59

)

$

(.74

)

$

(two.71

)

$

(three.13

)

Weighted typical popular shares outstanding, standard and diluted

94,280,553

75,587,851

84,574,869

74,843,482

BALANCE SHEET Information:

December 31, 2022

December 31, 2021

Money, money equivalents and marketable securities

$

255,678

$

325,218

Reversible capital

212,650

291,921

total assets

272,450

343,657

Total liabilities

260,373

222,194

Accumulated deficit

(1,032,223

)

(811,534

)

Total shareholders’ equity

12,077

121,463

See the original version on businessvire.com: https://vvv.businessvire.com/nevs/house/20230317005063/en/

Contacts

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

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