GOSS Gossamer Bio Inc

- Seralutinib Phase 2 TORREY Study on track for topline readout in second half of November or first half of December -

- $304 million in cash, cash equivalents & marketable securities, as of September 30, 2022 -

Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, today announced its financial results for the third quarter ended September 30, 2022 and provided a business update.

“It has been a productive quarter as we eagerly await topline results from the Phase 2 TORREY Study,” said Faheem Hasnain, Chairman, Co-Founder and CEO of Gossamer Bio. “Additionally, our team continues to enroll the dose escalation portion of the STAR CNS Study of GB5121, our CNS-penetrant BTK inhibitor for the treatment of CNS lymphomas.”

Product Candidate Updates

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

• Ongoing TORREY Study is a Phase 2 clinical trial in patients with PAH whose disease has progressed despite standard-of-care therapy. The primary endpoint is change in pulmonary vascular resistance from baseline at week 24.
• Topline data from the Phase 2 TORREY Study are expected in the second half of November or first half of December.
• Ahead of these data, Gossamer has commenced investment in operational activities to enable the commencement of a registrational PAH Phase 3 clinical program in the third quarter of 2023.

GB5121: Oral, CNS-Penetrant BTK Inhibitor for Primary CNS Lymphoma (PCNSL) and other Rare CNS Malignancies

• Enrollment ongoing in Phase 1b/2 STAR CNS Study in relapsed / refractory PCNSL and other rare CNS malignancies.
• Results from the STAR CNS study to be presented at relevant medical conferences, as data become available.

GB7208: Oral, CNS-Penetrant BTK Inhibitor for Multiple Sclerosis

• Program highlighted in two poster presentations at the 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS; October 2022):
  • P556: GB7208 is a CNS-Penetrant BTK Inhibitor Demonstrating Potent Activity on Pathogenic Pathways Implicated in Multiple Sclerosis
  • P690: GB7208 is a Novel, Highly Potent and Selective CNS-Penetrant BTK Inhibitor for Neuroinflammatory and Neurodegenerative Diseases
• Posters are available online at: https://www.gossamerbio.com/pipeline/posters-and-publications/

Preclinical Pipeline Updates

• Data generated for two internally developed preclinical programs presented at recent medical conferences:
  • 10th Annual Meeting of the International Cytokine & Interferon Society (September 2022):
    • P109: Identification of Novel Inhibitor(s) Targeting NLRP3 Inflammasome Activation
  • 34th EORTC-NCI-AACR Symposium (October 2022):
    • P350: An Orally Bioavailable ENPP1-Selective Inhibitor Demonstrates Superior Immune Preservation Effects over STING Agonists and Confers Anti-Tumor Efficacy in Combination with Other Therapies in Syngeneic Tumor Models
• Poster highlighting a third internally developed program to be presented at the upcoming 37th Annual Meeting of the Society for Immunotherapy of Cancer, or SITC, in Boston from November 8-12, 2022:
  • P855: Diacylglycerol Kinase Alpha and Zeta Dual Inhibitors Enhance T Cell Responses and Promote Robust and Durable Anti-Tumor T Cell Immunity
• Posters are available, or will be available, online at: https://www.gossamerbio.com/pipeline/posters-and-publications/

Financial Results for Quarter Ended September 30, 2022

• Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of September 30, 2022, were $304.4 million. The Company expects the combination of current cash, cash equivalents and marketable securities, and access to its debt facility, will be sufficient to fund its operating and capital expenditures into the second quarter of 2024.
• Research and Development (R&D) Expenses: For the quarter ended September 30, 2022, R&D expenses were $44.5 million, compared to $43.2 million for the same period in 2021.
• General and Administrative (G&A) Expenses: For the quarter ended September 30, 2022, G&A expenses were $11.5 million, compared to $12.5 million for the same period in 2021.
• Net Loss: Net loss for the quarter ended September 30, 2022, was $59.4 million, or $0.65 per share, compared to a net loss of $60.2 million, or $0.80 per share, for the same period in 2021.

About Gossamer Bio

Gossamer Bio is a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing 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 enhance and extend the lives of patients suffering from such diseases.

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 initiation and enrollment of clinical trials for our product candidates; including the expected initiation of a Phase 3 clinical program for seralutinib; plans to advance our product candidates; expectations on the timing of data readouts from our clinical studies, including the timing of topline results for the Phase 2 TORREY study for seralutinib; and the expected timeframe for funding our operating plan with current cash, cash equivalents and marketable securities, and access to our debt facility. 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: seralutinib may not advance into a Phase 3 clinical program in PAH whether due to the topline results from the Phase 2 TORREY Study or otherwise, potential delays in the commencement, enrollment and completion of clinical trials; disruption to our operations from the ongoing COVID-19 pandemic, including clinical trial delays and clinical site staff shortages; 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 its product candidates; interim results do not necessarily predict final results and one or more of the outcomes may materially change as the trial continues and more patient data become available and following more comprehensive audit and verification procedures; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval and/or commercialization, or may result in 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 in collaboration agreements with third parties or the agreements under which it licenses intellectual property rights from third parties; 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 September 30,

 

Nine months ended September 30,

 

 

2022

 

 

 

2021

 

 

 

2022

 

 

 

2021

 

Operating expenses:

 

 

 

 

 

 

 

Research and development

$

44,509

 

 

$

43,190

 

 

$

129,411

 

 

$

129,335

 

In process research and development

 

15

 

 

 

15

 

 

 

50

 

 

 

60

 

General and administrative

 

11,497

 

 

 

12,459

 

 

 

34,775

 

 

 

35,068

 

Total operating expenses

 

56,021

 

 

 

55,664

 

 

 

164,236

 

 

 

164,463

 

Loss from operations

 

(56,021

)

 

 

(55,664

)

 

 

(164,236

)

 

 

(164,463

)

Other income (expense), net

 

 

 

 

 

 

 

Interest income

 

465

 

 

 

191

 

 

 

989

 

 

 

525

 

Interest expense

 

(3,475

)

 

 

(4,889

)

 

 

(10,423

)

 

 

(14,503

)

Other income (expense)

 

(332

)

 

 

115

 

 

 

56

 

 

 

721

 

Total other income (expense), net

 

(3,342

)

 

 

(4,583

)

 

 

(9,378

)

 

 

(13,257

)

Net loss

$

(59,363

)

 

$

(60,247

)

 

$

(173,614

)

 

$

(177,720

)

Net loss per share, basic and diluted

$

(0.65

)

 

$

(0.80

)

 

$

(2.14

)

 

$

(2.38

)

Weighted average common shares outstanding, basic and diluted

 

91,181,427

 

 

 

75,001,510

 

 

 

81,304,089

 

 

 

74,592,632

 

Condensed Consolidated Balance Sheet

(in thousands)

(unaudited)

 

BALANCE SHEET DATA:

September 30, 2022

 

December 31, 2021

Cash, cash equivalents, and marketable securities

$

304,383

 

 

$

325,218

 

Working capital

 

259,387

 

 

 

291,921

 

Total assets

 

323,538

 

 

 

343,657

 

Total liabilities

 

267,187

 

 

 

222,194

 

Accumulated deficit

 

(976,459

)

 

 

(811,534

)

Total stockholders' equity

 

56,351

 

 

 

121,463

 

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20221103006082/en/

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