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GOSS Positive Sentiment Score: 75/100

Gossamer Bio Announces Second Quarter 2023 Financial Results and Provides Business Update - Seralutinib Phase 3 PROSERA Study in PAH Patients Expected to Initiate in 3Q23 - - Additional Data from TORREY Open-Label Extens

Key Takeaway: Gossamer Bio recently announced its financial results for Q2 2023, highlighting a significant cash position of $374 million following a recent private placement. The company is set to initiate a Phase 3 clinical trial for seralutinib in pulmonary arterial hypertension (PAH) patients in the third quarter of 2023, which represents a critical advancement in their business strategy. Additionally, Gossamer expects to release further data from its ongoing TORREY open-label extension study in PAH patients by late 2023 or early 2024. Despite the optimistic outlook, the company reported a net loss of $42.5 million for the quarter, although this figure showed improvement compared to the previous year.

Market Sentiment Analysis

POSITIVE FACTORS

  • Initiation of the Phase 3 PROSERA Study for seralutinib in PAH patients expected in 3Q23.
  • Company has significant cash reserves of $374 million post-private placement.
  • Reduction in research and development expenses indicates improved financial efficiency.

CONCERNS & RISKS

  • Net loss for the quarter was $42.5 million, though improved from the previous year.
  • Dependence on the successful outcome of ongoing clinical trials for future growth.

Full Press Release Details

Gossamer Bio Announces Second Quarter 2023 Financial Results and Provides Business Update
- Seralutinib Phase 3 PROSERA Study in PAH Patients Expected to Initiate in 3Q23 -
- Additional Data from TORREY Open-Label Extension Expected in 4Q23 or 1Q24 -
- $374 Million in Cash, Cash Equivalents Marketable Securities, as of June 30, 2023, Pro Forma for Gross Proceeds of $212 Million from a Private Placement Financing in July 2023 -
SAN DIEGO-(BUSINESS WIRE)- August 8, 2023 - 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), today announced its financial results for the second quarter ended June 30, 2023 and provided a business update.
"We are very excited to begin the Phase 3 PROSERA Study, the next step on our journey to make seralutinib available to patients with PAH," said Faheem Hasnain, Chairman, Co-Founder and CEO of Gossamer Bio. "Seralutinib, as a potentially disease-modifying therapy delivered via convenient dry powder inhaler, has the chance to fundamentally alter the treatment paradigm for this progressive disease. I am so proud of our team's efforts thus far and share in the enthusiasm for the work ahead."
Seralutinib (GB002) Inhaled PDGFR, CSF1R and c-KIT Inhibitor for PAH
In July, Gossamer announced an interim update of its Phase 2 TORREY Study open-label extension (OLE) data and details of the design of the Phase 3 PROSERA Study. A webcast was held on July 25th to discuss this information with global PAH leaders Dr. Ray Benza, Dr. Ardi Ghofrani, and Dr. Jim White. A recording of this webcast is available at https ir.gossamerbio.com events-and-presentations events.
The Phase 3 PROSERA Study in Functional Class II and III PAH patients is expected to initiate in the third quarter of 2023. The primary endpoint is change in six-minute walk distance (6MWD) from baseline at week 24.
Gossamer expects to release further TORREY OLE data from the ongoing extension study in PAH patients in the fourth quarter of 2023 or the first quarter of 2024.
On July 20, the Company announced the sale of 129,869,440 shares of its common stock and accompanying warrants to purchase up to 32,467,360 shares of common stock to new and existing institutional investors and certain directors and executive officers of Gossamer in a private placement, raising approximately $212 million in gross proceeds.
Financial Results for Quarter Ended June 30, 2023
Cash, Cash Equivalents and Marketable Securities Cash, cash equivalents and marketable securities as of June 30, 2023, were $162.1 million. The Company expects the combination of current cash, cash equivalents and marketable securities, inclusive of the proceeds from the July private placement, will be sufficient to fund its operating and capital expenditures into the first half of 2026.
Research and Development (R D) Expenses For the quarter ended June 30, 2023, R D expenses were $36.3 million, compared to $42.6 million for the same period in 2022, for a decrease of $6.3 million, which was primarily attributable to a decrease of $9.5 million of costs associated with preclinical studies and clinical trials for other programs and a decrease of $5.7 million of costs associated with preclinical studies and clinical trials for GB5121, offset by an increase of $8.9 million of costs associated with preclinical studies and clinical trials for seralutinib.
General and Administrative (G A) Expenses For the quarter ended June 30, 2023, G A expenses were $10.0 million, compared to $11.3 million for the same period in 2022.
Net Loss Net loss for the quarter ended June 30, 2023, was $42.5 million, or $0.45 per share, compared to a net loss of $56.5 million, or $0.74 per share, for the same period in 2022.
Gossamer Bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension. Its goal is to be an industry leader in, and to enhance the lives of patients suffering from, 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 anticipated timing of initiation and enrollment of clinical trials for seralutinib, including the expected initiation of a Phase 3 clinical program for seralutinib expectations on the timing of data readouts from our clinical studies, including our Phase 2 open-label extension trial of for seralutinib 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 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)
Three months ended June 30, Six months ended June 30,
2023 2022 2023 2022
Operating expenses
Research and development $ 36,309 $ 42,580 $ 74,104 $ 84,902
In process research and development 15 15 30 35
General and administrative 9,976 11,277 20,108 23,278
Total operating expenses 46,300 53,872 94,242 108,215
Loss from operations (46,300) (53,872) (94,242) (108,215)
Other income (expense), net
Interest income 695 300 1,282 524
Interest expense (3,429) (3,481) (6,929) (6,948)
Other income, net 6,538 587 8,228 388
Total other income (expense), net 3,804 (2,594) 2,581 (6,036)
Net loss $ (42,496) $ (56,466) $ (91,661) $ (114,251)
Net loss per share, basic and diluted $ (0.45) $ (0.74) $ (0.96) $ (1.50)
Weighted average common shares outstanding, basic and diluted 95,446,929 76,668,162 95,160,204 76,283,564
Condensed Consolidated Balance Sheet
BALANCE SHEET DATA June 30, 2023 December 31, 2022
(unaudited)
Cash, cash equivalents, and marketable securities $ 162,126 $ 255,678
Working capital 133,236 212,650
Total assets 181,746 272,450
Total liabilities 244,546 260,373
Accumulated deficit (1,123,884) (1,032,223)
Total stockholders' equity (deficit) (62,800) 12,077
For Investors and Media
Bryan Giraudo, Chief Operating Officer and Chief Financial Officer
Gossamer Bio Investor Relations

Frequently Asked Questions

What is the PROSERA Study about?

The PROSERA Study is a Phase 3 trial for seralutinib in patients with PAH.

When will the TORREY OLE data be released?

Further TORREY OLE data is expected in Q4 2023 or Q1 2024.

How much cash did Gossamer Bio report?

Gossamer Bio reported $374 million in cash and marketable securities.

What were Gossamer's net losses for Q2 2023?

The net loss for Q2 2023 was $42.5 million, or $0.45 per share.

What is seralutinib used for?

Seralutinib is developed for treating pulmonary arterial hypertension (PAH).

Last updated: Aug 8, 2023