Site icon pharmaceutical daily

Gossamer ends Q1 with net loss of $54.1 million

Gossamer Bio has reported a net loss for the first quarter  2020, was $54.1 million, or $0.87 per share, compared to a net loss of $32.6 million, or $0.90 per share, for the same period in 2019, while cash, cash equivalents and marketable securities totaled $346 million as of March 31, 2020.

SAN DIEGO–(BUSINESS WIRE)–$GOSS–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 first quarter 2020 and provided a corporate update.

“We are very pleased today to share initial results of the Gossamer team’s great execution and hard work, including that we have successfully completed the interim analysis of the LEDA study of GB001,” said Sheila Gujrathi, M.D., Co-Founder and Chief Executive Officer of Gossamer. “We have begun initial Phase 3 planning and supportive activities, while awaiting final data from the study which will inform our decision to proceed to Phase 3.”

“We are also excited to share topline results from our four-week Phase 1b study of GB004 in patients with active mild-to-moderate ulcerative colitis,” said Dr. Gujrathi. “The safety and tolerability data, in addition to the promising efficacy data observed in the study, give us confidence as we move into Phase 2.”

“The trends observed in the clinical endpoints from a 28-day study with a limited number of patients, especially those endpoints that reflect GB004’s novel mechanism of action, such as histologic remission and mucosal healing, are very exciting,” said William Sandborn, M.D., Chief of the Division of Gastroenterology of University of California San Diego. “An oral, gut-targeted therapy with a non-immunosuppressive mechanism of action and a robust effect on mucosal healing would be a very meaningful addition to the treatment options for patients with ulcerative colitis. These early signals of activity, combined with the tolerability data generated to date, position GB004 as a promising and differentiated potential treatment for IBD.”

Clinical-Stage Product Candidate Updates

GB001: Oral DP2 Antagonist for Eosinophilic Asthma and Chronic Rhinosinusitis (CRS)

GB004: Oral HIF-1α Stabilizer for Inflammatory Bowel Disease

GB002: Inhaled PDGFR Inhibitor for Pulmonary Arterial Hypertension (PAH)

GB1275: Oral CD11b Modulator for Oncology Indications

Corporate Updates

“I would like to thank our Chief Medical Officer, Jakob Dupont, for his contributions to Gossamer, especially with respect to our GB1275 program, which Jakob will continue to support as a consultant,” said Dr. Gujrathi. “I respect and support his personal decision to be closer to his family in the Bay Area in this unprecedented time,” she added.

Financial Results for the Quarter Ended March 31, 2020

Conference Call and Webcast

Gossamer’s management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Tuesday, May 12, to discuss its first quarter 2020 financial results and provide a corporate update.

The live audio webcast may be accessed through the Events/Presentations page in the Investors section of the Company’s website at www.gossamerbio.com. Alternatively, the conference call may be accessed through the following:

Conference ID: 8593375

Domestic Dial-in Number: (833) 646-0603

International Dial-in Number: (929) 517-9782

Live Webcast: https://edge.media-server.com/mmc/p/wf9kdou9

A replay of the audio webcast will be available for 30 days on the Investors section of the Company’s website, www.gossamerbio.com.

About the GB004 Phase 1b Study

The Phase 1b study of GB004 was a multi-center, randomized, double-blind, placebo-controlled study which enrolled 34 patients with active mild-to-moderate ulcerative colitis. Patients were randomized 2:1 to receive either a 120mg once-daily dose of a solution formulation of GB004 (n=23) or placebo (n=11). The primary objective of the study was to evaluate the safety and tolerability of GB004 administered over 28 days. Pharmacokinetics were evaluated as a secondary objective, while exploratory objectives included measurements of pharmacodynamics and clinical outcomes. Histology, endoscopic improvement, and mucosal healing were evaluated individually in two segments of the large intestine: the sigmoid colon and rectum.

Exploratory clinical outcomes in the study were defined as follows:

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: our plans to begin Phase 3 planning and supportive activities for GB001; the anticipated timing of initiation and enrollment of clinical trials for our product candidates; plans to advance our product candidates; expectations on the timing of data readouts from our clinical studies; the potential clinical benefits of our product candidates; the expected impact of COVID-19; the length of our intellectual property protection; 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 recent global outbreak of 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 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; Gossamer may not proceed into Phase 3 clinical trials for GB001 whether based on final data or otherwise; 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 March 31,

STATEMENTS OF OPERATIONS DATA:

2020

2019

Operating expenses:

Research and development

$

41,414

$

24,983

In process research and development

2,805

1,000

General and administrative

10,748

8,034

Total operating expenses

54,967

34,017

Loss from operations

(54,967

)

(34,017

)

Other income, net

893

1,406

Net loss

$

(54,074

)

$

(32,611

)

Net loss per share, basic and diluted

$

(0.87

)

$

(0.90

)

Weighted average common shares outstanding, basic and diluted

61,890,323

36,317,230

Condensed Consolidated Balance Sheet

(in thousands)

(unaudited)

BALANCE SHEET DATA:

March 31, 2020

December 31, 2019

Cash, cash equivalents, and marketable securities

$

346,165

$

401,829

Working capital

327,076

372,394

Total assets

371,478

426,604

Total liabilities

65,015

74,119

Accumulated deficit

(388,244

)

(334,170

)

Total stockholders’ equity (deficit)

306,463

352,485

Contacts

Bryan Giraudo, Chief Financial Officer

Gossamer Bio Investor Relations

IR@gossamerbio.com

Exit mobile version