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The Penny Stock Pundits: 3 Companies Poised to Become the Talk of Wall Street
Investor Place· 2024-06-13 19:35
The company is not profitable yet but is guiding to be profitable in 2024. And revenue is increasing at an impressive pace. The stock doesn't get much analyst attention, but the four analysts that have issued a rating give MVST a consensus price target of $4.50, an 857% gain from its closing price on June 12, 2024. Source: PopTika / Shutterstock.com But all it takes is one. And that's also the number of candidates in Gossamer Bio's pipeline. The company has a candidate, Seralutinib (GB002), in a Phase 3 cli ...
Gossamer Bio(GOSS) - 2024 Q1 - Quarterly Results
2024-05-07 20:02
Gossamer Bio Announces First Quarter 2024 Financial Results and Provides Business Update SAN DIEGO—(BUSINESS WIRE)— May 7, 2024 — 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 first quarter ended March 31, 2024 and provided a busine ...
Gossamer Bio(GOSS) - 2024 Q1 - Quarterly Report
2024-05-07 20:01
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q _________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________to_________. Commission File Number: 001-38796 GOSSAMER BIO, INC. (Exact name of Registrant as specified in its charter) ...
Gossamer Bio (GOSS) M&A Announcement Transcript
2024-05-06 13:30
Summary of Gossamer Bio (GOSS) Conference Call Company and Industry Overview - **Company**: Gossamer Bio (GOSS) - **Industry**: Pulmonary Hypertension Drug Development Key Points and Arguments 1. **Collaboration with Chiesi Group**: Gossamer announced a transformative collaboration with Chiesi Group, which is expected to enhance the development and commercialization of saralutinib for pulmonary hypertension (PH) [4][5][6] 2. **Financial Impact**: The collaboration provides Gossamer with $160 million in cash for clinical development reimbursement, potentially leading to over $600 million in total commitments from Chiesi for the development and commercialization of saralutinib [5][8][9] 3. **Accelerated Development Timeline**: The partnership allows Gossamer to initiate a Phase III clinical trial for pulmonary hypertension associated with interstitial lung disease (PHILD) much sooner than previously planned, potentially four to five years earlier [6][11][14] 4. **Market Opportunity**: PHILD is identified as a significant market opportunity with only one approved therapy in the U.S. and none globally, indicating a high unmet medical need [6][10][15] 5. **Regulatory Strategy**: Gossamer plans to engage with regulatory authorities to finalize the Phase III study design for PHILD, leveraging Chiesi's experience with global regulatory processes [45][46][56] 6. **Clinical Trial Design**: The ongoing PROCERA study for PAH is progressing well, with expectations for top-line results in Q4 2025. The study involves 175 patients per arm and focuses on the change in six-minute walk distance as a primary endpoint [17][18][19] 7. **Patient Population Characteristics**: The PHILD patient population is expected to be more severely impaired than typical PAH patients, which may enhance the observed treatment effects in clinical trials [21][73][74] 8. **Safety Profile**: Gossamer anticipates a favorable safety profile for saralutinib based on previous studies, which is crucial for its acceptance in the market [75] Additional Important Information 1. **Chiesi's Background**: Chiesi is a global biopharmaceutical group with extensive experience in respiratory and rare diseases, making it a suitable partner for Gossamer [11][12] 2. **Market Dynamics**: The introduction of new therapies like saralutinib is critical as existing treatments for PAH have limitations, and there is a growing need for alternative mechanisms of action [9][10][94] 3. **Regulatory Alignment**: Gossamer has achieved regulatory alignment with both the FDA and EMA for its ongoing studies, which is essential for the success of its clinical programs [56] 4. **Future Development Plans**: Gossamer retains strategic control over U.S. commercialization and global development, ensuring that it can guide the direction of its product pipeline effectively [90][91] This summary encapsulates the key discussions and insights from the Gossamer Bio conference call, highlighting the strategic collaboration with Chiesi, the financial implications, and the potential market opportunities in the pulmonary hypertension space.
Chiesi and Gossamer Bio Announce Transformative Global Collaboration to Develop and Commercialize Seralutinib in Pulmonary Arterial Hypertension and Other Respiratory Indications
Prnewswire· 2024-05-06 12:44
Strategic collaboration to leverage Chiesi's legacy of respiratory leadership and Gossamer Bio's development expertise in pulmonary hypertension. Gossamer to receive $160 million development reimbursement payment and eligible to receive up to $146 million in regulatory and $180 million in sales milestones. 50/50 commercial profit split in US and global development cost sharing arrangement. Chiesi obtains exclusive ex-US development, manufacturing, and commercial rights, with Gossamer to receive mid-to-high ...
Gossamer Bio(GOSS) - 2023 Q4 - Annual Report
2024-03-05 12:32
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 __________________________________________________________________________________ FORM 10-K __________________________________________________________________________________ ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-38796 _____ ...
Gossamer Bio(GOSS) - 2023 Q4 - Annual Results
2024-03-05 12:31
Exhibit 99.1 Gossamer Bio Announces Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update - First PAH Patient Dosed in Ongoing Registrational Phase 3 PROSERA Study - - Inclusion of Japan in Phase 3 PROSERA Study Following CTN Acceptance by PMDA - - Cash, cash equivalents and marketable securities totaled $296 million at year-end 2023 - SAN DIEGO — (BUSINESS WIRE) — March 5, 2024 — Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the developm ...
Gossamer Bio(GOSS) - 2023 Q3 - Quarterly Report
2023-11-09 12:31
PART I. FINANCIAL INFORMATION [Item 1. Condensed Consolidated Financial Statements (unaudited)](index=4&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) The company reported net losses for Q3 and the nine months ended September 30, 2023, while a July 2023 private placement significantly bolstered its financial position [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of September 30, 2023, total assets increased, liabilities decreased, and stockholders' equity turned positive, primarily driven by a recent capital raise Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2023 (unaudited) | Dec 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $82,609 | $111,973 | | Marketable securities | $246,279 | $143,705 | | **Total Assets** | **$347,925** | **$272,450** | | Total current liabilities | $42,316 | $49,230 | | Long-term convertible senior notes | $196,366 | $195,709 | | **Total Liabilities** | **$243,308** | **$260,373** | | **Total Stockholders' Equity** | **$104,617** | **$12,077** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported reduced net losses for Q3 and the nine months ended September 30, 2023, primarily due to lower research and development and general and administrative expenses Operating Results (in thousands, except per share data) | Metric | Q3 2023 | Q3 2022 | Nine Months 2023 | Nine Months 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $31,200 | $44,509 | $105,334 | $129,411 | | General and administrative | $9,290 | $11,497 | $29,398 | $34,775 | | **Total operating expenses** | **$40,490** | **$56,021** | **$134,732** | **$164,236** | | Loss from operations | ($40,490) | ($56,021) | ($134,732) | ($164,236) | | **Net loss** | **($40,008)** | **($59,363)** | **($131,669)** | **($173,614)** | | Net loss per share, basic and diluted | ($0.21) | ($0.65) | ($1.03) | ($2.14) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2023, net cash used in operations and investing was offset by significant financing proceeds, leading to a net decrease in cash and cash equivalents Cash Flow Summary (in thousands) | Activity | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($125,734) | ($139,302) | | Net cash used in investing activities | ($96,604) | ($9,499) | | Net cash provided by financing activities | $193,057 | $119,963 | | **Net decrease in cash and cash equivalents** | **($29,364)** | **($29,990)** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Key notes detail the company's clinical-stage biopharmaceutical business, significant accumulated deficit, recent private placement proceeds, existing debt, and employee stock option repricing - The company is a clinical-stage biopharmaceutical firm focused on immunology, inflammation, and oncology, with a historical record of significant operating losses and an accumulated deficit of **$1.16 billion** as of September 30, 2023[24](index=24&type=chunk)[26](index=26&type=chunk) - In July 2023, the company completed a private placement of common stock and warrants, raising approximately **$212.1 million** in gross proceeds (**$201.3 million** net) Management believes current capital is sufficient to fund operations for at least the next 12 months[27](index=27&type=chunk)[28](index=28&type=chunk) - In May 2023, the company repriced 6,817,057 outstanding employee stock options to an exercise price of **$1.36 per share**, resulting in **$3.4 million** of incremental stock-based compensation cost[81](index=81&type=chunk)[84](index=84&type=chunk) Indebtedness Summary (in thousands) | Debt Instrument | Net Carrying Amount (Sep 30, 2023) | | :--- | :--- | | Credit Facility | $15,247 | | 5.00% Convertible Senior Notes due 2027 | $196,366 | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus on seralutinib development, reduced operating expenses, and the sufficiency of its capital, bolstered by a July 2023 private placement, to fund operations for at least 12 months [Overview](index=24&type=section&id=Overview) The company, a clinical-stage biopharmaceutical firm, primarily focuses on developing seralutinib for PAH, with a Phase 3 study commencing in Q4 2023, and anticipates continued losses given its significant accumulated deficit - The company's primary focus is on developing seralutinib for the treatment of pulmonary arterial hypertension (PAH)[102](index=102&type=chunk) - The Phase 3 PROSERA study for seralutinib is expected to dose its first PAH patient in Q4 2023 Clinical development for pulmonary hypertension associated with interstitial lung disease is planned for H1 2024[102](index=102&type=chunk) - As of September 30, 2023, the company had **$328.9 million** in cash, cash equivalents, and marketable securities and an accumulated deficit of **$1,163.9 million**[104](index=104&type=chunk)[105](index=105&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20Operations) Operating expenses decreased for both the three and nine-month periods ended September 30, 2023, primarily due to lower R&D costs from terminated programs and reduced general and administrative expenses - R&D expenses for Q3 2023 decreased by **$13.3 million** year-over-year, primarily due to reduced costs for GB5121 and other terminated programs, partially offset by a **$9.2 million** increase in spending on seralutinib[119](index=119&type=chunk) - General and administrative expenses for Q3 2023 decreased by **$2.2 million** year-over-year, mainly due to a **$1.6 million** decrease in stock-based compensation expense[123](index=123&type=chunk) Research and Development Expenses by Program (in thousands) | Program | Q3 2023 | Q3 2022 | Nine Months 2023 | Nine Months 2022 | | :--- | :--- | :--- | :--- | :--- | | Seralutinib | $27,010 | $17,855 | $67,149 | $43,326 | | GB5121 | $1,815 | $14,477 | $22,473 | $38,013 | | Other programs | $2,375 | $7,873 | $15,175 | $25,091 | | Other terminated programs | $0 | $4,304 | $537 | $22,981 | | **Total R&D** | **$31,200** | **$44,509** | **$105,334** | **$129,411** | [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) The company has historically funded operations through equity and debt, raising $1.26 billion through September 2023, and believes its current capital, bolstered by a July 2023 private placement, is sufficient for at least the next 12 months - Operations have been financed by **$1.26 billion** raised from inception through September 30, 2023, via stock and debt offerings[130](index=130&type=chunk) - In July 2023, a private placement of common stock and warrants raised gross proceeds of **$212.1 million**[136](index=136&type=chunk) - The company believes its existing cash, cash equivalents, and marketable securities of **$328.9 million** are sufficient to fund operations for at least the next 12 months[130](index=130&type=chunk)[145](index=145&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) There have been no material changes to the company's market risk disclosures since its Annual Report on Form 10-K for the year ended December 31, 2022 - There have been no material changes in the company's market risk profile since the fiscal year ended December 31, 2022[148](index=148&type=chunk) [Item 4. Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2023, with no material changes in internal control over financial reporting during the quarter - Management concluded that as of September 30, 2023, the company's disclosure controls and procedures were effective at the reasonable assurance level[150](index=150&type=chunk) - No changes occurred in the company's internal control over financial reporting during Q3 2023 that have materially affected, or are reasonably likely to materially affect, these controls[151](index=151&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings, though it may be involved in ordinary course legal matters - The company is not currently a party to any material legal proceedings[154](index=154&type=chunk) [Item 1A. Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) A new risk factor highlights the potential delisting of the company's common stock from Nasdaq due to failing the minimum bid price requirement, with a compliance deadline of April 16, 2024 - On October 19, 2023, the company received a notice from Nasdaq because its common stock bid price had closed below the minimum **$1.00 per share** requirement for **30 consecutive business days**[155](index=155&type=chunk) - The company has an initial period of **180 calendar days**, until April 16, 2024, to regain compliance by having its stock close at or above **$1.00** for at least **10 consecutive business days**[155](index=155&type=chunk) - Failure to regain compliance could result in delisting, which would negatively affect the stock price, impair liquidity, and hinder future financing efforts[156](index=156&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=33&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or issuer repurchases of equity securities occurred during the period - None reported[157](index=157&type=chunk)[158](index=158&type=chunk) [Item 3. Defaults Upon Senior Securities](index=33&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section is not applicable - Not Applicable[159](index=159&type=chunk) [Item 4. Mine Safety Disclosures](index=34&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable - Not Applicable[160](index=160&type=chunk) [Item 5. Other Information](index=34&type=section&id=Item%205.%20Other%20Information) No other information is reported in this section - None[161](index=161&type=chunk) [Item 6. Exhibits](index=34&type=section&id=Item%206.%20Exhibits) This section references the Exhibit Index, listing all exhibits filed or furnished as part of the Quarterly Report on Form 10-Q - The report includes an Exhibit Index listing all filed or furnished exhibits[162](index=162&type=chunk)
Gossamer Bio(GOSS) - 2023 Q2 - Quarterly Report
2023-08-08 20:03
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q _________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________to_________. Commission File Number: 001-38796 GOSSAMER BIO, INC. (Exact name of Registrant as specified in its charte ...
Gossamer Bio(GOSS) - 2023 Q1 - Quarterly Report
2023-05-09 20:02
Table of Contents WASHINGTON, D.C. 20549 _________________________ FORM 10-Q _________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________to_________. Commission File Number: 001-38796 GOSSAMER BIO, INC. (Exact name of Registrant ...