Gossamer Bio, Inc. (GOSS): Results of Operations and Financial Condition
Gossamer Bio, Inc. (GOSS) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Gossamer Bio Announces Second Quarter 2026 Financial Results and Provides Business Update - NDA Submission for Seralutinib in PAH On Track for September 2026 Following Receipt of Pre-NDA Type B Meeting Minutes - - Gossamer Reacquired Worldwide Development and Commerc
How this was made
The 30-second read
Why it matters
The release combines (1) regulatory process clarity from FDA meeting minutes, (2) a corporate restructuring of seralutinib rights via termination with Chiesi, and (3) balance-sheet strengthening through a convertible note exchange and reverse split authorization. Together these can change both the probability-weighted path to approval and near-term financing risk.
Market read
Traders can update probability and timing for a key regulatory milestone (September 2026 NDA submission) while also reassessing capital structure and commercialization economics after the Chiesi rights reacquisition.
What to watch
Cash runway is extended only to Q1 2027 per the release, so any delay in NDA acceptance or trial/confirmatory evidence could increase financing risk despite the debt reduction.
Gossamer Bio Announces Second Quarter 2026 Financial Results and Provides Business Update
The company reported quarterly net income following a $43,846 (in thousands) gain on debt extinguishment, reduced R&D expense, and regained worldwide rights to seralutinib. Revenue from contracts with collaborators was lower than the prior-year period, the company reported a loss from operations, and the regulatory path remains contingent on FDA acceptance and review of the planned NDA.
Key metrics
as reported| Metric | Value | q/q | y/y |
|---|---|---|---|
| Revenue from contracts with collaborators, three months ended June 30, 2026GAAP | 9,238 (in thousands) | – | – |
| Total revenue, three months ended June 30, 2026GAAP | 9,238 (in thousands) | – | – |
| Research and development expense, three months ended June 30, 2026GAAP | 26,412 (in thousands) | – | – |
| General and administrative expense, three months ended June 30, 2026GAAP | 8,900 (in thousands) | – | – |
| Total operating expenses, three months ended June 30, 2026GAAP | 35,312 (in thousands) | – | – |
| Loss from operations, three months ended June 30, 2026GAAP | (26,074) (in thousands) | – | – |
| Interest income, three months ended June 30, 2026GAAP | 268 (in thousands) | – | – |
| Interest expense, three months ended June 30, 2026GAAP | (2,705) (in thousands) | – | – |
| Remeasurement of warrant liability, three months ended June 30, 2026GAAP | 1,602 (in thousands) | – | – |
| Remeasurement of derivative liability, three months ended June 30, 2026GAAP | 4,113 (in thousands) | – | – |
| Gain on debt extinguishment, three months ended June 30, 2026GAAP | 43,846 (in thousands) | – | – |
| Other income (expense), net, three months ended June 30, 2026GAAP | (4,150) (in thousands) | – | – |
| Total other income, net, three months ended June 30, 2026GAAP | 42,974 (in thousands) | – | – |
| Net income (loss), three months ended June 30, 2026GAAP | $ 16,900 (in thousands) | – | – |
| Net income (loss) per share, basic, three months ended June 30, 2026GAAP | $ 0.05 | – | – |
| Net loss per share, diluted, three months ended June 30, 2026GAAP | $ (0.08) | – | – |
| Weighted average common shares outstanding, basic, three months ended June 30, 2026GAAP | 320,014,255 | – | – |
| Weighted average common shares outstanding, diluted, three months ended June 30, 2026GAAP | 328,776,495 | – | – |
| Revenue from contracts with collaborators, six months ended June 30, 2026GAAP | $ 26,193 (in thousands) | – | – |
| Total revenue, six months ended June 30, 2026GAAP | 26,193 (in thousands) | – | – |
| Research and development expense, six months ended June 30, 2026GAAP | 69,487 (in thousands) | – | – |
| General and administrative expense, six months ended June 30, 2026GAAP | 27,646 (in thousands) | – | – |
| Total operating expenses, six months ended June 30, 2026GAAP | 97,133 (in thousands) | – | – |
| Loss from operations, six months ended June 30, 2026GAAP | (70,940) (in thousands) | – | – |
| Interest income, six months ended June 30, 2026GAAP | 622 (in thousands) | – | – |
| Interest expense, six months ended June 30, 2026GAAP | (5,460) (in thousands) | – | – |
| Remeasurement of warrant liability, six months ended June 30, 2026GAAP | 1,602 (in thousands) | – | – |
| Remeasurement of derivative liability, six months ended June 30, 2026GAAP | 4,113 (in thousands) | – | – |
| Gain on debt extinguishment, six months ended June 30, 2026GAAP | 43,846 (in thousands) | – | – |
| Other income (expense), net, six months ended June 30, 2026GAAP | (3,547) (in thousands) | – | – |
| Total other income, net, six months ended June 30, 2026GAAP | 41,176 (in thousands) | – | – |
| Net income (loss), six months ended June 30, 2026GAAP | $ (29,764) (in thousands) | – | – |
| Net income (loss) per share, basic, six months ended June 30, 2026GAAP | $ (0.11) | – | – |
| Net loss per share, diluted, six months ended June 30, 2026GAAP | $ (0.24) | – | – |
| Weighted average common shares outstanding, basic, six months ended June 30, 2026GAAP | 277,313,038 | – | – |
| Weighted average common shares outstanding, diluted, six months ended June 30, 2026GAAP | 287,855,108 | – | – |
| Cash, cash equivalents, and marketable securities as of June 30, 2026GAAP | $ 57,026 (in thousands) | – | – |
| Working capital as of June 30, 2026GAAP | (65,058) (in thousands) | – | – |
| Total assets as of June 30, 2026GAAP | 76,867 (in thousands) | – | – |
| Total liabilities as of June 30, 2026GAAP | 170,896 (in thousands) | – | – |
| Accumulated deficit as of June 30, 2026GAAP | (1,468,702) (in thousands) | – | – |
| Total stockholders' deficit as of June 30, 2026GAAP | (94,029) (in thousands) | – | – |
Into the first quarter of 2027 outlook
- NoteGossamer expects the combination of current cash, cash equivalents and marketable securities will be sufficient to fund its operating and capital expenditures into the first quarter of 2027.
- NoteThe Company intends to submit an NDA supported by one adequate and well-controlled study (Phase 3 PROSERA) plus confirmatory evidence (Phase 2 TORREY and supportive analyses) in September 2026.
- NoteIf accepted for filing, seralutinib could be eligible for an FDA approval decision in the third quarter of 2027.
What drove it
- Revenue associated with Gossamer's collaboration with Chiesi included $6.1 million of cost reimbursement revenue.
- The decrease in R&D expenses was primarily driven by lower costs associated with clinical trials for seralutinib.
- Gossamer and Chiesi agreed to terminate their Collaboration and License Agreement, and Gossamer reacquired worldwide development and commercial rights to seralutinib.
- The termination agreement required Chiesi to make a one-time $5 million payment to Gossamer, settling all outstanding and future obligations under the prior collaboration, including second quarter 2026 costs.
- Gossamer made no upfront cash payment to reacquire the rights.
- The termination dissolves the prior U.S. 50/50 profit share and returns ex-U.S. rights to Gossamer.
Concerns
- The FDA characterized the degree of statistical significance and the magnitude of the treatment effect observed in PROSERA as review issues rather than filing issues.
- The FDA’s ultimate determination on approvability will be made upon review of the complete NDA.
- The FDA may determine that the planned NDA does not qualify for filing.
- The Company’s future performance is dependent entirely on the success of seralutinib.
- Any path forward may require additional capital and other resources, which may not be available on reasonable terms, if at all, or may limit the commercial opportunity for seralutinib.
- Stockholders authorized the Board to effect a reverse stock split, with the timing and final ratio subject to Board approval.
What to watch
- Submission of the seralutinib NDA in September 2026.
- FDA acceptance for filing of the planned NDA.
- Potential FDA approval decision in the third quarter of 2027, if the NDA is accepted for filing.
- The Company's cash runway expectation into the first quarter of 2027.
- Board action on the timing and final ratio of a reverse stock split.
- The regulatory and commercial milestone payments and capped worldwide net-sales royalty payable to Chiesi.
Balance sheet and cash flow
- Cash, cash equivalents, and marketable securities were $ 57,026 (in thousands) as of June 30, 2026, compared to $ 136,932 (in thousands) as of December 31, 2025.
- Working capital was (65,058) (in thousands) as of June 30, 2026, compared to 104,209 (in thousands) as of December 31, 2025.
- Total assets were 76,867 (in thousands) as of June 30, 2026, compared to 172,249 (in thousands) as of December 31, 2025.
- Total liabilities were 170,896 (in thousands) as of June 30, 2026, compared to 295,009 (in thousands) as of December 31, 2025.
- Total stockholders' deficit was (94,029) (in thousands) as of June 30, 2026, compared to (122,760) (in thousands) as of December 31, 2025.
- Gossamer exchanged approximately $181.1 million, or 90.5%, of the $200.0 million aggregate principal amount of 2027 Notes outstanding for approximately $65.2 million of new 7.50% Convertible Senior Secured First Lien Notes due 2030, together with equity securities and warrants.
- The exchange reduced the aggregate principal amount of the Company’s debt by approximately $115.9 million and the outstanding balance of the 2027 Notes to approximately $18.9 million.
Analysis
Gossamer reported $ 16,900 (in thousands) of GAAP net income for the second quarter, compared with $ (38,273) (in thousands) in the prior-year period. The result followed a $43,846 (in thousands) gain on debt extinguishment, while the company still reported a $ (26,074) (in thousands) loss from operations. Total other income, net was 42,974 (in thousands), compared with 492 (in thousands) in the prior-year period, making the debt transaction a central contributor to the quarterly profit.
Management, verbatim
We completed a productive Pre-NDA Type B meeting with the FDA, received the official minutes and remain on track to submit our NDA for seralutinib in PAH in September. We also reacquired worldwide rights to seralutinib and completed a convertible note exchange that substantially reduced our debt. We are in a better position today, and our focus remains on the work required to move seralutinib forward.
Faheem Hasnain, Chairman, Co-Founder, and CEO of Gossamer
Not in the filing
stated, not guessed- Gross profit and gross margin
- Non-GAAP financial measures, including non-GAAP operating income, net income, and EPS
- Operating cash flow
- Free cash flow
- Capital expenditures
- Share repurchases
- Dividends
- Debt balance as of June 30, 2026
- Tax rate
- Quarter-over-quarter comparisons for reported operating metrics
- Percentage year-over-year changes for reported operating metrics
- Operating-segment revenue disclosure
- Quantitative revenue, gross-margin, operating-expense, or tax-rate guidance
- Previous-quarter outlook for comparison
AlphAI analysis generated from the company’s SEC earnings filing (Form 8-K Item 2.02, or Form 6-K for a foreign private issuer). Every figure was cross-checked against the filing text; consensus estimates, price targets and share-price reactions are not shown because they are not in the filing. AI-generated research, not investment advice.
Background
Gossamer is a clinical-stage biopharma developing inhaled seralutinib (GB002) for pulmonary arterial hypertension (PAH) and PH-ILD, with regulatory progress driven by a Pre-NDA Type B meeting and planned NDA submission.
Ticker impact
Gossamer says FDA Pre-NDA Type B minutes support a September 2026 seralutinib NDA submission, plus it reacquired worldwide rights from Chiesi.
Bias upward into the NDA filing window, with volatility around any FDA follow-up on approvability.
The filing timeline is explicitly stated (September 2026) and the FDA feedback is characterized as review issues rather than filing issues, while the Chiesi termination improves operational control and economics. However, ultimate approvability is still contingent on NDA review.
Market effects
Reinforces investor focus on FDA pre-NDA meeting minutes as a leading indicator for filing/approvability in rare-disease and pulmonary hypertension programs.
Limited, primarily US biotech sentiment given FDA interaction and Nasdaq-listed issuer.
Moderate, as reacquisition of ex-US rights can shift commercialization expectations and partner economics, but it is company-specific.
Counterpoint
FDA minutes may still translate into approvability risk once the full NDA is reviewed, so the stock could re-rate downward if additional data requirements emerge.
Key entities
- issuerGossamer Bio, Inc.
Announced Q2 2026 results, FDA Pre-NDA Type B minutes, planned September 2026 NDA submission, reacquisition of seralutinib rights from Chiesi, and convertible note exchange details.
- regulatorU.S. Food and Drug Administration (FDA)
Provided official Pre-NDA Type B meeting minutes characterizing issues as review-related rather than filing-related, with submission format/content feedback.
- partnerChiesi
Terminated collaboration and license agreement; made a one-time $5 million payment and retained a capped royalty with milestone payments.
- product_candidateSeralutinib (GB002)
Inhaled PDGFR, CSF1R and c-KIT inhibitor; NDA planned for PAH supported by Phase 3 PROSERA plus confirmatory Phase 2 TORREY evidence.
