Gossamer Bio, Inc.
For the period ended Sep 30, 2026. Filed Nov 10, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 10, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-13.
0001728117-26-000072
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-10.
0001728117-26-000114
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 111 previous paragraphs and 114 current paragraphs.
71 unchanged; 37 reworded; 6 added; 2 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 4 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (6)
Current report
Reverse Stock Split
Current report
On September 10, 2026, we effected a 1-for-80 reverse stock split of our common stock, or the Reverse Stock Split, and a proportionate reduction in the number of authorized shares of common stock. Our common stock began trading on a split-adjusted basis on the Nasdaq Global Select Market on September 11, 2026. Following the Reverse Stock Split, on September 25, 2026, we received a letter from Nasdaq stating that we had regained compliance with Nasdaq Listing Rule 5450(a)(1) and that the matter was closed. All shares of our common stock, per-share data and related information included in this Quarterly Report on Form 10-Q have been retroactively adjusted as though the Reverse Stock Split had been effected prior to all periods presented.
Current report
Warrant Liability. In August 2026, we issued warrants that are classified as liabilities and measured at fair value, with changed in fair value recognized in earnings each reporting period. We estimate the fair value of the warrants using a Monte Carlo simulation of our common stock price. See Note 4, Fair Value Measurement and Available for Sale Investments, and Note 7, Stockholders' Equity, for additional information.
Current report
Other income (expense), net
Current report
On August 20, 2026, we entered into a securities purchase agreement, or the Purchase Agreement, with certain purchasers identified therein, including certain of our executive officers and directors, pursuant to which we agreed to issue and sell securities in a private placement comprising two closings, or collectively, the Private Placement. At the initial closing, or the Initial Closing, on August 24, 2026, we issued pre-funded warrants, or the Initial Closing Pre-Funded Warrants, for gross proceeds of approximately $25.0 million, or approximately $22.8 million after deducting placement agent fees and offering expenses. Subject to the acceptance by the FDA for filing of our New Drug Application, or NDA, for seralutinib for the treatment of patients with PAH, or the NDA Acceptance Milestone, occurring in 2026 and the satisfaction of customary closing conditions, the purchasers have agreed to purchase additional pre-funded warrants, or the Second Closing Pre-Funded Warrants, in a second closing, or the Second Closing, for additional gross proceeds of approximately $125.0 million. At the Second Closing, if it is consummated, the purchasers will also receive milestone-based warrants for no additional consideration, or the FDA Approval Warrants, which become exercisable following FDA approval of our NDA for seralutinib for the treatment of patients with PAH, or the FDA Approval Milestone, and represent potential additional gross proceeds of approximately $100.0 million if exercised in full. If the Second Closing does not occur on or before December 31, 2026, the obligations relating to the
Current report
Second Closing Pre-Funded Warrants and the FDA Approval Warrants will automatically terminate. On October 27, 2026, our stockholders approved the issuance of the shares of common stock issuable pursuant to the Purchase Agreement.
Removed paragraphs (2)
Previous report
Research and development expenses
Previous report
Other income (loss), net
Reworded paragraphs (37)
Previous wording
This quarterly report on Form 10-Q contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and Section 27A of the Securities Act of 1933, as amended, or the Securities Act. All statements other than statements of historical facts contained in this quarterly report, including statements regarding our future results of operations and financial position, business strategies and plans, research and development plans, the anticipated timing, costs, design and conduct of our ongoing and planned preclinical studies and planned clinical trials for seralutinib, the timing and likelihood of regulatory filings and approvals for seralutinib, including the timing and potential submission, and potential acceptance for filing and approval, of an NDA for seralutinib in PAH, timing and likelihood of success, plans and objectives of management for future operations, the anticipated benefits of the termination of the Company’s Collaboration and License Agreement with Chiesi, the anticipated benefits of any reverse stock split, and the timing of the completion of any such reverse stock split, the potential impact of U.S. trade policy, including tariffs, and future results of seralutinib, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.
Current wording
This quarterly report on Form 10-Q contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and Section 27A of the Securities Act of 1933, as amended, or the Securities Act. All statements other than statements of historical facts contained in this quarterly report, including statements regarding our future results of operations and financial position, business strategies and plans, research and development plans, the anticipated timing, costs, design and conduct of our ongoing and planned preclinical studies and planned clinical trials for seralutinib, the timing and likelihood of regulatory filings and approvals for seralutinib, including the potential acceptance for filing and approval, of an NDA for seralutinib in PAH, timing and likelihood of success, plans and objectives of management for future operations, the anticipated benefits of the termination of the Chiesi Collaboration Agreement, the anticipated benefits of the completed reverse stock split, the expected timing and potential consummation of an additional closing of our private placement, the potential impact of U.S. trade policy, including tariffs, and future results of seralutinib, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.
Previous wording
We are a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of PH, including PAH and PH-ILD. Our goal is to be an industry leader in, and to enhance the lives of patients living with PH. In July 2026, we entered into the Rights Reacquisition Agreement with Chiesi, pursuant to which we reacquired worldwide development and commercial rights to seralutinib. In December 2022, we announced positive topline results from the Phase 2 TORREY Study in PAH patients. In February 2026, we announced topline results from the Phase 3 PROSERA Study in PAH patients. Seralutinib demonstrated a placebo-adjusted improvement in the primary endpoint, 6MWD at Week 24, of 13.3 meters (p = 0.0320), missing the prespecified alpha threshold of 0.025. Following a Pre-NDA Type B meeting with the FDA held in mid-June 2026 and receipt of the official meeting minutes, we plan to proceed with an NDA submission for seralutinib for the treatment of PAH in September 2026. The 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). If the NDA is accepted for filing, seralutinib could be eligible for an FDA approval decision in the third quarter of 2027. In addition to PAH, we believe that seralutinib holds potential as a therapeutic for the treatment of PH-ILD, and this indication remains an area of focus for us. We have assembled a deeply experienced and highly skilled group of industry veterans, scientists, clinicians and key opinion leaders from leading biotechnology and pharmaceutical companies, as well as leading academic centers from around the world. Our employees are a team of highly dedicated, passionate individuals who pride themselves on a culture of respect, humility, transparency, inclusion, dedication, collaboration and fun. Our ultimate goal is to enhance and extend the lives of patients.
Current wording
We are a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of PH, including PAH and PH-ILD. Our goal is to be an industry leader in, and to enhance the lives of patients living with PH. In July 2026, we entered into the Rights Reacquisition Agreement with Chiesi, pursuant to which we reacquired worldwide development and commercial rights to seralutinib. In December 2022, we announced positive topline results from the Phase 2 TORREY Study in PAH patients. In February 2026, we announced topline results from the Phase 3 PROSERA Study in PAH patients. Seralutinib demonstrated a placebo-adjusted improvement in the primary endpoint, 6MWD at Week 24, of 13.3 meters (p = 0.0320), missing the prespecified alpha threshold of 0.025. Following a Pre-NDA Type B meeting with the FDA held in mid-June 2026 and receipt of the official meeting minutes, we submitted an NDA for seralutinib for the treatment of PAH in September 2026. If the NDA is accepted for filing, seralutinib could be eligible for an FDA approval decision in the third quarter of 2027. In addition to PAH, we believe that seralutinib holds potential as a therapeutic for the treatment of PH-ILD, and this indication remains an area of focus for us. We have assembled a deeply experienced and highly skilled group of industry veterans, scientists, clinicians and key opinion leaders from leading biotechnology and pharmaceutical companies, as well as leading academic centers from around the world. Our employees are a team of highly dedicated, passionate individuals who pride themselves on a culture of respect, humility, transparency, inclusion, dedication, collaboration and fun. Our ultimate goal is to enhance and extend the lives of patients.
Previous wording
We were incorporated in October 2015 and commenced operations in 2017. To date, we have focused primarily on organizing and staffing our company, business planning, raising capital, identifying, acquiring and in-licensing our product candidates and conducting preclinical studies and clinical trials. We have funded our operations primarily through equity and debt financings and the Chiesi Collaboration Agreement. As of June 30, 2026, we had $57.0 million in cash, cash equivalents and marketable securities.
Current wording
We were incorporated in October 2015 and commenced operations in 2017. To date, we have focused primarily on organizing and staffing our company, business planning, raising capital, identifying, acquiring and in-licensing our product candidates and conducting preclinical studies and clinical trials. We have funded our operations primarily through equity and debt financings and the Chiesi Collaboration Agreement. As of September 30, 2026, we had $51.2 million in cash, cash equivalents and marketable securities.
Previous wording
We have incurred significant operating losses since our inception and expect to continue to incur significant operating losses for the foreseeable future. For the three months ended June 30, 2026 and 2025, our net gain was $16.9 million and net loss of $38.3 million, respectively. For the six months ended June 30, 2026 and 2025, our net loss was $29.8 million and $74.9 million, respectively. As of June 30, 2026, we had an accumulated deficit of $1,468.7 million. We expect to incur expenses and operating losses for the foreseeable future as we continue our development of and seek regulatory approvals for seralutinib, including the conduct of ongoing and planned clinical trials and other research and development activities; and as we hire additional personnel, protect our intellectual property and incur costs associated with being a public company. In addition, as seralutinib progresses through development and toward commercialization, we will need to make milestone payments to Pulmokine from whom we have in-licensed seralutinib. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending in particular on the timing of our clinical trials and preclinical studies and our expenditures on other research and development activities.
Current wording
We have incurred significant operating losses since our inception and expect to continue to incur significant operating losses for the foreseeable future. For the three months ended September 30, 2026 and 2025, our net loss was $48.1 million and $48.2 million, respectively. For the nine months ended September 30, 2026 and 2025, our net loss was $77.8 million and $123.1 million, respectively. As of September 30, 2026, we had an accumulated deficit of $1,516.8 million. We expect to incur expenses and operating losses for the foreseeable future as we continue our development of and seek regulatory approvals for seralutinib, including the conduct of ongoing and planned clinical trials and other research and development activities; and as we hire additional personnel, protect our intellectual property and incur costs associated with being a public company. In addition, as seralutinib progresses through development and toward commercialization, we will need to make milestone payments to Pulmokine from whom we have in-licensed seralutinib. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending in particular on the timing of our clinical trials and preclinical studies and our expenditures on other research and development activities.
Previous wording
To date, we have generated all of our revenue from the Chiesi Collaboration Agreement. Our revenue consists of a one-time development cost reimbursement payment for licenses and ongoing cost-sharing payments for performance of research and development services classified as revenue from contracts with collaborators.
Current wording
To date, we have generated all of our revenue from the Chiesi Collaboration Agreement. Our revenue consists of a one-time development cost reimbursement payment for licenses and ongoing cost-sharing payments for performance of research and development services classified as revenue from contracts with collaborators. Following the termination of the Chiesi Collaboration Agreement in July 2026, we will no longer recognize any additional revenue under the agreement in future periods.
Previous wording
In process research and development, or IPR&D, expenses include IPR&D acquired as part of an asset acquisition or in-license, for which there is no alternative future use, and the value of the right to acquire Respira Therapeutics via a merger, or the Respira Merger Option, with Prana Bio, the 100% owner of Respira Therapeutics, and are expensed as incurred.
Current wording
In process research and development, or IPR&D, expenses include IPR&D acquired as part of an asset acquisition or in-license, for which there is no alternative future use, the rights reacquired from Chiesi under the Rights Reacquisition Agreement and the value of the right to acquire Respira Therapeutics via a merger, or the Respira Merger Option, with Prana Bio, the 100% owner of Respira Therapeutics, and are expensed as incurred.
Previous wording
General and administrative expenses consist primarily of salaries and employee-related costs, including stock-based compensation, for personnel in executive, finance and other administrative functions. Other significant costs include facility-related costs, legal fees relating to intellectual property and corporate matters, professional fees for accounting and consulting services, insurance costs and commercial planning expenses. Subject to obtaining clarity on potential regulatory paths forward, we anticipate that our general and administrative expenses may increase in the future to support our continued research and development and commercial planning activities and, if seralutinib receives marketing approval, commercialization activities.
Current wording
General and administrative expenses consist primarily of salaries and employee-related costs, including stock-based compensation, for personnel in executive, finance and other administrative functions. Other significant costs include facility-related costs, legal fees relating to intellectual property and corporate matters, professional fees for accounting and consulting services, insurance costs and commercial planning expenses. Subject to the FDA accepting our NDA for filing, we anticipate that our general and administrative expenses will increase in the future to support commercial planning activities and, if seralutinib receives marketing approval, commercialization activities, as well as to support continued research and development activities.
Previous wording
Other income (expense), net consists of (1) interest income on our cash, cash equivalents and marketable securities, (2) investment accretion, (3) research and development tax credit, (4) other miscellaneous income (expense) and (5) interest expense.
Current wording
Other income (expense), net consists of (1) interest income on our cash, cash equivalents and marketable securities, (2) investment accretion, (3) research and development tax credit, (4) other miscellaneous income (expense) and (5) interest expense, (6) the remeasurement of the warrant liability, including the loss on issuance of the warrants issued in the August 2026 private placement, (7) the remeasurement of the derivative liability, (8) the gain on debt extinguishment and (9) offering costs related to the August private placement.
Previous wording
Our management’s discussion and analysis of our financial condition and results of operations are based on our condensed consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of these financial statements requires us to make judgments and estimates that affect the reported amounts of assets, liabilities, revenue, expenses and the disclosure of contingent assets and liabilities in our condensed consolidated financial statements. We base our estimates on historical experience, known trends and events, and various other factors that are believed to be reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions. On an ongoing basis, we evaluate our judgments and estimates in light of changes in circumstances, facts and experience. During the six months ended June 30, 2026, there have been no significant changes in our critical accounting policies and estimates as discussed in Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and Estimates” in our Annual Report on Form 10-K filed with the SEC on March 17, 2026. See Note 2, Summary of Significant Accounting Policies, for information about these critical accounting policies.
Current wording
Our management’s discussion and analysis of our financial condition and results of operations are based on our condensed consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of these financial statements requires us to make judgments and estimates that affect the reported amounts of assets, liabilities, revenue, expenses and the disclosure of contingent assets and liabilities in our condensed consolidated financial statements. We base our estimates on historical experience, known trends and events, and various other factors that are believed to be reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions. On an ongoing basis, we evaluate our judgments and estimates in light of changes in circumstances, facts and experience. During the nine months ended September 30, 2026, other than described below, there have been no significant changes in our critical accounting policies and estimates as discussed in Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and Estimates” in our Annual Report on Form 10-K filed with the SEC on March 17, 2026. See Note 2, Summary of Significant Accounting Policies, for information about these critical accounting policies.
Previous wording
Results of Operations – Comparison of the Three and Six Months Ended June 30, 2026 and 2025
Current wording
Results of Operations – Comparison of the Three and Nine Months Ended September 30, 2026 and 2025
Previous wording
The following table sets forth our selected statements of operations data for the six months ended June 30, 2026 and 2025 (in thousands):
Current wording
The following table sets forth our selected statements of operations data for the nine months ended September 30, 2026 and 2025 (in thousands):
Previous wording
Our revenue is generated from our ongoing collaboration with Chiesi and consists of ongoing research and development service performance and cost-sharing payments for performance of research and development and pre-commercial services. For the three months ended June 30, 2026 and 2025, our revenue was $9.2 million and $11.5 million, respectively, for a decrease of $2.3 million, which was primarily attributable to the decrease in research and development services and costs subject to reimbursement. For the six months ended June 30, 2026 and 2025, our revenue was $26.2 million and $21.4 million, respectively, for an increase of $4.8 million, which was primarily attributable to an increase in research and development and pre-commercial services.
Current wording
Our revenue is generated from our ongoing collaboration with Chiesi and consists of ongoing research and development service performance and cost-sharing payments for performance of research and development and pre-commercial services. For the three months ended September 30, 2026 and 2025, our revenue was $38.4 million and $13.3 million, respectively, for an increase of $25.1 million, which was primarily attributable to revenue recognized upon the termination of the Chiesi Collaboration Agreement, including the release of $37.1 million of contract liabilities, partially offset by a decrease in research and development costs subject to reimbursement. For the nine months ended September 30, 2026 and 2025, our revenue was $64.6 million and $34.7 million, respectively, for an increase of $30.0 million, which is primarily attributable to revenue recognized upon the termination of the Chiesi Collaboration Agreement, including the release of $37.1 million of contract liabilities, partially offset by a decrease in research and development expense subject to reimbursement.
Previous wording
Research and development expenses were $26.4 million for the three months ended June 30, 2026, compared to $41.6 million for the three months ended June 30, 2025, for a decrease of $15.2 million, which was primarily attributable to a decrease of $15.7 million of costs associated with clinical trials for seralutinib, offset by an increase of $0.5 million of costs associated with Respira.
Current wording
Research and development expenses were $18.8 million for the three months ended September 30, 2026, compared to $45.5 million for the three months ended September 30, 2025, for a decrease of $26.7 million, which was primarily attributable to a decrease of $27.3 million of costs associated with clinical trials for seralutinib, offset by an increase of $0.6 million of costs associated with Respira.
Previous wording
Research and development expenses were $69.5 million for the six months ended June 30, 2026, compared to $79.6 million for the six months ended June 30, 2025, for a decrease of $10.1 million, which was primarily attributable to a decrease of $11.4 million of costs associated with clinical trials for seralutinib and an increase of $1.2 million of costs associated with Respira.
Current wording
Research and development expenses were $88.3 million for the nine months ended September 30, 2026, compared to $125.2 million for the nine months ended September 30, 2025, for a decrease of $36.8 million, which was primarily attributable to a decrease of $38.7 million of costs associated with clinical trials for seralutinib, offset by an increase of $1.8 million of costs associated with Respira.
Previous wording
The following table shows our research and development expenses by program for the three and six months ended June 30, 2026 and 2025:
Current wording
The following table shows our research and development expenses by program for the three and nine months ended September 30, 2026 and 2025:
Previous wording
General and administrative expenses were $8.9 million for the three months ended June 30, 2026, compared to $8.7 million for the three months ended June 30, 2025, for an increase of $0.2 million, which was primarily attributable to a $0.2 million increase in legal expense, a $0.6 million increase in stock-based compensation expense and a $0.4 million increase in personnel expense due to severance, offset by a $1.0 million decrease in commercial costs.
Current wording
General and administrative expenses were $9.6 million for the three months ended September 30, 2026, compared to $9.4 million for the three months ended September 30, 2025, for an increase of $0.2 million, which was primarily attributable to a $0.9 million increase in legal expense and a $0.9 million increase in stock-based compensation expense, offset by a $1.2 million decrease in commercial costs.
Previous wording
General and administrative expenses were $27.6 million for the six months ended June 30, 2026, compared to $17.3 million for the six months ended June 30, 2025, for an increase of $10.3 million, which was primarily attributable to a $0.7 million increase in commercial expenses, a $4.4 million increase in personnel expense due to severance, a $2.8 million increase in stock-based compensation expense and a $1.1 million increase in professional services expense.
Current wording
General and administrative expenses were $37.3 million for the nine months ended September 30, 2026, compared to $26.7 million for the nine months ended September 30, 2025, for an increase of $10.6 million, which was primarily attributable to $4.3 million increase in personnel expense due to severance, a $3.7 million increase in stock-based compensation expense, a $1.2 million increase in legal expense, and $1.2 million increase in professional services expense, offset by a $0.4 million decrease in commercial expense.
Previous wording
Other income, net was $41.2 million for the six months ended June 30, 2026, compared to the other income, net of $0.7 million for the six months ended June 30, 2025, for an increase of $40.5 million, which was primarily attributable to a $43.9 million gain on the debt extinguishment, $4.1 million gain on the derivative liability remeasurement and $1.6 million gain on the warrant liability remeasurement, offset by the $3.6 million decrease in investment accretion and $4.4 million issuance costs attributable to the embedded derivative and purchase warrants.
Current wording
Other expense, net was $55.3 million for the three months ended September 30, 2026, compared to the other income, net of $0.9 million for the three months ended September 30, 2025, for a decrease of $56.2 million, which was primarily attributable to a $96.2 million loss on the issuance of the warrants issued in the August 2026 private placement, offset by a $39.7 million gain from the change in fair value of the warrant liability, for a net loss of $56.5 million on the warrant liability remeasurement, a $5.2 million decrease in other income (expense), net, which includes $2.2 million of offering costs related to the August 2026 private placement, offset by a $5.6 million gain on the derivative liability remeasurement.
Previous wording
Other income, net was $43.0 million for the three months ended June 30, 2026, compared to the other income, net of $0.5 million for the three months ended June 30, 2025, for an increase of $42.5 million, which was primarily attributable to a $43.9 million gain on the debt extinguishment, $4.1 million gain on the derivative liability remeasurement and $1.6 million gain on the warrant liability remeasurement, offset by the $1.6 million decrease in investment accretion and $4.4 million issuance costs attributable to the embedded derivative and purchase warrants..
Current wording
Other expense, net was $14.1 million for the nine months ended September 30, 2026, compared to the other income, net of $1.6 million for the nine months ended September 30, 2025, for a decrease of $15.6 million, wwhich was primarily attributable to a $96.2 million loss on the issuance of the warrants issued in the August 2026 private placement, offset by a $41.3 million gain from the change in fair value of the warrant liability, for a net loss of $54.9 million on the warrant liability remeasurement, and a $14.1 million decrease in other income (expense), net, which includes $2.2 million of offering costs related to the August 2026 private placement and $4.4 million of issuance costs attributable to the embedded derivative and purchase warrants and a $0.5 million decrease in interest income, offset by a $43.8 million gain on debt extinguishment and a $9.7 million gain on derivative liability remeasurement.
Previous wording
We have incurred substantial operating losses since our inception and expect to continue to incur significant operating losses for the foreseeable future and may never become profitable. As of June 30, 2026, we had an accumulated deficit of $1,468.7 million.
Current wording
We have incurred substantial operating losses since our inception and expect to continue to incur significant operating losses for the foreseeable future and may never become profitable. As of September 30, 2026, we had an accumulated deficit of $1,516.8 million.
Previous wording
From our inception through June 30, 2026, our operations have been financed primarily by proceeds of $1,396.9 million from the sale of Series A and Series B convertible preferred stock, proceeds from our IPO, proceeds from the 2027 Notes and 2030 Notes, proceeds from issuance of common stock in May 2020 and July 2022, proceeds from issuance of common stock and accompanying warrants in July 2023 and the Chiesi Collaboration Agreement. In addition, we have received $57.9 million as of June 30, 2026 through reimbursement related to the Chiesi Collaboration Agreement. As of June 30, 2026 we had cash, cash equivalents and marketable securities of $57.0 million. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to capital preservation and liquidity.
Current wording
From our inception through September 30, 2026, our operations have been financed primarily by proceeds of $1,419.7 million from the sale of Series A and Series B convertible preferred stock, proceeds from our IPO, proceeds from the 2027 Notes and 2030 Notes, proceeds from issuance of common stock in May 2020 and July 2022, proceeds from issuance of common stock and accompanying warrants in July 2023 and proceeds from the issuance of pre-funded warrants in August 2026, as well as payments received under and the Chiesi Collaboration Agreement. In addition, we have received $62.9 million as of September 30, 2026 through reimbursement related to the Chiesi Collaboration Agreement. As of September 30, 2026, we had cash, cash equivalents and marketable securities of $51.2 million. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to capital preservation and liquidity.
Previous wording
On May 21, 2020, we issued $200.0 million aggregate principal amount 5.00% convertible senior notes due 2027 in a registered public offering, or the 2027 Notes. The interest rate on the 2027 Notes is fixed at 5.00% per annum. Interest is payable semi-annually in arrears on June 1 and December 1 of each year commencing on December 1, 2020. The total net proceeds from the 2027 Notes, after deducting the underwriting discounts and commissions and other offering costs, were approximately $193.6 million. Concurrent with the registered underwritten public offering of the 2027 Notes, we completed an underwritten public offering of 9,433,963 shares of our common stock. We received net proceeds of $117.1 million, after deducting underwriting discounts and commissions and other offering costs. Our concurrent offerings of 2027 Notes and common stock were registered pursuant to the 2020 Shelf Registration Statement.
Current wording
On May 21, 2020, we issued $200.0 million aggregate principal amount 5.00% convertible senior notes due 2027 in a registered public offering, or the 2027 Notes. The interest rate on the 2027 Notes is fixed at 5.00% per annum. Interest is payable semi-annually in arrears on June 1 and December 1 of each year commencing on December 1, 2020. The total net proceeds from the 2027 Notes, after deducting the underwriting discounts and commissions and other offering costs, were approximately $193.6 million. Concurrent with the registered underwritten public offering of the 2027 Notes, we completed an underwritten public offering of 117,925 shares of our common stock. We received net proceeds of $117.1 million, after deducting underwriting discounts and commissions and other offering costs. Our concurrent offerings of 2027 Notes and common stock were registered pursuant to the 2020 Shelf Registration Statement.
Previous wording
On July 15, 2022, we completed a private placement of 16,649,365 shares of our common stock. The aggregate gross proceeds for the private placement were approximately $120.1 million, before deducting offering expenses. On August 9, 2022, we filed a registration statement on Form S-3 registering the resale of the shares of common stock issued in the private placement, which became automatically effective on August 9, 2022.
Current wording
On July 15, 2022, we completed a private placement of 208,117 shares of our common stock. The aggregate gross proceeds for the private placement were approximately $120.1 million, before deducting offering expenses. On August 9, 2022, we filed a registration statement on Form S-3 registering the resale of the shares of common stock issued in the private placement, which became automatically effective on August 9, 2022.
Previous wording
On July 24, 2023, we completed a private placement of 129,869,440 shares of our common stock and 32,467,360 accompanying warrants. The aggregate gross proceeds for the private placement were $212.1 million, before deducting offering expenses. On August 18, 2023, we filed a registration statement on Form S-3 registering the resale of the shares of common stock and shares of common stock issuable upon the exercise of warrants issued in the private placement, which was declared effective on August 28, 2023.
Current wording
On July 24, 2023, we completed a private placement of 1,623,368 shares of our common stock and 405,842 accompanying warrants. The aggregate gross proceeds for the private placement were $212.1 million, before deducting offering expenses. On August 18, 2023, we filed a registration statement on Form S-3 registering the resale of the shares of common stock and shares of common stock issuable upon the exercise of warrants issued in the private placement, which was declared effective on August 28, 2023.
Previous wording
On May 3, 2024, we entered into the Chiesi Collaboration Agreement. In consideration and as reimbursement for our development costs, Chiesi paid us an up-front, nonrefundable payment of $160.0 million. In addition, we and Chiesi share equally in the costs of ongoing global seralutinib clinical development, with the exception of the PROSERA Phase 3 study, and the costs of commercialization in the U.S. Territory. For the six months ended June 30, 2026, we received cost-sharing payments from Chiesi in the amount of $21.5 million.
Current wording
On May 3, 2024, we entered into the Chiesi Collaboration Agreement. In consideration and as reimbursement for our development costs, Chiesi paid us an up-front, nonrefundable payment of $160.0 million. In addition, we and Chiesi share equally in the costs of ongoing global seralutinib clinical development, with the exception of the PROSERA Phase 3 study, and the costs of commercialization in the U.S. Territory. For the nine months ended September 30, 2026, we received cost-sharing payments from Chiesi in the amount of $26.5 million.
Previous wording
On January 28, 2026, we filed a registration statement on Form S-3 ASR, or the 2026 Shelf Registration Statement, covering the offering from time to time of common stock, preferred stock, debt securities, warrants and units, which registration statement became automatically effective upon filing. On March 17, 2026, we filed Post-Effective Amendment No. 1 and Post-
Current wording
On January 28, 2026, we filed a registration statement on Form S-3 ASR, or the 2026 Shelf Registration Statement, covering the offering from time to time of common stock, preferred stock, debt securities, warrants and units, which registration statement became automatically effective upon filing. On March 17, 2026, we filed Post-Effective Amendment No. 1 and Post-Effective Amendment No. 2 to the 2026 Shelf Registration Statement, which became effective on March 18, 2026, to convert the registration statement to a non-automatic shelf registration statement as we were no longer a “well-known seasoned issuer.”
Previous wording
On June 4, 2026, we completed the early settlement of the exchange of the 2027 Notes in the Exchange Offer, pursuant to which, $181,052,000 in aggregate principal amount of the 2027 Notes were validly tendered, accepted for exchange by us and subsequently cancelled. Following such cancellation, $18,948,000 in aggregate principal amount of the 2027 Notes remain outstanding. On the Early Settlement Date, we issued (i) $65,174,000 in aggregate principal amount of 2030 Notes, (ii) 254,150,441 New Shares, (iii) 33,402,727 Prefunded Warrants and (iv) 135,789,000 Purchase Warrants, in exchange for the validly tendered and accepted Early Tendered Notes. Because no additional 2027 Notes were validly tendered in the Exchange Offer following the Early Settlement Date and prior to the expiration of the Exchange Offer, $18,948,000 in aggregate principal amount of 2027 Notes remain outstanding following the Exchange Offer.
Current wording
On June 4, 2026, we completed the early settlement of the exchange of the 2027 Notes in the Exchange Offer, pursuant to which, $181,052,000 in aggregate principal amount of the 2027 Notes were validly tendered, accepted for exchange by us and subsequently cancelled. Following such cancellation, $18,948,000 in aggregate principal amount of the 2027 Notes remain outstanding. On the Early Settlement Date, we issued (i) $65,174,000 in aggregate principal amount of 2030 Notes, (ii) 3,176,881 New Shares, (iii) 417,534 Prefunded Warrants and (iv) 1,697,363 Purchase Warrants, in exchange for the validly tendered and accepted Early Tendered Notes. Because no additional 2027 Notes were validly tendered in the Exchange Offer following the Early Settlement Date and prior to the expiration of the Exchange Offer, $18,948,000 in aggregate principal amount of 2027 Notes remain outstanding following the Exchange Offer.
Previous wording
Additional information about our long-term borrowings is presented in Note 5 “Indebtedness” and operating leases is presented in Note 9 "Commitments and Contingencies" to the Notes to Unaudited Condensed Consolidated Financial Statements included in Part I, Item 1, of this Form 10-Q.
Current wording
Additional information about our long-term borrowings is presented in Note 5 “Indebtedness,” information about our operating leases is presented in Note 9 "Commitments and Contingencies" and information about the Private Placement is presented in Note 7 "Stockholders Equity", to the Notes to Unaudited Condensed Consolidated Financial Statements included in Part I, Item 1, of this Form 10-Q.
Previous wording
The opinion of our independent registered public accounting firm on our audited financial statements as of and for the years ended December 31, 2025 contains an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern. Future reports on our financial statements may include an explanatory paragraph with respect to our ability to continue as a going concern. Our consolidated condensed financial statements as of and for the three and six months ended June 30, 2026 and 2025 included in this Form 10-Q do not include any adjustments relating to the recoverability and classification of recorded asset amounts or amounts of liabilities that might be necessary should we be unable to continue our operations.
Current wording
The opinion of our independent registered public accounting firm on our audited financial statements as of and for the years ended December 31, 2025 contains an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern. Future reports on our financial statements may include an explanatory paragraph with respect to our ability to continue as a going concern. Our consolidated condensed financial statements as of and for the three and nine months ended September 30, 2026 and 2025 included in this Form 10-Q do not include any adjustments relating to the recoverability and classification of recorded asset amounts or amounts of liabilities that might be necessary should we be unable to continue our operations.
Previous wording
The following table shows a summary of our cash flows for each of the six months ended June 30, 2026 and 2025, respectively:
Current wording
The following table shows a summary of our cash flows for each of the nine months ended September 30, 2026 and 2025, respectively:
Previous wording
During the six months ended June 30, 2026, operating activities used approximately $78.1 million of cash, primarily resulting from a net loss of $29.8 million and changes in contract liabilities of $12.4 million, changes in accrued research and development expenses of $12.0 million and gain on debt extinguishment of $43.8 million, reduced by changes in stock-based compensation expense of $8.8 million and changes in prepaid expenses and other current assets of $8.9 million.
Current wording
During the nine months ended September 30, 2026, operating activities used approximately $107.7 million of cash, primarily resulting from a net loss of $77.8 million and changes in contract liabilities of $49.6 million, changes in accrued research and development expenses of $13.6 million and gain on debt extinguishment of $43.8 million, reduced by changes in warrant liability of $54.9 million, stock-based compensation expense of $12.6 million and changes in prepaid expenses and other current assets of $9.2 million.
Previous wording
During the six months ended June 30, 2025, operating activities used approximately $86.8 million of cash, primarily resulting from the net loss of $74.9 million and changes in accounts payable of $6.8 million, changes in prepaid expenses and other current assets of $5.4 million and changes in amortization of premium on investments of $4.6 million, reduced by changes in stock-based compensation expense of $5.0 million.
Current wording
During the nine months ended September 30, 2025, operating activities used approximately $123.0 million of cash, primarily resulting from the net loss of $123.1 million and changes in accounts payable of $7.6 million, changes in prepaid expenses and other current assets of $4.5 million and changes in amortization of premium on investments of $6.2 million, reduced by changes in stock-based compensation expense of $7.7 million and in process research and development expense of $7.5 million.
Previous wording
During the six months ended June 30, 2026, investing activities provided approximately $84.3 million of cash, primarily resulting from the maturities of marketable securities of $109.3 million, offset by the purchases of marketable securities of $25.0 million.
Current wording
During the nine months ended September 30, 2026, investing activities provided approximately $100.2 million of cash, primarily resulting from the maturities of marketable securities of $125.2 million, offset by the purchases of marketable securities of $25.0 million.
Previous wording
During the six months ended June 30, 2025, investing activities provided approximately $66.2 million of cash, primarily resulting from the maturities of marketable securities of $242.8 million, offset by the purchases of marketable securities of $176.5 million.
Current wording
During the nine months ended September 30, 2025, investing activities provided approximately $83.2 million of cash, primarily resulting from the maturities of marketable securities of $289.4 million, offset by the purchases of marketable securities of $206.1 million.
Previous wording
During the six months ended June 30, 2026, financing activities used approximately $2.6 million of cash, primarily resulting from the payment of debt and equity issuance costs in connection with the exchange of the 2027 Notes of $3.1 million, reduced by the proceeds from issuance of common stock pursuant to the ESPP of $0.3 million and the proceeds from the exercise of stock options of $0.2 million.
Current wording
During the nine months ended September 30, 2026, financing activities provided approximately $21.1 million of cash, primarily resulting from the proceeds from the August Private Placement of $25.0 million, the proceeds from issuance of common stock pursuant to the ESPP of $0.4 million and the proceeds from the exercise of stock options of $0.2 million reduced by the payment of debt and equity issuance costs in connection with the exchange of the 2027 Notes of $3.1 million.
Previous wording
During the six months ended June 30, 2025, financing activities provided approximately $0.6 million of cash, primarily resulting from the proceeds from issuance of common stock pursuant to the ESPP of $0.4 million and the proceeds from the exercise of stock options of $0.2 million.
Current wording
During the nine months ended September 30, 2025, financing activities provided approximately $2.5 million of cash, primarily resulting from the proceeds from issuance of common stock pursuant to the ESPP of $0.8 million, the proceeds from the exercise of stock options of $0.7 million and proceeds from the exercise of warrants of $0.9 million.
Previous wording
•the costs, timing and outcome of regulatory review of seralutinib;
Current wording
•the costs, timing and outcome of regulatory review of seralutinib, including whether the FDA accepts our NDA for filing;
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
Effective Amendment No. 2 to the 2026 Shelf Registration Statement, which became effective on March 18, 2026, to convert the registration statement to a non-automatic shelf registration statement as we were no longer a “well-known seasoned issuer.”