US Market News
1月前
Gossamer Bio, Inc. Launches Exchange Offer and Consent Solicitation Intended to Eliminate Over $120 Million of Debt with Existing Noteholder SupportMay 18, 2026 7:05 AM
Business Wire Gossamer Bio, Inc. (NASDAQ: GOSS) (the “Company”), a 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 that it has commenced an exchange offer (the “Exchange Offer”) to exchange any and all of its 5.00% Convertible Senior Notes due 2027 (the “Existing Convertible Notes”) for a pro rata portion of (i) up to $72.0 million in aggregate principal amount of its new 7.50% Convertible Senior Secured First Lien Notes due 2030 (the “New Convertible Notes”), (ii) up to 317,647,058 shares of its common stock (the “Common Stock”) or, in lieu of issuing shares of Common Stock to the extent such shares would cause any Eligible Holder (as defined below) to beneficially own greater than 9.99% of the outstanding Common Stock, prefunded warrants to purchase shares of Common Stock (the “Prefunded Warrants” and, together with the Common Stock, the “Equity Securities”) and (iii) with respect to Eligible Holders who tender prior to the Early Tender Date, warrants to purchase shares of Common Stock (the “Purchase Warrants” and, together with the New Convertible Notes and Equity Securities, the “Offered Securities”). Simultaneously with the Exchange Offer, the Company is soliciting consents (the “Consent Solicitation”) from holders of the Existing Convertible Notes to adopt certain proposed amendments (the “Proposed Amendments”) to the indenture governing the Existing Convertible Notes (the “Existing Convertible Notes Indenture”). The Proposed Amendments would eliminate substantially all of the restrictive covenants in the Existing Convertible Notes Indenture as well as certain events of default and related provisions applicable to the Existing Convertible Notes. On the date hereof, holders of approximately 75.2% (the “Supporting Noteholders”) of the Existing Convertible Notes have entered into a transaction support agreement with the Company (the “Transaction Support Agreement”) to support the Exchange Offer and Consent Solicitation, including by tendering all of their Existing Convertible Notes in the Exchange Offer. The Transaction Support Agreement is subject to certain customary conditions, including a condition that the Company will not consummate the Exchange Offer unless the holders of 98% of the aggregate principal amount of Existing Convertible Notes tender their Existing Convertible Notes in the Exchange Offer. The New Convertible Notes will be secured, first lien obligations of the Company. The New Convertible Notes will mature on July 1, 2030, unless earlier converted or repurchased in accordance with the terms of the New Convertible Notes, provided that the New Convertible Notes shall have a springing maturity date of March 2, 2027 (91 days prior to the stated maturity of the Existing Convertible Notes) if more than $4.0 million of the Existing Convertible Notes remain outstanding at such time. The New Convertible Notes will bear interest at a rate of 7.50% per annum from the initial settlement date of such New Convertible Notes, which interest will be payable in cash semi-annually in arrears on January 1 and July 1 of each year, beginning on January 1, 2027. The conversion rate for the New Convertible Notes will initially be the number of shares of Common Stock per $1,000 principal amount of New Convertible Notes equal to the quotient of $1,000 divided by a 10% premium to the Reference Price, rounded to the nearest 1/10,000th of a share. The “Reference Price” will equal the greater of (i) $0.17 and (ii) the lower of (x) $0.34 and (y) the average of the daily volume-weighted average prices for the seven (7) consecutive VWAP trading days beginning on, and including, the VWAP trading day immediately following the final settlement date. The Purchase Warrants will be exercisable with a cash exercise price equal to the greater of (i) $0.34 and (ii) a 25% premium to the Reference Price, subject to adjustments. Prior to obtaining stockholder approval of certain proposals that will allow the issuance of Common Stock pursuant to the terms of the New Convertible Notes and Purchase Warrants, the Company will be permitted to satisfy its obligations upon conversion of the New Convertible Notes, and upon exercise of the Purchase Warrants, only in the form of cash settlement. Following such stockholder approval, the Company will be permitted to satisfy its obligations under the New Convertible Notes and Purchase Warrants with any settlement method it is otherwise permitted to elect, including by physical settlement of shares of Common Stock. A holder of New Convertible Notes will not be permitted to convert its New Convertible Notes at any time prior to the later of (i) the date the conversion rate has been determined and (ii) the earlier of (a) the date of the first special meeting at which the Company seeks stockholder approval of such proposals, whether or not such approvals are obtained, and (b) the date that is 61 calendar days following the initial settlement date of the New Convertible Notes. A “make whole” premium will be payable on the New Convertible Notes through an increase to the conversion rate in certain circumstances to compensate converting holders for interest that would have been payable to the maturity date. The New Convertible Notes will be convertible at any time following such date and prior to the close of business on the second trading day immediately preceding the maturity date. The Purchase Warrants will be exercisable at any time beginning on December 3, 2026 and ending on June 3, 2031. The Exchange Offer and Consent Solicitation will expire at 5:00 p.m., New York City time, on June 16, 2026 (such time and date, as the same may be extended, the “Expiration Deadline”), unless extended or earlier terminated. Rights to withdraw tendered Existing Convertible Notes and revoke consents terminate at 5:00 p.m., New York City time, on June 1, 2026 (such time and date, as the same may be extended, the “Withdrawal Deadline”), unless extended. The Company may, subject to the terms of the Transaction Support Agreement, accept for exchange (the “Early Settlement”) any Existing Convertible Notes validly tendered (and not validly withdrawn) in the Exchange Offer at or prior to 5:00 p.m., New York City time, on June 1, 2026 (such time and date, as the same may be extended, the “Early Tender Date”) if all conditions to the Exchange Offer have been or are concurrently satisfied or waived prior to the Early Tender Date. Whether or not the Early Settlement occurs, if, at or prior to the Expiration Deadline, unless extended, all conditions to the Exchange Offer have been or are concurrently satisfied or waived, the Company will accept for exchange all Existing Convertible Notes validly tendered in the Exchange Offer at or prior to the Expiration Deadline, and not validly withdrawn at or prior to the Withdrawal Deadline (the date of such exchange, the “Final Settlement Date”). The Final Settlement Date will be promptly after the Expiration Deadline and is currently expected to occur on June 18, 2026, the second business day immediately following the Expiration Deadline. The Company’s ability to amend, extend, terminate, or waive the conditions of the Exchange Offer are subject to the terms of the Transaction Support Agreement. Eligible Holders whose Existing Convertible Notes are accepted for exchange will also receive accrued and unpaid interest on such Existing Convertible Notes from, and including, the most recent interest payment date to, but excluding, the applicable Settlement Date, payable in cash on the applicable Settlement Date. Interest will cease to accrue on the applicable Settlement Date for all Existing Convertible Notes accepted for exchange in the Exchange Offer. The Exchange Offer and Consent Solicitation may each be amended or extended at any time prior to the Expiration Deadline and for any reason, and may be terminated or withdrawn if any of the conditions of the Exchange Offer and Consent Solicitation are not satisfied or waived by the Expiration Deadline (as it may be extended), subject to applicable law and the terms of the Transaction Support Agreement. Tenders of Existing Convertible Notes tendered in the Exchange Offer may be validly withdrawn at any time at or prior to the Withdrawal Deadline, unless extended by the Company, but will thereafter be irrevocable. Subject to applicable law and the terms of the Transaction Support Agreement, the Company may extend the Expiration Deadline at any time, which may or may not have the effect of extending the Withdrawal Deadline. The Company’s obligation to accept for exchange Existing Convertible Notes validly tendered (and not validly withdrawn) pursuant to the Exchange Offer is subject to the satisfaction or waiver of certain conditions, including without limitation, that a minimum of 98% of the aggregate principal amount of Existing Convertible Notes shall have been validly tendered (and, if applicable, not validly withdrawn) pursuant to the Exchange Offer. The New Convertible Notes, Purchase Warrants, Prefunded Warrants and shares of Common Stock offered in the Exchange Offer are being offered only to holders of Existing Convertible Notes that are “qualified institutional buyers” as defined in Rule 144A under the Securities Act (“Eligible Holders”). Eligible Holders who validly tender (and do not validly withdraw) their Existing Convertible Notes and deliver their related consents at or prior to the Early Tender Date will be eligible to receive for each $1,000 in aggregate principal amount of Existing Convertible Notes validly tendered for exchange, $360 in aggregate principal amount of New Convertible Notes and 1,588.2353 shares of Common Stock (or Prefunded Warrants) and 750 Purchase Warrants. Upon the terms and subject to the conditions of the Exchange Offer and Consent Solicitation, Eligible Holders who validly tender Existing Convertible Notes after the Early Tender Date but at or prior to the Expiration Deadline, and whose Existing Convertible Notes are accepted for exchange by the Company, will receive for each $1,000 in aggregate principal amount of Existing Convertible Notes validly tendered for exchange, $360 in aggregate principal amount of New Convertible Notes and 1,588.2353 shares of Common Stock (or Prefunded Warrants), but will not receive any Purchase Warrants, as described in the table below: Title of Existing Convertible Notes CUSIP
Number(1) Principal
Amount
Outstanding Consideration
per $1,000 Principal Amount of Existing Convertible
Notes(2) Early Exchange Premium per $1,000 Principal Amount of Existing Convertible
Notes(3) Total
Consideration per $1,000 Principal Amount of Existing Convertible
Notes(4) 5.00% Convertible Senior Notes due 2027 38341P AA0 $200,000,000 (1) $360 of New Convertible Notes and (2) 1,588.2353 shares of Common Stock (or Prefunded Warrants) 750 Purchase Warrants (the “Early Exchange Premium”) (1) $360 of New Convertible Notes, (2) 1,588.2353 shares of Common Stock (or Prefunded Warrants) and (3) 750 Purchase Warrants ____________________ (1) No representation is made as to the correctness or accuracy of the CUSIP number listed in this communication or printed on the Existing Convertible Notes. CUSIPs are provided solely for convenience. (2) Consideration per $1,000 principal amount of Existing Convertible Notes that are validly tendered (and are not validly withdrawn) and accepted for exchange, subject to any rounding as described herein. (3) Additional consideration per $1,000 principal amount of Existing Convertible Notes that are validly tendered (and are not validly withdrawn) and accepted for exchange at or prior to the Early Tender Date, subject to any rounding. For the avoidance of doubt, Eligible Holders who validly tender and do not validly withdraw their Existing Convertible Notes after the Early Tender Date and prior to the Expiration Deadline will not be eligible to receive the Early Exchange Premium. (4) For the Eligible Holders who validly tender prior to the Early Tender Date. Cantor Fitzgerald & Co. is acting as exclusive capital markets and financial advisor, sole dealer manager and sole solicitation agent to the Company (the “Dealer Manager”) in connection with the Exchange Offer and Consent Solicitation. D.F. King & Co., Inc. is acting as the exchange agent and the information agent (the “Exchange Agent”) in connection with the Exchange Offer and Consent Solicitation. Questions concerning the Exchange Offer and Consent Solicitation may be directed to the Dealer Manager at 110 East 59th Street, New York, NY 10022, email: elcm@cantor.com or to the Exchange Agent at 28 Liberty Street, 53rd Floor, New York, NY 10005, tel: (866) 620-9554 or (646) 582-7109, e-mail: goss@dfking.com. The eligibility letter is available electronically at: www.dfking.com/goss. Eligible Holders should also consult their broker, dealer, commercial bank, trust company or other institution for assistance concerning the Exchange Offer and Consent Solicitation. Latham & Watkins LLP is acting as legal counsel to the Company in connection with the Exchange Offer and Consent Solicitation. Akin Gump Strauss Hauer & Feld LLP is acting as legal counsel to certain holders of Existing Convertible Notes that are party to the Transaction Support Agreement. DLA Piper LLP (US) is acting as legal counsel to the Dealer Manager in connection with the Exchange Offer and Consent Solicitation. Only Eligible Holders may receive a copy of the offering memorandum relating to the Exchange Offer and Consent Solicitation and participate in the Exchange Offer and Consent Solicitation. None of the Company, the Dealer Manager, the Exchange Agent, any trustee or collateral agent for the Existing Convertible Notes or New Convertible Notes, or any affiliate of any of them makes any recommendation as to whether any Eligible Holder of Existing Convertible Notes should exchange or refrain from exchanging the principal amount of such Eligible Holder's Existing Convertible Notes in the Exchange Offer or submit consents in the Consent Solicitation. No one has been authorized by any of them to make such a recommendation. Eligible Holders must make their own decision whether to tender Existing Convertible Notes in the Exchange Offer or submit consents in the Consent Solicitation. No Eligible Holder may tender less than all of its Existing Convertible Notes in the Exchange Offer. The offering, issuance and sale of the Offered Securities has not been registered under the Securities Act of 1933, as amended, or any other securities laws. This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, the New Convertible Notes, shares of Common Stock (or Prefunded Warrants) and Purchase Warrants offered in the Exchange Offer, the shares of Common Stock issuable upon conversion of the New Convertible Notes, Prefunded Warrants or Purchase Warrants, the Existing Convertible Notes or any other securities, nor will there be any sale of such securities or any other securities, in any state or other jurisdiction in which such offer, sale or solicitation would be unlawful. About Gossamer Bio Gossamer Bio is a biopharmaceutical company focused on the development of treatments for pulmonary hypertension. Its goal is to be an industry leader in, and to enhance the lives of patients living with, pulmonary hypertension. Gossamer Bio Forward Looking Statements The Company 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 Company’s proposed Exchange Offer and Consent Solicitation relating to its Existing Convertible Notes, including the anticipated benefits thereof; the timing, occurrence and outcome of the Company’s planned Pre-NDA Type B meeting with the FDA; the timing and potential submission of an NDA for seralutinib in PAH; the potential significance, interpretation and implications of data from the Phase 3 PROSERA study, including the CT FRI substudy; and the development potential and market opportunity of seralutinib in PAH, PH-ILD and other indications. 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: the Company may not be able to complete the Exchange Offer on the anticipated timeline or at all, and the Company may not realize the anticipated benefits therefrom; the Company may not be able to identify a development path forward for seralutinib or submit an NDA on the timeframe we expect or at all, whether as a result of FDA feedback or otherwise, and 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; topline results the Company reports are based on preliminary analysis of key data, and such data may change following a more comprehensive review of the data related to the clinical trial or substudy and such topline data may not accurately reflect the complete results of a clinical trial or substudy; the Company’s interpretation, significance and regulatory relevance of data from the Phase 3 PROSERA study, including the CT FRI substudy, may be inconsistent with the views of the FDA or others; risks related to the proposed Exchange Offer and Consent Solicitation, including whether the transaction is completed and whether the anticipated benefits are realized; potential delays in the commencement, enrollment and completion of clinical trials; disruption to our operations from unexpected events, 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 with seralutinib 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 its 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 changes in healthcare legislation, tariffs and trade policies may adversely affect the Company’s 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. View source version on businesswire.com: https://www.businesswire.com/news/home/20260518442485/en/ For Investors and Media:
Bryan Giraudo, Chief Financial Officer & Chief Operating Officer
Gossamer Bio Investor Relations
ir@gossamerbio.com Original: Gossamer Bio, Inc. Launches Exchange Offer and Consent Solicitation Intended to Eliminate Over $120 Million of Debt with Existing Noteholder Support
US Market News
2月前
GOSS Investor Alert: Gossamer Bio Securities Fraud Lawsuit - Investors With Losses May Seek to Lead the Class Action After Executives Allegedly Concealed Placebo Risk: SueWallStApril 23, 2026 9:00 AM
PR Newswire (US)
Notice to Pension Funds, Asset Managers, and FiduciariesNEW YORK, April 23, 2026 /PRNewswire/ -- Institutional investors holding positions in Gossamer Bio, Inc. (NASDAQ: GOSS) during the period between June 16, 2025 and February 20, 2026 may wish to evaluate lead plaintiff opportunities in a pending securities class action. Request an institutional investor loss assessment. You may also contact Joseph E. Levi, Esq. at jlevi@SueWallSt.com or call (888) SueWallSt.
GOSS shares collapsed from $2.13 to $0.42 on February 23, 2026, more than an 80% single-day decline that erased over $1.71 per share in value across 231.5 million shares outstanding. The window to apply for lead plaintiff closes on June 1, 2026.Fiduciary Obligations and Recovery OptionsFiduciaries overseeing portfolios that held GOSS securities during the class period face specific obligations under ERISA and applicable state pension fund governance standards. Lead plaintiff appointment provides institutional holders with direct oversight of litigation strategy, counsel selection, and settlement terms. Key considerations for fiduciaries include:Pension funds and endowments with documented GOSS losses should evaluate whether seeking lead plaintiff status satisfies their duty to maximize recoveries for beneficiariesLead plaintiff appointment carries no additional financial obligation; securities class actions proceed on a contingency basis with no out-of-pocket costsInstitutional lead plaintiffs receive the same pro-rata recovery as all class members, but gain direct influence over case strategy and settlement approvalFiduciaries who fail to evaluate recovery options in securities fraud cases may face questions regarding their stewardship of plan assetsPortfolio monitoring services can assist institutions in identifying and tracking cases where holdings suffered fraud-related lossesPortfolio Impact AssessmentThe lawsuit contends that Gossamer and its CEO constructed a misleading narrative about the Phase 3 PROSERA clinical trial's likelihood of success while concealing that enrollment characteristics at Latin American sites created acute risks of an outsized placebo response. When topline results revealed the trial failed to meet its primary endpoint, the market repriced GOSS shares to reflect the removal of artificial inflation. Institutional holders who acquired shares based on the company's repeated assurances of disciplined trial execution and carefully selected patient populations may have suffered losses traceable to the alleged misrepresentations.Contact us for institutional recovery options or call (212) 363-7500.Case Summary"Institutional investors play a critical role in securities class actions. Their participation as lead plaintiffs helps ensure that cases are litigated vigorously and that recoveries reflect the full scope of harm suffered by the investing public." -- Joseph E. Levi, Esq.The action asserts claims under Section 10(b) and Section 20(a) of the Securities Exchange Act and SEC Rule 10b-5. It was filed in the United States District Court for the Southern District of California.INSTITUTIONAL INVESTOR REPRESENTATION -- Levi & Korsinsky, LLP provides sophisticated counsel to institutional investors evaluating lead plaintiff opportunities. The firm has recovered hundreds of millions of dollars. Ranked among ISS Top 50 for seven consecutive years.Frequently Asked Questions About the GOSS LawsuitQ: Who is eligible to join the GOSS investor lawsuit? A: Investors who purchased GOSS stock or securities between June 16, 2025 and February 20, 2026 and suffered financial losses may be eligible. Eligibility is based on purchase date and documented losses, not on whether you still hold the shares.Q: How much did GOSS stock drop? A: Shares fell approximately 80%, a decline of $1.71 per share, after Gossamer disclosed that its Phase 3 PROSERA trial failed to meet the primary endpoint due to outsized placebo performance at Latin American sites. Investors who purchased shares during the class period at artificially inflated prices may be entitled to compensation.Q: What is a lead plaintiff and why does it matter? A: A lead plaintiff is the investor appointed by the court to represent the entire class. Lead plaintiffs are typically investors with the largest documented losses. Being appointed does not increase individual recovery but gives direct oversight of how the case is run.Q: What does it cost me to participate? A: Nothing. Securities class actions are handled on a pure contingency basis. No upfront fees, no retainer, no out-of-pocket costs.Q: What if I already sold my GOSS shares -- can I still recover losses? A: Yes. Eligibility is based on when you purchased, not whether you still hold them. Investors who bought during the class period and sold at a loss may still participate.Q: What documents do I need to make a claim? A: Brokerage statements or trade confirmations showing purchase dates, share quantities, prices paid, and any subsequent sale dates and prices.Q: What if I live outside the United States? A: U.S. securities class actions generally cover purchases on U.S. exchanges regardless of investor's country of residence.CONTACT:SueWallStJoseph E. Levi, Esq.Ed Korsinsky, Esq.33 Whitehall Street, 27th FloorNew York, NY 10004jlevi @Icons1
View original content to download multimedia:https://www.prnewswire.com/news-releases/goss-investor-alert-gossamer-bio-securities-fraud-lawsuit---investors-with-losses-may-seek-to-lead-the-class-action-after-executives-allegedly-concealed-placebo-risk-suewallst-302751169.htmlSOURCE SueWallSt.com
Original: GOSS Investor Alert: Gossamer Bio Securities Fraud Lawsuit - Investors With Losses May Seek to Lead the Class Action After Executives Allegedly Concealed Placebo Risk: SueWallSt
US Market News
4月前
Gossamer Bio Announces Fourth Quarter and Full-Year 2025 Financial Results and Provides Corporate UpdateMarch 17, 2026 4:01 PM
Business Wire
- Following PROSERA Phase 3 topline results, the Company is focused on evaluating the totality of the dataset, engaging with the FDA, and assessing strategic options and capital allocation -
- Enrollment in the Phase 3 SERANATA Study in PH-ILD has been paused while the Company evaluates implications of PROSERA results -
- The Company implemented a reduction in force to align resources with near-term priorities -
- Cash, cash equivalents and marketable securities totaled $137 million at year-end 2025 -
Gossamer Bio, Inc. (Nasdaq: GOSS), a 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 fourth quarter and year ended December 31, 2025, and provided a corporate update. Gossamer Bio and the Chiesi Group are jointly developing seralutinib under a global collaboration agreement.
“Following our PROSERA topline results, we are focused on fully understanding the PROSERA dataset, engaging with the FDA, and evaluating strategic options and capital allocation to position the Company for the future,” said Faheem Hasnain, Chairman, Co-Founder and CEO of Gossamer Bio.
“PROSERA narrowly missed the prespecified statistical threshold for its primary endpoint; however, we believe the totality of evidence supports that seralutinib is an active drug in PAH, with the most pronounced effects observed in patients with more advanced disease.”
Seralutinib (GB002): Inhaled PDGFR, CSF1R and c-KIT Inhibitor
In February 2026, the Company announced topline results from PROSERA, its Phase 3 study of seralutinib in PAH. At Week 24, seralutinib demonstrated a placebo-adjusted improvement in six-minute walk distance (6MWD) of approximately +13.3 meters versus placebo (p = 0.0320), which did not meet the prespecified statistical alpha threshold of 0.025; therefore, all other p-values are nominal.
In the prespecified intermediate- and high-risk subgroup (REVEAL Lite 2 score ≥6 at screening), seralutinib demonstrated a placebo-adjusted improvement in 6MWD of approximately +20.0 meters at Week 24 (n = 234; nominal p = 0.0207). In this subgroup, three of four key secondary endpoints had nominal p-values below 0.0125, with results favoring seralutinib versus placebo.
Across the overall population, key secondary endpoints favored seralutinib versus placebo, including NT-proBNP (location shift of approximately -120.4 ng/L at Week 24; nominal p = 0.0002), as well as measures of clinical improvement, reduction in risk score, and time to clinical worsening.
In a prespecified subgroup of patients with connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH), seralutinib demonstrated a placebo-adjusted improvement in six-minute walk distance of approximately +37 meters at Week 24 versus placebo (n = 87; nominal p = 0.0104).
The Company has paused enrollment in the Phase 3 SERANATA Study in PH-ILD while it evaluates the implications of PROSERA results, including regional variability in placebo response, and engages with regulators on potential paths forward.
The Company continues to conduct additional analyses of the PROSERA dataset.
Based on the PROSERA results, the Company plans to request a Type C meeting with the U.S. Food and Drug Administration (FDA), to occur potentially in June 2026, to discuss the data and potential regulatory paths forward.
RT234: Inhaled PDE5 Inhibitor (Vardenafil)
As planned, the Company continues to support limited work on RT234 pursuant to its option agreement to support an ongoing assessment of the program. RT234-related spend is expected to remain modest and is not a near-term strategic focus as the Company prioritizes its evaluation of PROSERA and related regulatory and strategic planning.
Corporate Update
In connection with its ongoing evaluation of strategic options and capital allocation priorities, the Company implemented a reduction in force and other cost-containment measures intended to better align resources with its near-term priorities. The Company remains focused on advancing its regulatory and strategic planning related to seralutinib.
Financial Results for Quarter and Full Year Ended December 31, 2025
Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of December 31, 2025, were $136.9 million. As a result, the Company expects its current cash, cash equivalents and marketable securities will be sufficient to fund operating and capital expenditures into the first quarter of 2027.
Research and Development (R&D) Expenses: For the quarter ended December 31, 2025, R&D expenses were $48.9 million compared to R&D expenses of $36.1 million for the same period in 2024. R&D expenses for the full year ended December 31, 2025, were $174.1 million compared to $138.5 million for the full year ended December 31, 2024.
General and Administrative (G&A) Expenses: For the quarter ended December 31, 2025, G&A expenses were $10.9 million compared to $9.4 million for the same period in 2024. G&A expenses for the full year ended December 31, 2025, were $37.6 million compared to $36.1 million for the full year ended December 31, 2024.
Net Loss: Net loss for the three months ended December 31, 2025, was $47.2 million, or $0.21 per share, compared to a net loss of $33.0 million, or $0.15 per share, for the same period in 2024. Net loss for the full year ended December 31, 2025, was $170.4 million, or $0.75 per share compared to a net loss of $56.5 million, or $0.25 per share, for the full year ended December 31, 2024.
About Gossamer Bio
Gossamer Bio is a biopharmaceutical company focused on the development of treatments for pulmonary hypertension. Its goal is to be an industry leader in, and to enhance the lives of patients living with, 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 Company’s additional analyses and interpretation of the PROSERA dataset; the therapeutic potential of seralutinib; the expected plan to discuss topline results with the FDA and the potential to identify a development path forward for seralutinib, including the timing of a potential meeting in the June 2026 timeframe; the plans to pause the Phase 3 SERANATA Study; the Company’s evaluation of strategic options and capital allocation; the intended objectives and benefits of the workforce reduction; the expected spend related to RT234; and the expected timeframe for funding the Company’s 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; topline results Gossamer reports are based on preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial; Gossamer may not be able to identify a development path forward for seralutinib, whether as a result of FDA feedback or otherwise, and 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; Gossamer may need to further evaluate its current workforce in light of potential development paths for seralutinib; potential delays in the commencement, enrollment and completion of clinical trials; comparative safety information is not based on a head-to-head comparison and differences exist between study designs and subject characteristics which could confound the results; 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 with seralutinib are not necessarily predictive of future results; the success of any future 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 its 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; Gossamer may use its capital resources sooner than it expects; and other risks described in 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, INC.
CONDENSED CONSOLIDATED FINANCIAL STATEMENT DATA
(UNAUDITED; IN THOUSANDS, EXCEPT SHARE AND PER SHARE DATA)
Three months ended December 31,
Year ended December 31,
STATEMENTS OF OPERATIONS DATA:
2025
2024
2025
2024
Revenue:
Revenue from sale of licenses
$
—
$
1,931
$
—
$
90,682
Revenue from contracts with collaborators
13,799
7,448
48,471
24,019
Total revenue
13,799
9,379
48,471
114,701
Operating expenses:
Research and development
$
48,935
$
36,112
$
174,093
$
138,487
In process research and development
(1
)
—
7,475
—
General and administrative
10,904
9,395
37,631
36,133
Total operating expenses
59,838
45,507
219,199
174,620
Loss from operations
(46,039
)
(36,128
)
(170,728
)
(59,919
)
Other income (expense)
Interest income
447
(744
)
1,970
1,779
Interest expense
(2,751
)
(2,738
)
(10,989
)
(11,517
)
Other income, net
1,017
4,171
9,289
14,022
Total other income (loss), net
(1,287
)
689
270
4,284
Loss before provision (benefit) for income taxes
(47,326
)
(35,439
)
(170,458
)
(55,635
)
Provision (benefit) for income taxes
(88
)
(2,410
)
(88
)
893
Net loss
$
(47,238
)
$
(33,029
)
$
(170,370
)
$
(56,528
)
Net loss per share, basic and diluted
$
(0.21
)
$
(0.15
)
$
(0.75
)
$
(0.25
)
Weighted average common shares outstanding, basic and diluted
226,604,138
226,604,138
228,519,130
226,228,016
BALANCE SHEET DATA:
December 31, 2025
December 31, 2024
Cash, cash equivalents, and marketable securities
$
136,932
$
294,518
Working capital
104,209
264,878
Total assets
172,249
315,292
Total liabilities
295,009
285,800
Accumulated deficit
(1,438,938
)
(1,268,568
)
Total stockholders' equity (deficit)
(122,760
)
29,492
View source version on businesswire.com: https://www.businesswire.com/news/home/20260317488156/en/
For Investors and Media:
Bryan Giraudo, Chief Financial Officer & Chief Operating Officer
Gossamer Bio Investor Relations
ir@gossamerbio.com
Original: Gossamer Bio Announces Fourth Quarter and Full-Year 2025 Financial Results and Provides Corporate Update
fightstkcrime
10月前
$Gossamer Bio 🚨Gossamer Pharmaceuticals: Progress, Promise, and Pivotal Developments in 2025
Gossamer Bio (NASDAQ: GOSS) has emerged as a 🌟🌟beacon of innovation and determination🌟🌟 in the fight against pulmonary diseases, making significant strides in 2025 that position the company for a bright future. As a late-stage clinical biopharmaceutical company, Gossamer is devoted to developing novel therapies for patients facing severe and underserved conditions, particularly pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
🚨Major Pipeline Milestones: The Seralutinib Revolution
The company's lead drug candidate, 🚨seralutinib🚨, stands at the forefront of its pipeline. Designed to target abnormal cellular proliferation, inflammation, and fibrosis, three core drivers of pulmonary vascular disease 🔥🔥🔥seralutinib holds immense therapeutic promise🔥🔥🔥. In 2025, Gossamer reached several key inflection points:
🚨Completion of Phase 3 PROSERA Study Enrollment: Gossamer successfully enrolled 390 patients in its registrational global Phase 3 PROSERA trial for PAH. This study is designed to evaluate seralutinib in Functional Class II and III PAH patients, with topline data anticipated in Q4 2025 and a readout scheduled for February 2026.
The preliminary blinded baseline characteristics confirm the robustness of patient selection and trial design.
🚨PH-ILD Trial Expansion: The company is preparing to initiate the pivotal Phase 3 SERANATA study for PH-ILD patients later in 2025, targeting an additional 480 patients. By expanding into a second severe indication, Gossamer demonstrates commitment to broadening seralutinib's life-changing potential.
🚨Regulatory Achievements and Strategic Collaborations
🔥Building global awareness and access, Gossamer achieved Orphan Drug Designation for seralutinib in Japan. This regulatory advance not only reflects confidence in the drug’s unique mechanism but also promises favorable support for commercialization efforts and patient access in this critical market.
🔥A major driver of Gossamer’s progress is its strategic alliance with Chiesi Group, a global pharmaceutical leader. Under this collaboration, Chiesi provides funding support, including $160 million in development reimbursement and up to $326 million in regulatory and sales milestones, and takes responsibility for commercializing seralutinib outside the U.S., while Gossamer leads U.S. commercialization. Profits are shared equally in the U.S., further aligning incentives and ensuring wide-reaching expertise for global sales and distribution.
🚨Financial Strength and Investor Confidence
Despite its rapid R&D pace, Gossamer maintains a strong financial foundation. The company reported:
🚨Cash reserves of $212.9–$295 million, sufficient to fund operations well into 2027, adding critical financial security for long-term development and market launches.
🚨Strategic financial management ensured seamless trial execution, with operational readiness for key data releases and regulatory filings.
🚨R&D Excellence and Corporate Vision
The impact of Gossamer’s leadership and scientific rigor is evident in its rapid clinical development, regulatory advances, and expanding pipeline. The company’s CEO, Faheem Hasnain, has reiterated Gossamer’s commitment to “reshaping the treatment paradigm” for pulmonary hypertension, and the entire organization is intensely focused on 🔥🔥flawless execution of its Phase 3 studies and preparing for future launches🔥🔥.
Looking Ahead: Why Gossamer Is a Company to Watch
🚨Potential First-in-Class Therapy: Should Phase 3 data validate seralutinib’s efficacy and safety, Gossamer could introduce the first new mechanism for PAH in over two decades, potentially revolutionizing patient care.
🚨Expanding Indications: Success in PH-ILD and other related diseases could dramatically increase the addressable market and patient impact.
🚨Robust Partnerships and Financial Prudence: Industry-leading collaborators and prudent financial management maximize the probability of sustained success.
🔥Gossamer Bio continues to chart a dynamic course in pulmonary medicine, advancing toward the pivotal data readouts that could transform the future for patients with PAH and PH-ILD. Its commitment to clinical excellence, smart partnerships, and fiscal responsibility makes it not only a company to follow, but one that offers genuine hope to patients worldwide.
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