Organogenesis Holdings Inc. to Report Fourth Quarter and Fiscal Year 2025 Financial Results on February 26, 2026




Organogenesis Holdings Inc. to Report Fourth Quarter and Fiscal Year 2025 Financial Results on February 26, 2026

CANTON, Mass., Feb. 19, 2026 (GLOBE NEWSWIRE) — Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture and commercialization of product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, today announced that fourth quarter and fiscal year 2025 financial results will be reported after the market closes on Thursday, February 26th.

Management will host a conference call at 5:00 p.m. Eastern Time on February 26th to discuss the results of the quarter and the fiscal year, and to provide a corporate update with a question and answer session. Those who would like to participate may access the live webcast here, or access the teleconference here. The live webcast can also be accessed via the company’s website at investors.organogenesis.com. The webcast will be archived on the company website for approximately one year.

About Organogenesis Holdings Inc.
Organogenesis Holdings Inc. is a leading regenerative medicine company focused on the development, manufacture, and commercialization of solutions for the advanced wound care and surgical and sports medicine markets. Organogenesis offers a comprehensive portfolio of innovative regenerative products to address patient needs across the continuum of care. For more information, visit www.organogenesis.com.

Investor Inquiries:
ICR Healthcare
Mike Piccinino, CFA
OrganoIR@icrinc.com

Press and Media Inquiries:
Organogenesis
communications@organo.com

ICU Medical Announces Fourth Quarter 2025 Results and Provides Fiscal Year 2026 Guidance




ICU Medical Announces Fourth Quarter 2025 Results and Provides Fiscal Year 2026 Guidance

SAN CLEMENTE, Calif., Feb. 19, 2026 (GLOBE NEWSWIRE) — ICU Medical, Inc. (Nasdaq:ICUI), a leader in the development, manufacture and sale of innovative medical products, today announced financial results for the quarterly period ended December 31, 2025.

Fourth Quarter 2025 Results

Fourth quarter 2025 revenue was $540.7 million, as compared to $629.8 million in the same period in the prior year. GAAP gross profit for the fourth quarter of 2025 was $203.0 million, as compared to $227.3 million in the same period in the prior year. GAAP gross margin for the fourth quarter of 2025 was 38%, as compared to 36% in the same period in the prior year. GAAP net loss for the fourth quarter of 2025 was $(15.7) million, or $(0.64) per diluted share, as compared to GAAP net loss of $(23.8) million, or $(0.97) per diluted share, for the fourth quarter of 2024. Adjusted diluted earnings per share for the fourth quarter of 2025 was $1.91 as compared to $2.11 for the fourth quarter of 2024. Adjusted EBITDA was $98.2 million for the fourth quarter of 2025 as compared to $105.5 million for the fourth quarter of 2024.

Adjusted EBITDA and adjusted diluted earnings per share are measures calculated and presented on the basis of methodologies other than in accordance with GAAP. Please refer to the Use of Non-GAAP Financial Information following the financial statements herein for further discussion and reconciliations of these measures to GAAP measures.

Vivek Jain, ICU Medical’s Chief Executive Officer, said, “Fourth quarter results were generally in line with our expectations.”

Revenues by product line for the three and twelve months ended December 31, 2025 and 2024 were as follows (in millions):

^{*On May 1, 2025, we disposed of our IV Solutions business which was included within our Vital Care product line. Vital Care includes contract manufacturing revenue of $4.8 million and $19.0 million for the three and twelve months ended December 31, 2025, respectively, as compared to $8.2 million and $46.8 million for the three and twelve months ended December 31, 2024, respectively.
** Totals may differ from the income statement due to the rounding of product lines.}

Fiscal Year 2026 Guidance

For fiscal year 2026 the Company estimates GAAP net income to be in the range of $26 million to $44 million and GAAP net earnings per share estimated to be in the range of $1.03 to $1.74.

For the fiscal year 2026, the Company expects adjusted EBITDA to be in the range of $400 million to $430 million, and adjusted EPS to be in the range of $7.75 to $8.45.

Conference Call

The Company will host a conference call to discuss its fourth quarter and full year 2025 financial results, today at 4:30 p.m. ET (1:30 p.m. PT). The call can be accessed at (800) 274-8461, conference ID “ICUMED”. The conference call will be simultaneously available by webcast, which can be accessed by going to the Company’s website at www.icumed.com, clicking on the Investors tab, clicking on Event Calendar and clicking on the Webcast icon and following the prompts. The webcast will also be available by replay.

About ICU Medical

ICU Medical (Nasdaq: ICUI) is a global leader in infusion systems, infusion consumables and high-value critical care products used in hospital, alternate site and home care settings. Our team is focused on providing quality, innovation and value to our clinical customers worldwide. ICU Medical is headquartered in San Clemente, California. More information about ICU Medical can be found at www.icumed.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements contain words such as “aim,” “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” or the negative thereof or comparable terminology and may include (without limitation) information regarding the Company’s expectations, goals and intentions regarding the future and financial outlook for 2026. These forward-looking statements are based on management’s current expectations, estimates, forecasts and projections about the Company and assumptions management believes are reasonable, all of which are subject to risks and uncertainties that could cause actual results and events to differ materially from those stated in the forward-looking statements. These risks and uncertainties include, but are not limited to: risks from doing business in foreign countries, including related to tariffs and other barriers to trade; the Company’s ability to compete successfully, including with larger international companies and established local companies; decreased demand for the Company’s products; costs related to product development; cost volatility or potential loss of supply of raw materials due to our dependence on single and limited source third-party suppliers; ability to achieve operating efficiencies; risks related to significant sales through our distributors; inflation and foreign currency exchange rates; impacts from global macroeconomic and geopolitical conditions; healthcare costs and reimbursement levels; disruptions at the FDA and other governmental agencies; damage at the Company’s manufacturing or supply facilities; risks associated with the IV Solutions joint venture and the Smiths Medical integration; risks associated with the timing and resolution of the 2025 warning letter; risks related to protection of our information technology systems and compliance with privacy laws and regulations; risks related to our intellectual property; and the other important factors described under “Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and its Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2025, as such factors may be updated from time to time in the Company’s reports filed with the SEC, including without limitation its Annual Report on Form 10-K for the fiscal year ended December 31, 2025. Forward-looking statements contained in this press release are made only as of the date hereof, and the Company undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise unless required by law.

ICU MEDICAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)
(In thousands)

ICU MEDICAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
(In thousands, except per share data)

ICU MEDICAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)
(In thousands) 

Use of Non-GAAP Financial Information

This press release contains financial measures that are not calculated in accordance with U.S. generally accepted accounting principles (“GAAP”). The non-GAAP financial measures should be considered supplemental to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. There are material limitations in using these non-GAAP financial measures because they are not prepared in accordance with GAAP and may not be comparable to similarly titled non-GAAP financial measures used by other companies, including peer companies. Our management believes that the non-GAAP data provides useful supplemental information to management and investors regarding our performance and facilitates a more meaningful comparison of results of operations between current and prior periods. We use non-GAAP financial measures in addition to and in conjunction with GAAP financial measures to analyze and assess the overall performance of our business, in making financial, operating and planning decisions, and in determining executive incentive compensation.

The non-GAAP financial measures as shown in the tables below, exclude special items because they are highly variable or unusual and impact year-over-year comparisons.

For the three months ended December 31, 2025 and 2024, special items include the following:

Contract manufacturing: We manufacture certain products or product components in accordance with manufacturing services agreements. We do not include the contract revenue in our adjusted revenue, or any gross profit impact in our adjusted gross profit as the commercial relationship under these types of agreements are originally negotiated contemporaneously with a business combination or other transactions and are not indicative of normal market transactions.

Stock compensation expense: Stock-based compensation is generally fixed at the time the stock-based instrument is granted and amortized over a period of several years. The value of stock options is determined using a complex formula that incorporates factors, such as market volatility, that are beyond our control. The value of our restricted stock awards is determined using the grant date stock price, which may not be indicative of our operational performance over the expense period. Additionally, in order to establish the fair value of performance-based stock awards, which are currently an element of our ongoing stock-based compensation, we are required to apply judgment to estimate the probability of the extent to which performance objectives will be achieved. Based on the above factors, we believe it is useful to exclude stock-based compensation in order to better understand our operating performance.

Intangible asset amortization expense: We do not acquire businesses or capitalize certain patent costs on a predictable cycle. The amount of purchase price allocated to intangible assets and the term of amortization can vary significantly and are unique to each acquisition. Capitalized patent costs can vary significantly based on our current level of development activities. We believe that excluding amortization of intangible assets provides the users of our financial statements with a consistent basis for comparison across accounting periods.

Restructuring, strategic transaction and integration: We incur restructuring and strategic transaction charges that result from events, which arise from unforeseen circumstances and/or often occur outside of the ordinary course of our ongoing business. Although these events are reflected in our GAAP financial statements, these unique transactions may limit the comparability of our ongoing operations with prior and future periods.

Settlements: Occasionally, we are involved in contract renegotiations or other events that may result in one-time settlements. We exclude these settlements as they have no direct correlation to the operation of our ongoing business.

Change in fair value of contingent earn-out: We exclude the impact of certain amounts recorded in connection with business combinations. We exclude items that are either non-cash or not normal, recurring operating expenses due to their nature, variability of amounts, and lack of predictability as to occurrence and/or timing.

Quality system and product-related remediation: We exclude certain quality system and product-related remediation charges in determining our non-GAAP financial measures as they may limit the comparability of our ongoing operations with prior and future periods and distort the evaluation of our normal operating performance.

Asset write-offs and similar charges: Occasionally, we may write-off certain assets or we may sell certain assets. We exclude the non-cash gain/loss on the write-off/sale of these assets in determining our non-GAAP financial measures as they may limit the comparability of our ongoing operations with prior and future periods and distort the evaluation of our normal operating performance.

Noncash release of loss on contract provision: We provide certain services under fixed priced arrangements in accordance with a transition services arrangement. We do not include the loss on contract provision or subsequent release net of the related interest accretion as a result of providing those services in our non-GAAP financial measures as the agreement was negotiated contemporaneously with a disposition and is not indicative of a normal market transaction. The loss provision and subsequent release is a non-recurring noncash adjustment that if included may limit the comparability of our ongoing operations with prior and future periods.

Loss on extinguishment of debt (included in interest, net): We exclude any non-cash loss on extinguishment of debt in determining our non-GAAP financial measures as the inclusion may limit the comparability of our ongoing operations with prior and future periods and distort the evaluation of our normal operating performance.

Debt refinancing-related charges (included in interest, net): We exclude infrequent, event-driven debt refinancing-related charges in determining our non-GAAP financial measures as the inclusion may limit the comparability of our ongoing operations with prior and future periods and distort the evaluation of our normal operating performance.

From time to time in the future, there may be other items that we may exclude if we believe that doing so is consistent with the goal of providing useful information to investors and management.

In addition to the above special items, Adjusted EBITDA additionally excludes the following items from net income:

Depreciation expense: We exclude depreciation expense in deriving adjusted EBITDA because companies utilize productive assets of different ages and the depreciable lives can vary significantly resulting in considerable variability in depreciation expense among companies.

Interest, net: We exclude interest in deriving adjusted EBITDA as interest can vary significantly among companies depending on a company’s level of income generating instruments and/or level of debt.

Taxes: We exclude taxes in deriving adjusted EBITDA as taxes are deemed to be non-core to the business and may limit the comparability of our ongoing operations with prior and future periods and distort the evaluation of our normal operating performance.

Adjusted Diluted EPS excludes from diluted EPS, net of tax, the special items listed above. The tax effect on the special items is calculated using the specific tax rate applied to each adjustment based on the nature of the item/or the tax jurisdiction in which the item has been recorded. Additionally, adjusted diluted EPS may exclude the income tax impact of certain non-recurring discrete tax items that are not reflective of income tax expense/benefit incurred as a result of current period earnings/ loss, as well as the impact of certain deferred tax valuation allowances when assessed against non-GAAP profitability.

We also present Free cash flow as a non-GAAP financial measure as management believes that this is an important measure for use in evaluating overall company financial performance as it measures our ability to generate additional cash flow from business operations. Free cash flow should be considered in addition to, rather than as a substitute for, net income as a measure of our performance or net cash provided by operating activities as a measure of our liquidity. Additionally, our definition of free cash flow is limited and does not represent residual cash flows available for discretionary expenditures due to the fact that the measure does not deduct the payments required for debt service and other obligations or payments made for business acquisitions. Therefore, we believe it is important to view free cash flow as supplemental to our entire statement of cash flows.

We also present organic revenue growth as a non-GAAP financial measure as management believes that this measure provides a more representative view of the Company’s underlying growth trajectory by excluding the impact of revenue from non-arm’s length transactions, the impact of foreign currency and the revenue associated with acquisitions and divestitures. We calculate constant currency revenue by translating current period foreign currency revenue at prior period comparable exchange rates and we calculate the constant currency growth percentages by dividing the current period constant currency revenue by the prior year comparable period revenue.

The following tables reconcile our non-GAAP financial measures for the periods presented:

ICU MEDICAL, INC. AND SUBSIDIARIES
Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited)
(In thousands)

_________________

⁽¹⁾ Includes $2.5 million related to a loss on extinguishment of debt and $0.3 million of other debt refinancing-related charges.

ICU MEDICAL, INC. AND SUBSIDIARIES
Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited)
(In thousands, except percentages and per share data)

The Company’s U.S. GAAP results for the three months ended December 31, 2025 included special items which impacted the U.S. GAAP measures as follows:

______________________

* The Company’s non-GAAP annual effective tax rate is calculated without the tax expense related to the valuation allowance against certain U.S. Federal and State deferred tax assets. The valuation allowance was recorded based on an assessment of available positive and negative evidence, including, predominantly, an estimate that we will be in a three-year cumulative U.S. loss position on a GAAP basis as of December 31, 2025. However, based on the same assessment, including, predominantly, our being, in a three-year cumulative U.S. income position on a non-GAAP basis, which excludes the impact of our non-GAAP adjustments, we concluded that recording a valuation allowance would not have been appropriate for non-GAAP reporting. As a result, the tax expense for the valuation allowance was added back to our calculation of non-GAAP annual effective tax rate.
** Amounts may not foot due to rounding.

ICU MEDICAL, INC. AND SUBSIDIARIES
Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited)(continued)
(In thousands, except percentages and per share data)

The Company’s U.S. GAAP results for the three months ended December 31, 2024 included special items which impacted the U.S. GAAP measures as follows:

_____________
^{* The Company’s non-GAAP annual effective tax rate is calculated without the tax expense related to the valuation allowance against certain U.S. Federal and State deferred tax assets. The valuation allowance was recorded based on an assessment of available positive and negative evidence, including, predominantly, an estimate that we will be in a three-year cumulative U.S. loss position on a GAAP basis as of December 31, 2024. However, based on the same assessment, including, predominantly, our being, in a three-year cumulative U.S. income position on a non-GAAP basis, which excludes the impact of our non-GAAP adjustments, we concluded that recording a valuation allowance would not have been appropriate for non-GAAP reporting. As a result, the tax expense for the valuation allowance was added back to our calculation of non-GAAP annual effective tax rate.
** Amounts may not foot due to rounding}

ICU MEDICAL, INC. AND SUBSIDIARIES
Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited)(continued)
(In thousands, except percentages)

_____________________________________________

⁽¹⁾ We manufacture certain products or product components in accordance with manufacturing services agreements. We do not include the contract revenue in our adjusted revenue as the commercial relationship under these types of agreements are originally negotiated contemporaneously with a business combination or other transactions and are not indicative of normal market transactions.
⁽²⁾ For businesses divested in the current period, non-GAAP organic revenue growth excludes prior period revenue associated with the divested business for the same length of time they were not owned by the company in the current year. The divested business prior period revenue in this line item does not include MSA revenue, which is excluded on a separate line.
⁽³⁾ We exclude the impact of foreign exchange rate changes to show a constant currency comparison of our underlying business performance.

ICU MEDICAL, INC. AND SUBSIDIARIES
Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited)(continued)
(In thousands)

ICU MEDICAL, INC. AND SUBSIDIARIES
Fiscal Year 2026
Outlook (Unaudited)
(In millions, except per share data)

CONTACT:
ICU Medical, Inc.
Brian Bonnell, Chief Financial Officer
(949) 366-2183
     
ICR, Inc.
John Mills, Partner
(646) 277-1254

Nautilus Biotechnology to Participate in the TD Cowen 46th Annual Health Care Conference




Nautilus Biotechnology to Participate in the TD Cowen 46th Annual Health Care Conference

SEATTLE, Feb. 19, 2026 (GLOBE NEWSWIRE) — Nautilus Biotechnology, Inc. (NASDAQ: NAUT; or “Nautilus”), a company pioneering a single-molecule protein analysis platform, today announced the company will be participating in the TD Cowen 46^th Annual Health Care Conference.

Nautilus’ management is scheduled to participate in a fireside chat on Monday, March 2, 2026, at 10:30 a.m. Eastern Time. Interested parties may access a live and archived webcast of the presentation on the “Investors” section of the company website at: www.nautilus.bio.

About Nautilus Biotechnology, Inc.
With its corporate headquarters in Seattle, Washington and its research and development headquarters in San Carlos, California, Nautilus is a development stage life sciences company working to create a platform technology for quantifying and unlocking the complexity of the proteome. Nautilus’ mission is to transform the field of proteomics by democratizing access to the proteome and enabling fundamental advancements across human health and medicine. To learn more about Nautilus, visit www.nautilus.bio.

Media Contact
press@nautilus.bio

Investor Contact
investorrelations@nautilus.bio

Spyre Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update




Spyre Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update

On track for 6 proof-of-concept readouts in 2026 across the SKYLINE and SKYWAY Phase 2 trials 

Part A readouts from SKYLINE platform trial in ulcerative colitis (“UC”) expected to begin in the second quarter, with enrollment continuing ahead of schedule

Enrollment on track in Phase 2 SKYWAY basket trial evaluating TL1A inhibition in rheumatoid arthritis (“RA”), psoriatic arthritis (“PsA”), and axial spondyloarthritis (“axSpA”), with fourth quarter readouts expected in each sub-study

Strengthened the balance sheet with an underwritten public offering of common stock in October 2025 and announced the appointment of Kate Tansey Chevlen as Chief Commercial Officer (CCO)

$757 million of cash, cash equivalents, and marketable securities as of December 31, 2025, with expected runway into the second half of 2028

WALTHAM, Mass., Feb. 19, 2026 (GLOBE NEWSWIRE) — Spyre Therapeutics, Inc. (“Spyre” or the “Company”) (NASDAQ:SYRE), a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases, today announced its fourth quarter and full year 2025 financial results and provided program and corporate updates.

“This year is a pivotal period for Spyre as we begin to unveil results from our two groundbreaking Phase 2 trials with the potential to identify multiple products that leapfrog today’s standard of care and provide substantially improved therapies for patients suffering from severe autoimmune diseases. In IBD, we plan to reveal initial safety and efficacy data for our optimized antibodies against the most compelling targets in the space. If successful, these results would support our view that our antibodies are the ideal components for combination therapies with the potential to transform the treatment paradigm in this disease,” said Cameron Turtle, DPhil, Chief Executive Officer of Spyre. “Beyond IBD, we are moving full speed ahead with a potentially first- and best-in-class anti-TL1A antibody in a basket study of three rheumatic diseases. Numerous sources of evidence support potential efficacy of TL1A inhibition in these indications, and our quarterly or twice-annual subcutaneous dosing profile could be the leading product profile in these large markets. Taken together, we believe our assets, strategy, and execution can deliver meaningful value for patients, physicians, and shareholders alike.”

Development Pipeline Overview and Update

The Company is pioneering long-acting antibodies and antibody combinations to redefine the standard of care in IBD and rheumatic diseases. IBD is a chronic condition characterized by inflammation within the gastrointestinal tract, including two main disorders: ulcerative colitis (“UC”) and Crohn’s disease (“CD”). In the United States, it is estimated that approximately 2.4 million individuals are diagnosed with IBD. RA, PsA, and axSpA are chronic inflammatory autoimmune conditions primarily characterized by pain, stiffness, and swelling of the joints, as well as impacts on the spine and skin. Together, these rheumatic conditions affect more than three million individuals in the U.S. Existing therapies for these diseases today generally offer incomplete efficacy, meaningful safety warnings, and inconvenient dosing profiles.

Each of the Company’s monotherapy programs in IBD target validated mechanisms with the potential for safe and effective treatment of UC and CD with infrequent dosing as a monotherapy or in rational combinations. The Company is also studying its anti-TL1A program as a monotherapy in indications outside IBD, including RA, PsA, and axSpA.

The Company has two ongoing Phase 2 clinical trials with proof-of-concept data readouts beginning in 2026:

SKYLINE Phase 2 Platform Trial in IBD – in May 2025, the Company initiated a Phase 2 induction and maintenance platform trial of SPY001, SPY002, SPY003, as well as pairwise combinations thereof (six investigational agents in total) in patients with moderately to severely active UC. The trial consists of two parts:

• Part A: Open-label assessment of the safety and preliminary efficacy of a single dose level of each investigational monotherapy, with induction data expected beginning in the second quarter of 2026.
• Part B: Randomized and placebo-controlled assessment of the safety and efficacy of investigational monotherapies (two dose levels) and combinations, with induction data expected in 2027.

SKYLINE is currently enrolling subjects into Part A of the trial, with Part B expected to begin enrolling after all arms in Part A complete enrollment.

SKYWAY Phase 2 Basket Trial in Rheumatic Diseases (RA, PsA, axSpA) – in September 2025, the Company initiated a Phase 2 randomized and placebo-controlled basket trial of SPY072 in patients with moderately to severely active RA, PsA, or axSpA. The trial consists of three sub-studies, each expected to provide proof-of-concept data in the fourth quarter of 2026:

• RA sub-study: Double-blind, placebo-controlled safety and efficacy study of two dose levels of SPY072 at Week 12.
• PsA sub-study: Double-blind, placebo-controlled safety and efficacy study of a single dose level of SPY072 at Week 16.
• axSpA sub-study: Double-blind, placebo-controlled safety and efficacy study of a single dose level of SPY072 at Week 16.

The investigational therapies being studied in the SKYLINE and SKYWAY clinical trials include:

SPY001 – a highly potent and selective investigational monoclonal antibody targeting α4β7, engineered with half-life extension technology and formulated at high concentration with the goal of maximizing efficacy and enabling infrequent, subcutaneous maintenance dosing.

• In May 2025, extended follow up data were presented at Digestive Disease Week (“DDW”) 2025 from the Phase 1 healthy volunteer trial, demonstrating a favorable safety profile across all dose groups, a meaningfully differentiated pharmacokinetic (“PK”) profile supporting potential Q3M or Q6M maintenance dosing, and rapid and complete saturation of α4β7 receptors beyond six months with a single dose of 600mg.
• Based on these interim results, SPY001 was advanced into the SKYLINE Phase 2 platform trial.

SPY002 and SPY072 – two highly potent and selective, investigational anti-TL1A monoclonal antibodies, engineered with half-life extension technology and formulated at high concentration with the goal of maximizing efficacy and enabling infrequent, subcutaneous maintenance dosing. The Company believes TL1A has emerged as one of the most promising targets in IBD and broader immunology indications. SPY002 is being evaluated for the treatment of IBD in the SKYLINE study and SPY072 is being evaluated for the treatment of rheumatic diseases in the SKYWAY study.

• In June 2025, interim healthy volunteer data from two Phase 1 trials (one for SPY002 and one for SPY072) were presented, demonstrating favorable safety profiles, meaningfully differentiated PK profiles supporting potential Q3M or Q6M maintenance dosing, and complete suppression of free TL1A through up to 20 weeks at single 100mg doses. Longer-term data from these Phase 1 trials were presented at medical meetings in late 2025, providing further support for these potential best-in-class profiles.
• Based on these interim results, SPY002 was advanced to the SKYLINE Phase 2 platform trial, and SPY072 was advanced to the SKYWAY Phase 2 basket trial.

SPY003 – a highly potent and selective investigational monoclonal antibody targeting the p19 subunit of IL-23, engineered with half-life extension technology and formulated at high concentration with the goal of maximizing efficacy and enabling infrequent, subcutaneous maintenance dosing.

• In November 2025, interim healthy volunteer data from a Phase 1 trial were disclosed, demonstrating that SPY003 exhibited a favorable safety profile and a meaningfully differentiated PK profile supporting potential Q3M or Q6M maintenance dosing. Additional data from this Phase 1 trial were presented at the 21st Congress of the European Crohn’s and Colitis Organisation (“ECCO”) in February 2026, providing further support for this potential best-in-class profile.
• Based on these interim results, SPY003 was advanced to the SKYLINE Phase 2 platform trial.

Rational Combinations – the Company plans to investigate combinations of our proprietary antibodies in nonclinical studies and clinical trials in order to evaluate whether combinations can potentially lead to best-in-class efficacy in IBD, with less frequent dosing.

• In February and May 2025, preclinical data for SPY120 were presented at medical meetings, demonstrating that the combined inhibition of TL1A and α4β7 is superior to either monotherapy in mouse models of colitis and that the PK profiles of SPY001 and SPY002 were similar in non-human primates whether dosed as monotherapy or in combination, while also demonstrating no drug effects on PK.
• Preclinical data for SPY130 and SPY230 have demonstrated enhanced efficacy and pharmacodynamics with SPY003 in combination with SPY001 and with SPY002.
• The Company expects to include each of its rational combinations in Part B of the SKYLINE trial.

Fourth Quarter 2025 Financial Results        

Cash Position: As of December 31, 2025, Spyre had cash, cash equivalents, and marketable securities of $756.5 million. In October 2025, the Company raised $316.2 million in gross proceeds, before deducting $19.8 million in underwriting discounts and other offering expenses, from a public offering of common stock. Net cash used in operating activities was $44.6 million for the fourth quarter of 2025.

Research and Development (R&D) expenses: R&D expenses totaled $44.6 million for the fourth quarter of 2025 and $50.5 million for the fourth quarter of 2024. The decrease was primarily driven by lower early-stage R&D activities, partially offset by higher clinical trial expenses.

General and Administrative (G&A) expenses: G&A expenses totaled $12.5 million for the fourth quarter of 2025 and $10.8 million for the fourth quarter of 2024. The increase was primarily driven by higher headcount.

Total Other Expense (Income): For the fourth quarter of 2025, other expense totaled $5.4 million primarily driven by changes in the fair value of the contingent value right (CVR) liability, partially offset by interest earned on the Company’s cash and marketable securities. For the fourth quarter of 2024, other income totaled $5.0 million primarily driven by interest earned on the Company’s cash and marketable securities.

Net Loss: Net loss totaled $62.5 million and $56.3 million for the fourth quarters of 2025 and 2024, respectively.

About Spyre Therapeutics
Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases (“RD”). Spyre’s pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.

For more information, please visit http://spyre.com. 

Safe Harbor / Forward Looking Statements
Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding: the Company’s future results of operations and financial position; its business strategy, including the Company’s ability to deliver meaningful value for patients, physicians and shareholders through its assets, strategy and execution, including its ability to successfully develop best-in-class therapeutics for IBD or RD that meaningfully improve both efficacy and convenience compared to today’s standard of care and the Company’s ability to develop first-in-class therapeutics for RD; the potential consistency of the SPY001, SPY002, SPY072 and SPY003 Phase 1 trial final data readouts with previously disclosed data for our programs; the sufficiency of the Company’s funding to support the development of its assets, including expectations of cash runway extending into the second half of 2028; the length of time that the Company believes its existing cash resources will fund its operations; estimated market sizes and potential growth opportunities; its nonclinical and future clinical development activities, including the expected timing and results of the ongoing SKYWAY Phase 2 basket trial and SKYLINE phase 2 platform trial, including timing of cohort initiation and data readouts for the ongoing SKYWAY Phase 2 basket trial and SKYLINE Phase 2 platform trial, enrollment of clinical trials, the inclusion of each rational combination in Part B of the SKYLINE Phase 2 platform trial and the number of data readouts expected to be delivered in 2026 and 2027, and related regulatory feedback; the potential efficacy, tolerability, convenience, commercial viability and safety profile of its product candidates, including in combinations; the potential viability of the Company’s antibodies as ideal components for combination therapies; the planned dosing regimen for SPY001, SPY002, SPY072 and SPY003, including the potential for a Q3M or Q6M dosing profile and the potential for such dosing profile to be the leading product profile in IBD and RD; the potential therapeutic benefits and economic value of its product candidates as monotherapies or in combinations and their extended half-life; and Spyre’s business plans, milestones, and goals. The words “opportunity,” “potential,” “milestones,” “pipeline,” “strategy,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “might,” “plan,” “possible,” “predict,” “should,” “will,” “would,” and similar expressions (including the negatives of these terms) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs and involve a number of risks and uncertainties, many of which are beyond Spyre’s control, and other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited, uncertainties and risks arising from regulatory feedback, including potential disagreement by regulatory authorities with the Company’s interpretation of data and the Company’s clinical trials for its product candidates; the potential for interim data not being delivered within expected time frames or final data not being consistent with or different than the interim data reported for our programs; the potential impact of Trump Administration policies and changes in law on our business; and those uncertainties and factors described in Spyre’s most recent Annual Report on Form 10-K, as supplemented and updated by subsequent Quarterly Reports on Form 10-Q and any other filings that Spyre has made or may make with the SEC from time to time. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Spyre does not undertake or accept any duty to make any updates or revisions to any forward-looking statements.

Contact Information:

Media Contact
Josie Butler, 1AB
josie@1abmedia.com 

Investor Contact
Eric McIntyre
eric.mcintyre@spyre.com 

⁽¹⁾   Includes $1.0 million and $5.8 million in related party expenses for the three months ended December 31, 2025 and 2024, respectively. Includes $10.5 million and $40.1 million in related party expenses for the years ended December 31, 2025 and 2024, respectively.

⁽²⁾   Includes $0.2 million and $0.3 million in related party expenses for the three months ended December 31, 2025 and 2024, respectively. Includes $1.0 million and $1.1 million in related party expenses for the years ended December 31, 2025 and 2024, respectively.

Galapagos Welcomes Dr. Paulo Fontoura to its Board of Directors  




Galapagos Welcomes Dr. Paulo Fontoura to its Board of Directors  

Dr. Fontoura brings extensive global leadership, clinical development, and operational experience to the Board

Mechelen, Belgium; February 19, 2026, 22:01 CET — Galapagos NV (Euronext & NASDAQ: GLPG), today announced the appointment by way of co-optation of Dr. Paulo Fontoura as Non-Executive Independent Director to its Board of Directors, effective February 9, 2026.

“We are pleased to welcome Paulo to our Board,” said Jérôme Contamine, Chair of the Board of Galapagos. “His global leadership experience, deep understanding of clinical development strategy, and proven track record of assessing and advancing differentiated assets will strengthen the Board’s ability to provide strategic guidance as the Company evaluates transformative business development opportunities.” Dr. Paulo Fontoura replaces Dr. Susanne Schaffert, who stepped down from the Board effective November 1, 2025, as previously announced in the press release dated October 30, 2025.

“Galapagos is entering its next phase with a clear strategic focus and commitment to disciplined growth,” said Henry Gosebruch, CEO of Galapagos. “I look forward to continuing to work alongside our accomplished Board and senior leadership team and to welcoming Paulo as we execute our strategy to advance innovative medicines for patients and deliver long-term value for shareholders.”

Biography
Dr. Paulo Fontoura brings 20 years of pharmaceutical industry experience, with deep expertise in neurology, immunology, ophthalmology, and rare diseases. He currently serves as Chief Medical Officer at Xaira. Before joining Xaira, Dr. Fontoura was SVP and Global Head at Roche, where he led clinical development across neuroscience, immunology, ophthalmology, and rare diseases, contributed to the launch of multiple breakthrough therapies, and pioneered digital health approaches, such as smartphone‑based clinical endpoints. He previously held academic roles at the New University of Lisbon, where he earned his MD and PhD in Neuroimmunology. Dr. Fontoura also completed a postdoctoral fellowship at Stanford University, is a Fellow of the American Academy of Neurology, and continues to teach as a visiting professor in Lisbon and as a lecturer in Basel.

For further information, contact Galapagos:
Investor Relations
Glenn Schulman

+1 412 522 6239
ir@glpg.com

Media
Media
Katie Morris
+1 952 288 6821
katiemorris@ententeinc.com

Visit us at www.glpg.com or follow us on LinkedIn or X.

Forward-looking statements
This press release may include forward-looking statements, all of which involve certain risks and uncertainties. These statements are often, but not always, made through the use of words or phrases such as “will,” “long-term,” and “forward,” and any similar expressions. These statements include, but are not limited to, statements regarding the appointment by way of co-optation of a new director, our business development and associated transformative opportunities, the expected benefits associated with the changes to our Board, the Board’s ability to provide strategic guidance, the advancement of our innovative medicines for patients, and our ability to deliver long-term value for shareholders. Any forward-looking statements in this press release are based on our management’s current expectations and beliefs and are not guarantees of future performance. Forward-looking statements may involve unknown and known risks, uncertainties, and other factors which might cause our actual results, performance, or achievements to be materially different from any historic or future results, performance, or achievements expressed or implied by such statements. These risks, uncertainties, and other factors include, without limitation, the risk that we may not be able to realize the expected benefits from the appointment of the new director. A further list and description of these risks, uncertainties, and other factors can be found in our filings and reports with the Securities and Exchange Commission (SEC), including in our most recent annual report on Form 20‐F filed with the SEC, as supplemented and/or modified by any other filings and reports that we have made or will make with the SEC in the future. Given these risks and uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. In addition, even if our results, performance, or achievements are consistent with such forward-looking statements, they may not be predictive of results, performance, or achievements in future periods. These forward-looking statements speak only as of the date of publication of this press release. We expressly disclaim any obligation to update any forward-looking statements in this press release, unless required by law or regulation.

Attachment

• Galapagos Welcomes Dr. Paulo Fontoura to its Board of Directors

Kiniksa Pharmaceuticals to Report Fourth Quarter and Full Year 2025 Financial Results on February 24, 2026




Kiniksa Pharmaceuticals to Report Fourth Quarter and Full Year 2025 Financial Results on February 24, 2026

LONDON, Feb. 19, 2026 (GLOBE NEWSWIRE) — Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) announced today that it will host a conference call and live webcast on Tuesday, February 24, 2026 at 8:30 a.m. Eastern Time to report its fourth quarter and full year 2025 financial results and recent portfolio execution.

A live webcast will be accessible through the Investors & Media section of the company’s website at www.kiniksa.com. Individuals interested in participating in the call via telephone may register here. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the event will also be available on Kiniksa’s website within approximately 48 hours after the event.

About Kiniksa
Kiniksa is a biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating diseases by discovering, acquiring, developing, and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. Kiniksa’s portfolio of assets is based on strong biologic rationale or validated mechanisms and offers the potential for differentiation. For more information, please visit www.kiniksa.com.

Every Second Counts! ^®

Kiniksa Investor & Media Contact
Jonathan Kirshenbaum
(781) 829-3949
jkirshenbaum@kiniksa.com

Ardelyx Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update




Ardelyx Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

IBSRELA revenue grew 73% in 2025 to $274.2 million and total revenues reached $407.3 million

Patient-first XPHOZAH strategy preserved access and drove growth in total dispenses

Development programs for new IBSRELA indication and next-generation NHE3 inhibitor launched

Company is well capitalized to meet current business objectives

Conference call scheduled for 4:30 PM Eastern Time

WALTHAM, Mass., Feb. 19, 2026 (GLOBE NEWSWIRE) — Ardelyx, Inc. (Nasdaq: ARDX), a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative medicines that meet significant unmet medical needs, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update.

“The results we delivered in 2025 reflect our team’s hard work and disciplined execution to bring our medicines to more patients in need, underscored by significant IBSRELA growth, increased adoption of XPHOZAH and rapid advancement of our clinical development programs,” said Mike Raab, president and chief executive officer of Ardelyx. “As we look to build on this strong momentum, we see 2026 as a pivotal opportunity to further evolve our business into a meaningful enterprise built on a broad, thoughtful portfolio of best-in-class medicines. Our long-term strategy remains clear and unwavering: to deliver novel therapies to patients with significant unmet medical needs and generate sustained value for shareholders.”

IBSRELA^® (tenapanor) finishes 2025 with $274.2 million in revenue
Revenue for IBSRELA in 2025 was $274.2 million reflecting 73% growth compared to the $158.3 million reported for the full year 2024. The company recorded $86.6 million in IBSRELA revenue in the fourth quarter of 2025, 61% growth compared to the same period of 2024 and an 11% increase compared to the third quarter of 2025.

Ardelyx expects continued growth in 2026 and beyond, driven by increased depth and breadth of prescribing among target healthcare providers, increased engagement with patients with irritable bowel syndrome with constipation (IBS-C) as well as further improved prescription pull-through. Ardelyx expects full-year 2026 revenue for IBSRELA to be between $410 and $430 million, representing at least 50% growth compared to 2025. As a result of the significant momentum that IBSRELA has generated, the company expects IBSRELA to achieve $1 billion in annual revenue in 2029, with further growth thereafter.

XPHOZAH^® (tenapanor) finishes 2025 with $103.6 million in revenue
Revenue for XPHOZAH in 2025 was $103.6 million reflecting year-over-year growth in total XPHOZAH dispenses, including an increased number of non-Medicare patients on therapy. The company also recorded $27.8 million in revenue in the fourth quarter of 2025.

Ardelyx expects growth in 2026 to be driven by increased clinical conviction and writing among target healthcare prescribers. Ardelyx expects full-year 2026 XPHOZAH revenue to be between $110 and $120 million.

Building a pipeline of important medicines
The company advanced efforts to expand the eligible patient population for IBSRELA to include patients with chronic idiopathic constipation (CIC) and has launched a Phase 3 trial, ACCEL, to assess tenapanor in patients with CIC, dosing the first patient in Q1 2026. Pending the outcome of the Phase 3 trial, Ardelyx intends to submit a Supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) for the CIC indication. Enrollment in ACCEL is expected to be completed by the end of 2026 and topline readout is expected in the second half of 2027.

Ardelyx also launched a development program for RDX10531, a next-generation sodium/hydrogen exchanger 3 (NHE3) inhibitor, in 2025. The company is currently completing pre-clinical development activities in advance of an Investigational New Drug submission to the FDA in the second half of 2026 and initiation of a Phase 1 clinical trial thereafter.

Other Corporate Developments

• United States Patent and Trademark Office issued U.S. Patent No. 12,539,299 titled “Oral Formulations of Tenapanor.” The patent covers the commercial formulations of IBSRELA and XPHOZAH and has an expiration date of November 26, 2042. The patent is listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) for both products.
• Four posters were presented at the American Society of Nephrology’s annual Kidney Week, including data from real-world evidence studies demonstrating patient satisfaction and reduction in serum phosphate with XPHOZAH.
• Three posters were presented at the American College of Gastroenterology’s 2025 Annual Meeting supporting the benefits of IBSRELA.

Full Year 2025 Financial Results

• Cash Position: As of December 31, 2025, the company had total cash, cash equivalents and short-term investments of $264.7 million, compared to total cash, cash equivalents and short-term investments of $250.1 million as of December 31, 2024.
• Revenues: Total revenue for the year ended December 31, 2025 was $407.3 million, compared to $333.6 million in total revenue in 2024, driven by increases in IBSRELA revenue.
  • IBSRELA revenue was $274.2 million, compared to $158.3 million in 2024.
  • XPHOZAH revenue was $103.6 million, compared to $160.9 million in 2024.
  • Other revenues, including product supply, licensing and non-cash royalty revenue related to the sale of future royalties, totaled $29.5 million, compared to $14.4 million in 2024.
• R&D Expenses: Research and development expenses were $71.5 million for the year ended December 31, 2025, compared to $52.3 million for the year ended December 31, 2024. The increase was related to investments in recently announced pipeline programs and increased medical engagement with scientific communities.
• SG&A Expenses: Selling, general and administrative expenses were $337.2 million for the year ended December 31, 2025, compared to $258.7 million for the year ended December 31, 2024. The increase was primarily related to increased costs associated with the ongoing commercialization of IBSRELA and XPHOZAH.
• Net Loss: Net loss for the year ended December 31, 2025 was $61.6 million, or $(0.26) per share, compared to net loss of $39.1 million, or $(0.17) per share, for the year ended December 31, 2024. The net loss for the full year 2025 included share-based compensation expense of $49.0 million.

Conference Call Details
The company will host a conference call today, February 19, 2026, at 4:30 PM ET to discuss today’s announcement. To participate in the conference call, please dial (877) 346-6112 (domestic) or (848) 280-6350 (international) and ask to be joined into the Ardelyx call. A live audio webcast and related presentation materials can also be accessed by visiting the Investor page of the company’s website, www.ardelyx.com, and will be available on the website for 30 days following the call.

IMPORTANT SAFETY INFORMATION (IBSRELA)

CONTRAINDICATIONS

• IBSRELA is contraindicated in patients less than 6 years of age due to the risk of serious dehydration.
• IBSRELA is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.

WARNINGS AND PRECAUTIONS
Risk of Serious Dehydration in Pediatric Patients

• IBSRELA is contraindicated in patients below 6 years of age. The safety and effectiveness of IBSRELA in patients less than 18 years of age have not been established. In young juvenile rats (less than 1 week old; approximate human age equivalent of less than 2 years of age), decreased body weight and deaths occurred, presumed to be due to dehydration, following oral administration of tenapanor. There are no data available in older juvenile rats (human age equivalent 2 years to less than 12 years).
• Avoid the use of IBSRELA in patients 6 years to less than 12 years of age. Although there are no data in older juvenile rats, given the deaths in younger rats and the lack of clinical safety and efficacy data in pediatric patients, avoid the use of IBSRELA in patients 6 years to less than 12 years of age.

Diarrhea
Diarrhea was the most common adverse reaction in two randomized, double-blind, placebo-controlled trials of IBS-C. Severe diarrhea was reported in 2.5% of IBSRELA-treated patients. If severe diarrhea occurs, suspend dosing and rehydrate patient.

MOST COMMON ADVERSE REACTIONS
The most common adverse reactions in IBSRELA-treated patients (incidence ≥2% and greater than placebo) were: diarrhea (16% vs 4% placebo), abdominal distension (3% vs <1%), flatulence (3% vs 1%) and dizziness (2% vs <1%).

INDICATION
IBSRELA (tenapanor) is indicated for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adults.

Please see full Prescribing Information, including Boxed Warning, for additional risk information.

IMPORTANT SAFETY INFORMATION (XPHOZAH)

CONTRAINDICATIONS

XPHOZAH is contraindicated in:

• Pediatric patients under 6 years of age
• Patients with known or suspected mechanical gastrointestinal obstruction

WARNINGS AND PRECAUTIONS
Diarrhea
Patients may experience severe diarrhea. Treatment with XPHOZAH should be discontinued in patients who develop severe diarrhea.

MOST COMMON ADVERSE REACTIONS
Diarrhea, which occurred in 43-53% of patients, was the only adverse reaction reported in at least 5% of XPHOZAH-treated patients with CKD on dialysis across trials. The majority of diarrhea events in the XPHOZAH-treated patients were reported to be mild-to-moderate in severity and resolved over time, or with dose reduction. Diarrhea was typically reported soon after initiation but could occur at any time during treatment with XPHOZAH. Severe diarrhea was reported in 5% of XPHOZAH-treated patients in these trials.

INDICATION
XPHOZAH (tenapanor), 30 mg BID, is indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.

For additional safety information, please see full Prescribing Information.

About Ardelyx
Ardelyx is a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA^® (tenapanor) and XPHOZAH^® (tenapanor). The company’s pipeline includes the Phase 3 development of tenapanor for chronic idiopathic constipation, and RDX10531, a next-generation NHE3 inhibitor with potential application across multiple therapeutic areas. Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL^® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. For more information, please visit https://ardelyx.com/ and connect with us on X (formerly known as Twitter), LinkedIn and Facebook.

Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Ardelyx, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor of the Private Securities Reform Act of 1995, including Ardelyx’s current expectations regarding: the year in which IBSRELA will achieve annual U.S. net product sales revenue of $1 billion; the company’s planned label expansion for IBSRELA (tenapanor) to include patients with CIC, pending FDA approval; net product sales revenue for IBSRELA and XPHOZAH for 2026; the company’s ability to deliver sustainable revenue growth, expand its portfolio and deliver meaningful value for shareholders; the timing of the completion of enrollment in the CIC Phase 3 clinical trial and release of topline results; and the timing of an investigational new drug application and initiation of a Phase 1 clinical trial for RDX10531. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control, that could cause actual outcomes or results to differ materially from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties associated with the development of, regulatory process for, and commercialization of drugs in the U.S. and internationally. Ardelyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ardelyx’s business in general, please refer to Ardelyx’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 19, 2026 and its future current and periodic reports to be filed with the Securities and Exchange Commission.

Investor and Media Contact:
Caitlin Lowie
clowie@ardelyx.com

Candel Therapeutics Announces $100M Royalty Funding Agreement with RTW to Support the Potential Launch of Aglatimagene Besadenovec (CAN-2409) in Localized Prostate Cancer




Candel Therapeutics Announces $100M Royalty Funding Agreement with RTW to Support the Potential Launch of Aglatimagene Besadenovec (CAN-2409) in Localized Prostate Cancer

• RTW committed $100M in U.S. launch funding, subject to U.S. Food and Drug Administration (FDA) approval of aglatimagene besadenovec (aglatimagene or CAN-2409) for intermediate- to high-risk localized prostate cancer                   
• Royalties based on annual net sales of aglatimagene in the U.S.
• Funds will strengthen the Company’s balance sheet for potential U.S. commercial launch of aglatimagene in intermediate- to high-risk localized prostate cancer

NEEDHAM, Mass., Feb. 19, 2026 (GLOBE NEWSWIRE) — Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced a $100 million royalty funding agreement with funds managed by RTW Investments, LP (RTW), subject to FDA approval of aglatimagene in intermediate- to high-risk, localized prostate cancer.

“This non-dilutive strategic financing will support the U.S. launch of aglatimagene besadenovec, assuming FDA approval, and will allow us to further invest in what we believe will be a world class commercial program,” said Paul Peter Tak, M.D., Ph.D., FMedSci, President and CEO of Candel. “We remain on track to submit the BLA for aglatimagene in Q4 of this year, and we look forward to collaborating with the FDA to pursue an expeditious approval of aglatimagene. We are thrilled with our RTW partnership, as we seek to provide a new treatment option for patients in the early stages of prostate cancer who are treated with curative intent, a disease that has seen minimal innovation over the past two decades.”

“The pivotal phase 3 clinical trial demonstrated the potential of aglatimagene besadenovec in early, localized prostate cancer, and today’s commitment reflects our confidence in Candel and the strong commercial potential of this therapy,” said Roderick Wong, M.D., Managing Partner and Chief Investment Officer, RTW Investments, LP. “We are proud to partner with the Candel management team and look forward to supporting their efforts to bring this meaningful treatment to patients with localized prostate cancer.”

The commercial launch royalty financing will become available upon FDA’s approval of aglatimagene, and satisfaction of certain other customary conditions. Under the terms of the agreement, RTW will receive a tiered single digit percentage of annual net sales of aglatimagene in the U.S., subject to a cap.

About Candel Therapeutics

Candel is a clinical-stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical-stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. Aglatimagene besadenovec (CAN-2409 or aglatimagene) is the lead product candidate from the adenovirus platform. The Company recently completed successful phase 2a clinical trials of aglatimagene in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), and a pivotal, placebo-controlled, phase 3 clinical trial of aglatimagene in localized prostate cancer, conducted under a Special Protocol Assessment agreed with the U.S. Food and Drug Administration (FDA). The FDA also granted Fast Track Designation and Regenerative Medicine Advanced Therapy Designation to aglatimagene for the treatment of newly diagnosed localized prostate cancer in patients with intermediate-to-high-risk disease, Fast Track Designation in NSCLC, and both Fast Track Designation and Orphan Drug Designation to aglatimagene for the treatment of PDAC.

Linoserpaturev (CAN-3110) is the lead product candidate from the HSV platform and is currently in an ongoing phase 1b clinical trial in recurrent high-grade glioma, evaluating the effects of repeat linoserpaturev injections. Initial results were published in Nature and Science Translational Medicine and linoserpaturev received Fast Track Designation and Orphan Drug Designation from the FDA. Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors.

For more information about Candel, visit: www.candeltx.com

Forward-Looking Statements

Various statements in this release concerning the timing, size, structure and completion of the proposed public offering on the anticipated terms or at all may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995, as amended, and other federal securities laws. All such forward-looking statements are based on management’s current expectations of future events and are subject to a number of substantial risks and uncertainties, many of which are outside Candel’s control, that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include fluctuations in Candel’s stock price, changes in market conditions, the final terms of the public offering and satisfaction of customary closing conditions related to the public offering, as well as those risks more fully discussed in the section entitled “Risk Factors” in the prospectus supplement and registration statement referenced above, Candel’s Annual Report on Form 10-K for the year ended December 31, 2024, filed on March 13, 2025 with the SEC and subsequent filings with the SEC including Candel’s Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. There can be no assurance that Candel will be able to complete the public offering on the anticipated terms. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and Candel undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, unless required by law.

Investor Contact
Theodore Jenkins
Vice President, Investor Relations and Business Development
Candel Therapeutics, Inc.
tjenkins@candeltx.com

Media Contact
Ben Shannon
ICR Healthcare
CandelPR@icrhealthcare.com

Cosmos Health Highlights Approximately $15 Million Fair Market Value of Real Estate Assets, Exceeding Current Market Capitalization; Evaluates Monetization Options to Address Significant Discount to Book Value




Cosmos Health Highlights Approximately $15 Million Fair Market Value of Real Estate Assets, Exceeding Current Market Capitalization; Evaluates Monetization Options to Address Significant Discount to Book Value

CHICAGO, Feb. 19, 2026 (GLOBE NEWSWIRE) — Cosmos Health Inc. (“Cosmos Health” or the “Company”) (NASDAQ:COSM), a diversified, vertically integrated global healthcare group, today highlighted the intrinsic value of its wholly owned real estate portfolio and announced that it is evaluating strategic monetization options to unlock shareholder value.

Based on independent valuation reports, recent market data, and comparable transactions, management estimates the combined fair market value of the Company’s Cana Laboratories (“Cana”) manufacturing facility and CosmoFarm logistics center at approximately $15 million. This estimate reflects the value of the land and buildings only and excludes the value of machinery and equipment housed within the facilities.

The estimated value reflects favourable macro conditions in the Greek property market. According to Bank of Greece data, residential property prices in Greece have surpassed their 2008 pre-financial crisis peak and reached record highs. Commercial real estate, including office, retail, and logistics segments, has also experienced sustained pricing and rental growth in key urban centers, particularly in Athens.

The estimated fair market value of the Company’s real estate assets exceeds the Company’s current market capitalization, which stood at approximately $13.5 million as of the close of trading on February 17, 2026.

Cana Laboratories – Neo Iraklio, Athens

The Cana property comprises a land plot of approximately 54,000 square feet and a total constructed building area of approximately 35,700 square feet. Based on the applicable building coefficient, the site allows for additional buildable capacity, subject to zoning and regulatory approvals. The property is wholly owned by the Company and is free of any mortgage or other encumbrances.

It is strategically located in Neo Iraklio, a well-established northern suburb of Athens with strong residential density and developed commercial activity. The property offers direct access to Attiki Odos, one of the primary highway arteries serving the greater Athens metropolitan area, and is within a short drive of Athens International Airport, central Athens, and surrounding business districts. It is also located just minutes from The Mall Athens, one of the largest enclosed shopping malls in Greece. Beyond its current pharmaceutical manufacturing and research and development use, the property’s location supports meaningful alternative use potential.

CosmoFarm Logistics Center – Peristeri, Athens

The CosmoFarm facility is wholly owned by the Company, consists of approximately 29,100 square feet, and is located in Peristeri, a densely populated municipality in western Athens with strong infrastructure and transport connectivity. The property currently operates as a pharmaceutical wholesale and distribution hub for Cosmos Health’s logistics subsidiary, CosmoFarm, and incorporates advanced automation and robotic systems supporting inventory management and order execution.

Strategic Optionality
At the current trading levels, the Company’s market capitalization reflects a significant discount to its reported book value (stockholders’ equity) of $23.1 million as of Q3 2025. In this context, the estimated value of the Company’s real estate portfolio represents capital that is substantial relative to its public equity value. Monetization, if pursued at or near estimated fair market value, could generate proceeds comparable to, or exceeding, the Company’s current public float.

Potential alternatives under consideration may include an outright sale, joint venture structures, sale leaseback transactions, or other strategic arrangements, subject to market conditions. Proceeds, if realized, may be used for debt reduction, reinvestment into core growth initiatives, acquisitions, or shareholder value-enhancing actions.

Greg Siokas, CEO of Cosmos Health, stated: “We believe there is a meaningful disconnect between our current valuation and the intrinsic value of our assets, with our real estate assets alone worth more than our entire market capitalization. These strategically located properties provide meaningful financial optionality. As a diversified, vertically integrated pharmaceutical company, we have a clear mission in the healthcare space. If monetizing non-core real estate assets can unlock substantial value, we will evaluate such opportunities carefully and decisively, and act accordingly.”

About Cosmos Health Inc.

Cosmos Health Inc. (Nasdaq:COSM), incorporated in 2009 in Nevada, is a diversified, vertically integrated global healthcare group. The Company owns a portfolio of proprietary pharmaceutical and nutraceutical brands, including Sky Premium Life®, Mediterranation®, bio-bebe®, C-Sept® and C-Scrub®. Through its subsidiary Cana Laboratories S.A., licensed under European Good Manufacturing Practices (GMP) and certified by the European Medicines Agency (EMA), it manufactures pharmaceuticals, food supplements, cosmetics, biocides, and medical devices within the European Union. Cosmos Health also distributes a broad line of pharmaceuticals and parapharmaceuticals, including branded generics and OTC medications, to retail pharmacies and wholesale distributors through its subsidiaries in Greece and the UK. Furthermore, the Company has established R&D partnerships targeting major health disorders such as obesity, diabetes, and cancer, enhanced by artificial intelligence drug repurposing technologies, and focuses on the R&D of novel patented nutraceuticals, specialized root extracts, proprietary complex generics, and innovative OTC products. Cosmos Health has also entered the telehealth space through the acquisition of ZipDoctor, Inc., based in Texas, USA. With a global distribution platform, the Company is currently expanding throughout Europe, Asia, and North America, and has offices and distribution centers in Thessaloniki and Athens, Greece, and in Harlow, UK. More information is available at www.cosmoshealthinc.com, www.skypremiumlife.com, www.cana.gr, www.zipdoctor.co, www.cloudscreen.gr, as well as LinkedIn and X.

Forward-Looking Statements
With the exception of the historical information contained in this news release, the matters described herein may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Words such as “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans,” and similar expressions, or future or conditional verbs such as “will,” “should,” “would,” “may,” and “could,” generally identify forward-looking statements, although not all forward-looking statements contain these words. These statements involve risks and uncertainties that may individually or materially affect the matters discussed herein for a variety of reasons outside the Company’s control, including, but not limited to: the Company’s ability to raise sufficient financing to implement its business plan; the effectiveness of its digital asset strategies, including accumulation and yield-generating activities; the impact of the war in Ukraine on the Company’s business, operations, and the economy in general; and the Company’s ability to successfully develop and commercialize its proprietary products and technologies. Readers are cautioned not to place undue reliance on these forward-looking statements, as actual results could differ materially from those anticipated. Readers are encouraged to review the risk factors set forth in the Company’s filings with the SEC, which are available at the SEC’s website (www.sec.gov). The Company disclaims any obligation to update or revise forward-looking statements, whether as a result of any new information, future events, or otherwise.

Investor Relations Contact:
BDG Communications
cosm@bdgcommunications.com 

Photos accompanying this announcement are available at:
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Aaptiv Launches New MSK App in Partnership With movr




Aaptiv Launches New MSK App in Partnership With movr

Movement Health Solution Provides Clinical-Grade Care for Musculoskeletal Pain and Recovery

CARLSBAD, Calif., Feb. 19, 2026 (GLOBE NEWSWIRE) — Aaptiv, a leading fitness and wellness platform for employers, today announced the national launch of AaptivMSK, a new musculoskeletal (MSK) health app offered in partnership with movr, delivering personalized, mobility-focused movement programs for employees.

Available through an easy-to-use app, AaptivMSK provides targeted care plans for employees experiencing, or at risk of developing, MSK issues, the number one driver of employer medical claims. Common MSK problems, such as back, neck, and shoulder pain frequently limit mobility and significantly affect employee performance and well-being.

Shift Toward Better Movement Health

“MSK pain is a common and expensive problem for employers and health plans,” said Roy Simmons, President of Aaptiv. “Movement health is the answer. It’s not just about exercising more; it’s about improving mobility, stability, strength, and balance so individuals can move and function better in daily life, with less pain and lower risk of injury.”

Simmons added, “When people can’t move comfortably, or they’re in pain, everything suffers— productivity, absenteeism, and healthcare costs. By partnering with movr, we’re bringing clinical-grade MSK care into an accessible platform that helps employees move better, feel better, and stay more active for the long term.”

A Continuum of Support: From Prevention to Recovery

With the addition of AaptivMSK, the Aaptiv platform integrates physical fitness, wellness, and targeted MSK support into a single, user-friendly experience powered by PEAR Health Labs technology. With mobility-focused programs designed for busy schedules, employees can improve MSK function in as little as five minutes a day.

Highlights include:

• Self-guided movement assessments to identify risk areas before pain escalates
• Clinically validated programming that improves range of motion and functional stability
• Personalized care plans that address specific areas like lower back, neck or shoulders, and adapt based on user feedback to ensure appropriate intensity and progression over time
• Easy integration with existing wellness programs, with measurable ROI through reduced claims and improved engagement metrics

movr: Movement Science for Everyday Fitness

“Organizations are demanding preventive MSK care that actually prevents the need for reactive and costly treatment,” said Aaron de Jong, Co-Founder of movr. “We trained and refined our MSK prescription algorithm on over 100,000 people to identify the best corrective care path to improve the issues that affect nearly half the population, so problems can be addressed earlier, before they escalate.”

De Jong added, “When mobility is integrated into everyday fitness, employers can reduce preventable MSK issues, missed workdays, and the need for more expensive care down the road.”

About Aaptiv

Aaptiv is a leading provider of digital fitness and wellness solutions for employers, health plans, and organizations nationwide. The Aaptiv platform offers guided workouts, mobility and mindfulness programs, access to the industry’s largest gym network, and clinical-grade MSK care through AaptivMSK. These solutions help organizations improve health outcomes, reduce costs, and support a healthier, more resilient workforce. For more information, visit Aaptiv.com

CONTACT: Press@aaptiv.com