Celcuity To Participate in Upcoming Investor Conferences




Celcuity To Participate in Upcoming Investor Conferences

MINNEAPOLIS, Feb. 25, 2026 (GLOBE NEWSWIRE) — Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that Brian Sullivan, Chief Executive Officer, and Co-founder of Celcuity, will present and be available for one-on-one investor meetings at the following investor conferences:

• A fireside chat at the TD Cowen 46^th Annual Healthcare Conference at 10:30 a.m. ET on Wednesday, March 4, 2026. A live webcast will be available using this weblink: https://event.summitcast.com/view/9z5g2VrV6e6rbCqQgDRoHA/NYER3h287L9qyxak8BZiq2
• A fireside chat at the Leerink Global Healthcare Conference at 2:20 p.m. ET on Tuesday, March 10, 2026. A live webcast will be available using this weblink: https://event.summitcast.com/view/mT9poctHDNthc6b89WqVjf/VziaefXK3xAkvtByRaxLpT

• Jefferies Biotech on the Beach Summit; Wednesday, March 11, 2026. Management will host one-on-one investor meetings only.

Alternatively, the live webcasts will be accessible from the Investors section of the company’s website at https://ir.celcuity.com/events-presentations/ with a replay available shortly after the live events.

About Celcuity

Celcuity is a clinical-stage biotechnology company pursuing the development of targeted therapies for the treatment of multiple solid tumor indications. The company’s lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PI3K/AKT/mTOR (“PAM”) pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT, or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant, with or without palbociclib, in patients with HR+/HER2- advanced breast cancer (“ABC”), has completed enrollment, and the company has reported detailed results for the PIK3CA wild-type cohort. A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- ABC, is ongoing. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing. More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com. Follow us on LinkedIn and X.

Contacts: 

Celcuity Inc. 
Brian Sullivan, bsullivan@celcuity.com
Vicky Hahne, vhahne@celcuity.com  
(763) 392-0123  
Jodi Sievers, jsievers@celcuity.com
(415) 494-9924

MIMEDX Announces Record Fourth Quarter and Full Year 2025 Operating and Financial Results




MIMEDX Announces Record Fourth Quarter and Full Year 2025 Operating and Financial Results

Net Sales Grew 27% Year-Over-Year for the Fourth Quarter and 20% for the Full Year

Fourth Quarter GAAP Net Income and Earnings Per Share were $15 million and $0.10, Respectively

Fourth Quarter Adjusted EBITDA¹ was $29 Million, or 25% of Net Sales

Company Estimates 2026 Net Sales in a Range of $340-360 Million

Announces $100 Million Share Repurchase Program Authorization

Management to Host Conference Call Today, February 25, 2026, at 4:30 PM ET

MARIETTA, Ga., Feb. 25, 2026 (GLOBE NEWSWIRE) — MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”), today announced operating and financial results for the fourth quarter and full year 2025.

Joseph H. Capper, MIMEDX Chief Executive Officer, commented, “MIMEDX delivered a record year of revenue and profitability in 2025, with fourth quarter results that included net sales growth of 27% year-over-year, net income of $15 million, an Adjusted EBITDA margin of 25% of net sales, and robust free cash flow. These results were driven by strong double-digit contributions in both Wound and Surgical, which grew 28% and 25%, respectively, reflecting exceptional commercial execution across the markets we serve. We were particularly pleased with the durable double-digit growth seen in Surgical, and we are keenly focused on the untapped clinical opportunities for our current and future products.”

Mr. Capper continued, “Looking ahead to 2026, the Company remains committed to providing a best-in-class portfolio of evidence-based, differentiated products to capitalize on the many opportunities in front of us. With the recent product additions to our Wound and Surgical offerings, I am as confident as ever in our ability to make significant headway this year in a variety of clinical settings.”

“The short-term disruptions caused by Medicare reimbursement changes in the Wound market will likely have an impact on our 2026 revenue. Once demand patterns normalize, we expect to gain significant volume over time. Meanwhile, we believe the clear momentum we have across the rest of our business — Surgical, international and Wound commercial pay — will provide continued profitability and cash flow. Thus, enabling us to maintain our leadership position over both the short- and long-term,” concluded Mr. Capper.

____________________
¹ Adjusted EBITDA is a Non-GAAP Measure. This press release contains this and other Non-GAAP measures. For reconciliations of our Non-GAAP measures to their nearest GAAP measure, refer to the section titled “Reconciliation of Non-GAAP Measures” below.

Fourth Quarter and Full Year 2025 Results Discussion

Net Sales

MIMEDX reported net sales for the three months ended December 31, 2025 of $118 million, compared to $93 million for the three months ended December 31, 2024, an increase of 27%. The increase was driven by Wound product sales growth of 28%, which reflected the introduction of EPIXPRESS^® as well as the contribution from EMERGE™ during the quarter. Additionally, fourth quarter Surgical sales grew 25% and represented the sixth consecutive quarter of sequential sales growth for this product category, led by sustained momentum for AMNIOFIX^® and AMNIOEFFECT^® as well as another strong performance for the Company’s particulate portfolio.

For the full year 2025 MIMEDX reported net sales of $419 million, compared to $349 million in the prior year period, reflecting growth of 20%. On a full year basis, Wound growth of 20% was led by sales of new products, including CELERA™, EMERGE, and EPIXPRESS, which more than offset pressure from lower-priced products. Also in 2025, Surgical net sales rose 21% compared to the prior year period, with strong contributions from AMNIOFIX, AMNIOEFFECT and HELIOGEN^®.

Gross Profit and Margin

Gross profit for the three months ended December 31, 2025, was $99 million, an increase of $23 million as compared to the prior year period. Gross margin for the three months ended December 31, 2025 was 84%, compared to 82% in the prior year period. The increase was driven by favorable product mix. On an adjusted basis, fourth quarter 2025 gross margin was 86%, which reflects a roughly flat adjusted gross margin compared to the prior year period.

For the full year 2025, gross profit was $346 million, reflecting an increase of $57 million compared to the prior year period. Additionally, gross margin for the full year 2025 was 83%, flat compared to the full year 2024. On an adjusted basis, gross margin for the full year 2025 was 86% compared to 84% for the full year 2024.

Operating Expenses

Selling, general and administrative (“SG&A”) expenses for the three months ended December 31, 2025, were $73 million compared to $61 million for the three months ended December 31, 2024. For the full year 2025, SG&A expenses totaled $266 million, compared to $225 million for the prior period, reflecting a year over year increase of 18%. For both the fourth quarter and full year 2025, the year-over-year increase in SG&A was driven primarily by higher commissions.

Research and development (“R&D”) expenses for the three months ended December 31, 2025, were $5 million compared to $4 million for the three months ended December 31, 2024. For the full year 2025, research and development expenses totaled $15 million, compared to $12 million for 2024. R&D spend in the quarter and year was driven, in part, by the randomized controlled trial for EPIEFFECT and ongoing investments in the development of future products in our pipeline.

Net income for the three months and full year ended December 31, 2025 was $15 million and $49 million, respectively, compared to a net income of $7 million and $42 million for the three months and full year ended December 31, 2024, respectively.

Cash and Cash Equivalents

As of December 31, 2025, the Company had $166 million of cash and cash equivalents compared to $104 million as of December 31, 2024 and $142 million as of September 30, 2025. As of December 31, 2025, our cash position, net of debt on our balance sheet, was $148 million, representing a sequential increase of $24 million and an increase of $63 million for the year.

Share Repurchase Authorization Announced

Also today, the MIMEDX Board of Directors has authorized a share repurchase program of up to $100 million of the Company’s common stock over a two-year period.   The share repurchase program provides MIMEDX with the flexibility to purchase shares of its common stock in the open market or in privately negotiated transactions, subject to market conditions and other factors.

MIMEDX intends to use the repurchase program periodically on a discretionary basis, subject to general business and market conditions and balanced against other investment opportunities. The repurchase program may be commenced, suspended or discontinued at any time.

MIMEDX remains focused on executing its strategic priorities and its decision to establish this repurchase program reflects its balanced approach to capital allocation.  

Financial Outlook

For 2026, MIMEDX currently estimates net sales to be in a range of $340 to $360 million and for adjusted EBITDA margin to be in the mid-to-high teens.

Longer-term, the Company continues to expect to achieve annual net sales growth in the low double-digits as a percentage with an Adjusted EBITDA margin above 20%.

Conference Call and Webcast

MIMEDX will host a conference call and webcast to review its fourth quarter and full year 2025 results on Wednesday, February 25, 2026, beginning at 4:30 p.m., Eastern Time. The call can be accessed using the following information:

Webcast: Click here
U.S. Investors: 877-407-6184
International Investors: 201-389-0877
Conference ID: 13758446

A replay of the webcast will be available for approximately 30 days on the Company’s website at www.mimedx.com following the conclusion of the event.

Important Cautionary Statement

This press release and our investor conference call include forward-looking statements, which reflect management’s current beliefs and expectations regarding future events and operating performance and speak only as of the date hereof. These forward-looking statements are not guarantees of future performance and involve a number of risks and uncertainties. These statements include statements regarding: (i) future sales, sales growth, and Adjusted EBITDA margin; (ii) our longer term financial goals and expectations for future financial results, including levels of net sales, Adjusted EBITDA, and Adjusted EBITDA margin; (iii) our expectations regarding the size of the market for our products;(iv) our expectations regarding the impact of CMS’ updated 2026 Medicare reimbursement rules and model and our belief that Medicare is likely to introduce national coverage policy, given the withdrawal of the LCDs; (v) continued growth in different care settings and different products, specifically accounting for the change caused by CMS’ updated 2026 reimbursement rules and model; and (vi) our expected outcomes relating to improving workflow and strengthening bonds between the Company and its customers. Additional forward-looking statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “goal,” “outlook,” “potential,” “will,” “preliminary,” and similar expressions, and are based on management’s current beliefs and expectations.

Forward-looking statements are subject to risks and uncertainties, and the Company cautions investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Factors that could cause actual results to differ from expectations include: (i) future sales are uncertain and are affected by competition, access to customers, patient access to healthcare providers, the reimbursement environment, particularly in light of CMS’ updated 2026 Medicare spending rules and reimbursement model, and many other factors; (ii) the Company may change its plans due to unforeseen circumstances; (iii) the results of scientific research are uncertain and may have little or no value; (iv) our ability to sell our products in other countries depends on a number of factors including adequate levels of reimbursement, market acceptance of novel therapies, and our ability to build and manage a direct sales force or third party distribution relationship; (v) the effectiveness of amniotic tissue as a therapy for particular indications or conditions is the subject of further scientific and clinical studies; (vi) we may alter the timing and amount of planned expenditures for research and development based on regulatory developments; (vii) the impact of CMS’ updated 2026 spending rules and reimbursement model, particularly the shift to a capped rate for Medicare reimbursement, including the impact on our product utilization given the potential shift to alternate treatment modalities; and (viii) changes in the size of the addressable market for our products. Additional factors that could impact outcomes and our results include those described in the Risk Factors section of our Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q. filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and the Company assumes no obligation to update any forward-looking statement.

About MIMEDX

MIMEDX is a pioneer and leader focused on helping humans heal. With more than a decade and a half of helping clinicians manage chronic and other hard-to-heal wounds, MIMEDX provides a leading portfolio of products for applications in the wound care, burn, and surgical sectors of healthcare. The Company’s vision is to be the leading global provider of healing solutions through relentless innovation to restore quality of life. For additional information, please visit www.mimedx.com.

Contact:
Matt Notarianni
Investor Relations
470.304.7291
mnotarianni@mimedx.com

Selected Unaudited Financial Information

Reconciliation of Non-GAAP Measures

In addition to our GAAP results, we provide certain non-GAAP measures including Adjusted EBITDA, related margins, Free Cash Flow, Adjusted Gross Profit, Adjusted Gross Margin and Adjusted Net Income. We believe that the presentation of these measures provides important supplemental information to management and investors regarding our performance. These measures are not a substitute for GAAP measures. Company management uses these non-GAAP measures as aids in monitoring our ongoing financial performance from quarter-to-quarter and year-to-year on a regular basis and for benchmarking against comparable companies.

These non-GAAP financial measures reflect the exclusion of the following items:

• Share-based compensation expense – expense recognized related to awards to employees and our board of directors pursuant to our share-based compensation plans. This expense is reflected amongst cost of sales, research and development expense, and selling, general, and administrative expense in the consolidated statements of operations.
• Investigation, restatement, and related (benefit) expense – expenses incurred toward the legal defense of the Company and advanced on behalf of certain former officers and directors, net of negotiated reductions and settlements of amounts previously advanced, related to certain legal matters. This expense is reflected in the line of the same name in our consolidated statements of operations.
• Impairment of intangible assets – reflects the impairment of intangibles. This expense is reflected in the line of the same name in our consolidated statements of operations.
• Transaction-related expenses – reflects expenses incrementally incurred resulting from the consummation of material strategic transactions or the integration of acquired assets or operations into our core business.
• Strategic legal and regulatory expenses – With respect to the three months and year ended December 31, 2025, this relates to litigation and regulatory expenses. Litigation expenses incurred relate to suits filed against former employees and their employers for violation of non-compete and non-solicitation agreements and related matters. Regulatory expenses relate to legal fees incurred stemming from action taken against the United States Food & Drug Administration (“FDA”) surrounding the designation of one of our products.
• Loss on extinguishment of debt – reflects the excess of cash paid to extinguish debt over the carrying value of the debt on our balance sheet upon the repayment and termination of a loan agreement. With respect to the year ended December 31, 2025, this relates to the repayment and termination of the Company’s loan agreement with Hayfin. Amounts in this line reflect (i) prepayment premium paid and (ii) write-offs of unamortized original issue discount and deferred financing costs.
• Expenses related to the Disbanding of Regenerative Medicine – incremental expenses recognized or incurred directly as a result of our announcement to disband our Regenerative Medicine segment.
• Amortization of acquired intangible assets – reflects amortization expense recognized solely related to assets which were acquired as part of a transaction. These expenses are reflected in cost of sales in our consolidated statements of operations.
• Reorganization expenses – reflects severance expense arising from the enactment of various strategic initiatives, including separations from certain officers of the Company.
• Income Tax Adjustment – for purposes of calculating Adjusted Net Income and Adjusted Earnings Per Share, reflects our expectation of a long-term effective tax rate, which is normalized and balance sheet-agnostic. Actual reporting tax expense will be based on GAAP earnings, and may differ from the expected long-term effective tax rate due to a variety of factors, including the tax treatment of various transactions included in GAAP net income and other reconciling items that are excluded in determining Adjusted Net Income and Adjusted EPS. The actual long-term normalized effective tax rate was 25% for each of the years ended December 31, 2025 and 2024.

Adjusted EBITDA and Adjusted EBITDA margin

Adjusted EBITDA consists of GAAP net income excluding: (i) share-based compensation, (ii) income tax provision, (iii) amortization of intangible assets, (iv) strategic legal and regulatory expenses, (v) interest (income) expense, net, (vi) depreciation expense, (vii) reorganization expenses, (viii) transaction-related expenses, (ix) investigation, restatement and related expense (benefit), (x) impairment of intangible assets, and (xi) expenses related to disbanding of the Regenerative Medicine business unit.

A reconciliation of GAAP net income to Adjusted EBITDA appears in the table below (dollars in thousands):

Adjusted Net Income and Adjusted Gross Margin

Adjusted Net Income provides a view of our operating performance, exclusive of certain items which are non-recurring or not reflective of our core operations.

Adjusted Net Income is defined as GAAP net income plus (i) amortization of acquired intangible assets, (ii) strategic legal and regulatory expenses, (iii) transaction-related expenses, (iv) reorganization expenses, (v) investigation, restatement and related expense (benefit), (vi) impairment of intangible assets, (vii) loss on extinguishment of debt, (viii) expenses related to disbanding of Regenerative Medicine business unit, and (ix) the long-term effective income tax rate adjustment.

Each of the adjustments to reconcile Adjusted Net Income to GAAP net income affect individual financial statement captions which are reflected in our consolidated statements of operations, including gross profit. Adjusted Gross Profit is therefore defined as GAAP gross profit plus (i) amortization of acquired intangible assets, (ii) strategic legal and regulatory expenses, (iii) transaction-related expenses, (iv) reorganization expenses, (v) investigation, restatement and related expense (benefit), (vi) impairment of intangible assets, (vii) loss on extinguishment of debt, (viii) expenses related to disbanding of Regenerative Medicine business unit, and (ix) the long-term effective income tax rate adjustment
to the extent that these adjustments impact GAAP gross profit. Adjusted Gross Margin is calculated as Adjusted Gross Profit divided by GAAP net sales.
A reconciliation of GAAP net income to Adjusted Net Income appears in the table below (in thousands):

A reconciliation of various line items included in our GAAP unaudited condensed consolidated statements of operations to Adjusted Net Income, including Adjusted Gross Profit for the three months and years ended December 31, 2025 and 2024 are presented in the tables below (in thousands):

Adjusted Earnings Per Share

Adjusted Earnings Per Share is intended to provide a normalized view of earnings per share by removing items that may be irregular, one-time, or non-recurring from net income. This enables us to identify underlying trends in our business that could otherwise be masked by such items. Adjusted Earnings Per Share consists of GAAP diluted net income per common share including adjustments for: (i) amortization of acquired intangible assets, (ii) strategic legal and regulatory expenses, (iii) transaction-related expenses, (iv) reorganization expenses, (v) investigation, restatement and related expense (benefit), (vi) impairment of intangible assets, (vii) loss on extinguishment of debt, (viii) expenses related to disbanding of Regenerative Medicine business unit, and (ix) the long-term effective income tax rate adjustment. The effect of antidilution reflects the changes resulting from the removal of the dilutive impact of convertible securities which were dilutive for purposes of calculating GAAP net income per common share, but are antidilutive for non-GAAP purposes.

A reconciliation of GAAP diluted earnings per share to Adjusted Earnings Per Share appears in the table below (per diluted share):

Free Cash Flow

Free Cash Flow is intended to provide a measure of our ability to generate cash in excess of capital investments. It provides management with a view of cash flows which can be used to finance operational and strategic investments.

Free Cash Flow is defined as net cash provided by operating activities less capital expenditures, including purchases of equipment.

A reconciliation of GAAP net cash flows provided by operating activities to Free Cash Flow appears in the table below (in thousands):

Other Information

Net Sales by Product Category by Quarter

Below is a summary of net sales by product category (in thousands):

Selling, General and Administrative

Below is the breakout of selling, general and administrative expense by selling and marketing and general and administrative (in thousands):

MIMEDX Announces Record Fourth Quarter and Full Year 2025 Operating and Financial Results




MIMEDX Announces Record Fourth Quarter and Full Year 2025 Operating and Financial Results

Net Sales Grew 27% Year-Over-Year for the Fourth Quarter and 20% for the Full Year

Fourth Quarter GAAP Net Income and Earnings Per Share were $15 million and $0.10, Respectively

Fourth Quarter Adjusted EBITDA¹ was $29 Million, or 25% of Net Sales

Company Estimates 2026 Net Sales in a Range of $340-360 Million

Announces $100 Million Share Repurchase Program Authorization

Management to Host Conference Call Today, February 25, 2026, at 4:30 PM ET

MARIETTA, Ga., Feb. 25, 2026 (GLOBE NEWSWIRE) — MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”), today announced operating and financial results for the fourth quarter and full year 2025.

Joseph H. Capper, MIMEDX Chief Executive Officer, commented, “MIMEDX delivered a record year of revenue and profitability in 2025, with fourth quarter results that included net sales growth of 27% year-over-year, net income of $15 million, an Adjusted EBITDA margin of 25% of net sales, and robust free cash flow. These results were driven by strong double-digit contributions in both Wound and Surgical, which grew 28% and 25%, respectively, reflecting exceptional commercial execution across the markets we serve. We were particularly pleased with the durable double-digit growth seen in Surgical, and we are keenly focused on the untapped clinical opportunities for our current and future products.”

Mr. Capper continued, “Looking ahead to 2026, the Company remains committed to providing a best-in-class portfolio of evidence-based, differentiated products to capitalize on the many opportunities in front of us. With the recent product additions to our Wound and Surgical offerings, I am as confident as ever in our ability to make significant headway this year in a variety of clinical settings.”

“The short-term disruptions caused by Medicare reimbursement changes in the Wound market will likely have an impact on our 2026 revenue. Once demand patterns normalize, we expect to gain significant volume over time. Meanwhile, we believe the clear momentum we have across the rest of our business — Surgical, international and Wound commercial pay — will provide continued profitability and cash flow. Thus, enabling us to maintain our leadership position over both the short- and long-term,” concluded Mr. Capper.

____________________
¹ Adjusted EBITDA is a Non-GAAP Measure. This press release contains this and other Non-GAAP measures. For reconciliations of our Non-GAAP measures to their nearest GAAP measure, refer to the section titled “Reconciliation of Non-GAAP Measures” below.

Fourth Quarter and Full Year 2025 Results Discussion

Net Sales

MIMEDX reported net sales for the three months ended December 31, 2025 of $118 million, compared to $93 million for the three months ended December 31, 2024, an increase of 27%. The increase was driven by Wound product sales growth of 28%, which reflected the introduction of EPIXPRESS^® as well as the contribution from EMERGE™ during the quarter. Additionally, fourth quarter Surgical sales grew 25% and represented the sixth consecutive quarter of sequential sales growth for this product category, led by sustained momentum for AMNIOFIX^® and AMNIOEFFECT^® as well as another strong performance for the Company’s particulate portfolio.

For the full year 2025 MIMEDX reported net sales of $419 million, compared to $349 million in the prior year period, reflecting growth of 20%. On a full year basis, Wound growth of 20% was led by sales of new products, including CELERA™, EMERGE, and EPIXPRESS, which more than offset pressure from lower-priced products. Also in 2025, Surgical net sales rose 21% compared to the prior year period, with strong contributions from AMNIOFIX, AMNIOEFFECT and HELIOGEN^®.

Gross Profit and Margin

Gross profit for the three months ended December 31, 2025, was $99 million, an increase of $23 million as compared to the prior year period. Gross margin for the three months ended December 31, 2025 was 84%, compared to 82% in the prior year period. The increase was driven by favorable product mix. On an adjusted basis, fourth quarter 2025 gross margin was 86%, which reflects a roughly flat adjusted gross margin compared to the prior year period.

For the full year 2025, gross profit was $346 million, reflecting an increase of $57 million compared to the prior year period. Additionally, gross margin for the full year 2025 was 83%, flat compared to the full year 2024. On an adjusted basis, gross margin for the full year 2025 was 86% compared to 84% for the full year 2024.

Operating Expenses

Selling, general and administrative (“SG&A”) expenses for the three months ended December 31, 2025, were $73 million compared to $61 million for the three months ended December 31, 2024. For the full year 2025, SG&A expenses totaled $266 million, compared to $225 million for the prior period, reflecting a year over year increase of 18%. For both the fourth quarter and full year 2025, the year-over-year increase in SG&A was driven primarily by higher commissions.

Research and development (“R&D”) expenses for the three months ended December 31, 2025, were $5 million compared to $4 million for the three months ended December 31, 2024. For the full year 2025, research and development expenses totaled $15 million, compared to $12 million for 2024. R&D spend in the quarter and year was driven, in part, by the randomized controlled trial for EPIEFFECT and ongoing investments in the development of future products in our pipeline.

Net income for the three months and full year ended December 31, 2025 was $15 million and $49 million, respectively, compared to a net income of $7 million and $42 million for the three months and full year ended December 31, 2024, respectively.

Cash and Cash Equivalents

As of December 31, 2025, the Company had $166 million of cash and cash equivalents compared to $104 million as of December 31, 2024 and $142 million as of September 30, 2025. As of December 31, 2025, our cash position, net of debt on our balance sheet, was $148 million, representing a sequential increase of $24 million and an increase of $63 million for the year.

Share Repurchase Authorization Announced

Also today, the MIMEDX Board of Directors has authorized a share repurchase program of up to $100 million of the Company’s common stock over a two-year period.   The share repurchase program provides MIMEDX with the flexibility to purchase shares of its common stock in the open market or in privately negotiated transactions, subject to market conditions and other factors.

MIMEDX intends to use the repurchase program periodically on a discretionary basis, subject to general business and market conditions and balanced against other investment opportunities. The repurchase program may be commenced, suspended or discontinued at any time.

MIMEDX remains focused on executing its strategic priorities and its decision to establish this repurchase program reflects its balanced approach to capital allocation.  

Financial Outlook

For 2026, MIMEDX currently estimates net sales to be in a range of $340 to $360 million and for adjusted EBITDA margin to be in the mid-to-high teens.

Longer-term, the Company continues to expect to achieve annual net sales growth in the low double-digits as a percentage with an Adjusted EBITDA margin above 20%.

Conference Call and Webcast

MIMEDX will host a conference call and webcast to review its fourth quarter and full year 2025 results on Wednesday, February 25, 2026, beginning at 4:30 p.m., Eastern Time. The call can be accessed using the following information:

Webcast: Click here
U.S. Investors: 877-407-6184
International Investors: 201-389-0877
Conference ID: 13758446

A replay of the webcast will be available for approximately 30 days on the Company’s website at www.mimedx.com following the conclusion of the event.

Important Cautionary Statement

This press release and our investor conference call include forward-looking statements, which reflect management’s current beliefs and expectations regarding future events and operating performance and speak only as of the date hereof. These forward-looking statements are not guarantees of future performance and involve a number of risks and uncertainties. These statements include statements regarding: (i) future sales, sales growth, and Adjusted EBITDA margin; (ii) our longer term financial goals and expectations for future financial results, including levels of net sales, Adjusted EBITDA, and Adjusted EBITDA margin; (iii) our expectations regarding the size of the market for our products;(iv) our expectations regarding the impact of CMS’ updated 2026 Medicare reimbursement rules and model and our belief that Medicare is likely to introduce national coverage policy, given the withdrawal of the LCDs; (v) continued growth in different care settings and different products, specifically accounting for the change caused by CMS’ updated 2026 reimbursement rules and model; and (vi) our expected outcomes relating to improving workflow and strengthening bonds between the Company and its customers. Additional forward-looking statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “goal,” “outlook,” “potential,” “will,” “preliminary,” and similar expressions, and are based on management’s current beliefs and expectations.

Forward-looking statements are subject to risks and uncertainties, and the Company cautions investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Factors that could cause actual results to differ from expectations include: (i) future sales are uncertain and are affected by competition, access to customers, patient access to healthcare providers, the reimbursement environment, particularly in light of CMS’ updated 2026 Medicare spending rules and reimbursement model, and many other factors; (ii) the Company may change its plans due to unforeseen circumstances; (iii) the results of scientific research are uncertain and may have little or no value; (iv) our ability to sell our products in other countries depends on a number of factors including adequate levels of reimbursement, market acceptance of novel therapies, and our ability to build and manage a direct sales force or third party distribution relationship; (v) the effectiveness of amniotic tissue as a therapy for particular indications or conditions is the subject of further scientific and clinical studies; (vi) we may alter the timing and amount of planned expenditures for research and development based on regulatory developments; (vii) the impact of CMS’ updated 2026 spending rules and reimbursement model, particularly the shift to a capped rate for Medicare reimbursement, including the impact on our product utilization given the potential shift to alternate treatment modalities; and (viii) changes in the size of the addressable market for our products. Additional factors that could impact outcomes and our results include those described in the Risk Factors section of our Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q. filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and the Company assumes no obligation to update any forward-looking statement.

About MIMEDX

MIMEDX is a pioneer and leader focused on helping humans heal. With more than a decade and a half of helping clinicians manage chronic and other hard-to-heal wounds, MIMEDX provides a leading portfolio of products for applications in the wound care, burn, and surgical sectors of healthcare. The Company’s vision is to be the leading global provider of healing solutions through relentless innovation to restore quality of life. For additional information, please visit www.mimedx.com.

Contact:
Matt Notarianni
Investor Relations
470.304.7291
mnotarianni@mimedx.com

Selected Unaudited Financial Information

Reconciliation of Non-GAAP Measures

In addition to our GAAP results, we provide certain non-GAAP measures including Adjusted EBITDA, related margins, Free Cash Flow, Adjusted Gross Profit, Adjusted Gross Margin and Adjusted Net Income. We believe that the presentation of these measures provides important supplemental information to management and investors regarding our performance. These measures are not a substitute for GAAP measures. Company management uses these non-GAAP measures as aids in monitoring our ongoing financial performance from quarter-to-quarter and year-to-year on a regular basis and for benchmarking against comparable companies.

These non-GAAP financial measures reflect the exclusion of the following items:

• Share-based compensation expense – expense recognized related to awards to employees and our board of directors pursuant to our share-based compensation plans. This expense is reflected amongst cost of sales, research and development expense, and selling, general, and administrative expense in the consolidated statements of operations.
• Investigation, restatement, and related (benefit) expense – expenses incurred toward the legal defense of the Company and advanced on behalf of certain former officers and directors, net of negotiated reductions and settlements of amounts previously advanced, related to certain legal matters. This expense is reflected in the line of the same name in our consolidated statements of operations.
• Impairment of intangible assets – reflects the impairment of intangibles. This expense is reflected in the line of the same name in our consolidated statements of operations.
• Transaction-related expenses – reflects expenses incrementally incurred resulting from the consummation of material strategic transactions or the integration of acquired assets or operations into our core business.
• Strategic legal and regulatory expenses – With respect to the three months and year ended December 31, 2025, this relates to litigation and regulatory expenses. Litigation expenses incurred relate to suits filed against former employees and their employers for violation of non-compete and non-solicitation agreements and related matters. Regulatory expenses relate to legal fees incurred stemming from action taken against the United States Food & Drug Administration (“FDA”) surrounding the designation of one of our products.
• Loss on extinguishment of debt – reflects the excess of cash paid to extinguish debt over the carrying value of the debt on our balance sheet upon the repayment and termination of a loan agreement. With respect to the year ended December 31, 2025, this relates to the repayment and termination of the Company’s loan agreement with Hayfin. Amounts in this line reflect (i) prepayment premium paid and (ii) write-offs of unamortized original issue discount and deferred financing costs.
• Expenses related to the Disbanding of Regenerative Medicine – incremental expenses recognized or incurred directly as a result of our announcement to disband our Regenerative Medicine segment.
• Amortization of acquired intangible assets – reflects amortization expense recognized solely related to assets which were acquired as part of a transaction. These expenses are reflected in cost of sales in our consolidated statements of operations.
• Reorganization expenses – reflects severance expense arising from the enactment of various strategic initiatives, including separations from certain officers of the Company.
• Income Tax Adjustment – for purposes of calculating Adjusted Net Income and Adjusted Earnings Per Share, reflects our expectation of a long-term effective tax rate, which is normalized and balance sheet-agnostic. Actual reporting tax expense will be based on GAAP earnings, and may differ from the expected long-term effective tax rate due to a variety of factors, including the tax treatment of various transactions included in GAAP net income and other reconciling items that are excluded in determining Adjusted Net Income and Adjusted EPS. The actual long-term normalized effective tax rate was 25% for each of the years ended December 31, 2025 and 2024.

Adjusted EBITDA and Adjusted EBITDA margin

Adjusted EBITDA consists of GAAP net income excluding: (i) share-based compensation, (ii) income tax provision, (iii) amortization of intangible assets, (iv) strategic legal and regulatory expenses, (v) interest (income) expense, net, (vi) depreciation expense, (vii) reorganization expenses, (viii) transaction-related expenses, (ix) investigation, restatement and related expense (benefit), (x) impairment of intangible assets, and (xi) expenses related to disbanding of the Regenerative Medicine business unit.

A reconciliation of GAAP net income to Adjusted EBITDA appears in the table below (dollars in thousands):

Adjusted Net Income and Adjusted Gross Margin

Adjusted Net Income provides a view of our operating performance, exclusive of certain items which are non-recurring or not reflective of our core operations.

Adjusted Net Income is defined as GAAP net income plus (i) amortization of acquired intangible assets, (ii) strategic legal and regulatory expenses, (iii) transaction-related expenses, (iv) reorganization expenses, (v) investigation, restatement and related expense (benefit), (vi) impairment of intangible assets, (vii) loss on extinguishment of debt, (viii) expenses related to disbanding of Regenerative Medicine business unit, and (ix) the long-term effective income tax rate adjustment.

Each of the adjustments to reconcile Adjusted Net Income to GAAP net income affect individual financial statement captions which are reflected in our consolidated statements of operations, including gross profit. Adjusted Gross Profit is therefore defined as GAAP gross profit plus (i) amortization of acquired intangible assets, (ii) strategic legal and regulatory expenses, (iii) transaction-related expenses, (iv) reorganization expenses, (v) investigation, restatement and related expense (benefit), (vi) impairment of intangible assets, (vii) loss on extinguishment of debt, (viii) expenses related to disbanding of Regenerative Medicine business unit, and (ix) the long-term effective income tax rate adjustment
to the extent that these adjustments impact GAAP gross profit. Adjusted Gross Margin is calculated as Adjusted Gross Profit divided by GAAP net sales.
A reconciliation of GAAP net income to Adjusted Net Income appears in the table below (in thousands):

A reconciliation of various line items included in our GAAP unaudited condensed consolidated statements of operations to Adjusted Net Income, including Adjusted Gross Profit for the three months and years ended December 31, 2025 and 2024 are presented in the tables below (in thousands):

Adjusted Earnings Per Share

Adjusted Earnings Per Share is intended to provide a normalized view of earnings per share by removing items that may be irregular, one-time, or non-recurring from net income. This enables us to identify underlying trends in our business that could otherwise be masked by such items. Adjusted Earnings Per Share consists of GAAP diluted net income per common share including adjustments for: (i) amortization of acquired intangible assets, (ii) strategic legal and regulatory expenses, (iii) transaction-related expenses, (iv) reorganization expenses, (v) investigation, restatement and related expense (benefit), (vi) impairment of intangible assets, (vii) loss on extinguishment of debt, (viii) expenses related to disbanding of Regenerative Medicine business unit, and (ix) the long-term effective income tax rate adjustment. The effect of antidilution reflects the changes resulting from the removal of the dilutive impact of convertible securities which were dilutive for purposes of calculating GAAP net income per common share, but are antidilutive for non-GAAP purposes.

A reconciliation of GAAP diluted earnings per share to Adjusted Earnings Per Share appears in the table below (per diluted share):

Free Cash Flow

Free Cash Flow is intended to provide a measure of our ability to generate cash in excess of capital investments. It provides management with a view of cash flows which can be used to finance operational and strategic investments.

Free Cash Flow is defined as net cash provided by operating activities less capital expenditures, including purchases of equipment.

A reconciliation of GAAP net cash flows provided by operating activities to Free Cash Flow appears in the table below (in thousands):

Other Information

Net Sales by Product Category by Quarter

Below is a summary of net sales by product category (in thousands):

Selling, General and Administrative

Below is the breakout of selling, general and administrative expense by selling and marketing and general and administrative (in thousands):

Soleno Therapeutics Reports Fourth Quarter and Full-Year 2025 Financial Results and Provides Update on U.S. Launch of VYKAT™ XR




Soleno Therapeutics Reports Fourth Quarter and Full-Year 2025 Financial Results and Provides Update on U.S. Launch of VYKAT™ XR

REDWOOD CITY, Calif., Feb. 25, 2026 (GLOBE NEWSWIRE) — Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today reported financial results for the fourth quarter and full-year ended December 31, 2025 and provided an update on the U.S. launch of VYKAT™ XR (diazoxide choline) extended-release tablets.

Fourth Quarter and Full-Year 2025 and Recent Corporate Highlights

• Revenue, net, from the sale of VYKAT XR for the three and twelve months ended December 31, 2025, was $91.7 million and $190.4 million, respectively.
• From approval on March 26, 2025 through December 31, 2025, Soleno reports:
  • 1,250 patient start forms received, including 207 in the fourth quarter
  • 630 unique prescribers, including 136 new prescribers in the fourth quarter
  • 859 active patients on drug as of December 31, 2025
  • Over 185 million lives covered
• Achieved profitability with positive net income of $20.9 million for the year.
• Generated $48.7 million of cash flow from operating activities in the fourth quarter.
• Invested $100 million in accelerated share repurchase program announced in November 2025 and ended the year with $506.1 million of cash, cash equivalents and marketable securities.

“Our first year as a commercial organization has been an outstanding success,” stated Anish Bhatnagar, M.D., Chairman and Chief Executive Officer of Soleno Therapeutics. “In just nine months, we received patient start forms representing over 12% of the U.S. VYKAT XR addressable market, reflecting both the strength of our world-class commercial team as well as the substantial disease burden that is addressed by VYKAT XR. We are very pleased with the positive trajectory of our other leading indicators, including patient start forms, patients on active therapy, unique prescribers, and lives covered.”

“Looking ahead, with the U.S. VYKAT XR launch well underway, we plan to pursue regulatory approval in other territories, starting with the EU. We will also begin to evaluate diazoxide choline extended-release (DCCR) in additional high-need rare diseases as we expand our development pipeline. We have made excellent progress in 2025 and are excited for the year ahead.”

Fourth Quarter and Full-Year Ended December 31, 2025 Financial Results

Product revenue, net, was $91.7 million and $190.4 million for the three and twelve months ended December 31, 2025, respectively. VYKAT XR had not been approved or commercially launched in the three and twelve months ended December 31, 2024, and accordingly, generated no revenue during those periods.

Research and development expense was $9.6 million, which includes $2.8 million of non-cash stock-based compensation, for the three months ended December 31, 2025, compared to $21.5 million, which includes $10.1 million of non-cash stock-based compensation, in the same period of 2024. For the year ended December 31, 2025, research and development expense was $40.6 million, which includes $11.7 million of non-cash stock-based compensation, a decrease of $38.0 million compared to $78.6 million, which includes $33.7 million non-cash stock-based compensation, in the same period of 2024.

For the year, the $15.9 million decrease in expense not related to stock-based compensation was due to a reduction in pre-commercial launch costs in support of the Company’s 2024 NDA submission, supply chain, and clinical activities. These expenses decreased $7.5 million, $6.0 million, and $3.8 million, respectively. These decreases were partially offset by the Company incurring an additional $1.4 million of expense towards its MAA submission in Europe, which was submitted in the second quarter of 2025. The cadence of the Company’s research and development expenditures will fluctuate depending upon the state of its research activities, clinical programs, and the timing of manufacturing and other projects necessary to support the submission of its regulatory filings.

Selling, general and administrative expense was $40.9 million, which includes $8.7 million of non-cash stock-based compensation, for the three months ended December 31, 2025, compared to $37.3 million, which includes $19.7 million of non-cash stock-based compensation, in the same period of 2024. For the year ended December 31, 2025, selling, general and administrative expense was $132.1 million, which includes $34.1 million of non-cash stock-based compensation, an increase of $26.2 million compared to $105.9 million, which includes $66.2 million of non-cash stock-based compensation, in the same period of 2024.

For the year, personnel costs, including hiring expense and other associated headcount costs, increased $31.3 million as the Company hired additional employees in support of its commercial launch and increased business activities. New program costs associated with commercial launch activities, including disease state education, analytics, other marketing programs, medical affairs and patient advocacy activities, increased $23.4 million. Costs for international expansion increased $3.5 million. These increases were offset by the $32.1 million reduction in stock-based compensation. Selling, general and administrative expenses are anticipated to increase as the Company continues commercialization of VYKAT XR.

The Company is obligated to make cash payments of up to a maximum of $21.2 million to the former Essentialis stockholders upon the achievement of certain commercial milestones associated with the sales of DCCR in accordance with the terms of the Company’s 2017 merger agreement with Essentialis. The fair value of the liability for the contingent consideration payable by the Company upon the achievement of commercial sales milestones of $100 million and $200 million in aggregate revenue, respectively, was estimated to be $20.3 million as of December 31, 2025, a $5.5 million increase from the estimate as of December 31, 2024. The first commercial milestone was achieved in the fourth quarter 2025 and $7.0 million will be paid in the first quarter 2026.

Total other income, net, was $3.8 million for the three months ended December 31, 2025, compared to total other income, net, of $3.1 million in the same period of 2024. For the year, total other income, net, was $11.5 million for 2025, compared to $11.8 million for 2024.

For the year ended December 31, 2025, net income was approximately $20.9 million, or $0.40 per basic and $0.39 per diluted share, compared to a net loss of $(175.9) million, or $(4.38) per basic and diluted share, for the same period of 2024.

Conference Call and Webcast Information

Soleno management will host an investor conference call and webcast to discuss its fourth quarter and full-year 2025 financial and operating results and provide an update on the U.S. launch of VYKAT XR today, February 25, 2026, at 4:30pm ET. Details can be found below:

About PWS
Prader-Willi syndrome (PWS) is a rare genetic neurodevelopmental disorder caused by an abnormality in the gene expression on chromosome 15. The Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births. The defining symptom of PWS is hyperphagia, a chronic and life-threatening condition characterized by an intense persistent sensation of hunger accompanied by food preoccupations, an extreme drive to consume food, food-related behavior problems, and a lack of normal satiety, which can severely diminish the quality of life for individuals with PWS and their families. Hyperphagia can lead to significant mortality (e.g., stomach rupture, choking, accidental death due to food seeking behavior) and longer term, co-morbidities such as diabetes, obesity, and cardiovascular disease.

INDICATION
VYKAT XR (diazoxide choline) extended-release tablets is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS).

IMPORTANT SAFETY INFORMATION

Contraindications
Use of VYKAT XR is contraindicated in patients who have a known hypersensitivity to diazoxide, other components of VYKAT XR, or to thiazides.

Warnings and Precautions

Hyperglycemia
Hyperglycemia, including diabetic ketoacidosis, has been reported. Before initiating VYKAT XR, test fasting plasma glucose (FPG) and HbA1c; optimize blood glucose in patients who have hyperglycemia. During treatment, regularly monitor fasting glucose (FPG or fasting blood glucose) and HbA1c. Monitor fasting glucose more frequently during the first few weeks of treatment in patients with risk factors for hyperglycemia.

Risk of Fluid Overload
Edema, including severe reactions associated with fluid overload, has been reported. Monitor for signs or symptoms of edema or fluid overload. VYKAT XR has not been studied in patients with compromised cardiac reserve and should be used with caution in these patients.

Adverse Reactions
The most common adverse reactions (incidence ≥10% and at least 2% greater than placebo) included hypertrichosis, edema, hyperglycemia, and rash.

Please see the full Prescribing Information, including Medication Guide.

About Soleno Therapeutics, Inc.
Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The Company’s first commercial product, VYKAT XR (diazoxide choline) extended-release tablets, formerly known as DCCR, is a once-daily oral treatment for hyperphagia in adults and children 4 years of age and older with Prader-Willi syndrome. For more information, please visit www.soleno.life.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including those described in the company’s prior press releases and in the periodic reports it files with the SEC including its Annual Report on Form 10-K which it intends to release later today. The events and circumstances reflected in the company’s forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, the company does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Corporate Contact:
Brian Ritchie
LifeSci Advisors, LLC
212-915-2578

Soleno Therapeutics Reports Fourth Quarter and Full-Year 2025 Financial Results and Provides Update on U.S. Launch of VYKAT™ XR




Soleno Therapeutics Reports Fourth Quarter and Full-Year 2025 Financial Results and Provides Update on U.S. Launch of VYKAT™ XR

REDWOOD CITY, Calif., Feb. 25, 2026 (GLOBE NEWSWIRE) — Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today reported financial results for the fourth quarter and full-year ended December 31, 2025 and provided an update on the U.S. launch of VYKAT™ XR (diazoxide choline) extended-release tablets.

Fourth Quarter and Full-Year 2025 and Recent Corporate Highlights

• Revenue, net, from the sale of VYKAT XR for the three and twelve months ended December 31, 2025, was $91.7 million and $190.4 million, respectively.
• From approval on March 26, 2025 through December 31, 2025, Soleno reports:
  • 1,250 patient start forms received, including 207 in the fourth quarter
  • 630 unique prescribers, including 136 new prescribers in the fourth quarter
  • 859 active patients on drug as of December 31, 2025
  • Over 185 million lives covered
• Achieved profitability with positive net income of $20.9 million for the year.
• Generated $48.7 million of cash flow from operating activities in the fourth quarter.
• Invested $100 million in accelerated share repurchase program announced in November 2025 and ended the year with $506.1 million of cash, cash equivalents and marketable securities.

“Our first year as a commercial organization has been an outstanding success,” stated Anish Bhatnagar, M.D., Chairman and Chief Executive Officer of Soleno Therapeutics. “In just nine months, we received patient start forms representing over 12% of the U.S. VYKAT XR addressable market, reflecting both the strength of our world-class commercial team as well as the substantial disease burden that is addressed by VYKAT XR. We are very pleased with the positive trajectory of our other leading indicators, including patient start forms, patients on active therapy, unique prescribers, and lives covered.”

“Looking ahead, with the U.S. VYKAT XR launch well underway, we plan to pursue regulatory approval in other territories, starting with the EU. We will also begin to evaluate diazoxide choline extended-release (DCCR) in additional high-need rare diseases as we expand our development pipeline. We have made excellent progress in 2025 and are excited for the year ahead.”

Fourth Quarter and Full-Year Ended December 31, 2025 Financial Results

Product revenue, net, was $91.7 million and $190.4 million for the three and twelve months ended December 31, 2025, respectively. VYKAT XR had not been approved or commercially launched in the three and twelve months ended December 31, 2024, and accordingly, generated no revenue during those periods.

Research and development expense was $9.6 million, which includes $2.8 million of non-cash stock-based compensation, for the three months ended December 31, 2025, compared to $21.5 million, which includes $10.1 million of non-cash stock-based compensation, in the same period of 2024. For the year ended December 31, 2025, research and development expense was $40.6 million, which includes $11.7 million of non-cash stock-based compensation, a decrease of $38.0 million compared to $78.6 million, which includes $33.7 million non-cash stock-based compensation, in the same period of 2024.

For the year, the $15.9 million decrease in expense not related to stock-based compensation was due to a reduction in pre-commercial launch costs in support of the Company’s 2024 NDA submission, supply chain, and clinical activities. These expenses decreased $7.5 million, $6.0 million, and $3.8 million, respectively. These decreases were partially offset by the Company incurring an additional $1.4 million of expense towards its MAA submission in Europe, which was submitted in the second quarter of 2025. The cadence of the Company’s research and development expenditures will fluctuate depending upon the state of its research activities, clinical programs, and the timing of manufacturing and other projects necessary to support the submission of its regulatory filings.

Selling, general and administrative expense was $40.9 million, which includes $8.7 million of non-cash stock-based compensation, for the three months ended December 31, 2025, compared to $37.3 million, which includes $19.7 million of non-cash stock-based compensation, in the same period of 2024. For the year ended December 31, 2025, selling, general and administrative expense was $132.1 million, which includes $34.1 million of non-cash stock-based compensation, an increase of $26.2 million compared to $105.9 million, which includes $66.2 million of non-cash stock-based compensation, in the same period of 2024.

For the year, personnel costs, including hiring expense and other associated headcount costs, increased $31.3 million as the Company hired additional employees in support of its commercial launch and increased business activities. New program costs associated with commercial launch activities, including disease state education, analytics, other marketing programs, medical affairs and patient advocacy activities, increased $23.4 million. Costs for international expansion increased $3.5 million. These increases were offset by the $32.1 million reduction in stock-based compensation. Selling, general and administrative expenses are anticipated to increase as the Company continues commercialization of VYKAT XR.

The Company is obligated to make cash payments of up to a maximum of $21.2 million to the former Essentialis stockholders upon the achievement of certain commercial milestones associated with the sales of DCCR in accordance with the terms of the Company’s 2017 merger agreement with Essentialis. The fair value of the liability for the contingent consideration payable by the Company upon the achievement of commercial sales milestones of $100 million and $200 million in aggregate revenue, respectively, was estimated to be $20.3 million as of December 31, 2025, a $5.5 million increase from the estimate as of December 31, 2024. The first commercial milestone was achieved in the fourth quarter 2025 and $7.0 million will be paid in the first quarter 2026.

Total other income, net, was $3.8 million for the three months ended December 31, 2025, compared to total other income, net, of $3.1 million in the same period of 2024. For the year, total other income, net, was $11.5 million for 2025, compared to $11.8 million for 2024.

For the year ended December 31, 2025, net income was approximately $20.9 million, or $0.40 per basic and $0.39 per diluted share, compared to a net loss of $(175.9) million, or $(4.38) per basic and diluted share, for the same period of 2024.

Conference Call and Webcast Information

Soleno management will host an investor conference call and webcast to discuss its fourth quarter and full-year 2025 financial and operating results and provide an update on the U.S. launch of VYKAT XR today, February 25, 2026, at 4:30pm ET. Details can be found below:

About PWS
Prader-Willi syndrome (PWS) is a rare genetic neurodevelopmental disorder caused by an abnormality in the gene expression on chromosome 15. The Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births. The defining symptom of PWS is hyperphagia, a chronic and life-threatening condition characterized by an intense persistent sensation of hunger accompanied by food preoccupations, an extreme drive to consume food, food-related behavior problems, and a lack of normal satiety, which can severely diminish the quality of life for individuals with PWS and their families. Hyperphagia can lead to significant mortality (e.g., stomach rupture, choking, accidental death due to food seeking behavior) and longer term, co-morbidities such as diabetes, obesity, and cardiovascular disease.

INDICATION
VYKAT XR (diazoxide choline) extended-release tablets is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS).

IMPORTANT SAFETY INFORMATION

Contraindications
Use of VYKAT XR is contraindicated in patients who have a known hypersensitivity to diazoxide, other components of VYKAT XR, or to thiazides.

Warnings and Precautions

Hyperglycemia
Hyperglycemia, including diabetic ketoacidosis, has been reported. Before initiating VYKAT XR, test fasting plasma glucose (FPG) and HbA1c; optimize blood glucose in patients who have hyperglycemia. During treatment, regularly monitor fasting glucose (FPG or fasting blood glucose) and HbA1c. Monitor fasting glucose more frequently during the first few weeks of treatment in patients with risk factors for hyperglycemia.

Risk of Fluid Overload
Edema, including severe reactions associated with fluid overload, has been reported. Monitor for signs or symptoms of edema or fluid overload. VYKAT XR has not been studied in patients with compromised cardiac reserve and should be used with caution in these patients.

Adverse Reactions
The most common adverse reactions (incidence ≥10% and at least 2% greater than placebo) included hypertrichosis, edema, hyperglycemia, and rash.

Please see the full Prescribing Information, including Medication Guide.

About Soleno Therapeutics, Inc.
Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The Company’s first commercial product, VYKAT XR (diazoxide choline) extended-release tablets, formerly known as DCCR, is a once-daily oral treatment for hyperphagia in adults and children 4 years of age and older with Prader-Willi syndrome. For more information, please visit www.soleno.life.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including those described in the company’s prior press releases and in the periodic reports it files with the SEC including its Annual Report on Form 10-K which it intends to release later today. The events and circumstances reflected in the company’s forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, the company does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Corporate Contact:
Brian Ritchie
LifeSci Advisors, LLC
212-915-2578

Cellectar Biosciences to Report Full Year Financial Results and Host a Conference Call on Wednesday, March 4, 2026




Cellectar Biosciences to Report Full Year Financial Results and Host a Conference Call on Wednesday, March 4, 2026

FLORHAM PARK, N.J., Feb. 25, 2026 (GLOBE NEWSWIRE) — Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced that the Company will report financial results for the full year ended December 31, 2025, and provide a corporate update on March 4, 2026, at 8:30 a.m. Eastern Time.

A replay of the corporate presentation will be available on the Events section of the Company’s Investor Relations website.

About Cellectar Biosciences, Inc.
Cellectar Biosciences is a late-stage clinical radiopharmaceutical company focused on the discovery and development of proprietary drugs for the treatment of cancer. The company’s core objective is to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop the next-generation of cancer cell-targeting treatments that deliver improved efficacy and better safety.

The company’s product pipeline includes its lead assets: iopofosine I 131, a PDC designed to provide targeted delivery of iodine-131 (radioisotope) for the treatment of hematologic and solid tumor cancers such as Waldenstrom’s macroglobulinemia (WM) and pediatric high grade gliomas; CLR 121125 (CLR 125), an iodine-125 Auger-emitting program targeting solid tumors, such as triple negative breast, lung and colorectal cancers; CLR 121225 (CLR 225), an actinium-225 based program targeting solid tumors with significant unmet need, such as pancreatic cancer; and proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets.

Iopofosine I 131 has been studied in Phase 2b trials for relapsed or refractory WM and multiple myeloma (MM), non-Hodgkin’s lymphomas and central nervous system (CNS) lymphoma, and the CLOVER-2 Phase 1b study, targeting pediatric patients with high-grade gliomas, for which Cellectar is eligible to receive a Pediatric Review Voucher from the FDA upon approval. The FDA has granted iopofosine I 131 Breakthrough Therapy, six Orphan Drug, five Rare Pediatric Drug and two Fast Track Designations for various cancer indications. The European Medicines Agency (EMA) has also granted iopofosine I 131 PRIME and orphan drug designations for the treatment of WM.

For more information, please visit www.cellectar.com or join the conversation by liking and following us on the company’s social media channels: X, LinkedIn, and Facebook.

Investor Contact:
Anne Marie Fields
Precision AQ
212-362-1200
annemarie.fields@precisionaq.com

Rivus Pharmaceuticals Appoints Jorge Bartolome as Chief Executive Officer




Rivus Pharmaceuticals Appoints Jorge Bartolome as Chief Executive Officer