Market Newsdesk

Clearmind Medicine has received Independent Data and Safety Monitoring Board (DSMB) approval to advance its clinical evaluation of CMND
‑
100 in patients with Alcohol Use Disorder (AUD) – a key milestone in the progression of the Company
’
s clinical development program.

Vancouver, Canada, Aug. 13, 2026 (GLOBE NEWSWIRE) — Clearmind Medicine Inc. (Nasdaq: CMND) (the “Company”), a clinical-stage biotech company focused on the discovery and development of novel, non-hallucinogenic, second generation, neuroplastogen-derived therapeutics to solve major under-treated health problems, such as addictions and weight-loss, recently  announced that its independent DSMB has unanimously approved advancing the Company’s ongoing FDA-regulated Phase I/II clinical trial to parts B and C (the two of the remaining 3 parts) of the clinical trial, evaluating CMND-100 in patients actively suffering from AUD as well as in healthy participants. The DSMB’s approval follows the successful completion of Part A of the study, where CMND-100 achieved its primary safety endpoint, demonstrating a favorable safety and tolerability profile across all planned dose levels in healthy participates. After reviewing the full safety dataset from Part A, the DSMB unanimously recommended advancing the study to Parts B and C in accordance with the previously approved study protocol.

Part B marks a key clinical milestone for Clearmind, as CMND100 will be evaluated for the first time in human patients  with moderate to severe AUD, unlike Part A that included only healthy participants. The part B phase will enroll, sequentially, two cohorts of six patients receiving 80 mg and 160 mg doses, respectively, and will assess safety, tolerability, and early signals of clinical activity, including CMND100’s potential to reduce alcohol consumption and craving. Part C will be conducted, concurrently with Part B, in healthy participants and will evaluate CMND‑100 at a fixed daily dose of 160 mg administered over five consecutive days. This double‑blind, placebo-controlled segment is expected to further characterize the safety and tolerability profile of CMND‑100.

“Receiving DSMB approval to advance our clinical trial to patients with AUD marks an important milestone for Clearmind,” said Dr. Adi Zuloff-Shani, Chief Executive Officer of Clearmind Medicine. ” With the successful demonstration of safety and tolerability throughout the dose-escalation phase of the study, we are now positioned to evaluate CMND-100 in the population it is designated to help. This transition represents a meaningful step toward advancing a potential new treatment option for individuals living with AUD.”

The Phase I/II clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy in reducing drinking patterns and alcohol craving in individuals with moderate to severe AUD of CMND-100. The study is being conducted at leading clinical sites, including Johns Hopkins University, Yale School of Medicine, Tel Aviv Sourasky Medical Center and Hadassah Medical Center.

The Company expects to provide additional updates as patient enrollment progresses and the clinical program advances.

About CMND-100 and Neuroplastogen Approach

CMND-100 is Clearmind’s proprietary oral formulation of MEAI (5-methoxy-2-aminoindane). The Company is developing it as a non-hallucinogenic neuroplastogen-derived candidate intended to promote adaptive neuroplasticity while avoiding the perceptual effects associated with classical psychedelics. This profile aims to support scalable treatment models that do not require intensive clinical supervision or prolonged monitored sessions.

About Clearmind Medicine Inc.

Clearmind is a clinical-stage neuroplastogens pharmaceutical biotech company focused on the discovery and development of non-hallucinogenic, second generation, neuroplastogen-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods, or supplements.

The Company’s intellectual portfolio currently consists of nineteen patent families, including 32 granted patents. The Company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio.

Shares of Clearmind are listed for trading on Nasdaq under the symbol “CMND.”

For further information, visit: https://www.clearmindmedicine.com or contact:

Investor Relations

[email protected]

www.Clearmindmedicine.com

Forward-Looking Statements:

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses the   timing and progress of its clinical trial, advancing a potential new treatment option for individuals living with AUD and the Company’s expectation to provide additional updates as patient enrollment progresses the clinical program advances. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report on Form 20-F for the fiscal year ended October 31, 2025 and subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Clearmind is not responsible for the contents of third-party websites.

NEW YORK, Aug. 13, 2026 (GLOBE NEWSWIRE) — IREN Limited (NASDAQ: IREN) (“IREN”) today announced that Horizon 1 has been delivered to and accepted by Microsoft, and that IREN has achieved NVIDIA Exemplar Cloud status on NVIDIA GB300 NVL72.

Horizon 1 is the first of four 50MW (IT load) direct-to-chip liquid cooled AI Cloud deployments scheduled for delivery to Microsoft at IREN’s Childress, Texas campus in 2026 under a five-year, $9.7bn cloud services contract announced in November 2025.

The rapid delivery of Horizon 1 to Microsoft reflects the agility of IREN’s vertically integrated model, which provides end-to-end control across design, engineering and construction of the data centers supporting its GPU deployments.

IREN’s Exemplar Cloud status was achieved following NVIDIA’s testing of its NVIDIA GB300 NVL72 deployment at Horizon 1. The designation demonstrates IREN’s ability to support demanding AI workloads with performance, reliability and scale.

IREN continues to target a broader expansion to 480MW (gross) AI Cloud capacity in 2026 and 1.2GW (gross) AI Cloud capacity in 2027.

Daniel Roberts, Co-Founder and Co-CEO of IREN, said:

“Delivering Horizon 1 demonstrates the strength of our vertically integrated model and our ability to execute complex AI infrastructure projects at speed and scale.

I want to congratulate and thank the more than 3,000 people across our site team whose expertise, commitment and execution made this milestone possible.

We look forward to building on this momentum with Microsoft as we work to deliver Horizons 2-4 later this year.”

About IREN

IREN is a vertically integrated AI Cloud platform, delivering data centers, compute and software for AI training and inference. IREN’s platform is underpinned by its expansive portfolio of land and grid-connected power in renewable-rich regions across North America, Europe and APAC.

Contacts

Investors

[email protected]

Media

[email protected]

Forward-Looking Statements

This news 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, that involve substantial risks and uncertainties. Forward-looking statements generally relate to future events or IREN’s future financial or operating performance. Forward-looking statements include information concerning possible or assumed future results of operations, including descriptions of our business plan and strategies, revenue targets, expectations regarding GPU deployment, expansion and build out of data center capacity, and trends we expect to affect our business. These statements often include words such as “anticipate,” “believe,” “may,” “can,” “should,” “could,” “might,” “plan,” “possible,” “project,” “strive,” “budget,” “forecast,” “expect,” “intend,” “target”, “will,” “estimate,” “predict,” “potential,” “continue,” “scheduled”. Forward-looking statements may also be made, verbally or in writing, by members of our Board or management team in connection with this news release.

These forward-looking statements are based on management’s current expectations and beliefs. These statements are neither promises nor guarantees, but involve and are subject to known and unknown risks, uncertainties and other important factors that may cause IREN’s actual results, performance or achievements to differ materially from any future results performance or achievements expressed or implied by the forward-looking statements, including IREN’s ability to successfully execute on its growth strategies and operating plans, achieve its targeted annualized AI Cloud revenue, continue to develop its existing data center sites, design and deploy direct-to-chip liquid cooling systems, and diversify and expand into the market for high performance computing solutions (including the market for cloud services and potential colocation services), along with other important factors discussed under the caption “Risk Factors” in IREN’s Annual Report on Form 10-K, filed with Securities and Exchange Commission (the “SEC”) on August 28, 2025 and our other filings with the SEC. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any forward-looking statement included in this press release speaks only as of the date of such statement. Except as required by law, IREN disclaims any obligation to update or revise, or to publicly announce any update or revision to, any of the forward-looking statements, whether as a result of new information, future events or otherwise.

Second quarter 2026 GAAP net investment income (“NII”) of $3.5 million, 

or $0.15 per weighted average share

WEST PALM BEACH, Fla., Aug. 13, 2026 (GLOBE NEWSWIRE) — Advanced Flower Capital Inc. (Nasdaq: AFCG) (“AFC,” or the “Company”) today announced its financial results for the second quarter ended June 30, 2026.

Second Quarter 2026 Highlights

• Total investment income of $8.7 million and GAAP NII of $3.5 million, or $0.15 per weighted average share
• Net asset value (“NAV”) per share of $8.25 as of June 30, 2026, compared with $7.90 as of March 31, 2026
• GAAP net increase in net assets resulting from operations of $5.4 million, or $0.23 per weighted average share
• Gross and net investment fundings of $17.2 million and $8.0 million, respectively
• Investment portfolio of $289.8 million at fair value across 17 portfolio companies, compared with $279.2 million as of March 31, 2026
• Weighted average yield on income producing debt investments of 13.2% as of June 30, 2026
• Debt-to-equity of 1.10x and net debt-to-equity of 0.53x; total available liquidity of over $70 million
• Repurchased 839,406 shares at a weighted average price of $3.29, generating $0.17 per share of NAV accretion in connection with our recently adopted Share Repurchase Program (as defined below)

“AFC generated net investment income of $0.15 per weighted average share in the second quarter. NAV per share increased to $8.25, including $0.17 of accretion from repurchasing shares at a substantial discount to NAV. We remained selective in the attractive lower middle-market and will continue to prioritize credit quality and risk-adjusted returns,” said Dan Neville, Chief Executive Officer.

Common Stock Distribution

On July 15, 2026, the Company paid a regular cash distribution of $0.05 per common share for the second quarter of 2026 to shareholders of record as of June 30, 2026.

Share Repurchase Program

On May 4, 2026, the Company’s Board of Directors (the “Board”) authorized a program for the purpose of repurchasing up to $5.0 million of the Company’s common stock (the “Repurchase Program”). Under the Repurchase Program, the Company may, but is not obligated to, repurchase its outstanding common stock in the open market from time to time, subject to certain limitations and applicable law. Unless amended or extended by the Company’s Board, the Company expects the Repurchase Program to be in place until the earlier of such time that $5.0 million of the Company’s outstanding shares of common stock have been repurchased, or May 4, 2027.

During the quarter, AFC repurchased and extinguished 839,406 shares at a weighted average price of $3.29, or approximately $2.8 million in the aggregate, generating $0.17 per share of NAV accretion.

Operating Results

(1) Total operating expenses and income tax expense is presented net of the management fee rebate of $176,420 and $233,988 for the three months ended June 30, 2026 and March 31, 2026, respectively.

Amounts may not sum due to rounding.

Portfolio and Investment Activity

As of June 30, 2026, AFC’s investment portfolio had a fair value of $289.8 million across 17 portfolio companies in 4 industries, compared with $279.2 million across 15 portfolio companies as of March 31, 2026. Senior secured first lien debt investments represented 100% of the portfolio at fair value.

During the second quarter, AFC funded $17.2 million, including $5.1 million to two new portfolio companies and $12.1 million to two existing portfolio companies. Net fundings were $8.0 million after $9.2 million of repayments, amortization, and sale proceeds.

Liquidity and Capital Resources

As of June 30, 2026, AFC had $207.0 million of debt outstanding, including $110.0 million under its secured revolving credit facility, $20.0 million under its unsecured revolving credit facility with an affiliate, and $77.0 million of senior unsecured notes. The weighted average interest rate on debt outstanding was 6.3% for the quarter.

Debt-to-equity was 1.10x as of June 30, 2026, compared with 1.09x as of March 31, 2026. Net debt-to-equity was 0.53x, compared with 0.48x. Asset coverage was 190%, compared with 191%.

Additional Information

AFC issued a presentation of its second quarter 2026 results, titled “Second Quarter 2026 Earnings Presentation,” which can be viewed on the Investor Relations section of AFC’s website found here AFC — Investor Relations. The Company also filed its Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, with the Securities and Exchange Commission (the “SEC”) on August 13, 2026.

AFC routinely posts important information for investors on its website here. The Company intends to use this webpage as a means of disclosing material information, for complying with our disclosure obligations under Regulation FD and to post and update investor presentations and similar materials on a regular basis. AFC encourages investors, analysts, the media and others interested in AFC to monitor the Investor Relations section of its website, in addition to following its press releases, SEC filings, public conference calls, presentations, webcasts and other information posted from time to time on the website. To sign-up for email-notifications, please visit the “Email Alerts” section of the website under the “IR Resources” section.

Conference Call & Discussion of Financial Results

AFC will host a conference call at 10:00 a.m. (Eastern Time) on Thursday, August 13, 2026, to discuss its quarterly financial results. All interested parties are welcome to participate. The call will be available through a live audio webcast at the Investor Relations section of AFC’s website found here AFC — Investor Relations. To participate via telephone, please register in advance at this link. 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. The complete webcast will be archived for 90 days on the Investor Relations section of AFC’s website.

AFC distributes its earnings releases via its website and email lists. Those interested in receiving firm updates by email can sign up for them here.

About AFC

AFC (Nasdaq: AFCG) is a publicly traded business development company that provides flexible credit solutions to lower middle-market companies. The company primarily originates, structures, invests and manages direct senior debt investments, targeting companies generating annual EBITDA of $5 to $50 million. The company seeks to maximize risk-adjusted returns for its stockholders with an opportunistic approach across all industries. AFC is headquartered in West Palm Beach, Florida. For additional information regarding the company, please visit www.afcbdc.com.

Forward-Looking Statements

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that reflect our current views and projections with respect to, among other things, future events and financial performance. Words such as “believes,” “expects,” “will,” “intends,” “plans,” “guidance,” “estimates,” “projects,” “anticipates,” and “future” or similar expressions are intended to identify forward-looking statements. These forward-looking statements, including statements about our future growth and strategies for such growth, are subject to the inherent uncertainties in predicting future results and conditions and are not guarantees of future performance, conditions or results. Certain factors, including our ability to maintain our status as a BDC; our ability to maintain our status under Subchapter M of the Internal Revenue Code of 1986, as amended, as a regulated investment company (“RIC”) and our qualification for tax treatment as a RIC; the ability of our adviser to locate suitable loan opportunities for us, monitor and actively manage our loan portfolio and implement our investment strategy; actual and potential conflicts of interest with our adviser and its affiliates; our being subject to regulations and SEC oversight as a BDC, including limits on affiliated transactions, co-investments, asset diversification requirements, and limits on issuance of debt; changes in interest rates and impacts of such changes on our results of operations, cash flows and the market value of our loans; and other factors could cause actual results and performance to differ materially from those projected in these forward-looking statements. More information on these risks and other potential factors that could affect our business and financial results is included in AFC’s filings with the SEC, including in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of AFC’s most recently filed periodic reports on Form 10-K, Form 10-Q and subsequent filings. New risks and uncertainties arise over time, and it is not possible to predict those events or how they may affect AFC. We do not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Investor Relations Contact

Robyn Tannenbaum
561-510-2293
[email protected]

Media Contact

Doug Allen
Dukas Linden Public Relations
646-722-6530
[email protected]

HOUSTON, Aug. 13, 2026 (GLOBE NEWSWIRE) — Intuitive Machines, Inc. (Nasdaq: LUNR, “Intuitive Machines,” or the “Company”), a leading space technology and infrastructure services company, today announced its financial results for the second quarter ended June 30, 2026.

Intuitive Machines CEO Steve Altemus said, “We delivered a strong quarter, highlighted by revenue over four times Q2 2025 as we executed across our programs, recorded unprecedented bookings and backlog, and positioned the Company for the next phase of growth.”

Highlights

• Closed Goonhilly Earth Station and COMSAT acquisition in August to expand our space‑to‑ground data services network configured to support missions across LEO, MEO, GEO, cislunar, and deep space environments

• Booked $920 million of awards in Q2 with an additional $300 million of awards in Q3 QTD across commercial, civil, and national security space customers

• Signed $600+ million contract for three commercial GEO satellites as commercial demand strength continues

• Awarded additional CLPS lander contract under NASA’s Moonbase program, Intuitive Machines’ sixth CLPS mission, for a standardized production lander

• Expanded YoY National Security revenue from
  3%
  to
  30%
  in Q2 2026; expect continued growth driven by an award in July for 18 spacecraft to support Accelerated Missile Defense Tranche 3 (“AMDT3”) Golden Dome constellation

• Contracted with NASA for two prime lunar reconnaissance awards (Lunar Reconnaissance Orbiter Camera “LROC” and ShadowCam) to lead lunar imaging operations, data storage, data processing, and analytics in support of NASA’s Artemis Program / Moonbase Initiatives and commercial lunar missions
  

Financial Highlights

• Achieved record quarterly revenue of
  $206 million
  driven by spacecraft production, CLPS, OMES, and NSNS execution

• Ended Q2 with a strong cash balance of
  $367 million
  ; Q2 included strategic growth investments through the procurement of advanced inventory that directly resulted in new awards during the quarter; additional investments were made across our ground station network, along with long-lead material purchases for satellites two through five of our lunar constellation, as we look to accelerate NSNS recurring service revenues

• Ended Q2 with record backlog of
  $1.8 billion
  , an increase of
  $1.5 billion
  from year-end 2025 as Intuitive Machines booked record levels of diverse awards across commercial, civil, and national security space customers
  

Mr. Altemus continued, “We believe the next era of space will require a next-generation space prime, capable of building spacecraft, connecting them through resilient networks, and operating the resulting infrastructure across civil, commercial, and national security markets. Over the past eighteen months, every strategic decision we have made has been focused on building that next-generation space prime.”

Outlook

• Full-year 2026 revenue of $900 million – $1 billion
• Full-year 2026 Adjusted EBITDA positive

Conference Call Information

Intuitive Machines will host a conference call today, August 13, 2026, at 8:30 am Eastern Time to discuss these results. A link to the live webcast of the earnings conference call will be made available on the investors portion of the Intuitive Machines’ website at https://investors.intuitivemachines.com.

Following the conference call, a webcast replay will be available through the same link on the investors portion of the Intuitive Machines’ website at https://investors.intuitivemachines.com.

Key Business Metrics and Non-GAAP Financial Measures

In addition to the GAAP financial measures set forth in this press release, the Company has included certain financial measures that have not been prepared in accordance with generally accepted accounting principles (“GAAP”) and constitute “non-GAAP financial measures” as defined by the SEC. This includes adjusted EBITDA (“Adjusted EBITDA”).

Adjusted EBITDA is a key performance measure that our management team uses to assess the Company’s operating performance and is calculated as net income (loss) excluding results from non-operating sources including interest income or interest expense from cash deposits, loans, or investments, transaction and integration costs related to acquisitions, gain on extinguishing of debt, share-based compensation, change in fair value instruments, gain or loss on issuance of securities, other income/expense, depreciation, impairment of property and equipment, and provision for income taxes. Intuitive Machines has included Adjusted EBITDA because we believe it is helpful in highlighting trends in the Company’s operating results and because it is frequently used by analysts, investors, and other interested parties to evaluate companies in our industry.

Adjusted EBITDA has limitations as an analytical measure, and investors should not consider it in isolation or as a substitute for analysis of the Company’s results as reported under GAAP. Other companies, including companies in Intuitive Machines’ industry, may calculate Adjusted EBITDA differently, which reduces its usefulness as a comparative measure. Because of these limitations, you should consider Adjusted EBITDA alongside other financial performance measures, including various cash flow metrics, net income (loss) and our other GAAP results. A reconciliation of Adjusted EBITDA to the most directly comparable GAAP financial measure is included below under the heading “Reconciliation of GAAP to Non-GAAP Financial Measure.”

We define free cash flow as net cash (used in) provided by operating activities less purchases of property and equipment. We believe that free cash flow is a meaningful indicator of liquidity that provides information to management and investors about the amount of cash generated from operations that, after purchases of property and equipment, can be used for strategic initiatives, including continuous investment in our business and strengthening our balance sheet. Free Cash Flow has limitations as a liquidity measure, and you should not consider it in isolation or as a substitute for analysis of our cash flows as reported under GAAP. Some of these limitations are: Free Cash Flow is not a measure calculated in accordance with GAAP and should not be considered in isolation from, or as a substitute for financial information prepared in accordance with GAAP; Free Cash Flow may not be comparable to similarly titled metrics of other companies due to differences among methods of calculation; and Free Cash Flow may be affected in the near to medium term by the timing of capital investments, fluctuations in our growth and the effect of such fluctuations on working capital and changes in our cash conversion cycle. A reconciliation of Free Cash Flow to the most directly comparable GAAP financial measure is included below under the heading “Reconciliation of GAAP to Non-GAAP Financial Measure.”

The Company has also included contracted backlog, which is defined as the total estimate of the revenue the Company expects to realize in the future as a result of performing work on awarded contracts, less the amount of revenue the Company has previously recognized. Intuitive Machines monitors its backlog because we believe it is a forward-looking indicator of potential sales which can be helpful to investors in evaluating the performance of its business and identifying trends over time.

About Intuitive Machines

Intuitive Machines is a next-generation space infrastructure company delivering integrated capabilities across spacecraft manufacturing, communications, networks, mission operations, and ground infrastructure to build, connect, and operate systems across Earth orbit, cislunar space, and deep space. Serving commercial, civil, and national security customers, Intuitive Machines is focused on enabling resilient, scalable infrastructure for sustained operations in space.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements that do not relate to matters of historical fact should be considered forward looking. These forward-looking statements generally are identified by the words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “strive,” “would,” “strategy,” “outlook,” the negative of these words or other similar expressions, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include but are not limited to statements regarding: our expectations and plans related to any proposed business combination; our expectations and plans relating to our missions to the Moon, including the expected timing of launch and our progress in preparation thereof; our expectations with respect to, among other things, demand for our product portfolio, our submission of bids for contracts; our expectations regarding revenue for government contracts awarded to us; our expectations regarding changes to government contracts or programs; our operations, our financial performance and our industry; our business strategy, business plan, and plans to drive long-term sustainable shareholder value; information under “Outlook,” or “Guidance” including, our expectations on revenue generation, backlog and cash. These forward-looking statements reflect the Company’s predictions, projections, or expectations based upon currently available information and data. Our actual results, performance or achievements may differ materially from those expressed or implied by the forward-looking statements, and you are cautioned not to place undue reliance on these forward looking statements. The following important factors and uncertainties, among others, could cause actual outcomes or results to differ materially from those indicated by the forward-looking statements in this presentation: our reliance upon the efforts of our Board and key personnel to be successful; our limited operating history; our failure to manage our growth effectively; competition from existing or new companies; unsatisfactory safety performance of our spaceflight systems or security incidents at our facilities; cyber incidents; failure of the market for commercial spaceflight to achieve the growth potential we expect; any delayed launches, launch failures, failure of our satellites or lunar landers to reach their planned orbital locations, significant increases in the costs related to launches of satellites and lunar landers, and insufficient capacity available from satellite and lunar lander launch providers; our customer concentration; risks associated with commercial spaceflight, including any accident on launch or during the journey into space; risks associated with the handling, production and disposition of potentially explosive and ignitable energetic materials and other dangerous chemicals in our operations; our reliance on a limited number of suppliers for certain materials and supplied components; failure of our products to operate in the expected manner or defects in our products; counterparty risks on contracts entered into with our customers and failure of our prime contractors to maintain their relationships with their counterparties and fulfill their contractual obligations; failure to successfully defend protest from other bidders for government contracts; failure to comply with various laws and regulations relating to various aspects of our business and any changes in the funding levels of various governmental entities with which we do business; our failure to protect the confidentiality of our trade secrets and know how; our failure to comply with the terms of third-party open source software our systems utilize; our ability to maintain an effective system of internal control over financial reporting, and to address and remediate material weaknesses in our internal control over financial reporting; the U.S. government’s budget deficit and the national debt, as well as any inability of the U.S. government to complete its budget process for any government fiscal year, and our dependence on U.S. government contracts and funding by the government for the government contracts; our failure to comply with U.S. export and import control laws and regulations and U.S. economic sanctions and trade control laws and regulations; uncertain global macro-economic and political conditions and rising inflation; our history of losses and failure to achieve profitability and our need for substantial additional capital to fund our operations; the fact that our financial results may fluctuate significantly from quarter to quarter; our holding company status; the risk that our business and operations could be significantly affected if it becomes subject to any litigation, including securities litigation or stockholder activism; our public securities’ potential liquidity and trading; and other public filings and press releases other factors detailed under the section titled Part I, Item 1A. Risk Factors of our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 filed with the Securities and Exchange Commission (the “SEC”), the section titled Part I, Item 2, Management’s Discussion and Analysis of Financial Condition and Results of Operations and the section titled Part II. Item 1A. “Risk Factors” in our most recently filed Quarterly Report on Form 10-Q, and in our subsequent filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.

These forward-looking statements are based on information available as of the date of this presentation and current expectations, forecasts, and assumptions, and involve a number of judgments, risks, and uncertainties. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date, and we do not undertake any obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events, or otherwise, except as may be required under applicable securities laws.

Contacts

For investor inquiries:
[email protected]

For media inquiries:
[email protected]

INTUITIVE MACHINES, INC.

Condensed Consolidated Statements of Operations

(In thousands)

(Unaudited)

Adjusted EBITDA

The following table presents a reconciliation of net loss, the most directly comparable financial measure presented in accordance with GAAP, to Adjusted EBITDA.

Free Cash Flow

We define free cash flow as net cash (used in) provided by operating activities less purchases of property and equipment. We believe that free cash flow is a meaningful indicator of liquidity that provides information to management and investors about the amount of cash generated from operations that, after purchases of property and equipment, can be used for strategic initiatives, including continuous investment in our business and strengthening our balance sheet.

Free Cash Flow has limitations as a liquidity measure, and you should not consider it in isolation or as a substitute for analysis of our cash flows as reported under GAAP. Some of these limitations are:

• Free Cash Flow is not a measure calculated in accordance with GAAP and should not be considered in isolation from, or as a substitute for financial information prepared in accordance with GAAP.
• Free Cash Flow may not be comparable to similarly titled metrics of other companies due to differences among methods of calculation.
• Free Cash Flow may be affected in the near to medium term by the timing of capital investments, fluctuations in our growth and the effect of such fluctuations on working capital and changes in our cash conversion cycle.

The following table presents a reconciliation of net cash used in operating activities, the most directly comparable financial measure presented in accordance with GAAP, to free cash flow:

Backlog

The following table presents our backlog as of the periods indicated:

Backlog increased by $1.55 billion as of June 30, 2026 compared to December 31, 2025, which includes $612.8 million of acquired backlog associated with the Lanteris acquisition in January 2026, new awards of $1.34 billion primarily associated with a multi-satellite program in support of three commercial satellites, for which we received a $45.0 million authority to proceed and recorded backlog reflecting an estimated total program value of more than $600.0 million. Additionally, we recognized new awards or expanded contract values for the IM-5 and IM-6 missions, the NSN contract, a government defense contract, and various other contract award. These increases were partially offset by continued performance on existing contracts of $392.9 million, and several adjustments of $15.5 million mostly related to the descoping of a rideshare contract associated with the IM-4 mission.

This press release was published by a CLEAR® Verified individual.

Registrational RESET-Myositis

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clinical data on track to be reported in mid-2027 to support 2H27 BLA submission for rese-cel

Juvenile myositis Phase 1/2 data expected to be submitted with BLA to support potential FDA Priority Review Voucher

Registrational RESET-SSc

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enrollment in approximately 25 patients with SSc-associated interstitial lung disease anticipated to initiate in 4Q26

PC-free approach being incorporated in RESET-MG

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based on emerging insights from PC-free RESET-SLE

^®

and RESET-PV

^®

cohorts and previously reported Phase 1/2 clinical data

Pursuing expansion of outpatient dosing option for rese-cel within the RESET™ clinical development program based in part on favorable safety data reported at EULAR 2026

ElevateBio selected as second CDMO for clinical and commercial manufacturing of rese-cel

PHILADELPHIA, Aug. 13, 2026 (GLOBE NEWSWIRE) — Cabaletta Bio, Inc. (Nasdaq: CABA), a late-stage clinical biotechnology company focused on developing and launching curative targeted cell therapies designed specifically for patients with autoimmune diseases, today reported financial results for the second quarter ended June 30, 2026, and provided a business update.

“A single infusion of rese-cel has demonstrated the potential to deliver deep, clinical responses after discontinuation of all immunomodulators with up to 1.5 years of follow-up as reported in the most recent Phase 1/2 clinical experience. Continued expansion of the outpatient dosing option with rese-cel remains a top priority, and we believe the reported safety profile supports its incorporation across the RESET clinical development program,” said Steven Nichtberger, M.D., Chief Executive Officer of Cabaletta. “Additionally, we view the product design and development characteristics of rese-cel, including the use of a fully-human CAR construct, weight-based dosing, and a well-characterized manufacturing process, to have contributed to the compelling clinical outcomes reported in adult and juvenile patients across multiple autoimmune diseases. As we progress rese-cel through and into registrational trials for myositis and systemic sclerosis, respectively, we are also particularly encouraged by the reported PC-free data in lupus and PV patients which have prompted us to incorporate the PC-free approach in RESET-MG.”

Recent Operational Highlights and Anticipated Upcoming Milestones

Resecabtagene autoleucel (rese-cel) for autoimmune diseases

Cabaletta is advancing rese-cel as an investigational CAR T cell therapy designed to reset the immune system in patients living with autoimmune diseases. Following a single, weight-based intravenous infusion after discontinuation of immunomodulators, rese-cel has shown the ability to deliver an immune system reset in treated patients across multiple autoimmune diseases, leading to compelling clinical outcomes that have persisted over time. Cabaletta is evaluating rese-cel across the RESET (REstoring SElf-Tolerance) clinical development program, which includes multiple ongoing company-sponsored trials in rheumatology, neurology, and dermatology with disease-specific cohorts designed to evolve directly into registrational studies. Cabaletta is also advancing a program of innovations to broaden and deepen the treatment potential of rese-cel across autoimmune diseases.

Registrational RESET-Myositis data on track for mid-2027 to support first potential BLA submission for rese-cel in 2H27

• Cabaletta continues to anticipate reporting data from the registrational, 17-patient dermatomyositis (DM) and antisynthetase syndrome (ASyS) cohort in mid-2027, including 14 adult DM patients and 3 adult ASyS patients. If successful, Cabaletta plans to submit its first Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in 2H27, inclusive of data from the registrational cohort and the juvenile cohort which may facilitate the potential to be granted a Priority Review Voucher.
• At the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress, Cabaletta presented Phase 1/2 data demonstrating that 80% (8/10) of evaluable adult DM and ASyS patients would have met the primary endpoint of the registrational cohort, with all DM responders maintaining their responses through up to 1.5 years of follow-up. Cabaletta also reported that the first juvenile DM patient achieved an immunomodulator-free moderate Total Improvement Score response at 16 weeks, which was maintained through latest follow-up at 32 weeks.
• Across all 17 RESET-Myositis Phase 1/2 patients reported at EULAR 2026, 100% experienced no or Grade 1 (fever) cytokine release syndrome (CRS) and none experienced immune effector cell-associated neurotoxicity syndrome (ICANS), reinforcing a safety profile supportive of the outpatient dosing option already incorporated in the trial.

SSc-associated ILD selected as second registrational cohort to initiate in 4Q26

• Based on complete RESET-SSc Phase 1/2 cohort data and FDA feedback, Cabaletta is preparing to conduct a single-arm registrational study in a new cohort of approximately 25 patients with systemic sclerosis (SSc)-associated interstitial lung disease (ILD) using a forced vital capacity-based primary endpoint at 52 weeks. Cabaletta anticipates initiating this study in 4Q26.
• Updated data from RESET-SSc presented at the EULAR 2026 Congress demonstrated that patients showed overall improvement in skin and improvement in lung disease activity, achieving clinical responses while off immunomodulators and off or tapering steroids that appeared to increase in magnitude with longer follow-up.

PC-free approach being incorporated in RESET-MG and enrolling in higher-dose cohorts in RESET-PV and RESET-SLE

• Based on complete RESET-MG Phase 1/2 cohort data shared at the American Academy of Neurology Annual Meeting in April 2026 and emerging insights from the broader preconditioning (PC)-free program for rese-cel, Cabaletta is incorporating dose exploration with PC-free rese-cel in RESET-MG. In addition, rese-cel was granted Regenerative Medicine Advanced Therapy designation by the FDA for the treatment of generalized myasthenia gravis, building on this designation already granted to rese-cel as a potential treatment for myositis, systemic sclerosis, and lupus.
• Cabaletta presented PC-free data from RESET-PV at the American Society of Gene & Cell Therapy (ASGCT) 2026 Annual Meeting, with findings published in Blood, and from RESET-SLE at the EULAR 2026 Congress. Across both trials, rese-cel exhibited a predictable translational profile consistent with observations in patients treated with rese-cel and preconditioning. Based on the reported clinical findings, Cabaletta believes the lowest dose of rese-cel may represent a threshold dose in both trials and is advancing higher-dose cohorts in each trial.

Manufacturing partnerships expanded for long-term supply chain resiliency at scale

• Cabaletta has partnered with ElevateBio as an additional contract development and manufacturing organization (CDMO) partner alongside Lonza, adding capacity and supply chain security to support the anticipated scale of demand for rese-cel across autoimmune indications. Cabaletta expects ElevateBio and Lonza to support the transition from clinical to commercial supply using our substantially closed and partially automated process with increased capacity that was implemented prior to registrational evaluation of rese-cel.
• As part of its automated manufacturing strategy, Cabaletta announced a 10-year commercial supply agreement with Cellares in April 2026. The agreement enables Cabaletta to leverage Cellares’ automated manufacturing capabilities to supply thousands of rese-cel batches per year with minimal capital investment and at a per batch cost anticipated to be among the lowest in the industry for autologous cell therapy production. At ASGCT 2026, translational data were presented demonstrating that rese-cel manufactured using the Cellares Cell Shuttle™ platform produces comparable CAR T cell expansion and B cell depletion kinetics relative to current clinical manufacturing processes, providing further proof of concept in addition to product comparability data for the Cellares automated manufacturing approach.

Second Quarter 2026 Financial Results

• Research and development expenses were $44.4 million for the three months ended June 30, 2026, compared to $37.6 million for the same period in 2025.
• General and administrative expenses were $7.6 million for the three months ended June 30, 2026, compared to $8.3 million for the same period in 2025.
• As of June 30, 2026, Cabaletta had cash, cash equivalents, and short-term investments of approximately $225.1 million, inclusive of net proceeds from the May 2026 registered direct offering, compared to $133.6 million as of December 31, 2025. The Company expects that its cash position as of June 30, 2026, will enable it to fund its operating plan into mid-2027.

About Cabaletta Bio

Cabaletta Bio (Nasdaq: CABA) is a late-stage clinical biotechnology company focused on developing and launching curative targeted cell therapies designed specifically for patients with autoimmune diseases. Cabaletta’s lead product candidate, rese-cel, is an investigational 4-1BB-containing fully human CD19-CAR T cell therapy being advanced across the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, visit www.cabalettabio.com and connect with us on LinkedIn.

Forward-Looking Statements

This press release contains “forward-looking statements” of Cabaletta Bio within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including without limitation, express or implied statements regarding: Cabaletta’s business plans and objectives as a whole; Cabaletta’s ability to realize its vision of launching curative targeted cell therapies designed specifically for patients with autoimmune diseases; Cabaletta’s ability to successfully complete research and further development and commercialization of its drug candidates in current or future indications, including the timing and results of Cabaletta’s clinical trials and its ability to conduct and complete clinical trials; expectation that clinical results will support rese-cel’s safety and activity profile; statements regarding the timing of interactions with the FDA, including review of safety information from Cabaletta’s ongoing clinical trials and discussions with the FDA on potential registrational pathways for rese-cel, including the timing and acceptance of registrational designs related thereto; Cabaletta’s expectations regarding the timing of topline data from the registrational DM/ASyS cohort in mid-2027 and its plans to submit a BLA for rese-cel in myositis, inclusive of adult and juvenile DM data, in 2H27; Cabaletta’s expectations regarding the potential eligibility for a Priority Review Voucher based on Rare Pediatric Disease Designation for juvenile DM; Cabaletta’s plans regarding the initiation of a SSc-associated ILD registrational program in 4Q26; significance of the clinical data read-out at upcoming scientific meetings and timing thereof; Cabaletta’s expectations around the potential success and therapeutic benefits of rese-cel; the advancement of clinical trials of rese-cel in patients with SLE, myositis, SSc, gMG and PV and advancement of the RESET-MS trial, including updates related to status, enrollment, safety data, trial design and timing of data read-outs or otherwise; Cabaletta’s plans and expectations regarding the timing and results of clinical data from patients treated with rese-cel without preconditioning; Cabaletta’s plans to generate and report PC-free dose-ranging data across multiple autoimmune indications; Cabaletta’s expectations regarding the safety profile of rese-cel and its belief that such profile supports outpatient administration; Cabaletta’s plans to expand the outpatient dosing option across the RESET clinical development program; Cabaletta’s plans to advance rese-cel to potential commercial launch; Cabaletta’s expectations regarding its manufacturing strategies, including the anticipated transition from clinical to commercial supply and plans to implement automated manufacturing of rese-cel with Cellares; the anticipated benefits of the 10-year commercial supply agreement with Cellares; and Cabaletta’s use of capital, expense and other financial results in the future and its ability to fund operations into mid-2027.

Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events and are subject to a number of risks and uncertainties 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, but are not limited to: risks related to regulatory filings and potential clearance; the risk that preclinical or clinical data, including signs of biologic activity or clinical response, may not be predictive of long-term results or translate across programs; Cabaletta’s ability to demonstrate sufficient evidence of safety, efficacy and tolerability in its preclinical studies and clinical trials of rese-cel; the risk that the results observed with the similarly-designed construct employed in academic publications, including due to the dosing regimen, are not indicative of the results Cabaletta seeks to achieve with rese-cel; risks that modifications to trial design or approach may not have the intended benefits and that the trial design may need to be further modified; risks related to clinical trial site activation, delays in enrollment generally or enrollment rates that are lower than expected; delays related to assessment of clinical trial results; risks related to unexpected safety or efficacy data observed during clinical studies; risks related to volatile market and economic conditions and public health crises; Cabaletta’s ability to retain and recognize the intended incentives conferred by Orphan Drug Designation, Fast Track Designation, Regenerative Medicine Advanced Therapy Designation or other designations for its product candidates, as applicable; risks related to Cabaletta’s ability to protect and maintain its intellectual property position; risks related to fostering and maintaining successful relationships with Cabaletta’s collaboration and manufacturing partners; uncertainties related to the initiation and conduct of studies and other development requirements for its product candidates; the risk that any one or more of Cabaletta’s product candidates will not be successfully developed and/or commercialized; and the risk that the initial or interim results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Cabaletta’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Cabaletta’s most recent annual report on Form 10-K as well as discussions of potential risks, uncertainties, and other important factors in Cabaletta’s other subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Cabaletta undertakes no duty to update this information unless required by law.

Contacts

Investors: [email protected]
Media: [email protected]

STOUGHTON, Mass., Aug. 13, 2026 (GLOBE NEWSWIRE) — Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a leading biopharmaceutical company focused on improving the lives of people living with serious and often misunderstood conditions, today announced that it has entered into an Accelerated Share Repurchase (“ASR”) agreement with Jefferies LLC to repurchase $50 million of the Company’s common stock. Collegium will execute the ASR as part of the $150 million share repurchase program authorized by its Board of Directors in July 2025. Upon completion of this ASR, Collegium will have $100 million remaining under the program.

“Collegium’s strong financial position, rapidly growing ADHD portfolio and robust cash generation provide us with substantial flexibility to execute our disciplined capital allocation strategy,” said Vikram Karnani, President and Chief Executive Officer. “Given our confidence in the long-term growth trajectory of our ADHD portfolio and the expected durability of our pain business, we believe our current valuation does not fully reflect the strength of our business or our future prospects. Accordingly, we view this share repurchase program as a compelling opportunity to create long-term shareholder value. As we continue to grow, we remain committed to a balanced capital allocation strategy that includes investing behind our key growth drivers, further diversifying our portfolio, rapidly reducing debt and opportunistically repurchasing shares.”

Under terms of the agreement, Collegium will pay $50 million to Jefferies LLC and will receive an initial delivery of 1,556,420 shares, based on the $25.70 closing stock price of Collegium’s common stock on August 12, 2026, representing approximately 80% of the total shares the Company expects to repurchase under the ASR agreement. The final number of shares repurchased will be based on the volume-weighted average prices of Collegium’s common stock during the term of the ASR and subject to adjustments related to the terms and conditions of the ASR agreement. The final settlement of the ASR is expected to be completed no later than the fourth quarter of 2026. As of June 30, 2026, Collegium had approximately 32.5 million shares outstanding.

About Collegium Pharmaceutical, Inc.

Collegium Pharmaceutical is a dynamic, biopharmaceutical company delivering medicines with formulation and delivery innovation for people living with complex central nervous system and pain conditions. Collegium has spent more than a decade proving that responsible stewardship and bold, science-backed approaches can redefine what treatment looks like in categories too often shaped by complexity and misconceptions.

With a portfolio of differentiated ADHD medications, anchored by JORNAY PM^® (methylphenidate HCl) and AZSTARYS^® (serdexmethylphenidate and dexmethylphenidate), and an established leadership position in responsible pain management, Collegium leads with the scientific rigor and commercial expertise to deliver treatment options around how people live their lives. For more information, please visit collegiumpharma.com or find us on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “forecasts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, statements related to the share repurchase program, the transactions under the ASR and the expected completion date of the ASR, current and future market opportunities for our products and our assumptions related thereto, expectations (financial or otherwise) and intentions, and other statements that are not historical facts. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results, performance, or achievements to differ materially from the company’s current expectations, including risks relating to, among others: developments or changes in the securities markets and fluctuations in the trading volume and market price of the Company’s common stock; unknown liabilities; risks related to future opportunities and plans for our products, including uncertainty of the expected financial performance of such products; our ability to commercialize and grow sales of our products; our ability to manage our relationships with licensors; the success of competing products that are or become available; our ability to maintain regulatory approval of our products, and any related restrictions, limitations, and/or warnings in the label of our products; the size of the markets for our products, and our ability to service those markets; our ability to obtain reimbursement and third-party payor contracts for our products; the rate and degree of market acceptance of our products; the costs of commercialization activities, including marketing, sales and distribution; changing market conditions for our products; the outcome of any patent infringement or other litigation that may be brought by or against us; the outcome of any governmental investigation related to our business; our ability to secure adequate supplies of active pharmaceutical ingredient for each of our products and manufacture adequate supplies of commercially saleable inventory; our ability to obtain funding for our operations and business development; regulatory developments in the U.S.; our expectations regarding our ability to obtain and maintain sufficient intellectual property protection for our products; our ability to comply with stringent U.S. and foreign government regulation in the manufacture of pharmaceutical products, including U.S. Drug Enforcement Agency compliance; our customer concentration; and the accuracy of our estimates regarding expenses, revenue, capital requirements and need for additional financing. These and other risks are described under the heading “Risk Factors” in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other filings with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Investor Contact:

Ian Karp
Head of Investor Relations
[email protected]

Media Contact:

Jessica Cotrone
Senior Vice President, Corporate Communications & Corporate Affairs
[email protected]

‒ Q2 2026 Consolidated Revenue of 
$101.9 million
‒

‒ Q2 2026 Net Income of
$26.0 million
; Adjusted EBITDA of
$58.7 million
‒

‒
Company Maintains FY 2026 Revenue and Raises Adjusted EBITDA Guidance
‒

‒ Conference Call Scheduled for Today at 8:30 a.m. Eastern Time ‒

PARSIPPANY, N.J., Aug. 13, 2026 (GLOBE NEWSWIRE) — CorMedix Therapeutics (Nasdaq: CRMD) today announced financial results for the second quarter ended June 30, 2026, and provided an update on its business.

Recent Corporate Highlights:

• CorMedix announces $101.9 million of total revenue and grant income (“consolidated revenue”) for the second quarter of 2026, reflecting strong second quarter execution and positive underlying demand trends. The Company also recognized net income of $26.0 million and adjusted EBITDA of $58.7 million (1). Basic and fully diluted EPS were $0.33 and $0.29 per share, respectively, for the quarter.
• DefenCath® (taurolidine and heparin) sales contributed $66.1 million of net revenue in the second quarter, driven by continued utilization of DefenCath by large outpatient dialysis customers. The acquired Melinta portfolio contributed $35.8 million.
• CorMedix announced today that in collaboration with our global development partner Mundipharma, the company anticipates FDA submission of the sNDA for an expanded indication of REZZAYO for the prophylaxis of invasive fungal disease in the third quarter of this year. Provided the application is accepted for FDA review, the Company anticipates agency action on the application in H1 2027.
• The Company signed a new multi-year commercial supply agreement for DefenCath® with a Large Dialysis Operator (LDO), expanding the company’s commercial contract footprint to include all of the top 5 providers of dialysis services in the U.S. market. The LDO has commenced ordering of DefenCath® and will begin a pilot in the third quarter this year.
• The Company maintains full-year 2026 consolidated revenue guidance of $325 to $345 million, and raises full-year adjusted EBITDA guidance to a range of $125 to $140 million. Cash OpEx guidance is narrowed to a range of $145 to $155 million.
• Cash and short-term investments, excluding restricted cash, at June 30, 2026 totaled $256.7 million.

Joseph Todisco, CorMedix Chairman & CEO, commented, “CorMedix delivered a strong second quarter, generating $101.9 million in consolidated revenue and $58.7 million of adjusted EBITDA, reflecting continued execution across our business. We remain confident in our full-year 2026 outlook and our revenue and adjusted EBITDA guidance as we continue to navigate the post-TDAPA reimbursement environment for DefenCath with discipline and focus. We also made meaningful progress across our pipeline and expect the near-term submission of the REZZAYO sNDA for prophylaxis. With a strong balance sheet, meaningful cash position, and a disciplined capital allocation strategy, we believe CorMedix is well positioned to support our commercial priorities, advance high-value development programs, and create sustainable long-term value for shareholders.”

(1)   Adjusted EBITDA is a non-GAAP financial measure and excludes non-cash items such as depreciation, amortization, stock-based compensation, interest and other income and expense, taxes and certain non-recurring items.  See “Non-GAAP Financial Measures” on the following pages for additional information regarding the use of EBITDA and Adjusted EBITDA and a reconciliation to the most comparable GAAP measure.

Second Quarter 2026 Financial Highlights

For the second quarter of 2026, CorMedix recorded $101.9 million in consolidated revenue, comprised of $66.1 million in sales of DefenCath and $35.8 million associated with the acquired Melinta portfolio, an increase from $39.7 million in total revenue in the comparable period of 2025. DefenCath sales increased year over year largely due to the onboarding of a large dialysis organization in mid-2025. As the Melinta acquisition occurred in August 2025, the second quarter of 2025 included revenue from only sales of DefenCath.

Total operating expenses in the second quarter of 2026 were $34.2 million, compared with $18.3 million in the second quarter of 2025, an increase of approximately 87%. The increase of $15.9 million over the prior period was driven primarily by the contribution of operating expenses from the Melinta acquisition for the full quarter and reflects the larger combined company.

Research and development (R&D) expenses in the second quarter of 2026 were $6.7 million, compared with $2.4 million for the same period in 2025. The increase in R&D was primarily due to an increase in personnel and clinical trial services in support of the ongoing clinical programs, including pediatric studies for several brands and the continued investment in the development of DefenCath for the TPN indication.

Selling and marketing expense increased approximately 95% to $12.4 million in the second quarter of 2026 from $6.4 million in the second quarter of 2025. The increase was primarily due to higher personnel cost associated with the larger product portfolio and related marketing programs.

General and administrative expenses increased approximately 59% to $15.1 million in the second quarter of 2026 from $9.5 million in the second quarter of 2025. The increase was primarily attributable to higher costs associated with operating as a combined company following the acquisition, including branded prescription drug fees, and higher personnel, information technology, legal and facilities costs. This year-over-year increase in G&A was partially offset by the recognition of $4.2 million during the three months ended June 30, 2026, of expected insurance reimbursement of legal fees incurred by the Company to support its ongoing securities litigation. Of the $4.2 million credit recorded in the second quarter, $2.7 million related to legal fees that were incurred in prior periods.

CorMedix recorded net income of $26.0 million, or $0.33 and $0.29 per basic and diluted share, respectively, in the second quarter of 2026, compared with net income of $19.8 million, or $0.29 and $0.28 per basic and diluted share, respectively, in the second quarter of 2025. Also for the second quarter of 2026, CorMedix reported adjusted EBITDA of $58.7 million, compared to adjusted EBITDA of $22.4 million in the second quarter of 2025.

The Company reported cash and cash equivalents of $256.7 million at June 30, 2026, excluding restricted cash. The Company believes that it has sufficient resources to fund operations for at least twelve months from the issuance of the Company’s Quarterly Report on Form 10-Q.

Conference Call Information

CorMedix will host a conference call and webcast today, August 13, 2026, at 8:30AM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information are as follows:

August 13, 2026 @ 8:30am ET



Domestic: 1-844-676-2922 
International: 1-412-634-6840
Webcast: Webcast Link         

About CorMedix

CorMedix Therapeutics is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases in the United States. CorMedix is focused on selling and marketing products in institutional settings of care in the US and has field based medical and commercial infrastructure deployed in hospitals, clinics and infusion centers. For more information visit: www.cormedix.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, as amended (the “Exchange Act”), that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements including, but not limited to statements regarding financial and business guidance; sales, revenue and operating expense estimates; Adjusted EBITDA estimates; expectations regarding product utilization and sales; the risk that topline data from CorMedix’s and its partners’ clinical trials, including the ReSPECT study, that CorMedix announces or publishes from time to time may change as more patient data become available or may be interpreted differently if additional data is disclosed; estimates of total addressable market size; failure to successfully conduct future clinical trials, including due to CorMedix’s or its partners’ potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval, among other things; development of unexpected safety or efficacy concerns related to CorMedix’s product candidates; expectations and timing regarding clinical trials and development, performance expectations and revenue opportunities of CorMedix’s product pipeline; expectations regarding implementation and perceived benefits of CorMedix’s products; continued pricing pressures and the impact of actions of governmental and private payers affecting pricing of, reimbursement for, and patient access to pharmaceuticals and reporting obligations related thereto; the expiration of intellectual property protection for certain of the company’s products and competition from generic and biosimilar products. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its most recent Annual Report on Form 10-K, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. In addition, pro forma financial information does not necessarily reflect the actual results that we would have achieved had the pro forma transaction been consummated as of the date indicated nor does it reflect the potential future results of the combined company. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Non-GAAP Financial Measures

This release includes certain non-GAAP financial measures, including EBITDA and adjusted EBITDA, which are intended as supplemental measures of the Company’s performance that are not required by or presented in accordance with GAAP. Management uses these non-GAAP measures internally to evaluate and manage the Company’s operations and to better understand its business because they facilitate a comparative assessment of the Company’s operating performance relative to its performance based on results calculated under GAAP. These non-GAAP measures also isolate the effects of some items that vary from period to period without any correlation to core operating performance and eliminate certain charges that management believes do not reflect the Company’s operations and underlying operational performance.

The Company believes that these non-GAAP measures also provide useful information to investors regarding certain financial and business trends relating to the Company’s financial condition and operating results, which facilitates an evaluation of the financial performance of the Company and its operations on a consistent basis. Providing this information therefore allows investors to make independent assessments of the Company’s financial performance, results of operations and trends while viewing the information through the eyes of management.

These non-GAAP measures are subject to limitations. The non-GAAP measures presented in this release may not be comparable to similarly titled measures used by other companies because other companies may not calculate one or more in the same manner. Additionally, the non-GAAP performance measures exclude significant expenses and income that are required by GAAP to be recorded in the Company’s financial statements; do not reflect changes in, or cash requirements for, working capital needs. Further, our historical adjusted results are not intended to project our adjusted results of operations or financial position for any future period. To compensate for these limitations, management presents and considers these non-GAAP measures in conjunction with the Company’s GAAP results; no non-GAAP measure should be considered in isolation from or as alternatives to any measure determined in accordance with GAAP. Readers should review the reconciliations included below, and should not rely on any single financial measure to evaluate the Company’s business.

Investor Contact:

Dan Ferry
Managing Director
LifeSci Advisors
[email protected]
(617) 430-7576