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Bullish receives Gibraltar Financial Services Commission approval to offer trading in tokenized securities

Bullish receives Gibraltar Financial Services Commission approval to offer trading in tokenized securities

Approval positions Bullish among the first regulated venues to offer trading in issuer-sponsored tokenized securities.

CAYMAN ISLANDS–(BUSINESS WIRE)–Bullish (NYSE: BLSH), an institutionally focused global digital asset platform that provides market infrastructure and information services, today announced that it has received approval from the Gibraltar Financial Services Commission (GFSC) for tokenized securities. The approval marks a further milestone in the deepening collaboration between Bullish and Gibraltar to build regulated infrastructure for digital assets.

The approval builds on the ongoing collaboration between Bullish and the GFSC, which began in 2025, to explore regulated infrastructure for digital assets. It reflects Gibraltar’s continued leadership as the first jurisdiction globally to introduce a bespoke legal framework for firms using Distributed Ledger Technology (DLT).

“Gibraltar has once again shown how thoughtful regulation can unlock innovation. This approval allows us to bring the benefits of tokenization to securities markets within a robust, supervised framework, and continues the work we began with the GFSC to set a global standard for regulated digital asset markets,” said Tom Farley, CEO of Bullish Group.

The Hon Nigel Feetham KC MP, Minister for Financial Services, said: “Gibraltar is committed to being at the forefront of regulated innovation in financial services. We are pleased to deepen our relationship with Bullish and to support the responsible development of tokenised securities, reinforcing Gibraltar’s reputation as a quality financial center.”

Tokenized securities aim to bring the efficiencies of blockchain infrastructure to traditional capital markets. For traders and investors, tokenization can enable continuous 24/7 trading, near-instant settlement, and the ability to move assets without the multi-day delays of conventional post-trade processing. For issuers, it offers the prospect of a more direct relationship with their shareholders, greater transparency into ownership, and the potential to streamline corporate actions. By offering trading in tokenized securities within Gibraltar’s supervisory framework, Bullish intends to make these benefits available to eligible non-U.S. investors while maintaining the investor protections and regulatory oversight expected of established markets.

The approval advances Bullish’s broader strategy to build end-to-end infrastructure for tokenized securities. In May 2026, Bullish agreed to acquire Equiniti (EQ), a leading global transfer agent that serves as the system of record for nearly 3,000 issuer clients and supports more than 20 million shareholders. Once that transaction completes, the combined platform is designed to span the full lifecycle of a tokenized security, inclusive of issuance, registry, and trading, connecting the trusted record-keeping of a regulated transfer agent with Bullish’s blockchain and trading infrastructure. The GFSC approval adds a regulated venue for secondary trading to that vision.

Trading in tokenized securities is expected to go live in the coming weeks, subject to pre-go live conditions. Bullish will continue to work with the GFSC as it develops its tokenized securities offering, with further details to follow.

About Bullish:

Bullish (NYSE: BLSH) is an institutionally focused global digital asset platform that provides regulated market infrastructure and information services. This includes Bullish Exchange – an institutionally focused digital assets spot and derivatives exchange, integrating a high-performance central limit order book matching engine with automated market making to provide deep and predictable liquidity. Bullish Europe is regulated under MiCAR as a crypto asset service provider offering spot trading and custody services for digital assets.

Bullish is the parent company of CoinDesk, a leading provider of digital asset media and information services. CoinDesk’s offerings include: CoinDesk Indices – a collection of tradable proprietary and single-asset benchmarks and indices that track the performance of digital assets for global institutions in the digital assets and traditional finance industries; CoinDesk Data – a broad suite of digital asset market data and analytics, providing real-time insights into prices, trends and market dynamics; and CoinDesk Insights – a digital asset media and events provider and operator of coindesk.com, a digital media platform that covers news and insights about digital assets, the underlying markets, policy and blockchain technology. For more information, please visit bullish.com and follow LinkedIn and X.

Use Of Websites to Distribute Material Company Information:

We use the Bullish Investor Relations website (investors.bullish.com) and our X account (x.com/bullish) to publicize information relevant to investors, including information that may be deemed material, in addition to filings we make with the U.S. Securities and Exchange Commission (SEC) and press releases. We encourage investors to regularly review the information posted on our website and X account in addition to our SEC filings and press releases to be informed of the latest developments.

Forward Looking Statements:

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Sentences containing words such as “believe,” “intend,” “plan,” “may,” “expect,” “should,” “could,” “anticipate,” “estimate,” “predict,” “project,” or their negatives, or other similar expressions of a future or forward-looking nature generally should be considered forward-looking statements and include, without limitation, statements and information relating to the acquisition of Equiniti, the timing of, and our ability to obtain, maintain, and operate under, regulatory approvals, authorizations, licenses, registrations, and consents, including the expected timing of, and the satisfaction of pre-go-live and other conditions to, the commencement of trading in tokenized securities and the receipt of regulatory and other approvals required to complete the acquisition of Equiniti, the future financial or operating performance, business strategy, and potential market opportunity of Bullish, Equiniti or the combined companies, expectations related to the growth and adoption of tokenized securities and blockchain technology, future events or Bullish’s future financial or operating performance, business strategy, and potential market opportunity. Such forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Bullish, are inherently uncertain and are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause results to differ from those expressed in our forward-looking statements include, but are not limited to, the satisfaction of the conditions to closing the acquisition and combination in the anticipated timeframe or at all, the failure to obtain or maintain necessary regulatory approvals, licenses, and consents, including in connection with tokenized securities trading, and the risk that related pre-go live conditions are delayed, conditioned, withdrawn, or not satisfied on the anticipated timeline or at all, the ability to realize the anticipated benefits of the combination, the ability to successfully integrate the business, litigation or regulatory actions related to the acquisition and combination, disruption from the acquisition and combination and its impact on our ability to grow our business and operations, including in new geographic locations, the costs or expenditures associated therewith, competition in our industry, and the evolving rules and regulations applicable to digital assets, tokenization and our industry. You should not place undue reliance on any such forward-looking statements, which speak only as of the date they are made, and Bullish undertakes no duty to update these forward-looking statements.

[email protected]

KEYWORDS: United States Cayman Islands Caribbean North America Gibraltar Europe

INDUSTRY KEYWORDS: Blockchain Cryptocurrency Finance Asset Management Professional Services Technology Digital Cash Management/Digital Assets Other Technology

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Kolibri Global Energy Inc. Provides Strategy Update and Higher 2026 Forecast

Kolibri Global Energy Inc. Provides Strategy Update and Higher 2026 Forecast

All amounts are in US$

THOUSAND OAKS, Calif.–(BUSINESS WIRE)–
Kolibri Global Energy Inc. (the “Company” or Kolibri”) (TSX: KEI, NASDAQ: KGEI) is announcing an update to its long-term strategy along with a revised forecast based on updates to its 2026 drilling program.

Company Strategy

The Company’s strategy to date has been to mainly focus on developing the Lower Caney in the Company’s Tishomingo field in Oklahoma. However, the Company has long known that there are other benches in its field that are not currently reflected in the Company’s reserve report. It believes that, with modifications to its latest completion techniques, these benches can be economically developed. The Company has revised its strategy to include targeting these benches while continuing the development of the Lower Caney. These benches include the False Caney, the Upper Caney, the T-zone, and the Sycamore. The Company’s strategy will be to continue drilling mainly one and a half and two-mile lateral development wells in the Lower Caney formation while also drilling longer lateral wells into these additional benches to determine their economic viability.

The Company is adding an additional well to its 2026 drilling program, which will target the False Caney. The Upper Caney is likely to be the next bench targeted and may be drilled in late 2026 or early 2027. The Company will determine the next T-zone well and potentially test the Sycamore at a later date.

Operations & Corporate Update

The Company is currently drilling the three previously announced Clifton Mack wells. Immediately following the drilling of these wells, the drilling rig is scheduled to move over to drill the Lovina 5-8-1H well (98.5% working interest), which will be a two-mile lateral False Caney well.

The Clifton Mack 11-14-1HR well has been drilled and cased after being redrilled with a redesigned casing program. Unexpected geologic conditions were encountered in the drilling of the first Clifton Mack well, which resulted in the need to redrill and redesign the well with extra casing strings.

The Company is currently batch drilling the Clifton Mack 11-14-2HR and the Clifton Mack 11-14-3HR wells, with the learnings from the first Clifton Mack well being applied to these wells. The Clifton Mack wells are located in the Southwest corner of Kolibri’s acreage block and were probable locations on the Company’s December 2025 reserve report. The wells are planned to be completed in the third quarter.

Based on the updated plans, the Company is forecasting the following results, assuming a $70 oil price for the rest of the year. All amounts are in U.S. dollars:

 

2026 Base

Forecast

% Increase from

Fiscal Year 2025

 

 

 

Average production

4,700 to 5,200 boepd

17% to 30%

Revenue(1)

$78 million to $84 million

37% to 48%

Adjusted EBITDA(2)

$56 million to $62 million

33% to 47%

Capital Expenditures

$39 million to $43 million

 

Net Debt at December 2026

$38 million to $42 million

 

(1)

Assumptions include forecasted pricing for July – December 2026 of WTI US $70/bbl, $3.50 Henry Hub and NGL pricing of $28.00/boe and includes the impact of the Company’s existing hedges and a 100% working interest in the Clifton Mac wells.

(2)

Adjusted EBITDA is considered a non-GAAP measure. Refer to the section entitled “Non-GAAP Measures” of this news release

Wolf Regener, President and CEO, commented, “This revised forecast generates an Adjusted EBITDA of $56 to $62 million on capital expenditures of $39 to $43 million. Our forecasted revenue increases by over 40 percent from 2025 with this drilling program and is based on a future oil price of $70 per barrel (our previous forecast was based on $74 per barrel). This forecast not only demonstrates the Company’s strong cash flow generation, but it also reflects the beginning of our updated strategy to target other benches in the Tishomingo field. The forecast also accounts for the extra costs incurred in drilling and redrilling the first Clifton Mack well and the redesigned second and third Clifton Mack wells. These wells will be more expensive than our normal Caney well design due to the extra casing strings needed in this area. Although we encountered unexpected geologic conditions in drilling the first Clifton Mack well, the pressures we encountered are supportive of high production rates from the Clifton Mack wells. Our standard Caney well design will continue to be used in other areas of the field.

“I’m excited to announce our updated corporate strategy and that testing our first False Caney well, will happen soon, hopefully proving up a new bench. Successful results in these additional benches will have the potential to add many future drilling locations not currently booked, which would increase our reserves and thus value for our shareholders.”

David Neuhauser, Chairman, commented, “The Board, including its new members, who have extensive technical and financial experience, is fully supportive of Kolibri’s continued focus on increasing both production and reserves to further unlock intrinsic value for its shareholders through the drill bit. Being a low-cost energy producer in the heart of America is vital for future energy security and should command a premium valuation which we feel is not reflected in our current stock price.”

About Kolibri Global Energy Inc.

Kolibri Global Energy Inc. is a North American energy company focused on finding and exploiting energy projects in oil and gas. Through various subsidiaries, the Company owns and operates energy properties in the United States. The Company continues to utilize its technical and operational expertise to identify and acquire additional projects in oil and gas. The Company’s shares are traded on the Toronto Stock Exchange under the stock symbol KEI and on the NASDAQ under the stock symbol KGEI.

Cautionary Statements

In this news release and the Company’s other public disclosure:

  1. The Company’s natural gas production is reported in thousands of cubic feet (“Mcfs”). The Company also uses references to barrels (“Bbls”) and barrels of oil equivalent (“Boes”) to reflect natural gas liquids and oil production and sales. Boes may be misleading, particularly if used in isolation. A Boe conversion ratio of 6 Mcf:1 Bbl is based on an energy equivalency conversion method primarily applicable at the burner tip and does not represent a value equivalency at the wellhead. Given that the value ratio based on the current price of crude oil as compared to natural gas is significantly different from the energy equivalency of 6:1, utilizing a conversion on a 6:1 basis may be misleading as an indication of value.

  2. Discounted and undiscounted net present value of future net revenues attributable to reserves do not represent fair market value.

  3. Possible reserves are those additional reserves that are less certain to be recovered than probable reserves. There is a 10% probability that the quantities actually recovered will equal or exceed the sum of proved plus probable plus possible reserves.

  4. The Company discloses peak and 30-day initial production rates and other short-term production rates. Readers are cautioned that such production rates are preliminary in nature and are not necessarily indicative of long-term performance or of ultimate recovery.

  5. “Oil” refers to light crude oil and medium crude oil combined, and “natural gas” refers to shale gas, in each case as defined by NI 51-101. Production from our wells, primarily disclosed in this news release in BOEs, consists of mainly oil and associated wet gas. The wet gas is delivered via gathering system and then pipelines to processing plants where it is treated and sold as natural gas and NGLs.

Non-GAAP Measures

Adjusted EBITDA is not a measure recognized under Canadian Generally Accepted Accounting Principles (“GAAP“) and does not have any standardized meaning prescribed by IFRS. Management of the Company believes that Adjusted EBITDA is relevant for evaluating returns on the Company’s project as well as the performance of the enterprise as a whole. Adjusted EBITDA may differ from similar computations as reported by other similar organizations and, accordingly, may not be comparable to similar non-GAAP measures as reported by such organizations. Adjusted EBITDA should not be construed as an alternative to net income, cash flows related to operating activities, working capital, or other financial measures determined in accordance with IFRS as an indicator of the Company’s performance.

Adjusted EBITDA is calculated as net income before interest, taxes, depletion and depreciation and other non-cash and non-operating gains and losses. The Company considers this a key measure as it demonstrates its ability to generate cash from operations necessary for future growth excluding non-cash items, gains and losses that are not part of the normal operations of the Company and financing costs.

The following is the reconciliation of the non-GAAP measure Adjusted EBITDA to the comparable financial measures disclosed in the Company’s financial statements:

(US $000)

Year Ended

December 31,

2025

2024

Net income

$ 15,477

$ 18,115

Depletion and depreciation

17,038

15,892

Accretion

250

172

Interest expense

3,291

3,382

Unrealized (gain) loss on commodity contracts

32

(336)

Stock based compensation

1,744

1,075

Interest income

(31)

(2)

Income tax expense

4,868

5,864

Other income

(565)

(127)

Foreign currency loss

3

4
 

Adjusted EBITDA

$ 42,107

$ 44,039

Caution Regarding Forward-Looking Information

Certain statements contained in this news release constitute “forward-looking information” as such term is used in applicable Canadian securities laws and “forward-looking statements” within the meaning of United States securities laws (collectively, “forward looking information”), including statements regarding the Company’s revised corporate strategy of targeting additional benches on its Tishomingo field in Oklahoma, the timing of and expected results from planned wells development, wells performing as anticipated, including anticipated increases in production, cash flow, higher rates of return and efficiencies, projected average production, revenue, capital expenditures, Adjusted EBITDA and net debt for 2026, the Company’s internal estimates, forecasts, timing of completion and anticipated production regarding the Clifton Mack wells, the expectation that oil saturation and higher clay shale will be a frack barrier separating the False Caney from the main Caney formation, the expectation thatdrilling both Upper and Lower Caney wells will result in recovering more reserves from the field, the expectation that the T-zone can be produced economically without interfering with the Company’s production from the Lower Caney, and the anticipated drilling of the Upper Caney in late 2026 or early 2027. Forward-looking information is based on plans and estimates of management and interpretations of data by the Company’s technical team at the date the data is provided and is subject to several factors and assumptions of management, including that indications of early results are reasonably accurate predictors of the prospectiveness of the shale intervals, that required regulatory approvals will be available when required, that no unforeseen delays, unexpected geological or other effects, including flooding and extended interruptions due to inclement or hazardous weather conditions, equipment failures, permitting delays or labor or contract disputes are encountered, that the necessary labor and equipment will be obtained, that the development plans of the Company and its co-venturers will not change, that the offset operator’s operations will proceed as expected by management, that the demand for oil and gas will be sustained, that the price of oil will be sustained or increase, that the gathering system issues will be resolved, that the Company will continue to be able to access sufficient capital through cash flow, debt, financings, farm-ins or other participation arrangements to maintain its projects, and that global economic conditions will not deteriorate in a manner that has an adverse impact on the Company’s business, its ability to advance its business strategy and the industry as a whole. Forward-looking information is subject to a variety of risks and uncertainties and other factors that could cause plans, estimates and actual results to vary materially from those projected in such forward-looking information. Factors that could cause the forward-looking information in this news release to change or to be inaccurate include, but are not limited to, the risk that any of the assumptions on which such forward looking information is based vary or prove to be invalid, including that the Company or its subsidiaries is not able for any reason to obtain and provide the information necessary to secure required approvals or that required regulatory approvals are otherwise not available when required, that unexpected geological results are encountered, that equipment failures, permitting delays, labor or contract disputes or shortages of equipment, labor or materials are encountered, the risks associated with the oil and gas industry (e.g. operational risks in development, exploration and production; delays or changes in plans with respect to exploration and development projects or capital expenditures; the uncertainty of reserve and resource estimates and projections relating to production, costs and expenses, and health, safety and environmental risks, including flooding and extended interruptions due to inclement or hazardous weather conditions), the risk of commodity price and foreign exchange rate fluctuations, that the offset operator’s operations have unexpected adverse effects on the Company’s operations, that completion techniques require further optimization, that production rates do not match the Company’s assumptions, that very low or no production rates are achieved, that the gathering system operator doesn’t get the issues resolved, that the price of oil will decline, that the Company is unable to access required capital, that occurrences such as those that are assumed will not occur, do in fact occur, and those conditions that are assumed will continue or improve, do not continue or improve, and the other risks and uncertainties applicable to exploration and development activities and the Company’s business as set forth in the Company’s management discussion and analysis and its annual information form, both of which are available for viewing under the Company’s profile at www.sedarplus.ca, any of which could result in delays, cessation in planned work or loss of one or more leases and have an adverse effect on the Company and its financial condition. The Company undertakes no obligation to update these forward-looking statements, other than as required by applicable law.

Caution Regarding Future-Oriented Financial Information and Financial Outlook

This news release may contain information deemed to be “future-oriented financial information” or a “financial outlook” (collectively, “FOFI”) within the meaning of applicable securities laws. The FOFI has been prepared by management to provide an outlook of the Company’s activities and results and may not be appropriate for other purposes. The FOFI has been prepared based on a number of assumptions including the assumptions discussed above under “Caution Regarding Forward-Looking Information”. The actual results of operations of the Company and the resulting financial results may vary from the amounts set forth herein, and such variations may be material. The Company and management believe that the FOFI has been prepared on a reasonable basis, reflecting management’s best estimates and judgments. FOFI contained in this news release was made as of the date of this news release and the Company disclaims any intention or obligations to update or revise any FOFI contained in this news release, whether as a result of new information, future events or otherwise, unless required pursuant to applicable law.

For further information, contact:

Wolf E. Regener +1 (805) 484-3613

Email: [email protected]

Website: www.kolibrienergy.com

KEYWORDS: California North America United States Ireland United Kingdom Europe

INDUSTRY KEYWORDS: Oil/Gas Energy

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Merck Announces New Agreement with ADAP Crisis Task Force to Improve Access and Care for People Living with HIV

Merck Announces New Agreement with ADAP Crisis Task Force to Improve Access and Care for People Living with HIV

Agreement will help state ADAP programs provide access to IDVYNSO™ (doravirine/islatravir) for eligible individuals

RAHWAY, N.J.–(BUSINESS WIRE)–
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced an agreement with the ADAP Crisis Task Force (ACTF) to help state AIDS Drug Assistance Programs (ADAPs) provide access to the company’s new once-daily HIV treatment, IDVYNSO™ (doravirine/islatravir). In 2024, state ADAPs supported more than 250,000 people with HIV in the United States.

IDVYNSO was approved by the U.S. Food and Drug Administration (FDA) in April 2026 as a new, two-drug single-tablet regimen of 100 mg doravirine and 0.25 mg islatravir, for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine.

“ADAP programs play a critical role in supporting access to treatment for people living with HIV who are uninsured or underserved,” said Tim Horn, Director, Medication Access, National Alliance of State and Territorial AIDS Directors (NASTAD). “We appreciate Merck’s continued engagement and its willingness to work collaboratively to help address the critical access challenges facing state ADAP programs.”

“Merck is pleased to have reached this agreement with the ADAP Crisis Task Force to expand access to IDVYNSO for eligible people with HIV,” said Conrod Kelly, U.S. HIV business unit head, Merck. “This agreement reflects our long-standing commitment to working with the ACTF, state ADAPs and the HIV community to strengthen access and help address persistent gaps in care.”

For individuals with questions about coverage and affordability, the Merck Access Program may be able to provide information about insurance benefits, estimated out-of-pocket costs and co-pay assistance options for eligible patients.

The Merck Access Program for IDVYNSO

Merck offers support to individuals who are prescribed IDVYNSO, including information about patient insurance coverage and out-of-pocket costs, co-pay assistance for eligible, commercially insured individuals, and how individuals may access IDVYNSO through The Merck Access Program. For additional information, healthcare providers and individuals can call 1-877-709-4455 or visit https://www.merckaccessprogram-idvynso.com/.

About IDVYNSO

IDVYNSO is a fixed-dose combination of two medicines, doravirine and islatravir. Doravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that inhibits HIV-1 replication by non-competitive inhibition of HIV-1 reverse transcriptase. Islatravir is a potent, next-generation nucleoside analog reverse transcriptase inhibitor (NRTI) that blocks HIV-1 replication by multiple mechanisms including:

  • inhibition of reverse transcriptase translocation, resulting in immediate chain termination, and

  • induction of structural changes in the viral DNA (delayed chain termination).

Selected Safety Information for IDVYNSO

Contraindications

IDVYNSO is contraindicated when co-administered with:

  • drugs that are strong cytochrome P450 (CYP)3A enzyme inducers as significant decreases in doravirine plasma concentrations may occur, which may decrease the effectiveness of IDVYNSO.

  • lamivudine (3TC) or emtricitabine (FTC) as significant decreases in islatravir-triphosphate (ISL-TP) concentrations may occur, which may decrease the effectiveness of IDVYNSO. (See Drug Interactions)

Warnings and Precautions

Severe skin reactions, including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN), have been reported during postmarketing experience with doravirine-containing regimens. In addition, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome) was reported with IDVYNSO in a clinical trial. Discontinue IDVYNSO, and other medications associated with these reactions, immediately if a painful rash with mucosal involvement, a progressive severe rash, or a rash with constitutional symptoms, eosinophilia, lymphadenopathy, or other organ involvement develops. Close clinical monitoring, and appropriate therapy should be initiated.

The concomitant use of IDVYNSO and certain other drugs may result in known or potentially significant drug interactions, some of which may lead to loss of therapeutic effect of IDVYNSO and possible development of resistance or possible clinically significant adverse reactions from greater exposures of a component of IDVYNSO.

Consider the potential for drug interactions prior to and during IDVYNSO therapy, review concomitant medications during IDVYNSO therapy, and monitor for adverse reactions. (See Drug Interactions)

Adverse Reactions

The most common adverse reactions (incidence ≥ 2%, all grades in any treatment group) reported in virologically suppressed participants in the IDVYNSO treatment groups in Trials 051 and 052, respectively, were: diarrhea (3% and 1%), dizziness (2% and 1%), fatigue (2% and 1%), abdominal distension (2% and 1%), headache (2% and 1%) and weight increased (2% and <1%).

A single case of severe immune thrombocytopenia (platelet count nadir of 2 x109/L) characterized by abrupt onset of subcutaneous hematoma, petechiae, and hematuria was reported in a participant 32 days after initiating IDVYNSO. The case resolved with discontinuation of IDVYNSO, in conjunction with treatments including corticosteroids and intravenous immunoglobulin (IVIG). Among all participants in Trials 052 and 051, there were no patterns of platelet decreases over time with IDVYNSO and no differences between treatment arms in mean change from baseline in platelet count.

Drug Interactions

IDVYNSO is a complete regimen; co-administration with other antiretroviral medications for treatment of HIV-1 infection is not recommended.

Co-administration of IDVYNSO with a CYP3A inducer decreases doravirine plasma concentrations, which may reduce the efficacy of IDVYNSO. If IDVYNSO is co-administered with rifabutin, one tablet of doravirine should be taken approximately 12 hours after the dose of IDVYNSO. Co-administration of IDVYNSO with other moderate CYP3A inducers is not recommended.

Co-administration of IDVYNSO and drugs that are inhibitors of CYP3A may result in increased plasma concentrations of doravirine.

Co-administration of IDVYNSO is not recommended with deoxycytidine kinase (dCK) substrates (e.g., nucleoside antimetabolites) as they may reduce the exposure of islatravir-triphosphate or with adenosine deaminase (ADA) inhibitors (e.g., pentostatin) as they may increase the exposure of islatravir. (see Contraindications)

Use in Specific Populations

There are insufficient human data on the use of IDVYNSO during pregnancy to inform a drug-associated risk of birth defects and miscarriage. Healthcare providers are encouraged to call the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263 to report pregnancy outcomes in individuals exposed to IDVYNSO.

It is unknown whether IDVYNSO or any of its components are present in human milk, affects human milk production, or has effects on the breastfed infant. Inform patients that the potential risks of breastfeeding include: (1) HIV-1 transmission (in infants without HIV-1), (2) developing viral resistance (in infants with HIV-1), and (3) serious adverse reactions in a breastfed infant similar to those seen in adults.

Clinical trials in virologically suppressed participants who received IDVYNSO included 81 (11%) participants aged 65 years and older, including 10 (1%) aged 75 years and older. Overall differences in response have not been identified between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

No dosage adjustment of IDVYNSO is required in patients with eGFR ≥30 mL/min/1.73 m2. IDVYNSO is not recommended in patients with eGFR <30 mL/min/1.73 m2 and has not been studied in participants undergoing dialysis.

No dosage adjustment of IDVYNSO is recommended in patients with mild or moderate hepatic impairment (Child- Pugh Class A or B). IDVYNSO has not been studied in patients with severe hepatic impairment (Child-Pugh Class C) and therefore is not recommended in these patients.

IDVYNSO does not have activity against hepatitis B virus (HBV). Patients with HBV coinfection who switch to IDVYNSO from an antiretroviral regimen with activity against HBV, and patients on IDVYNSO who are newly diagnosed with HBV coinfection, should be closely monitored and specific anti-HBV therapy should be considered, as clinically appropriate.

Merck’s Commitment to HIV

For 40 years, Merck has been committed to scientific research and discovery in HIV leading to scientific breakthroughs that have helped change HIV treatment. Our work has helped pioneer the development of new options across multiple drug classes to help those impacted by HIV. Today, we are developing a series of antiviral options designed to help people manage HIV and protect people from HIV. We are researching for real life and want to ensure people are not defined by HIV. Our work focuses on transformational innovations, collaborations with others in the global HIV community and access initiatives aimed at helping to end the HIV epidemic for everyone.

About Islatravir (MK-8591) and Merck’s HIV Research

Islatravir (MK-8591) is Merck’s potent, next-generation nucleoside analog reverse transcriptase inhibitor (NRTI) that blocks HIV-1 replication by multiple mechanisms including inhibition of reverse transcriptase translocation, resulting in immediate chain termination, and induction of structural changes in the viral DNA (delayed chain termination).

Islatravir is approved in combination with Merck’s NNRTI, doravirine, in the United States and Japan as IDVYNSO™, a once-daily, single-tablet regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine.

Islatravir is also under evaluation in multiple ongoing early and late-stage clinical trials in combination with other antiretrovirals for potential once-weekly treatments for HIV-1, in Merck’s proprietary two-drug regimens.

Islatravir in combination with Gilead’s lenacapavir is in Phase 3 development as a novel oral once-weekly treatment for HIV-1 [ISLEND-1 (NCT06630286) and ISLEND-2 (NCT06630299)], and islatravir in combination with Merck’s investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) ulonivirine (MK-8507) is in Phase 2b development (MK-8591B-060, NCT06891066 and MK-8591B-062, NCT07266831) as an oral once-weekly treatment.

MK-8527 is Merck’s investigational, novel, once-monthly, oral candidate for pre-exposure prophylaxis (PrEP) for HIV-1. In collaboration with the Gates Foundation, the Phase 3 EXPrESSIVE-10 trial (MK-8527-010, NCT07071623) trial is evaluating the safety and efficacy of MK-8527 as PrEP to reduce the risk of sexually acquired HIV-1 infection among women and adolescent girls in sub-Saharan Africa. The Phase 3 EXPrESSIVE-11 trial (MK-8527-011, NCT07044297) in 16 countries is evaluating the safety and efficacy of MK-8527 as PrEP to reduce the risk of sexually acquired HIV-1 infection among people likely to be exposed to HIV-1. Both trials are now enrolling.

For an overview of Merck’s HIV treatment and prevention clinical development program, please click here.

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Please see Prescribing Information for IDVYNSO™ (doravirine and islatravir) at https://www.merck.com/product/usa/pi_circulars/i/idvynso/idvynso_pi.pdf and Patient Information for IDVYNSO at https://www.merck.com/product/usa/pi_circulars/i/idvynso/idvynso_ppi.pdf.

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HONEYWELL TECHNOLOGIES LAUNCHES AS INDEPENDENT, PURE-PLAY AUTOMATION COMPANY FOLLOWING COMPLETION OF HONEYWELL AEROSPACE SPIN-OFF

PR Newswire

  • Marks completion of Honeywell’s plan to create three independent, focused market leaders
  • Honeywell Technologies will continue to trade on Nasdaq under the ticker symbol “HON”
  • Honeywell Aerospace will begin trading today on Nasdaq under the ticker symbol “HONA”
  • Reverse stock split for shares of Honeywell Technologies effective today

CHARLOTTE, N.C., June 29, 2026 /PRNewswire/ — Honeywell Technologies (NASDAQ:HON) today announced it has completed the previously announced spin-off of its Aerospace Technologies business, which now operates as Honeywell Aerospace. Honeywell Technologies will continue to trade “regular way” on the Nasdaq Stock Market LLC (“Nasdaq”) under the ticker symbol “HON,” and shares of Honeywell Aerospace common stock will begin trading “regular way” on Nasdaq under the ticker symbol “HONA,” effective at the market opening today.

“Today is a defining moment in Honeywell’s legacy,” said Vimal Kapur, Chairman and CEO of Honeywell Technologies. “With the completion of this separation, we have successfully transformed Honeywell into three independent, industry-leading companies: Honeywell Technologies, Honeywell Aerospace and Solstice Advanced Materials. Each company is built around a distinct strategy with greater focus and financial flexibility to pursue a long-term growth agenda.”

Kapur added, “This milestone is the culmination of years of disciplined execution and marks the conclusion of the portfolio transformation we began in 2023. As standalone companies, Honeywell Technologies and Honeywell Aerospace are uniquely positioned to accelerate innovation, invest with greater precision and capitalize on the value creation opportunities in our respective industries. We are confident each company is strongly positioned to create enduring value for decades to come.”

Honeywell Technologies is now uniquely positioned to lead the industrial sector’s transition from automation to autonomy with a portfolio that spans the building, process and industrial sectors. By pairing its deep domain expertise with decades of data from its vast global installed base, Honeywell Technologies is delivering mission-critical outcomes for customers through services, solutions and products that enable safety, productivity, efficiency and uptime. 

The spin-off was completed through the distribution, effective as of today at 12:01 a.m. New York City time, of all of the issued and outstanding shares of Honeywell Aerospace common stock to Honeywell Technologies shareowners of record on the basis of one share of Honeywell Aerospace common stock for every two shares of Honeywell Technologies common stock held as of the close of business on June 15, 2026, the record date for the distribution. Honeywell Technologies shareowners of record will receive cash in lieu of any fractional shares to which they would otherwise be entitled.

Information on the spin-off and prior transactions can be found in the “About Our Spin-offs” section of Honeywell Technologies’ investor relations website at investor.honeywell.com.

Reverse Stock Split

Honeywell Technologies also announced today that it has completed the previously announced reverse stock split of Honeywell Technologies common stock at a ratio of 1-for-2 and a proportionate reduction in the number of authorized shares of Honeywell Technologies common stock.

Honeywell Technologies common stock will begin trading on a split-adjusted basis effective at the market opening today and will continue trading on Nasdaq under the symbol “HON”, with a new CUSIP number (438516205).

As a result of the reverse stock split, every two shares of Honeywell Technologies common stock issued and outstanding or held by Honeywell Technologies as treasury shares were automatically combined into one share of Honeywell Technologies common stock. This reduced the number of issued and outstanding shares of Honeywell Technologies common stock from approximately 634 million as of March 31, 2026 to approximately 317 million. Concurrently with the reverse stock split, the number of shares of Honeywell Technologies common stock authorized for issuance was also reduced from 2 billion to 1 billion. The par value of Honeywell Technologies common stock did not change. Outstanding Honeywell Technologies equity-based awards and shares or share units under Honeywell Technologies’ benefit plans were proportionately adjusted.

No fractional shares were issued in connection with the reverse stock split. As soon as practicable after the effective time of the reverse stock split, Honeywell Technologies’ transfer agent will aggregate such fractional shares into whole shares and sell the whole shares at the then-prevailing trading prices in the open market on behalf of those shareowners who would otherwise be entitled to receive a fractional share, and after Honeywell Technologies’ transfer agent’s completion of such sale, such shareowners will receive a cash payment (without interest or deduction) from Honeywell Technologies’ transfer agent in an amount equal to their respective pro rata shares of the total net proceeds of that sale and, where shares are held in certificated form, upon the surrender of such shareowners’ stock certificates.

Supplemental Quarterly Information for Honeywell Technologies

In connection with the spin-off, Honeywell Technologies will file a Current Report on Form 8-K later this morning presenting the former Aerospace Technologies (now Honeywell Aerospace) business as discontinued operations, along with the former Advanced Materials (now Solstice Advanced Materials) business which was previously presented as discontinued operations effective Q4 2025. The information in the filing will contain recast historical financial information for Honeywell Technologies and its segments on a quarterly basis for fiscal years 2024 and 2025, and Q1 2026, and will include reported and organic sales percentage change, operating income and segment profit, and Earnings per share of common stock– diluted and Adjusted earnings per share of common stock– diluted.

About
Honeywell Technologies

Honeywell Technologies is a global, pure-play automation company with a legacy of innovating to help solve the world’s most mission-critical challenges, enhancing the quality of life for people and communities around the world. We serve the building, industrial, and process sectors with a broad portfolio of services, solutions, and products, underpinned by our Honeywell Technologies Accelerator operating system and Honeywell Technologies Forge intelligence layer. By combining the deep domain expertise of our more than 50,000 employees with decades of data from our global installed base, we are uniquely positioned to lead the industrial sector’s transition from automation to autonomy. For more news and information on Honeywell Technologies, please visit Honeywell Technologies Newsroom.

Advisors

Goldman Sachs & Co. LLC acted as lead financial advisor and Morgan Stanley & Co. LLC acted as financial advisor to Honeywell Technologies. Wachtell, Lipton, Rosen & Katz and DLA Piper LLP acted as legal counsel to Honeywell Technologies.

Additional
Information

Honeywell Technologies uses our Investor Relations website, investor.honeywell.com, as a means of disclosing information which may be of interest or material to our investors and for complying with disclosure obligations under Regulation FD. Accordingly, investors should monitor our Investor Relations website, in addition to following our press releases, SEC filings, public conference calls, webcasts, and social media.

Forward-Looking
Statements

Certain statements in this release are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are those that address activities, events, or developments that management intends, expects, projects, believes, or anticipates will or may occur in the future. They are based on management’s assumptions and assessments in light of past experience and trends, current economic and industry conditions, expected future developments, and other relevant factors, many of which are difficult to predict and outside of our control. They are not guarantees of future performance, and actual results, developments and business decisions may differ significantly from those envisaged by our forward-looking statements. We do not undertake to update or revise any of our forward-looking statements, except as required by applicable securities law. Our forward-looking statements are also subject to material risks and uncertainties, including ongoing macroeconomic and geopolitical risks, such as changes in or application of trade and tax laws and policies, including the impacts of tariffs and other trade barriers and restrictions, lower GDP growth or recession in the U.S. or globally, supply chain disruptions, capital markets volatility, inflation, and certain regional conflicts, including ongoing conflicts in the Middle East, that can affect our performance in both the near- and long-term. In addition, no assurance can be given that any plan, initiative, projection, goal, commitment, expectation, or prospect set forth in this release can or will be achieved. Some of the important factors that could cause Honeywell Technologies’ actual results to differ materially from those projected in any such forward-looking statements include, but are not limited to: (i) the possibility that the spin-off transaction will not achieve its intended benefits; (ii) the impact of the spin-off transaction on Honeywell Technologies’ businesses, including the impact on Honeywell Technologies’ resources, systems, procedures and controls, diversion of management’s attention and the impact on, and possible disruption of, existing relationships with regulators, customers, suppliers, employees and other business counterparties; (iii) the possibility of disruption, including disputes, litigation or unanticipated costs, in connection with the spin-off transaction; (iv) the uncertainty of the expected financial performance of Honeywell Technologies following completion of the spin-off transaction; (v) the ability to achieve anticipated tax treatments in connection with the spin-off transaction and future, if any, divestitures, mergers, acquisitions and other portfolio changes and the impact of changes in relevant tax and other laws; and (vi) the failure to realize expected benefits and effectively manage and achieve anticipated synergies and operational efficiencies in connection with the spin-off transaction and completed and future, if any, divestitures, mergers, acquisitions, and other portfolio management, productivity and infrastructure actions. These forward-looking statements should be considered in light of the information included in this release, our Form 10-K and other filings with the SEC. Any forward-looking plans described herein are not final and may be modified or abandoned at any time.



Media



Investor Relations

Stacey Jones

Mark Macaluso

(980) 378-6258

(704) 627-6118


[email protected] 


[email protected] 

 

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SOURCE Honeywell Technologies

Posted on

Collective Mining Discovers a New Tungsten Enriched High-Grade Subzone 300 Meters Below Surface at Apollo by Drilling 27.35 m at 37.55 g/t AuEq (1.68% WO3, 11.62 g/t Au, 54 g/t Ag, 0.43% Cu)

PR Newswire

  • High-grade tungsten, gold, silver and copper mineralization has been discovered along the eastern contact of the Apollo breccia body as follows:

    • 27.35m @ 37.55 g/t gold equivalent (1.68% WO

      3

      , 11.62 g/t Au, 54 g/t Ag, 0.43% Cu) from 300m below surface (APC-162)
  • APC-162 was designed to target 30 meters up-dip of previously released hole APC107-D5, which cut a tungsten rich intercept of 28.45m @ 0.80% WO

    3,

    1.63 g/t Au, 13 g/t Ag, 0.12% Cu.
  • The new tungsten rich subzone, as defined by holes APC107-D5 and APC-162, begins at approximately 300 meters below surface and is distinct and separate from the upper tungsten rich zone in the Apollo breccia body, which covers the top 100 meters of the Apollo system from surface.
  • The new tungsten enriched subzone remains fully open down dip with follow-up drilling expected to commence in the near future.
  • Drill hole APC160-D1 has locally extended the Apollo breccia by 77 meters to the northwest beyond the current outline at 900 meters below surface by intersecting:

    • 28.80m @ 1.67 g/t gold equivalent

MIAMI, June 29, 2026 /PRNewswire/ – Collective Mining Ltd. (NYSE: CNL) (TSX: CNL) (“Collective” or the “Company”) is pleased to announce result for eleven holes as part of the 2026 drilling program at the Guayabales and San Antonio projects located in Caldas, Colombia.

Ari Sussman, Executive Chairman
commented: “These results reinforce the exceptional scale and depth potential of the Apollo system. The discovery of a new high-grade, tungsten-enriched subzone beginning 300 meters below surface, distinct from and well below the near-surface tungsten zone, demonstrates that Apollo continues to grow in both size and metal endowment with virtually every hole we drill. With 13 rigs turning and a fully funded 2026 program, we are well positioned to continue expanding the Apollo system in multiple directions.”

To date, Collective has completed 184,000 meters of diamond drilling across the Guayabales and San Antonio projects, including 120,000 meters at the flagship Apollo system, which anchors the Guayabales Project.

With US$113.3 million in cash (as of March 31, 2026), the Company is fully funded for its planned 2026 program, which envisions up to 100,000 meters of drilling. The Company presently has 13 diamond drill rigs operating across the Guayabales Project.

Details (See Table 1 and Figure 1-2)

Drill hole APC-162, collared from Pad31 and directed to the southwest, was designed as the initial follow-up hole to test for a potential up-dip extension to the Tungsten rich subzone initially intersected in hole APC107-D5, which returned 28.45m at 0.80% WO3 (see press release dated June 24, 2025). APC-162 cut high-grade mineralization with observable coarse scheelite, chalcopyrite, sporadic sphalerite and galena as follows:

  • 27.35m @ 37.55 g/t gold equivalent (1.68% WO

    3

    , 11.62 g/t Au, 54 g/t Ag, 0.43% Cu) from 300 meters below surface

This newly identified tungsten enriched subzone remains open down-dip along the Apollo breccia body eastern contact margin, with follow up drilling expected to commence shortly.

Drill hole APC160-D1 is the initial directional drill hole collared from mother hole APC-160D from Pad27 and was directed to the north on the breccia’s western margin. The hole meaningfully expanded the breccia body by 77 meters to the northwest at 900 meters below surface with assay results as follows:

  • 28.80m @ 1.67 g/t gold equivalent

APC160-D1 also intersected infill mineralization along the western margin of the breccia body with results as follow:

  • 116.25 m @ 1.41 g/t gold equivalent from 647m below surface including 15.15m @ 2.36 g/t gold equivalent and 17.35 m @ 4.75 g/t gold equivalent and
  • 51.05 m @ 1.00 g/t gold equivalent from 800m below surface

Two holes, APC-167D and APC-162, were drilled into diorite host rock to the north and outside the main breccia body to improve confidence in the lower grade halo mineralization surrounding the main Apollo breccia body. Both holes intersected sheeted veinlet mineralization with better grades than the existing internal block model, with assay results as follows: 

  • 58.00 m @ 1.03 g/t gold equivalent from 418m below surface including 7.15 m @ 3.76 g/t gold equivalent (APC-167D)
  • 6.70 m @ 3.90 g/t gold equivalent from 223m below surface and 13.00 m @ 6.47 g/t gold equivalent from 264m below surface (APC-162)

Holes APC160-D2, APC169-D1, APC169-D2 and APC-173 were exploratory in nature and failed to intersect any significant mineralization other than thin modest grading individual veinlets.

Table 1: Assays Results for Apollo Drill Holes APC160-D1, APC160-D2, APC-162, APC-167D, APC169-D1, APC169-D2 and APC-173


Hole #


From

(m)


To

(m)


Length

(m)


Au

g/t


Ag

g/t


Cu

%


Zn

%


WO

3


%


AuEq

g/t*

APC160-D1

433.10

549.35


116.25


1.23


11


0.02


0.11


1.41

Incl.

433.10

448.25

15.15

2.09

15

0.02

0.34

2.36

& Incl.

532.00

549.35


17.35


4.46


23


0.04


0.22


4.75

and

618.05

669.10

51.05

0.86

9

0.03

–

1.00

and

790.00

818.80


28.80


1.55


8


0.03


0.10


1.67

APC-162

194.25

200.95

6.70

3.37

34

0.03

0.44

3.90

and

250.70

251.80

1.10

21.70

25

0.03

0.34

21.51

and

267.90

269.30

1.40

30.90

56

0.05

0.73

31.01

and

296.00

309.00


13.00


5.09


12


0.04


–


0.09


6.47

and

336.40

363.75


27.35


11.62


54


0.43


–


1.68


37.55

APC-167D

392.20

450.20


58.00


0.85


10


0.01


0.18


1.03

Incl.

425.80

432.95

7.15

3.16

38

0.01

0.59

3.76

APC160-D2

Greenfield Exploratory Drill Holes with no Significant Values

APC169-D1

APC169-D2

APC-173

*AuEq (g/t) is calculated as follows: (Au (g/t) x 0.97) + (Ag (g/t) x 0.017 x 0.85) + (Cu (%) x 1.14 x 0.95) + (Zn (%) x 0.31 x 0.85) + (WO3 (%) x 20.74 x 0.72) utilizing metal prices of Au – US$3,000/oz, Ag – US$50/oz, Cu – US$5.0/lb, Zn – US$1.35/lb and WO3 – US$90.72/lb and recovery rates of 97% for Au, 85% for Ag, 95% for Cu, 85% for Zn and 72% for WO3. AuEq (g/t) calculation considers Zn or WO3 values when Zn>0.1% or WO3>0.05% for each intercept. Recovery rate assumptions for metals are based on metallurgical results announced on October 17, 2023, April 11, 2024 and October 3, 2024. The recovery rate assumption for zinc is speculative as limited metallurgical work has been completed to date. True widths are between 60%-100% of the total length and grades are uncut.

San Antonio Drill Holes (See Table 2)

Four exploratory drill holes (SAC-36, SAC-37, SAC-38 and SAC-39) were collared from Pad15 and Pad16 at the Dollar target, which locates in the southern portion of the San Antonio Project approximately 700 meters to the south of the deep porphyry discovery made at the Pound target. Modest porphyry-related vein mineralization was encountered in two of the holes with assay results as follows:

  • 0.90m @ 962 g/t Ag, 0.98 g/t Au, 0.15% Cu and 0.58% Zn from 101.40 meters down hole and;

    2.00m @ 14.15 g/t Au from 471.35 meters down hole (SAC-36)
  • 29.20m @ 1.28 g/t Au, 11 g/t Ag and 0.30% Zn from 246.30 meters down hole including;   

                5.95 m @ 3.51 g/t Au, 1.03% Zn from 269.55 meters down hole (SAC-39)

The Company is evaluating the San Antonio Project to assess its exploration potential and define priority targets ahead of future field work.

Table 2: Assays Results for San Antonio Drill Holes SAC-36, SAC-37, SAC-38 and SAC-39


Hole #


From

(m)


To

(m)


Length

(m)


Au

g/t


Ag

g/t


Cu

%


Zn

%

SAC-36

101.40

102.30


0.90


0.98


962


0.15


0.58

and

471.35

473.35


2.00


14.15


9


–


–

SAC-37

No significant values

SAC-38

SAC-39

246.30

275.50


29.20


1.28


11


0.04


0.30

Incl.

269.55

275.50

5.95

3.51

12

0.02

1.03


Composite widths are presented as core lengths. Additional drilling will be required to confirm the geometry of the mineralized zones, with not enough drilling to estimate the true width of the zone. No grade capping has been applied and internal and continuous dilution of up to 20% below a cutoff grade of 0.30 g/t Au may be included within the total interval. 

About Collective Mining Ltd.

To see our latest corporate presentation and related information, please visit www.collectivemining.com.

Founded by the team that developed and sold Continental Gold Inc. to Zijin Mining for approximately $2 billion in enterprise value, Collective is a gold, silver, copper and tungsten exploration company with projects in Caldas, Colombia. The Company’s two projects are located directly within an established mining camp with ten fully permitted and operating mines.

The Company’s flagship project, Guayabales, is anchored by the Apollo system, which hosts the large-scale, bulk-tonnage and high-grade gold-silver-copper-tungsten Apollo system. The Company’s objectives at the Guayabales Project are to expand the newly discovered high-grade Ramp Zone along strike and to depth, drill test the new outcropping Northern Apollo Oxidized area, drill the recently granted license covering the northwestern extension of the Trap target, and drill a series of greenfield generated targets across the property. 

Management, insiders, a strategic investor and close family and friends own 45.2% of the outstanding shares of the Company and as a result, are fully aligned with shareholders. The Company is listed on both the NYSE American and TSX under the trading symbol “CNL”.

Qualified Person (QP) and NI43-101 Disclosure

David J Reading, Independent Consultant, is the designated Qualified Person for this news release within the meaning of National Instrument 43-101 (“NI 43-101”) and has reviewed and verified that the technical information contained herein is accurate and has approved of the written disclosure of same. Mr. Reading has an MSc in Economic Geology and is a Fellow of the Institute of Materials, Minerals and Mining and of the Society of Economic Geology (SEG).

Technical Information

Samples were cut by Company personnel at Collective Mining’s core facility in Caldas, Colombia. Diamond drill core was sawed and then sampled in maximum 2-meter intervals, stopping at geological boundaries. Drill hole core diameter is a mix of PQ, HQ and NQ depending on the depth of the drill hole. Core samples have been prepared and analyzed at ALS laboratory facilities in Medellin, Colombia and Lima, Peru for copper, gold and silver assays, and multi-element ICP. ALS is an accredited laboratory which is independent of the Company. Gold assays are obtained by fire assay fusion with AAS finish on a 50g sample (Au-AA24). Any samples returning > 10 g/t were then reanalyzed by fire assay with gravimetric finish on a 50g sample (Au-GRA22). Copper and silver were assayed by inductively Coupled Plasma – Atomic Emission Spectroscopy (ICP-AES) and Mass Spectrometry (ICP-MS) following a 4-acid digestion. Samples were also analyzed for a suite of 48 elements with ME-MS61 plus mercury and a sequential copper leach analysis was completed on each sample with copper greater than 10,000 parts per million. Blanks, duplicates, and certified reference standards are inserted into the sample stream to monitor laboratory performance. Crush rejects and pulps are kept and stored in a secured storage facility for future assay verification. No capping has been applied to sample composites. The Company utilizes a rigorous, industry-standard QA/QC program.


Information Contact:

Follow Executive Chairman Ari Sussman (@Ariski73) on X

Follow Collective Mining (

@CollectiveCNL

) on X, (Collective Mining) on LinkedIn, and (@collectivemining) on Instagram


FORWARD-LOOKING STATEMENTS
  

This news release contains “forward-looking statements” and “forward-looking information” within the meaning of applicable securities legislation (collectively, “forward-looking statements”). All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates and projections as at the date of this news release. Any statement that involves discussion with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often, but not always using phrases such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, or “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved) are not statements of historical fact and may be forward-looking statements. In this news release, forward-looking statements relate, among other things, to the anticipated advancement of mineral properties or programs; future operations; future recovery metal recovery rates; future growth potential of Collective; and future development plans.

These forward-looking statements, and any assumptions upon which they are based, are made in good faith and reflect our current judgment regarding future events including the direction of our business. Management believes that these assumptions are reasonable. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include, among others: risks related to the speculative nature of the Company’s business; the Company’s formative stage of development; the Company’s financial position; possible variations in mineralization, grade or recovery rates; actual results of current exploration activities; conclusions of future economic evaluations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; fluctuations in spot and forward prices of gold, precious and base metals or certain other commodities; fluctuations in currency markets; change in national and local government, legislation, taxation, controls regulations and political or economic developments; risks and hazards associated with the business of mineral exploration, development and mining (including environmental hazards, industrial accidents, unusual or unexpected formation pressures, cave-ins and flooding); inability to obtain adequate insurance to cover risks and hazards; the presence of laws and regulations that may impose restrictions on mining; employee relations; relationships with and claims by local communities and indigenous populations; availability of increasing costs associated with mining inputs and labor; the speculative nature of mineral exploration and development (including the risks of obtaining necessary licenses, permits and approvals from government authorities); and title to properties, as well as those risk factors discussed or referred to in the annual information form of the Company dated March 30, 2026. Forward-looking statements contained herein are made as of the date of this news release and the Company disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or results, except as may be required by applicable securities laws. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements and there may be other factors that cause results not to be anticipated, estimated or intended. Accordingly, readers should not place undue reliance on forward-looking statements.

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SOURCE Collective Mining Ltd.

Posted on

Nova Minerals Announces Korbel Floatation Test-work Produces High-Grade Gold Concentrate up to 26.7 g/t Au with Consistent Recoveries Exceeding 95%

Anchorage, Alaska, June 29, 2026 (GLOBE NEWSWIRE) — Nova Minerals Corp (“Nova Minerals” or the “Company”) (NYSE American: NVA | ASX: NVA) is pleased to report results from bench-scale rougher flotation testing on low-grade Korbel ore, undertaken within a broader Feasibility Study (FS) level metallurgical test-work program. Flotation of low-grade Korbel ore at a coarser-than-conventional grind size has the potential to materially reduce both capital and operating costs while maintaining strong gold recovery.

Highlights

  • >95% Gold Recovery: Low-grade Korbel ore (0.39–0.42 g/t Au) delivered a strong flotation response at 250 µm or finer, producing a low-mass pull of only 2-3% (meaning a 97-98% reduction in the volume going to downstream processing), and a high-grade concentrate of 14.7–26.7 g/t Au (Table 1).
  • Significant Potential FS Value Upside: Application of coarse particle flotation to the bulk tonnage S-K 1300 compliant pit constrained 425 Mt @ 0.3 g/t Au (4.05 Moz Au) Korbel resource (Table 4) is expected to enhance Estelle’s FS outcomes by upgrading low-grade ore, reducing processing intensity, lowering energy use, improving gold recovery, and simplifying the flowsheet (Figure 2) by potentially eliminating ore sorting and heap leach requirements and allowing a significantly smaller Carbon-in-Leach (CIL) plant.
  • Ongoing PFS Optimization: Korbel CIL test-work and further coarse particle flotation studies are underway to refine the flowsheet, confirm high gold recovery and gangue rejection, and optimize plant design, scale, configuration, and overall project economics.

Nova Minerals CEO, Mr. Christopher Gerteisen, commented:

“As part of our ongoing Feasibility Study optimization work, these results represent a major breakthrough in our metallurgical test program. The demonstration that Korbel ore is highly amenable to coarse particle flotation, producing a very high-grade concentrate representing only 2-3% of the total mass while achieving gold recoveries in excess of 90%, has the potential to be a game changer for the project.

The successful application of coarse particle HydroFloat technology to our process flowsheet has the potential to deliver substantial reductions in processing and capital costs, while simplifying downstream operations. These improvements could significantly enhance the project’s overall economics and increase our ability to profitably recover gold from lower-grade material across the bulk-tonnage Korbel deposit.

Metallurgical test work is continuing to evaluate even coarser particle sizes, which could further improve the project’s processing cost profile and strengthen our strategy of maximizing gold production and resource conversion over the life of the mine.”

Korbel Flotation Metallurgical Test-work

The test-work was undertaken on a composite sample generated from diamond drill core from the Korbel Main deposit, representing predominantly fresh sulfide intrusive-hosted ore from an intrusion-related gold system. The sample material was selected from drill holes KBDH-005, KBDH-011 and KBDH-025 over the intervals summarized in Table 2, with the results outlined in Table 1.


Table 1.

Bench rougher floatation test-work results

Test ID Grind Size

µm 		Mass Pull % Au Recovery % Au Grade g/t S-2 Recovery % As

Recovery %
BF2939 150 2.05 94.9 26.7 91.2 97.0
BF2940 150 3.18 96.1 15.1 90.6 96.7
BF2941 75 2.79 97.7 14.7 90.7 96.6
BF2942 250 2.67 95.9 17.2 90.3 96.6
BF2943 500 2.82 83.6 15.8 89.5 87.6
BF2944 1000 3.00 41.6 5.3 75.0 69.6
BF2945 75 2.56 97.9 17.6 90.5 96.6
BF2946 75 3.06 98.3 18.7 90.4 96.5


 


Table 2. 

Korbel drill samples used for test-work composite

Hole ID Sample ID Sample ID From m To m From ft From ft
KBDH-005 A0393009 A0393118 26 307 87 1009
KBDH-005 B709084 B709108 307 309 1009 1017
KBDH-011 A0393488 A0393677 6 499 22 1638
KBDH-025 A0394774 A0394902 258 593 847 1948


 


Table 3. 

Korbel drill hole locations

Hole ID Easting Northing Elev

(m) 		EOH

(m) 		Azi Dip Zone Assay Results
KBDH-005 505300.5 6874852.9 977.5 456.3 90 -45 Korbel Core ASX: 19/8/2020
KBDH-011 505288.1 6874848.4 977.3 499.3 45 -70 Korbel Core ASX: 19/8/2020
KBDH-025 505276.9 6874846.8 978.8 593.8 135 -45 Korbel Core ASX: 26/11/2020

Figure 1 presents the Korbel flotation response across a range of grind sizes, as determined from the metallurgical test-work program, together with the indicative operating windows for available flotation technologies.


Figure 1.

Korbel floatation grind sensitivity test-work results

Korbel Coarse Particle Floatation Flowsheet

The proposed flowsheet (Figure 2) demonstrates the potential to fully utilize the Korbel resource by integrating coarse particle flotation for early upgrading with downstream CIL treatment for gold recovery.


Figure 2.

High-level conceptual flowsheet for Korbel ore


Table 4.

S-K 1300 compliant pit constrained mineral resource estimate – January 2024

Deposit Cutoff Measured Indicated Inferred Total
    Tonnes Grade Moz Tonnes Grade Moz Tonnes Grade Moz Tonnes Grade Moz
    Mt g/t Au Au Mt g/t Au Au Mt g/t Au Au Mt g/t Au Au
RPM North 0.2 1 4.1 0.18 3 1.6 0.15 23 0.6 0.45 28 0.9 0.78
RPM South 0.2             23 0.5 0.35 23 0.5 0.35
Total RPM    1 4.1 0.18 3 1.6 0.15 46 0.5 0.8 51 0.7 1.13
Korbel Main 0.15       240 0.3 2.39 35 0.3 0.3 275 0.3 2.7
Cathedral 0.15             150 0.3 1.35 150 0.3 1.35
Total Korbel         240 0.3 2.39 185 0.3 1.65 425 0.3 4.05
Total Estelle    1 4.1 0.18 243 0.3 2.54 231 0.3 2.45 476 0.3 5.17

 

S-K 1300 compliant pit-constrained resource at a US$2,000 oz gold price as per the S-K 1300 Initial Assessment Technical Report Summary on the Estelle Gold Project, Alaska, USA, with an effective date of January 31, 2024. 5.2 Moz refers to the measured, indicated, and inferred resources on 100% basis, 85% attributable to Nova Minerals (4.4 Moz).

Qualified Persons

The information contained in this announcement, relating to metallurgical results, is based on, and fairly and accurately represent the information and supporting documentation prepared by Mr Damian Connelly. Mr Connelly is a full-time employee of METS Engineering who are a contractor to Nova Minerals, and a Fellow of The Australasian Institute of Mining and Metallurgy. Mr Connelly has sufficient experience which is relevant to the style of mineralization and type of deposit under consideration, and to the activity being undertaken to qualify as a Competent Person as defined in the 2012 Edition of the Australasian Code for Reporting of Exploration Results, Exploration Targets, Mineral Resources and Ore Reserves and as a Qualified Person as defined in Regulation S-K 1300 under the Securities Act of 1933, as amended (S-K 1300). Mr Connelly consents to the inclusion in the announcement of the matters based on the results in the form and context in which they appear.

About Nova Minerals Corp

Nova Minerals Corp is advancing one of the world’s largest undeveloped gold deposits into production and securing a US domestic supply of the critical mineral antimony. The Company is focused on the exploration and development of the Estelle Gold and Critical Minerals Project, located in Alaska, a tier-one mining jurisdiction.

Estelle hosts two defined multi-million-ounce gold resources, and more than 20 prospects distributed along a 35-kilometre mineralized trend, in the prolific Tintina Gold Belt, a province which hosts a >220 million ounce (Moz) documented gold endowment and some of the world’s largest gold mines and discoveries including, Kinross Gold Corporation’s Fort Knox Gold Mine. In parallel, Nova is advancing its critical minerals strategy, fully-funded by a US$43.4 million U.S. Department of War award to develop a domestic antimony supply chain, targeted for production in late 2026/2027.

Further discussion and analysis of the Estelle Project is available through the interactive Vrify 3D animations, presentations, and videos, all available on the Company’s website www.novamineralscorp.com.

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act, and Section 21E of the Exchange Act which are subject to the “safe harbor” created by those sections. All statements, other than statements of historical fact, contained in this press release are forward-looking statements and that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Nova Minerals Corp’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Forward-looking statements contained in this announcement are made as of this date, and Nova Minerals Corp undertakes no duty to update such information except as required under applicable law.

Investor Relations: Nova Minerals
Dave Gentry, CEO Craig Bentley
RedChip Companies, Inc. Director
Phone: 1-407-644-4256 Phone: 1-720-550-4223
Email: [email protected] Email: [email protected]

Attachments



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Diana Shipping Inc. Announces Extension of Tender Offer for All Outstanding Shares of Genco Shipping & Trading

10.6 Million, or 28.4% of Outstanding Shares Not Owned By Diana, Tendered into Offer as of June 26

$27.34 Per Share Offer Made to Genco Board — Comprised of $24.80 in Cash and One Diana Share Valued at $2.54

1

— Remains on the Table, Providing an Opportunity to Deliver Premium Value for Genco Shareholders

Significant Show of Support for Diana’s Tender Offer Sends Clear Message that Genco and Diana Should Negotiate a Transaction

ATHENS, Greece, June 29, 2026 (GLOBE NEWSWIRE) — Diana Shipping Inc. (NYSE: DSX) (“Diana” or “the Company”), a global shipping company specializing in the ownership and bareboat charter-in of dry bulk vessels that is the largest shareholder of Genco Shipping & Trading Limited (NYSE: GNK) (“Genco”), today announced that its tender offer to acquire all outstanding shares of Genco not already owned by Diana has been extended to July 10, 2026, at 5:00 p.m., New York City time. As of Friday, June 26, 2026, 10,583,484 shares – or 28.4% of the outstanding shares of Genco not owned by Diana – have been tendered into the offer. The shares tendered do not include any of the more than 14% of the outstanding shares of Genco owned by Diana.

Diana’s recently increased offer made to the Genco Board to acquire the outstanding shares of Genco that it does not already own for $27.34 per share — comprised of $24.80 per share in cash plus one Diana share valued at $2.54 based on Diana’s 30-day volume-weighted average price as of June 16, 2026 — remains on the table.

Semiramis Paliou, Diana’s Chief Executive Officer, commented:

“Diana’s commitment to acquiring the Genco shares that we do not currently own has not diminished, and we are grateful to the many shareholders who have tendered their shares. This significant show of support for our offer sends a clear message that there is considerable shareholder interest in Genco and Diana negotiating a value-creating transaction. Our leadership team remains eager and available to meet immediately with the Genco Board and its advisors to negotiate a transaction in good faith, and in the meantime we have extended the tender offer date by two weeks to provide time for additional shareholders to tender.”

Diana’s offer is supported by $1.433 billion in committed financing from six leading international banks with no financing condition. It represents a 53% premium to Genco’s undisturbed share price and a 6% premium to Genco’s net asset value per share based on VesselsValue data, at cyclically high drybulk asset values that are at or near 15-year highs.

About Diana Shipping Inc.

Diana Shipping Inc. (“Diana”) (NYSE: DSX) is a global provider of shipping transportation services through its ownership and bareboat charter-in of dry bulk vessels. Diana’s vessels are employed primarily on short to medium-term time charters and transport a range of dry bulk cargoes, including such commodities as iron ore, coal, grain and other materials along worldwide shipping routes.

About Star Bulk Carriers Corp.

Star Bulk Carriers Corp. (“Star Bulk”) is a global shipping company providing worldwide seaborne transportation solutions in the dry bulk sector. Star Bulk’s vessels transport major bulks, which include iron ore, minerals and grain, and minor bulks, which include bauxite, fertilizers and steel products. Star Bulk was incorporated in the Marshall Islands on December 13, 2006 and maintains executive offices in Athens, New York, Stamford and Singapore.

Cautionary Statement Regarding Forward-Looking Statements

Matters discussed in this communication and other statements made by Diana, may constitute forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding the intent, beliefs, expectations, objectives, goals, future events, performance or strategies and other statements of Diana or its management team, which are other than statements of historical facts.

These forward-looking statements relate to, among other things, Diana’s proposal to acquire Genco and the anticipated benefits of such a transaction, and Diana’s ability to finance such transaction. Forward looking statements can be identified by words such as “believe,” “will,” “anticipate,” “intend,” “estimate,” “forecast,” “project,” “plan,” “potential,” “may,” “should,” “expect,” “pending” and similar expressions identify forward-looking statements.

The forward-looking statements in this press release and in other statements made by Diana or Star Bulk, as applicable, are based upon various assumptions, many of which are based, in turn, upon further assumptions, including without limitation, management’s examination of historical operating trends, data contained in Diana’s records, Genco’s public filings and disclosures and data available from third parties. Although Diana believes that these assumptions were reasonable when made, because these assumptions are inherently subject to significant uncertainties and contingencies that are difficult or impossible to predict and are beyond its control, Diana cannot assure you that it will achieve or accomplish these expectations, beliefs or projections.

The forward-looking statements in this communication are based on current expectations, assumptions, and estimates, and are subject to numerous risks and uncertainties. These include, without limitation, risks relating to: (i) the possibility that the proposed transaction may not proceed; (ii) the ability to obtain regulatory or shareholder approvals, if required; (iii) the risk that Genco’s Board of Directors or management may continue to oppose the proposal or not respond to further attempted engagement by Diana; (iv) failure to realize anticipated benefits of the transaction; (v) changes in the financial or operating performance of Diana, Star Bulk or Genco; (vi) the possibility that shareholders of Genco will not elect to tender their shares of common stock of Genco in connection with the Offer (as defined below) or that the conditions to consummation of the Offer are not satisfied; and (vii) general economic, market, and industry conditions. These and other risks are described in documents filed by Diana with, or furnished by Diana to, the U.S. Securities and Exchange Commission (“SEC”), including its Annual Report on Form 20-F for the fiscal year ended December 31, 2025, and its other subsequent documents filed with, or furnished to, the SEC, and are described in documents filed by Genco with, or furnished by Genco to, the SEC, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2025, and its other subsequent documents filed with, or furnished to, the SEC. Diana undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

Information Regarding the Offer

On May 4, 2026, Diana commenced a tender offer, through its wholly owned subsidiary 4 Dragon Merger Sub Inc., to purchase all outstanding shares of Genco common stock at $23.50 per share in cash. On May 27, 2026, Diana increased the offer price from $23.50 per share in cash to $24.80 per share in cash. To the extent that Genco declares a cash dividend or other distribution on the Genco shares, the cash component of the offer price will be reduced by the amount payable per share. Diana intends to file with the SEC an amended tender offer statement on Schedule TO and a registration statement on Form F-4 reflecting the terms of its increased offer made to the Genco Board reflecting an implied value of $27.34 per Genco share comprised of $24.80 in cash and one Diana share with an implied value of $2.54 based on Diana’s 30-day VWAP as of June 16, 2026. . These materials, as may be amended from time to time, will contain important information, including the terms and conditions of the revised Offer. Shareholders of Genco are strongly advised to read Diana’s amended tender offer statement, registration statement and other offer documents as they become available because they will contain important information regarding the revised offer. Diana’s tender offer statement, offer to purchase and other offer documents, when filed, will be available at no charge on the SEC’s website at www.sec.gov.

The Offer is conditioned upon, among other things: (i) Genco entering into a definitive merger agreement with Diana substantially in the form of the merger agreement included with the Offer documents; (ii) Genco shareholders validly tendering a majority of Genco’s outstanding shares on a fully diluted basis; (iii) the termination or inapplicability of Genco’s shareholder rights plan; (iv) the Genco Board’s approval of the transaction under certain affiliate transaction provisions in Genco’s charter, and (v) other customary conditions. When Diana files an amended tender offer statement on Schedule TO and a registration statement on Form F-4 reflecting the terms of its increased offer, the Offer will be conditioned on Diana’s registration statement on Form F-4 being declared effective by the SEC. Satisfaction of the merger agreement condition, the shareholder rights plan condition and the affiliate transaction condition is solely within the control of Genco and the members of the Genco Board.

If the Offer is successfully completed, Diana intends to consummate a second-step merger as promptly as practicable, in which any remaining Genco shareholders who did not tender their shares in the Offer would receive the same consideration that was paid in the Offer. As a result, if the Offer is completed and the second-step merger is consummated, all Genco shareholders — whether or not they tender their shares — would receive the same consideration. Importantly, shareholders who tender in the Offer may receive their consideration sooner than those whose shares are acquired in the second-step merger.

Questions and requests for assistance regarding the Offer may be directed to Okapi Partners LLC, the information agent for the Offer, toll-free at (855) 305-0857 or by email at [email protected].


Corporate Contact:

Margarita Veniou

Chief Corporate Development, Governance &

Communications Officer and Board Secretary

Tel: + 30-210-9470-100

Email: [email protected]

Website: www.dianashippinginc.com

X: @Dianaship


Investor Relations Contact:

Nicolas Bornozis / Daniela Guerrero

Capital Link, Inc.

Tel: (212) 661-7566

Email: [email protected]

Bruce Goldfarb / Chuck Garske / Lisa Patel

Okapi Partners

Tel:(212) 297-0720

[email protected]


Media Contact:

Mark Semer / Grace Cartwright

Gasthalter & Co.

Tel: (212) 257-4170

[email protected]

1 Based on Diana’s 30-day volume-weighted average price as of June 16, 2026.



Posted on

Larimar Therapeutics Reports Positive Open Label Data and Submission of First Module of Rolling BLA for Accelerated Approval of Nomlabofusp for Friedreich’s Ataxia

  • FDA alignment on submission of BLA data package in multi-disciplinary Type B pre-BLA meeting minutes; first module of rolling BLA submitted with remaining modules expected 2H 2026
  • Daily nomlabofusp increased and sustained skin FXN levels at 1 year and 18 months; 100% (9/9) of participants achieved and maintained levels over 50% of mean levels in healthy volunteers (comparable to asymptomatic heterozygous carriers) at 1-year
  • Continued directional improvement across mFARS, FARS-ADL, 9-HPT, MFIS observed at 1 year of nomlabofusp treatment (n = 13) relative to a worsening in a FACOMS natural history study reference population
  • One of six non-ambulatory participants at baseline became ambulatory after 1 year of dosing; none of the seven ambulatory participants progressed to non-ambulatory at 1 year
  • Well-characterized safety profile; long-term dosing continues to be generally well-tolerated; anaphylaxis occurred in 10/43 patients with 9 of the 10 having exposure to nomlabofusp in a prior study
  • 11 participants had no exposure to nomlabofusp in a prior study; 1 experienced anaphylaxis
  • Dosing of first patient in global confirmatory Phase 3 study expected Q3 2026 
  • Company management to host webcast and conference call today at 7:45 a.m. EDT

BALA CYNWYD, Pa., June 29, 2026 (GLOBE NEWSWIRE) — Larimar Therapeutics, Inc. (Larimar) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced it has submitted the first module of its rolling Biologics License Application (BLA) submission to the Food and Drug Administration (FDA) for accelerated approval of nomlabofusp; the remaining modules are expected to be submitted in the second half of 2026. The submission was made after obtaining FDA meeting minutes of a Type B multidisciplinary pre-BLA meeting. The Company also announced positive data from the ongoing long-term open label (OL) study evaluating daily subcutaneous injections of nomlabofusp in adolescent and adult patients with Friedreich’s ataxia (FA). FA is a rare, progressive, and fatal neurological disease with no approved disease modifying therapies that address the root cause of the disease.

“Today’s data represent a pivotal milestone for Larimar and, most importantly, for the FA community,” said Carole Ben-Maimon, MD, President and Chief Executive Officer of Larimar. “In the Type B multi-disciplinary pre-BLA meeting minutes, FDA confirmed that our existing data package appears to be sufficient to support a BLA submission seeking accelerated approval based on skin frataxin as a potential novel surrogate endpoint and approval will be a matter of review. We are very excited to share some unique and important initial observations in our publicly available program update deck and on our conference call later this morning. These data together reinforce the strong clinical and biomarker evidence we have built to date for nomlabofusp. With compelling and consistent OL study data in hand, rolling BLA submission initiated, and dosing of the first patient in our global confirmatory Phase 3 study approaching, we are executing on all fronts to bring what could be the first disease-modifying therapy to pediatric and adult patients living with FA.”

Dr. Rusty Clayton, Chief Medical Officer of Larimar added, “With longer-term treatment of more patients at the 50 mg dose, we continue to see improvements in multiple clinical outcome measures reinforcing the positive benefit-risk profile of nomlabofusp. Moreover, study participants who received nomlabofusp treatment for at least one year were able to improve FA disease progression. Further improvement was observed in participants who completed 18 months of dosing. Collectively, sustained elevations in skin FXN concentrations with concomitant directional improvements in key clinical outcomes relative to a FA natural reference population, along with a well-characterized safety profile, support the potential of nomlabofusp to meaningfully alter the course of this devastating disease.”

The OL study is evaluating the safety and tolerability, pharmacokinetics (PK), and frataxin (FXN) levels in skin and buccal cells, along with exploratory pharmacodynamic (PD) markers (lipid profiles and gene expression) and clinical outcomes following long-term subcutaneous administration of nomlabofusp. The OL study protocol has now been amended to include children 2-11 years of age, adolescents and adults who have not participated in a prior nomlabofusp study.

As of June 2026, 43 adolescent and adult participants in the OL study had received at least one dose of nomlabofusp and 22 participants remain in the study with a maximum treatment duration of more than 800 days. Among the study participants, approximately 49% were non-ambulatory at baseline.

Consistent Long-term Safety Profile

  • Long-term daily dosing was generally well tolerated with 13 adults on treatment for 1 year, 7 for 18 months, and 3 for 2 years
  • >10,000 doses of nomlabofusp have been administered in the OL study
  • Most common adverse events are local injection site reactions that were mild to moderate, decreased in frequency over time, and did not lead to any withdrawals from the study
  • 21 participants discontinued
    • 10 of 41 participants in OL study experienced anaphylaxis
      • 9 had prior exposure to nomlabofusp, one had no prior exposure
      • All participants returned to their usual state of health after receiving standard treatment with no further sequelae
    • 3 experienced generalized urticaria (no new occurrences since initiating antihistamine therapy)
    • 8 withdrew (3 due to other adverse events)
  • 11 participants with no prior exposure; one had anaphylaxis

Skin FXN Increased and Reached Steady State with Long-term Daily Nomlabofusp

*Absolute Mean Skin FXN Levels pg/µg (Range)
Baseline 1 month 3 months 6 months 1 year 18 months
3.7

(1.5, 8.8),
n = 27		 8.9

(2.9, 22.9),
n = 26		 12.5

(5.6, 37.1),
n = 20		 12.3

(5.6, 26.7),
n = 11		 12.1

(8.1, 16.1),
n = 9		 10.7

(9.9, 11.8),
n = 3


Note: 8.2 pg/µg represents 50% of the average FXN concentration of healthy volunteers
* Data include all participants with quantifiable FXN levels at each measurement point who had received 25 mg, 50 mg or had the dose increased from 25 mg to 50 mg
Data are presented as of the March 2026 cutoff date

Majority of Participants Achieved Skin FXN Levels Similar to Levels Reported in Asymptomatic Heterozygous Carriers Following Nomlabofusp for 6 Months

% of Participants with Skin FXN Levels in the Range of Asymptomatic Heterozygous Carriers

(> 8.2 pg/µg; ~50% of Mean Healthy Volunteer FXN Concentration)
Baseline 1 month 3 months 6 months 12 months 18 months
4%

1/27		 38%

10/26		 50%

10/20		 82%

9/11		 100%

9/9		 100%

3/3


*Data include all participants with quantifiable FXN levels at each measurement point who had received 25 mg, 50 mg or had the dose increased from 25 mg to 50 mg
Data are presented as of the March 2026 cutoff date

Nomlabofusp OL Data Shows Potential for Clinical Benefit vs. FACOMS Reference Population

  • Directional improvement across mFARS, FARS-ADL, and 9-HPT at 1 year of nomlabofusp treatment (n = 13) relative to a worsening in a Friedreich’s Ataxia Clinical Outcome Measures Study (FACOMS), natural history study reference population
  • At 1 year: a mean 1.0-point improvement in mFARS with nomlabofusp treatment compared to a mean 1.6-point worsening in FACOMS reference group, resulting in a 2.6-point difference
  • At 18 months: a mean 2.3-point improvement in mFARS with nomlabofusp treatment compared to a calculated mean 2.3-point worsening in FACOMS reference group, resulting in a calculated 4.6-point difference
  • In participants entering the OL study, key clinical outcome measures had worsened when compared to baseline in prior studies over an average of 2.5 years. Improvement in these same participants occurred during the first year of participation in the OL study
  • In the 13 participants completing 1 year of dosing with nomlabofusp, 6 participants were non-ambulatory and 7 were ambulatory at baseline. At the 1 year timepoint, none of the ambulatory patients had progressed to non-ambulatory status, and 1 patient who was non-ambulatory became ambulatory.
  • Improvement in clinical outcomes was associated with increased skin FXN levels
  • These clinical findings support that increase in tissue FXN levels after treatment with nomlabofusp may lead to clinical benefit across a broad spectrum of patients with FA, including those with advanced disease

FACOMS Reference Population is Based on Characteristics Similar to OL Study

  • FACOMS, a longitudinal natural history study, includes patients with confirmed FA diagnosis
  • Reference population is based on the range of baseline characteristics of participants in the OL study and FDA recommendations on the methodology to generate the reference population
Clinical Outcome Measure Change from Baseline, Mean (Range)
  mFARS
3

[0- 93]		 FARS-ADL
3

[0- 36]		 9-HPT: Dominant Hand
3

[Seconds]		 MFIS
3

[0- 84]2
  Nomlabofsp FACOMS1 Nomlabofusp FACOMS1 Nomlabofusp FACOMS1 Nomlabofusp
1 year -1.0

(-6.5, 3.0)
n=13		 1.6

(-15.7, 18.0)
n=189		 -1.1

(-9.0, 2.5)
n=13		 1.5

(-5.5, 9.0)
n=211		 -15.6

(-46.7, 15.4)
n=12		 6.1

(-40.1, 203.7)
N=194		 -5.2

(-25.0, 10.0)
n=13
18 mos -2.3

(-10.0, 4.5)
n=7		 2.3

2
 		-0.3

(-1.5, 1.0)
n=7		 NA -11.8

(-13.6, 6.5)
n=7		 NA 0.6

(-16.0, 15.0)
n=7


Range = min, max
1 Based on the range of baseline characteristics of participants in the OL study, Larimar identified patients from the FACOMS dataset with similar characteristics using data recorded over the last 4 years for each patient
2 Data collected annually in FACOMS; 18-month value was interpolated using a linear equation constructed with annual data up to 3 years
3Modified Friedreich Ataxia Rating Scale (mFARS), FARS-Activities of Daily Living (FARS-ADL), 9-hole peg test (9-HPT)
Data are presented as of the March 2026 cutoff date

Dr. Marshall Summar, Chief Executive Officer (CEO) of Uncommon Cures, past Founding Director of the Rare Disease Institute and Margaret O’Malley Chair of Genetic Medicine at Children’s National Hospital added, “As the CEO of a key clinical site in the OL study and a career Medical Geneticist, I have seen firsthand the significant burden that FA places on patients and their families. The data generated to date suggest that nomlabofusp has the potential to meaningfully impact the underlying biology of the disease and translate into clinically relevant benefits. The clinical improvements observed so far are promising and mark a meaningful step toward what could become the first disease-modifying therapy for a patient population with significant unmet medical needs.”

FDA Alignment for Submission of the BLA Package for Accelerated Approval in Multi-disciplinary Type B Pre-BLA Meeting Minutes

  • Sufficient Data Package: FDA reviewed OL data submitted in a briefing package and confirmed that the existing data package appears capable of supporting submission and review of a BLA seeking accelerated approval; approval will be a matter of review.
  • FXN as Surrogate Endpoint: FDA had reaffirmed willingness to consider FXN as a novel surrogate endpoint and confirmed that Larimar’s exposure-response analysis linking nomlabofusp exposures to clinical outcomes is the type that could support the BLA submission.
  • Gene Expression and Lipid Data: FDA noted that prospectively collected exploratory gene expression and lipid biomarkers may support the biomarker data and provide additional support to the novel surrogate endpoint and mechanism of action of nomlabofusp beyond tissue FXN concentrations.
  • Rolling BLA Submission: FDA agreed to a rolling BLA submission, and the first module has been submitted.

Key Upcoming Milestones

  • Dosing of first patient in global confirmatory Phase 3 study planned Q3 2026
  • Submission of final modules for rolling BLA submission expected 2H 2026
  • Targeting mid-2027 launch, if approved

Webcast Details
To access the webcast on Monday, June 29, 2026, at 7:45 am EDT, please visit this link to the event. Following the live event, an archived webcast will be available on the “Events & Presentations” page of the Larimar website.

About Larimar Therapeutics

Larimar Therapeutics, Inc. (Nasdaq: LRMR), is a clinical-stage biotechnology company focused on developing treatments for complex rare diseases. Larimar’s lead compound, nomlabofusp, is being developed as a potential treatment for Friedreich’s ataxia. Larimar also plans to use its intracellular delivery platform to design other fusion proteins to target additional rare diseases characterized by deficiencies in intracellular bioactive compounds. For more information, please visit: https://larimartx.com.

Forward-Looking Statements

This press release contains forward-looking statements that are based on Larimar’s management’s beliefs and assumptions and on information currently available to management. All statements contained in this press release other than statements of historical fact are forward-looking statements, including but not limited to statements regarding Larimar’s ability to develop and commercialize nomlabofusp and any other planned product candidates, Larimar’s planned research and development efforts, including the timing of its nomlabofusp clinical trials, including the dosing of a first patient in a global confirmatory Phase 3 study, interactions and filings with the FDA, the safety and therapeutic potential of nomlabofusp , expectations regarding the timing of completion of the BLA submission, the expectations of the timing of, and potential for, accelerated approval or accelerated access, time to launch and market and overall development plans and other matters regarding Larimar’s business strategies, ability to raise capital, use of capital, results of operations and financial position, and plans and objectives for future operations. In some cases, you can identify forward-looking statements by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors include, among others, the success, cost and timing of Larimar’s product development activities, nonclinical studies and clinical trials, including nomlabofusp clinical milestones and continued interactions with the FDA; that preliminary clinical trial results may differ from final clinical trial results, that earlier non-clinical and clinical data and testing of nomlabofusp may not be predictive of the results or success of later non-clinical or clinical trials, and assessments; delays in patient recruitment, including as a result of changes in clinical protocols and adverse events; that the FDA may not ultimately agree with Larimar’s nomlabofusp development strategy; Larimar’s ability to submit BLA modules on the intended timeline; Larimar’s ability to realize the benefits of Breakthrough Therapy Designation; the potential impact of public health crises on Larimar’s future clinical trials, manufacturing, regulatory, nonclinical study timelines and operations, and general economic conditions; Larimar’s ability and the ability of third-party manufacturers Larimar engages, to optimize and scale nomlabofusp’s manufacturing process; Larimar’s ability to obtain regulatory approvals for nomlabofusp and future product candidates; Larimar’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators, and to successfully commercialize any approved product candidates; Larimar’s ability to raise the necessary capital to conduct its product development activities; and other risks described in the filings made by Larimar with the Securities and Exchange Commission (SEC), including but not limited to Larimar’s periodic reports, including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the SEC and available at www.sec.gov. These forward-looking statements are based on a combination of facts and factors currently known by Larimar and its projections of the future, about which it cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent Larimar’s management’s views only as of the date hereof. Larimar undertakes no obligation to update any forward-looking statements for any reason, except as required by law.

Investor Contact:                                                        
Joyce Allaire                                                                
LifeSci Advisors                                                        
[email protected]                                                   
(212) 915-2569

Company Contact:

Michael Celano        
Chief Financial Officer
[email protected]
(484) 414-2715



Posted on

FTAI Infrastructure Announces Acquisition of Tidewater Logistics

NEW YORK, June 29, 2026 (GLOBE NEWSWIRE) — FTAI Infrastructure Inc. (NASDAQ: FIP) (the “Company” or “FIP”) announced today that it has completed the acquisition of AP Shale Logistics ManagementCo LLC, doing business as Tidewater Logistics (“Tidewater”), a barge and rail transloading company with operations in Ohio, West Virginia, and Texas. The Company acquired Tidewater for a cash consideration of approximately $45 million, funded through an upsizing of FIP’s existing term loan with existing lenders.

Tidewater Logistics is an established transloading platform, highly complementary with FIP’s Wheeling & Lake Erie Railway, serving producers, shippers, and industrial customers across key shale and energy markets in the Appalachian Basin and Gulf Coast region. FIP expects Tidewater to generate $9 million of Adjusted EBITDA in the next twelve months, with additional upside from expanded customer relationships, increased throughput volumes, and integration with FIP’s broader rail platform.

“Tidewater Logistics is a natural fit for FIP’s growing infrastructure platform. Tidewater’s barge and rail transloading capabilities are highly complementary to our existing railroad assets, and we see meaningful opportunities to expand Tidewater’s customer base and throughput volumes across its network of strategically located facilities,” said Ken Nicholson, CEO of FIP. “We continue to pursue high-quality infrastructure businesses with defensible market positions, stable cash flows, and compelling growth prospects, and Tidewater checks each of those boxes.”

Calfee, Halter & Griswold LLP served as legal counsel to the Company in connection with the acquisition.

Additional Information

For additional information that management believes to be useful for investors, please refer to the presentation posted on the IR Resources section of the Company’s website, www.fipinc.com, and the Company’s recent Form 8-K, when available on the Company’s website. Nothing on the Company’s website is included or incorporated by reference herein.

Cautionary Note Regarding Forward-Looking Statements

This communication contains forward-looking statements. Words such as, but not limited to, “will,” “believes,” “expects,” “anticipates,” “plans,” “could,” “may,” “should,” and similar expressions are intended to identify forward-looking statements. All forward-looking statements rely on a number of assumptions, estimates and data concerning future results and events and are subject to a number of uncertainties and other factors that could cause actual results to differ materially from those reflected in such statements. Factors that could cause or contribute to changes in such forward-looking statements include, but are not limited to: (1) the Company’s ability to integrate Tidewater with its existing assets and operations and to realize anticipated growth and other benefits; (2) risks related to disruption of management’s attention from the ongoing business operations of the Company due to the acquisition; (3) loss of key employees or customers following the acquisition; and (4) estimated growth opportunities and operating efficiencies being materially different from actual results. Accordingly, FIP cautions that the forward-looking statements contained herein are qualified by these and other important factors and uncertainties that could cause results to differ materially from those reflected by such statements. For more information on additional potential risk factors, please review FIP’s filings with the SEC, including, but not limited to, FIP’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and its Current Reports on Form 8-K.

About FTAI Infrastructure Inc.

FTAI Infrastructure primarily invests in critical infrastructure with high barriers to entry across the rail, ports and terminals, and power and gas sectors that, on a combined basis, generate strong and stable cash flows with the potential for earnings growth and asset appreciation. FTAI Infrastructure is externally managed by an affiliate of Fortress Investment Group LLC, a leading, diversified global investment firm.

Non-GAAP Metrics

Adjusted EBITDA is defined as net income (loss) attributable to stockholders, adjusted (a) to exclude the impact of provision for (benefit from) income taxes, equity-based compensation expense, acquisition and transaction expenses, losses on the modification or extinguishment of debt and capital lease obligations, changes in fair value of non-hedge derivative instruments, asset impairment charges, incentive allocations, depreciation and amortization expense, interest expense, interest and other costs on pension and other pension expense benefit liabilities, dividends and accretion of redeemable preferred stock, and other non-recurring items, (b) to include the impact of our pro-rata share of Adjusted EBITDA from unconsolidated entities, and (c) to exclude the impact of equity in earnings (losses) of unconsolidated entities and the non-controlling share of Adjusted EBITDA.

For further information, please contact:

Alan Andreini
Investor Relations
FTAI Infrastructure Inc.
(646) 734-9414
[email protected]



Posted on

United Therapeutics Corporation Announces FDA Approval of the LungFX™ Device for Centralized Ex Vivo Lung Perfusion

United Therapeutics Corporation Announces FDA Approval of the LungFX™ Device for Centralized Ex Vivo Lung Perfusion

LungFX™ is the first device approved for centralized ex vivo lung perfusion for donor organs not otherwise used for transplant, an important step in advancing United Therapeutics’ platforms

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–
United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of the LungFXTM device (LungFX) for use in centralized ex vivo lung perfusion (EVLP), a procedure that enables donor lungs to be assessed outside the body after procurement and before transplantation.

The PMA, submitted by United Therapeutics’ wholly owned subsidiary, Lung Bioengineering Inc., included comprehensive safety and effectiveness data supporting use of LungFX to perform EVLP in a centralized facility.

LungFX is indicated for centralized, ex vivo (outside the body) evaluation of deceased-donor lungs (single and double) that cannot be placed for transplantation by an organ procurement organization (OPO) with any of the matched candidates if using direct-to-recipient procurement and preservation procedures. LungFX provides normothermic perfusion and ventilation of procured donor lungs initially stored with cold static preservation solution.

LungFX is intended to allow for re-assessment, in a controlled environment, of the suitability of procured donor lungs for transplantation into male and female patients aged 18 years or older with end-stage lung disease awaiting first-time (double or single) lung transplantation. Lungs accepted for transplantation after LungFX require a second period of storage with cold static preservation solution, and cumulative preservation time of transplanted lungs is not intended to exceed 20 hours.

To date, Lung Bioengineering has performed 1,100 EVLP procedures using other approved devices, with 600 lungs accepted for transplant. Lung Bioengineering expects to add LungFX to its available services in 2027.

“Today’s approval is a big step forward in reducing the large number of donor lungs — over 80% — that are unfortunately left behind instead of being transplanted,” said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. “The FDA approval of our LungFX device also marks an important milestone on our path toward using advanced technologies to create an unlimited supply of transplantable organs.”

“Too many donor lungs go unused today,” said Dr. Kenneth McCurry, M.D., Director of the Cleveland Clinic Enterprise Transplant Center and investigator in the LungFX pivotal trial. “EVLP with this device provides additional clinical data to transplant teams to help determine whether donated lungs that might otherwise go unused are suitable for transplant. Our work with Lung Bioengineering over the last ten years has significantly increased the number of patients we have been able to successfully transplant.”

“LungFX is the first EVLP device approved specifically for use in a fit-for-purpose centralized facility, expanding access for transplant programs without requiring them to build EVLP capabilities within their own hospitals. It also strengthens United Therapeutics’ platform for advancing new technologies designed to enhance donor lung function,” said Brandi Zofkie, M.P.H., Associate Vice President of Lung Bioengineering.

Lung Bioengineering Inc., a wholly owned subsidiary of United Therapeutics, is the global leader in centralized EVLP. The company owns and operates facilities in Silver Spring, Maryland, and Jacksonville, Florida, dedicated to performing centralized EVLP procedures designed to extend preservation and enable assessment of donor lungs that might otherwise be deemed unsuitable for transplant.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

There are no known contraindications.

WARNINGS AND PRECAUTIONS

  • The LungFX device is not intended for the preservation of donor lungs that could be matched and successfully placed by an OPO without utilization of the device. In the CLES Pivotal Study, the observed 12-month survival rate among recipients of LungFX lungs did not meet the pre-specified performance goal (> 95% posterior probability of 1 year survival > 81.2%); rates of 12-month overall mortality and Clinical Events Committee (CEC)-adjudicated lung graft-related mortality were higher in EVLP subjects as compared to non-EVLP contemporaneous control subjects; and two-year survival within several pre-specified subgroups were clinically less favorable among EVLP donor lungs than among non-EVLP control donor lungs. Before deciding to proceed with LungFX organ preservation, a physician should fully consider the risks and benefits of this device and those of other organ preservation modalities. Transplant physicians are advised to carefully review the available clinical data in the LungFX device labeling when considering its use for any donor lungs and recipients.

  • Only qualified Lung Bioengineering personnel can operate the LungFX device.

  • Only trained physicians can evaluate lung suitability for transplantation after LungFX device evaluation.

  • Safety and effectiveness of the LungFX device is derived principally from clinical data collected prospectively in the CLES Pivotal Study within 1 year after organ preservation and transplantation and from 2 years of observational, post-transplantation survival. Therefore, the impact of the LungFX device on clinical outcomes such as longer-term recipient survival and graft function (e.g., chronic lung allograft dysfunction (CLAD)) is uncertain. Other approved devices allow for pre-transplant assessment of procured donor lungs under conditions of ex vivo normothermic perfusion and ventilation, and there are various approaches available for isolated cold static storage preservation of procured donor lungs. Each alternative has its own advantages and disadvantages. A physician should fully discuss these alternatives with transplant candidates to identify the type of donor organ and preservation method that best meets patient expectations.

  • Safety and effectiveness of the LungFX device have not been studied in:

    • Patients: individuals under 18 years of age; patients listed for same-side lung re-transplantation, multiple-organ transplantation involving the lung and another organ, or live donor lobar lung transplantation; and patients with HIV infection or Burkholderia cenocepacia infection.
    • Donors/donor lungs: donors or donor lungs with confirmed pneumonia, persistent purulent secretions identified by bronchoscopy before donor lung excision, confirmed evidence of aspiration, significant mechanical lung injury or trauma, HIV or active hepatitis C.
  • A device malfunction or User error could lead to a potential loss of a donor lung.

ADVERSE EVENTS

Patients receiving a lung evaluated with LungFX may experience adverse events (AEs) including those experienced with any lung transplant. Below is a list of some of the AEs observed during clinical studies of the device.

  • Death

  • Primary graft dysfunction (PGD)

  • Chronic lung allograft dysfunction (CLAD)

  • Respiratory failure

  • Lung transplant rejection

  • Pulmonary embolism

  • Pneumonia

  • Bronchostenosis

  • Hypoxia

  • Dysphagia

These AEs were also observed in transplant recipients whose lungs did not undergo evaluation with the LungFX device prior to transplantation.

PRESCRIPTION INFORMATION

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Please see the LungFX Physician Labeling and Instructions for Use for further detailed information.

About United Therapeutics

Founded by CEO Martine Rothblatt to discover a cure for her daughter’s life-threatening rare disease, pulmonary arterial hypertension, United Therapeutics transforms the treatment of rare diseases and pioneers alternatives to expand the supply of transplantable organs. From our innovative therapies to our groundbreaking manufactured organs, we are bold and unconventional. We move quickly from scientific theory to practical technologies that can save lives. As a public benefit corporation, even our legal structure reflects our commitments. We serve patients, act with integrity, create long-term shareholder value, and operate with sustainable practices that protect the future we are working to build. Visit us at www.unither.com and follow us on LinkedIn, Facebook, and Instagram.

Forward-Looking Statements

Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements regarding Lung Bioengineering’s expectation to add LungFX to its available services in 2027; our goal of reducing the number of donor lungs that are left behind not transplanted; our goal of using advanced technologies to create an unlimited supply of transplantable organs; and our goals of expanding the supply of transplantable organs, developing practical technologies that can save lives, creating long-term shareholder value, and operating with sustainable practices. Forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language, and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of June 29, 2026, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason.

For Further Information Contact:

Investor Inquiries

https://ir.unither.com/contact-ir

Media Inquiries

[email protected]

KEYWORDS: United States North America North Carolina Maryland

INDUSTRY KEYWORDS: Medical Devices Surgery FDA Clinical Trials Cardiology Other Health Biotechnology General Health Pharmaceutical Health

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