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  • Newsmax Announces Second Quarter 2025 Financial Results

    Newsmax Announces Second Quarter 2025 Financial Results

    Company Reports Revenues of $46.4 million, an 18.4% Increase Year-Over-Year

    Broadcast Revenues Soar to $38.0 Million, a 28.5% Increase Year-Over-Year

    Newsmax Remains the Fourth Highest-Rated Cable News Channel With Over 26 Million Quarterly Viewers

    BOCA RATON, FL / ACCESS Newswire / August 19, 2025 / Newsmax Inc. (NYSE:NMAX) (“Newsmax” or the “Company”) today announced its financial results for the second quarter ended June 30, 2025.

    Management Commentary

    “We are excited to report another strong quarter with impressive financial and operational results that demonstrate the power of our growing cable and FAST channels,” said Christopher Ruddy, Chief Executive Officer of Newsmax Inc. “Our second quarter revenue growth reflects the continued strength of our business model and the resonance of our content with American audiences.”

    Ruddy continued, “Our strong financial position, bolstered by our successful IPO and access to public markets, provides the strategic flexibility to capitalize on the significant opportunities in the evolving media landscape. We are building for sustainable, long-term growth while expanding our reach across multiple distribution channels and platforms.”

    “With our diversified revenue streams showing growth across affiliate fees, advertising, and subscription services, and supported by a strong balance sheet, we are well-positioned to capitalize on ongoing trends in streaming, international markets and multi-platform distribution. We remain committed to delivering long-term value for our shareholders as we execute on this strategy.”

    Dominion Resolution

    On August 18, 2025, Newsmax announced that the Company reached a settlement agreement with Dominion Voting Systems, concluding a defamation lawsuit that Dominion filed in Delaware Superior Court in 2021.

    “We are pleased to have reached a resolution with Dominion,” commented Ruddy. “This settlement enables us to move forward from the litigation and remain focused on delivering the trusted news and analysis our viewers rely on every day. This was a strategic business decision made in the best interests of the company and its shareholders, and we remain confident in the integrity of our journalism and steadfast in our commitment to a free and vibrant press.”

    The resolution of the Dominion suit, which ends all litigation the Company faced relating to the 2020 election, is expected to significantly reduce Newsmax’s legal expenses for the foreseeable future.

    Second Quarter 2025 Business and Operational Highlights

    • Newsmax continued to grow its domestic and global reach, expanding its footprint to over 60 million U.S. homes and to over 100 countries:

      • Extended multi-year carriage partnership with Fubo and launched Newsmax en Español on Fubo’s Latino plan, the first and only U.S.-based news channel to use advanced AI technology to dub its content into another language on a live basis.

      • Expanded distribution through pay TV Hulu+ achieving household penetration of approximately 60 million U.S. homes.

      • Formed strategic partnerships with Cellcom Israel, Telecom Armenia and Supercanal in the Dominican Republic.

      • Expanded Newsmax+ streaming availability across Comcast entertainment devices including Xfinity X1, Xfinity Flex, Xumo Stream Box and Xumo TV.

    • Secured multi-year contract renewal with veteran anchor Greta Van Susteren to continue leading prime-time programming with “The Record”.

    • Grew social media following to 20 million followers and achieved over 16 million downloads of the free Newsmax App.

    • Appointed Ambassador Paula J. Dobriansky and former U.S. Secretary of Labor Alex Acosta to Board of Directors, bringing extensive government, regulatory and international affairs expertise.

    • Added to Russell 2000® and Russell 3000® indexes, providing increased visibility via the $10.6 trillion in institutional investor assets benchmarked against Russell’s U.S. indexes.

    Second Quarter 2025 Financial Highlights

    • Newsmax reported total quarterly revenues of $46.4 million for the three-month period ended June 30, 2025, representing an 18.4% year-over-year increase.

      • Total Broadcasting revenues grew significantly year-over-year, increasing from $29.6 million in the second quarter of 2024 to $38.0 million for the second quarter of 2025 – an increase of 28.5%.

      • Advertising Revenues increased 26.2% year-over-year to $29.9 million driven by higher linear cable and satellite advertising due to higher Nielsen ratings which translated to higher rates.

      • Affiliate Revenues increased 7.3% year-over-year to $7.3 million driven by new contractual relationships as well as rate increases that went into effect in 2025.

      • Subscription Revenues increased 5.2% year-over-year to $7.0 million driven by an increase in Newsmax + subscribers.

      • Product Sales Revenues increased 5.1% year-over-year to $1.6 million driven by continued sales of “Pay Zero Taxes” but was offset by lower nutraceutical sales.

    • Newsmax reported a quarterly Net Loss of $(75.2) million as compared to a Net Loss of $(4.8) million reported in the prior year quarter primarily driven by the settlement of the Dominion lawsuit which was settled on August 18, 2025 but recognized in Q2 2025 in accordance with GAAP.

    • Quarterly Adjusted EBITDA was $(3.8) million, a decrease of $5.7 million, or 300.1%, from the amount reported in the same quarter last year, primarily due to an increase in cost of revenues and general and administrative costs associated with the continued expansion of the business and costs associated with becoming a public company (see reconciliation of net loss to adjusted EBITDA below).

    • The Company ended the quarter with $197.9 million in Cash and short-term investments. Cash and Cash Equivalents was $33.8 million and short-term investment was $164.1 million

    Newsmax is reiterating its previously issued full-year 2025 revenue guidance of $180 million to $190 million.

    “Our second quarter results demonstrate the strength and resilience of our diversified revenue model,” commented Darryle Burnham, Chief Financial Officer. “The growth we’re seeing across our affiliate fees, advertising revenue and Newsmax+ subscriptions, combined with our strong balance sheet and access to capital markets, positions us well to execute on our long-term strategic vision while maintaining the operational flexibility needed to pursue emerging growth opportunities.”

    About Newsmax

    Newsmax Inc. is listed on the NYSE (NMAX) and operates, through Newsmax Broadcasting LLC, one of the nation’s leading news outlets, the Newsmax channel. The fourth highest-rated network is carried on all major pay TV providers. Newsmax’s media properties reach more than 40 million Americans regularly through Newsmax TV, the Newsmax App, its popular website Newsmax.com, and publications such as Newsmax Magazine. Through its social media accounts, Newsmax reaches 20 million combined followers. Reuters Institute says Newsmax is one of the top U.S. news brands and Forbes has called Newsmax “a news powerhouse.”

    For more information, please visit Investor Relations | Newsmax Inc.

    Investor Contacts

    Newsmax Investor Relations
    ir@newsmax.com

    Forward-Looking Statements

    This communication contains forward-looking statements. From time to time, we or our representatives may make forward-looking statements orally or in writing. We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us. Forward-looking statements can be identified by those that are not historical in nature. The forward-looking statements discussed in this communication and other statements made from time to time by us or our representatives, may not occur, and actual events and results may differ materially and are subject to risks, uncertainties and assumptions about us. Newsmax does not guarantee future results, performance or achievements. Moreover, neither we nor any other person assumes responsibility for the accuracy or completeness of any of these forward-looking statements. Forward-looking statements should not be relied upon as predictions of future events. We are under no duty to update any of these forward-looking statements after the date of this communication to conform our prior statements to actual results or revised expectations, and we do not intend to do so. Factors that may cause actual results to differ materially from current expectations include various factors, including but not limited changes in domestic and global general economic and macro-economic conditions and the volatility of the price of Common Stock that may result from, among other things, comments by securities analysts or other third parties, including blogs, articles, message boards and social and other media, large shareholders exiting their position in our Common Stock, any negative public perception of us, sales of shares previously registered for resale, or other uncertainties and the factors set forth in the sections entitled “Risk Factors” in Newsmax’s Annual Report on Form 10-K for the twelve months ended December 31, 2024, Newsmax’s Quarterly Report on Form 10-Q for the three months ended June 31, 2025, and other filings Newsmax makes with the Securities and Exchange Commission. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. Undue reliance should not be placed on forward-looking statements in this communication, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein.

    USE AND DEFINITION OF NON-GAAP FINANCIAL MEASURES

    This press release contains a financial measure that has not been prepared in accordance with United States Generally Accepted Accounting Principles (“U.S. GAAP”). This financial measure is Adjusted EBITDA.

    Non-GAAP financial measures are used to supplement the financial information presented on a U.S. GAAP basis and should not be considered in isolation or as a substitute for the relevant U.S. GAAP measures and should be read in conjunction with information presented on a U.S. GAAP basis. Because not all companies use identical calculations, our presentation of Non-GAAP measures may not be comparable to other similarly titled measures of other companies.

    Adjusted EBITDA1 is defined as revenues less cost of revenues and general and administrative expenses and does not include depreciation and amortization, interest expense, net, impairment charges, unrealized gains (losses) on marketable securities, other corporate matters (consisting primarily of certain litigation expenses, and related fees, for specific legal proceedings that the Company has determined are infrequent and unusual in terms of their magnitude), other, net, and income tax expense.

    1The Company compensates for limitations of the adjusted EBITDA measure by prominently disclosing GAAP net income (loss), which the Company believes is the most directly comparable GAAP measure, and providing investors with a reconciliation from GAAP net income (loss) to adjusted EBITDA on page 13.

    NEWSMAX INC. AND SUBSIDIARIES
    CONDENSED CONSOLIDATED BALANCE SHEETS
    (Unaudited)

    June 30,
    2025

    December 31,
    2024

    ASSETS
    Current assets:
    Cash and cash equivalents

    $

    33,842,039

    $

    24,052,887

    Investments

    164,052,830

    58,310,955

    Accounts receivable, net

    29,553,260

    28,265,721

    Inventories, net

    1,640,952

    1,792,697

    Prepaid expenses and other current assets

    8,209,833

    8,925,294

    Total current assets

    237,298,914

    121,347,554

    Property and equipment, net

    6,187,097

    6,225,617

    Right of use asset, operating lease

    5,431,334

    7,191,606

    Other assets

    10,282,124

    10,698,660

    Security deposits

    598,319

    609,426

    Total assets

    $

    259,797,788

    $

    146,072,863

    LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
    Current liabilities
    Accounts payable

    $

    15,729,014

    $

    14,670,846

    Accrued expenses

    7,772,710

    9,882,720

    Accrued payroll

    1,973,340

    2,220,872

    Accrued distribution

    895,071

    1,068,366

    Deferred revenue

    11,511,584

    13,652,699

    Lease liability, operating lease

    3,555,150

    3,894,102

    Lease liability, finance lease

    190,239

    199,237

    Settlement Liability

    53,231,010

    29,099,265

    Warrant liability

    6,499,821

    Derivative liability

    41,459,418

    Total current liabilities

    94,858,118

    122,647,346

    Long-term liabilities:
    Deferred revenue, net of current portion

    2,926,255

    2,835,218

    Lease liability, operating lease, net of current portion

    2,494,520

    4,049,256

    Lease liability finance lease, net of current portion

    33,933

    129,930

    Share repurchase liability

    5,301,080

    Other long-term liabilities

    1,000,000

    Settlement liability, net of current portion

    46,330,986

    25,477,941

    Total liabilities

    152,944,892

    155,139,691

    Commitments and contingencies (Note 11)
    Convertible and redeemable preferred stock, $0.001 par value; 11,034 shares authorized; and 0 and 5,575 shares issued and outstanding as of June 30, 2025 and December 31, 2024

    128,576,901

    Stockholders’ equity (deficit)
    Convertible and redeemable preferred stock, $0.001 par value; 60,000 shares authorized; and 0 and 27,612 shares issued and outstanding as of June 30, 2025 and December 31, 2024

    86,742,045

    Class A common stock, 0.001 par value; 50,000,000 shares authorized; 39,239,297 shares issued and outstanding; Class B common stock, 0.001 par value; 940,000,000 shares authorized 89,768,339 shares issued and outstanding at June 30, 2025. Class A common stock, 0.001 par value; 20,000 Class A shares authorized; 68,127,538 Class A shares issued and outstanding at December 31, 2024; 60,000 Class B shares authorized; 0 Class B shares issued and outstanding at December 31, 2024 (1)

    129,008

    10

    Treasury stock, 0 and 27,061,584 shares at cost, respectively

    (14,622,222

    )

    Additional paid-in capital

    426,631,367

    18,056,702

    Accumulated other comprehensive income (loss)

    876,320

    (52,849

    )

    Accumulated deficit

    (320,783,799

    )

    (227,767,415

    )

    Total stockholders’ equity (deficit)

    106,852,896

    (137,643,729

    )

    Total liabilities, convertible and redeemable preferred stock and stockholders’ equity (deficit)

    $

    259,797,788

    $

    146,072,863

    (1) On March 28, 2025, the Company announced a 6,765.396 for 1 stock split, effective March 31, 2025. This stock split is reflected retroactively in all periods presented for the common shares issued and outstanding.

    NEWSMAX INC. AND SUBSIDIARIES
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
    (Unaudited)

    For the three months ended

    For the six months ended

    June 30,

    June 30,

    2025

    2024

    2025

    2024

    Revenues:
    Service revenue

    $

    44,884,207

    $

    37,746,093

    $

    88,619,548

    $

    76,909,470

    Product revenue

    1,555,537

    1,480,639

    3,121,904

    2,916,907

    Total revenues

    46,439,744

    39,226,732

    91,741,452

    79,826,377

    Cost of services

    27,758,685

    21,073,281

    52,407,148

    41,576,599

    Cost of products sold

    1,039,298

    1,431,756

    2,230,404

    2,623,036

    Gross profit

    17,641,761

    16,721,695

    37,103,900

    35,626,742

    General and administrative expenses:
    Personnel costs

    8,614,761

    6,047,773

    16,628,179

    11,839,569

    Advertising costs

    5,941,417

    3,852,379

    10,359,871

    8,344,979

    Professional fees

    4,766,085

    1,132,068

    7,390,549

    2,470,818

    Rent and utilities

    1,540,453

    1,472,394

    2,990,244

    2,969,458

    Depreciation

    734,590

    820,044

    1,471,465

    1,625,093

    Other corporate matters

    68,437,098

    5,838,233

    78,104,701

    59,074,353

    Other

    4,012,806

    2,309,934

    8,137,119

    4,896,946

    Total general and administrative expenses

    94,047,210

    21,472,825

    125,082,128

    91,221,216

    Loss from operations

    (76,405,449

    )

    (4,751,130

    )

    (87,978,228

    )

    (55,594,474

    )

    Other income (expense), net
    Interest and dividend income

    1,802,054

    26,168

    2,856,340

    53,461

    Interest expense

    (7,456

    )

    (22,377

    )

    (13,511

    )

    (48,162

    )

    Unrealized (loss) gain on marketable securities

    (500,736

    )

    (34,772

    )

    1,084,844

    128,574

    Other, net

    (54,342

    )

    (28,461

    )

    (8,342,898

    )

    (31,686

    )

    Total other income (expense), net

    1,239,520

    (59,442

    )

    (4,415,225

    )

    102,187

    Net loss before income taxes

    (75,165,929

    )

    (4,810,572

    )

    (92,393,453

    )

    (55,492,287

    )

    Income tax expense

    9,693

    18,988

    14,693

    20,960

    Net loss

    $

    (75,175,622

    )

    $

    (4,829,560

    )

    $

    (92,408,146

    )

    $

    (55,513,247

    )

    Other comprehensive income:
    Unrealized gain on available for sale debt investments, net of income tax

    446,778

    929,169

    Comprehensive loss

    $

    (74,728,844

    )

    $

    (4,829,560

    )

    $

    (91,478,977

    )

    $

    (55,513,247

    )

    Weighted average common stock outstanding, basic and diluted (1)

    128,333,356

    41,065,954

    86,938,585

    41,065,954

    Net loss per share attributable to common stockholders, basic and diluted

    $

    (0.59

    )

    $

    (0.15

    )

    $

    (1.12

    )

    $

    (1.42

    )

    (1) On March 28, 2025, the Company announced a 6,765.396 for 1 stock split, effective March 31, 2025. This stock split is reflected retroactively in all periods presented for the common shares issued and outstanding. See Note 1. Nature of Business.

    NEWSMAX INC. AND SUBSIDIARIES
    CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
    FOR THE SIX MONTHS ENDED JUNE 30, 2025 AND 2024
    (Unaudited)

    2025

    2024

    Cash flows from operating activities:
    Net loss

    $

    (92,408,146

    )

    $

    (55,513,247

    )

    Adjustments to reconcile net loss to net cash used in operating activities:
    Depreciation and amortization

    3,089,126

    3,153,473

    Stock-based compensation

    4,994,794

    Change in fair value of warrant liability

    1,824,179

    6,373,757

    Change in fair value of derivative liability

    6,104,230

    (Recovery of) provision for credit losses

    (266,076

    )

    (458,695

    )

    Unrealized gain on marketable securities

    (1,084,844

    )

    (128,574

    )

    Non-cash lease expense

    1,788,532

    1,706,637

    Non-cash expense related to SEPA Agreement

    500,000

    Changes in operating assets and liabilities:
    (Increase) decrease in assets:
    Accounts receivable

    (1,021,463

    )

    (545,163

    )

    Inventory

    151,745

    1,072,475

    Prepaid expenses and other current assets

    (1,226,532

    )

    (1,151,295

    )

    Other asset

    (1,201,125

    )

    Security deposits

    11,107

    54,989

    Increase (decrease) in liabilities:
    Accounts payable

    314,683

    (1,918,363

    )

    Accrued expenses

    (2,530,837

    )

    3,677,186

    Lease liabilities

    (1,921,948

    )

    (1,753,792

    )

    Settlement liability

    44,984,790

    40,000,000

    Other long-term liabilities

    1,000,000

    Deferred revenue

    (2,050,078

    )

    (1,996,968

    )

    Net cash used in operating activities

    (38,947,863

    )

    (7,427,580

    )

    Cash flows from investing activities:
    Purchase of investments

    (131,727,862

    )

    Proceeds from maturity of investments

    28,000,000

    Sale of investments

    314,185

    Purchase of property and equipment

    (689,460

    )

    (207,489

    )

    Net cash (used in) provided by investing activities

    (104,417,322

    )

    106,696

    Cash flows from financing activities:
    Proceeds from issuance of convertible preferred stock, net

    80,742,222

    8,025,738

    Proceeds from issuance of common stock IPO, net

    66,659,453

    Proceeds from exercise of stock options

    6,707,723

    Proceeds from additional stock issuance

    65,000

    Payment of dividend

    (915,067

    )

    Principal payment under finance lease obligation

    (104,995

    )

    (90,102

    )

    Net cash provided by financing activities

    153,154,337

    7,935,636

    Net change in cash

    9,789,152

    614,752

    Cash and cash equivalents – beginning

    24,052,887

    6,037,211

    Cash and cash equivalents – ending

    $

    33,842,039

    $

    6,651,963

    Supplemental disclosures of cash flow information:
    Operating lease assets obtained in exchange for operating lease liabilities

    $

    28,391

    $

    76,708

    Allocation from equity to derivative liability for Series B Preferred Stock

    $

    $

    2,358,376

    Interest paid

    $

    1,829

    $

    19,968

    Non-cash transactions:
    Property and equipment acquired through accounts payable:

    $

    743,485

    $

    217,172

    Non-cash financing activities:
    Issuance of warrants in connection with the issuance of convertible stock

    $

    1,144,976

    $

    Common stock issuance costs reclassified from prepaid expenses

    $

    (1,798,989

    )

    $

    IPO funds receivable in escrow

    $

    34,500

    $

    Proceeds from exercise of stock options in transit

    $

    38,320

    $

    NEWSMAX INC. AND SUBSIDIARIES
    ADJUSTED EBITDA RECONCILIATION
    (Unaudited)

    For the three months ended June 30,

    For the six months ended June 30,

    2025

    2024

    2025

    2024

    Net loss

    $

    (75,175,622

    )

    $

    (4,829,560

    )

    $

    (92,408,146

    )

    $

    (55,513,247

    )

    Add
    Depreciation

    734,590

    820,044

    1,471,465

    1,625,093

    Interest, net

    (1,794,598

    )

    (3,791

    )

    (2,842,829

    )

    (5,299

    )

    Unrealized (gain) loss on marketable securities

    500,736

    34,772

    (1,084,844

    )

    (128,574

    )

    Stock-based compensation

    3,417,686

    4,994,794

    Other corporate matters

    68,437,098

    5,838,233

    78,104,701

    59,074,353

    Other, net2

    54,342

    28,461

    8,342,898

    31,686

    Income tax expense

    9,693

    18,988

    14,693

    20,960

    Adjusted EBITDA3

    $

    (3,816,075

    )

    $

    1,907,147

    $

    (3,407,268

    )

    $

    5,104,972

    2Comprised of miscellaneous items such as derivative adjustments, income tax credits, and unrealized gains on securities

    3For a discussion of Adjusted EBITDA, see “Non-GAAP Financial Measures” above.

    SOURCE: Newsmax Inc.

    View the original press release on ACCESS Newswire

    The post Newsmax Announces Second Quarter 2025 Financial Results appeared first on Local News Hub.

  • Jaguar Health Reports Approval of All Proposals at August 2025 Annual Meeting of Stockholders

    Jaguar Health Reports Approval of All Proposals at August 2025 Annual Meeting of Stockholders

    Jaguar CEO Lisa Conte presenting August 20 at Emerging Growth Conference to provide updates on near-term catalysts; Click here to register

    As announced, initial proof-of-concept results from the ongoing investigator-initiated trial in Abu Dhabi show crofelemer reduced the required total parenteral nutrition in the first participating microvillus inclusion disease (MVID) patient by up to 27% and in the first participating short bowel syndrome (SBS-IF) patient by up to 12.5%; FDA meeting resulted in planned Jaguar regulatory pathway to complete supplemental NDA strategy for crofelemer for patients with metastatic breast cancer, a population meeting orphan definition in US

    Company strategy: Seek business development partnerships for license to develop and commercialize Jaguar’s orphan indication products, resulting in non-dilutive funding for Jaguar

    SAN FRANCISCO, CA / ACCESS Newswire / August 19, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (“Jaguar” or the “Company”) today announced the voting results of the Company’s Annual Meeting of Stockholders held on August 19, 2025 (the “Annual Meeting”).

    Seven proposals were submitted to and approved by the stockholders of the Company at the Annual Meeting. The proposals are described in detail in the Company’s definitive proxy statement on Schedule 14A relating to the Annual Meeting and supplemental information filed with the Securities and Exchange Commission on July 21, 2025 and as amended on August 6, 2025. Stockholders may obtain a free copy of the proxy statement and other documents filed by Jaguar with the SEC at http://www.sec.gov. The proxy statement is also available on the Company’s corporate website.

    About the Jaguar Health Family of Companies

    Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo’s crofelemer is FDA-approved under the brand name Mytesi® for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar’s Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.

    For more information about:

    Jaguar Health, visit https://jaguar.health

    Napo Pharmaceuticals, visit www.napopharma.com

    Napo Therapeutics, visit napotherapeutics.com

    Magdalena Biosciences, visit magdalenabiosciences.com

    Canalevia-CA1, visit canalevia.com

    Visit the Make Cancer Less Shitty patient advocacy program on Bluesky, X, Facebook & Instagram

    Forward-Looking Statements

    Certain statements in this press release constitute “forward-looking statements.” These include statements regarding Jaguar’s expectation that Jaguar management will present at the August 2025 Emerging Growth Conference, and statements regarding Jaguar’s planned regulatory pathway to complete a supplemental NDA for crofelemer for patients with metastatic breast cancer. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar’s control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

    Contact:

    hello@jaguar.health

    Jaguar-JAGX

    SOURCE: Jaguar Health, Inc.

    View the original press release on ACCESS Newswire

    The post Jaguar Health Reports Approval of All Proposals at August 2025 Annual Meeting of Stockholders appeared first on Local News Hub.

  • Discover Advanced Car Accident Care at Arrowhead Clinic in Garden City, GA: New Resource Unveiled for Auto Injury Treatment

    Discover Advanced Car Accident Care at Arrowhead Clinic in Garden City, GA: New Resource Unveiled for Auto Injury Treatment

    Arrowhead Clinic in Garden City is excited to announce a new resource available on their WordPress site detailing advanced car accident treatment techniques. Known for their expertise in treating auto accident injuries, the clinic has developed this article to help people understand their care options after a car accident.

    In the Garden City Arrowhead Clinic auto accident treatment article, the clinic emphasizes the need for quick medical attention and explains the detailed chiropractic care methods they use. Often, injuries from accidents don’t show immediate symptoms, so the clinic stresses how important it is to seek early treatment to avoid further complications.

    Arrowhead Clinic in Garden City Georgia for auto accident chiropractic treatment

    Dr. NiAmber Harris, a seasoned practitioner at Arrowhead Clinic in Garden City, explained, “Our aim is to provide care that tackles both the obvious and hidden injuries. Using advanced diagnostics and specialized therapies helps people recover not just from immediate pain but toward better overall health.”

    The article highlights the variety of diagnostic and therapeutic technologies available at the clinic. Patients receive a thorough evaluation, which includes advanced imaging, orthopedic testing, and neurological screenings. These methods create a clear picture of the injuries, helping in the development of personalized treatment plans.

    Treatment at the Garden City clinic combines modern chiropractic techniques with rehabilitation practices. Techniques like diversified methods, soft tissue mobilization, and advanced therapies such as cold laser therapy are utilized to speed up recovery and improve patient results. Additionally, electrical stimulation devices and rehabilitation exercise plans are available to help patients regain their strength and functionality.

    A key feature of the clinic’s approach is the use of technology in treatments. Patients benefit from digital X-ray analyses, computerized postural assessments, and other digital tools that assist in tracking progress and planning exercises. This approach allows treatment to be tailored to individual needs and keeps patients informed about their progress.

    For more detailed information about these techniques, visit the Arrowhead Clinic Chiropractor website. This resource is invaluable for understanding the integrated approaches being taken by the clinic.

    Dr. Harris noted, “Technology allows us to continuously monitor each patient’s recovery journey, ensuring the best possible outcomes. The personalized care at our Arrowhead Clinic in Garden City location helps us adjust to each patient’s unique situation, aiding in more effective healing.”

    Beyond treatment, the clinic focuses on education and prevention. Regular educational initiatives offer patients valuable advice on preventing injuries and maintaining wellness after treatment.

    Reviews from former patients often highlight the welcoming and professional atmosphere of the clinic. With an impressive 4.8-star rating, many patients have praised the effectiveness of the treatment protocols and the supportive environment. Such positive feedback demonstrates the lasting impact the clinic aims to achieve in its community.

    For those impacted by auto accidents, quickly connecting with knowledgeable healthcare providers is very important. Garden City Arrowhead Clinic auto accident treatment services prioritize rapid and thorough care after such incidents. This newly released article aims to offer guidance and assistance to those seeking recovery options.

    Anyone interested in learning more about the advanced treatment methods used by the clinic can read the full article on the Arrowhead Clinic website or connect with our Arrowhead Clinic Garden City location directly. The staff is ready to answer questions and help individuals seeking advice on their health and wellness after an accident.

    Arrowhead Clinic is committed to enhancing patient outcomes through advanced chiropractic care, ensuring that individuals involved in auto accidents receive the comprehensive treatment necessary for a speedy and effective recovery.

    The post Discover Advanced Car Accident Care at Arrowhead Clinic in Garden City, GA: New Resource Unveiled for Auto Injury Treatment appeared first on Local News Hub.

  • Zenapet Re-Launches Cat Colostrum Plus to Support Cat Wellness

    Zenapet Re-Launches Cat Colostrum Plus to Support Cat Wellness

    Zenapet is re-launching its Cat Colostrum Plus supplement, a daily mix-in crafted to support feline immune health and overall wellness. The formula helps promote gut balance and a shiny, healthy coat while delivering essential nutrients. The supplement is easy to add to a cat’s diet, using an effortless mix-in scoop that provides essential nutrients. Pet owners can check out Zenapet’s full product line, including items like the Hip & Joint Superfood Supplement for Dogs and the Superfood Allergy & Immune Support Booster for Dogs, all found on the Zenapet Cat Colostrum Official Website.

    The Zenapet Cat Colostrum helps support the immune system with naturally occurring immunoglobulins, which are key to maintaining strong defenses. It also aids in maintaining gentle gut balance and healthy digestion, crucial for a cat’s overall health. It is targeted to help manage seasonal sensitivities, reduce itching, and improve coat quality. Made in the USA at a GMP-certified facility, the product focuses on purity and flavor. It has no artificial flavors or colors, appealing to both cats and their mindful owners.

    Zenapet’s commitment to quality is evident in this updated Zenapet Cat Colostrum, offering an everyday solution for cat parents looking for reliable, scientifically backed wellness options. Caren Collins, a Zenapet representative, shared, “Our re-imagined Zenapet Cat Colostrum provides an easy, effective way for cat owners to support their pet’s health. We’ve focused on making our product as beneficial and convenient as possible, so both cats and their owners can enjoy the best daily health support.”

    Aside from its health benefits, the supplement is well-liked for its taste and ease of use. It mixes effortlessly into both wet and dry foods, making it a breeze for even finicky eaters to benefit. With its U.S.-made composition and lack of unnecessary additives, it is a dependable choice for pet owners.

    Zenapet also seeks to foster community among pet lovers, connecting with customers on various online platforms, such as the Zenapet Instagram page. Through this, the brand listens to consumer feedback and provides updates about its products.

    Those interested in Zenapet’s pet wellness products can easily find them for sale on major online retail sites. Shopping for Zenapet on Amazon offers a convenient option for people who like the ease of online shopping, making it simple for pet owners to make informed choices for their pets’ care.

    Caren Collins adds, “Our goal with Zenapet is to make it easier for pet owners to nurture their furry friends. With the re-launch of Zenapet Cat Colostrum, we’re reinforcing our commitment to quality and efficacy, providing a product that supports the everyday needs of cats.”

    The re-launch of Zenapet Cat Colostrum highlights Zenapet’s goal to be a leader in pet health and wellness. By offering products that focus on practical benefits and are trusted by pet owners, Zenapet continues to differentiate itself with solutions that meet the needs of both pets and their human companions.

    To learn more about Zenapet Cat Colostrum or explore other products, pet owners can visit the Zenapet Cat Colostrum Official Website and join the conversation on the Zenapet Instagram page. For those ready to make a purchase, remember to shop Zenapet on Amazon for ease and peace of mind.

    The post Zenapet Re-Launches Cat Colostrum Plus to Support Cat Wellness appeared first on Local News Hub.

  • ClaimNotify.org Launches to Help Californians Reclaim Millions in Unclaimed Assets

    ClaimNotify.org Launches to Help Californians Reclaim Millions in Unclaimed Assets

    LOS ANGELES, CA / ACCESS Newswire / August 19, 2025 / ClaimNotify.org, a new online tool and educational hub for all things unclaimed assets, launched today to help Californians easily navigate the complex world of abandoned assets. With a mission to become the trusted national resource, the platform empowers residents to recover funds and assets that rightfully belong to them.

    Unclaimed assets- ranging from forgotten bank accounts and uncashed checks to insurance benefits and safe deposit box contents- are currently valued at over $2.5 billion in Los Angeles County and $600 million in San Diego County, according to recent public notices. Until now, finding and reclaiming these funds has been a confusing and time-consuming process.

    The launch comes at a pivotal moment: on September 4, 2025, new California code changes- driven by the passage of SB 822, which expands the state’s Unclaimed Property Law to include digital financial assets- will make it easier for residents to submit claims online. ClaimNotify.org will offer up-to-the-minute guidance on these changes, ensuring no eligible Californian misses their opportunity to reclaim what’s theirs.

    ClaimNotify.org streamlines the journey, offering:

    • A Centralized Resource for Californians: One place to access news, updates, and verified links for unclaimed asset searches, starting with California and expanding to other states.

    • Educational Tools: Easy-to-follow guides explaining what unclaimed assets are, how they get lost, and how residents can submit claims.

    • Breaking Updates: Timely alerts on new policies, large asset disclosures, and deadlines for filing claims.

    • Step-by-Step Support: Clear instructions to help users submit claims directly, without costly third-party services.

    “Unclaimed assets can be life-changing, but most people don’t even realize they exist- let alone how to recover them,” said a ClaimNotify.org spokesperson. “Our goal is to be the go-to source for accurate, accessible, and timely information, so Californians can claim what’s theirs without unnecessary stress or confusion.”

    Claim Notify plans to expand its coverage to include news and resources from multiple states, helping Americans nationwide access the billions in unclaimed property sitting in government coffers.

    To view the resources and learn more, visit: Claimnotify.org

    About ClaimNotify.org
    ClaimNotify.org is a public information portal dedicated to helping individuals navigate the often-confusing process of recovering unclaimed property. By consolidating updates, official resources, and step-by-step guides, ClaimNotify.org empowers people to reclaim their money and property with confidence. For more information, visit: ClaimNotify.org

    Contact:
    info@claimnotify.org

    SOURCE: govrecover

    View the original press release on ACCESS Newswire

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  • Rieg’s Gun Shop & Shooting Range Launches Franchise Program After 55 Years in Business

    Rieg’s Gun Shop & Shooting Range Launches Franchise Program After 55 Years in Business

    Trusted firearms retailer and training center offers entrepreneurs a rare chance to own a piece of its legacy.

    ORLANDO, FL / ACCESS Newswire / August 19, 2025 / Rieg’s Gun Shop & Shooting Range, a family-founded business serving firearm owners since 1968, has announced the launch of its first-ever franchise program.

    Known for its strong brand recognition, comprehensive training, and proven business model, Rieg’s is opening franchise opportunities to qualified entrepreneurs with a passion for firearms and a commitment to responsible ownership.

    Franchisees will benefit from:

    • A 2-week hands-on training program

    • Established supply chain and exclusive territories

    • Multiple revenue streams including retail, range fees, classes, and rentals

    • Ongoing support from industry veterans

    “The firearm industry is booming, and our franchise partners will enter the market backed by a respected name and over five decades of experience,” said Justin Hilton

    According to the NSSF, over 26 million new gun owners have entered the U.S. market since 2020, fueling growth in an industry that generated $91.65 billion in 2024.

    Contact:

    Justin Hilton
    Email: Franchise@TheRiegs.com
    Office: 407.473.0869

    SOURCE: Rieg’s Gun Shop & Range

    View the original press release on ACCESS Newswire

    The post Rieg’s Gun Shop & Shooting Range Launches Franchise Program After 55 Years in Business appeared first on Local News Hub.

  • Fence and Deck Depot Unveils Mold-Resistant Option for Unmatched Durability in St. Charles, MO

    Fence and Deck Depot Unveils Mold-Resistant Option for Unmatched Durability in St. Charles, MO

    Fence and Deck Depot, located in St. Charles, Missouri, is rolling out a new line of mold-resistant decking this fall. This addition responds to the increasing humidity that often creates challenges for homeowners. Their goal is to offer durable and practical products for outdoor living spaces.

    As the weather shifts and humidity rises, mold tends to become a common issue for deck owners. Fence and Deck Depot is addressing this problem by offering mold-resistant decking materials. These materials are crafted to endure the tough conditions typical of the fall season. Homeowners in St. Charles and nearby areas can look forward to an easier maintenance routine and less worry.

    The mold-resistant decking brings a lot to the table. By keeping mold at bay, it holds onto its look and lasts longer than traditional materials. This means fewer cleaning tasks and maintenance jobs. This new option shows the company’s commitment to meeting the changing needs of their customers.

    “We’re excited to bring mold-resistant decking to our clients,” a representative from Fence and Deck Depot said. “We want to help people make the most of their outdoor areas without worrying about upkeep during the change of seasons. This material not only boosts a home’s look but also provides sturdy, long-term protection.”

    This launch fits into Fence and Deck Depot’s larger plan to broaden their deck offerings. They also have a variety of deck styles and materials, such as composite, vinyl, and wood. By adding this mold-resistant technology, they show their commitment to top-notch service and customer satisfaction.

    Fence and Deck Depot doesn’t just stop at decks. They’re a leading name among St. Charles, MO Deck Builders and also provide all kinds of fencing solutions. They install everything from privacy and pool fences to garden fences using wood, aluminum, and vinyl. Each product is made with an eye for detail, making sure they look good and serve their purpose well.

    “Our team is dedicated to offering outdoor solutions that are both beautiful and dependable,” the media relations representative added. “Adding mold-resistant decking fits right in with this promise. We believe it will greatly improve our customers’ outdoor experiences.”

    This new mold-resistant decking highlights Fence and Deck Depot’s status as a trusted name in outdoor home improvements. They stick to their mission of delivering top-notch service and products to clients in both Missouri and Illinois.

    For anyone interested in upgrading to mold-resistant decking, more details are available on their website. The site offers full information about their services and the materials they offer for decks and fences. They also encourage potential clients to reach out for a consultation to discuss individual needs and explore suitable materials.

    With over 20 years of experience, Fence and Deck Depot has made a name for itself in the world of outdoor home improvements. They keep finding ways to innovate and adapt to what homeowners need. This new addition to their products works as a strong defense against the weather, enhancing how enjoyable outdoor spaces can be. Customers in the area are welcome to see this advancement and the peace of mind it offers. Visit their website for more information about their services and to schedule a consultation.

    Revent News: Fence and Deck Depot’s Essential Guide: How to Fix Backyard Safety Hazards and Make Them Safe for The Family

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  • Commonwealth M&A Welcomes Industry Veteran Joe DiGiacomo As Senior Advisor & Managing Director

    Commonwealth M&A Welcomes Industry Veteran Joe DiGiacomo As Senior Advisor & Managing Director

    The new relationship brings extensive experience to elevate client offerings and support future growth

    PHILADELPHIA, PA / ACCESS Newswire / August 19, 2025 / Commonwealth M&A, LLC, a premier full-service Merger & Acquisition advisory firm providing transactional and valuation services to small and medium sized businesses, today announced that Joe DiGiacomo has joined the team as a Senior Advisor and Managing Director. DiGiacomo will play a key role in company operations managing specific transactions, and will also offer counsel on other transactions, utilizing his 40+ years of experience to ensure deals close smoothly, companies get the valuation they deserve, and sellers are optimized to secure the best transition for their business.

    A seasoned professional who is well-established in the lower middle market, DiGiacomo has a diverse background in investment banking, business valuation, accounting, and mergers and acquisitions. Most recently as the Founder and President of D5 Capital Advisors, a boutique lower middle market M&A advisory firm headquartered in the Lehigh Valley, as well as previous positions as the President and CFO of a $135 million multimodal transportation and logistics business, and Partner of a regional CPA firm.

    “Our goals for Commonwealth M&A have been big from the start and bringing Joe on our team is going to supercharge our capabilities,” said Rick Calabrese, co-founder of Commonwealth M&A. “Having previously worked with Joe in my capacity as a transactional attorney, I know first hand the wealth of knowledge and experience he brings to the table. We are excited to add his expertise to our team to continue to bring our clients exceptional results, which is always our top priority.”

    “When I was considering combining my practice with another firm, I knew I wanted to join a team that was talented and motivated. I had worked with Rick in the past and when I found out he had started his own firm, I immediately wanted to learn more. I met with him and Joe [Bergin] and the pieces just fell into place, their mindset and business approach is exactly what I was looking for,” commented Joe DiGiacomo. “This team knows what they’re doing and I really think that their energy and technical experience paired with my background is going to be a dynamic offering. I’m very excited about this new chapter and know there’s an extremely bright future ahead for Commonwealth M&A.”

    In the last calendar year alone, Commonwealth M&A has closed more than $50M in transaction value for clients. Founders Rick Calabrese and Joe Bergin both offer unique expertise, Calabrese as a transactional attorney and CPA, and Bergin with a decade of corporate M&A experience at Johnson & Johnson. The team believes they can leverage DiGiacomo’s broad expertise to help lower middle market businesses find a deal that fits all of their needs.

    About Commonwealth M&A, LLC
    Commonwealth M&A, LLC is a full-service Merger & Acquisition advisory firm providing transactional and valuation services to small and medium-sized businesses. Commonwealth M&A offers a differentiated approach derived from the team’s diverse set of experiences. Our mission is to deliver personalized, high-quality service that exceeds expectations. Visit us at https://commonwealthmna.com/

    Media Contact
    Martina Corona
    Martina@notablypr.com

    SOURCE: Commonwealth M&A

    View the original press release on ACCESS Newswire

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  • Jaguar Health Family Company Napo Pharmaceuticals to Meet with FDA to Discuss Potential Regulatory Pathways for Crofelemer for Treatment of Ultrarare Pediatric Indication Microvillus Inclusion Disease (MVID)

    Jaguar Health Family Company Napo Pharmaceuticals to Meet with FDA to Discuss Potential Regulatory Pathways for Crofelemer for Treatment of Ultrarare Pediatric Indication Microvillus Inclusion Disease (MVID)

    As announced, initial proof-of-concept results from the ongoing investigator-initiated trial in Abu Dhabi show crofelemer reduced the required total parenteral nutrition in the first participating MVID patient by up to 27%; abstract describing results accepted for presentation at upcoming North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) 2025 Annual Meeting in Chicago

    SAN FRANCISCO, CA / ACCESS Newswire / August 19, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today announced that it plans to meet with the U.S. Food and Drug Administration (FDA) to discuss the company’s ongoing clinical development program for crofelemerfor the treatment of microvillus inclusion disease (MVID), an ultrarare pediatric disorder. Members of Napo’s Scientific Advisory Board will join Napo and Jaguar representatives at the meeting.

    “We’re very pleased that Napo has been granted a meeting with the FDA to discuss Napo’s development plans for crofelemer for MVID – a devastating pediatric disease characterized by severe malabsorption that requires life-sustaining parenteral support to meet the nutritional, fluid and electrolyte requirements of the child, and for which there no approved drug treatments,” said Pravin Chaturvedi, PhD, Napo’s and Jaguar’s Chief Scientific Officer and Chair of the Scientific Advisory Board. “A core Napo goal for this meeting is to obtain input from the FDA on the clinical program and potential expedited regulatory pathways for this rare orphan indication.”

    As announced, and as presented April 26, 2025 at the Annual ELITE PED-GI Congress, the initial proof-of-concept results of the ongoing investigator-initiated trial (IIT) of a novel crofelemer powder formulation for oral solution in Abu Dhabi in the United Arab Emirates show that crofelemer reduced the required total parenteral nutrition (TPN) and supplementary intravenous fluids in the first participating MVID patient by up to 27%. An abstract describing the initial results of this trial has been accepted for presentation at the upcoming North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) Annual Meeting taking place November 5-8, 2025 in Chicago.

    Jaguar, through Napo, is supporting the independent proof-of-concept IIT in pediatric intestinal failure (IF) patients at Sheikh Khalifa Medical City in Abu Dhabi, and is conducting the placebo-controlled Phase 2 study of crofelemer in pediatric MVID patients with IF at sites in the U.S., European Union, and Middle East/North Africa regions under appropriate regulatory approvals in each of these geographies.

    “Given the ultrarare nature of MVID, and the groundbreaking initial proof-of-concept results from the IIT in Abu Dhabi, even a small number of MVID patients showing benefit with crofelemer may allow Napo to explore pathways for expedited regulatory approval,” said Lisa Conte, Jaguar’s Founder and CEO.

    Based on the initial findings from the IIT in Abu Dhabi, crofelemer’s paradigm-shifting mechanism of action has the potential to provide a novel therapeutic option to reduce parenteral support and associated complications in MVID patients.

    About the Jaguar Health Family of Companies

    Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress. Jaguar family companies Napo Pharmaceuticals (Napo) and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including MVID and short bowel syndrome.

    For more information about:

    Jaguar Health, visit https://jaguar.health

    Napo Pharmaceuticals, visit www.napopharma.com

    Napo Therapeutics, visit napotherapeutics.com

    Forward-Looking Statements

    Certain statements in this press release constitute “forward-looking statements.” These include statements regarding Jaguar’s expectation that Napo personnel will meet with the FDA to discuss Napo’s development plans for crofelemer for MVID, statements regarding Jaguar’s expectation that an abstract describing the results of the investigator-initiated trial in Abu Dhabi will be presented at NASPGHAN 2025, Jaguar’s expectation that even a small number of MVID patients showing benefit with crofelemer may allow Napo to explore pathways for expedited regulatory approval, and Jaguar’s expectation that crofelemer’s paradigm-shifting mechanism of action has the potential to provide a novel therapeutic option to reduce parenteral support and associated complications in MVID patients. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar’s control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

    Contact:

    hello@jaguar.health
    Jaguar-JAGX

    SOURCE: Jaguar Health, Inc.

    View the original press release on ACCESS Newswire

    The post Jaguar Health Family Company Napo Pharmaceuticals to Meet with FDA to Discuss Potential Regulatory Pathways for Crofelemer for Treatment of Ultrarare Pediatric Indication Microvillus Inclusion Disease (MVID) appeared first on Local News Hub.

  • MIRA Pharmaceuticals Announces Completion of Phase 1 Single Ascending Dose for Oral Ketamir-2 with No Safety Concerns, Advances to Multiple Ascending Dose Stage

    MIRA Pharmaceuticals Announces Completion of Phase 1 Single Ascending Dose for Oral Ketamir-2 with No Safety Concerns, Advances to Multiple Ascending Dose Stage

    Following FDA IND clearance for neuropathic pain, the Company is preparing to initiate its U.S. Phase 2a trial in Q4 2025

    MIAMI, FL / ACCESS Newswire / August 19, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) (“MIRA” or the “Company”), a clinical-stage pharmaceutical company developing novel oral therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced the successful completion of the Single Ascending Dose (SAD) portion of its ongoing Phase 1 clinical trial evaluating oral Ketamir-2. The study, conducted at the Hadassah Clinical Research Center in Israel under the direction of Principal Investigator Prof. Yoseph Caraco, demonstrated a favorable safety and tolerability profile, with no severe or clinically significant adverse effects observed to date.

    “Completion of the SAD portion with a favorable safety and tolerability profile is an important milestone in the clinical development of Ketamir-2,” said Prof. Yoseph Caraco, Principal Investigator of the Phase 1 study. “Importantly, no severe or clinically significant adverse effects have been observed to date, which supports continued progression into the Multiple Ascending Dose stage of the trial.”

    Phase 1 Study Overview

    The study-A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Centre Study of Single and Repeated Dosing of Ascending Doses, to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral Ketamir-2 in Healthy Adult Subjects-is designed to establish the safety, tolerability, and pharmacokinetics of Ketamir-2 in healthy adult volunteers.

    • Design: Single-center, randomized, double-blind, placebo-controlled SAD/MAD with sentinel dosing and Safety Steering Committee (SSC) reviews between cohorts.

    • SAD completed: Four cohorts (single doses 50 mg to 600 mg); 32 participants treated (male and female).

    • Safety monitoring: Extensive central nervous system (CNS) safety assessments were performed using well-validated clinical research tools:

      • Columbia-Suicide Severity Rating Scale (C-SSRS) – screens for suicidal ideation or behavior, supporting early detection of potential mood or psychiatric changes.

      • Bowdle Visual Analogue Scale (VAS) – measures possible psychedelic or dissociative effects sometimes seen with ketamine and related compounds.

      • Ketamine Side Effect Tool (KSET) – tracks a broad range of known ketamine-related side effects over time, including sensory, cognitive, and mood changes.
        These tools provided multiple, complementary layers of safety evaluation to help detect even subtle CNS effects throughout the trial.

    • Status: To date, no severe or clinically significant adverse effects have been observed at any dose level in the SAD portion of the study.

    While the study remains ongoing and blinded, it is worth noting that, across the pharmaceutical industry as a whole, approximately one-third of investigational drugs fail during Phase 1 due to safety concerns (Tufts Center for the Study of Drug Development). These interim observations provide encouraging context as MIRA advances Ketamir-2 through the next stage of clinical evaluation, consistent with the Company’s mission to prioritize safety in every step of development.

    The Company is advancing to the Multiple Ascending Dose (MAD) portion, which will evaluate three cohorts receiving daily oral doses of 150 mg, 300 mg, or 600 mg for five consecutive days in up to 24 participants.

    “The emerging human safety profile complements the preclinical data we’ve generated, which show Ketamir-2’s superior efficacy in multiple neuropathic pain models without triggering the hallmark CNS side effects of ketamine,” said Dr. Itzchak Angel, Chief Scientific Advisor of MIRA. “This combination of efficacy, safety, and oral delivery positions Ketamir-2 as a promising next-generation treatment for neuropathic pain and potentially other CNS disorders.

    Strategic & Commercial Potential

    Ketamir-2 is a proprietary, orally bioavailable new molecular entity that selectively targets the NMDA receptor (PCP site) with low affinity and shows no significant off-target activity across a broad receptor panel. Preclinical studies have demonstrated superior performance versus ketamine, pregabalin, or gabapentin (depending on comparator and model) in gold-standard neuropathic pain models-without the dissociative effects associated with ketamine.

    Neuropathic pain affects an estimated 36-51 million people in North America and represents a multi-billion-dollar market today, with long-term growth driven by diabetes prevalence, cancer survivorship, and aging-related nerve damage. MIRA intends to submit a Phase 2a clinical protocol in neuropathic pain by year-end 2025 and continue evaluating potential applications in depression, anxiety, PTSD, and localized pain, subject to ongoing results and regulatory feedback.

    “We are pleased to see our Phase 1 program progress as planned,” said Erez Aminov, CEO of MIRA. “Advancing into the MAD stage is an important operational step as we continue to build a rigorous safety and PK foundation for Ketamir-2 and work to deliver a differentiated, non-opioid option for patients with neuropathic pain.

    About MIRA Pharmaceuticals, Inc.

    MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) is a clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders. The Company’s pipeline includes oral drug candidates designed to address significant unmet medical needs in areas such as neuropathic pain, inflammatory pain, obesity, addiction, anxiety, and cognitive decline.

    For more information, please visit www.mirapharmaceuticals.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release and the statements of MIRA’s management related thereto contain “forward-looking statements,” which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. Any forward-looking statements in this press release are based on MIRA’s current expectations, estimates, and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond MIRA’s control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including related to MIRA’s potential merger with SKNY Pharmaceuticals, Inc. These and other risks concerning MIRA’s programs and operations are described in additional detail in the Annual Report on Form 10-K for the year ended December 31, 2024, and the Form 14A filed by MIRA on June 18, 2025, and other SEC filings, which are on file with the SEC at www.sec.gov and on MIRA’s website at https://www.mirapharmaceuticals.com/investors/sec-filings. MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

    Contact:
    Helga Moya
    info@mirapharma.com
    (786) 432-9792

    SOURCE: MIRA Pharmaceuticals

    View the original press release on ACCESS Newswire

    The post MIRA Pharmaceuticals Announces Completion of Phase 1 Single Ascending Dose for Oral Ketamir-2 with No Safety Concerns, Advances to Multiple Ascending Dose Stage appeared first on Local News Hub.