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Tag: Charlie's Holdings

  • Ispire Revenue Falls 9.3% in Fiscal Q1

    Ispire Revenue Falls 9.3% in Fiscal Q1

    Ispire Technology reported fiscal first-quarter revenue of $27.5 million, down 9.3% from $30.4 million a year earlier, primarily due to lower European sales amid tighter vaping regulations. Net loss widened to $6.4 million from $3.3 million, including $4.8 million in credit loss expenses. Gross margin was 16.2%, down from 17% a year earlier but up from 6.3% in the previous quarter. Adjusted EBITDA was positive $136,000, compared with $639,000 a year earlier.

    The company said it is expanding manufacturing in Malaysia and pursuing new OEM and ODM relationships, including a potential deal with a regional Southeast Asian brand. Ispire is also advancing its nicotine pouch joint venture with Jincheng Pharma and plans a U.S. pilot of its IKE 2.0 age-gating platform with Charlie’s Holdings. Ispire ended the quarter with $15.6 million in cash and $400,000 in working capital.

  • Trump Administration Looking to Change PMTA Process

    Trump Administration Looking to Change PMTA Process

    The Trump administration is reportedly preparing changes to the FDA’s review process for new tobacco products that could make it faster and easier for products such as flavored vapes and nicotine pouches to receive marketing authorization, according to The Wall Street Journal. The FDA is expected to revisit requirements established in 2021 for Premarket Tobacco Product Applications (PMTAs), following years of industry criticism over lengthy reviews.

    Reuters reported it could not independently verify the report, but quoted an HHS spokesperson as saying, “The Trump administration is committed to keeping nicotine out of the hands of kids, getting ⁠counterfeit vaping products off the streets and providing safer alternatives for adults who want to quit smoking cigarettes.”

    Industry groups and companies welcomed the potential changes. Laura Leigh Oyler, vice president of regulatory affairs at Haypp Group USA, said the FDA has not met congressional review deadlines for noncombustible products and has authorized fewer than 100 reduced-risk products compared with thousands of combustible products. “An overhaul isn’t just welcome, it’s necessary,” Oyler said, adding that the current process has contributed to the influx of foreign, illicit products.

    Charlie’s Holdings also supported the reported changes, saying it has been seeking FDA authorization for certain tobacco-derived nicotine e-liquids since 2020 and hundreds of synthetic nicotine products since 2022. CEO Henry Sicignano said the PMTA process has imposed high costs on smaller U.S. businesses while illicit products have entered the market. Charlie’s said it currently retains 678 timely filed PMTA assets and expects a streamlined authorization process to increase the value of its portfolio.

  • Charlie’s Holdings Reports 116% Growth, Optimism on FDA Front

    Charlie’s Holdings Reports 116% Growth, Optimism on FDA Front

    Charlie’s Holdings reported second-quarter revenue of $3.8 million, up 116% from $1.8 million a year earlier, driven by higher sales of nicotine-based and nicotine-alternative products. Gross profit rose 130% to $1.1 million, while gross margin increased to 29.4% from 27.6%. Operating expenses increased 63% to $2.4 million, resulting in an operating loss of $1.2 million, compared with $1 million in Q2 2025.

    The company said the FDA has tentatively identified 30 PACHA SKUs with submitted premarket tobacco applications for inclusion on a public webpage covering products for which the agency generally does not intend to prioritize enforcement of PMTA requirements. Charlie’s said the development could improve the regulatory outlook for the products, although the company described the status as tentative. The company also cited the FDA’s May authorization of four flavored ENDS products from Glas as a potentially significant development for the U.S. vapor market.

    Charlie’s said it remains on schedule to test-market what it describes as the first age-gated flavored disposable vape in the U.S. through hundreds of retail stores. The company also launched SBX 25K Virginia Tobacco disposables in California and said it has received California Unflavored Tobacco List authorization for four modern disposable products. Charlie’s ended the quarter with $500,000 in cash, down from $1.3 million at year-end 2025, while total assets increased to $12.8 million. Management and directors purchased 1.35 million restricted shares during the first half at $0.20 per share.

  • Charlie’s Holdings Touts Progress to Shareholders

    Charlie’s Holdings Touts Progress to Shareholders

    Charlie’s Holdings, Inc. sent out a shareholder letter today (June 8), outlining its recent progress and highlighting improved financial stability, portfolio expansion, and regulatory positioning across its premium vapor products business. The company said it strengthened liquidity and operations over the past year, including the $7.5 million sale of 16 PMTA-authorized products to a major tobacco company and the expansion of its U.S. manufacturing footprint to support domestic production, reduce costs, and meet state-level compliance requirements.

    The letter also emphasized Charlie’s strategic focus on regulatory innovation and capital market advancement. The company detailed its licensing agreement with IKE Tech to commercialize an AI-powered age-gating system for disposable vapes, which it believes could unlock significant licensing revenue and potential partnerships. It also noted steps toward a potential uplisting to a national exchange, including a clean 2025 audit, elimination of prior business lines, and shareholder approval of a reverse stock split, while reaffirming its goal of growing compliant nicotine and alternative vapor product sales amid tightening enforcement against illicit products.

  • Charlie’s Holdings Talks Opportunities as FDA Flavor Stance Shifts  

    Charlie’s Holdings Talks Opportunities as FDA Flavor Stance Shifts  

    Charlie’s Holdings said it is well-positioned to capitalize on potential regulatory changes in the U.S. flavored vape market, highlighting its portfolio of 678 PMTA-submitted products and its planned rollout of age-gated devices using AI-powered verification technology. The company said its ability to combine pending applications with advanced access-restriction systems could align with evolving FDA expectations around youth prevention, positioning it to bring new products to market if approvals expand.

    The company pointed to recent reports that President Donald Trump has urged the FDA to accelerate flavored vape authorizations, along with the agency’s approval of four new ENDS products—including its first flavored pod authorizations using age-gating—as signals of a possible policy shift. Charlie’s said these developments could support broader regulatory acceptance of flavored products and create new commercial opportunities for companies able to meet stricter access and compliance requirements.

  • Charlie’s Holdings Reports 169% Revenue Increase

    Charlie’s Holdings Reports 169% Revenue Increase

    Charlie’s Holdings, Inc. reported a sharp turnaround in 2025, with revenue rising 169% year over year to $20.9 million and net income of $4.5 million, compared with a $4.2 million loss in 2024. The company’s auditor, Urish Popeck & Co., LLC, issued a clean opinion that removed prior “going concern” language, strengthening Charlie’s position for a planned uplisting to a national exchange in 2026. Balance sheet metrics improved materially, with cash increasing to $1.3 million, total assets to $11.6 million, and shareholders’ equity returning to a positive $3.4 million from a deficit position a year earlier.

    Performance was supported by $7.5 million in PMTA-related asset sales to a strategic buyer, growth in SBX nicotine-analogue disposables, and the opening of a U.S. manufacturing facility in Q4. Looking ahead, Charlie’s plans to expand chain convenience distribution, pilot an AI/blockchain age-gating system with IKE Tech, introduce high-capacity disposable devices under SBX and Pachamama, pursue additional PMTA partnerships, grow international sales, and advance its exchange uplisting, while positioning its regulatory compliance and youth-access controls as differentiators in a market the company says is pressured by illicit imports.

  • Charlie’s Holdings’ 25K-Puff Vape Cleared in Calif.

    Charlie’s Holdings’ 25K-Puff Vape Cleared in Calif.

    Charlie’s Holdings, Inc. announced that California regulators have added its Virginia Tobacco 25K-puff SBX disposable vape to the state’s Unflavored Tobacco List (UTL), which, according to the company, makes it the first 25,000-puff vaping device authorized for legal sale in the state. The approval follows California’s strengthened flavor restrictions under Assembly Bill 3218, which requires that only products classified as unflavored and included on the UTL can be sold in the state. Company executives said the listing positions the SBX device to access California’s retail market while underscoring Charlie’s focus on regulatory compliance and youth-access prevention.

  • Charlie’s Holdings, IKE Tech Launch AI Verification for Vapes

    Charlie’s Holdings, IKE Tech Launch AI Verification for Vapes

    Charlie’s Holdings announced a licensing deal to bring what it describes as the first AI-powered, blockchain-based age-verification system for vape products to the U.S. market. The California–based company said it signed a definitive agreement with IKE Tech to commercialize the technology, which is designed to prevent underage access to vapor products while allowing compliant sales to adults.

    The company positioned the move as a response to regulatory pressure on flavored vaping products, which it said are preferred by 80–90% of adult consumers and play a key role in helping smokers switch away from combustible cigarettes. Charlie’s noted that despite broad recognition of vaping as a lower-risk alternative to smoking, the FDA has yet to authorize a single flavored vapor product, while state-level flavor bans in markets such as California and Massachusetts have reshaped the legal landscape.

    According to Charlie’s, those restrictions have contributed to growth in illicit products and reduced legal options for adult smokers seeking alternatives. The company said its age-gating system is intended to address youth-access concerns directly, potentially offering regulators a technology-based compliance tool that could support more balanced oversight of the flavored vapor category.

  • Charlie’s Holdings’ New Factory to Serve Texas Market

    Charlie’s Holdings’ New Factory to Serve Texas Market

    Yesterday (December 1), Charlie’s Holdings, Inc. announced the opening of its first U.S.-based manufacturing facility in Huntington Beach, California, which will exclusively produce the company’s own brands, including the Pachamama 25K line. The move ensures full compliance with Texas’ new law banning certain vape products imported from China and other restricted countries.

    “We originally expected our US-filling facility to mitigate Far East shipping delays and to lessen tariff costs, but Texas’ new domestic manufacturing requirements have also created a massive sales opportunity for Charlie’s,” Charlie’s president Henry Sicignano III, said. “Demand is so great, we now plan to devote 100% of our current U.S. manufacturing capacity to the state of Texas; if all goes well, and if we expand our U.S. manufacturing initiative in the coming months, we believe Texas could double Charlie’s sales forecasts for 2026.”

    This week, 300 retail accounts across Texas will begin receiving shipments of Charlie’s U.S.-filled disposables.

    “To my knowledge, Pachamama is the only vapor products brand that has been on the market for more than a decade and is now fully compliant with Texas domestic manufacturing requirements,” said Ryan Stump, Charlie’s co-founder and Chief Operating Officer.

  • Charlie’s Holdings Receives PMTA Acceptance Filings for 11 Products

    Charlie’s Holdings Receives PMTA Acceptance Filings for 11 Products

    Charlie’s Holdings, Inc. announced today that it received acceptance filings for 11 of its best-selling flavored PACHA Disposables brands from the Center for Tobacco Products of the U.S. Food and Drug Administration. Charlie’s has received more than 700 acceptance filings for its PMTA submissions.

    The FDA has received PMTAs for nearly 27 million electronic nicotine delivery system products and has made determinations on more than 99% of the applications. However, the FDA has authorized fewer than three dozen tobacco- and menthol-flavored e-cigarette products and devices. To date, no company in the world has received an FDA marketing order for a flavored (non-tobacco or non-menthol) disposable vape product.