Tag: Charlie's Chalk Dust

  • Charlie’s Holdings Confirms its PMTAs Still Under Review

    Charlie’s Holdings Confirms its PMTAs Still Under Review

    Charlie’s Holding’s, parent to e-liquid manufacturer Charlie’s Chalk Dust, confirmed that it premarket tobacco product applications (PMTA) remain under scientific review by the U.S. Food and Drug Administration. The company has not received a marketing denial orders (MDOs) or refuse-to-file letters for any of its submitted products.

    “Including product-specific scientific data, thorough perception studies, and detailed environmental assessments, Charlie’s PMTA’s cost more than $5 million and are among the most comprehensive PMTA’s in the entire industry,” a press release states. “The Company has publicly expressed its commitment to full regulatory compliance and youth access prevention and believes its submissions to the FDA will be recognized as both distinguished and suitable for approval.”

    Ryan Stump, Charlie’s COO, explained that in addition to human clinical trials that measured the nicotine delivery efficiency of the company’s products via pharmacokinetic studies, Charlie’s PMTA’s also included “product-specific, scientific evidence” that demonstrates the marketing of Charlie’s products meets the statutory standard of appropriate for the protection of the public health that is required for an FDA marketing order.

    “This is an important reason why we are highly confident that the FDA will recognize Charlie’s PMTA submissions as both distinguished and suitable for approval,” said Stump. “As a result of the painstaking efforts we invested in our PMTA’s, when others are forced to withdraw their products from the market, Charlie’s will be one of a very select group still legally allowed to operate in the flavored nicotine product space. We look forward to the competitive advantage – and to the corresponding increases in sales, profits, and market share – that will result from our steadfast commitment to providing Charlie’s customers with a trusted product portfolio in full regulatory compliance.”

    To date, the FDA has now issued 168 companies MDOs for an estimated 992,000 products. According to a press release, the regulatory agency released a revised listing of MDOs that includes 125 company names but not any specific products that were denied. There were no updates provided on several high-profile submissions, such as those submitted by Juul Labs, BAT and Japan Tobacco International. The agency also offered no response to any submitted open-system hardware products or tobacco-flavored e-liquids.

  • Charlie’s Holdings Profits Increase to Start 2021

    Charlie’s Holdings Profits Increase to Start 2021

    Charlie’s Holdings, parent to the Charlie’s Chalk Dust brand, announced the company’s financial results for the first quarter (Q1) ending March 31, 2021. Charlie’s reported that revenue, gross profit, gross margin, and cash balance all increased from Q4 2020 to Q1 2021, according to a release.

    Revenue for the 1Q of 2021 was $4,361,000, an increase of $131,000 compared to Q4 2020, and a decrease of $44,000 or 1 percent, compared to $4,405,000 for the same time the previous year. Gross profit for Q1 2021 was $2,418,000, an increase of $305,000 compared to Q4 2020 and a decrease of $24,000, or 1 percent, compared to $2,442,000 for the same period 2020.

    Other announcments include:

    • Operating loss decreased 95 percent year-over-year, and 70 percent from Q4 2020, to $229,000,
    • Cash balance of $3.5 million,
    • Total assets of $8.1 million,
    • Closed a $3 million capital raise in common stock (priced at $0.0085) with company founders,
    • Introduced Pachamama Disposables, Charlie’s first-ever entrant into the rapidly expanding U.S. disposable e-cigarette market,
    • Successfully assembled a solution “network” in order to meet the requirements of both the Consolidated Appropriations Act of 2021 and the Prevent All Cigarette Trafficking (PACT) Act to ensure uninterrupted service to the company’s distributor partners.

    The company announced in mid-2020 that its premarket tobacco product application (PMTA) had entered the substantive review phase of the U.S Food and Drug Administration (FDA) regulatory process. “Having engaged a team of more than 200 professionals and invested nearly $5 million to compile and submit Charlie’s initial PMTA submission, the company is confident that the FDA will recognize that Charlie’s submission is both distinguished and suitable for approval,” the release states. “The company believes its comprehensive PMTA will ultimately prove a competitive advantage for Charlie’s. Most of the company’s competitors did not have the desire, the technical expertise, or the financial resources to complete the PMTA process. As a result, in fewer than 12 months’ time, when others are forced to withdraw their products from the market, Charlie’s may be one of a very select group still legally allowed to operate in the premium e-liquid product space.”

  • Charlie’s Holdings Raises $3 Million in Private Stock Sale

    Charlie’s Holdings Raises $3 Million in Private Stock Sale

    Charlie’s Holdings, Inc., parent to the Charlie’s Chalk Dust and Pacha Mama brands, announced that it has closed a $3 million capital raise through the private sale of 351,669,883 shares of common stock to the company’s founders, Brandon Stump, CEO, and Ryan Stump, COO, according to a press release. The company intends to use the proceeds from the offering to drive substantial future growth, facilitate new product launches, increase working capital, retire outstanding debt, and for other general corporate purposes.

    “The extensive process required to compile and submit a comprehensive premarket tobacco product application (PMTA) to the FDA will ultimately prove a huge differentiating factor for Charlie’s; but it was also very expensive. Charlie’s invested nearly $5 million for its initial PMTA submission and the company was in need of additional capital,” explained Jeff Fox, a member of Charlie’s board of directors. “After lengthy negotiations with numerous other potential investors did not produce acceptable terms, we are pleased that our founders, Brandon and Ryan Stump, chose to personally fund this $3 million common stock only investment. This financing does not include warrants or any other inducements. It will provide Charlie’s with sufficient proceeds to meet all of the Company’s current financial obligations and to drive substantial future growth opportunities.”

    David Allen, CFO said the proceeds from the private placement will strengthen the company’s balance sheet, accelerate European growth, allow for expansion into the Middle East, and facilitate the company reaching several important near-term milestones, including the FDA’s anticipated announcement of Charlie’s successful PMTA.

    “Such an accomplishment will allow Charlie’s to benefit tremendously as one of only a select group of companies operating responsibly in the premium e-liquid product space,” said Allen. “Combined with our international growth, a domestic PMTA approval will dramatically increase Charlie’s sales, profits, and market share. We expect 2021 will be a very exciting year for our shareholders.”