Quarterly Report for Quarter Ending March 31, 2025 (Form 10-Q)

- MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion of the financial condition and results of operations of Charlie's Holdings, Inc. should be read in conjunction with the financial statements and the notes to those statements appearing elsewhere in this Quarterly Report on Form 10-Q (this "Report") and without audited financial statements and other information presented in our Annual Report on Form 10-K for the year ended December 31, 2024 (the "2024 Annual Report"). Some of the information contained in this discussion and analysis or set forth elsewhere in this Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. Such forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by the forward-looking statements. Factors that could cause or contribute to these differences include, but are not limited to, those discussed below and elsewhere in this Report, and in our other filings with the Securities and Exchange Commission ("SEC"), including particularly matters set forth under Part I, Item 1A (Risk Factors) of the 2024 Annual Report. Furthermore, such forward-looking statements speak only as of the date of this Report. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements.

As used in this Report, unless otherwise stated or the context otherwise requires, references to the "Company", "we", "us", "our", or similar references mean Charlie's Holdings, Inc., its subsidiaries and consolidated variable interest entity on a consolidated basis.

Overview

The Company's objective is to become a leader in two broad product categories: (i) non-combustible nicotine-related products, and (ii) alternative alkaloid vapor products. Through our Charlie's subsidiary, we formulate, market, and distribute premium, nicotine-based and alternative alkaloid vapor products. Charlie's products are produced through contract manufacturers for sale through select distributors, specialty retailers, and third-party online resellers throughout the United States and in select international markets.

Operational Plan

In today's economic landscape, particularly within the vapor products industry, seeking and securing competitive advantage is paramount. Unlike many competitors in our industry, Charlie's has focused on achieving full compliance with FDA regulations - while also establishing a regulatory "hedge" through the development of alternative "zero-nicotine" product lines that are not currently subject to FDA review. Simultaneous to undertaking these initiatives, in 2024 management took aggressive steps to "right size" the business, preserve working capital, and achieve profitability in 2025. Our key initiatives include:

1.

Product Innovation: In late 2023 Charlie's initiated a plan to dramatically expand its business from nicotine products only, to a portfolio of products that includes nicotine substitute products. This strategic hedge, and the market testing that the shift entailed, significantly reduced Company revenue in 2024. However, the Company believes that its nicotine substitute, Metatine™, in the SBX™ product line, will position the Company to capture very significant future sales and market share in the vapor products marketplace.

2.

PMTA Assets: At this date, Charlie's has received FDA Acceptance Filings for more than 650 PMTAs. By investing an additional $1.2 million in Q4 2024 to amend and enhance certain of our 2022 PMTA submissions, we maintained our commitment to full regulatory compliance, and we enhanced the strategic value of our PMTA portfolio. The Company believes Charlie's 650+ PMTAs, as a stand-alone asset, have a monetary value that far exceeds Charlie's current market cap.

3.

Age-Gating Technology: We have continued to develop intellectual property around, and to seek strategic partnerships for, technologies designed to prevent youth access to nicotine vapor products. We believe this is both a responsible business practice as well as a potential future competitive advantage in the marketplace.

4.

Cost Structure Optimization: In order to right-size the Company during a time of significantly reduced revenue, we continue to reduce our overall cost structure while improving margins. Company executives voluntarily reduced their salaries by 20-50%.

5.

Headcount Reduction: We have significantly reduced our headcount and associated salary expenses, focusing on maintaining a core group of key employees as we collectively right-size the business.

6.

Sales Team Improvement: We have upgraded, and will continue to upgrade, our sales team from a solely account management-centric team to a skilled and driven sales team to acquire new customers while maintaining excellent service with our existing customers.

7.

Uplist to a National Securities Exchange: As the business returns to growth, and as soon as we are able to meet listing requirements, we plan to uplist from the OTCQB exchange to a national securities exchange. An uplist will increase Charlie's market visibility, liquidity, and access to capital. Such a shift could lead to new strategic opportunities and, potentially, to a substantially higher market cap.

Management believes that these initiatives will enhance Charlie's competitive position in the marketplace, significantly reduce costs, help accelerate the Company's path to profitability, support business growth, and, ultimately, allow the Company to achieve greater liquidity and visibility through an uplist to a national securities exchange.

Considering industry-specific hurdles, as well as the potential for future regulatory changes, management has prioritized several principal initiatives as opportunities for growth:

Priority 1: Over the last two years, we initiated a plan and began to invest substantial time and resources to develop various proprietary products and new technologies in order to achieve competitive advantages in the vapor and alternative products marketplace. Marshaling very significant internal and external research and development resources, we endeavored to identify a nicotine substitute ("Metatine™") to be used in lieu of tobacco-based and synthetically derived nicotine. We believe adult consumers will enjoy Metatine alternative alkaloid vapor products in much the same way that they enjoy traditional vapor products. Notably, because Metatine is not made or derived from tobacco, and because Metatine does not consist of or contain nicotine from any source, the FDA's Center for Tobacco Products does not have jurisdiction to regulate Metatine. Accordingly, if the Company is successful utilizing Metatine in a viable commercial product, such a product will allow us additional flexibility in offering both flavored and non-flavored vapor products to adult consumers looking to transition away from traditional combustible and smokeless tobacco products.

In 2024, to test consumer acceptance of nicotine substitute vapor products in the marketplace, we launched the SPREE BAR disposable flavor pod system (with Metatine inside) in select markets across the US. This initiative demonstrated that adult consumers: (i) overwhelmingly prefer "flavored" vapor products over plain tobacco products; (ii) are highly receptive to nicotine substitute products that offer the same vaping experience as that provided by conventional nicotine vapor products; and, surprisingly (iii) are not particularly interested in the cost savings that SPREE BAR flavor pods (with reusable batteries) represent vs. conventional disposable vapes (with single use batteries).

Applying these findings to our ongoing product development initiatives, by the end of 2024 Charlie's unveiled the Company's second-generation Metatine product line: SBX Disposables. SBX Disposables feature: (i) the modern disposable product format (with digital display) that consumers overwhelmingly prefer over pod system vapes; (ii) award-winning flavors (preferred over plain tobacco vapor by more than 80% of adult consumers); and, most significantly, for regional and national convenience store chains that are our largest potential customers, (iii) Charlie's proprietary nicotine substitute that makes SBX legal across most of the United States (without FDA PMTA review).

In a Company-sponsored focus group survey of adult consumers who vape, Charlie's SBX Disposables were overwhelming preferred over Juul tobacco-flavored vapes. Of 306 survey participants, 287 preferred SBX over Juul. In Company marketing materials, SBX advantages are highlighted: "Compared to mass-market vapes offered by Big Tobacco ̶ namely Juul ̶ SBX provides many MORE FLAVOR options, UNBEATABLE TAX ADVANTAGES, and THOUSANDS MORE PUFFS!"

Following up on these encouraging early results, we are currently test marketing SBX in mass market convenience chains. If one or more of these tests prove successful, regional and national rollouts could prove transformational for Charlie's.

Further, we have recently begun test-marketing Metatine-based e-liquids under the PACHAMAMA PLUS+ trademark. In response to the rapidly emerging new "pouch products" category in the nicotine products industry, we are also developing a Metatine-based pouch line that could be ready for market in late 2025. We do, however, recognize the challenges in marketing non-nicotine-based alternative alkaloid products in a market that is saturated with traditional nicotine products; accordingly, we are committed to continuous improvement of our Metatine-based products in order to satisfy the ever-evolving demands of US adult consumers.

Priority 2: Since our founding in 2014, Charlie's has created literally hundreds of products that provide adult smokers with a viable means of abandoning cigarettes. Not coincidentally, over the last 10-15 years e-cigarette usage in the United States has grown significantly, and cigarette smoking rates have dropped. Accordingly, tobacco and synthetically derived nicotine vapor products continue to provide significant growth opportunities for Charlie's. In 2021, we launched our synthetic nicotine (not derived from tobacco) Pacha (formerly Pachamama Disposable) product line, which provides access to additional sales channels and broadens our customer base. These innovative product formats continue to represent an extremely important product category for Charlie's and we intend to develop new distribution partnerships in order to grow our nicotine disposable business in 2025.

We believe that our substantial investments in FDA regulatory compliance make Charlie's an attractive partner in this space. Charlie's has received FDA Acceptance Filings for more than 650 PMTAs. By investing an additional $1.2 million in Q4 2024 to amend and enhance certain of our 2022 PMTA submissions, we maintained our commitment to full regulatory compliance and we enhanced the strategic value of our PMTA portfolio. The Company believes Charlie's 650+ PMTAs, as a stand-alone asset, have a monetary value that far exceeds Charlie's current market cap.

In total, Charlie's has invested more than $6.5 million on the submission of Premarket Tobacco Applications ("PMTAs") and subsequent amendments to these applications to the FDA. We engaged a team of more than 200 professionals, including doctors, scientists, biostatisticians, data analysts, and numerous contract research organizations to create Charlie's comprehensive PMTA submissions. Notwithstanding Charlie's meaningful and costly regulatory initiatives - and even though hundreds of other companies across the United States invested hundreds of millions of dollars to submit more than 26 million PMTAs - to date, the FDA has authorized only 34 tobacco-flavored (and a handful of menthol) e-cigarette products and devices. Accordingly, even though former FDA Commissioner Dr. Scott Gottlieb described e-cigarettes as far lower on the "continuum of risk" than combustible cigarettes, fewer than 1% of the PMTA's for e-cigarette products and devices have survived FDA's regulatory gauntlet.

Nonetheless, we are continuing to seek FDA marketing authorization for certain of both our nicotine vapor products and our synthetic nicotine vapor products. Obtaining one or more marketing orders from the FDA could, we believe, help to remediate perceived health issues related to vaping, and further position the Company as a trusted industry leader. While we continue in the FDA review process, we are also beginning to seek out strategic partners to monetize our PMTAs; given that Charlie's 650+ PMTAs (primarily for flavored vapor products) remain among the fraction of 1% that are still under active review with the FDA, and given that more than 80% of adults in the United States prefer flavored vapor products over plain tobacco vapor products, we believe that Charlie's PMTA portfolio represents an important competitive advantage - of significant monetary value.

Priority 3: The Company continues to develop intellectual property around, and to seek strategic partnerships for, technologies designed to prevent youth access to nicotine vapor products. Edward Carmines, Ph.D., a member of Charlie's Board of Directors and an accomplished scientist and regulatory affairs expert, is spearheading Charlie's development of patented "age-gating technology" for both Charlie's and potential licensees of the Company. Currently, there is a need for age-gated product technologies that can satisfy or accommodate concerns the FDA has related to under-age youth access in the ENDS market. We believe age-gating is both a responsible business practice as well as a potential future competitive advantage for Charlie's. If our age-gated e-cigarettes-in-development are recognized as "products of merit" by the FDA, Charlie's e-cigarettes could emerge among the select minority of flavored nicotine disposables able to be sold legally in the $8 billion U.S. vapor products market.

Underlining the importance of Charlie's work with age-gating technology are initiatives taken by JUUL Labs, Altria, and R.J. Reynolds, three of the largest competitors in our industry. In July 2023 JUUL announced that it had submitted a PMTA with the FDA for a new e-cigarette device that also included information on novel, data-driven technologies to restrict underage access. JUUL's chief product officer explained, "With our next-generation platform, we have designed a technological solution for two public-health problems: improving adult-smoker switching from combustible cigarettes and restricting underage access to vapor products..." In the second quarter of 2024, Altria and R.J. Reynolds announced news of their own PMTA submissions to the FDA for mobile applications that verify consumers' ages through third-party age verification providers. Similar to the age-gating technology under development at Charlie's, the Big Tobacco company devices include mobile and web-based apps that enable age-verification technology, including device-locking, and real-time product information and usage insights for age-verified consumers with industry-leading data-privacy protections.

Priority 4: In order to mitigate FDA regulatory risk in the domestic market and to capture what management continues to believe is a significant commercial opportunity, we have dedicated additional resources to efforts focused on growing our market share internationally. Presently, approximately 10% of our vapor product sales come from the international market and we are well positioned to increase sales in countries where we already have presence and, in additional overseas markets, as we have already built an international distribution platform.

Risks and Uncertainties and Ability to Continue as a Going Concern

The Company operates in an environment that is subject to rapid changes and developments in laws and regulations that could have a significant impact on the Company's ability to sell its products. Beginning in September 2019, certain states temporarily banned the sale of flavored e-cigarettes, and several states and municipalities are considering implementing similar restrictions. Federal, state, and local governmental bodies across the United States have indicated that flavored e-cigarette liquid, vaporization products and certain other consumption accessories may become subject to new laws and regulations at the federal, state, and local levels. In addition, in June 2022, the FDA announced a plan to reduce nicotine levels in cigarettes to minimally or non-addictive levels. The application of any new laws or regulations that may be adopted in the future, at a federal, state, or local level, directly or indirectly implicating nicotine, flavored e-cigarette liquid, and other electronic nicotine delivery system ("ENDS") products, could significantly limit the Company's ability to sell such products, result in additional compliance expenses, and/or require the Company to change its labeling and/or methods of distribution. Any ban of the sale of flavored e-cigarettes directly limits the markets in which the Company may sell its products. In the event the prevalence of such bans and/or changes in laws and regulations increase across the United States, or internationally, the Company's business, results of operations, and financial condition could be adversely impacted. In addition, the Company is presently seeking to obtain marketing authorization for certain of its tobacco-derived nicotine e-liquid products. The Company's applications were submitted in September 2020 on a timely basis, which if approved, will allow the Company to continue to sell its approved products in the United States. Beginning in August 2021, the FDA began issuing Marketing Denial Orders ("MDO") for ENDS products that lack evidence to demonstrate that permitting the marketing of such products would be appropriate for the protection of the public health. The Company has not received an MDO for any of its 2020 PMTA submissions; however, there is no assurance that regulatory approval to sell our products will be granted or that we would be able to raise additional financing if required, which could have a significant impact on our sales. On March 15, 2022, a new rider to the Federal Food, Drug and Cosmetic Act was passed granting the FDA authority over synthetic nicotine. These regulations make the Company's synthetic nicotine products subject to the same FDA rules as tobacco-derived nicotine products. As such, the Company was required to file a PMTA for its existing synthetic nicotine products marketed under the Pacha brands by May 14, 2022 or be subject to FDA enforcement. The Company filed new PMTAs, for its synthetic Pacha products on May 13, 2022, prior to the May 14, 2022 deadline. On November 3, 2022, FDA accepted for scientific review certain of our PMTAs for synthetic nicotine products and, on November 4, 2022, FDA refused to accept certain other PMTAs for these products, rendering the latter products subject to FDA enforcement. The Company submitted an administrative appeal with FDA regarding its refusal to accept certain of the PMTAs. The administrative appeal was granted on October 30, 2023 and the products were accepted to move forward in the PMTA review process. The Company continues to sell the affected synthetic nicotine products while the PMTA review process continues. The FDA may bring an enforcement action against our synthetic nicotine products for lack of premarket authorization and/or issue an MDO to our pending applications at any time. More generally, FDA's regulatory initiatives and enforcement priorities regarding ENDS products are unpredictable and continue to evolve, and we cannot predict whether FDA's priorities and review of our premarket submissions will impact our products to a greater degree than our competitors in the industry. In the event the FDA denies our PMTAs, we would be required to remove products and cease selling them.

The Company recently launched new alternative alkaloid Metatine-based disposable vape products, under the "SBX™" brand, that the Company expects will (i) replace a significant portion of its legacy products and (ii) become the single largest, most important commercial opportunity in Charlie's history. The Company and its attorneys believe Metatine-based products are not subject to FDA review. Based on the information provided by the Company's contracted chemical suppliers and its consultants, the proprietary Metatine™ (patented in the United States and in China by the Company's chemical supplier) in the Company's alternative alkaloid products does not meet the definition of nicotine set forth in 21 U.S.C. § 387(12) and therefore its products containing Metatine, as their active ingredient, are not subject to regulation as "tobacco products" under 21 U.S.C. § 321(rr). Further, according to information provided by the Company's chemists, the other ingredients in the Company's alternative alkaloids vape liquid are not made or derived from tobacco, nor do they contain nicotine from any source. The documentary support for these facts, including a Certificate of Analysis (COA) for the Metatine used in the Company's alternative alkaloid products, corroborates these conclusions. However, should any of these understandings be incorrect, the Company's position on Metatine not qualifying as a "tobacco product" would need to be revisited. Further, should Congress bestow regulatory control over Metatine to the FDA, or should the FDA deem Metatine disposable vape devices "tobacco products" despite the facts that Metatine is not a salt or complex of nicotine, and is not itself derived from nicotine or tobacco, Metatine-based products might then be subject to the FDA tobacco requirements, including, but not limited to, the requirement that all newly deemed tobacco products obtain premarket authorization before entering the U.S. market. If this were to happen, the FDA could bring an enforcement action against our Metatine products for lack of premarket authorization. More generally, FDA's regulatory initiatives and enforcement authority regarding our products are unpredictable and continue to evolve and we cannot predict whether FDA's priorities and/or potential jurisdiction over our products will require us to remove our products from the market and to cease selling them.

As discussed below, our financial statements and working capital raise substantial doubt about the Company's ability to continue as a going concern. Our financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. See Liquidity and Capital Resources below for additional information.

Recent Developments

Entry into a Material Definitive Agreement for the Disposition of Assets

On April 16, 2025, the Company entered into and closed an Asset Purchase Agreement (the "Agreement") with R.J. Reynolds Vapor Company (the "Buyer") pursuant to which the Buyer purchased 12 of the Company's PACHA synthetic products and related assets (the "Assets") that are covered by a premarket tobacco application ("PMTA") first submitted by the Company in 2022. The purchase price for the Assets was $5.0 million paid at closing, plus a contingent one-time payment of up to $4.2 million based on product sold by the Buyer during the one year following the first day of commercialization of the Assets. The Agreement contains customary representations, warranties, and indemnities by each of the parties.

On May 29, 2025, the Company amended the Agreement (the "Amendment") with the Buyer pursuant to which the Buyer purchased three additional PACHA synthetic products and related assets (the "Additional Assets") that are covered by a PMTA first submitted by the Company in 2022, bringing the total purchased by the Buyer, to date, to 15 products. The purchase price for the Additional Assets was $1.5 million paid at closing.

Results of Operations for the Three Months Ended March 31, 2025 Compared to the Three Months Ended March 31, 2024

Regarding results from operations for the quarter ended March 31, 2025, we generated revenue of approximately $2,306,000, as compared to revenue of $3,051,000 for the three months ended March 31, 2024. This $745,000 decrease in revenue was due primarily to a $1,296,000 decrease in sales of our nicotine-based vapor products, and offset by an increase of $551,000 in sales of other alternative products distributed through Don Polly.

We generated a net loss for the three months ended March 31, 2025, of approximately $1,217,000 as compared to a net loss of $1,045,000 for the three months ended March 31, 2024.

A review of the three-month period ended March 31, 2025, follows:

		For the three months ended
		March 31,								Change
		2025				2024				Amount				Percentage
($ in thousands)
Revenues:
Product revenue, net		$	2,306			$	3,051			$	(745	)			-24.4	%
Total revenues			2,306				3,051				(745	)			-24.4	%
Operating costs and expenses:
Cost of goods sold - product revenue			1,778				2,107				(329	)			-15.6	%
General and administrative			1,134				1,545				(411	)			-26.6	%
Sales and marketing			214				334				(120	)			-35.9	%
Research and development			6				6				-				0.0	%
Total operating costs and expenses			3,132				3,992				(860	)			-21.5	%
Loss from operations			(826	)			(941	)			115				-12.2	%
Other income (expense):
Interest expense			(242	)			(183	)			(59	)			32.2	%
Debt extinguishment loss			(149	)			-				(149	)			100	%
Change in fair value of derivative liabilities			-				79				(79	)			-100.0	%
Total other loss			(391	)			(104	)			(287	)			276.0	%
Net loss		$	(1,217	)		$	(1,045	)		$	(172	)			16.5	%

Revenue

Revenue for the three months ended March 31, 2025, decreased by approximately $745,000 or 24.4%, to approximately $2,306,000, as compared to approximately $3,051,000 for same period in 2024 due to a $2,875,000 decrease in sales of our nicotine-based vapor products, and offset by an increase of $551,000 in sales of other alternative products distributed by Don Polly. The decrease in our nicotine-based vapor product sales was primarily driven by decreased sales of our Pacha Disposable line as well as reduced demand for our e-liquid products. The launch of the Company's SPREE BAR nicotine substitute vapor products did not meet performance expectations, resulting in further development efforts and ultimately the release our Metatine-based, SBX line of disposable vapor products. The increase in alternative products primarily consisted of products distributed through Don Polly on behalf of other brands. These partnerships have allowed us to leverage existing customer relationships and sales infrastructure to generate incremental revenue.

Cost of Revenue

Cost of revenue, which consists of direct costs of materials, direct labor, third party subcontractor services, and other overhead costs decreased by approximately $329,000 or 15.6%, to approximately $1,778,000, or 77.1% of revenue, for the three months ended March 31, 2025, as compared to approximately $2,107,000, or 69.1% of revenue, for the same period in 2024. This cost, decreased compared to last year due primarily to lower sales volume across all product categories. As a percentage of sales it increased slightly due to lower fixed cost absorption and overall margin compression across certain of our products.

General and Administrative Expenses

For the three months ended March 31, 2025, total general and administrative expenses decreased by approximately $411,000 to $1,134,000 as compared to approximately $1,545,000 for the same period in 2024. This change was primarily due to decreases of approximately $73,000 in non-sales related payroll and benefits costs, $188,000 in certain professional fees and $150,000 of other general and administrative costs. The decrease in payroll and benefits costs was primarily driven by reduced headcount compared to the same period in 2024. The decrease in professional fees was primarily the result of reductions in audit costs as well as fees pays to members of our Board of Directors. The decrease in other general and administrative costs was primarily due to lower insurance costs as well as bad debt and merchant processing fees, both of which vary with sales.

Sales and Marketing Expense

For the three months ended March 31, 2025, total sales and marketing expense decreased by approximately $120,000 to approximately $214,000 as compared to approximately $334,000 for the same period in 2024, which was primarily due to lower sales commissions paid as well as a significant reduction in tradeshow and customer event related costs. Commissions decreased due to reduced sales activity during the year.

Research and Development Expense

For the three months ended March 31, 2025 and 2024, research and development expense was $6,000.

Loss from Operations

We incurred a loss from operations of approximately $826,000 for the three months ended March 31, 2025, compared to loss of approximately $941,000 for the three months ended March 31, 2024, due primarily to lower sales and gross profit. Net loss is determined by adjusting loss from operations by the following items:

●	Interest Expense. For the three months ended March 31, 2025, and 2024, we recorded interest expense related to notes payable of approximately $242,000 and $183,000, respectively. The increase was primarily due to an increase of outstanding notes payable.

●	Debt Extinguishment Loss. For the three months ended March 31, 2025, we recorded approximately $149,000 of loss from debt extinguishment, which was related to the amendment to the Pinnacle Receivables Financing Agreement and the settlement of Chemular's outstanding note payable (see Note 9).

●	Change in Fair Value of Derivative Liabilities. For the three months ended March 31, 2024, the gain in fair value of derivative liabilities was $79,000. The derivative liability was associated with certain investor warrants which was expired without being exercised in April 2024.

Net Loss

For the three months ended March 31, 2025, we incurred a net loss of $1,217,000 as compared to net loss of $1,045,000 for the same period in 2024.

Effects of Inflation

Inflation has not had a material impact on our business.

Liquidity and Capital Resources

As of March 31, 2025, we had working capital deficit of approximately $2,829,000, which consisted of current assets of approximately $3,000,000 and current liabilities of approximately $5,829,000, as compared to working capital deficit of approximately $1,855,000 at December 31, 2024. The current liabilities include approximately $2,683,000 of accounts payable and accrued expenses, notes payable of $1,405,000, notes payable from related parties of $1,581,000, approximately $130,000 of deferred revenue associated with product shipped but not yet received by customers, and approximately $30,000 of current lease liabilities.

Our cash and cash equivalents balance at March 31, 2025 was approximately $112,000. As of March 31, 2025, we have the following notes outstanding:

●

February 2025 Note. On February 27, 2025, the Company and Henry Sicignano III entered into a loan agreement (the "Loan") in the principal amount of $100,000. As of March 31, 2025, $100,000 of principal plus accrued interest held by remained outstanding and the maturity dates of the outstanding notes.

●

September 2024 & January 2025 Pinnacle Receivables Financing. On September 6, 2024, the Company entered into a future receivables sale agreement ("Pinnacle Receivables Financing Agreement") with Pinnacle Business Funding ("Pinnacle") by which Pinnacle purchases from the Company its future accounts receivable and contract rights arising from the sale of goods or services to the Company's customers. On January 10, 2025, the Pinnacle Receivables Financing Agreement was restructured. As of March 31, 2025, the outstanding balance was approximately $1,378,000. On April 16, 2025, the Company issued a payment of approximately $1,250,000 to satisfy all outstanding principal and interest owed to Pinnacle.

●

July 2023 Notes. As of March 31, 2025, $400,000 notes payable plus accrued interest held by Ryan Stump and Henry Sicignano III remained outstanding and the maturity dates of the outstanding notes had been extended to April 1, 2025. On April 28, 2025, Ryan Stump and Henry Sicignano III were each paid approximately $75,000 of accrued interest and have agreed to modify the Notes to include a 10% interest rate, with monthly payments of principal and interest of approximately $18,000. The maturity date has been extended to April 28, 2026.

●

August 2022 Note. As of March 31, 2025, $300,000 notes payable plus accrued interest held by Ryan Stump remained outstanding and the maturity dates of the outstanding notes had been extended to April 1, 2025. On April 28, 2025, the Company paid to Ryan Stump approximately $308,000 to satisfy all remaining outstanding principal and interest due.

●

April 2022 Note. As of March 31, 2025, approximately $781,000 of principal plus accrued interest held by Michael King (the "Lender") remained outstanding and the maturity dates of the outstanding notes had been extended to March 28, 2025. On April 28, 2025, the Lender agreed to accept a payment of approximately $420,000 and entered into a further modification for the remaining balance that includes monthly payments of approximately $37,000 and a maturity date of April 28, 2026.

For the three months ended March 31, 2025, net cash used in operating activities was approximately $409,000, resulting from a net loss of $1,217,000, offset by a change in operating assets and liabilities of $473,000 and net non-cash activity of $335,000. For the three months ended March 31, 2024, net cash used in operating activities was approximately $431,000, resulting from a net loss of $1,045,000, offset by a change in operating assets and liabilities of $412,000 and net non-cash activity of $202,000.

For the three months ended March 31, 2025, we generated approximately $310,000 in cash from financing activities related to the issuance of notes payable of $546,000, notes payable to a related party of $100,000 and the repayment of $325,000 in notes payable, including $11,000 to a related party.

Substantial Doubt to Continue as a Going Concern Regarding the Legal and Regulatory Environment, Liquidity and Management's Plan of Operation

Our consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company operates in a rapidly changing legal and regulatory environment; new laws and regulations or changes to existing laws and regulations could significantly limit the Company's ability to sell its products, and/or result in additional costs. Additionally, the Company was required to apply for FDA approval to continue selling and marketing its products used for the vaporization of nicotine in the United States. Currently, a substantial portion of the Company's sales are derived from products that are subject to approval by the FDA. There was a significant cost associated with the application process and there can be no assurance the FDA will approve previous and/or future applications. For the three months ended March 31, 2025, the Company's revenue declined, the Company generated a loss from operations of approximately $826,000, and a consolidated net loss of approximately $1,217,000. Cash used in operations was approximately $409,000. The Company had a stockholders' deficit of $2,809,000 at March 31, 2025. As of March 31, 2025, the Company had working capital deficit of $2,829,000, compared to a deficit of $1,855,000 as of December 31, 2024. Considering these facts, the issuance of one or several Marketing Denial Orders ("MDOs") from the FDA would increase the potential for inventory obsolescence and uncollectable accounts receivables and the removal of certain products for sale. These regulatory risks, as well as other industry-specific challenges and our low working capital and cash position, remain factors that raise substantial doubt about the Company's ability to continue as a going concern. However, as disclosed in "Subsequent Events," in the second quarter of 2025, the Company entered into and closed an Asset Purchase Agreement (the "Agreement") and subsequent Amendment with R.J. Reynolds Vapor Company (the "Buyer") pursuant to which the Buyer purchased 15 of the Company's PACHA synthetic products and related assets (the "Assets") that are covered by a premarket tobacco application ("PMTA") first submitted by the Company in 2022. The combined purchase price for the Assets was $6.5 million paid at closings in April and May 2025, plus a contingent one-time payment of up to $4.2 million based on product sold by the Buyer during the one year following the first day of commercialization of the Assets. These asset sales have substantially addressed the Company's debt and working capital short term concerns, and have improved the Company's cash position.

Our plans and growth depend on our ability to increase revenues, procure cost-effective financing, and continue our business development efforts, including cumulative expenditures of approximately $6,500,000 as of March 31, 2025, to support our PMTA process for the Company's submissions to the FDA. The Company has undergone cost-cutting measures including salary reductions of up to 50% for officers and certain managers and a reduction in headcount for certain departments. During the fourth quarter of 2024, the Company launched SBX, a non-nicotine, disposable vapor product which is not subject to FDA review. The Company may require additional financing in the future to support the development of new product categories as well as subsequent PMTA filings, and/or in the event the FDA requests additional testing for one, or several, of the Company's prior PMTA submissions. There can be no assurance that additional financing will be available on acceptable terms, or at all, and there can be no assurance that any such arrangement, if required or otherwise sought, would be available on terms deemed to be commercially acceptable and, in the Company's best interests. The financial statements do not include any adjustments to the carrying amount and classification of recorded assets and liabilities should the Company be unable to continue operations. If we do not have sufficient funds to continue operations, we could be required to seek bankruptcy protection or other alternatives that would likely result in our stockholders losing some or all their investment in us.

Off-Balance Sheet Arrangements

The Company has no off-balance sheet arrangements other than operating lease commitments.

Critical Accounting Policies

The condensed consolidated financial statements are prepared in conformity with U.S. GAAP, which require the use of estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent liabilities at the date of the financial statements, and the reported amounts of expense in the periods presented. We believe that the accounting estimates employed are appropriate and resulting balances are reasonable; however, due to inherent uncertainties in making estimates, actual results could differ from the original estimates, requiring adjustments to these balances in future periods. The critical accounting estimates that affect the consolidated financial statements and the judgments and assumptions used are consistent with those described under Part II, Item 7 of our Annual Report on the 2024 Annual Report.