The following discussion and analysis should be read in conjunction with the historical condensed financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q (this "Quarterly Report") as well as our audited financial statements for the fiscal year endedDecember 31, 2021 included in our Annual Report on Form 10-K for the year endedDecember 31, 2021 , filed with theSecurities and Exchange Commission (the "SEC") onApril 1, 2022 (our "Annual Report"). This discussion contains forward-looking statements reflecting our current expectations and estimates and assumptions concerning events and financial trends that may affect our future operating results or financial position. See "Cautionary Statement Regarding Forward-Looking Statements" and "Risk Factors" appearing elsewhere in this Quarterly Report. You should review the "Risk Factors" section of our Annual Report and our quarterly reports on Form 10-Q for the fiscal quarters endedMarch 31, 2022 andJune 30, 2022 , as well as under the caption "Risk Factors" in our Form S-1 filed with theSEC onJuly 11, 2022 , as amended onJuly 20, 2022 , for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. OnOctober 3, 2022 , we announced that we entered into an Agreement and Plan of Merger (the "Merger Agreement") by and amongAeroClean ,Air King Merger Sub Inc. , aDelaware corporation and direct wholly-owned subsidiary ofAeroClean ("Merger Sub"), andMolekule, Inc. , aDelaware corporation ("Molekule"), pursuant to which Merger Sub will merge with and into Molekule, in an all-stock merger transaction with Molekule continuing as the surviving entity and a wholly-owned subsidiary ofAeroClean (the "Merger"). The transaction is summarized in Note 14 of our notes to the condensed financial statements (unaudited).
Overview
AeroClean Technologies is an interior space air purification technology company. Our immediate objective is to initiate full-scale commercialization of our high-performance interior air sterilization and disinfection products for the eradication of harmful airborne pathogens, including COVID-19. We were established to develop unmatched, technology-driven medical-grade air purification solutions for hospitals and other healthcare settings. The onset of the COVID-19 global pandemic underscores the urgency of bringing to market air purification solutions to protect front-line healthcare workers, patients and the general population.
We incorporate our proprietary, patented UV-C LED technology in equipment and devices to reduce the exposure of occupants of interior spaces to airborne particles and pathogens. These spaces include hospital and non-hospital healthcare facilities (such as outpatient chemotherapy and other infusion facilities and senior living centers and nursing homes), schools and universities, commercial properties and other indoor spaces.
InJuly 2021 , we completed the development stage of our first device, the P?rgo room air purification unit, including design and independent testing and certification, as well as the scale-up of manufacturing, and began commercial production and sales. P?rgo's launch also marks the debut of our go-to-market strategy for SteriDuct, our patented air purification technology. We intend to incorporate SteriDuct into a broad line of autonomous air treatment devices. InFebruary 2022 , we debuted a prototype of P?rgo Lift, our air purification solution for elevators and other wall-mount applications, and since then, certain of our customers have been testing and evaluating P?rgo Lift for future deployment in their facilities. To support the transition to commercial operations, inJuly 2021 , we also completed the build out of our corporate headquarters inPalm Beach Gardens, Florida , which includes our warehouse and distribution facility, as well as the site for our future service operations. Our products are being designed and engineered to exceed the rigorous standards set by theU.S. Food and Drug Administration (the "FDA") for Class II medical devices used for interior air sterilization and disinfection products. InJune 2022 , the FDA granted our P?rgo technology 510(k) clearance for use in healthcare and other markets for which product performance to reduce the amount of certain airborne particles and infectious microbes in an indoor environment must be validated to specific standards. Our P?rgo technology was tested and certified to meet such standards by independent laboratories. Regulatory clearances and independent certifications serve as important indications of product quality and performance that also influence decision-making by non-healthcare market equipment purchasers. 17
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P?rgo has been well-received by our customers. Our success depends to a large extent on our ability to increase sales of our P?rgo device during 2022 and beyond.
We have incurred operating losses each year since our inception and have only begun to recognize revenue starting inJuly 2021 . We incurred losses of approximately$1.1 million and$7.9 million during the nine months endedSeptember 30, 2022 and the year endedDecember 31, 2021 , respectively, and had an accumulated deficit of approximately$2.8 million as ofSeptember 30, 2022 . As ofSeptember 30, 2022 , we had an aggregate cash balance of approximately$25.8 million . As part of our business strategy, we continually evaluate a wide array of strategic opportunities, including the acquisition, disposition or licensing of intellectual property, mergers and acquisitions, joint ventures and other strategic transactions. In connection with these activities, we may enter into non-binding letters of intent as we assess the commercial appeal of potential strategic transactions. We may seek to acquire technologies, product lines and companies that operate in businesses similar to our own or that are ancillary, complementary or adjacent to our own or in which we do not currently operate. Such businesses could operate in the air purification space or more generally in the health and wellness space or in other industries. We could also seek to merge with or into another company or sell all or substantially all of our assets to another company. Any transactions that we enter into could be material to our business, financial condition and operating results. As part of this strategy, the Company has been in discussions with several acquisition candidates and may seek to effect transactions that the Company believes would substantially increase revenues, distribution and selling capability, and expand product lines, and, most importantly, add sensor and monitoring technology to enable the Company to effect its recurring revenue "Safe Air As a Service" model. The Company's goal is to provide actionable data to clients through the internet of things (IoT) to enable clients to provide Indoor Air Quality ("IAQ") as part of their Indoor Environmental Quality ("IEQ") initiatives. The Company's recently closed acquisition of GSI Technologies and recently announced merger with Molekule are in alignment with the Company's strategy to increase its scale and add complementary products and services. While the Company continues to evaluate additional opportunities, there can be no assurance that these will be consummated. Please see related risks described under the captions "We may acquire other companies or technologies, which could divert our management's attention, result in additional dilution to stockholders and otherwise disrupt our operations, and adversely affect our business, financial condition and results of operations" and "Our executive officers, directors and principal stockholders have the ability to control all matters submitted to stockholders for approval" in the "Risk Factors" section of our Annual Report.
COVID-19 Pandemic
We continue to monitor the COVID-19 pandemic and its variants, including the emergence of variant strains, which continue to spread throughout the world and have adversely impacted global commercial activity and contributed to significant declines and volatility in financial markets. Across many industries, including the Company's, COVID-19 - among other factors - has negatively impacted personnel and operations at third-party manufacturing and component part supplier facilities inthe United States and around the world. These disruptions have adversely impacted the availability and cost of raw materials and component parts. For example, various electronic components and semi-conductor chips have become increasingly difficult to source, and, when available, may be subject to substantially longer lead times and higher costs than historically applicable. While the Company's manufacturing run rate is not currently being impacted, past shortages have impacted the Company's ability to manufacture units. We continue to actively monitor the situation and may take further actions that impact operations as may be required by federal, state or local authorities or that we determine is in the best interests of our employees, customers, suppliers and stockholders. As of the date of this Quarterly Report, the pandemic presents uncertainty and risk as we cannot reasonably determine or predict the nature, duration or scope of the overall impact the COVID-19 pandemic and the evolving strains of COVID-19 will have on our business, results of operations, liquidity or capital resources. 18 Table of Contents Results of Operations
The following table summarizes our results of operations for the periods indicated:
Comparison of the Nine Months and Three Months endedSeptember 30, 2022 and 2021 Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 Change 2022 2021 Change Product revenues$ 58,385 $ 261,299 $ (202,914) $ 136,037 $ 261,299 $ (125,262) Cost of sales 30,834 147,733 (116,899) 70,724 147,733 (77,009) Gross profit 27,551 113,566 (86,015) 65,313 113,566 (48,253) Operating expenses: Selling, general and administrative 4,440,645 685,079
3,755,566 10,687,936 2,678,689 8,009,247 Research and development
633,262 956,499
(323,237) 1,743,806 3,617,101 (1,873,295) Total operating expenses
5,073,907 1,641,578
3,432,329 12,431,742 6,295,790 6,135,952 Income/ (Loss) from operations
(5,046,356) (1,528,012)
(3,518,344) (12,366,429) (6,182,224) (6,184,205) Change in fair value of warrant liability
(11,489,000) - (11,489,000) (10,839,000) - (10,839,000) Loss before income tax benefit 6,442,644 (1,528,012) 7,970,656 (1,527,429) (6,182,224) 4,654,795 Income tax benefit (206,849) - (206,849) (426,681) - (426,681) Net income (loss)$ 6,649,493 $ (1,528,012) $ 8,177,505 $ (1,100,748) $ (6,182,224) $ 5,081,476 Revenues and Cost of Sales
The Company began the production and sale of its first commercial product, P?rgo, inJuly 2021 , and therefore, did not have any revenue in the prior year period. Revenues for the three and nine months endedSeptember 30, 2022 were$58,385 and$136,037 , respectively, as compared to$261,299 for the prior year three and nine months endedSeptember 30, 2021 . Sales decreased by$202,914 for the quarter endedSeptember 30, 2022 as compared to the prior year period due to a large sale to a healthcare system in the prior year period with no such sale in the current period. Cost of sales decreased in line with the decrease in revenues as compared to the prior year period.
Operating Expenses
Selling, General and Administrative Expenses
Selling, general and administrative expenses ("SG&A") consist primarily of costs related to our employees, independent contractors and consultants. Other significant general and administrative expenses include accounting and legal services and expenses associated with obtaining and maintaining patents as well as marketing and advertising services and expenses associated with establishing our brand and developing our website, marketing materials and call center. For the three months endedSeptember 30, 2022 and 2021, we incurred$4,440,645 and$685,079 , respectively, of SG&A expenses. The increase of$3,755,566 is primarily due to an increase in legal fees (approximately$1,689,000 ), public company costs (an increase of approximately$471,000 ), insurance expense (an increase of approximately$290,000 ) and stock-based compensation (an increase of approximately$794,000 ). For the nine months endedSeptember 30, 2022 and 2021, we incurred$10,687,936 and$2,678,689 , respectively, of SG&A expenses. We attribute the increase of$8,009,247 primarily to the offering costs associated with the Private Placement (approximately$1,300,000 ) and an increase in costs required to be a public company as well as a greater level of business activities being conducted in the nine months endedSeptember 30, 2022 as compared to the same period in 2021. Public company costs include: audit and legal fees; costs required to establish investor relations, financial reporting and public relations functions; increased insurance costs; public company filing and registration fees; and related costs. These public company costs drove an increase in SG&A of approximately$3,954,000 for the nine months endedSeptember 30, 2022 as compared to the prior year period, including the increase in stock-based compensation expense of approximately$1,250,000 and increased personnel costs of approximately$512,000 . 19 Table of Contents
Research and Development Expenses
Since our inception, we have focused our resources on our research and development activities. We expense research and development costs as they are incurred. Our research and development expenses primarily consist of outsourced engineering, product development and manufacturing design costs. For the three months endedSeptember 30, 2022 and 2021, we incurred$633,262 and$956,499 respectively, in research and development costs. For the nine months endedSeptember 30, 2022 and 2021, we incurred$1,743,806 and$3,617,101 , respectively, in research and development costs. Research and development expenses decreased by$323,237 and$1,873,295 for the three and nine months endedSeptember 30, 2022 , respectively, as compared to the prior year period. Research and development activities were higher in the third quarter of 2021 as compared to the current quarter of 2022 due to product development, engineering, testing and regulatory costs incurred to prepare our P?rgo device for launch inJuly 2021 . Research and development expenses decreased for the three and nine months endedSeptember 30, 2022 due to streamlining of our manufacturing processes and reduction in expenses after testing and preparing for the FDA submission in the previous quarter.
Change in Fair Value of Warrant Liability
The change in fair value of the warrant liability was a non-cash gain of$11,489,000 and$10,839,000 resulting from a decrease in the fair value of the warrant liability, which was reported in our unaudited condensed statement of operations for the three and nine months endedSeptember 30, 2022 , respectively.
Net Income (Loss)
Our net income was$6,649,493 for the three months endedSeptember 30, 2022 and our net loss was$1,528,012 for the three months endedSeptember 30, 2021 . Our net losses were$1,100,748 and$6,182,224 for the nine months endedSeptember 30, 2022 and 2021, respectively. We incurred net income in the third quarter of 2022 as compared to the third quarter 2021 as a result of the decrease in the fair value of the warrant liability.
Liquidity and Capital Resources
Sources of Liquidity
As ofSeptember 30, 2022 , we had cash of$25,818,620 compared to cash of$19,629,649 as ofDecember 31, 2021 . OnNovember 29, 2021 , we completed our initial public offering (the "IPO") of 2,514,000 shares of our common stock, which included the partial exercise of the underwriters' overallotment option, at a public offering price of$10.00 per share for aggregate gross proceeds of$25,140,000 and net proceeds of approximately$21,640,000 , after deducting underwriting fees and closing costs of approximately$3,500,000 . The Company issued a purchase option to the underwriters (the "Underwriter Option") exercisable within five years of our IPO for 5.0% of the shares of common stock issued, or 125,700 shares of common stock, at an exercise price of$12.50 per share. OnJune 21, 2022 , 31,192 shares of common stock were issued pursuant to the Underwriter Option. Prior to its IPO,AeroClean Technologies, LLC , our predecessor, funded its operations principally with approximately$15,000,000 in gross proceeds from the sale of Class A units. As ofSeptember 30, 2022 , we had an accumulated deficit of$2,848,608 . The Company's net cash used in operating activities was$7,232,949 for the nine months endedSeptember 30, 2022 as compared to$5,524,098 used in operating activities for the prior year period. OnJune 29, 2022 , we completed a private placement with a single institutional investor (the "Purchaser") pursuant to which we received gross cash proceeds of$15,000,000 in connection with the issuance of (i) 1,500,000 shares of our common stock and (ii) a common stock purchase warrant (the "Warrant") to purchase up to 1,500,00 shares of our common stock (the "Private Placement"). The Warrant has an exercise price of$11.00 and is exercisable untilJuly 21, 2027 . Net proceeds amounted to$13,578,551 after issuance costs of$1,421,449 , of which$1,326,212 was charged to expense, and$95,237 was charged to additional paid-in capital. The Purchaser has contractually agreed to restrict its ability to exercise the Warrant if the number of shares of common stock held by the Purchaser and its affiliates after such exercise would exceed 4.99% of the then issued and outstanding shares of common stock. The Purchaser may increase or decrease this limitation upon notice to the Company, but in no event will any such limitation exceed 9.99%. 20 Table of Contents Pursuant to a registration rights agreement between us and the Purchaser, we filed a registration statement on Form S-1, which became effective onJuly 21, 2022 , registering the offering and resale, from time to time, by the Purchaser of up to 3,000,000 shares of our common stock which includes 1,500,000 shares of our common stock issued in the Private Placement and 1,500,00 shares issuable upon the exercise of the Warrant acquired in the Private Placement. We have incurred operating losses since our inception. While the Company began producing and selling its P?rgo device inJuly 2021 , these losses are expected to continue through at least the end of 2022 as we continue to make investments to develop and market our products and to establish our consumables and service business.
Future Funding Requirements and Outlook
We have incurred operating losses each year since our inception. These losses are expected to continue through at least the end of 2022 because we plan to continue to make investments to develop and market our products and to establish our consumables and service business. We also expect to continue to incur increased costs to comply with corporate governance, internal controls and similar requirements applicable to public companies. OnFebruary 1, 2021 , we entered into a lease withGarden Bio Science Partners, LLC , an entity controlled by the chair of our board of directors, with a term of ten years at an annual base rent of$260,000 , subject to escalation of 2.5% on an annual basis. As ofSeptember 30, 2022 , the future minimum lease payments under this arrangement approximated$2,475,000 . Based on our current financial resources, our expected revenues and our expected level of operating expenditures, we believe that we will be able to fund our projected operating requirements for at least the next 12 months from the date of issuance of this Quarterly Report. Over the long-term, the Company will continue to have capital requirements, and expects to devote resources to grow its operations. Moreover, if the Company pursues an acquisition strategy, it may need to raise incremental capital in order to finance the purchase price to be paid to target stockholders. As a result of these funding requirements, we will likely need to obtain additional financing by engaging in debt and/or equity offerings or seeking additional borrowings. To the extent that we raise additional capital through the sale of convertible debt or equity securities, or pay for acquisitions in whole or in part with the issuance of equity securities (either as merger consideration or to finance the cash portion of merger consideration), the ownership interests of our common stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. The availability of debt financing or equity capital will depend upon the Company's financial condition and results of operations as well as prevailing market conditions.
Inflation
Inflation has adversely affected our business, and we expect this to continue through the end of 2022. We have been and expect to continue to be negatively impacted by increased component and logistics costs. In addition, our cost of labor and materials may increase, which would negatively impact our business and financial results. Alternatively, deflation may cause a deterioration of global and regional economic conditions, which could impact unemployment rates and consumer discretionary spending. These, and other factors that may increase the risk of significant deflation, could negatively impact our business and results of operations.
Critical Accounting Policies and Estimates
Our management's discussion and analysis of our financial condition and results of operations is based on our condensed financial statements, which we have prepared in accordance with accounting principles generally accepted inthe United States of America ("U.S. GAAP"). The preparation of the financial statements in accordance withU.S. GAAP requires us to make estimates and assumptions that affect the reported amounts and related disclosures. We evaluate these estimates, judgments and methodologies on an ongoing basis. We base our estimates on historical experience and on various other assumptions that we believe are reasonable. Our actual results could differ from those estimates. Our significant accounting policies are more fully described in Note 2, Summary of Significant Accounting Policies to our audited financial statements included in our Annual Report. We believe that the accounting policies are critical for fully understanding and evaluating our financial condition and results of operations. 21 Table of Contents JOBS Act OnApril 5, 2012 , the JOBS Act was enacted. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. We have irrevocably elected to avail ourselves of this exemption from new or revised accounting standards and, therefore, will not be subject to the same new or revised accounting standards as public companies that are not emerging growth companies. As a result of this election, our financial statements may not be comparable to companies that are not emerging growth companies. We are in the process of evaluating the benefits of relying on other exemptions and reduced reporting requirements provided by the JOBS Act. Subject to certain conditions set forth in the JOBS Act, as an "emerging growth company," we intend to rely on certain of these exemptions, including without limitation, (i) an exemption from the requirement to provide an auditor's attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (ii) an exemption from any requirement that may be adopted by the Public Company Oversight Board ("PCAOB") regarding mandatory audit firm rotation or a supplement to the auditor's report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We will remain an "emerging growth company" until the earliest of: (i) the last day of the fiscal year in which we have total annual gross revenues of$1.07 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of the date of the completion of the IPO; (iii) the date on which we have issued more than$1 billion in non-convertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of theSEC .
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements to encourage companies to provide prospective information to investors. This Quarterly Report includes forward-looking statements that reflect our current expectations and projections about our future results, performance and prospects. Forward-looking statements include all statements that are not historical in nature or are not current facts. When used in this Quarterly Report, the words "believe," "expect," "plan," "project," "intend," "anticipate," "estimate," "predict," "potential," "continue," "may," "might," "likely," "should," "could," "will," "target" or the negative of these terms or similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain such identifying words. These forward-looking statements are based on our current expectations and assumptions about future events and are based on currently available information as to the outcome and timing of future events. These forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause our actual results, performance and prospects to differ materially from those expressed in, or implied by, these forward-looking statements. Factors that might cause such a difference include, but are not limited to, those discussed in our filings with theSEC , in particular those discussed under the heading "Risk Factors" in our Registration Statement on Form S-1, filed with theSEC onJuly 11, 2022 , as amended onJuly 20, 2022 , and in our Annual Report and our quarterly reports on Form 10-Q for the fiscal quarters endedMarch 31, 2022 andJune 30, 2022 , filed with theSEC onMay 12, 2022 andAugust 15, 2022 , respectively, including the following factors:
?general economic conditions in the markets in which
?the impact of the COVID-19 pandemic and related prophylactic measures;
?expected timing of regulatory approvals and product launches;
?non-performance of third-party vendors and contractors;
?risks related to
?compliance with, and changes to, applicable laws and regulations;
?the limited operating history of
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?the ability of
?the ability of
?the ability to expand
?the ability of
?the ability of
?the ability of certain existing stockholders to determine the outcome of matters which require stockholder approval;
?our ability to retain the listing of our common stock on Nasdaq;
?the ability of
?success in retaining or recruiting, or changes required in, our officers, key employees or directors;
?the risk that the Merger may not be completed;
?the ability to successfully integrate the businesses of
?the ability of the parties to achieve the expected benefits from the proposed transaction within the expected time frames or at all;
?the incurrence of significant transaction and other related fees and costs;
?the incurrence of unexpected costs, liabilities or delays relating to the Merger;
?the risk that the public assigns a lower value to Molekule's business than the value used in negotiating the terms of the transaction;
?the risk that the Merger may not be accretive to
?the risk that the Merger may prevent
?the dilutive impact of the stock consideration which will be issued in the Merger;
?the risk that any goodwill or identifiable intangible assets recorded due to the transaction could become impaired;
?potential disruptions to the business of the companies while the Merger is pending;
?the risk that a closing condition to the proposed Merger may not be satisfied;
?the occurrence of any event, change or other circumstances that could give rise to the termination of the Merger; and
?other economic, business, competitive, and regulatory factors affecting the businesses ofAeroClean and Molekule generally, including those set forth herein under "Risk Factors" as well as those set forth inAeroClean's filings with theSEC , including in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of our Annual Report, quarterly reports on Form 10-Q, current reports on Form 8-K, and otherSEC
filings. 23 Table of Contents In light of these risks, uncertainties and assumptions, you are cautioned not to put undue reliance on any forward-looking statements in this Quarterly Report. These statements should be considered only after carefully reading this entire Quarterly Report. Except as required under the federal securities laws and rules and regulations of theSEC , we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Additional risks that we may currently deem immaterial or that are not presently known to us could also cause the forward-looking events discussed in this Quarterly Report not to occur.
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