Acurx Pharmaceuticals(ACXP) - 2023 Q1 - Quarterly Report

Special Note Regarding Forward-Looking Statements This section warns readers about forward-looking statements concerning future operations and financial position, noting inherent risks and uncertainties - The report contains forward-looking statements about the company's future operations, financial position, strategy, and plans, identified by specific keywords like 'believe,' 'may,' 'will,' 'estimate,' 'continue,' 'anticipate,' 'design,' 'intend,' 'expect'[6] - Key areas of forward-looking statements include patient enrollment in clinical trials, regulatory approval, commercialization efforts, third-party contracts, market potential, funding, research and development timelines, data availability, the impact of the COVID-19 pandemic, expense estimates, personnel retention, and intellectual property[8][10] - Readers are cautioned against undue reliance on these statements due to inherent risks and uncertainties, including those detailed in the 'Risk Factors' section, and the company disclaims any obligation to update them after the report date[7][10][11] PART I - FINANCIAL INFORMATION This part presents the company's condensed interim financial statements and management's discussion and analysis of financial condition ITEM 1. Condensed Interim Financial Statements This section presents the unaudited condensed interim financial statements for Acurx Pharmaceuticals, Inc., including the balance sheets, statements of operations, changes in shareholders' equity, and cash flows for the periods ended March 31, 2023, and 2022, along with detailed explanatory notes Condensed Interim Balance Sheets This section provides a snapshot of the company's financial position, detailing assets, liabilities, and equity as of specific dates | Metric | March 31, 2023 | December 31, 2022 | Change (vs. Dec 31, 2022) | | :--------------------------- | :------------- | :---------------- | :------------------------ | | Cash | $7,178,820 | $9,111,751 | -$1,932,931 | | Total Assets | $7,385,421 | $9,376,706 | -$1,991,285 | | Total Current Liabilities | $2,073,982 | $2,061,685 | +$12,297 | | Total Shareholders' Equity | $5,311,439 | $7,315,021 | -$2,003,582 | | Accumulated Deficit | $(41,544,042) | $(38,641,085) | -$(2,902,957) | Condensed Interim Statements of Operations This section outlines the company's financial performance over specific periods, focusing on revenues, expenses, and net loss | Metric | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | Change (YoY) | | :--------------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Research and Development | $1,015,583 | $818,888 | +$196,695 | | General and Administrative | $1,887,374 | $1,851,250 | +$36,124 | | Total Operating Expenses | $2,902,957 | $2,670,138 | +$232,819 | | Net Loss | $(2,902,957) | $(2,670,138) | -$(232,819) | | Basic and Diluted Net Loss Per Common Share | $(0.25) | $(0.26) | +$0.01 | | Weighted Average Common Shares Outstanding | 11,639,395 | 10,232,843 | +1,406,552 | Condensed Interim Statements of Changes in Shareholders' Equity This section details changes in the company's equity accounts, including common shares, additional paid-in capital, and accumulated deficit | Metric | Balance at Jan 1, 2023 | Balance at Mar 31, 2023 | Change (QoQ) | | :--------------------------- | :--------------------- | :---------------------- | :----------- | | Common Shares | 11,627,609 | 11,671,795 | +44,186 | | Common Stock Amount | $11,628 | $11,672 | +$44 | | Additional Paid-In Capital | $45,944,478 | $46,843,809 | +$899,331 | | Accumulated Deficit | $(38,641,085) | $(41,544,042) | -$(2,902,957)| | Total Shareholders' Equity | $7,315,021 | $5,311,439 | -$(2,003,582)| - Share-based compensation and payments to vendors contributed $733,472 and $165,903, respectively, to additional paid-in capital during the three months ended March 31, 2023[19] Condensed Interim Statements of Cash Flows This section presents cash inflows and outflows from operating, investing, and financing activities over specific periods | Metric | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | Change (YoY) | | :--------------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Net Loss | $(2,902,957) | $(2,670,138) | -$(232,819) | | Net Cash Used in Operating Activities | $(1,932,931) | $(1,876,000) | -$(56,931) | | Cash at Beginning of Period | $9,111,751 | $12,958,846 | -$(3,847,095)| | Cash at End of Period | $7,178,820 | $11,082,846 | -$(3,904,026)| - Adjustments to reconcile net loss to net cash used in operating activities for Q1 2023 included $733,472 in share-based compensation and $165,903 in share-based payments to vendors[22] Notes to the Condensed Interim Financial Statements (Unaudited) This section provides detailed explanatory notes that supplement the condensed interim financial statements, offering context and additional information NOTE 1 – Nature of Operations This note describes the company's business as a clinical-stage biopharmaceutical firm, its lead product, and its going concern status - Acurx Pharmaceuticals is a clinical-stage biopharmaceutical company, formed in July 2017 with operations commencing in February 2018, focused on developing novel antibiotics for serious bacterial infections[25] - The lead antibiotic product candidate, ibezapolstat (formerly ACX-362E), targets C. difficile infections (CDI) and was acquired in February 2018[27] - The company has not generated any revenues since inception, has experienced net losses and negative cash flows, and as of March 31, 2023, had approximately $7.2 million in cash, which is insufficient to meet anticipated cash requirements for at least 12 months, raising substantial doubt about its ability to continue as a going concern[28][29] - The COVID-19 pandemic has disrupted and is expected to continue disrupting operations, with potential material adverse effects on the company's operational and financial performance, although current financial statements do not reflect specific adjustments[26] NOTE 2 – Summary of Significant Accounting Policies This note outlines the key accounting principles and estimates applied in the preparation of the financial statements Basis of Presentation This section details the framework and principles used for preparing the unaudited condensed interim financial statements - The unaudited condensed interim financial statements are prepared in accordance with GAAP and SEC rules for interim reporting, including all necessary normal, recurring adjustments[31] - Interim results are not necessarily indicative of full fiscal year results and should be read in conjunction with the audited financial statements from December 31, 2022[31] Use of Estimates This section explains the necessity of management's judgments and assumptions in preparing the financial statements - Financial statements require management to make estimates and assumptions that affect reported asset and liability amounts, contingent disclosures, and expenses[32] - Actual results could differ from these estimates, which are based on historical experience and various reasonable factors[32] Income Taxes This section describes the company's approach to income tax accounting, including its effective tax rate and valuation allowance - The company estimates an annual effective tax rate of 0% due to net losses, resulting in no current federal or state income tax expense[33] - A full valuation allowance has been recorded against all deferred tax assets, as the realization of tax benefits from net operating losses is not considered more likely than not[33] Concentration of Credit Risk This section highlights the company's exposure to credit risk due to its cash balances held in a single financial institution - The company maintains its cash balance in one financial institution, with approximately $7.2 million in U.S. bank accounts not fully insured by the FDIC as of March 31, 2023[34] Research and Development This section details the accounting policy for research and development costs, including expensing and estimation of clinical trial expenses - Research and development costs are expensed when incurred; cash advances for future services are deferred and expensed in the period the service is provided[35] - Clinical trial costs are estimated based on the progress to completion of specific tasks, such as subject enrollment and clinical site activations, and are reflected as prepaid or accrued expenses[36] | Metric | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--------------------------- | :-------------------------------- | :-------------------------------- | | Research and Development Expenses | $1,015,583 | $818,888 | Share-Based Compensation This section outlines the accounting treatment for equity awards granted to officers and directors, including valuation methods - The cost of services performed by officers and directors in exchange for equity awards is recognized over the requisite service period based on the grant-date fair value[38] - Compensation expense for stock options is determined using the Black-Scholes option pricing model, which requires subjective assumptions like expected price volatility, derived from comparable public companies due to the lack of a public market for the company's stock options[39] Share-Based Payments to Vendors This section describes the accounting for equity awards issued to vendors in exchange for services - The cost of services performed by vendors in exchange for common stock, stock options, or warrants is accounted for based on the grant-date fair value of the award or the fair value of services rendered, whichever is more readily determinable, and expensed in the same period as if cash were paid[40] Major Vendor This section highlights the company's significant reliance on a single major vendor for R&D expenditures and liabilities | Metric | March 31, 2023 | December 31, 2022 | | :----------------------------------- | :------------- | :---------------- | | R&D Expenditures from Major Vendor | ~60% | ~49% | | Accounts Payable & Accrued Expenses from Major Vendor | ~82% | ~56% | - The company continues to maintain this major vendor relationship and anticipates incurring significant expenses with this vendor over the next 12 months[41] NOTE 3 - Accounts Payable and Accrued Expenses This note provides a detailed breakdown of the company's accounts payable and accrued expenses by category | Category | March 31, 2023 | December 31, 2022 | Change (QoQ) | | :-------------------------------------- | :------------- | :---------------- | :----------- | | Accrued compensation expenses | $20,390 | $542,895 | -$(522,505) |\n| Accrued research and development | $1,910,749 | $1,405,536 | +$505,213 |\n| Accrued professional fees | $124,430 | $83,715 | +$40,715 |\n| Other accounts payable and accrued expenses | $18,413 | $29,539 | -$(11,126) |\n| Total | $2,073,982 | $2,061,685 | +$12,297 | NOTE 4 – Issuance of Equity Interests This note details the company's equity issuances, including its IPO and subsequent offerings, and their impact on common stock - Acurx Pharmaceuticals, LLC converted to Acurx Pharmaceuticals, Inc. in June 2021, authorizing 200,000,000 shares of common stock, with 11,671,795 outstanding as of March 31, 2023[43] - The IPO in June 2021 issued 2,875,000 shares at $6.00 per share, resulting in $14.8 million net cash proceeds, and converted 14,082,318 membership interests into 7,041,208 common shares[44] - A July 2022 registered direct offering and concurrent private placement issued 1,159,211 common shares and 130,769 pre-funded warrants, generating $4.2 million gross proceeds ($3.7 million net)[47][48] - In connection with the July 2022 offering, the company issued series A and B warrants to purchase 1,289,980 shares each to investors and affiliates, and 63,018 warrants to placement agents[47][49] NOTE 5 – Share-Based Compensation This note describes the company's equity incentive plan, stock option activity, and unrecognized compensation expense - The 2021 Equity Incentive Plan reserves an aggregate of 2,874,063 shares of common stock, with 535,868 shares still available for issuance as of March 31, 2023, to attract, retain, and incentivize directors, officers, employees, and consultants[51] - In February 2023, the company granted 467,500 stock options to employees and consultants at an exercise price of $3.41, resulting in $36,507 of general and administrative expense for the three months ended March 31, 2023[57] | Stock Option Activity (as of March 31, 2023) | Number of Options | Weighted Average Exercise Price | | :------------------------------------------- | :---------------- | :------------------------------ | | Outstanding at beginning of period | 2,467,500 | $6.12 | | Granted | 467,500 | $3.41 | | Exercised | — | — | | Forfeited | — | — | | Outstanding at end of period | 2,935,000 | $5.69 | | Exercisable | 1,714,861 | $6.12 | - Total unrecognized compensation expense for stock options as of March 31, 2023, was $4,824,706, with a weighted average vesting period for unvested options of 1.88 years[62] NOTE 6 – Share-Based Payments to Vendors This note details the issuance of common stock and warrants to vendors for services and the associated expenses - In the first quarter of 2023, the company granted 36,000 shares of common stock at a grant date fair value of $3.31 to an investor relations consultant, recognizing $119,160 in general and administrative expenses[65] - In the fourth quarter of 2022, grants of 43,186 common shares and up to 10,096 warrants were made to vendors, resulting in $46,742 of general and administrative expenses for the three months ended March 31, 2023[65] NOTE 7 – Net Loss Per Share This note explains the calculation of basic and diluted net loss per share and the treatment of potentially dilutive securities - Basic and diluted net loss per share are determined by dividing net loss by the weighted average common shares outstanding during the period[66] - Potentially dilutive shares, consisting of 4,217,809 warrants and 2,935,000 stock options, are excluded from diluted net loss per share computations for all periods because their inclusion would be antidilutive[66] NOTE 8 – Commitments and Contingencies This note outlines the company's contractual obligations, including milestone and royalty payments related to product development - The company is required to make certain milestone payments totaling $700,000 in aggregate related to the development of ACX-362E (ibezapolstat), with $50,000 already paid and no additional milestones reached as of March 31, 2023[67] - The company is also obligated to make royalty payments equal to 4% of net sales of ACX-362E for a period equal to the last to expire of any applicable patents[67] ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides a narrative analysis of Acurx Pharmaceuticals' financial condition and results of operations, covering its business overview, recent developments, the impact of COVID-19, a breakdown of operating expenses, liquidity and capital resources, critical accounting policies, and its status as an emerging growth company Overview This section provides a general introduction to the company's business, its lead product candidate, and development strategy - Acurx Pharmaceuticals is a clinical-stage biopharmaceutical company developing a new class of antibiotics that block DNA polymerase IIIC (Pol IIIC) for Gram-positive bacterial infections, including C. difficile, Enterococcus, Staphylococcus, and Streptococcus[70][71][72] - The lead antibiotic candidate, ibezapolstat, demonstrated a 100% clinical cure rate (10 out of 10 patients) in a Phase 2a clinical trial for C. difficile infections (CDI) and commenced enrollment in a Phase 2b trial on December 3, 2021[73][76] - The company intends to 'de-risk' this new class of antibiotics through its drug development activities and potentially partner with a fully-integrated pharmaceutical company for late-stage clinical trials and commercialization[72] Recent Developments This section highlights key recent events and milestones impacting the company's operations and financial position ECCMID 2023 Scientific Conference Presentations This section details the company's presentations at a major scientific conference regarding its lead product candidate - In April 2023, the company provided two presentations at the 33rd Annual European Congress of Clinical Microbiology and Infectious Disease (ECCMID), covering ibezapolstat's novel pharmacology against C. difficile and an update on the preclinical, systemic oral and IV program for other gram-positive infections[78] Protocol Amendment, Referring Physician Program and Trial Site Expansion This section describes strategic initiatives to accelerate patient enrollment and trial progress for the Phase 2b study - A protocol amendment was filed in January 2023 and accepted by the FDA in March 2023, allowing an Independent Data Monitoring Committee (IDMC) to review interim clinical data for the Phase 2b trial after 36 patients are enrolled (26 currently enrolled)[79] - The company launched an innovative Referring Physician Program and increased Phase 2b clinical trial sites from 12 to 28 in July 2022 to optimize and accelerate patient enrollment[80][83] Registered Direct Offering This section details the company's recent equity financing, including shares, warrants, and net proceeds - In July 2022, the company completed a registered direct offering and concurrent private placement, issuing 1,159,211 common shares and 130,769 pre-funded warrants, generating $4.2 million in gross proceeds and approximately $3.7 million in net proceeds[84][85] - Series A and B warrants to purchase 1,289,980 shares each were issued to investors and affiliates, with exercise prices of $3.55 and $3.25, respectively[86] - Placement agents received a cash fee of $287,874 and 63,018 warrants with an exercise price of $3.60[87][49] Initial Public Offering This section provides information on the company's IPO, including shares issued, proceeds, and allocation of funds - The company completed its IPO on June 29, 2021, issuing 2,875,000 shares of common stock at $6.00 per share, resulting in $14.8 million in net cash proceeds[90] - IPO proceeds are allocated to complete the Phase 2b clinical trial of ibezapolstat, preclinical development of ACX-375C, and general corporate purposes[90] Effects of Coronavirus (COVID-19) on Our Business This section discusses the ongoing and potential impacts of the COVID-19 pandemic on the company's operations and financial performance - The COVID-19 pandemic has caused significant disruptions, including decreased patient enrollment rates in clinical trials, and its ongoing impact remains uncertain due to new variants, inflation, supply chain issues, and labor shortages[91][92] - While the company has not experienced material adverse impacts to date, it acknowledges potential material adverse effects on its business, financial condition, and operations if the pandemic's challenges persist[93] Components of our Results of Operations This section breaks down the key elements contributing to the company's financial performance, including revenue and expenses Revenue This section clarifies the company's revenue generation status and future expectations - The company has not generated any revenue since its inception and does not expect to generate revenue from product sales in the near future, if at all[94] Research and Development Expenses This section details the nature and expected trajectory of the company's research and development expenditures - Research and development expenses are recognized as incurred and primarily relate to the development of ibezapolstat, preclinical studies, and other portfolio activities, including external CRO and consultant fees, laboratory supplies, manufacturing, and license fees[96] - The company plans to substantially increase R&D expenses for the foreseeable future as it continues the development of product candidates, with the timing, duration, and costs of future clinical trials and preclinical studies being inherently unpredictable[98] - Future clinical development costs will vary significantly based on factors such as per-patient trial costs, the number of trials and sites, patient enrollment rates, safety monitoring, and the efficacy and safety profile of the product candidate[99][100] General and Administrative Expenses This section describes the composition and anticipated future trends of the company's general and administrative costs - General and administrative expenses primarily consist of salaries, employee-related costs (including stock-based compensation), facility costs, legal fees for intellectual property and corporate matters, professional fees, and insurance costs[101] - These expenses are anticipated to increase in the future to support continued research and development, pre-commercialization, and commercialization activities, as well as increased audit, legal, regulatory, and investor relations costs associated with operating as a public company[101] Results of Operations (Three Months Ended March 31, 2023 Compared to the Three Months Ended March 31, 2022) This section provides a comparative analysis of the company's financial performance for the specified three-month periods | Metric | Three Months Ended March 31, 2023 (in thousands) | Three Months Ended March 31, 2022 (in thousands) | Percentage Change | | :--------------------------- | :----------------------------------------------- | :----------------------------------------------- | :---------------- | | Research and Development | $1,016 | $819 | 24 % | | General and Administrative | $1,887 | $1,851 | 2 % | | Total Operating Expenses | $2,903 | $2,670 | 9 % | | Net Loss | $(2,903) | $(2,670) | 9 % | - Research and development expenses increased by $0.2 million (24%) due to Phase 2b clinical trial related costs and increased consulting costs[103] - Net loss increased by $0.2 million (9%) to $2.9 million, primarily due to the increase in research and development expenses[103][104] Liquidity and Capital Resources This section discusses the company's ability to meet its short-term and long-term financial obligations and its funding sources Overview (Liquidity) This section provides a summary of the company's financial position, cumulative losses, and funding needs - Since inception, the company has incurred cumulative losses of approximately $41.5 million as of March 31, 2023, and has generated no revenue from operations, relying primarily on equity issuances for funding[105] - As of March 31, 2023, the company had approximately $7.2 million in cash and $5.3 million in working capital, but these resources are not sufficient to fund anticipated operations for at least 12 months, raising substantial doubt about its ability to continue as a going concern[106][143] - The company received net cash proceeds of approximately $14.8 million from its IPO in June 2021 and $3.7 million from a registered direct offering and private placement in July 2022[105] Net Cash Used in Operating Activities This section details the cash outflows from the company's primary business operations | Metric | Three Months Ended March 31, 2023 (in thousands) | Three Months Ended March 31, 2022 (in thousands) | | :--------------------------- | :----------------------------------------------- | :----------------------------------------------- | | Net Cash Used in Operating Activities | $(1,933) | $(1,876) | - Net cash used in operating activities was $1.9 million for the three months ended March 31, 2023, with the net loss exceeding cash used by $1.0 million, primarily due to $0.9 million in share-based compensation and vendor payments[108] Net Cash Provided by Financing Activities This section reports the cash flows generated from or used in the company's financing activities - There was no cash provided from financing activities for the three months ended March 31, 2023, or 2022[109] Critical Accounting Policies and Estimates This section highlights the accounting policies that require significant judgment and estimation by management Research and Development (Critical Accounting Policy) This section details the critical accounting policy for expensing and estimating research and development costs - Research and development costs are expensed as incurred, with cash advances deferred and expensed when services are provided[112] - Costs for clinical trial activities are estimated based on the progress to completion of specific tasks, such as subject enrollment, and are subject to adjustment, with potential differences between estimated and actual service timing[113] Share-Based Compensation (Critical Accounting Policy) This section outlines the critical accounting policy for valuing and recognizing share-based compensation expenses - Share-based compensation for employees, officers, and directors is recognized over the service period at grant-date fair value, determined using the Black-Scholes option pricing model[114][115] - The Black-Scholes model relies on subjective assumptions, particularly expected price volatility, which is estimated using comparable public companies due to the lack of a public market for the company's stock; changes in these assumptions could impact reported expenses[115] Share-Based Payments to Vendors (Critical Accounting Policy) This section describes the critical accounting policy for valuing and expensing equity awards issued to vendors - Share-based payments to vendors are expensed based on the grant-date fair value of the award or the fair value of services rendered, whichever is more readily determinable[116] - The Black-Scholes option pricing model is also used for valuing options and warrants issued to vendors, and changes in its assumptions or alternative valuation methods could impact reported expenses[116] Other Company Information This section provides additional relevant information about the company, including its regulatory status and accounting pronouncements Emerging Growth Company Status This section explains the company's status as an emerging growth company and the associated reduced reporting requirements - The company is an 'emerging growth company' (EGC) and 'smaller reporting company,' allowing it to take advantage of reduced reporting requirements[117][243][247] - Exemptions include providing only two years of audited financial statements, not requiring auditor attestation on internal controls (Section 404(b)), and delaying the adoption of new accounting standards[119][244][246] - EGC status will last for up to five years or until specific revenue or market capitalization thresholds are met[245] Recent Accounting Pronouncements This section addresses the impact of newly issued accounting standards on the company's financial reporting - The Financial Accounting Standards Board has issued new accounting pronouncements, but the company does not believe they will significantly impact its financial accounting measurements or disclosures[120] ITEM 3. Quantitative and Qualitative Disclosures about Market Risk As a smaller reporting company, Acurx Pharmaceuticals, Inc. is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, Acurx Pharmaceuticals is exempt from providing quantitative and qualitative disclosures about market risk[122] ITEM 4. Controls and Procedures This section details the company's disclosure controls and procedures, which management, including the CEO and CFO, evaluated as effective at a reasonable assurance level as of March 31, 2023. It also confirms no material changes in internal control over financial reporting during the period and acknowledges the inherent limitations of control systems Evaluation of Disclosure Controls and Procedures This section describes management's assessment of the effectiveness of the company's disclosure controls and procedures - Management, including the principal executive and financial officers, concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of March 31, 2023[124] - Disclosure controls and procedures are designed to ensure that information required to be disclosed in SEC reports is recorded, processed, summarized, and reported timely[123] Changes in Internal Control over Financial Reporting This section reports on any material changes to the company's internal control over financial reporting during the period - There were no changes in the company's internal control over financial reporting during the period covered by this Quarterly Report that materially affected, or are reasonably likely to materially affect, its internal control over financial reporting[126] Inherent Limitations over Internal Controls This section acknowledges the intrinsic limitations of control systems, which prevent absolute assurance against errors or fraud - Management believes that disclosure controls and internal control over financial reporting are designed to provide reasonable, not absolute, assurance of achieving their objectives and preventing or detecting all errors and fraud[127] - Control systems are subject to inherent limitations, including resource constraints and the possibility of deterioration over time due to changes in conditions or compliance, meaning misstatements due to error or fraud may occur and not be detected[127][128] PART II - OTHER INFORMATION This part provides additional information not covered in the financial statements, including legal proceedings and risk factors ITEM 1. Legal Proceedings The company is not currently involved in any litigation or legal proceedings that management believes would have a material adverse effect on its business. However, it acknowledges that litigation, regardless of outcome, can negatively impact the company due to defense and settlement costs and diversion of management resources - The company is not currently a party to any litigation or legal proceedings that, in management's opinion, are likely to have a material adverse effect on its business[130] - Regardless of outcome, litigation can have an adverse impact on the company due to defense and settlement costs, diversion of management resources, and other factors[130] ITEM 1A. Risk Factors This comprehensive section outlines various risks that could materially and adversely affect the company's business, financial condition, results of operations, and future growth prospects. These risks span operational challenges as a clinical-stage company, funding needs, reliance on its lead product candidate, regulatory hurdles, dependence on third parties, intellectual property issues, and risks related to common stock ownership and general market conditions Risks Related to Our Business This section details the inherent operational and financial risks associated with the company's clinical-stage biopharmaceutical business model - As a clinical-stage biopharmaceutical company with a limited operating history (formed July 2017, acquired lead candidate Feb 2018), it is difficult to evaluate current business and predict future performance[134][135] - The company has incurred significant net losses since inception ($2.9 million for Q1 2023, $12.1 million for FY 2022) and expects continued losses, with no revenue from product sales[137] - The independent registered public accounting firm has expressed substantial doubt about the company's ability to continue as a going concern due to accumulated deficit and negative operating cash flows[139][140] - The company will need substantial additional funding beyond its $7.2 million cash as of March 31, 2023, to continue operations for more than 12 months, and inability to raise capital could delay or eliminate product development[142][143] - The business is heavily reliant on the success of its lead product candidate, ibezapolstat, for CDI treatment, and failure to commercialize it would materially harm the business[151] - Potential serious adverse side effects or unexpected characteristics identified during development could lead to abandonment or limitation of a product candidate's development[152][153] - Market acceptance of ibezapolstat or other candidates, even if approved, is uncertain and depends on factors like efficacy, safety, pricing, and competition[154][157] - The company is exposed to product liability and non-clinical/clinical liability risks, which could place a substantial financial burden if lawsuits are filed[158][159] - The business substantially depends on its management team (David P. Luci, Robert J. DeLuccia, Robert G. Shawah) and the ability to attract and retain other key qualified personnel[159][160] - Failure to complete key milestones relating to technology and product development, such as demonstrating safety and efficacy in trials and establishing cGMP, would significantly impair financial condition[162][163] - The company will compete with larger and better-capitalized companies, and competitors may develop superior or supplanting products[165][166] - The COVID-19 pandemic could adversely impact the business, including preclinical studies and clinical trials, through delays in enrollment, supply chain disruptions, and limited operations[169][170] - Disruption in the global supply chain for research materials and drug supplies could negatively impact business operations, financial condition, and results of operations[173] - Uncertainty regarding insurance coverage and reimbursement status of newly approved products could limit marketability and revenue generation[174][175] - Results of preclinical studies and early clinical trials are not necessarily predictive of future results, and interim, 'top-line,' and preliminary data may change, impacting regulatory approval and product profile[176][180][181] - A previously identified material weakness in internal control over financial reporting (inadequate segregation of duties) has been remediated, but additional weaknesses could be identified in the future, affecting financial reporting accuracy[182][183][184] Risks Related to Regulatory Approval This section outlines the significant challenges and uncertainties involved in obtaining and maintaining government approvals for product candidates - Clinical testing is expensive, difficult to design and implement, can take many years, and is uncertain as to outcome; a failure of one or more clinical trials can occur at any stage[187][188] - Unforeseen events during clinical trials, such as negative or inconclusive results, enrollment delays, or contractor non-compliance, could delay or prevent marketing approval or commercialization of product candidates[189][190] - Delays or difficulties in patient enrollment, particularly for acute infections like CDI requiring rapid diagnosis and enrollment within 24 hours, could significantly delay or require abandonment of clinical trials[191][192][193] - Failure to obtain costly government approvals (e.g., FDA) or to comply with ongoing governmental regulations relating to proposed products could delay or limit product introduction and result in failure to achieve revenues[193][194][195] - Current and potential future healthcare legislative and regulatory actions, including efforts to repeal/amend the ACA and control prescription drug prices, could adversely affect the company's results of operations[195][198][199][201] Risks Related to Our Dependence on Third Parties This section addresses the risks arising from the company's reliance on external partners for manufacturing, clinical trials, and commercialization - The company lacks a sales or marketing infrastructure and relies on developing its own sales force or outsourcing these functions, both of which carry risks of high costs, delays, or lower profitability[202][205][207] - Dependence on third-party manufacturers for product candidates for preclinical studies, clinical trials, and commercial supply increases risks of manufacturing failures, supply disruptions, and non-compliance with cGMP regulations[208][209][211][212] - Reliance on third-party clinical investigators, CROs, and consultants for preclinical studies and clinical trials means less control over timing, quality, and resource allocation, and non-compliance could delay or invalidate trial results[213][214][216] - Commercialization success depends on obtaining adequate reimbursement from governmental authorities, private health insurers, and other third-party payers, which is uncertain due to cost-containment efforts and healthcare reform[217][218][219] - Relationships with future customers and third-party payers are subject to applicable anti-kickback, fraud and abuse, and other healthcare laws and regulations, exposing the company to potential criminal sanctions, civil penalties, and reputational harm[220][221][223][224] Risks Related to Intellectual Property This section discusses the challenges and potential litigation associated with protecting and enforcing the company's intellectual property rights - The company may be involved in expensive and time-consuming lawsuits to protect or enforce its patents, with risks of patent invalidation, unenforceability, or non-infringement findings[225][229] - Intellectual property litigation, even if resolved favorably, incurs significant expenses, distracts management, and could lead to substantial damages, injunctions, or the need for costly licenses[230][231] - The company may need to license certain intellectual property from third parties, and such licenses may not be available or on commercially reasonable terms, potentially harming or preventing product commercialization[232][233] - Failure to adequately protect or enforce intellectual property rights (patents, trade secrets) or secure rights to third-party patents could lead to loss of valuable rights, reduced market share, or costly litigation[234][235][237] - Inability to protect the confidentiality of trade secrets, including unpatented know-how, could harm the company's business and competitive position[238][239] Risks Related to Ownership of Our Common Stock This section covers risks pertinent to investors, including stock price volatility, dividend policy, and corporate governance provisions - The company does not anticipate paying any cash dividends on its common stock in the foreseeable future, meaning capital appreciation, if any, will be the sole source of gain for stockholders[240] - Provisions in the corporate charter documents and under Delaware law (e.g., classified board, restrictions on stockholder action by written consent, special meeting calls, advance notice for nominations, supermajority vote for certain amendments) could make an acquisition of the company more difficult and may prevent attempts by stockholders to replace or remove current management[240][241][243] - The price of the company's stock may be volatile due to numerous factors, including clinical trial results, regulatory decisions, manufacturing issues, key personnel changes, market valuations, and general economic conditions[248][249][250] - Officers, directors, and their affiliates collectively own approximately 31% of outstanding common stock, giving them significant influence over matters requiring stockholder approval[252] - Failure to satisfy Nasdaq's continued listing requirements could lead to delisting, negatively affecting stock price, liquidity, and the ability to raise future financing[253][255] - The company's certificate of incorporation and bylaws designate the Delaware Court of Chancery as the exclusive forum for certain disputes, potentially limiting stockholders' ability to choose a favorable judicial forum[278] General Risk Factors This section addresses broad risks impacting the company, such as public company costs, internal controls, cybersecurity, and litigation - Operating as a public company incurs significant increased legal, accounting, and compliance costs, diverting management time and potentially impacting net income or increasing net loss[256][257][258] - Failure to maintain an effective system of internal control over financial reporting could lead to inaccurate financial reports, fraud, and loss of investor confidence, potentially requiring restatements[259][260][261][267][268] - Dependence on digital technologies exposes the company to cyber incidents or attacks, which could result in information theft, data corruption, operational disruption, and financial loss[262] - Future issuances of additional capital stock in connection with financings, acquisitions, investments, or stock incentive plans will dilute existing stockholders' ownership interests[263] - The company is exposed to risks of fraud or misconduct by employees, principal investigators, consultants, and collaborators, including non-compliance with regulatory standards and healthcare fraud and abuse laws[264][265] - Inaccuracies in estimates and judgments used in financial statements, or the assumptions underlying them, could materially affect financial results, harm the business, and cause the share price to decline[268][269] - Failure to comply with environmental, health, and safety laws and regulations could result in fines, penalties, or costs that harm the business[271][274][275] - Litigation, even in the normal course of business, can adversely affect financial condition and operations due to defense costs, diversion of resources, and negative publicity[271] - If securities or industry analysts do not publish research or reports about the business, or they publish negative reports, the share price and trading volume could decline[275][276] ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds This section details the use of proceeds from the company's Initial Public Offering (IPO), confirming no material change in the planned allocation of funds Use of Proceeds from Initial Public Offering This section outlines the specific allocation and investment of funds raised from the company's initial public offering - The IPO, completed on June 29, 2021, generated $14.8 million in net cash proceeds from the sale of 2,875,000 common shares at $6.00 each[279] - Proceeds have been invested in a money market fund, and there has been no material change in the planned use of funds, which includes completing the Phase 2b clinical trial of ibezapolstat, preclinical development of ACX-375C, and general corporate purposes[279][90] ITEM 3. Defaults Upon Senior Securities The company reported no defaults upon senior securities during the period - There were no defaults upon senior securities[280] ITEM 4. Mine Safety Disclosures This item is not applicable to the company's operations - This item is not applicable[280] ITEM 5. Other Information No other information was reported under this item - No other information was reported under this item[280] ITEM 6. Exhibits This section lists the exhibits filed or incorporated by reference as part of the Quarterly Report, including various certifications, XBRL documents, and the company's Certificate of Incorporation - The section lists exhibits filed or incorporated by reference, including certifications (31.1*, 31.2*, 32.1*, 32.2*), XBRL documents (101.INS, 101.SCH, 101.CAL, 101.DEF, 101.LAB, 101.PRE, 104), and the Certificate of Incorporation (3.1)[282][283] Signatures The report is duly signed on behalf of Acurx Pharmaceuticals, Inc. by its President, CEO, and CFO on May 12, 2023 - The report was signed by David P. Luci (President and Chief Executive Officer) and Robert G. Shawah (Chief Financial Officer) on May 12, 2023[284][285]