MannKind(MNKD) - 2023 Q3 - Quarterly Report

PART I: FINANCIAL INFORMATION This section provides MannKind Corporation's unaudited condensed consolidated financial statements and management's discussion and analysis for the reporting period Item 1. Financial Statements (Unaudited) Presents MannKind Corporation's unaudited condensed consolidated financial statements and related notes, detailing financial position and performance Condensed Consolidated Statements of Operations The company reported a net income of $1.7 million for Q3 2023, with significant revenue growth driven by collaborations and royalties Total Revenues (in thousands) | Period | 2023 (in thousands) | 2022 (in thousands) | Change (YoY) | % Change (YoY) | | :----- | :------------------ | :------------------ | :----------- | :------------- | | 3 Months Ended Sep 30 | $51,253 | $32,825 | $18,428 | 56% | | 9 Months Ended Sep 30 | $140,490 | $63,711 | $76,779 | 121% | Net Income (Loss) (in thousands) | Period | 2023 (in thousands) | 2022 (in thousands) | Change (YoY) | | :----- | :------------------ | :------------------ | :----------- | | 3 Months Ended Sep 30 | $1,721 | $(14,432) | $16,153 | | 9 Months Ended Sep 30 | $(13,339) | $(69,453) | $56,114 | Basic and Diluted EPS | Period | 2023 | 2022 | | :----- | :--- | :--- | | 3 Months Ended Sep 30 | $0.01 | $(0.06) | | 9 Months Ended Sep 30 | $(0.05) | $(0.27) | Condensed Consolidated Statements of Comprehensive Income (Loss) Comprehensive income improved to $1.7 million for Q3 2023, with a reduced nine-month loss partly due to unrealized gains Comprehensive Income (Loss) (in thousands) | Period | 2023 (in thousands) | 2022 (in thousands) | | :----- | :------------------ | :------------------ | | 3 Months Ended Sep 30 | $1,721 | $(14,432) | | 9 Months Ended Sep 30 | $(12,896) | $(70,659) | - Unrealized gain (loss) on available-for-sale securities (9 months ended Sep 30): $443 thousand in 2023 vs. $(1,206) thousand in 2022[11] Condensed Consolidated Balance Sheets Total assets increased to $320.3 million, driven by property and equipment, while liabilities and stockholders' deficit also rose Balance Sheet Summary (in thousands) | Metric | Sep 30, 2023 (in thousands) | Dec 31, 2022 (in thousands) | Change | | :----- | :-------------------------- | :-------------------------- | :----- | | Total Assets | $320,328 | $295,282 | +$25,046 | | Total Liabilities | $572,107 | $545,820 | +$26,287 | | Total Stockholders' Deficit | $(251,779) | $(250,538) | $(1,241) | - Cash and Cash Equivalents: Increased to $83.0 million as of Sep 30, 2023, from $69.8 million as of Dec 31, 2022[14] - Property and Equipment, net: Increased to $80.4 million as of Sep 30, 2023, from $45.1 million as of Dec 31, 2022[14] Condensed Consolidated Statements of Stockholders' Deficit Stockholders' deficit slightly increased to $(251.8) million, influenced by net loss and stock issuances, partially offset by gains Stockholders' Deficit (in thousands) | Date | Amount (in thousands) | | :--- | :-------------------- | | Jan 1, 2023 | $(250,538) | | Sep 30, 2023 | $(251,779) | - Common Shares Outstanding: Increased from 263,793 thousand at Jan 1, 2023, to 269,543 thousand at Sep 30, 2023[19] - Additional Paid-in Capital: Increased by $11.6 million during the nine months ended Sep 30, 2023[19] Condensed Consolidated Statements of Cash Flows Operating activities generated $12.4 million cash for the nine months, a significant improvement, with investing providing cash and financing using cash Net Cash from Operating Activities (in thousands) | Period | 2023 (in thousands) | 2022 (in thousands) | | :----- | :------------------ | :------------------ | | 9 Months Ended Sep 30 | $12,416 | $(78,303) | Net Cash from Investing Activities (in thousands) | Period | 2023 (in thousands) | 2022 (in thousands) | | :----- | :------------------ | :------------------ | | 9 Months Ended Sep 30 | $5,907 | $(10,136) | Net Cash from Financing Activities (in thousands) | Period | 2023 (in thousands) | 2022 (in thousands) | | :----- | :------------------ | :------------------ | | 9 Months Ended Sep 30 | $(5,074) | $18,563 | - Cash and Cash Equivalents, End of Period: Increased to $83.0 million as of Sep 30, 2023, from $54.3 million as of Sep 30, 2022[22] Notes to Condensed Consolidated Financial Statements Provides detailed explanations and disclosures for the financial statements, covering business, accounting policies, and key financial components 1. Description of Business and Significant Accounting Policies MannKind is a biopharmaceutical company focused on endocrine and orphan lung diseases, detailing key accounting policies including revenue recognition - Business Focus: Development and commercialization of innovative therapeutic products and devices for endocrine and orphan lung diseases, utilizing Technosphere dry-powder formulations and Dreamboat inhalation devices[28] - Key Products: Afrezza (inhaled insulin), V-Go (wearable insulin delivery device), and Tyvaso DPI (treprostinil inhalation powder, commercialized by United Therapeutics)[28] - Revenue Recognition: Recognizes revenue when customers obtain control of goods/services, applying a five-step model for contracts. Commercial product sales are net of variable consideration (rebates, discounts, returns). Collaboration revenue is recognized based on performance obligations and stand-alone selling prices[31][32][36] Net Revenue by Type (in thousands) | Revenue Type | 3 Months Ended Sep 30, 2023 (in thousands) | 3 Months Ended Sep 30, 2022 (in thousands) | 9 Months Ended Sep 30, 2023 (in thousands) | 9 Months Ended Sep 30, 2022 (in thousands) | | :----------- | :----------------------------------------- | :----------------------------------------- | :----------------------------------------- | :----------------------------------------- | | Product sales | $30,727 | $26,175 | $88,731 | $54,602 | | Services | $308 | $430 | $808 | $2,585 | | Royalties | $20,218 | $6,220 | $50,951 | $6,524 | | Total Net Revenue | $51,253 | $32,825 | $140,490 | $63,711 | 2. Acquisition MannKind acquired V-Go in May 2022 for $15.3 million upfront, with potential $10.0 million in sales-based milestones - V-Go Acquisition Date: May 2022[87] - Up-front Consideration: $15.3 million cash[87] - Contingent Milestone Payments: Up to $10.0 million based on annual revenue milestones ($40M-$100M)[87] - Goodwill: $1.9 million as of September 30, 2023, adjusted for rebate-related liabilities and inventory obsolescence[110] 3. Investments Investments include Thirona convertible notes and debt securities, with the fair value of Thirona notes increasing to $8.4 million - Fair Value of Thirona Convertible Notes: $8.4 million as of Sep 30, 2023 (vs. $7.1 million as of Dec 31, 2022)[95] Interest Income from Held-to-Maturity Investments (in thousands) | Period | 2023 (in thousands) | 2022 (in thousands) | | :----- | :------------------ | :------------------ | | 3 Months Ended Sep 30 | $1,000 | $700 | | 9 Months Ended Sep 30 | $3,200 | $1,600 | Held-to-Maturity Debt Securities by Maturity (in thousands) | Maturity | Sep 30, 2023 (in thousands) | Dec 31, 2022 (in thousands) | | :------- | :-------------------------- | :-------------------------- | | One year or less | $126,616 | $152,862 | | After one year through five years | $3,271 | $1,961 | | Total | $129,887 | $154,823 | 4. Accounts Receivable Total accounts receivable, net, increased to $21.8 million, primarily in collaboration and services receivables, with high concentration among distributors - Total Accounts Receivable, Net: $21.8 million as of Sep 30, 2023 (vs. $16.8 million as of Dec 31, 2022)[103] - Accounts Receivable – Collaborations and Services: Increased to $11.2 million as of Sep 30, 2023 (vs. $4.1 million as of Dec 31, 2022)[103] - Concentration: Three wholesale distributors represented ~79% of commercial accounts receivable as of Sep 30, 2023. United Therapeutics comprised 100% of collaboration and services net accounts receivable[103][104] 5. Inventories Total inventory increased to $27.1 million, driven by finished goods, with $3.7 million in inventory write-offs for the nine months - Total Inventory: $27.1 million as of Sep 30, 2023 (vs. $21.8 million as of Dec 31, 2022)[105] - Finished Goods: Increased to $8.8 million as of Sep 30, 2023 (vs. $2.2 million as of Dec 31, 2022)[105] - Inventory Write-offs: $3.7 million for the nine months ended Sep 30, 2023 (vs. $1.4 million in 2022)[106] 6. Property and Equipment Total property and equipment, net, significantly increased to $80.4 million, primarily due to construction in progress, with higher depreciation expense - Total Property and Equipment, Net: $80.4 million as of Sep 30, 2023 (vs. $45.1 million as of Dec 31, 2022)[108] - Construction in Progress: $48.3 million as of Sep 30, 2023 (vs. $16.7 million as of Dec 31, 2022)[108] - Depreciation Expense (9 months ended Sep 30): $3.3 million in 2023 (vs. $2.3 million in 2022)[109] 7. Goodwill and Other Intangible Asset Goodwill from the V-Go acquisition was $1.9 million, with other intangible assets having a net book value of $1.1 million - Goodwill Balance: $1.9 million as of Sep 30, 2023 (vs. $2.4 million as of Dec 31, 2022)[110] - Other Intangible Asset (Developed Technology): Net Book Value of $1.093 million as of Sep 30, 2023[111] - Estimated Annual Amortization: Approximately $0.1 million per year for the other intangible asset through 2027[112] 8. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities decreased to $32.1 million, including salary expenses and commercial product discounts - Total Accrued Expenses and Other Current Liabilities: $32.1 million as of Sep 30, 2023 (vs. $35.6 million as of Dec 31, 2022)[114] - Discounts and Allowances for Commercial Product Sales: $9.9 million as of Sep 30, 2023 (vs. $8.5 million as of Dec 31, 2022)[114] 9. Borrowings Total debt carrying amount was $273.2 million, primarily Senior convertible notes ($230.0 million) and MidCap credit facility ($38.3 million) - Total Debt – Net Carrying Amount: $273.2 million as of Sep 30, 2023 (vs. $273.5 million as of Dec 31, 2022)[116] Debt Summary (as of Sep 30, 2023) | Debt Type | Amount (Sep 30, 2023) | Annual Interest Rate | Maturity Date | Conversion Price | | :-------- | :-------------------- | :------------------- | :------------ | :--------------- | | Senior convertible notes | $230.0 million | 2.50% | March 2026 | $5.21 per share | | MidCap credit facility | $38.3 million | One-month SOFR (1% floor) + 6.25%; cap of 8.25% | August 2025 | N/A | | Mann Group convertible note | $8.8 million | 2.50% | December 2025 | $2.50 per share | Future Principal Payments on Debt (in thousands) | Year | Amount (in thousands) | | :--- | :-------------------- | | 2023 | $5,000 | | 2024 | $20,000 | | 2025 | $22,163 | | 2026 | $230,000 | | Total | $277,163 | 10. Collaboration, Licensing and Other Arrangements Collaboration revenue significantly increased to $86.5 million from United Therapeutics, with deferred revenue rising to $71.7 million Revenue from United Therapeutics (in thousands) | Period | 2023 (in thousands) | 2022 (in thousands) | | :----- | :------------------ | :------------------ | | 3 Months Ended Sep 30 | $33,289 | $16,529 | | 9 Months Ended Sep 30 | $86,546 | $24,268 | - Deferred Revenue: $71.7 million as of Sep 30, 2023 (vs. $37.9 million as of Dec 31, 2022), with $3.5 million current and $68.2 million long-term[146] - UT CSA Agreement Revenue Allocation: Total anticipated cash flow of $722.3 million, with $10.0 million for Next-Gen R&D Services and $712.3 million for Manufacturing Services and Product Sales[145] - Thirona Collaboration: Amended to extend term through June 2024, with MannKind funding a minimum of $1.1 million for development[147] 11. Fair Value of Financial Instruments Fair values of financial liabilities, including Senior convertible notes ($237.3 million) and Milestone Rights ($11.7 million), are determined using Level 3 inputs Fair Value of Financial Liabilities (in thousands) | Financial Liability | Carrying Amount (in thousands) | Fair Value (in thousands) | | :------------------ | :----------------------------- | :------------------------ | | Senior convertible notes | $226,487 | $237,293 | | MidCap credit facility | $37,921 | $40,032 | | Mann Group convertible note | $8,829 | $15,857 | | Milestone rights | $3,914 | $11,700 | | Contingent milestone liability | $610 | $610 | | Financing liability | $104,122 | $99,940 | - Valuation Method: Fair values determined using discounted cash flow analysis and Monte Carlo simulation, primarily with Level 3 inputs[153] 12. Common and Preferred Stock Authorized common stock increased to 800 million shares, with 269.5 million outstanding, including shares issued via ATM offerings and for note interest - Authorized Common Stock: Increased from 400 million to 800 million shares in May 2023[158] - Common Shares Outstanding: 269,543,539 as of Sep 30, 2023 (vs. 263,793,305 as of Dec 31, 2022)[158] - At-the-Market Offerings (9 months ended Sep 30, 2023): Sold 1,478,090 shares for $6.9 million gross proceeds[159] - Mann Group Convertible Note Interest: Issued 37,122 common shares for interest payments during the nine months ended Sep 30, 2023[160] 13. Earnings per Common Share ("EPS") Basic and diluted EPS was $0.01 for Q3 2023 and $(0.05) for the nine months, with antidilutive securities excluded - Basic and Diluted EPS (3 months ended Sep 30, 2023): $0.01[164] - Basic and Diluted EPS (9 months ended Sep 30, 2023): $(0.05)[164] - Antidilutive Securities (9 months ended Sep 30, 2023): Excluded 7.7 million RSUs/Market RSUs, 12.1 million options/PNQs, and 47.5 million shares from convertible notes[164] 14. Stock-Based Compensation Expense Stock-based compensation expense increased to $13.8 million for the nine months, and the 2018 Equity Incentive Plan authorized 25 million more shares Stock-Based Compensation Expense (in thousands) | Period | 2023 (in thousands) | 2022 (in thousands) | | :----- | :------------------ | :------------------ | | 3 Months Ended Sep 30 | $4,601 | $3,622 | | 9 Months Ended Sep 30 | $13,836 | $10,850 | - 2018 Equity Incentive Plan: Authorized shares increased by 25 million in May 2023[167] - Unrecognized Stock-Based Compensation: $21.1 million for RSUs (2.56 years weighted average period) and $17.4 million for Market RSUs (1.83 years weighted average period) as of Sep 30, 2023[170] 15. Commitments and Contingencies Milestone Rights liability is $3.9 million with $55.0 million remaining, financing liability is $104.1 million, and insulin purchase commitments total €64.6 million - Milestone Rights Liability: $3.9 million as of Sep 30, 2023 (vs. $4.8 million as of Dec 31, 2022), with $55.0 million remaining payable upon achievement of milestones[176][175] - Financing Liability (Sale-Leaseback): $104.1 million as of Sep 30, 2023 ($9.7 million current, $94.4 million long-term)[180] Insulin Purchase Commitments (€ in millions) | Year | Amount (€) | | :--- | :--------- | | 2023 | 2.4 | | 2024 | 14.6 | | 2025 | 15.5 | | 2026 | 19.4 | | 2027 | 9.2 | | Total | 64.6 | - Operating Lease Liabilities: $5.5 million as of Sep 30, 2023 ($1.2 million current, $4.3 million long-term)[188] 16. Income Taxes A full valuation allowance is maintained against net deferred tax assets, with no liability for unrecognized tax benefits expected - Valuation Allowance: Full valuation allowance recorded against net deferred tax assets[191] - Unrecognized Tax Benefits: No liability recognized; no significant changes expected in the next 12 months[191] - Tax Years Subject to Examination: Since 2018[191] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses MannKind's financial condition, operating results, key trends, revenue drivers, expense changes, and liquidity needs Overview MannKind, a biopharmaceutical company, reported $1.7 million net income for Q3 2023, with an accumulated deficit of $3.2 billion, funded by various sources - Business Focus: Biopharmaceutical company developing and commercializing products for endocrine and orphan lung diseases (Afrezza, V-Go, Tyvaso DPI)[195] - Financial Performance (Q3 2023): Net income of $1.7 million for the three months ended Sep 30, 2023[197] - Accumulated Deficit: $3.2 billion as of Sep 30, 2023[197] - Funding Sources: Equity and convertible debt sales, upfront/milestone payments from collaborations, borrowings, product sales (Afrezza, V-Go), royalties/manufacturing revenue (UT), and sale-leaseback proceeds[197] Critical Accounting Policies and Estimates Refers to the Annual Report on Form 10-K and Note 1 for detailed critical accounting policies and estimates - Reference: Critical accounting policies and estimates are detailed in Item 7 of the Annual Report on Form 10-K for December 31, 2022, and Note 1 of the current 10-Q[198] Results of Operations Total revenues grew 56% (QoQ) and 121% (YoY), driven by collaboration royalties, with Afrezza revenue up and R&D expenses significantly increasing Total Revenues (in thousands) | Period | 2023 (in thousands) | 2022 (in thousands) | Change (YoY) | % Change (YoY) | | :----- | :------------------ | :------------------ | :----------- | :------------- | | 3 Months Ended Sep 30 | $51,253 | $32,825 | $18,428 | 56% | | 9 Months Ended Sep 30 | $140,490 | $63,711 | $76,779 | 121% | - Royalty Revenue – Collaborations: Increased by $14.0 million (225%) for the three months and $44.4 million for the nine months ended Sep 30, 2023, primarily due to increased patient demand for Tyvaso DPI[202][203][208][209] - Afrezza Net Revenue: Increased by 24% for the three months and 26% for the nine months ended Sep 30, 2023, driven by higher product demand and price[203][204] - V-Go Net Revenue: Decreased by 18% for the three months but increased by 92% for the nine months ended Sep 30, 2023 (due to acquisition in May 2022)[206][207] - Commercial Product Gross Margin: 78% for the three months and 73% for the nine months ended Sep 30, 2023 (vs. 69% for both periods in 2022)[211][212] - Research and Development Expenses: Increased by 142% ($5.9 million) for the three months and 75% ($9.5 million) for the nine months ended Sep 30, 2023, due to MNKD-101 development, INHALE-3 study, headcount, and other pipeline products[215][216][217] Liquidity and Capital Resources Liquidity is $144.3 million, with $12.4 million cash from operations, $277.1 million outstanding debt, and €64.6 million in insulin purchase commitments - Cash, Cash Equivalents, and Investments: $83.0 million in cash and cash equivalents, $58.0 million in short-term investments, and $3.3 million in long-term investments as of Sep 30, 2023[233] - Net Cash from Operating Activities (9 months ended Sep 30): $12.4 million provided in 2023 (vs. $78.3 million used in 2022)[230] - Outstanding Debt: $277.1 million principal amount as of Sep 30, 2023[227] - Insulin Purchase Commitments: €64.6 million as of Sep 30, 2023[227] - Liquidity Outlook: Believes resources are sufficient for the next twelve months[226][234] Contractual Obligations Refers to Note 9 (Borrowings) and Note 15 (Commitments and Contingencies) for details on contractual obligations - Reference: Material changes in contractual obligations are discussed in Note 9 – Borrowings and Note 15 – Commitments and Contingencies[235] Item 3. Quantitative and Qualitative Disclosures About Market Risk Discusses market risks, including interest rate risk from the MidCap credit facility and foreign currency risk from Euro-denominated obligations Interest Rate Risk Exposed to interest rate risk from the variable-rate MidCap credit facility, but a 10% SOFR change would not materially affect obligations - MidCap Credit Facility: Variable interest rate (one-month SOFR + 6.25%, capped at 8.25%, 1% SOFR floor)[237] - Other Debt: Fixed interest rates (Senior convertible notes 2.50%, Mann Group convertible note 2.50%)[237] - Sensitivity: A hypothetical 10% change in one-month SOFR would not have a material effect on interest payment obligations[238] Foreign Currency Exchange Risk Faces foreign currency exchange risk from Euro-denominated obligations, uses hedging, and a 10% USD to Euro change could impact pre-tax loss by $6.5 million - Exposure: Euro-denominated insulin supply obligations[240] - Hedging: Uses 90-day foreign currency hedging transactions[239] - Currency Gain (9 months ended Sep 30, 2023): $0.9 million[240] - Sensitivity: A hypothetical 10% change in USD to Euro exchange rate could result in a $6.5 million impact on pre-tax loss[241] Item 4. Controls and Procedures Evaluates disclosure controls and procedures, confirming effectiveness as of Sep 30, 2023, with no material changes in internal control Disclosure Controls and Procedures Management concluded that disclosure controls and procedures were effective as of September 30, 2023 - Effectiveness: Disclosure controls and procedures were effective as of September 30, 2023[243] Changes in Internal Control over Financial Reporting No material changes in internal control over financial reporting were identified during the latest fiscal quarter - No Material Changes: No material changes in internal control over financial reporting during the latest fiscal quarter[245] PART II: OTHER INFORMATION This section provides additional information including legal proceedings, risk factors, equity sales, and executive trading plans Item 1. Legal Proceedings MannKind is involved in ordinary course legal proceedings, not expected to materially affect financial position or results - Impact: Final disposition of legal proceedings not expected to have a material adverse effect on financial position, results of operations, or cash flows[247] Item 1A. Risk Factors Outlines significant risks to common stock investment, categorized into business, government regulation, common stock, and general market conditions - Summary of Key Risks: Investment in common stock is speculative due to risks related to commercial success, manufacturing, capital needs, regulatory environment, stock price volatility, and general market conditions[248][249][250][253][254][255] Summary Risk Factors Summarizes principal factors making common stock investment speculative, categorized into business, government regulation, common stock, and general risks - Categorized list of key risks (commercial success, manufacturing, capital needs, regulatory, stock price volatility)[250][253][254] Risks Related to Our Business Details business risks including commercialization, manufacturing, supply chain, capital needs, operating losses, indebtedness, and IT systems - Commercial success of products (Afrezza, V-Go, Tyvaso DPI) is uncertain[256] - Manufacturing risks at Danbury facility and reliance on contract manufacturers in China for V-Go[260][265] - Dependence on single-source suppliers for critical components[267] - Need for additional capital to fund operations[274] - History of operating losses and potential for future losses[280] - Ability to service indebtedness and commitments depends on financial performance[282] - Business susceptible to health pandemics/epidemics and geopolitical events[286][320] - Delays in product development goals (e.g., MNKD-101 Phase 2/3 study)[295] - Risks related to V-Go acquisition and integration[298] - Vulnerability to cyber-attacks and data breaches[324][325] - Adverse developments in financial services industry[334] Risks Related to Government Regulation Covers risks from regulatory approval, ongoing compliance with healthcare laws, data privacy, and impacts of healthcare legislation - Costly and time-consuming regulatory approval process[340] - Ongoing stringent government regulation and compliance requirements[347] - Impact of healthcare legislation (PPACA, IRA) on product pricing and reimbursement[353][355] - Compliance with federal and state healthcare fraud and abuse laws[357] - Stringent and changing data privacy and security obligations (HIPAA, CCPA, GDPR)[360][363] - Risks from generative AI technologies[364] Risks Related to Our Common Stock Addresses stock price volatility, potential dilution from future equity sales, delisting risks, anti-takeover provisions, and reliance on appreciation - Stock price volatility due to various factors[395] - Potential for dilution from future equity/debt sales[406] - Risk of delisting from Nasdaq Global Market[398] - Anti-takeover provisions and exclusive forum provisions[401][402] - No expected dividends; reliance on stock appreciation[405] General Risk Factors Discusses broader risks from unstable market, economic, and geopolitical conditions and their potential adverse impact - Impact of unstable market, economic, and geopolitical conditions[410][411] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds MannKind issued 13,439 common shares in July 2023 to The Mann Group LLC for convertible note interest, relying on registration exemptions - Common Stock Issuance: 13,439 shares issued in July 2023 to pay interest on Mann Group convertible note[412] - Exemption: Relied on Section 3(a)(9) or 4(a)(2) of the Securities Act of 1933[412] Item 3. Defaults Upon Senior Securities The company reported no defaults upon senior securities - No Defaults: No defaults upon senior securities[413] Item 4. Mine Safety Disclosures This item is not applicable to MannKind Corporation - Not Applicable: Mine safety disclosures are not applicable[413] Item 5. Other Information Three executive officers adopted Rule 10b5-1 trading plans in Q3 2023 for orderly disposition of company securities - Executive Trading Plans: Three executive officers adopted Rule 10b5-1 trading plans in Q3 2023[414][415] - Shares to be Sold: Michael Castagna (190,482 shares), Steven Binder (approx. 31,000 shares), David Thomson (approx. 37,000 shares)[415] Item 6. Exhibits Lists all exhibits filed with the Form 10-Q, including corporate documents, debt agreements, and certifications - Exhibit List: Includes Amended and Restated Certificate of Incorporation, Bylaws, Milestone Rights Purchase Agreement, Convertible Promissory Notes, Indenture for Senior Convertible Notes, and CEO/CFO certifications[417][422][424][426][429][431][433] SIGNATURES This section contains the official signatures of the Chief Executive Officer and Chief Financial Officer, certifying the report Signature The report is duly signed by the Chief Executive Officer and Chief Financial Officer on November 7, 2023 - Signatories: Michael E. Castagna (CEO) and Steven B. Binder (CFO)[434] - Date: November 7, 2023[434]