Inovio Pharmaceuticals(INO) - 2023 Q3 - Quarterly Report

Part I. Financial Information This section presents the company's financial statements, management's analysis, market risks, and internal controls Item 1. Financial Statements This section presents INOVIO Pharmaceuticals, Inc.'s unaudited condensed consolidated financial statements for the quarter ended September 30, 2023, including balance sheets, statements of operations, comprehensive loss, stockholders' equity, and cash flows, along with detailed notes explaining the company's accounting policies, liquidity, and specific financial items Condensed Consolidated Balance Sheets This section details the company's financial position, including assets, liabilities, and stockholders' equity at specific dates Condensed Consolidated Balance Sheets (Unaudited) | Metric | Sep 30, 2023 (Unaudited) | Dec 31, 2022 | | :----------------------------------- | :----------------------- | :------------- | | ASSETS | | | | Cash and cash equivalents | $18,804,602 | $46,329,359 | | Short-term investments | $148,668,866 | $206,669,397 | | Total current assets | $174,767,197 | $315,242,680 | | Total assets | $193,097,198 | $348,533,302 | | LIABILITIES AND STOCKHOLDERS' EQUITY | | | | Total current liabilities | $43,711,026 | $96,868,074 | | Total liabilities | $54,937,485 | $126,170,546 | | Total stockholders' equity | $138,159,713 | $222,362,756 | - Total assets decreased from $348.5 million at December 31, 2022, to $193.1 million at September 30, 2023, primarily driven by reductions in cash and cash equivalents, short-term investments, and prepaid expenses[9] - Total liabilities decreased from $126.2 million at December 31, 2022, to $54.9 million at September 30, 2023, largely due to a significant reduction in accounts payable and accrued expenses, including the settlement of accrued litigation[9][60][64] Condensed Consolidated Statements of Operations This section outlines the company's revenues, expenses, and net loss over specific reporting periods Condensed Consolidated Statements of Operations (Unaudited) | Metric | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--------------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Revenue from collaborative arrangements | $388,446 | $9,154,133 | $729,359 | $10,137,602 | | Research and development expenses | $15,503,032 | $33,087,130 | $69,423,513 | $145,530,626 | | General and administrative expenses | $9,925,055 | $11,824,047 | $37,338,763 | $76,234,341 | | Impairment of goodwill | $10,513,371 | $— | $10,513,371 | $— | | Total operating expenses | $35,941,458 | $44,911,177 | $117,275,647 | $221,764,967 | | Loss from operations | $(35,553,012) | $(35,757,044) | $(116,546,288) | $(211,627,365) | | Net loss | $(33,929,864) | $(37,783,896) | $(110,113,714) | $(225,354,926) | | Net loss per share (Basic and diluted) | $(0.13) | $(0.15) | $(0.42) | $(0.96) | - Revenue from collaborative arrangements significantly decreased by 95.7% for the three months ended September 30, 2023, and by 92.8% for the nine months ended September 30, 2023, compared to the same periods in 2022, primarily due to the satisfaction of performance obligations under the DoD Procurement Contract in 2022[12][173] - Research and development expenses decreased by 53.2% for the three months and 52.3% for the nine months ended September 30, 2023, year-over-year, mainly due to the discontinuation of the INO-4800 program and reductions in force[12][176][177] - The company recognized a goodwill impairment charge of $10.5 million for both the three and nine months ended September 30, 2023, due to a sustained decline in stock price and market capitalization[12][62][180] - Net loss per share improved from $(0.15) to $(0.13) for the three months and from $(0.96) to $(0.42) for the nine months ended September 30, 2023, compared to the same periods in 2022[12] Condensed Consolidated Statements of Comprehensive Loss This section presents the company's net loss and other comprehensive income/loss components, leading to total comprehensive loss Condensed Consolidated Statements of Comprehensive Loss (Unaudited) | Metric | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :-------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Net loss | $(33,929,864) | $(37,783,896) | $(110,113,714) | $(225,354,926) | | Other comprehensive loss: | | | | | | Foreign currency translation | $(2,109) | $(16,563) | $(4,403) | $(37,903) | | Unrealized loss on short-term investments, net of tax | $(57,703) | $(218,985) | $(47,930) | $(565,073) | | Comprehensive loss | $(33,989,676) | $(38,019,444) | $(110,166,047) | $(225,957,902) | - Total comprehensive loss for the three months ended September 30, 2023, was $(34.0) million, an improvement from $(38.0) million in the prior year. For the nine months, it improved from $(226.0) million in 2022 to $(110.2) million in 2023[15] Condensed Consolidated Statements of Stockholders' Equity This section details changes in stockholders' equity, including net loss, stock issuances, and stock-based compensation - Total stockholders' equity decreased from $222.4 million at December 31, 2022, to $138.2 million at September 30, 2023, primarily due to net losses incurred during the period, partially offset by common stock issuances[18] - Issuance of common stock for legal settlement contributed $14.0 million to equity during the nine months ended September 30, 2023[18][64][105] - Net proceeds from common stock issuance for cash (ATM Equity Offering) amounted to $3.6 million for the nine months ended September 30, 2023[18][75][193] - Stock-based compensation added $8.8 million to additional paid-in capital for the nine months ended September 30, 2023[18][85] Condensed Consolidated Statements of Cash Flows This section summarizes cash flows from operating, investing, and financing activities Condensed Consolidated Statements of Cash Flows (Unaudited) | Cash Flow Activity | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(98,089,766) | $(179,875,389) | | Net cash provided by investing activities | $67,412,596 | $55,585,048 | | Net cash provided by financing activities | $3,156,816 | $75,172,705 | | Decrease in cash and cash equivalents | $(27,524,757) | $(49,155,539) | | Cash and cash equivalents, end of period | $18,804,602 | $21,988,239 | - Net cash used in operating activities decreased by 45.5% to $98.1 million for the nine months ended September 30, 2023, compared to $179.9 million in the prior year, primarily due to working capital changes and decreased operating expenses[23][190] - Net cash provided by investing activities increased to $67.4 million for the nine months ended September 30, 2023, from $55.6 million in the prior year, mainly due to timing differences in short-term investment purchases, sales, and maturities[23][191] - Net cash provided by financing activities significantly decreased to $3.2 million for the nine months ended September 30, 2023, from $75.2 million in the prior year, primarily due to lower net proceeds from common stock sales under the ATM Equity Offering Sales Agreement[23][192][193] Notes to Condensed Consolidated Financial Statements This section provides detailed explanations and disclosures for the condensed consolidated financial statements 1. Organization and Operations This note describes INOVIO's business, DNA medicine focus, product candidates, and key collaborations - INOVIO Pharmaceuticals, Inc. is a biotechnology company focused on developing and commercializing DNA medicines for HPV, cancer, and infectious diseases[26][163] - The company's DNA medicine candidates generate immune responses (CD4+, CD8+, memory T-cells) using precisely designed plasmids delivered by its proprietary smart device, CELLECTRA[27][164] - INO-3107, a candidate for recurrent respiratory papillomatosis (RRP), showed a statistically significant reduction in surgical interventions in Phase 1/2 trials, supporting its potential role in HPV-related diseases[28][165] - INOVIO is also developing DNA medicines for HPV-related precancers and cancers (vulvar, anal dysplasia, head & neck cancer), glioblastoma multiforme (GBM), and an Ebola vaccine booster[29][167] - The company collaborates with various partners including Advaccine, ApolloBio, AstraZeneca, Bill & Melinda Gates Foundation, CEPI, DoD, and academic institutions[30][168] 2. Basis of Presentation, Liquidity and Risks and Uncertainties This note outlines financial statement presentation, liquidity assessment, and key risks and uncertainties - The company reported a net loss of $33.9 million for the three months and $110.1 million for the nine months ended September 30, 2023, with an accumulated deficit of $1.6 billion[35] - Working capital was $131.1 million as of September 30, 2023. Cash, cash equivalents, and short-term investments of $167.5 million are sufficient for at least 12 months of planned operations[35] - Additional capital will be required for future R&D, potentially through strategic alliances, licensing, grants, or debt/equity financings, with a risk of dilution or adverse terms[36] - The company's ability to continue operations depends on obtaining additional capital and achieving profitability, with no guarantee of positive cash flow[37] 3. Critical Accounting Policies This note details significant accounting policies and estimates, including revenue recognition and impairment assessments - Collaboration agreements are assessed under ASC Topic 808 or Topic 606, with revenue recognized from license fees, product supply, milestone payments, and royalties[39][40] - Milestone payments are included in transaction price if probable of being reached and a significant revenue reversal would not occur, with re-evaluation each reporting period[44] - Research and development expenses, particularly clinical trial accruals, rely on estimates of total costs based on participant enrollment and study completion, subject to revision[46] - Goodwill and long-lived assets are reviewed for impairment annually or more frequently if triggering events occur, using qualitative and quantitative assessments[47][48] 4. Short-term Investments and Fair Value Measurements This note provides information on short-term investments and fair value measurements, including unrealized gains and losses Available-for-Sale Securities as of September 30, 2023 | Type | Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Market Value | | :----------------------------- | :----------- | :--------------------- | :---------------------- | :---------------- | | Mutual funds | $65,340,680 | $— | $(5,451,695) | $59,888,985 | | U.S. treasury securities | $84,892,403 | $5,888 | $(3,041) | $84,895,250 | | Certificates of deposit | $2,978,576 | $12,202 | $(305) | $2,990,473 | | U.S. agency mortgage-backed securities | $1,364,516 | $— | $(470,358) | $894,158 | | Total | $154,576,175 | $18,090 | $(5,925,399) | $148,668,866 | - Net unrealized loss on available-for-sale equity securities was $(219,000) for the three months and a gain of $3.9 million for the nine months ended September 30, 2023, compared to losses of $(1.8) million and $(10.6) million, respectively, in 2022[54][185] - Unrealized losses of $5.9 million on available-for-sale debt securities as of September 30, 2023, were primarily due to changes in interest rates, not credit risks, and no allowance for credit losses was recorded[55] 5. Certain Balance Sheet Items This note provides detailed breakdowns of specific balance sheet accounts like prepaid expenses and accrued liabilities Prepaid and Other Current Assets | Item | Sep 30, 2023 | Dec 31, 2022 | | :-------------------------- | :----------- | :----------- | | Insurance recovery | $— | $30,000,000 | | Prepaid manufacturing expenses | $21,918 | $1,401,028 | | Other prepaid expenses | $5,092,955 | $18,729,453 | | Total | $5,114,873 | $50,130,481 | Accounts Payable and Accrued Expenses | Item | Sep 30, 2023 | Dec 31, 2022 | | :-------------------------- | :----------- | :----------- | | Trade accounts payable | $3,192,053 | $19,862,487 | | Accrued compensation | $10,214,707 | $12,574,921 | | Accrued litigation settlement | $— | $44,000,000 | | Other accrued expenses | $2,146,982 | $3,249,477 | | Total | $15,553,742 | $79,686,885 | - The significant decrease in prepaid and other current assets and accounts payable and accrued expenses is largely due to the settlement of class action securities litigation, which involved a $30.0 million cash payment by insurance carriers and $14.0 million in common stock issuance[60][64][105] 6. Goodwill and Intangible Assets This note discusses goodwill and intangible assets, including impairment charges recognized - A non-cash, pre-tax goodwill impairment charge of $10.5 million was recognized during the three months ended September 30, 2023, fully impairing goodwill, due to a sustained decline in stock price and market capitalization[61][62][180] - Long-lived assets (property, equipment, leasehold improvements, right-of-use assets) were tested for impairment and concluded not to be impaired[63] - An impairment charge of $2.0 million was recorded for remaining intangible assets from Bioject Medical Technologies during Q2 2023, as there are no current plans to develop or utilize this technology[64][65] 7. Convertible Debt This note details convertible senior notes, including carrying amount, interest expense, and accounting treatment - The company has $78.5 million aggregate principal amount of 6.50% convertible senior notes due March 1, 2024[67][68] - As of September 30, 2023, the net carrying amount of the Notes was $16.5 million, with $16.9 million in future minimum payments due in 2024[72][73] - Interest expense related to the Notes was $313,000 for the three months and $940,000 for the nine months ended September 30, 2023 and 2022[72] - The company adopted ASU 2020-06 on January 1, 2022, simplifying accounting for convertible instruments, resulting in a net reduction to accumulated deficit of $1.8 million and an increase to convertible senior notes of $1.5 million[71] 8. Stockholders' Equity This note provides information on common stock, stock issuances, and equity incentive plans - As of September 30, 2023, 269,731,481 shares of common stock were outstanding, compared to 253,091,319 shares at December 31, 2022[74] - During the nine months ended September 30, 2023, the company sold 6,718,168 shares of common stock under its ATM Equity Offering Sales Agreement for net proceeds of $3.6 million[75][193] - 9,121,000 shares of common stock were issued in Q1 2023 as part of a securities class action settlement[75][105][195] - The 2023 Omnibus Incentive Plan was approved, allowing for the issuance of up to 14,000,000 shares plus returns from the 2016 Plan, with 15,072,020 shares available for future grant as of September 30, 2023[77][78] 9. Net Loss Per Share This note explains basic and diluted net loss per share calculation, identifying anti-dilutive securities - Basic and diluted net loss per share were the same for the three and nine months ended September 30, 2023 and 2022, as potential dilutive shares (stock options, RSUs, convertible notes) were anti-dilutive[82] Potential Shares Excluded from Diluted Net Loss Per Share Calculation (Anti-Dilutive Effect) | Item | Three and Nine Months Ended Sep 30, 2023 | Three and Nine Months Ended Sep 30, 2022 | | :-------------------------------- | :--------------------------------------- | :--------------------------------------- | | Options to purchase common stock | 14,519,877 | 13,381,977 | | Service-based restricted stock units | 3,329,281 | 2,643,840 | | Performance-based restricted stock units | — | 111,941 | | Convertible preferred stock | 3,309 | 3,309 | | Convertible notes | 3,049,980 | 3,049,980 | | Total | 20,902,447 | 19,191,047 | 10. Stock-Based Compensation This note details stock-based compensation expense for employees and directors, and unrecognized compensation Employee and Director Stock-Based Compensation Expense | Period | Total Expense | R&D Expenses | G&A Expenses | | :--------------------------------------- | :------------ | :----------- | :----------- | | Three Months Ended Sep 30, 2023 | $1.9 million | $846,000 | $1.1 million | | Nine Months Ended Sep 30, 2023 | $8.3 million | $3.5 million | $4.8 million | | Three Months Ended Sep 30, 2022 | $3.0 million | $1.4 million | $1.6 million | | Nine Months Ended Sep 30, 2022 | $19.0 million | $7.3 million | $11.7 million | - Total employee and director stock-based compensation expense decreased significantly year-over-year, primarily due to a lower weighted average grant date fair value for awards granted in 2023[85][181] - Unrecognized compensation expense for unvested stock options was $5.9 million (weighted-average period of 1.4 years) and for unvested service-based RSUs was $4.6 million (weighted-average period of 1.6 years) as of September 30, 2023[86][88] 11. Related Party Transactions This note discloses related party transactions, including revenue and expense recognition from collaborative agreements - The company recognized no revenue from Plumbline Life Sciences (PLS) for the three and nine months ended September 30, 2023, compared to $7,000 and $22,000, respectively, in 2022[90] - Deferred grant funding recognized from The Wistar Institute (Wistar) as contra-research and development expense was $316,000 and $705,000 for the three and nine months ended September 30, 2023, a decrease from $824,000 and $6.3 million in 2022[96] - Research and development expenses recorded from Wistar were $407,000 and $1.3 million for the three and nine months ended September 30, 2023, respectively[97] 12. Commitments and Contingencies This note outlines operating lease liabilities, legal settlements, and ongoing litigation Operating Lease Liabilities Maturities as of September 30, 2023 | Year | Amount | | :------------------ | :----------- | | Remainder of 2023 | $956,000 | | 2024 | $3,050,000 | | 2025 | $3,063,000 | | 2026 | $3,139,000 | | 2027 | $2,526,000 | | Thereafter | $4,223,000 | | Total remaining lease payments | $16,957,000 | | Less: present value adjustment | $(3,645,000) | | Total operating lease liabilities | $13,312,000 | - The company settled a shareholder class action complaint in January 2023 for $30.0 million in cash (paid by insurance) and $14.0 million in common stock[105][213] - A shareholder derivative litigation was preliminarily approved for settlement in June 2023, with the company paying $1.2 million for plaintiffs' counsel fees and implementing corporate governance reforms[112][219] - The company is involved in ongoing litigation with VGXI, Inc. and GeneOne Life Science, Inc. regarding alleged breaches of supply and license agreements, respectively, with trial dates not yet set[113][116][220][224] 13. Collaborative Agreements This note provides details on key collaborative agreements, including terms, development, and financial impacts - Under the Advaccine Agreement, INOVIO granted exclusive rights to Advaccine for INO-4800 development and commercialization in Greater China and 33 other Asian countries, with potential milestones up to $200.0 million and high single-digit royalties[120][122] - INOVIO discontinued internally funded efforts for INO-4800 as a COVID-19 heterologous booster vaccine in Q4 2022, but Advaccine continues its development[121][253] - Reimbursements from Advaccine recorded as contra-research and development expense were $1.2 million for the three months and $3.6 million for the nine months ended September 30, 2023[129][179] - The company received $238,000 and $243,000 in revenue from the ApolloBio Agreement for the three and nine months ended September 30, 2023, respectively, for VGX-3100 development[133] - Development of Lassa fever and MERS vaccine candidates with CEPI was discontinued in November 2022. Funding received from CEPI for these programs decreased significantly in 2023[135][136][178][179] - Funding from the DoD for CELLECTRA 3PSP device and INO-4800 development, totaling $54.5 million, saw no amounts recorded in 2023, compared to $6.1 million in contra-R&D expense in 2022[139][179] 14. Income Taxes This note discusses the company's income tax provision, deferred tax assets, and valuation allowance - No income tax provision or benefit was recorded for the nine months ended September 30, 2023 and 2022, due to a history of net operating losses and a full valuation allowance against net deferred tax assets[141] 15. Geneos Therapeutics, Inc. This note describes INOVIO's investment in Geneos Therapeutics, Inc., and its accounting treatment - INOVIO formed Geneos in 2016 for personalized cancer therapies. After several financing rounds, INOVIO's ownership decreased, leading to deconsolidation in June 2020[142][145] - INOVIO now accounts for its common stock investment in Geneos using the equity method and preferred stock investments as equity securities, with no further investment made since March 31, 2022[147][155] - The company's share of net losses of Geneos reduced its investment to $0 as of March 31, 2022, and it will not record further losses as it has no obligation to fund Geneos[155] 16. Subsequent Events This note discloses significant events occurring after the reporting period but before financial statement issuance - From October 1, 2023, through the financial statement date, the company sold 3,254,943 shares of common stock under the 2021 Sales Agreement for net proceeds of $1.6 million at a weighted average price of $0.51 per share[158] ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS This section analyzes INOVIO's financial condition, operational results, and liquidity, including key trends and future outlook Overview This section provides an overview of INOVIO's business, its DNA medicine development, and financial position - INOVIO is a biotechnology company developing DNA medicines for HPV, cancer, and infectious diseases, utilizing its CELLECTRA smart device to deliver plasmids that generate immune responses[163][164] - INO-3107 for recurrent respiratory papillomatosis (RRP) showed statistically significant reduction in surgical interventions in Phase 1/2 trials, and the FDA indicated this data could support a Biologic License Application (BLA) for accelerated approval, eliminating the need for a previously planned Phase 3 trial[165][166] - The company has an accumulated deficit of $1.6 billion as of September 30, 2023, and expects to incur substantial operating losses in the future as all DNA medicine candidates are in the research and development phase[169][170] Recent Developments This section highlights key recent events impacting the company's operations and financial performance - In Q3 2023, INOVIO undertook a corporate reorganization, including a 30% reduction in its full-time employees (58 employees), incurring a one-time charge of $2.1 million primarily for severance payments[171] Critical Accounting Policies and Estimates This section discusses the company's critical accounting policies and estimates, noting any significant changes - There have been no significant changes to critical accounting estimates since December 31, 2022, with details provided in Note 3 to the Condensed Consolidated Financial Statements[172] Results of Operations This section analyzes the company's financial performance, focusing on revenue and expense trends for the reporting periods Revenue from Collaborative Arrangements and Other Contracts | Period | 2023 | 2022 | Change ($) | Change (%) | | :--------------------------------------- | :----------- | :----------- | :----------- | :--------- | | Three Months Ended Sep 30 | $388,000 | $9.2 million | $(8.8 million) | (95.7%) | | Nine Months Ended Sep 30 | $729,000 | $10.1 million | $(9.4 million) | (92.8%) | - The decrease in revenue was primarily due to the satisfaction of all performance obligations under the Procurement Contract with the DoD during 2022[173] Research and Development Expenses | Period | 2023 | 2022 | Change ($) | Change (%) | | :--------------------------------------- | :----------- | :----------- | :----------- | :--------- | | Three Months Ended Sep 30 | $15.5 million | $33.1 million | $(17.6 million) | (53%) | | Nine Months Ended Sep 30 | $69.4 million | $145.5 million | $(76.1 million) | (52%) | - Key drivers for the decrease in R&D expenses include lower drug manufacturing and clinical study expenses for INO-4800 (discontinued in Q4 2022), reduced employee and consultant compensation due to workforce reductions, and lower expenses for VGX-3100 and CELLECTRA 3PSP device development[177] General and Administrative Expenses | Period | 2023 | 2022 | Change ($) | Change (%) | | :--------------------------------------- | :----------- | :----------- | :----------- | :--------- | | Three Months Ended Sep 30 | $9.9 million | $11.8 million | $(1.9 million) | (16.1%) | | Nine Months Ended Sep 30 | $37.3 million | $76.2 million | $(38.9 million) | (51.0%) | - Decreases in G&A expenses were driven by lower legal expenses related to settled litigation, reduced employee compensation (including stock-based compensation), and lower outside services for INO-4800 and VGX-3100. The nine-month decrease also reflects a $44.0 million reduction related to the class action securities litigation settlement (net of insurance recoveries) and $6.9 million in severance expenses for the former CEO in 2022[180][183] - Interest income increased due to higher interest rates, while interest expense remained consistent. Gain on investment in affiliated entities (PLS) improved from a loss in 2022 to a gain in 2023[182][183][184] Liquidity and Capital Resources This section assesses the company's ability to meet its financial obligations and fund future operations, including cash position and funding requirements - As of September 30, 2023, cash, cash equivalents, and short-term investments totaled $167.5 million, with working capital of $131.1 million, down from $253.0 million and $218.4 million, respectively, at December 31, 2022[189] - Net cash used in operating activities decreased to $98.1 million for the nine months ended September 30, 2023, from $179.9 million in 2022, primarily due to working capital changes and decreased operating expenses[190] - Net cash provided by financing activities significantly decreased to $3.2 million in 2023 from $75.2 million in 2022, mainly due to lower proceeds from common stock sales under the ATM Equity Offering Sales Agreement[192][193] - The company believes current cash and short-term investments are sufficient for planned working capital requirements for at least the next twelve months and expects its cash runway to extend into Q2 2025, considering expense reductions and changes to the INO-3107 development plan[196][197] - The company has a $2.9 million minimum purchase obligation under supply agreements and expects to satisfy the $16.4 million obligation for its Senior Convertible Notes maturing March 1, 2024, from existing cash[198][199] ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK This section outlines INOVIO's exposure to market risks, including interest rate, foreign currency, and inflation risks. It details how changes in interest rates have impacted the company's investment portfolio and addresses the limited foreign currency exposure and the minimal effect of inflation on its business - Primary market risk exposure is interest rate sensitivity, with a $5.9 million unrealized loss in the investment portfolio as of September 30, 2023, due to increased prevailing interest rates[201] - The company has limited exposure to foreign currency risk, primarily from cash and equity investments denominated in South Korean Won, and does not use derivative instruments for hedging[203][204][205] - Inflation has not had a material effect on the company's business, financial condition, or results of operations during the nine months ended September 30, 2023[206] ITEM 4. CONTROLS AND PROCEDURES This section confirms the effectiveness of INOVIO's disclosure controls and procedures as of September 30, 2023, at a reasonable assurance level, and states that there have been no material changes in internal control over financial reporting during the quarter - The CEO and CFO concluded that disclosure controls and procedures were effective as of September 30, 2023, at the reasonable assurance level[209] - No material changes in internal control over financial reporting occurred during the quarter ended September 30, 2023[210] Part II. Other Information This section details legal proceedings, risk factors, and exhibits, offering crucial non-financial context ITEM 1. LEGAL PROCEEDINGS This section details INOVIO's legal proceedings, including settlements and ongoing disputes with manufacturers - A shareholder class action complaint was settled in January 2023, with INOVIO paying $30.0 million in cash (covered by insurance) and issuing $14.0 million in common stock[213] - Multiple shareholder derivative complaints were consolidated and a settlement was preliminarily approved in June 2023, leading to a $1.2 million payment for plaintiffs' counsel fees and implementation of corporate governance reforms[214][219] - INOVIO is actively litigating against VGXI, Inc. for alleged material breach of a supply agreement, with VGXI filing counterclaims for breach of contract, trade secret misappropriation, and unjust enrichment[220][222] - The company is also in litigation with GeneOne Life Science, Inc. over an alleged breach of the CELLECTRA Device License Agreement, with INOVIO filing counterclaims[224] ITEM 1A. RISK FACTORS This section outlines significant risks to INOVIO's business, financial condition, and stock price, including financial, product development, and operational challenges Risks Related to Our Financial Position and Need for Additional Capital This section details risks associated with the company's financial stability, historical losses, and need for additional funding - The company has incurred significant losses since inception ($1.6 billion accumulated deficit as of Sep 30, 2023) and expects to continue incurring net losses, with no guarantee of profitability[227] - Success is dependent on developing DNA medicines and proprietary smart device technology, as there are limited revenue sources and no approved products for sale[228][229] - Substantial additional capital is needed for R&D, clinical testing, and commercialization, which may be difficult or costly to obtain, potentially leading to dilution or adverse terms[231][232] - Failure to secure adequate funding could force delays, scope reductions, or cessation of clinical/preclinical programs[233] Risks Related to Product Development, Manufacturing and Regulatory Approval This section addresses risks inherent in the development, manufacturing, and regulatory approval processes for DNA medicine candidates - Failure to obtain FDA approval for product candidates would prevent commercialization in the U.S., significantly impairing revenue generation[234][237] - Pursuing accelerated approval for INO-3107 or other candidates does not guarantee faster development or approval and does not increase the likelihood of marketing approval[238][240] - Clinical trials are lengthy, expensive, and uncertain, with results from earlier stages not always predictive of future outcomes, and potential for delays or termination due to various factors[244][247][249] - No DNA medicine candidates have been approved for sale, and there's no guarantee of developing commercially successful products due to potential ineffectiveness, safety concerns, manufacturing difficulties, or competition[250] - The company discontinued internally funded efforts for INO-4800 as a COVID-19 heterologous booster vaccine in Q4 2022, and its collaborator Advaccine's pursuit of Emergency Use Authorization (EUA) in Asia is not guaranteed[253][254] - Negative public perception of DNA medicines' efficacy, safety, or tolerability could adversely affect business, development, and regulatory approvals[256] - Reliance on contract manufacturers for smart devices and DNA medicine candidates poses risks of production difficulties, delays, non-compliance with regulations (cGMP), and supply interruptions[257][258][259][261][262] - Dependence on single-source suppliers for components and materials creates risks of supply disruptions, price increases, and delays, which could harm the business[263][264][265][266] - Even with regulatory approval, products may face future development and regulatory difficulties, including restrictions on use, ongoing post-approval studies, and strict promotional claims regulations[267] - Developing investigational DNA medicines using new endpoints or methodologies for rare diseases (e.g., INO-3107 for RRP) may lead to longer, costlier, or less effective trials, and regulatory authorities may not consider endpoints clinically meaningful[270][271] - Obtaining and maintaining Orphan Drug Designation for DNA medicine candidates is uncertain, and exclusivity benefits may be limited or lost[272][273] - Breakthrough therapy or fast track designations do not guarantee faster development, review, or approval, nor do they increase the likelihood of marketing approval[274][275] Risks Related to Reliance on Third Parties This section outlines risks associated with dependence on external collaborators, partners, and CROs for product development and funding - Loss of or inability to secure collaborators/partners, or inadequate resource allocation by existing partners, could hinder product development and profitability[276][277][278] - Agreements with government agencies are subject to termination and uncertain future funding, which could negatively impact pipeline development and require alternative funding[280][281][282] - Reliance on third-party CROs to conduct clinical trials carries risks of non-compliance with GCPs, delays, or termination, which could impede regulatory approval and commercialization[283][284] - Indemnification provisions in contracts could lead to substantial liabilities if obligations exceed insurance coverage or if indemnifying parties fail to perform[285][286] Risks Related to Commercialization of Our DNA Medicine Candidates This section details challenges and uncertainties in successfully bringing DNA medicine candidates to market - The company has a small marketing organization and no sales organization; failure to establish these capabilities or partner with third parties could prevent product revenue generation[287][288] - Commercial success depends on broad market acceptance by the medical community and patients, influenced by factors like safety, efficacy, convenience, pricing, and third-party payor coverage[289][290] - Uncertainty regarding coverage and reimbursement policies by third-party payors (government, private insurers) could hinder or prevent commercial success if rates are inadequate or coverage is denied[291][292][295][296] Risks Related to Employee and Operational Matters This section covers risks related to human resources, litigation, competition, IT systems, product liability, and regulatory compliance - Corporate restructuring and cost reduction efforts (including a 30% headcount reduction in Q3 2023) may not achieve anticipated results, leading to unintended consequences like increased attrition, reduced morale, and potential employment litigation[297][298] - The company is subject to ongoing litigation (e.g., VGXI, GeneOne) and may face additional lawsuits, which could result in substantial damages, costly legal expenses, diversion of management attention, and harm to business and reputation[299][300] - Dependence on key personnel and the ability to attract/retain qualified staff is critical; loss of key personnel could negatively affect product development and commercialization[301] - Health epidemics (e.g., COVID-19) could adversely affect clinical trial operations, supply chains, and overall business, leading to delays and increased costs[302][303] - Intense and increasing competition from larger pharmaceutical and biotechnology companies, including those with disruptive technologies, could impede the ability to develop and commercialize DNA medicines[304][305][306][307][308] - Failure to successfully acquire, develop, and market additional product candidates or approved products would impair growth, as the process is lengthy, complex, and competitive[309][310][311] - Changes in funding for the FDA and other government agencies could delay product development and commercialization, negatively impacting the business[312][313] - Reliance on information technology systems and infrastructure exposes the company to cybersecurity breaches and data leakage, which could negatively impact operations, lead to financial/reputational harm, and increase compliance costs[314][315] - Potential product liability exposure from clinical trials and product sales could lead to substantial liabilities, even with insurance coverage, and harm business reputation[316][317] - Healthcare reform measures (e.g., ACA, IRA) could hinder commercial success by impacting pricing, reimbursement, and market access for products[318][320][321][323][324] - Failure to comply with applicable healthcare regulations (fraud, abuse, transparency, privacy) could result in substantial penalties, adversely affecting business operations and financial condition[326][327] - Business involves hazardous materials and compliance with environmental laws, which can be expensive and restrict operations[328] - Collaborations with Chinese companies and reliance on materials manufactured in China expose the company to uncertainties in Chinese laws, trade wars, political unrest, and unstable economic conditions[329][330] - Risk of misconduct by employees, principal investigators, and consultants, including non-compliance with regulatory standards and insider trading, could lead to regulatory sanctions and reputational harm[331] - Employee litigation and unfavorable publicity could negatively affect future business and reputation[332][333] Risks Related to Our Intellectual Property This section discusses challenges and uncertainties in generating, protecting, and enforcing intellectual property rights - Generating and protecting intellectual property (patents, trademarks, trade secrets) is difficult and costly, with uncertainties in patent laws and potential for limited protection or invalidation[334][335][336] - Reliance on licensors and collaborators to protect intellectual property means their failure to do so could significantly harm the business[336] - Trade secrets are difficult to protect from unintentional or willful disclosure, and enforcement is expensive and unpredictable[337] - Being sued for infringing third-party intellectual property rights would be costly, time-consuming, and could lead to substantial damages, injunctions, or required licensing fees[340][342] - Failure to register trademarks in all potential markets could adversely affect the ability to enforce them against third parties[343] Risks Related to an Investment in Our Common Stock This section outlines risks specific to investing in common stock, including market volatility, liquidity, and corporate governance - An active trading market for common stock may not be sustained, making it difficult for investors to sell shares without depressing the market price[344] - The price of common stock has been and may continue to be volatile, subject to substantial drops due to various factors including clinical trial developments, financial results, and industry trends[345][346] - Management has broad discretion in using cash, cash equivalents, and investments, and ineffective use could lead to financial losses and stock price decline[347] - Anti-takeover provisions in charter documents and Delaware law could delay or prevent a change of control, potentially limiting the market price of common stock[348][350] - The company has never paid cash dividends and does not anticipate doing so in the foreseeable future, making capital appreciation the sole source of potential gain[351] - Ability to utilize net operating loss carryforwards and other tax attributes may be limited due to ownership changes or changes in tax laws[352] General Risk Factors This section covers broad risks impacting the company, including listing standards, market fluctuations, economic conditions, and regulatory changes - Failure to comply with Nasdaq's continued listing standards (e.g., minimum bid price) could result in delisting, negatively impacting stock price, access to capital markets, and financial condition[353][354][356][357] - Quarterly operating results may fluctuate significantly due to variations in expenses, clinical trials, litigation, regulatory developments, and investment fair value changes, leading to stock price volatility[358] - Market fluctuations and general economic conditions (inflation, interest rates, geopolitical issues, financial services industry instability) could materially affect results of operations and liquidity[359][360][361][362] - Limited equity research analyst coverage or unfavorable reports could cause stock price and trading volume to decline[363] - Issuance of additional stock in connection with financings, acquisitions, or incentive plans will dilute existing stockholders[364] - Incurring significant costs and demands upon management as a public company due to legal, accounting, and compliance requirements[365][366] - Changes in tax laws (e.g., Tax Cuts and Jobs Act) could adversely affect business and financial condition[367][368] - Increasing use of social media platforms presents new risks and challenges, including noncompliance with regulations, inappropriate disclosure of sensitive information, and negative publicity[369] ITEM 6. EXHIBITS This section lists exhibits filed with the Form 10-Q, including corporate governance documents, certifications, and XBRL files - Exhibits include corporate governance documents (Certificate of Incorporation, Bylaws), certifications from the CEO and CFO (Sarbanes-Oxley Act), and XBRL financial data files[371] SIGNATURES This section contains official signatures of INOVIO's President, CEO, and CFO, affirming the Form 10-Q submission - The report is signed by Jacqueline E. Shea, President, Chief Executive Officer and Director, and Peter Kies, Chief Financial Officer, on November 9, 2023[376]