Inovio Pharmaceuticals(INO) - 2025 Q2 - Quarterly Report

Part I. Financial Information Item 1. Financial Statements Presents Inovio Pharmaceuticals' unaudited condensed consolidated financial statements for Q2 2025 and FY 2024, detailing financial position, performance, equity, and cash flows, with explanatory notes Condensed Consolidated Balance Sheets Details the company's financial position as of June 30, 2025, and December 31, 2024, showing decreased total assets and equity from reduced cash, investments, and accumulated deficit | Metric | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :-------------- | :---------------- | | Cash and cash equivalents | $24,351,377 | $65,813,297 | | Short-term investments | $23,198,083 | $28,300,232 | | Total current assets | $52,697,149 | $97,830,050 | | Total assets | $68,240,504 | $113,197,206 | | Total current liabilities | $31,707,610 | $35,325,584 | | Total liabilities | $39,709,599 | $44,693,411 | | Total stockholders' equity | $28,530,905 | $68,503,795 | | Accumulated deficit | $(1,773,433,371)| $(1,730,219,262) | Condensed Consolidated Statements of Operations Shows financial performance for Q2 2025 and 2024, indicating continued net losses, decreased revenue from collaborative arrangements, and reduced operating expenses, especially in R&D | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :----------------------------------------- | :------------------------------- | :------------------------------- | | Revenue from collaborative arrangement | $0 | $100,762 | | Research and development | $14,521,407 | $23,090,989 | | General and administrative | $8,563,112 | $10,206,686 | | Total operating expenses | $23,084,519 | $33,297,675 | | Loss from operations | $(23,084,519) | $(33,196,913) | | Net loss | $(23,519,412) | $(32,237,098) | | Basic and diluted net loss per share | $(0.61) | $(1.19) | | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------------- | :----------------------------- | :----------------------------- | | Revenue from collaborative arrangement | $65,343 | $100,762 | | Research and development | $30,612,309 | $44,001,307 | | General and administrative | $17,588,082 | $20,781,337 | | Total operating expenses | $48,200,391 | $64,782,644 | | Loss from operations | $(48,135,048) | $(64,681,882) | | Net loss | $(43,214,109) | $(62,706,969) | | Basic and diluted net loss per share | $(1.12) | $(2.48) | Condensed Consolidated Statements of Comprehensive Loss Details net loss and other comprehensive loss components for Q2 2025 and 2024, showing total comprehensive loss for each period | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :---------------------- | :------------------------------- | :------------------------------- | | Net loss | $(23,519,412) | $(32,237,098) | | Other comprehensive loss| $(422) | $(13,322) | | Comprehensive loss | $(23,519,834) | $(32,250,420) | | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------- | :----------------------------- | :----------------------------- | | Net loss | $(43,214,109) | $(62,706,969) | | Other comprehensive loss| $13,925 | $(59,338) | | Comprehensive loss | $(43,200,184) | $(62,733,904) | Condensed Consolidated Statements of Stockholders' Equity Illustrates changes in equity components for Q2 2025 and 2024, reflecting net losses, common stock issuances, RSU vesting, and stock-based compensation | Metric | Balance at Dec 31, 2024 | Balance at Jun 30, 2025 | | :-------------------------------------- | :---------------------- | :---------------------- | | Common stock (shares) | 36,099,991 | 36,718,527 | | Common stock (amount) | $36,099 | $36,719 | | Additional paid-in capital | $1,799,362,625 | $1,802,589,299 | | Accumulated deficit | $(1,730,219,262) | $(1,773,433,371) | | Total stockholders' equity | $68,503,795 | $28,530,905 | - Issuance of common stock for cash, net of financing costs, contributed $1,102,149 to additional paid-in capital during the six months ended June 30, 2025[18] - Stock-based compensation added $1,399,349 and $834,792 to additional paid-in capital for the periods ending March 31, 2025, and June 30, 2025, respectively[18] Condensed Consolidated Statements of Cash Flows Summarizes cash movements from operating, investing, and financing activities for H1 2025 and 2024, showing a significant decrease in cash and cash equivalents in 2025 | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(47,685,386) | $(56,969,306) | | Net cash provided by investing activities | $5,230,313 | $55,348,949 | | Net cash provided by financing activities | $993,153 | $21,669,496 | | (Decrease) Increase in cash and cash equivalents | $(41,461,920) | $20,081,542 | | Cash and cash equivalents, end of period | $24,351,377 | $34,392,404 | Notes to Condensed Consolidated Financial Statements Provides detailed explanations and disclosures supporting the condensed consolidated financial statements, covering business, accounting policies, liquidity, fair value, equity, related parties, commitments, contingencies, and subsequent events 1. Organization and Operations Inovio Pharmaceuticals is a clinical-stage biotechnology company developing DNA medicines for HPV, cancer, and infectious diseases using proprietary CELLECTRA devices, with INO-3107 for RRP as its lead candidate - Inovio is a clinical-stage biotechnology company developing DNA medicines for HPV, cancer, and infectious diseases, leveraging its proprietary CELLECTRA devices[25][26] - The lead candidate, INO-3107 for RRP, showed 81.3% of patients experienced a reduction in surgical interventions in a Phase 1/2 trial[27] - The company is also developing DNA medicines for HPV-related OPSCC and anal dysplasia, glioblastoma multiforme (GBM), and an Ebola vaccine booster[28] 2. Basis of Presentation, Liquidity and Risks and Uncertainties Outlines financial statement basis, highlights liquidity challenges from net losses and accumulated deficit, and raises substantial doubt about going concern beyond Q2 2026 without additional capital - The company incurred net losses of $23.5 million and $43.2 million for the three and six months ended June 30, 2025, respectively[34] - As of June 30, 2025, the company had working capital of $21.0 million and an accumulated deficit of $1.8 billion[34] - Cash, cash equivalents, and short-term investments of $47.5 million as of June 30, 2025, combined with $22.5 million net proceeds from the July 2025 Offering, are expected to fund operations into Q2 2026[38][35] - Management believes there is substantial doubt about the company's ability to continue as a going concern beyond Q2 2026 without additional capital[40] Liquidity Liquidity is constrained by net losses and accumulated deficit; recent public offerings provided capital, but further financing is required to sustain future operations - Net proceeds from the July 2025 Offering were $22.5 million[35] - Net proceeds from the December 2024 Offering were $27.6 million[36] - Net proceeds from the April 2024 Offering were $33.2 million[37] Going Concern Ability to continue operations depends on securing additional capital, as current resources are projected to last only into Q2 2026, raising substantial doubt about going concern beyond this period - Current financial resources are expected to support planned operations into the second quarter of 2026[38] - Additional capital is needed for future R&D activities, potentially through strategic alliances, licensing, grants, or debt/equity financings[39] - Substantial doubt exists about the company's ability to continue as a going concern beyond Q2 2026[40] 3. Critical Accounting Policies Details critical accounting policies, focusing on revenue recognition from collaboration agreements and the estimation and accrual of research and development expenses for clinical trials Collaboration Agreements and Revenue Recognition Assesses collaboration agreements under ASC Topic 808 and 606, recognizing payments as R&D expense reduction if the partner is not a customer, or as revenue if a customer - Collaboration agreements are assessed under ASC Topic 808 and Topic 606[43] - Payments from collaboration partners are presented as a reduction of R&D expense if the partner is not a customer, or as revenue if the partner is a customer[43] Research and Development Expenses - Clinical Trial Accruals Clinical trial expenses are accrued based on estimates of total costs, participant enrollment, and study completion, subject to revisions expensed when known, though historically not material - Clinical trial expenses are accrued based on estimates of total costs, participant enrollment, and study completion[44] - Accrued clinical trial costs are subject to revisions, which are charged to expense in the period the facts become known[44] 4. Short-term Investments and Fair Value Measurements Summarizes available-for-sale securities and fair value measurements, categorizing assets and liabilities into Level 1, 2, and 3, and details changes in common stock warrant liability fair value | Investment Type | Fair Market Value (June 30, 2025) | Fair Market Value (Dec 31, 2024) | | :------------------------------ | :-------------------------------- | :------------------------------- | | Mutual funds | $14,438,567 | $24,480,709 | | U.S. treasury securities | $4,957,550 | N/A | | Certificates of deposit | $2,989,454 | $2,989,742 | | U.S. agency mortgage backed securities | $812,512 | $829,781 | | Total short-term investments | $23,198,083 | $28,300,232 | - The company recorded net unrealized gains on available-for-sale equity securities of $759,000 and $900,000 for the three and six months ended June 30, 2025, respectively[46] | Liability | June 30, 2025 | December 31, 2024 | | :------------------------------ | :------------ | :---------------- | | Common stock warrant liability | $11,420,326 | $13,255,188 | - The fair value of the common stock warrant liability decreased by $1,834,862 for the six months ended June 30, 2025[56] 5. Certain Balance Sheet Items Provides a breakdown of specific balance sheet items, including prepaid and other current assets, and accounts payable and accrued expenses, showing changes between June 30, 2025, and December 31, 2024 | Account | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Prepaid clinical expenses | $1,180,456 | $627,962 | | Other prepaid expenses | $3,126,921 | $1,889,503 | | Total prepaid and other current assets | $4,307,377 | $2,517,465 | | Account | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Trade accounts payable | $5,114,144 | $5,091,503 | | Accrued compensation | $8,655,207 | $10,007,180 | | Other accrued expenses | $1,981,340 | $1,101,330 | | Total accounts payable and accrued expenses | $15,750,691 | $16,200,013 | 6. Convertible Debt Details the company's 6.50% convertible senior notes due 2024, fully repaid in March 2024, resulting in no interest expense for H1 2025 - The $78.5 million aggregate principal amount of 6.50% convertible senior notes due 2024 were fully repaid on March 1, 2024[58][59] - No interest expense was recognized for the six months ended June 30, 2025, compared to $178,000 for the same period in 2024[59] 7. Stockholders' Equity Outlines authorized and issued common and preferred stock, details recent equity offerings, At-The-Market sales agreements, and information on stock options and RSUs under incentive plans | Stock Type | Authorized Shares | Issued Shares (June 30, 2025) | Issued Shares (Dec 31, 2024) | | :------------------------------ | :---------------- | :---------------------------- | :--------------------------- | | Common Stock, $0.001 par value | 600,000,000 | 36,718,527 | 36,099,991 | | Series C Preferred Stock, $0.001 par value | 1,091 | 9 | 9 | - The December 2024 Offering involved 10,000,000 shares of common stock and warrants, with net proceeds of $27.6 million[61][36] - The April 2024 Offering included 2,536,258 shares of common stock and 2,135,477 pre-funded warrants, generating net proceeds of $33.2 million[63][37] - Under the 2024 Sales Agreement, 518,670 shares of common stock were sold for $1.1 million net proceeds during the six months ended June 30, 2025[67] - The 2023 Omnibus Incentive Plan was amended to increase shares available for issuance by 2,200,000[69] 8. Net Loss Per Share Details the calculation of basic and diluted net loss per share, which were identical due to the anti-dilutive effect of common stock warrants, stock options, and RSUs | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :----------------------------------------- | :------------------------------- | :------------------------------- | | Net loss | $(23,519,412) | $(32,237,098) | | Weighted-average common shares outstanding | 38,830,053 | 27,197,802 | | Net loss per share (Basic and diluted) | $(0.61) | $(1.19) | | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(43,214,109) | $(62,706,969) | | Weighted-average common shares outstanding | 38,722,451 | 25,244,657 | | Net loss per share (Basic and diluted) | $(1.12) | $(2.48) | - Potential common stock shares (warrants, options, RSUs, convertible preferred stock) totaling 12,873,206 for 2025 and 1,783,353 for 2024 were excluded from diluted EPS calculation due to their anti-dilutive effect[78] 9. Stock-Based Compensation Details stock-based compensation expenses for employees, directors, and non-employees, including valuation assumptions for stock options and RSUs, and information on performance- and market-based RSU awards | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :-------------------------------------- | :------------------------------- | :------------------------------- | | Total employee and director stock-based compensation | $819,000 | $1,500,000 | | R&D expenses (included) | $319,000 | $581,000 | | G&A expenses (included) | $500,000 | $890,000 | | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------------- | :----------------------------- | :----------------------------- | | Total employee and director stock-based compensation | $2,200,000 | $3,900,000 | | R&D expenses (included) | $866,000 | $1,600,000 | | G&A expenses (included) | $1,300,000 | $2,300,000 | - Unrecognized compensation expense for unvested stock options was $2.0 million, expected to be recognized over 1.7 years[82] - Unrecognized compensation expense for unvested service-based RSUs was $2.2 million, expected to be recognized over 2.0 years[84] - No stock-based compensation expense was recognized for Milestone-based RSUs for the six months ended June 30, 2025, as achievement was not probable[93] 10. Related Party Transactions Details transactions and relationships with related parties, including an investment in Plumbline Life Sciences (PLS) and collaborative research agreements with The Wistar Institute, where a director holds positions - The company holds a 15.7% ownership interest in Plumbline Life Sciences, Inc. (PLS), valued at $3.1 million as of June 30, 2025[97] - Collaborative research agreements with The Wistar Institute involve reimbursement for research costs and exclusive rights to in-license new intellectual property[99] | Metric | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | | :-------------------------------------- | :------------------------------- | :----------------------------- | | Contra-research and development expense from Wistar | $315,000 | $601,000 | | Research and development expenses from Wistar | $72,000 | $72,000 | 11. Commitments and Contingencies Outlines lease commitments for office, laboratory, and manufacturing space, and provides updates on ongoing legal proceedings, including VGXI and GeneOne litigations, with GeneOne settled post-period | Operating Lease Liabilities Maturity | Amount | | :----------------------------------- | :----- | | Remainder of 2025 | $1,766,000 | | 2026 | $3,592,000 | | 2027 | $2,992,000 | | 2028 | $2,319,000 | | 2029 | $2,132,000 | | Total remaining lease payments | $12,801,000 | - The company is involved in litigation with VGXI, Inc. regarding alleged breach of a supply agreement and counterclaims[112][113] - The GeneOne litigation, concerning a breached CELLECTRA Device License Agreement, was settled on August 1, 2025, via a Settlement Agreement and Mutual Release[115][116] 12. Collaborative Agreements Details key collaborative agreements, including with ApolloBio Corporation for VGX-3100, and the discontinuation of development efforts with CEPI and the Bill & Melinda Gates Foundation for certain vaccine candidates - ApolloBio Corporation has exclusive rights to develop and commercialize VGX-3100 in agreed territories, with potential milestone payments up to $20.0 million and tiered royalties[119][120] | Revenue Source | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2024 | | :---------------------- | :------------------------------- | :----------------------------- | :------------------------------- | :----------------------------- | | ApolloBio Agreement | $0 | $65,000 | $101,000 | $101,000 | - Development of Lassa fever and MERS vaccine candidates with CEPI was discontinued in 2022[122] - The grant from the Bill & Melinda Gates Foundation for DMAbs development was closed out in Q1 2024[124] 13. Income Taxes Explains income tax accounting, noting no provision or benefit due to net operating losses and a full valuation allowance, and mentions evaluation of the One Big Beautiful Bill Act (OBBBA) impact - No income tax provision or benefit was recorded for the six months ended June 30, 2025, and 2024, due to net operating losses and a full valuation allowance[126] - The company is evaluating the impact of the One Big Beautiful Bill Act (OBBBA), signed July 4, 2025, on its financial condition, but does not anticipate a material change to its effective income tax rate due to the full valuation allowance[127] 14. Geneos Therapeutics, Inc. Describes the company's equity method investment in Geneos Therapeutics, formed for personalized cancer therapies; due to Geneos's net losses, Inovio's investment is reduced to $0 with no future funding obligation - The company holds 23% of Geneos Therapeutics' outstanding equity on an as-converted basis[130] - The investment in Geneos has been reduced to $0 as of June 30, 2025, and December 31, 2024, due to Geneos's continuing net losses[130] - Inovio exclusively licenses its immunotherapy platform and CELLECTRA technology to Geneos for neoantigen-based cancer therapy, with potential royalty payments[131] 15. Segment Information Operates as a single reportable segment focused on developing and commercializing DNA medicines; the CEO uses aggregated financial information, primarily total net loss, to assess performance and allocate resources - The company operates as one reportable segment in the United States[132] - The CEO is the Chief Operating Decision Maker, using total net loss and detailed expense information to allocate resources[133] | R&D Program (Six Months Ended June 30) | 2025 (in thousands) | 2024 (in thousands) | | :------------------------------------- | :------------------ | :------------------ | | INO-3107 | $7,437 | $18,689 | | INO-3112 and other Immuno-oncology | $2,752 | $3,583 | | Other programs | $260 | $827 | | Engineering and device-related | $10,146 | $8,589 | | Stock-based compensation | $875 | $1,650 | | Other unallocated expenses | $9,139 | $10,661 | | Total R&D expenses | $30,612 | $44,001 | 16. Subsequent Events Discloses significant events after the reporting period, including the July 2025 Offering closing, full exercise of April 2024 Pre-Funded Warrants, and GeneOne litigation settlement - On July 7, 2025, the company closed an underwritten public offering, raising $22.5 million in net proceeds from the issuance of common stock and accompanying warrants[136][137] - In July 2025, 2,135,477 Pre-Funded Warrants from the April 2024 Offering were fully exercised, yielding $2,000 in proceeds[137] - On August 1, 2025, the company and GeneOne entered into a Settlement Agreement and Mutual Release to resolve all claims between them[138] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Provides management's perspective on financial condition and results of operations, including business overview, critical accounting policies, revenue/expense analysis, and liquidity/capital resources, emphasizing ongoing funding needs Overview Inovio is a clinical-stage biotech developing DNA medicines and CELLECTRA devices; lead candidate INO-3107 for RRP is on track for BLA submission in H2 2025, with other candidates in development, but no commercialized products and expected continued operating losses - Inovio is a clinical-stage biotechnology company focused on DNA medicines for HPV-associated diseases, cancer, and infectious diseases, delivered by proprietary CELLECTRA devices[146][147][148] - The lead candidate, INO-3107 for RRP, is expected to have its BLA submitted in the second half of 2025, with a goal of FDA file acceptance by year-end, following resolution of a manufacturing issue with the CELLECTRA 5PSP device[149] - The company has an accumulated deficit of $1.8 billion as of June 30, 2025, and expects to incur substantial operating losses in the future[155] Critical Accounting Policies and Estimates No significant changes to critical accounting estimates since December 31, 2024; key estimates include collaboration agreements, revenue recognition, and clinical trial accruals - No significant changes to critical accounting estimates since December 31, 2024[157] - Critical accounting estimates include collaboration agreements and revenue recognition, and research and development expenses (clinical trial accruals)[43][44] Results of Operations Analyzes financial performance for Q2 2025 and 2024, detailing changes in revenue, operating expenses (R&D, G&A), and other income/expense, reflecting decreased losses but also reduced revenue and increased engineering costs Revenue Total revenue decreased significantly for Q2 2025 and H1 2025 compared to 2024, primarily from the ApolloBio collaborative arrangement | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :----------------------------------- | :------------------------------- | :------------------------------- | | Revenue from collaborative arrangement | $0 | $101,000 | | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :----------------------------- | :----------------------------- | | Revenue from collaborative arrangement | $65,000 | $101,000 | Research and development expenses R&D expenses decreased by 37% and 30% for Q2 2025 and H1 2025, respectively, primarily due to lower drug manufacturing, clinical study, and contract labor costs for INO-3107 and INO-5401, partially offset by increased engineering and device-related expenses | R&D Category (Three Months Ended June 30) | 2025 (in thousands) | 2024 (in thousands) | Change ($) | Change (%) | | :---------------------------------------- | :------------------ | :------------------ | :--------- | :--------- | | INO-3107 | $3,930 | $11,043 | $(7,113) | (64)% | | INO-3112 and other Immuno-oncology | $1,438 | $1,563 | $(125) | (8)% | | Other research and development programs | $153 | $204 | $(51) | (25)% | | Engineering and device-related | $5,085 | $4,839 | $246 | 5% | | Stock-based compensation | $322 | $590 | $(268) | (45)% | | Other unallocated expenses | $3,593 | $4,852 | $(1,259) | (26)% | | Total R&D expense | $14,521 | $23,091 | $(8,570) | (37)% | | R&D Category (Six Months Ended June 30) | 2025 (in thousands) | 2024 (in thousands) | Change ($) | Change (%) | | :-------------------------------------- | :------------------ | :------------------ | :--------- | :--------- | | INO-3107 | $7,437 | $18,689 | $(11,252) | (60)% | | INO-3112 and other Immuno-oncology | $2,754 | $3,584 | $(830) | (23)% | | Other research and development programs | $260 | $827 | $(567) | (69)% | | Engineering and device-related | $10,147 | $8,590 | $1,557 | 18% |\ | Stock-based compensation | $875 | $1,650 | $(775) | (47)% | | Other unallocated expenses | $9,139 | $10,661 | $(1,522) | (14)% | | Total R&D expense | $30,612 | $44,001 | $(13,389) | (30)% | - Contributions from grant agreements recorded as contra-R&D expense increased to $315,000 and $601,000 for the three and six months ended June 30, 2025, respectively, from $9,000 and $188,000 in 2024[162] General and administrative expenses G&A expenses decreased for Q2 2025 and H1 2025 compared to 2024, primarily due to lower employee severance, stock-based compensation, outside services, contract labor, and legal expenses | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :----------------------------------- | :------------------------------- | :------------------------------- | | General and administrative expenses | $8.6 million | $10.2 million | | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :----------------------------- | :----------------------------- | | General and administrative expenses | $17.6 million | $20.8 million | - Lower employee severance expenses: $525,000 (3 months), $505,000 (6 months)[172] - Lower employee and consultant stock-based compensation: $411,000 (3 months), $1.0 million (6 months)[172] - Lower outside services: $377,000 (3 months), $588,000 (6 months)[172] - Lower legal expenses: $31,000 (3 months), $776,000 (6 months)[172] Stock-based compensation Total employee and director stock-based compensation expense decreased for Q2 2025 and H1 2025 compared to 2024, primarily due to a lower weighted average grant date fair value for awards granted in 2025 | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :-------------------------------------- | :------------------------------- | :------------------------------- | | Total employee and director stock-based compensation | $819,000 | $1.5 million | | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------------- | :----------------------------- | :----------------------------- | | Total employee and director stock-based compensation | $2.2 million | $3.9 million | - The decrease in stock-based compensation was due to a lower weighted average grant date fair value for awards granted during 2025[163] Interest income Interest income decreased for Q2 2025 and H1 2025 compared to 2024, primarily due to a lower short-term investment balance | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :-------------- | :------------------------------- | :------------------------------- | | Interest income | $611,000 | $1.3 million | | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------- | :----------------------------- | :----------------------------- | | Interest income | $1.4 million | $2.8 million | - The decrease in interest income was primarily due to a lower short-term investment balance[164] Interest expense Interest expense was $0 for Q2 2025 and H1 2025, a decrease from the prior year due to the full repayment of senior convertible notes in March 2024 | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :-------------- | :------------------------------- | :------------------------------- | | Interest expense| $0 | $0 | | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------- | :----------------------------- | :----------------------------- | | Interest expense| $0 | $178,000 | - The decrease in interest expense was due to the full repayment of senior convertible promissory notes on March 1, 2024[165] Change in Fair Value of Common Stock Warrant Liability The company recorded a gain of $1.8 million for H1 2025 from the revaluation of its common stock warrant liability, reflecting changes in fair value | Metric | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | | :----------------------------------------- | :------------------------------- | :----------------------------- | | Change in fair value of common stock warrant liability | $(1,878,010) | $1,834,862 | - The change in fair value of the common stock warrant liability is related to the revaluation of warrants issued in December 2024[166] Gain (loss) on investment in affiliated entity Recognized a gain on its investment in Plumbline Life Sciences (PLS) for Q2 2025 and H1 2025, reversing prior year losses, due to changes in PLS's market value | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :----------------------------------- | :------------------------------- | :------------------------------- | | Gain (loss) on investment in affiliated entity | $776,000 | $(334,000) | | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :----------------------------- | :----------------------------- | | Gain (loss) on investment in affiliated entity | $1.5 million | $(460,000) | - The gain/loss resulted from changes in the fair market value of the investment in Plumbline Life Sciences, Inc. (PLS)[167] Net unrealized gain (loss) on available-for-sale equity securities Reported net unrealized gains on available-for-sale equity securities for Q2 2025 and H1 2025, compared to a loss and a gain in the prior year, reflecting market value fluctuations | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :----------------------------------------- | :------------------------------- | :------------------------------- | | Net unrealized gain (loss) on available-for-sale equity securities | $759,000 | $(21,000) | | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------------- | :----------------------------- | :----------------------------- | | Net unrealized gain (loss) on available-for-sale equity securities | $900,000 | $480,000 | Other (expense) income, net Other (expense) income, net, primarily reflected realized losses on short-term investments sold, resulting in net expenses for Q2 2025 and H1 2025 | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :-------------------------- | :------------------------------- | :------------------------------- | | Other (expense) income, net | $(703,000) | $8,000 | | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------- | :----------------------------- | :----------------------------- | | Other (expense) income, net | $(704,000) | $(675,000) | - The net expense was primarily related to realized losses on short-term investments sold[169] Liquidity and Capital Resources Discusses the company's liquidity position, cash flow activities, and capital raising efforts, reiterating substantial doubt about its ability to continue as a going concern beyond Q2 2026 without additional financing Working Capital and Liquidity Working capital and cash, cash equivalents, and short-term investments significantly decreased from December 31, 2024, to June 30, 2025, indicating tightening liquidity | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------------- | :------------ | :---------------- | | Cash, cash equivalents and short-term investments | $47.5 million | $94.1 million | | Working capital | $21.0 million | $62.5 million | Cash Flows Operating cash flows decreased, investing activities provided less cash, and financing activities saw a substantial decrease in cash provided, reflecting changes in debt repayment and equity offerings Operating Activities Net cash used in operating activities decreased for H1 2025 compared to 2024, primarily due to timing and changes in working capital balances, offset by decreased operating expenses | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(47.7) million | $(57.0) million | Investing Activities Net cash provided by investing activities significantly decreased for H1 2025 compared to 2024, mainly due to timing differences and an overall decrease in short-term investment purchases, sales, and maturities | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------------- | :----------------------------- | :----------------------------- | | Net cash provided by investing activities | $5.2 million | $55.3 million | Financing Activities Net cash provided by financing activities decreased substantially for H1 2025 compared to 2024, primarily due to convertible senior note repayment in 2024 and lower equity offering proceeds | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------------- | :----------------------------- | :----------------------------- | | Net cash provided by financing activities | $993,000 | $21.7 million | - The variance was primarily due to the repayment of $16.4 million in convertible senior notes in March 2024 and lower net proceeds from equity offerings in 2025[177] Offering of Common Stock and Warrants Completed a public offering in July 2025, raising $22.5 million net, and a December 2024 offering, raising $27.6 million net, through common stock and warrant issuance - The July 2025 Offering generated $22.5 million in net proceeds from the sale of 14,285,715 shares of common stock and accompanying warrants[178] - The December 2024 Offering generated $27.6 million in net proceeds from the sale of 10,000,000 shares of common stock and accompanying warrants[179] Offering of Common Stock and Pre-Funded Warrants In April 2024, the company completed a registered direct offering of common stock and pre-funded warrants, yielding $33.2 million in net proceeds - The April 2024 Offering generated $33.2 million in net proceeds from the sale of 2,536,258 shares of common stock and 2,135,477 pre-funded warrants[180] At-The-Market Sales Agreements Utilized ATM sales agreements, selling 518,670 shares for $1.1 million net proceeds in H1 2025 under the 2024 Sales Agreement, with $57.9 million remaining capacity; the 2021 Sales Agreement was terminated in August 2024 - During the six months ended June 30, 2025, 518,670 shares were sold under the 2024 Sales Agreement, generating $1.1 million in net proceeds[182] - As of June 30, 2025, $57.9 million of capacity remained under the 2024 Sales Agreement[183] - The 2021 Sales Agreement was terminated in August 2024[184] Other Issuances of Common Stock In H1 2025, no stock options were exercised, and $109,000 in tax payments were made for RSU settlements; in H1 2024, stock options generated $68,000, offset by $414,000 in RSU settlement tax payments - During the six months ended June 30, 2025, no stock options were exercised, and $109,000 in tax payments were made for RSU settlements[185] - During the six months ended June 30, 2024, stock option exercises generated $68,000, offset by $414,000 in tax payments for RSU settlements[185] Funding Requirements The company has an accumulated deficit of $1.8 billion and expects continued losses; current cash, including recent offerings, funds operations into Q2 2026, but substantial additional financing is required, raising doubt about going concern ability - As of June 30, 2025, the company had an accumulated deficit of $1.8 billion and expects continued operating losses[186] - Current cash resources, including the July 2025 Offering proceeds, are expected to fund operations into the second quarter of 2026[186] - Substantial doubt exists about the company's ability to continue as a going concern beyond Q2 2026 without additional capital[187] Item 3. Quantitative and Qualitative Disclosures About Market Risk Discusses the company's exposure to market risks, including interest rate, foreign currency, and inflation risks, and their potential impact on financial condition and results of operations Interest Rate Risk Primary market risk is interest rate sensitivity, leading to an accumulated unrealized loss of $945,000 in its investment portfolio as of June 30, 2025, due to rising U.S. interest rates - Primary market risk is interest rate sensitivity, affected by changes in U.S. interest rates[190] - Accumulated unrealized loss of $945,000 in the investment portfolio as of June 30, 2025, due to increased prevailing interest rates[190] Foreign Currency Risk Limited material exposure to foreign currency fluctuations, primarily from South Korean Won-denominated cash and equity investments, and transactions in Euros, British Pounds, and Canadian Dollars; no derivative instruments are used for hedging - Limited material exposure to foreign currency rate fluctuations, primarily from South Korean Won-denominated cash and equity investments in PLS[191] - Certain transactions are denominated in South Korean Won, Euros, British Pounds, and Canadian Dollars[192] - The company does not use derivative financial instruments for speculative purposes or engage in exchange rate hedging[193] Inflation Risk While U.S. inflation has increased, the company does not believe it had a material effect on its business, financial condition, or results of operations during H1 2025 - Inflation generally affects the company by increasing its cost of labor[194] - Inflation has not had a material effect on the company's business, financial condition, or results of operations during the six months ended June 30, 2025[194] Item 4. Controls and Procedures Confirms the effectiveness of disclosure controls and procedures as of June 30, 2025, and reports no material changes in internal control over financial reporting during the quarter Evaluation of Disclosure Controls and Procedures CEO and CFO concluded disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2025, ensuring timely and accurate reporting - Disclosure controls and procedures are designed to ensure timely and accurate reporting of information required under the Securities Exchange Act of 1934[195] - The CEO and CFO concluded that disclosure controls and procedures were effective as of June 30, 2025, at the reasonable assurance level[197] Changes in Internal Control over Financial Reporting No material changes in internal control over financial reporting occurred during Q2 2025 that materially affected, or are reasonably likely to materially affect, its internal control over financial reporting - No material changes in internal control over financial reporting occurred during the quarter ended June 30, 2025[198] Part II. Other Information Item 1. Legal Proceedings Provides updates on the company's legal proceedings, specifically detailing the ongoing VGXI litigation and the recently settled GeneOne litigation VGXI Litigation Actively prosecuting a complaint against VGXI, Inc. for alleged material breach of a supply agreement and vigorously defending against VGXI's counterclaims, with no trial date set - In June 2020, the company filed a complaint against VGXI, Inc. alleging material breach of a supply agreement[200] - VGXI filed counterclaims in July 2020, alleging breach of supply agreement, misappropriation of trade secrets, and unjust enrichment[201] - The company intends to aggressively prosecute its claims and vigorously defend against counterclaims; a trial date has not been set[202] GeneOne Litigation Litigation with GeneOne, concerning a breached CELLECTRA Device License Agreement, was settled on August 1, 2025, through a Settlement Agreement and Mutual Release - GeneOne filed a complaint in December 2020, alleging breach of the CELLECTRA Device License Agreement[203] - The company filed counterclaims alleging GeneOne breached the agreement[203] - On August 1, 2025, the company and GeneOne entered into a Settlement Agreement and Mutual Release to settle all claims[204] Item 1A. Risk Factors Details numerous risks that could adversely affect the company's business, financial condition, results of operations, cash flows, and prospects, categorized into financial, product development, third-party reliance, commercialization, operational, intellectual property, and investment-related risks Risks Related to Our Financial Position and Need for Additional Capital Faces significant financial risks, including substantial losses, limited revenue, and ongoing need for additional capital, raising substantial doubt about going concern beyond Q2 2026 without further financing, which may be difficult or costly and could dilute stockholders - The company has incurred significant operating losses and had an accumulated deficit of $1.8 billion as of June 30, 2025[206] - Success is dependent on developing DNA medicines and proprietary device technology, with limited current revenue from product sales[207] - Substantial additional capital is needed for R&D, regulatory approvals, and commercialization, which may be difficult or costly to obtain and could dilute existing stockholders[209][210] - There is substantial doubt about the company's ability to continue as a going concern beyond Q2 2026[215] Risks Related to Product Development, Manufacturing and Regulatory Approval Faces substantial risks in product development, manufacturing, and regulatory approval, including complex drug-device products, uncertain clinical trials, negative public perception of DNA medicines, reliance on single-source suppliers, and ongoing regulatory obligations that could delay or prevent commercialization - Failure to obtain FDA approval for proprietary devices and DNA medicine candidates, especially for complex drug-device combination products, will prevent commercialization in the U.S[217][218][219] - Clinical trials are lengthy, expensive, and uncertain, with results from earlier studies not always predictive of later stages, and delays can increase costs and hinder revenue generation[230][231] - Negative public perception of DNA medicines or CELLECTRA devices could adversely affect business, regulatory approvals, and demand[243][244] - Reliance on contract manufacturers and single-source suppliers for devices and DNA medicine candidates poses risks of production difficulties, delays, and non-compliance with stringent regulations[245][252] - Even with regulatory approval, ongoing obligations and potential policy changes (e.g., Loper Bright decision) could result in significant additional expense or penalties[255][258] Risks Related to Reliance on Third Parties Success relies heavily on third-party collaborators for development, manufacturing, and clinical trials; loss of these relationships, inadequate partner resources, or disputes could severely impact product development and profitability, with government agreements also posing termination and funding risks, and indemnification provisions creating financial exposure - Loss of collaborators or partners, or their failure to apply adequate resources, could harm product development and profitability, including delays in event-based, milestone, or royalty payments[266][267] - Agreements with government agencies are subject to termination and uncertain future funding, which could negatively impact pipeline development or require alternative funding[270] - Reliance on third-party CROs for clinical trials means delays or failures in their contractual duties could prevent regulatory approval or commercialization[272][273] - Indemnification provisions in various contracts could lead to material adverse effects if obligations exceed insurance coverage or if third parties fail to indemnify[274][275] Risks Related to Commercialization of Our DNA Medicine Candidates Commercialization risks include lacking an established sales organization, needing to build or partner for marketing/sales, and uncertainty of market acceptance and favorable reimbursement for novel DNA medicines; healthcare reform and cost containment efforts could also hinder success - The company has a small marketing organization and no sales organization, requiring significant investment or third-party partnerships to commercialize approved products[276] - Commercial success depends on broad market acceptance by the medical community and patients, influenced by factors like safety, efficacy, convenience, pricing, and reimbursement[277] - Uncertainty regarding coverage and reimbursement policies from third-party payors could hinder or prevent commercial success, as adequate reimbursement is crucial for product adoption[279][282] - Healthcare reform measures (e.g., ACA, IRA) and governmental scrutiny of pharmaceutical pricing could adversely affect product pricing, revenue generation, and profitability[314][319] Risks Related to Employee and Operational Matters Operational risks include potential litigation, dependence on key personnel, health epidemics, intense competition, and challenges in acquiring/developing new candidates. Also faces risks from IT system compromises, healthcare regulation compliance, hazardous materials, and geopolitical factors affecting international collaborations and supply chains - The company is subject to litigation, including shareholder actions and disputes with third parties, which could result in substantial damages, legal expenses, and reputational harm[286][287] - Success depends on retaining key personnel and attracting additional qualified staff, with intense competition for talent[288] - Health epidemics (e.g., COVID-19) can adversely affect clinical trial operations, manufacturing, and supply chains[289][290] - Intense competition from larger pharmaceutical companies and disruptive technologies may impede development and commercialization of DNA medicines[291][292] - Compromises to information technology systems or data, including cyber-attacks and AI/ML related risks, could lead to adverse business consequences, financial losses, and reputational harm[302][305][308] - Failure to comply with stringent federal, state, local, and foreign healthcare laws and regulations (e.g., Anti-Kickback Statute, False Claims Act, HIPAA) could result in significant penalties and adversely affect business operations[321][324] - Collaborations with Chinese companies and reliance on Chinese-manufactured materials expose the company to uncertainties in Chinese laws, trade wars, political unrest, and potential U.S. trade restrictions (e.g., BIOSECURE Act)[328][329] Risks Related to Our Intellectual Property Faces challenges in generating and protecting intellectual property (IP), including uncertain patent protection in biotechnology, potential for third-party infringement claims, and difficulties in safeguarding trade secrets; failure to secure or defend IP rights could impair competitiveness and revenue - It is difficult and costly to generate and protect intellectual property, with patent positions in biotechnology being highly uncertain and subject to evolving laws and interpretations[339][340] - The company relies on licensors and collaborators to protect some IP rights, and their failure to do so could harm the business[341] - Trade secrets are difficult to protect and may be unintentionally or willfully disclosed, or independently developed by competitors[342] - Being sued for infringing third-party intellectual property rights would be costly, time-consuming, and could lead to substantial damages, injunctions, or the need to redesign products[347][349] - Failure to register trademarks in all potential markets could adversely affect the ability to enforce them against third parties[350] Risks Related to an Investment in Our Common Stock Investment risks include common stock price volatility, broad management discretion in capital use, anti-takeover provisions limiting market price, and absence of cash dividends; ability to utilize net operating loss carryforwards may also be limited - The price of the common stock has been and may continue to be highly volatile, subject to substantial drops, and influenced by numerous factors beyond the company's control[352][357] - Management has broad discretion in using cash, cash equivalents, and investments, which may not always improve operating results or stock value[355] - 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[356][358] - 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[360] - The ability to utilize net operating loss carryforwards and other tax attributes may be limited by ownership changes or changes in tax laws[361] General Risk Factors General risks include significant quarterly operating result fluctuations, material impacts from market/economic conditions, adverse financial services developments, potential stock price decline from lack of analyst coverage, dilution from additional stock issuances, and increased public company costs/demands. Changes in tax laws and social media challenges also pose risks - Quarterly operating results may fluctuate significantly due to various factors, and comparisons are not necessarily meaningful for future performance[362] - Market fluctuations and general economic conditions (e.g., inflation, rising interest rates, geopolitical issues) could materially affect operations and liquidity[363] - Adverse developments in the financial services industry, such as bank failures, could impact access to capital and liquidity[366] - Lack of equity research analyst coverage or unfavorable reports could cause stock price and trading volume to decline[367] - Issuance of additional stock for fin