vTv Therapeutics(VTVT) - 2025 Q2 - Quarterly Report

PART I – FINANCIAL INFORMATION This section presents the company's financial statements, management's discussion and analysis, market risk disclosures, and internal controls Item 1. Condensed Consolidated Financial Statements This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations, equity changes, cash flows, and explanatory notes Condensed Consolidated Balance Sheets This section presents the company's financial position, detailing assets, liabilities, and equity at specific reporting dates | Metric | June 30, 2025 (Unaudited) (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :--------------------------------------- | :------------------------------- | | Cash and cash equivalents | $25,922 | $36,746 | | Total current assets | $26,374 | $38,113 | | Total assets | $26,448 | $38,266 | | Total current liabilities | $5,295 | $5,196 | | Total liabilities | $24,043 | $23,965 | | Total stockholders' equity | $2,405 | $14,301 | - The company's cash and cash equivalents decreased by approximately $10.8 million from December 31, 2024, to June 30, 2025, reflecting a significant reduction in liquidity[12] - Total stockholders' equity saw a substantial decrease from $14.3 million at December 31, 2024, to $2.4 million at June 30, 2025[12] Unaudited Condensed Consolidated Statements of Operations This section details the company's financial performance over specific periods, including revenue, expenses, and net loss | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Revenue | $— | $— | $— | $1,000 | | R&D Expenses | $4,103 | $3,439 | $6,933 | $6,088 | | G&A Expenses | $3,618 | $3,716 | $7,291 | $7,694 | | Operating Loss | $(7,721) | $(7,155) | $(14,224) | $(12,782) | | Net Loss Attributable to vTv Therapeutics Inc. | $(6,046) | $(5,180) | $(11,138) | $(10,045) | | Net Loss Per Share (Basic & Diluted) | $(0.92) | $(0.81) | $(1.69) | $(1.97) | - The company reported no revenue for the three and six months ended June 30, 2025, compared to $1.0 million in revenue for the six months ended June 30, 2024[14] - Research and development expenses increased by 19.3% for the three months ended June 30, 2025, and by 13.9% for the six months ended June 30, 2025, primarily due to higher indirect R&D costs[14][117][123] Unaudited Condensed Consolidated Statement of Changes in Redeemable Noncontrolling Interest and Stockholders' Equity (Deficit) This section outlines changes in the company's equity, including net losses, share-based compensation, and noncontrolling interest adjustments - Total stockholders' equity decreased from $14,301 thousand at December 31, 2024, to $2,405 thousand at June 30, 2025, primarily due to net losses attributable to vTv Therapeutics Inc. and noncontrolling interest[22] - Share-based compensation expense contributed $1,743 thousand to additional paid-in capital for the six months ended June 30, 2025[22] - Net loss attributable to noncontrolling interest was $(2,459) thousand for the six months ended June 30, 2025, compared to $(2,383) thousand for the same period in 2024[22][24] Unaudited Condensed Consolidated Statements of Cash Flows This section presents the company's cash inflows and outflows from operating, investing, and financing activities | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(10,782) | $(14,064) | | Net cash (used in) provided by financing activities | $(42) | $50,144 | | Net (decrease) increase in cash and cash equivalents | $(10,824) | $36,080 | | Total cash and cash equivalents, end of period | $25,922 | $45,526 | - Net cash used in operating activities decreased by $3.3 million for the six months ended June 30, 2025, compared to the same period in 2024, primarily due to working capital changes[133] - Financing activities provided $50.1 million in cash for the six months ended June 30, 2024, mainly from a private placement, while cash flows from financing activities were immaterial for the same period in 2025[135] Notes to Unaudited Consolidated Financial Statements This section provides detailed explanations and disclosures supporting the condensed consolidated financial statements Note 1: Description of Business and Basis of Presentation and Going Concern This note describes the company's business, its accounting basis, and addresses the going concern assessment - vTv Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing oral, small molecule drug candidates for diabetes and other chronic diseases, with cadisegliatin (Phase 3 for type 1 diabetes) as its lead candidate[30][95] - The company operates as a holding company, consolidating vTv Therapeutics LLC (a variable-interest entity) as its principal operating subsidiary[31][32][103] - As of June 30, 2025, the company had an accumulated deficit of $310.9 million and cash and cash equivalents of $25.9 million, leading to substantial doubt about its ability to continue as a going concern[34][127][130] Note 2: Summary of Significant Accounting Policies This note outlines the key accounting principles and policies applied in preparing the financial statements - The unaudited interim financial statements are prepared in accordance with GAAP and SEC rules for interim financial information, reflecting all necessary adjustments[41] - There have been no material changes to the company's significant accounting policies during the three and six months ended June 30, 2025[48] - The company is evaluating the impact of recently issued accounting pronouncements: ASU 2023-09 (Improvements to Income Tax Disclosures, effective Jan 1, 2025) and ASU 2024-03 (Expense Disaggregation Disclosures, effective Dec 15, 2026)[49][50] Note 3: Collaboration Agreements This note details the company's collaboration agreements, including licensing arrangements and related revenue recognition - The Second Newsoara Amendment, which would have expanded the global license for the PDE4 program contingent on a $20.0 million upfront fee, became null and void as of June 26, 2025, due to non-payment by Newsoara[52] - No revenue related to the Newsoara License Agreement was recognized during the three and six months ended June 30, 2025[54] - In the first quarter of 2024, the company recognized $1.0 million in revenue from a development milestone under the Newsoara License Agreement, which was fully satisfied[54] Note 4: Share-Based Compensation This note describes the company's share-based compensation plans and related expenses - As of June 30, 2025, the company had $6.7 million in total unrecognized stock-based compensation expense, expected to be recognized over a weighted average period of 2.7 years[55] | Share-Based Compensation Expense (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $307 | $217 | $534 | $283 | | General and administrative | $623 | $642 | $1,209 | $796 | | Total share-based compensation expense | $930 | $859 | $1,743 | $1,079 | Note 5: Commitments and Contingencies This note discloses the company's legal proceedings, contractual obligations, and potential future liabilities - The company is not currently a party to any material legal proceedings[57][156] - Under the amended Novo License Agreement, the company has potential developmental and regulatory milestone payment obligations totaling up to $7.0 million for T1D, $50.5 million for T2D, or $115.0 million for other indications, plus $75.0 million in potential sales-based milestones and mid-single digit royalties[59] Note 6: Noncontrolling Interest This note explains the company's noncontrolling interest in its consolidated subsidiary, vTv LLC - The company holds an 81.9% economic interest in vTv LLC, with various holders owning an 18.1% noncontrolling interest[33][60] - On February 27, 2024, $5.3 million representing the fair value of redeemable noncontrolling interest was reclassified from temporary equity to noncontrolling interest as a component of permanent equity, following changes in M&F's governance rights[61] Note 7: Stockholders' Equity (Deficit) This note details changes in stockholders' equity, including stock splits, private placements, and ATM offerings - A 1-for-40 reverse stock split was effected on November 20, 2023, for both Class A and Class B common stock[64] - In February 2024, the company completed a private placement, issuing 464,377 shares of Class A common stock and pre-funded warrants to purchase 3,853,997 shares of Class A common stock, with gross proceeds of approximately $51.0 million[35][36][66] - As of June 30, 2025, the company had sold 179,400 shares of Class A common stock under the TD Cowen ATM Offering for net proceeds of $2.5 million, with $47.5 million remaining available[131] Note 8: Related-Party Transactions This note describes transactions and relationships with related parties, including significant shareholders and governance agreements - MacAndrews & Forbes Incorporated directly or indirectly controls approximately 46.6% of the combined voting power of the company's outstanding common stock[71] - The Investor Rights Agreement was amended on February 27, 2024, altering M&F's governance rights and granting Private Placement Investors the right to designate three board members, making third-party acquisition of control more difficult[77] - The company is party to a Tax Receivable Agreement with M&F, but no liability has been recognized as of June 30, 2025, as no transactions triggering payments have occurred[76][83] Note 9: Segment Information This note provides information on the company's operating segments and allocation of research and development expenses - The company operates in a single reportable segment, primarily focused on the research and development of its lead product candidate, cadisegliatin[79] | R&D Expense (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Direct - Cadisegliatin | $1,992 | $2,034 | $2,910 | $3,597 | | Direct - Other projects | $136 | $182 | $249 | $405 | | Indirect R&D expense | $1,975 | $1,223 | $3,774 | $2,086 | | Total R&D expense | $4,103 | $3,439 | $6,933 | $6,088 | Note 10: Income Taxes This note discusses the company's income tax provisions, deferred tax assets, and valuation allowances - The company did not record an income tax provision for the three and six months ended June 30, 2025[81] - A $0.1 million income tax provision was recorded for the six months ended June 30, 2024, related to foreign withholding taxes from license agreements[81] - A valuation allowance has been established against deferred tax assets due to the company's history of losses, indicating that realization of these assets is not more-likely-than-not[82] Note 11: Net Loss per Share This note presents the calculation of basic and diluted net loss per share for the reporting periods - Basic and diluted net loss per share are the same for all periods presented because the inclusion of potentially issuable shares would be antidilutive[84] | Metric | For the Three Months Ended June 30, 2025 | For the Three Months Ended June 30, 2024 | For the Six Months Ended June 30, 2025 | For the Six Months Ended June 30, 2024 | | :------------------------------------------------ | :--------------------------------------- | :--------------------------------------- | :------------------------------------- | :------------------------------------- | | Net loss attributable to common shareholders (in thousands) | $(6,046) | $(5,180) | $(11,138) | $(10,045) | | Weighted average Class A common stock (basic and diluted) | 6,587,070 | 6,403,444 | 6,584,969 | 5,098,877 | | Net loss per share (basic and diluted) | $(0.92) | $(0.81) | $(1.69) | $(1.97) | Note 12: Fair Value of Financial Instruments This note describes the fair value measurements for the company's financial instruments, particularly warrant liabilities - The fair value of warrant liabilities (related party and other) is determined using Level 3 inputs, primarily through the Black-Scholes option pricing model[91][92] | Liability (in thousands) | Balance at June 30, 2025 | Balance at December 31, 2024 | | :----------------------- | :----------------------- | :--------------------------- | | Warrant liability, related party | $31 | $57 | | Warrant liability | $48 | $43 | | Total | $79 | $100 | - The total warrant liability decreased from $100 thousand at December 31, 2024, to $79 thousand at June 30, 2025[91] Note 13: Subsequent Events This note discloses events occurring after the balance sheet date that may require financial statement adjustment or disclosure - The company evaluated subsequent events through August 12, 2025, and determined that no events occurred requiring adjustments to disclosures or the unaudited condensed consolidated financial statements[93] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's analysis of financial condition, operating results, clinical program developments, liquidity, and going concern status Company Overview This section provides a high-level description of the company's business and strategic focus - vTv Therapeutics is a late-stage biopharmaceutical company focused on developing oral, small molecule drug candidates for diabetes and other chronic diseases[95] - The company's lead clinical pipeline candidate is cadisegliatin, an oral liver-selective glucokinase activator, currently in a Phase 3 trial for the treatment of type 1 diabetes (T1D)[95] Recent Developments This section highlights key recent events, including clinical trial progress, executive appointments, and intellectual property updates - In May 2025, the company reinitiated screening of patients in its Phase 3 CATT1 clinical trial for cadisegliatin in T1D, with top-line data expected in the second half of 2026[96] - Michael Tung, M.D., MBA, was appointed Executive Vice President and Chief Financial Officer in May 2025[96] - In August 2025, the U.S. Patent and Trademark Office allowed claims covering the crystalline salt form of cadisegliatin, strengthening the company's intellectual property[97] Our Type 1 Diabetes Program – Cadisegliatin (TTP399) This section details the progress and status of the company's lead drug candidate, cadisegliatin, for type 1 diabetes - Cadisegliatin received FDA Breakthrough Therapy designation in 2021 for T1D, supported by positive Phase 2 SimpliciT-1 study results showing significant HbA1c improvement and a 40% decrease in severe and symptomatic hypoglycemia[99] - The clinical hold on the cadisegliatin program was removed by the FDA on March 14, 2025, after the company resolved a chromatographic signal issue[100] - The CATT1 study protocol was amended to shorten its duration from 12 to 6 months, with top-line data still expected in the second half of 2026. A food effect study in healthy volunteers began in June 2025[100] Holding Company Structure This section explains the company's organizational structure as a holding company with a consolidated operating subsidiary - vTv Therapeutics Inc. is a holding company, with its principal asset being a controlling equity interest in vTv Therapeutics LLC, which is consolidated under the VIE accounting model[103] Financial Overview This section provides a summary of the company's financial performance, revenue sources, and expense categories - The company has not generated any revenue from drug sales to date, with past revenue primarily from milestone payments, upfront proceeds, and research fees under collaboration and license agreements[104] - Significant research and development expenses are expected to continue as the company advances cadisegliatin and other drug candidates, subject to additional funding[106][108] - General and administrative expenses consist mainly of salaries, benefits, accounting, legal, patent, and occupancy costs[111] Results of Operations This section analyzes the company's financial results for the reported periods, focusing on revenue and expense trends Comparison of the three months ended June 30, 2025 and 2024 This section compares the company's financial performance for the three-month periods ended June 30, 2025 and 2024 | Metric (in thousands) | June 30, 2025 | June 30, 2024 | Change | | :-------------------- | :------------ | :------------ | :----- | | Revenue | $— | $— | $— | | R&D Expenses | $4,103 | $3,439 | $664 | | G&A Expenses | $3,618 | $3,716 | $(98) | | Operating Loss | $(7,721) | $(7,155) | $(566) | | Interest Income | $275 | $553 | $(278) | | Net Loss Attributable to vTv Therapeutics Inc. | $(6,046) | $(5,180) | $(866) | - Research and development expenses increased by $0.7 million (19.3%) due to higher indirect R&D expenses, primarily payroll[117] - General and administrative expenses decreased by $0.1 million (2.6%) due to lower other operating costs, partially offset by increased payroll-related costs[118] Comparison of the six months ended June 30, 2025 and 2024 This section compares the company's financial performance for the six-month periods ended June 30, 2025 and 2024 | Metric (in thousands) | June 30, 2025 | June 30, 2024 | Change | | :-------------------- | :------------ | :------------ | :------- | | Revenue | $— | $1,000 | $(1,000) | | R&D Expenses | $6,933 | $6,088 | $845 | | G&A Expenses | $7,291 | $7,694 | $(403) | | Operating Loss | $(14,224) | $(12,782) | $(1,442) | | Interest Income | $606 | $632 | $(26) | | Net Loss Attributable to vTv Therapeutics Inc. | $(11,138) | $(10,045) | $(1,093) | - Revenue decreased by $1.0 million for the six months ended June 30, 2025, as the prior year included a milestone payment from the Newsoara License Agreement[122] - Research and development expenses increased by $0.8 million (13.9%) due to higher indirect costs and other projects, partially offset by reduced spending on cadisegliatin[123] - General and administrative expenses decreased by $0.4 million (5.2%) due to lower operating and legal costs, partially offset by increased share-based expense[124] Liquidity and Capital Resources This section discusses the company's cash position, funding needs, and strategies to address its going concern status - As of June 30, 2025, the company had an accumulated deficit of $310.9 million and cash and cash equivalents of $25.9 million, with a history of negative operating cash flows[127][128] - These conditions raise substantial doubt about the company's ability to continue as a going concern, necessitating additional capital[130] - The company is evaluating various financing strategies, including direct equity investments and potential licensing/monetization of other programs, to increase cash reserves[130] - As of June 30, 2025, $47.5 million remains available under the TD Cowen ATM Offering, following $2.5 million in net proceeds from prior sales[131] Off-Balance Sheet Arrangements This section confirms the absence of any material off-balance sheet arrangements as of the reporting date - As of June 30, 2025, the company did not have any outstanding off-balance sheet arrangements[143] Discussion of Critical Accounting Policies and Estimates This section addresses the company's critical accounting policies and estimates, noting no material changes from the prior year - There have been no material changes to the company's critical accounting policies and estimates in 2025, as compared to those disclosed in its Annual Report on Form 10-K for the year ended December 31, 2024[144] Forward-Looking Statements This section cautions readers about forward-looking statements, emphasizing inherent risks and the company's disclaimer to update them - The report contains forward-looking statements regarding intentions, plans, estimates, and beliefs, which are subject to numerous uncertainties and factors that could cause actual results to differ materially[94][145] - The company disclaims any obligation to update or revise these forward-looking statements, which are made only as of the report date[146] Effect of Recent Accounting Pronouncements This section refers to Note 2 for details on the impact of recently issued accounting pronouncements - The company refers to Note 2, 'Summary of Significant Accounting Policies,' for a discussion of recent accounting pronouncements[147] Item 3. Quantitative and Qualitative Disclosures About Market Risk This section details the company's limited exposure to market risks, including interest rate, general market, and foreign currency risks - The company does not currently have any material interest rate exposure[148] - Market risk exposure is limited to cash and cash equivalents, which have maturities of one year or less, managed with a strategy focused on capital preservation and liquidity[149] - The company does not have any material foreign currency exposure[150] Item 4. Controls and Procedures This section confirms the effectiveness of disclosure controls and procedures and reports no material changes to internal control over financial reporting - As of June 30, 2025, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective[151] - No changes in internal control over financial reporting occurred during the most recent fiscal quarter that materially affected, or are reasonably likely to materially affect, internal control over financial reporting[154] - The company maintains a corporate governance program and makes SEC filings and corporate governance materials available on its investor relations website[155] PART II – OTHER INFORMATION This section covers additional disclosures including legal proceedings, risk factors, equity sales, defaults, mine safety, other information, and exhibits Item 1. Legal Proceedings This section confirms that the company is not currently involved in any material legal proceedings - The company is not currently a party to any material legal proceedings[156] Item 1A. Risk Factors This section refers to the Annual Report on Form 10-K for detailed risk factors and notes material changes in prior quarterly reports - Risk factors are detailed in Item 1A of Part I in the Annual Report on Form 10-K for the year ended December 31, 2024[157] - Material changes to risk factors were disclosed in the Quarterly Report on Form 10-Q for the quarter ended March 31, 2025[157] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds This section states that there were no unregistered sales of equity securities or use of proceeds to report - There were no unregistered sales of equity securities or use of proceeds to report[158] Item 3. Defaults Upon Senior Securities This section indicates that there were no defaults upon senior securities - There were no defaults upon senior securities[159] Item 4. Mine Safety Disclosures This section confirms that there are no mine safety disclosures to report - There are no mine safety disclosures to report[160] Item 5. Other Information This section reports no new adoptions or terminations of Rule 10b5-1 trading plans by directors or executive officers - During the second fiscal quarter ended June 30, 2025, none of the company's directors or executive officers adopted or terminated any Rule 10b5-1 trading plans[161] Item 6. Exhibits This section lists all exhibits filed as part of the Form 10-Q, including certifications and XBRL documents - The report includes certifications from the President and CEO, and Chief Financial Officer, as required by the Securities Exchange Act of 1934 and the Sarbanes-Oxley Act of 2002[161] - Inline XBRL Instance Document and Taxonomy Extension files are included as exhibits[161] SIGNATURES This section contains the required signatures for the Form 10-Q, confirming its submission by authorized officers - The report is signed by Paul J. Sekhri, President, Chief Executive Officer and Executive Chairperson, and Michael Tung, Executive Vice President and Chief Financial Officer, on August 12, 2025[164]