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vTv Therapeutics(VTVT) - 2025 Q2 - Quarterly Report
2025-08-12 20:09
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](index=4&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) 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](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=12&type=chunk) - Total stockholders' equity saw a substantial decrease from **$14.3 million** at December 31, 2024, to **$2.4 million** at June 30, 2025[12](index=12&type=chunk) [Unaudited Condensed Consolidated Statements of Operations](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations) 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](index=14&type=chunk) - 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](index=14&type=chunk)[117](index=117&type=chunk)[123](index=123&type=chunk) [Unaudited Condensed Consolidated Statement of Changes in Redeemable Noncontrolling Interest and Stockholders' Equity (Deficit)](index=7&type=section&id=Unaudited%20Condensed%20Consolidated%20Statement%20of%20Changes%20in%20Redeemable%20Noncontrolling%20Interest%20and%20Stockholders'%20Equity%20(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](index=22&type=chunk) - Share-based compensation expense contributed **$1,743 thousand** to additional paid-in capital for the six months ended June 30, 2025[22](index=22&type=chunk) - Net loss attributable to noncontrolling interest was **$(2,459) thousand** for the six months ended June 30, 2025, compared to **$(2,383) thousand** for the same period in 2024[22](index=22&type=chunk)[24](index=24&type=chunk) [Unaudited Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) 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](index=133&type=chunk) - 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](index=135&type=chunk) [Notes to Unaudited Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Consolidated%20Financial%20Statements) 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](index=11&type=section&id=Note%201%3A%20Description%20of%20Business%20and%20Basis%20of%20Presentation%20and%20Going%20Concern) 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](index=30&type=chunk)[95](index=95&type=chunk) - The company operates as a holding company, consolidating vTv Therapeutics LLC (a variable-interest entity) as its principal operating subsidiary[31](index=31&type=chunk)[32](index=32&type=chunk)[103](index=103&type=chunk) - 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](index=34&type=chunk)[127](index=127&type=chunk)[130](index=130&type=chunk) [Note 2: Summary of Significant Accounting Policies](index=12&type=section&id=Note%202%3A%20Summary%20of%20Significant%20Accounting%20Policies) 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](index=41&type=chunk) - There have been no material changes to the company's significant accounting policies during the three and six months ended June 30, 2025[48](index=48&type=chunk) - 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](index=49&type=chunk)[50](index=50&type=chunk) [Note 3: Collaboration Agreements](index=13&type=section&id=Note%203%3A%20Collaboration%20Agreements) 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](index=52&type=chunk) - No revenue related to the Newsoara License Agreement was recognized during the three and six months ended June 30, 2025[54](index=54&type=chunk) - 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](index=54&type=chunk) [Note 4: Share-Based Compensation](index=14&type=section&id=Note%204%3A%20Share-Based%20Compensation) 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](index=55&type=chunk) | 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](index=14&type=section&id=Note%205%3A%20Commitments%20and%20Contingencies) 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](index=57&type=chunk)[156](index=156&type=chunk) - 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](index=59&type=chunk) [Note 6: Noncontrolling Interest](index=15&type=section&id=Note%206%3A%20Noncontrolling%20Interest) 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](index=33&type=chunk)[60](index=60&type=chunk) - 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](index=61&type=chunk) [Note 7: Stockholders' Equity (Deficit)](index=15&type=section&id=Note%207%3A%20Stockholders'%20Equity%20(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](index=64&type=chunk) - 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](index=35&type=chunk)[36](index=36&type=chunk)[66](index=66&type=chunk) - 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](index=131&type=chunk) [Note 8: Related-Party Transactions](index=16&type=section&id=Note%208%3A%20Related-Party%20Transactions) 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](index=71&type=chunk) - 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](index=77&type=chunk) - 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](index=76&type=chunk)[83](index=83&type=chunk) [Note 9: Segment Information](index=17&type=section&id=Note%209%3A%20Segment%20Information) 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](index=79&type=chunk) | 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](index=18&type=section&id=Note%2010%3A%20Income%20Taxes) 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](index=81&type=chunk) - 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](index=81&type=chunk) - 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](index=82&type=chunk) [Note 11: Net Loss per Share](index=18&type=section&id=Note%2011%3A%20Net%20Loss%20per%20Share) 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](index=84&type=chunk) | 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](index=19&type=section&id=Note%2012%3A%20Fair%20Value%20of%20Financial%20Instruments) 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](index=91&type=chunk)[92](index=92&type=chunk) | 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](index=91&type=chunk) [Note 13: Subsequent Events](index=21&type=section&id=Note%2013%3A%20Subsequent%20Events) 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](index=93&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's analysis of financial condition, operating results, clinical program developments, liquidity, and going concern status [Company Overview](index=22&type=section&id=Company%20Overview) 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](index=95&type=chunk) - 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](index=95&type=chunk) [Recent Developments](index=22&type=section&id=Recent%20Developments) 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](index=96&type=chunk) - Michael Tung, M.D., MBA, was appointed Executive Vice President and Chief Financial Officer in May 2025[96](index=96&type=chunk) - 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](index=97&type=chunk) [Our Type 1 Diabetes Program – Cadisegliatin (TTP399)](index=23&type=section&id=Our%20Type%201%20Diabetes%20Program%20%E2%80%93%20Cadisegliatin%20(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](index=99&type=chunk) - 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](index=100&type=chunk) - 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](index=100&type=chunk) [Holding Company Structure](index=24&type=section&id=Holding%20Company%20Structure) 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](index=103&type=chunk) [Financial Overview](index=24&type=section&id=Financial%20Overview) 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](index=104&type=chunk) - Significant research and development expenses are expected to continue as the company advances cadisegliatin and other drug candidates, subject to additional funding[106](index=106&type=chunk)[108](index=108&type=chunk) - General and administrative expenses consist mainly of salaries, benefits, accounting, legal, patent, and occupancy costs[111](index=111&type=chunk) [Results of Operations](index=26&type=section&id=Results%20of%20Operations) 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](index=26&type=section&id=Comparison%20of%20the%20three%20months%20ended%20June%2030%2C%202025%20and%202024) 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](index=117&type=chunk) - 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](index=118&type=chunk) [Comparison of the six months ended June 30, 2025 and 2024](index=27&type=section&id=Comparison%20of%20the%20six%20months%20ended%20June%2030%2C%202025%20and%202024) 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](index=122&type=chunk) - 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](index=123&type=chunk) - 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](index=124&type=chunk) [Liquidity and Capital Resources](index=27&type=section&id=Liquidity%20and%20Capital%20Resources) 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](index=127&type=chunk)[128](index=128&type=chunk) - These conditions raise substantial doubt about the company's ability to continue as a going concern, necessitating additional capital[130](index=130&type=chunk) - The company is evaluating various financing strategies, including direct equity investments and potential licensing/monetization of other programs, to increase cash reserves[130](index=130&type=chunk) - 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](index=131&type=chunk) [Off-Balance Sheet Arrangements](index=30&type=section&id=Off-Balance%20Sheet%20Arrangements) 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](index=143&type=chunk) [Discussion of Critical Accounting Policies and Estimates](index=30&type=section&id=Discussion%20of%20Critical%20Accounting%20Policies%20and%20Estimates) 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](index=144&type=chunk) [Forward-Looking Statements](index=30&type=section&id=Forward-Looking%20Statements) 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](index=94&type=chunk)[145](index=145&type=chunk) - The company disclaims any obligation to update or revise these forward-looking statements, which are made only as of the report date[146](index=146&type=chunk) [Effect of Recent Accounting Pronouncements](index=30&type=section&id=Effect%20of%20Recent%20Accounting%20Pronouncements) 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](index=147&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) 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](index=148&type=chunk) - 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](index=149&type=chunk) - The company does not have any material foreign currency exposure[150](index=150&type=chunk) [Item 4. Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) 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](index=151&type=chunk) - 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](index=154&type=chunk) - The company maintains a corporate governance program and makes SEC filings and corporate governance materials available on its investor relations website[155](index=155&type=chunk) 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](index=31&type=section&id=Item%201.%20Legal%20Proceedings) 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](index=156&type=chunk) [Item 1A. Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) 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](index=157&type=chunk) - Material changes to risk factors were disclosed in the Quarterly Report on Form 10-Q for the quarter ended March 31, 2025[157](index=157&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=31&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) 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](index=158&type=chunk) [Item 3. Defaults Upon Senior Securities](index=33&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section indicates that there were no defaults upon senior securities - There were no defaults upon senior securities[159](index=159&type=chunk) [Item 4. Mine Safety Disclosures](index=33&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section confirms that there are no mine safety disclosures to report - There are no mine safety disclosures to report[160](index=160&type=chunk) [Item 5. Other Information](index=33&type=section&id=Item%205.%20Other%20Information) 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](index=161&type=chunk) [Item 6. Exhibits](index=33&type=section&id=Item%206.%20Exhibits) 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](index=161&type=chunk) - Inline XBRL Instance Document and Taxonomy Extension files are included as exhibits[161](index=161&type=chunk) [SIGNATURES](index=34&type=section&id=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](index=164&type=chunk)
vTv Therapeutics(VTVT) - 2025 Q2 - Quarterly Results
2025-08-12 20:05
[Executive Summary & Corporate Update](index=1&type=section&id=Executive%20Summary%20%26%20Corporate%20Update) vTv Therapeutics presents its Q2 2025 financial results and corporate updates, highlighting the progression of cadisegliatin into Phase 3 trials for Type 1 Diabetes [Introduction and CEO Commentary](index=1&type=section&id=Introduction%20and%20CEO%20Commentary) vTv Therapeutics reported Q2 2025 financial results and provided a corporate update, highlighting the advancement of cadisegliatin into Phase 3 trials for Type 1 Diabetes, which the CEO believes addresses a significant unmet medical need - vTv Therapeutics is a late-stage biopharmaceutical company focused on the development of cadisegliatin, a potential first-in-class oral adjunctive therapy to insulin for the treatment of type 1 diabetes (T1D)[2](index=2&type=chunk) - The first participant was randomized in the CATT1 Phase 3 trial for cadisegliatin, reflecting continued momentum in its advancement[3](index=3&type=chunk) - Cadisegliatin is designed to selectively activate glucokinase in the liver, aiming to improve glycemic control and reduce hypoglycemia risk when used alongside insulin[3](index=3&type=chunk) [Recent Company Highlights](index=1&type=section&id=Recent%20Company%20Highlights) Key recent developments include the initiation of the Phase 3 CATT1 trial for cadisegliatin, expansion of its intellectual property portfolio, participation in a corporate presentation, and the appointment of a new Chief Financial Officer - First study participant randomized in Phase 3 CATT1 trial evaluating cadisegliatin for T1D in August 2025, with topline data expected in the second half of 2026[5](index=5&type=chunk)[6](index=6&type=chunk) - Patent allowance for a crystalline salt form of cadisegliatin, extending the patent term through 2041[5](index=5&type=chunk)[6](index=6&type=chunk) - Michael Tung, MD, MBA, was appointed as Chief Financial Officer in May 2025, bringing over 20 years of financial management and strategic leadership experience[6](index=6&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) This section details vTv Therapeutics' financial performance for Q2 2025, including cash position, R&D and G&A expenses, net loss, and condensed consolidated balance sheets and statements of operations [Financial Summary](index=2&type=section&id=Financial%20Summary) vTv Therapeutics reported a decrease in cash position, an increase in R&D expenses due to payroll, a slight decrease in G&A expenses, and an increased net loss for Q2 2025 compared to Q2 2024 Cash Position | Metric | June 30, 2025 (in millions) | December 31, 2024 (in millions) | | :----- | :-------------------------- | :------------------------------ | | Cash | $25.9 | $36.7 | Research & Development (R&D) Expenses (Three Months Ended June 30) | Metric | 2025 (in millions) | 2024 (in millions) | | :----- | :----------------- | :----------------- | | R&D Expenses | $4.1 | $3.4 | General & Administrative (G&A) Expenses (Three Months Ended June 30) | Metric | 2025 (in millions) | 2024 (in millions) | | :----- | :----------------- | :----------------- | | G&A Expenses | $3.6 | $3.7 | Net Loss Attributable to vTv Shareholders (Three Months Ended June 30) | Metric | 2025 (in millions) | 2024 (in millions) | | :----- | :----------------- | :----------------- | | Net Loss | $6.0 | $5.2 | | Basic EPS | $0.92 | $0.81 | [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet shows a decrease in total assets from $38.266 million at December 31, 2024, to $26.448 million at June 30, 2025, primarily driven by a reduction in cash and cash equivalents. Total stockholders' equity also significantly decreased Key Balance Sheet Figures | Metric | June 30, 2025 (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 liabilities | $24,043 | $23,965 | | Total stockholders' equity | $2,405 | $14,301 | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended June 30, 2025, vTv Therapeutics reported no revenue, an operating loss of $7.721 million, and a net loss attributable to shareholders of $6.046 million, an increase from the prior year. The six-month period also showed an increased net loss Statements of Operations (Three Months Ended June 30) | Metric | 2025 (in thousands) | 2024 (in thousands) | | :-------------------------------------------------- | :------------------ | :------------------ | | Revenue | $— | $— | | Research and development | $4,103 | $3,439 | | General and administrative | $3,618 | $3,716 | | Total operating expenses | $7,721 | $7,155 | | Operating loss | $(7,721) | $(7,155) | | Net loss attributable to vTv Therapeutics Inc. | $(6,046) | $(5,180) | | Net loss per share (basic and diluted, in dollars) | $(0.92) | $(0.81) | Statements of Operations (Six Months Ended June 30) | Metric | 2025 (in thousands) | 2024 (in thousands) | | :-------------------------------------------------- | :------------------ | :------------------ | | Revenue | $— | $1,000 | | Research and development | $6,933 | $6,088 | | General and administrative | $7,291 | $7,694 | | Total operating expenses | $14,224 | $13,782 | | Operating loss | $(14,224) | $(12,782) | | Net loss attributable to vTv Therapeutics Inc. | $(11,138) | $(10,045) | | Net loss per share (basic and diluted, in dollars) | $(1.69) | $(1.97) | [Company and Product Information](index=4&type=section&id=Company%20and%20Product%20Information) This section provides an overview of cadisegliatin as a potential first-in-class treatment for Type 1 Diabetes and details vTv Therapeutics' focus as a late-stage biopharmaceutical company [About Cadisegliatin](index=4&type=section&id=About%20Cadisegliatin) Cadisegliatin (TTP399) is an investigational oral, small molecule, liver-selective glucokinase activator being developed as a potential first-in-class adjunctive treatment for Type 1 Diabetes, aiming to improve glycemic control through hepatic glucose uptake and glycogen storage - Cadisegliatin (TTP399) is a novel, oral small molecule, liver-selective glucokinase activator[12](index=12&type=chunk) - It is being investigated as a potential first-in-class oral adjunctive treatment for type 1 diabetes (T1D)[12](index=12&type=chunk) - Non-clinical studies suggest cadisegliatin, acting selectively on the liver, increases glucokinase activity independently from insulin, supporting improved glycemic control through hepatic glucose uptake and glycogen storage[12](index=12&type=chunk) [About vTv Therapeutics](index=4&type=section&id=About%20vTv%20Therapeutics) vTv Therapeutics is a late-stage biopharmaceutical company focused on developing oral, small molecule drug candidates for diabetes and other chronic diseases, with cadisegliatin for Type 1 Diabetes leading its clinical pipeline - vTv Therapeutics is a late-stage biopharmaceutical company[14](index=14&type=chunk) - The company focuses on developing oral, small molecule drug candidates intended to help treat people living with diabetes and other chronic diseases[14](index=14&type=chunk) - vTv's clinical pipeline is led by cadisegliatin, currently in a Phase 3 trial for the treatment of type 1 diabetes[14](index=14&type=chunk) [Additional Information](index=4&type=section&id=Additional%20Information) This section contains important cautionary statements regarding forward-looking information and provides essential contact details for investor relations and media inquiries [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This section contains cautionary statements regarding forward-looking information, emphasizing that actual results may differ materially due to known and unknown risks and uncertainties, and the company undertakes no obligation to update these statements - The release contains forward-looking statements, identifiable by terms such as 'anticipate,' 'believe,' 'could,' 'expect,' 'intend,' 'may,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'will,' 'would'[15](index=15&type=chunk) - These statements involve known and unknown risks, uncertainties, and other important factors that may cause actual results, performance, or achievements to be materially different from those expressed or implied[15](index=15&type=chunk) - The company undertakes no obligation to update or review publicly any forward-looking statements, whether as a result of new information, future events, or otherwise, after the date of the release, except as required by law[16](index=16&type=chunk) [Investor and Media Contacts](index=6&type=section&id=Investor%20and%20Media%20Contacts) Contact information for investor relations (John Fraunces, LifeSci Advisors, LLC) and media inquiries (Caren Begun, TellMed Strategies) is provided - Investor Contact: John Fraunces, LifeSci Advisors, LLC, 917-355-2395, jfraunces@lifesciadvisors.com[17](index=17&type=chunk) - Media Contact: Caren Begun, TellMed Strategies, 201-396-8551, caren.begun@tmstrat.com[17](index=17&type=chunk)
vTv Therapeutics Announces USPTO Allowance of Patent Covering Cadisegliatin
Globenewswire· 2025-08-11 12:00
Core Viewpoint - vTv Therapeutics Inc. has received a Notice of Allowance from the USPTO for a patent application related to cadisegliatin, which strengthens the protection of this potential first-in-class oral adjunctive therapy for type 1 diabetes [1][2] Company Overview - vTv Therapeutics is a late-stage biopharmaceutical company focused on developing oral, small molecule drug candidates for diabetes and other chronic diseases [4] - The company's lead asset, cadisegliatin, is currently in a Phase 3 trial and has been granted Breakthrough Therapy designation by the FDA [2][4] Product Details - Cadisegliatin (TTP399) is a liver-selective glucokinase activator being investigated as a potential first-in-class oral adjunctive treatment for type 1 diabetes [2] - In non-clinical studies, cadisegliatin has shown the ability to increase glucokinase activity independently from insulin, which may improve glycemic control [2] Patent Information - The patent term for the compositions of matter related to cadisegliatin runs through 2041, providing long-term protection for the innovation [1][2]
vTv Therapeutics Announces First Study Participant Randomized in CATT1 Phase 3 Trial of Cadisegliatin in Type 1 Diabetes
Globenewswire· 2025-08-07 12:00
Core Insights - vTv Therapeutics Inc. has initiated the CATT1 Phase 3 trial for cadisegliatin, an oral glucokinase activator for type 1 diabetes, with topline results expected in the second half of 2026 [1][2] - The trial aims to enroll approximately 150 participants across 25 sites in the U.S., evaluating the efficacy and safety of cadisegliatin compared to placebo [2][4] - Cadisegliatin has received Breakthrough Therapy designation from the FDA and has shown good tolerability in over 500 subjects [1][2] Company Overview - vTv Therapeutics is a late-stage biopharmaceutical company focused on developing oral small molecule drug candidates for diabetes and other chronic diseases [6] - The company's lead program, cadisegliatin, is being investigated as a potential first-in-class oral adjunctive treatment for type 1 diabetes [6] Industry Context - There is a significant unmet need for therapeutic advances in type 1 diabetes, as current medical devices have not been complemented by effective oral adjunct therapies [2][3] - The introduction of glucokinase activators like cadisegliatin could potentially improve glycemic control while reducing the risks of hypoglycemia and diabetic ketoacidosis [3][4]
vTv Therapeutics to Participate in the H.C. Wainwright “HCW@Home” Series
Globenewswire· 2025-06-11 12:00
Company Overview - vTv Therapeutics Inc. is a clinical stage biopharmaceutical company focused on developing cadisegliatin, a potential first-in-class oral adjunctive therapy to insulin for treating type 1 diabetes (T1D) [1][3] - The company is in the late stages of developing oral, small molecule drug candidates aimed at treating diabetes and other chronic diseases [3] Upcoming Event - vTv Therapeutics management will participate in the H.C. Wainwright "HCW@Home" Series on June 12, 2025, at 10:00 AM ET [1][2] - The event will be a fireside chat moderated by Emily Bodnar, Director at H.C. Wainwright [2] Clinical Development - Cadisegliatin is currently in a Phase 3 trial, being investigated as a potential oral glucokinase activator for type 1 diabetes [3] - The company is exploring multiple molecules for various indications related to chronic diseases [3]
vTv Therapeutics Appoints Michael Tung, M.D., MBA, to Chief Financial Officer as Company Reinitiates Phase 3 Trial of Oral T1D Adjunctive Therapy to Insulin
Globenewswire· 2025-05-19 13:00
Core Viewpoint - vTv Therapeutics Inc. has appointed Dr. Michael Tung as Executive Vice President and Chief Financial Officer, which is a strategic move as the company reinitiates its CATT1 Phase 3 trial for cadisegliatin, a potential treatment for type 1 diabetes [1][2] Company Overview - vTv Therapeutics Inc. is a late-stage biopharmaceutical company focused on developing oral small molecule drug candidates for diabetes and other chronic diseases [3] - The company's clinical pipeline is led by cadisegliatin, currently in a Phase 3 trial, which is being investigated as a potential first-in-class oral glucokinase activator for type 1 diabetes [3][4] Appointment of Dr. Michael Tung - Dr. Tung brings over 20 years of experience in finance, corporate strategy, investor relations, and business development within the biopharmaceutical industry [2] - His previous roles include Chief Financial Officer at AdvanCell Pty Limited and senior positions at FibroGen Inc. and Aclaris Therapeutics [2] - Dr. Tung holds degrees in economics and biology from The George Washington University and an M.D./M.B.A. from Tufts University School of Medicine [2] Cadisegliatin Details - Cadisegliatin (TTP399) is a novel oral small molecule that selectively activates glucokinase in the liver, aimed at improving glycemic control in type 1 diabetes [4] - Non-clinical studies indicate that cadisegliatin increases glucokinase activity independently from insulin, supporting its clinical investigation [4]
vTv Therapeutics(VTVT) - 2025 Q1 - Quarterly Results
2025-05-15 20:11
[vTv Therapeutics Announces 2025 First Quarter Financial Results and Provides Corporate Update](index=1&type=section&id=vTv%20Therapeutics%20Announces%202025%20First%20Quarter%20Financial%20Results%20and%20Provides%20Corporate%20Update) [Recent Company Highlights](index=1&type=section&id=Recent%20Company%20Highlights) vTv Therapeutics reinitiated screening for its CATT1 Phase 3 trial of cadisegliatin for Type 1 Diabetes and amended the protocol to shorten the study duration, aiming for topline data in 2H 2026 - Screening has been reinitiated in the Company's CATT1 Phase 3 trial evaluating cadisegliatin for type 1 diabetes (T1D), with topline data expected in the **second half of 2026**[1](index=1&type=chunk)[3](index=3&type=chunk)[5](index=5&type=chunk) - A protocol amendment for the CATT1 Phase 3 trial reduced the overall study duration from **12 to 6 months**, expediting time to topline data without impacting key endpoints, and will now provide continuous glucose monitors (CGM) to participants[3](index=3&type=chunk)[5](index=5&type=chunk) [First Quarter 2025 Financial Results Overview](index=1&type=section&id=First%20Quarter%202025%20Financial%20Results) The company reported a decrease in cash position, a slight increase in R&D expenses, a decrease in G&A expenses, and a net loss of $5.1 million for Q1 2025 Cash Position (in millions) | Metric | March 31, 2025 | December 31, 2024 | | :----- | :------------- | :---------------- | | Cash | $31.1 million | $36.7 million | Key Expenses (in millions) | Expense Type | Q1 2025 | Q1 2024 | Change (YoY) | | :----------- | :------ | :------ | :----------- | | R&D Expenses | $2.8 million | $2.6 million | +$0.2 million | | G&A Expenses | $3.7 million | $4.0 million | -$0.3 million | - The increase in R&D expenses reflects higher indirect costs and other project-related expenses, partially offset by lower spending on cadisegliatin and other projects[5](index=5&type=chunk) - The decrease in G&A expenses was primarily due to decreases in payroll costs, legal expense, and other operating costs, partially offset by an increase in share-based expense[5](index=5&type=chunk)[6](index=6&type=chunk) Net Loss and EPS (in millions, except per share data) | Metric | Q1 2025 | Q1 2024 | | :----- | :------ | :------ | | Net Loss | $5.1 million | $4.9 million | | EPS (basic) | $(0.77) | $(1.17) | [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets decreased to $32.0 million from $38.3 million at December 31, 2024, primarily driven by a reduction in cash and cash equivalents. Total liabilities also decreased, while total stockholders' equity saw a reduction Condensed Consolidated Balance Sheets Highlights (in thousands) | Metric | March 31, 2025 (Unaudited) | December 31, 2024 | | :-------------------------------- | :------------------------- | :---------------- | | Cash and cash equivalents | $31,059 | $36,746 | | Total current assets | $31,916 | $38,113 | | Total assets | $32,027 | $38,266 | | Total current liabilities | $4,316 | $5,196 | | Total liabilities | $23,130 | $23,965 | | Total stockholders' equity | $8,897 | $14,301 | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended March 31, 2025, the company reported no revenue, an operating loss of $6.5 million, and a net loss attributable to vTv Therapeutics Inc. of $5.1 million, or $(0.77) per basic and diluted share Condensed Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------------------------------------ | :-------------------------------- | :-------------------------------- | | Revenue | $0 | $1,000 | | Research and development expenses | $2,830 | $2,649 | | General and administrative expenses | $3,673 | $3,978 | | Total operating expenses | $6,503 | $6,627 | | Operating loss | $(6,503) | $(5,627) | | Net loss attributable to vTv Therapeutics Inc. | $(5,092) | $(4,865) | | Net loss per share (basic and diluted) | $(0.77) | $(1.17) | | Weighted average shares outstanding | 6,582,844 | 4,141,492 | [About Cadisegliatin](index=4&type=section&id=About%20Cadisegliatin) Cadisegliatin (TTP399) is a novel, oral, liver-selective glucokinase activator being investigated as a potential first-in-class oral adjunctive treatment to insulin for type 1 diabetes (T1D), aiming to improve glycemic control - Cadisegliatin (TTP399) is a novel, oral small molecule, liver selective glucokinase activator[12](index=12&type=chunk) - It is being investigated as a potential first-in-class oral adjunctive treatment to insulin for type 1 diabetes (T1D)[12](index=12&type=chunk) - Nonclinical studies showed cadisegliatin increased glucokinase activity independently from insulin, supporting improved glycemic control through hepatic glucose uptake and glycogen storage[12](index=12&type=chunk) [About vTv Therapeutics](index=4&type=section&id=About%20vTv%20Therapeutics) vTv Therapeutics Inc. is a late-stage biopharmaceutical company focused on developing novel oral, small molecule drug candidates for chronic diseases, with cadisegliatin for T1D as its lead clinical pipeline asset - vTv Therapeutics Inc. is a late-stage biopharmaceutical company[14](index=14&type=chunk) - The company focuses on developing novel oral, small molecule drug candidates intended to help treat millions with chronic diseases[14](index=14&type=chunk) - Cadisegliatin, a potential first-in-class oral adjunctive therapy to insulin for type 1 diabetes, leads vTv's clinical pipeline[14](index=14&type=chunk) [Forward-Looking Statement](index=4&type=section&id=Forward-Looking%20Statement) The release contains forward-looking statements subject to risks and uncertainties, including those described in SEC filings, and the company undertakes no obligation to update them - This release contains forward-looking statements, identifiable by specific terminology, which involve risks and uncertainties[15](index=15&type=chunk) - Important factors, including those described in the company's Annual Report on Form 10-K and other SEC filings, could cause actual results to differ materially from expectations[15](index=15&type=chunk)[16](index=16&type=chunk) - The company undertakes no obligation to update or review publicly any forward-looking statements, except as required by law[16](index=16&type=chunk) [Investor and Media Contact](index=6&type=section&id=Investor%20Contact) Contact information for investor relations and media inquiries is provided - Investor Contact: Sandya von der Weid, LifeSci Advisors, LLC, svonderweid@lifesciadvisors.com[17](index=17&type=chunk) - Media Contact: Caren Begun, TellMed Strategies, 201-396-8551, caren.begun@tmstrat.com[17](index=17&type=chunk)
vTv Therapeutics(VTVT) - 2025 Q1 - Quarterly Report
2025-05-15 20:07
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ____________________________ FORM 10-Q _____________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 Or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37524 _____________________________ vTv Therapeuti ...
vTv Therapeutics Announces 2025 First Quarter Financial Results and Provides Corporate Update
Globenewswire· 2025-05-15 20:01
Core Insights - vTv Therapeutics is advancing its cadisegliatin program, which is being evaluated as a potential first-in-class oral adjunct therapy for type 1 diabetes (T1D) [2][3] - The company has reinitiated screening in its Phase 3 CATT1 trial and expects topline data in the second half of 2026 following a protocol amendment that shortens the trial duration from 12 to 6 months [3][6] Company Developments - Financial results for Q1 2025 show a net loss of $5.1 million, or $0.77 per share, compared to a net loss of $4.9 million, or $1.17 per share, in Q1 2024 [6][9] - The cash position as of March 31, 2025, was $31.1 million, down from $36.7 million as of December 31, 2024 [6][7] - Research and Development (R&D) expenses increased to $2.8 million in Q1 2025 from $2.6 million in Q1 2024, reflecting higher indirect costs [6][9] - General and Administrative (G&A) expenses decreased to $3.7 million in Q1 2025 from $4.0 million in Q1 2024, primarily due to lower payroll and legal expenses [6][9] Financial Overview - Total operating expenses for Q1 2025 were $6.5 million, slightly down from $6.6 million in Q1 2024 [9] - The company reported no revenue for Q1 2025, compared to $1 million in Q1 2024 [9] - Total assets as of March 31, 2025, were $32.0 million, down from $38.3 million as of December 31, 2024 [7][8] Product Information - Cadisegliatin (TTP399) is a novel oral small molecule being investigated for its potential to improve glycemic control in T1D patients by selectively activating glucokinase in the liver [10][12]
vTv Therapeutics Announces Reinitiation of Screening in CATT1 Phase 3 Trial Evaluating Potential First-in-Class Liver-Selective Glucokinase Activator Cadisegliatin for Type 1 Diabetes
Globenewswire· 2025-05-15 16:00
Core Viewpoint - vTv Therapeutics has resumed its CATT1 Phase 3 trial for cadisegliatin, an oral treatment for type 1 diabetes, with topline data expected in the second half of 2026 [2][3]. Group 1: Trial Details - The CATT1 Phase 3 trial duration has been shortened from 12 months to 6 months through a protocol amendment, expediting the timeline for topline data without affecting key study endpoints [3][4]. - The trial will enroll approximately 150 patients aged 18 and older at 20-25 sites in the U.S., comparing two doses of cadisegliatin against a placebo [4]. - Continuous glucose monitors will be provided to all participants to assess the primary efficacy endpoint, which focuses on the incidence of level 2 and level 3 hypoglycemic events [3][4]. Group 2: Product Information - Cadisegliatin (TTP399) is a novel, liver-selective glucokinase activator being investigated as a potential first-in-class oral adjunctive treatment for type 1 diabetes [5]. - Non-clinical studies indicate that cadisegliatin enhances glucokinase activity independently of insulin, suggesting potential improvements in glycemic control [5]. Group 3: Company Overview - vTv Therapeutics Inc. is a late-stage biopharmaceutical company focused on developing oral, small molecule drug candidates, with cadisegliatin as its lead program for type 1 diabetes [7].