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vTv Therapeutics Inc. (5VT.F)

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1.7200+0.0100 (+0.58%)
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Neutralpattern detected
Previous Close1.7100
Open1.7200
Bid0.0000 x 120000
Ask0.0000 x 120000
Day's Range1.7200 - 1.7200
52 Week Range1.2300 - 3.7000
Volume1,000
Avg. Volume123
Market Cap124.295M
Beta (5Y Monthly)-1.99
PE Ratio (TTM)N/A
EPS (TTM)-0.4330
Earnings DateN/A
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target EstN/A
  • GlobeNewswire

    vTv Therapeutics to Present Additional Positive Clinical Study Results from Phase 2 Simplici-T1 Study of TTP399 as Adjunctive Therapy for Patients with Type 1 Diabetes at EASD Virtual Meeting

    Potential First-in-Class, Liver-Selective Glucokinase ActivatorHIGH POINT, N.C., Sept. 16, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT) today announced it will deliver two oral presentations emphasizing the potential of TTP399 as an oral adjunctive therapy in type 1 diabetes at the 56th Annual Meeting of the European Association for the Study of Diabetes, held virtually September 21-25, 2020. In June 2020 at the American Diabetes Association’s 80th Virtual Scientific Sessions, the Company presented positive clinical data from the Phase 2 Simplici-T1 Study confirming that treatment with TTP399 resulted in significant improvements in HbA1c, with reduction in bolus insulin dose, without increasing the risk of hypoglycemia or diabetic ketoacidosis (DKA).Details of the EASD virtual presentations follow:Oral Presentation Title: “The Simplici-T1 Trial: Activation of Glucokinase by TTP399 Improves Glycaemic Control in Patients with Type 1 Diabetes” Presentation Number: 50 Category: OP 09 Novel Agents in Type 1 Diabetes Date and Time: Tuesday, September 22, 2020, 8:45 AM - 9:00 AM ETOral Presentation Title: “Mechanism Matter: Preliminary Evidence That Activation of Glucokinase by TTP399 Does Not Increase Plasma or Urine Ketones in Type 1 Diabetes” Presentation Number: 51 Category: OP 09 Novel Agents in Type 1 Diabetes Date and Time: Tuesday, September 22, 2020, 9:00 AM - 9:15 AM ETAbout the Simplici-T1 Study Simplici-T1 was a multi-center, randomized, double-blind, adaptive study assessing the safety and efficacy of TTP399 as an adjunct to insulin therapy in adults with T1D. The primary endpoint was the change in HbA1c at week 12. The study was conducted with support from JDRF, the leading global organization funding research in type 1 diabetes.This Phase 2 learn-and-confirm study was conducted in two parts under a treat-to-target protocol to evaluate the safety and efficacy of TTP399 in T1D patients over 12 weeks of daily dosing following a multi-week insulin optimization and placebo run-in period. Part 1 enrolled 19 patients on both insulin pumps and CGMs. The positive topline results from the learning phase - Part 1 were reported in June 2019. The confirming phase, Part 2, enrolled 85 patients that used either insulin pumps or multiple daily injections of insulin; CGMs were allowed for those patients using the devices for at least three months prior to the start of the study.About Type 1 Diabetes Type 1 diabetes is an autoimmune disease in which a person’s pancreas stops producing insulin, a hormone that enables people to get energy from food. It occurs when the body’s immune system attacks and destroys the insulin-producing cells in the pancreas, called beta cells. While its causes are not yet entirely understood, scientists believe that both genetic factors and environmental triggers are involved. Its onset has nothing to do with diet or lifestyle. There is nothing you can do to prevent T1D, and—at present—nothing you can do to cure it.About vTv Therapeutics vTv Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing oral small molecule drug candidates. vTv has a pipeline of clinical drug candidates led by programs for the treatment of type 1 diabetes, Alzheimer’s disease, and inflammatory disorders. vTv’s development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease (COPD), and genetic mitochondrial diseases. For more information, please visit www.vtvtherapeutics.com or follow us on Twitter: @vTvTherapeutics.Forward-Looking Statements This release contains forward-looking statements, which involve risks and uncertainties. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and, in each case, their negative or other various or comparable terminology. All statements other than statements of historical facts contained in this release, including statements regarding the timing of our clinical trials, our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause our results to vary from expectations include those described under the heading “Risk Factors” in our Annual Report on Form 10-K and our other filings with the SEC. These forward-looking statements reflect our views with respect to future events as of the date of this release and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements represent our estimates and assumptions only as of the date of this release and, except as required by law, we undertake 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 this release. We anticipate that subsequent events and developments will cause our views to change. Our forward-looking statements do not reflect the potential impact of any future acquisitions, merger, dispositions, joint ventures or investments we may undertake. We qualify all of our forward-looking statements by these cautionary statements.Contact Investors: Corey Davis LifeSci Advisors CDavis@LifeSciAdvisors.com

  • GlobeNewswire

    vTv Therapeutics Announces Appointment of Edward P. Taibi to its Board of Directors

    HIGH POINT, N.C., Sept. 15, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT) announced the appointment of Edward P. Taibi, Executive Vice President of MacAndrews & Forbes Incorporated (“MacAndrews”), to the vTv Board of Directors. Effective August 31, 2020, Mr. Taibi will serve a term through the date of the next annual meeting of the Company’s stockholders. “Ed will add significant value as a vTv board member and will be a tremendous asset in helping to drive our near-and long-term goals,” said Steve Holcombe, CEO of vTv Therapeutics. “As a member of the senior leadership team at MacAndrews, we look forward to leveraging his keen insights and future contributions.”Mr. Taibi has gained extensive business leadership experience over the course of his sixteen-year tenure at MacAndrews, advising on transformative business development opportunities, as well as large and complex capital markets and financing transactions.  Prior to joining MacAndrews, Mr. Taibi served as a lawyer in the Mergers and Acquisitions group at Skadden, Arps, Slate, Meagher & Flom LLP.“I am honored to join vTv Therapeutics’ Board of Directors,” said Edward P. Taibi. “I look forward to collaborating with vTv’s management team as we progress the development of the company’s pipeline of innovative clinical drug candidates that have the potential to significantly improve the lives of patients suffering with type 1 diabetes and Alzheimer’s disease.”MacAndrews is a holding company with a portfolio of public and private companies in diverse industries.  MacAndrews has been a significant investor in vTv and its predecessor companies for more than 20 years.  About vTv Therapeutics vTv Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing oral small molecule drug candidates. vTv has a pipeline of clinical drug candidates led by programs for adjunctive treatment for type 1 diabetes, Alzheimer’s disease, and inflammatory disorders. vTv’s development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease (COPD), and genetic mitochondrial diseases. For more information, please visit www.vtvtherapeutics.com or follow us on Twitter: @vTvTherapeutics.Forward-Looking Statements This release contains forward-looking statements, which involve risks and uncertainties. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and, in each case, their negative or other various or comparable terminology. All statements other than statements of historical facts contained in this release, including statements regarding the timing of our clinical trials, our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause our results to vary from expectations include those described under the heading “Risk Factors” in our Annual Report on Form 10-K and our other filings with the SEC. These forward-looking statements reflect our views with respect to future events as of the date of this release and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements represent our estimates and assumptions only as of the date of this release and, except as required by law, we undertake 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 this release. We anticipate that subsequent events and developments will cause our views to change. Our forward-looking statements do not reflect the potential impact of any future acquisitions, merger, dispositions, joint ventures or investments we may undertake. We qualify all of our forward-looking statements by these cautionary statements.Contact Investors: Corey Davis LifeSci Advisors CDavis@LifeSciAdvisors.com

  • GlobeNewswire

    vTv Therapeutics Announces 2020 Second Quarter Financial Results and Update

    HIGH POINT, N.C., Aug. 03, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq:VTVT) today reported financial results for the second quarter ended June 30, 2020, and provided an update on the progress of its clinical programs. “Building on the successful phase 2 study completed earlier this year with TTP399, we have been highly focused on advancing this promising candidate as an adjunct to insulin for type 1 diabetes into the next stage of clinical development,” said Steve Holcombe, president and CEO. “To this end, we have been engaging with the FDA to determine the development path for TTP399 and are in the planning stages for our first pivotal study, which we anticipate commencing by the end of 2020.  We have also continued to enroll patients in our phase 2 study of azeliragon for the treatment of Alzheimer’s disease in patients with type 2 diabetes, despite the clinical challenges posed by COVID-19.”Recent Achievements and OutlookType 1 Diabetes * FDA Engagement and Pivotal Study Planning.  Following a Type C Meeting request, vTv received written feedback from the FDA in June regarding the design of the Company’s proposed pivotal studies.  vTv expects to commence the next study for TTP399 by the end of 2020 with a six-month treatment period and a six-month open label extension.  A second study with a 6-month treatment period would be initiated within 12 months after initiation of the first trial.   * Two Presentations at ADA of Simplici-T1 Study Results.  Dr. John Buse, University of North Carolina at Chapel Hill, and Dr. Carmen Valcarce, chief scientific officer, made separate presentations at the American Diabetes Association’s 80th Scientific Sessions on the results of the Simplici-T1 Study in which TTP399 improved HbA1c in patients with type 1 diabetes, while reducing insulin dose and lowering the incidence of hypoglycemia and diabetic ketoacidosis.Dementia with Diabetes * Enrollment continues for Phase 2 Elevage Study of azeliragon. vTv continues to enroll patients in the Elevage Study to evaluate the efficacy and safety of azeliragon in patients with probable mild Alzheimer's disease (AD) and type 2 diabetes. Recruitment for the study will conclude by September 30, 2020 with a target of approximately 50 patients enrolled. The Company expects to report topline results from this study in the second quarter of 2021.   * Additional Clinical Data from STEADFAST Presented at AAIC. Dr. Aaron Burstein, SVP clinical development, presented additional clinical data at the Alzheimer’s Association International Conference of the impact of azeliragon on the individual components of CDR-sb and ADAS-cog, the two primary instruments used to evaluate Alzheimer’s disease.Financing ActivitiesDuring the second quarter, vTv entered into agreements in order to provide additional financial flexibility and availability of additional capital to fund its near-term operations. * Amendment to the Loan Agreement. On July 29, 2020, vTv entered into the Third Amendment to the Company’s existing Loan Agreement to allow monthly, interest-only payments on the outstanding principal balance for two additional months beginning July 1, 2020 and to extend the maturity date of the first tranche from August 1 to September 1, 2020.  The Third Amendment also eliminates the requirement for the Company to maintain a minimum cash balance.   * ATM Sales. Under the Controlled Equity OfferingSM Sales Agreement with Cantor Fitzgerald, vTv sold shares of its Class A common stock having an aggregate offering price of $7.6 million as of the end of the second quarter.Second Quarter 2020 Financial Results * Cash Position: The Company’s cash position as of June 30, 2020, was $6.4 million compared to $0.4 million as of March 31, 2020.   * Revenue: Revenues were insignificant for both the first and second quarter of 2020.   * R&D Expenses: Research and development expenses were $2.5 million and $4.2 million for the three months ended June 30, 2020 and March 31, 2020, respectively.  This decrease of $1.7 million was driven primarily by a decrease of $0.5 million related to the development of TTP399, as the Simplici-T1 Study was completed in early 2020. Further, costs related to the development of azeliragon decreased approximately $0.8 million related to lower costs incurred for the Elevage Study due to a slowdown in enrollment caused, in part, by COVID-19.   * G&A Expenses: General and administrative expenses were $1.7 million for the second quarter of 2020 and $2.5 million for the first quarter, respectively. The decrease of $0.8 million was driven by lower professional fees, an adjustment made to the Company’s asset retirement obligation recorded in connection with a leased facility, and overall expense curtailment.   * Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $5.0 million for the second quarter of 2020 compared to $7.2 million for the first quarter of 2020.   * Net Loss Per Share: GAAP net loss per share was $0.07 and $0.11 for the three months ended June 30, 2020 and March 31, 2020, respectively, based on weighted-average shares of 45.7 million and 43.5 million for the three-month periods ended June 30, 2020 and March 31, 2020, respectively. Non-GAAP net loss per fully exchanged share was $0.08 and $0.11 for the three months ended June 30, 2020 and March 31, 2020, respectively, based on non-GAAP fully exchanged weighted-average shares of 68.8 million and 66.6 million for the three months ended June 30, 2020 and March 31, 2020, respectively. vTv Therapeutics Inc. Condensed Consolidated Balance Sheets (in thousands) June 30,  March 31   2020  2020   (Unaudited)  (Unaudited)  Assets        Current assets:        Cash and cash equivalents$6,392  $406  Restricted cash and cash equivalents —   2,500  Accounts receivable, net —   5  Prepaid expenses and other current assets 299   591  Current deposits 87   —  Total current assets 6,778   3,502  Property and equipment, net 412   434  Operating lease right-of-use assets 514   529  Long-term investments 2,480   2,480  Long-term deposits 444   444  Total assets$10,628  $7,389  Liabilities, Redeemable Noncontrolling Interest and Stockholders’ Deficit        Current liabilities:        Accounts payable and accrued expenses$6,697  $7,395  Operating lease liabilities 143   136  Current portion of contract liabilities 31   31  Current portion of notes payable 4,543   4,408  Total current liabilities 11,414   11,970  Contract liabilities, net of current portion 1,025   1,025  Operating lease liabilities, net of current portion 756   795  Warrant liability, related party 3,529   2,964  Other liabilities 54   260  Total liabilities 16,778   17,014  Commitments and contingencies        Redeemable noncontrolling interest 63,378   52,196  Stockholders’ deficit:        Class A Common Stock 479   447  Class B Common Stock 232   232  Additional paid-in capital 198,634   190,200  Accumulated deficit (268,873)  (252,700) Total stockholders’ deficit attributable to vTv Therapeutics Inc. (69,528)  (61,821) Total liabilities, redeemable noncontrolling interest and stockholders’ deficit$10,628  $7,389  vTv Therapeutics Inc. Condensed Consolidated Statements of Operations - Unaudited (in thousands, except per share data) Three Months Ended   June 30, 2020  March 31, 2020  Revenue$—  $8  Operating expenses:        Research and development 2,509   4,204  General and administrative 1,695   2,450  Total operating expenses 4,204   6,654  Operating loss (4,204)  (6,646) Interest income —   12  Interest expense (222)  (168) Other (expense) income, net (565)  (363) Loss before income taxes and noncontrolling interest (4,991)  (7,165) Income tax provision —   —  Net loss before noncontrolling interest (4,991)  (7,165) Less:  net loss attributable to noncontrolling interest (1,623)  (2,441) Net loss attributable to vTv Therapeutics Inc.$(3,368) $(4,724) Net loss attributable to vTv Therapeutics Inc. common shareholders$(3,368) $(4,724) Net loss per share of vTv Therapeutics Inc. Class A   Common Stock, basic and diluted$(0.07) $(0.11) Weighted-average number of vTv Therapeutics Inc.   Class A Common Stock, basic and diluted 45,661,221   43,462,551  vTv Therapeutics Inc. Condensed Consolidated Statements of Operations (in thousands, except per share data) Three Months Ended June 30,  For the Six Months Ended June 30,   2020  2019  2020  2019   (Unaudited)  (Unaudited)  Revenue$—  $1,828  $8  $2,749  Operating expenses:                Research and development 2,509   4,228   6,713   7,050  General and administrative 1,695   2,392   4,145   4,778  Total operating expenses 4,204   6,620   10,858   11,828  Operating loss (4,204)  (4,792)  (10,850)  (9,079) Interest income —   16   12   26  Interest expense (222)  (514)  (390)  (1,140) Other (expense) income, net (565)  276   (928)  1,197  Loss before income taxes and noncontrolling interest (4,991)  (5,014)  (12,156)  (8,996) Income tax provision —   100   —   100  Net loss before noncontrolling interest (4,991)  (5,114)  (12,156)  (9,096) Less:  net loss attributable to noncontrolling interest (1,623)  (2,232)  (4,064)  (4,059) Net loss attributable to vTv Therapeutics Inc.$(3,368) $(2,882) $(8,092) $(5,037) Net loss attributable to vTv Therapeutics Inc. common shareholders$(3,368) $(2,882) $(8,092) $(8,765) Net loss per share of vTv Therapeutics Inc. Class A Common   Stock, basic and diluted$(0.07) $(0.10) $(0.18) $(0.34) Weighted-average number of vTv Therapeutics Inc. Class A   Common Stock, basic and diluted 45,661,221   28,037,628   44,561,886   25,464,562  About vTv Therapeutics vTv Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing oral small molecule drug candidates. vTv has a pipeline of clinical drug candidates led by programs for the treatment of type 1 diabetes, Alzheimer’s disease, and inflammatory disorders. vTv’s development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease (COPD), and genetic mitochondrial diseases.Forward-Looking Statements This release contains forward-looking statements, which involve risks and uncertainties. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and, in each case, their negative or other various or comparable terminology. All statements other than statements of historical facts contained in this release, including statements regarding the timing of our clinical trials, our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause our results to vary from expectations include those described under the heading “Risk Factors” in our Annual Report on Form 10-K and our other filings with the SEC. These forward-looking statements reflect our views with respect to future events as of the date of this release and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements represent our estimates and assumptions only as of the date of this release and, except as required by law, we undertake 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 this release. We anticipate that subsequent events and developments will cause our views to change. Our forward-looking statements do not reflect the potential impact of any future acquisitions, merger, dispositions, joint ventures or investments we may undertake. We qualify all of our forward-looking statements by these cautionary statements.Non-GAAP Financial Measures To supplement our consolidated financial statements, which are prepared and presented in accordance with generally accepted accounting principles in the U.S. (“GAAP”), we use non-GAAP adjusted net loss per fully exchanged share, which is a non-GAAP financial measure. Non-GAAP adjusted net loss per fully exchanged share adjusts the net loss attributable to vTv common shareholders for the impact of adjustments related to outstanding warrants, share-based compensation expense and the portion of net loss attributable to the noncontrolling interest. It also assumes the exchange of all the Class B common stock of vTv Therapeutics Inc. and an equal number of non-voting common units of vTv Therapeutics LLC (“vTv Units”) for shares of Class A common stock of vTv Therapeutics Inc. We believe that this measure provides useful information to investors as it eliminates the variability of non-controlling interest resulting from the exchanges of Class B common stock and vTv Units into Class A common stock and other items of a non-cash nature. This measure is not intended to be considered in isolation or as a substitute for, or superior to, financial measures prepared and presented in accordance with GAAP.The following is a reconciliation of non-GAAP adjusted net loss per fully exchanged share, basic and diluted to its most directly comparable GAAP measure, net loss per share of vTv Therapeutics Inc. Class A common stock, basic and diluted and the computation of the components of this non-GAAP measure: Three Months Ended   June 30, 2020  March 31,2020  Numerator:        Net loss attributable to vTv Therapeutics Inc. common shareholders$(3,368) $(4,724) Other income - related party (565)  (363) Share-based compensation expense 186   380  Deemed distribution to related party —   —  Reallocation of net income attributable to noncontrolling   interest from the assumed exchange of Class B shares (1) (1,623)  (2,441) Adjusted net loss before noncontrolling interest$(5,370) $(7,148) Denominator:        Weighted-average number of vTv Therapeutics Inc.   Class A Common Stock, basic and diluted 45,661,221   43,462,551  Assumed exchange of Class B Common Stock (1) 23,094,221   23,094,221  Adjusted proforma fully exchanged weighted-average   shares of Class A common stock outstanding,   basic and diluted 68,755,442   66,556,772  Adjusted net loss per fully exchanged share,   basic and diluted$(0.08) $(0.11)  Three Months Ended June 30,  Six Months Ended June 30,   2020  2019  2020  2019  Numerator:                Net loss attributable to vTv Therapeutics Inc. common shareholders$(3,368) $(2,882) $(8,092) $(8,765) Other income - related party (565)  275   (928)  1,196  Share-based compensation expense 186   401   566   682  Deemed distribution to related party —   —   —   3,728  Reallocation of net income attributable to noncontrolling   interest from the assumed exchange of Class B shares (1) (1,623)  (2,232)  (4,064)  (4,059) Adjusted net loss before noncontrolling interest$(5,370) $(4,438) $(12,518) $(7,218) Denominator:                Weighted-average number of vTv Therapeutics Inc.   Class A Common Stock, basic and diluted 45,661,221   28,037,628   44,561,886   25,464,562  Assumed exchange of Class B Common Stock (1) 23,094,221   23,094,221   23,094,221   23,094,221  Adjusted proforma fully exchanged weighted-average   shares of Class A common stock outstanding,   basic and diluted 68,755,442   51,131,849   67,656,107   48,558,783  Adjusted net loss per fully exchanged share,   basic and diluted$(0.08) $(0.09) $(0.19) $(0.15) (1) Assumes the exchange of all outstanding Class B common stock, resulting in the elimination of the noncontrolling interest and recognition of the net income attributable to noncontrolling interests. Contacts Investors: Corey Davis LifeSci Advisors CDavis@LifeSciAdvisors.comor Media: Glenn Silver Lazar FINN Partners 646-871-8485 gsilver@lazarpartners.com