VTVT vTv Therapeutics Inc.

1.92
-0.07  -4%
Previous Close 1.99
Open 1.99
52 Week Low 1.44
52 Week High 4.75
Market Cap $159,912,628
Shares 83,287,827
Float 23,541,468
Enterprise Value $158,088,775
Volume 225,542
Av. Daily Volume 1,769,799
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Upcoming Catalysts

Drug Stage Catalyst Date
HPP737
Psoriasis
Phase 1
Phase 1
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TTP399
Type 1 Diabetes
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
Azeliragon
Mild Alzheimer’s disease with type 2 diabetes
Phase 2
Phase 2
Phase 2 top-line data did not meet primary endpoint - December 15, 2020.
Azeliragon - STEADFAST
Mild Alzheimer’s disease
Phase 3
Phase 3
Phase 3 data both Part A (April 9, 2018) and Part B (June 12, 2018) did not meet endpoints.
TTP273 - LOGRA
Type 2 Diabetes
Phase 2
Phase 2
Phase 2 primary endpoint met - December 14, 2016.

Latest News

  1. HIGH POINT, N.C., June 29, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) a clinical-stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes and psoriasis, today announced that it will be presenting data from the clinical development of HPP737 as a treatment for psoriasis in a poster presentation at the 6th World Psoriasis & Psoriatic Arthritis Conference held virtually June 30 – July 3, 2021 in Stockholm, Sweden.

    Poster Details:

    • Poster Title: Pharmacokinetics and Pharmacodynamics of the Phosphodiesterase 4 (PDE4) Inhibitor HPP737 Following Single-dose Oral Administration in Healthy Subjects
    • Presenting author: Aaron Burstein, PharmD
    • ID: 35201
    • Topic: 4. Current and new therapeutic…

    HIGH POINT, N.C., June 29, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) a clinical-stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes and psoriasis, today announced that it will be presenting data from the clinical development of HPP737 as a treatment for psoriasis in a poster presentation at the 6th World Psoriasis & Psoriatic Arthritis Conference held virtually June 30 – July 3, 2021 in Stockholm, Sweden.

    Poster Details:

    • Poster Title: Pharmacokinetics and Pharmacodynamics of the Phosphodiesterase 4 (PDE4) Inhibitor HPP737 Following Single-dose Oral Administration in Healthy Subjects
    • Presenting author: Aaron Burstein, PharmD
    • ID: 35201
    • Topic: 4. Current and new therapeutic modalities

    The poster will be added to vTv's website following the presentation and will be available at: https://vtvtherapeutics.com/pipeline/hpp737/.

    About HPP737

    HPP737 is a novel, potent, orally administered PDE4 inhibitor discovered by vTv Therapeutics. PDE4 is a validated therapeutic target for the treatment of a variety of disorders including psoriasis. In the phase 1 single ascending dose study presented here and a subsequent multiple-ascending dose study, HPP737 was well tolerated, with little or no gastrointestinal adverse events, such as nausea, vomiting or diarrhea, across the range of doses tested. HPP737 has evidence supporting target engagement from an ex vivo LPS stimulation TNF-alpha production assay and has demonstrated very potent activity in the Th17 skin resident immune cell activation (sRICA) assay, in which HPP737 was 10-100 fold more potent than apremilast in inhibiting the generation of cytokines/chemokines, depending upon the analyte. HPP737 is currently being tested in an on-going multiple ascending dose phase 1 study that is expected to complete during the third quarter.

    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 (T1D) and psoriasis. vTv's development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease (COPD), renal disease, and primary mitochondrial myopathy.

    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.

    Contacts

    Investors:

    Corey Davis

    LifeSci Advisors





    or



    Media:

     

    Source: vTv Therapeutics Inc.



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  2. HIGH POINT, N.C. and WESTON, Fla., June 22, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (("vTv", NASDAQ:VTVT) and Cantex Pharmaceuticals, Inc. ("Cantex") today announced that they have entered into a licensing agreement under which Cantex has obtained exclusive worldwide rights to develop and commercialize azeliragon, vTv's novel antagonist of RAGE (the receptor for advanced glycation endproducts).

    Stephen Marcus, M.D., president and chief executive officer of Cantex, stated: "RAGE has been implicated in several serious cancer complications associated with increased mortality and decreased quality of life. Our team has deep expertise and a successful track record in transforming known drugs into innovative products with large clinical…

    HIGH POINT, N.C. and WESTON, Fla., June 22, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (("vTv", NASDAQ:VTVT) and Cantex Pharmaceuticals, Inc. ("Cantex") today announced that they have entered into a licensing agreement under which Cantex has obtained exclusive worldwide rights to develop and commercialize azeliragon, vTv's novel antagonist of RAGE (the receptor for advanced glycation endproducts).

    Stephen Marcus, M.D., president and chief executive officer of Cantex, stated: "RAGE has been implicated in several serious cancer complications associated with increased mortality and decreased quality of life. Our team has deep expertise and a successful track record in transforming known drugs into innovative products with large clinical and commercial potential. As such, the opportunity to develop azeliragon, a phase 2-ready oral medication administered once daily, which has demonstrated a good safety profile in several Alzheimer's disease trials, is an excellent fit for Cantex. We intend to move rapidly to prepare for clinical trials assessing the potential of azeliragon for the treatment of a number of complications associated with cancer."

    "RAGE is a highly attractive target for the treatment of a wide spectrum of disorders," said Steve Holcombe, president and chief executive officer of vTv. "We believe Cantex is the right partner to further the development of azeliragon, which vTv had studied in Alzheimer's disease, in new therapeutic indications. They have deep experience in clinical development and the proven capability of repurposing drug candidates for new indications."

    Under the terms of the agreement, Cantex will be responsible for the development and commercialization of azeliragon and the companies will allocate downstream profits under a tiered arrangement.

    About Azeliragon

    Azeliragon, also known as TTP488, is an orally active, small molecule, antagonist of the receptor for advanced glycation endproducts (RAGE). vTv Therapeutics discovered azeliragon using its proprietary drug discovery platform, TTP Translational Technology®, and developed it into phase 3. A broad range of evidence suggests that RAGE—ligand interactions lead to sustained inflammatory states that play a role in chronic diseases.

    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 and psoriasis. vTv's development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease, renal disease, and primary mitochondrial myopathies. For more information, please visit http://www.vtvtherapeutics.com or follow us on Twitter: @vTvTherapeutics.

    About Cantex Pharmaceuticals

    Cantex Pharmaceuticals, Inc. is a privately-held, clinical stage pharmaceutical company focused on the transformation of known drugs into innovative products with blockbuster potential. Cantex is currently developing novel treatments for cancer and inflammatory lung diseases. With the addition of azeliragon, Cantex's pipeline consists of three product candidates in Phase 2 and Phase 3 development for diseases with significant unmet medical needs: Dicopp® for cancer and inflammatory lung conditions, azeliragon for serious complications of cancer, and DSTAT, licensed to Chimerix, Inc. For more information, please visit www.cantex.com.

    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.

    vTv Contacts

    Investors:

    Corey Davis

    LifeSci Advisors





    or



    Media:

    Cantex Contacts

    Investors:

    Stephen G. Marcus, M.D.

    (954) 315-3660

    or

    Media:

    Barbara Lindheim

    BLL Partners, LLC

    (917) 355-9234



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  3. Awarded Breakthrough Therapy designation for TTP399 for the treatment of type 1 diabetes

    Initiated two phase 1 clinical studies, mechanistic study of TTP399 and multiple ascending dose study of HPP737

    HIGH POINT, N.C., May 05, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) today reported financial results for the first quarter ended March 31, 2021, and provided an update on the progress of its clinical programs.

    "The vTv team continued to build on the clinical success of our type 1 diabetes program during the quarter by obtaining Breakthrough Therapy designation from the FDA for TTP399 and by initiating a phase 1 study to understand TTP399's impact on ketoacidosis. The FDA's grant of Breakthrough is an acknowledgment of the…

    Awarded Breakthrough Therapy designation for TTP399 for the treatment of type 1 diabetes

    Initiated two phase 1 clinical studies, mechanistic study of TTP399 and multiple ascending dose study of HPP737

    HIGH POINT, N.C., May 05, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) today reported financial results for the first quarter ended March 31, 2021, and provided an update on the progress of its clinical programs.

    "The vTv team continued to build on the clinical success of our type 1 diabetes program during the quarter by obtaining Breakthrough Therapy designation from the FDA for TTP399 and by initiating a phase 1 study to understand TTP399's impact on ketoacidosis. The FDA's grant of Breakthrough is an acknowledgment of the significant unmet need for patients with type 1 diabetes, and the encouraging clinical results we have generated to date," said Steve Holcombe, president and CEO, vTv Therapeutics. "We look forward to working closely with the FDA to optimize the development pathway for TTP399 to bring this potential treatment to patients with type 1 diabetes as quickly as possible."

    Recent Achievements and Outlook

    Type 1 Diabetes

    • Breakthrough Therapy Designation. As announced in April, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for TTP399 as an adjunctive therapy to insulin for the treatment of type 1 diabetes. Breakthrough Therapy designation is intended to expedite the development and review of a drug candidate that is planned for the treatment of a serious or life-threatening disease where initial clinical evidence indicates that the drug may demonstrate a substantial improvement over existing therapies on one or more clinically significant endpoints.



    • Mechanistic Study of Ketoacidosis with TTP399. The Company began dosing patients in a mechanistic study of TTP399 in people with type 1 diabetes to determine the impact of TTP399 on ketone body formation during a period of acute insulin withdrawal. vTv expects to report topline results from the mechanistic study in the third quarter of 2021.



    • Pivotal Study Planning. The Company is planning to initiate the first of two pivotal, placebo-controlled, six-month clinical trials of TTP399 in subjects with type 1 diabetes in the fourth quarter of 2021. The current study designs will be shared with the FDA for its input and advice as part of the collaborative process enabled by the Breakthrough Therapy designation.

    Psoriasis

    • Multiple Ascending Dose Study with HPP737. The Company began dosing healthy subjects in a phase 1 multiple ascending dose study to assess the safety, tolerability, and pharmacokinetic profile of HPP737, an oral PDE4 inhibitor. This phase 1 study is expected to report topline results in the third quarter and will inform dose selection for a planned phase 2 study in psoriasis.

    License Partner Updates

    • Reneo Pharmaceuticals Completes Initial Public Offering. We congratulate our licensee, Reneo Pharmaceuticals, Inc. (NASDAQ:RPHM), for successfully completing an initial public offering in April. The Company is party to a license agreement with Reneo for its lead asset REN001, which Reneo is currently developing in three rare genetic diseases: primary mitochondrial myopathies, long-chain fatty acid oxidation disorders, and glycogen storage disease type V (McArdle disease).

    First Quarter 2021 Financial Results

    • Cash Position: The Company's cash position as of March 31, 2021, was $8.4 million compared to $5.7 million as of December 31, 2020.



    • Revenue: Revenue for the first quarter of 2021 was $1.0 million and was $6.4 million for the fourth quarter of 2020. The revenue for the first quarter was non-cash and related to the recognition of revenue pertaining to the Huadong license agreement. The revenue for the fourth quarter was primarily attributable to the upfront consideration, consisting of cash and an equity interest, received in connection with the Company's license agreement with Anteris Bio.



    • R&D Expenses: Research and development expenses were $3.1 million and $2.5 million for the three months ended March 31, 2021 and December 31, 2020, respectively. This increase of $0.6 million was driven primarily by the increase in spending for our study of HPP737 in psoriasis.



    • G&A Expenses: General and administrative expenses were consistent between periods at $2.2 million and $2.0 million for the three months ended March 31, 2021 and December 31, 2020, respectively.



    • Net (Loss)/Income Before Non-Controlling Interest: Net loss before non-controlling interest was $5.9 million for the first quarter of 2021 compared to net income of $1.6 million for the fourth quarter of 2020.



    • Net (Loss)/Income Per Share: Diluted net loss per share was ($0.08) for the three months ended March 31, 2021 compared to a diluted net income per share of $0.02 for the three months ended December 31, 2020, based on weighted-average diluted shares of 56.5 million and 74.4 million for the three-month periods ended March 31, 2021 and December 31, 2020, respectively. Non-GAAP net loss per fully exchanged share was ($0.09) for the three months ended March 31, 2021 compared to a net income per fully exchanged share of $0.02 at December 31, 2020, based on non-GAAP fully exchanged weighted-average shares of 79.6 million and 74.4 million for the three months ended March 31, 2021 and December 31, 2020, respectively.





    vTv Therapeutics Inc.

    Condensed Consolidated Balance Sheets

    (in thousands)

     March 31,  December 30, 
     2021  2020 
     (Unaudited)     
    Assets       
    Current assets:       
    Cash and cash equivalents$8,449  $5,747 
    Accounts receivable, net 2   158 
    Prepaid expenses and other current assets 710   939 
    Current deposits 60   371 
    Total current assets 9,221   7,215 
    Property and equipment, net 344   367 
    Operating lease right-of-use assets 464   482 
    Long-term investments 6,725   6,725 
    Total assets$16,754  $14,789 
    Liabilities, Redeemable Noncontrolling Interest and Stockholders' Deficit       
    Current liabilities:       
    Accounts payable and accrued expenses$4,965  $6,120 
    Operating lease liabilities 162   155 
    Current portion of contract liabilities 35   31 
    Current portion of notes payable    84 
    Total current liabilities 5,162   6,390 
    Contract liabilities, net of current portion 18   1,009 
    Operating lease liabilities, net of current portion 633   676 
    Warrant liability, related party 4,519   2,871 
    Other liabilities 50   50 
    Total liabilities 10,382   10,996 
    Commitments and contingencies       
    Redeemable noncontrolling interest 62,647   83,895 
    Stockholders' deficit:       
    Class A Common Stock 576   541 
    Class B Common Stock 232   232 
    Additional paid-in capital 217,647   209,161 
    Accumulated deficit (274,730)  (290,036)
    Total stockholders' deficit attributable to vTv Therapeutics Inc. (56,275)  (80,102)
    Total liabilities, redeemable noncontrolling interest and stockholders' deficit$16,754  $14,789 
            

    vTv Therapeutics Inc.

    Condensed Consolidated Statements of Operations - Unaudited

    (in thousands, except per share data)

     Three Months Ended 
     March 31, 2021  December 31, 2020 
    Revenue$987  $6,399 
    Operating expenses:       
    Research and development 3,103   2,534 
    General and administrative 2,164   2,035 
    Total operating expenses 5,267   4,569 
    Operating (loss)/income (4,280)  1,830 
    Interest income 1    
    Interest expense    (67)
    Other expense, net (1,648)  (156)
    Loss before income taxes and noncontrolling interest (5,927)  1,607 
    Income tax provision 15    
    Net loss before noncontrolling interest (5,942)  1,607 
    Less: net (loss)/income attributable to noncontrolling interest (1,701)  481 
    Net (loss)/income attributable to vTv Therapeutics Inc.$(4,241) $1,126 
    Net (loss)/income attributable to vTv Therapeutics Inc. common shareholders$(4,241) $1,126 
            
    Net (loss)/income per share:       
    Basic net (loss)/income per share of vTv Therapeutics Inc. Class A

    Common Stock
    $(0.08) $0.02 
    Diluted net (loss)/income per share of vTv Therapeutics Inc. Class A

    Common Stock
    $(0.08) $0.02 
            
    Weighted average shares used in calculating:       
    Basic net (loss)/income per share of vTv Therapeutics Inc. Class A

    Common Stock
     56,472,535   51,133,609 
    Diluted net (loss)/income per share of vTv Therapeutics Inc. Class A

    Common Stock
     56,472,535   74,397,085 
            

    vTv Therapeutics Inc.

    Condensed Consolidated Statements of Operations

    (in thousands, except per share data)

     Three Months Ended March 31, 
     2021  2020 
     (Unaudited) 
    Revenue$987  $8 
    Operating expenses:       
    Research and development 3,103   4,204 
    General and administrative 2,164   2,450 
    Total operating expenses 5,267   6,654 
    Operating loss (4,280)  (6,646)
    Interest income 1   12 
    Interest expense    (168)
    Other expense, net (1,648)  (363)
    Loss before income taxes and noncontrolling interest (5,927)  (7,165)
    Income tax provision 15    
    Net loss before noncontrolling interest (5,942)  (7,165)
    Less: net loss attributable to noncontrolling interest (1,701)  (2,441)
    Net loss attributable to vTv Therapeutics Inc.$(4,241) $(4,724)
    Net loss attributable to vTv Therapeutics Inc. common shareholders$(4,241) $(4,724)
    Net loss per share of vTv Therapeutics Inc. Class A Common

    Stock, basic and diluted
    $(0.08) $(0.11)
    Weighted-average number of vTv Therapeutics Inc. Class A

    Common Stock, basic and diluted
     56,472,535   43,462,551 
            

    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 and psoriasis. vTv's development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease, renal disease, and primary mitochondrial myopathy.

    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 income/(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 
     March 31, 2021  December 30, 2020 
    Numerator:       
    Net (loss)/income attributable to vTv Therapeutics Inc. common shareholders$(4,241) $1,126 
    Other expense - related party (1,648)  (156)
    Share-based compensation expense 436   272 
    Reallocation of net income attributable to noncontrolling

    interest from the assumed exchange of Class B shares (1)
     (1,701)  481 
    Adjusted net (loss)/income before noncontrolling interest$(7,154) $1,723 
    Denominator:       
    Weighted-average number of vTv Therapeutics Inc.

    Class A Common Stock, diluted
     56,472,535   74,397,085 
    Assumed exchange of Class B Common Stock (1) 23,094,137    
    Adjusted proforma fully exchanged weighted-average

    shares of Class A common stock outstanding, diluted
     79,566,672   74,397,085 
    Adjusted net (loss)/income per fully exchanged share, diluted$(0.09) $0.02 



       
     Three Months Ended March 31, 
     2021  2020 
    Numerator:       
    Net loss attributable to vTv Therapeutics Inc. common shareholders$(4,241) $(4,724)
    Other expense - related party (1,648)  (363)
    Share-based compensation expense 436   380 
    Reallocation of net income attributable to noncontrolling

    interest from the assumed exchange of Class B shares (1)
     (1,701)  (2,441)
    Adjusted net loss before noncontrolling interest$(7,154) $(7,148)
    Denominator:       
    Weighted-average number of vTv Therapeutics Inc.

    Class A Common Stock, diluted
     56,472,535   43,462,551 
    Assumed exchange of Class B Common Stock (1) 23,094,137   23,094,221 
    Adjusted proforma fully exchanged weighted-average

    shares of Class A common stock outstanding,

    diluted
     79,566,672   66,556,772 
    Adjusted net loss per fully exchanged share,

    diluted
    $(0.09) $(0.11)



    (1)Assumes the exchange of all outstanding Class B common stock, resulting in the inclusion of shares of Class B common stock in the weighted average share count, if not already considered, and the elimination of the noncontrolling interest and recognition of the net income attributable to noncontrolling interests.

    Contacts

    Investors:

    Corey Davis

    LifeSci Advisors

    or



    Media:

     



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  4. HIGH POINT, N.C., April 13, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) a clinical-stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes and psoriasis, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for TTP399 as an adjunctive therapy to insulin for the treatment of type 1 diabetes. TTP399 is a novel, oral, investigational once-daily glucokinase activator.

    Breakthrough Therapy designation is based on FDA's determination that preliminary clinical evidence indicates that an investigational therapy may demonstrate substantial improvement on one or more significant endpoints relative to available therapies…

    HIGH POINT, N.C., April 13, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) a clinical-stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes and psoriasis, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for TTP399 as an adjunctive therapy to insulin for the treatment of type 1 diabetes. TTP399 is a novel, oral, investigational once-daily glucokinase activator.

    Breakthrough Therapy designation is based on FDA's determination that preliminary clinical evidence indicates that an investigational therapy may demonstrate substantial improvement on one or more significant endpoints relative to available therapies for a serious or life-threatening condition. Once granted, Breakthrough Therapy designation provides a sponsor with added support and the potential to expedite development and review timelines for a promising new investigational medicine. The Breakthrough Therapy designation for TTP399 in type 1 diabetes was supported by the recent positive results from the phase 2 SimpliciT-1 Study, a multi-center, randomized, double-blind, adaptive study assessing the safety and efficacy of TTP399 as an adjunct to insulin therapy in adults with type 1 diabetes. In this trial, treatment with TTP399 resulted in a statistically significant improvement in HbA1c relative to placebo and a clinically meaningful decrease (40%) in the frequency of severe and symptomatic hypoglycemia. TTP399 demonstrated a favorable safety profile, with abnormal levels of serum or urine ketones detected less frequently in patients taking TTP399 than those taking placebo.

    "This FDA Breakthrough Therapy designation is an important milestone in the development of TTP399 for the treatment of type 1 diabetes, a serious, life threatening, and life-long condition impacting the day-to-day lives of more than a million Americans," said Steve Holcombe, chief executive officer of vTv. "Hypoglycemia remains a leading cause of morbidity and potential mortality in the treatment of type 1 diabetes. Patient and prescriber fear of hypoglycemia often precludes tight glycemic control and this FDA designation highlights the potential of TTP399 to address this serious unmet medical need. We look forward to working with the FDA as we advance the development of TTP399, and in particular as we begin pivotal trials later this year."

    About FDA Breakthrough Therapy Designation

    Breakthrough Therapy designation is granted by the FDA in order to expedite the development and review of drugs for serious or life-threatening conditions. In order to receive Breakthrough Therapy designation, a drug must demonstrate preliminary clinical evidence that the drug may have substantial improvement on at least one clinically significant endpoint over available therapy. Breakthrough Therapy designation provides an organizational commitment involving senior managers from the FDA, more intensive FDA guidance on an efficient drug development program, and greater access to and more frequent communication with the FDA throughout the entire drug development and review process. It also provides the opportunity to submit sections of a New Drug Application on a rolling basis, where the FDA may review portions of the application as they are received instead of waiting for the entire submission. In addition, Breakthrough Therapy designated products are eligible for Priority Review, where the FDA has a goal to take action on an application within six months, as opposed to ten months under standard review. Breakthrough Therapy designation does not change the standards for approval.

    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 type 1 diabetes, 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 and psoriasis. vTv's development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease, renal disease, and primary mitochondrial myopathy. 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.

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    Corey Davis

    LifeSci Advisors





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  5. HIGH POINT, N.C., April 12, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) a clinical-stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes and inflammatory diseases, today announced that results from the JDRF-supported SimpliciT-1 Study will be presented at A Scientific Symposium: In celebration of the 100th anniversary of the University of Toronto's discovery of insulin (Insulin100) held virtually, April 15 & 16, 2021.

    The presentation titled "The SimpliciT-1 Study: Hepatoselective Glucokinase Activation Via TTP399 For The Treatment Of Type 1 Diabetes Mellitus" was awarded first place in the symposium's Post Doc - Clinical Category and earned the opportunity to be…

    HIGH POINT, N.C., April 12, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) a clinical-stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes and inflammatory diseases, today announced that results from the JDRF-supported SimpliciT-1 Study will be presented at A Scientific Symposium: In celebration of the 100th anniversary of the University of Toronto's discovery of insulin (Insulin100) held virtually, April 15 & 16, 2021.

    The presentation titled "The SimpliciT-1 Study: Hepatoselective Glucokinase Activation Via TTP399 For The Treatment Of Type 1 Diabetes Mellitus" was awarded first place in the symposium's Post Doc - Clinical Category and earned the opportunity to be presented to the world's leading experts on type 1 diabetes. Dr. Klara Klein, MD, PhD, Division of Endocrinology and Metabolism at the University of North Carolina at Chapel Hill, and Sub-Principal Investigator of the SimpliciT-1 study, will present the data in a 15 minute presentation on April 15th in a session held from 1:10-1:25pm ET. Registration is available here.

    The Insulin100 symposium, chaired by Dr. Daniel Drucker of the University of Toronto, celebrates the 100th anniversary of the life-saving discovery of insulin and aims to provide comprehensive updates on the latest advances in diabetes treatment and management.

    "We are pleased that vTv's research in type 1 diabetes is being recognized by the diabetes community," said Steve Holcombe, chief executive officer, vTv Therapeutics. "We are dedicated to advancing TTP399 and believe that it has the potential to be a new treatment option for type 1 diabetes that improves patients' lives."

    vTv is currently conducting a mechanistic study exploring the effects of TTP399 on ketone body formation during a period of insulin withdrawal in people with type 1 diabetes and is planning a pivotal trial that will be initiated later this year.

    About the SimpliciT-1 Study

    The SimpliciT-1 Study 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 Phase 2 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.

    Results from the study showed that treatment with 800mg of TTP399 demonstrated statistically significant reductions in HbA1c, as previously announced. Importantly, it also resulted in a clinically relevant (~40%) reduction in the frequency of severe or symptomatic hypoglycemia, as compared to placebo. TTP399 exhibited a favorable safety profile, with abnormal serum and urine ketones detected less frequently in participants in the TTP399 group than in the placebo group. These data suggest the potential of TTP399 to lower HbA1c and reduce hypoglycemia without increasing the risk of ketosis and should be further evaluated as an adjunctive therapy for the treatment of type 1 diabetes.

    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 and inflammatory disorders, including psoriasis. vTv's development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease (COPD), renal disease, and primary mitochondrial myopathy. 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.

    Contacts

    Investors:

    Corey Davis

    LifeSci Advisors





    or



    Media:

     

    Source: vTv Therapeutics Inc. 



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