VTVT vTv Therapeutics Inc.

2.16
-0.11  -5%
Previous Close 2.27
Open 2.26
52 Week Low 1.23
52 Week High 4.23
Market Cap $147,717,525
Shares 68,387,743
Float 11,044,529
Enterprise Value $160,173,175
Volume 104,674
Av. Daily Volume 490,099
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Upcoming Catalysts

Drug Stage Catalyst Date
Azeliragon
Mild Alzheimer’s disease with type 2 diabetes
Phase 2/3
Phase 2/3
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Drug Pipeline

Drug Stage Notes
TTP399 (ADA)
Type 1 Diabetes
Phase 1/2
Phase 1/2
Phase 2 Part 2 data met primary endpoint - February 10, 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.
TTP399 - AGATA
Type 2 Diabetes
Phase 2b
Phase 2b
Phase 2 data released August 2016. Primary endpoint met.
TTP273 - LOGRA
Type 2 Diabetes
Phase 2
Phase 2
Phase 2 primary endpoint met - December 14, 2016.

Latest News

  1. - Treatment with TTP399 resulted in significant improvements in HbA1c with reduction in insulin, without increasing risk of hypoglycemia or diabetic ketoacidosis (DKA) -

    HIGH POINT, N.C., June 13, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) today made two presentations at the American Diabetes Association's 80th Scientific Sessions. The clinical data presented from the positive Phase 2 Simplici-T1 Study confirms the potential for TTP399 to provide a benefit beyond standalone insulin treatment for patients living with type 1 diabetes.

    "These results from the Simplici-T1 Trial are a major step towards the future of care in type 1 diabetes.  They demonstrate that TTP399, a once-a-day pill, reduces HbA1c and improves time in…

    - Treatment with TTP399 resulted in significant improvements in HbA1c with reduction in insulin, without increasing risk of hypoglycemia or diabetic ketoacidosis (DKA) -

    HIGH POINT, N.C., June 13, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) today made two presentations at the American Diabetes Association's 80th Scientific Sessions. The clinical data presented from the positive Phase 2 Simplici-T1 Study confirms the potential for TTP399 to provide a benefit beyond standalone insulin treatment for patients living with type 1 diabetes.

    "These results from the Simplici-T1 Trial are a major step towards the future of care in type 1 diabetes.  They demonstrate that TTP399, a once-a-day pill, reduces HbA1c and improves time in range, without increasing hypoglycemia or any signal for adverse events including diabetic ketoacidosis," said John Buse, MD, Director of the North Carolina Translational and Clinical Sciences Institute and of the Diabetes Center at the University of North Carolina School of Medicine. "Despite advances in insulin and type 1 diabetes technologies, affected patients continue to have difficulty achieving optimal glucose control. A safe and effective oral adjunctive therapy would be an important tool for patients and treating endocrinologists to improve both the daily burden of T1D and its long-term outcomes."

    A copy of the poster presentations is available on the company website at http://vtvtherapeutics.com/publications/

    Details of the presentations follow:

    Late Breaking Poster Presentation: Poster #122-LB, The Simplici-T1 Trial: Glucokinase Activator TTP399 Improves Glycemic Control in Patients with Type 1 Diabetes.

    Presenter: John Buse, M.D., Ph.D., Director of the North Carolina Translational and Clinical Sciences Institute and of the Diabetes Center at the University of North Carolina School of Medicine

    Key results presented included:

    • Part 2 of the Simplici-T1 Study confirmed the results from Part 1 in a greater number of subjects (n=85) with TTP399 significantly reducing HbA1c by 0.3% (p<0.01; trial product estimand); 0.2% (p<0.05; FAS), compared to placebo.
    • An analysis conducted with treatment responders found a significant difference in the number of responders taking TTP399 (42%) vs. those on placebo (12%) (ITT: p<0.01). Treatment responders were patients that exhibited all of the following: improved HbA1c, no severe or symptomatic hypoglycemia or increase in insulin bolus dose >3U/day, and no abnormal beta-hydroxybutyrate or lactic acid levels.
    • Treatment-emergent adverse events were numerically lower in the TTP399 treatment group, with trends towards reduction in hypoglycemic and ketone events in the TTP399-treated group.

    Late Breaking Poster Presentation: Poster #123-LB, The Simplici-T1 Trial: Relationship between Glycemic Control and Insulin Dose

    Presenter: Carmen Valcarce, Ph.D., Chief Scientific Officer, vTv Therapeutics

    Key results presented included:

    The treat-to-target (FPG: ~80-130mg/dL; post meal glucose: <180-200 mg/dL) design of the study allowed changes in insulin dose after the insulin-optimization period. To evaluate the effect of these insulin adjustments on HbA1c, several pre-planned analyses were performed grouping the participants according to their change in total insulin doses (decreased, stable or increased).

    • Patients randomized to TTP399 achieved better glycemic control (improved HbA1c) while reducing insulin dose. In the placebo-treated group, as expected, reduction in insulin dose was on average associated with a worsening in HbA1c.
    • TTP399 significantly reduced HbA1c compared to placebo (0.41%, p=0.01) in patients that decreased their insulin dose or maintained stable insulin dose throughout the study (0.35%, p=0.04).
    • Significantly fewer patients in the TTP399 treated group required increases to their insulin dose to maintain their glycemic targets.
    • In agreement with the overall analysis, trends towards reduction in hypoglycemic and ketone events were observed in the TTP399 treated group compared to placebo in the subgroups.

    About 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. The positive topline results from Part 2 of the SimpliciT-1 Study were reported in February 2020.

    About Type 1 Diabetes

    Type 1 diabetes (T1D) 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.

    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.

    Nura Strong

    VP of Business Development

    Primary Logo

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  2. HIGH POINT, N.C., May 22, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) today announced that it will host its 2020 Annual Meeting of Stockholders (the "Annual Meeting") as a virtual-only meeting that will be held via live audio webcast due to the public health and safety concerns related to the COVID-19 pandemic, recommendations and orders from federal, state and local authorities, and to support the health and well-being of its stockholders, employees, and others.

    The previously announced date and time of the Annual Meeting, Thursday, June 11, 2020 at 9:00 a.m. Eastern Daylight Time, as disclosed in the previously distributed Notice of the Annual Meeting and Definitive Proxy Statement (the "Notice and Proxy Statement"), has…

    HIGH POINT, N.C., May 22, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) today announced that it will host its 2020 Annual Meeting of Stockholders (the "Annual Meeting") as a virtual-only meeting that will be held via live audio webcast due to the public health and safety concerns related to the COVID-19 pandemic, recommendations and orders from federal, state and local authorities, and to support the health and well-being of its stockholders, employees, and others.

    The previously announced date and time of the Annual Meeting, Thursday, June 11, 2020 at 9:00 a.m. Eastern Daylight Time, as disclosed in the previously distributed Notice of the Annual Meeting and Definitive Proxy Statement (the "Notice and Proxy Statement"), has not changed. Stockholders will not be able to attend the Annual Meeting in person.  A notice regarding this change to a virtual meeting format is being filed with the Securities and Exchange Commission together with this press release.

    Registering and Asking Questions

    In order to attend the Annual Meeting, vTv stockholders of record as of April 20, 2020 must register in advance by accessing www.proxydocs.com/vtvt.  During the registration process, you may submit a question regarding the business of the meeting. Questions submitted in advance will be answered depending on the availability of time and members of management present at the Annual Meeting. All registrations and questions from stockholders must be received by 5:00 p.m. Eastern Daylight Time on Tuesday, June 9, 2020. After completing your registration by the registration deadline, further instructions, including a link to access the Annual Meeting, will be emailed to you.

    Attending the Meeting

    Online access to the Annual Meeting will begin 15 minutes prior to the meeting start time of 9:00 a.m. Eastern Daylight Time on June 11, 2020. To be admitted to the Annual Meeting's live webcast, you must have previously registered at www.proxydocs.com/vtvt by the registration deadline of Tuesday, June 9, 2020 at 5:00 p.m. Eastern Daylight Time.

    Voting

    All stockholders, whether or not planning to attend the virtual Annual Meeting, are encouraged to vote promptly in advance of the meeting by using one of the methods described in the proxy materials for the Annual Meeting. The proxy card and voting instruction form included with the previously distributed proxy materials (or notice of internet availability) will not be reissued and may continue to be used to vote shares in connection with the Annual Meeting.

    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.

    Contacts
    Investors:
    Corey Davis
    LifeSci Advisors

    or

    Media:
    Glenn Silver
    Lazar FINN Partners
    646-871-8485

    Primary Logo

    View Full Article Hide Full Article
  3. HIGH POINT, N.C., May 07, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) today reported financial results for the first quarter ended March 31, 2020, and provided an update on recent clinical achievements.

    "In spite of the challenges presented by the COVID-19 pandemic, we are encouraged by the continued progress we made this past quarter with our two key late stage clinical programs for TTP399 for the treatment of type 1 diabetes and azeliragon for the treatment of Alzheimer's disease in patients with type 2 diabetes," said Steve Holcombe, chief executive officer. "With respect to TTP399, we are engaging with the FDA regarding our proposed pivotal study development plan to seek regulatory approval for this oral adjunct therapy…

    HIGH POINT, N.C., May 07, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) today reported financial results for the first quarter ended March 31, 2020, and provided an update on recent clinical achievements.

    "In spite of the challenges presented by the COVID-19 pandemic, we are encouraged by the continued progress we made this past quarter with our two key late stage clinical programs for TTP399 for the treatment of type 1 diabetes and azeliragon for the treatment of Alzheimer's disease in patients with type 2 diabetes," said Steve Holcombe, chief executive officer. "With respect to TTP399, we are engaging with the FDA regarding our proposed pivotal study development plan to seek regulatory approval for this oral adjunct therapy to insulin. Additionally, we continue to enroll patients in the Elevage study of azeliragon and are considering various strategies to maintain our expected timelines for announcing certain study results in the first half of next year."

    Recent Achievements and Outlook

    Type 1 Diabetes Study

    • Full results from the SimpliciT-1 Study to be presented at ADA. We will present posters detailing further results from the phase 2 Simplici-T1 Study of TTP399 in patients with type 1 diabetes at the 80th Scientific Sessions held virtually by the American Diabetes Association, June 12-16th.

    Alzheimer's Disease Study

    • Enrollment continues for Phase 2 Elevage Study of azeliragon. vTv Therapeutics continues to enroll patients in the Phase 2 part of the Elevage Study to evaluate the efficacy and safety of azeliragon in patients with mild Alzheimer's disease (AD) and type 2 diabetes.

    Financing Activities

    During April, we entered into a pair of agreements in order to provide additional financial flexibility and availability of additional capital to fund our operations.

    • Amendment to the Loan Agreement. On April 1, 2020, we entered into the Second Amendment to our existing Loan Agreement to allow monthly, interest-only payments on the outstanding principal balance for three months beginning April 1, 2020 before reverting to the previous payment schedule. The Second Amendment also removes the requirement for the Company to maintain a minimum cash balance for the three months beginning April 1, 2020. Thereafter, the Company must maintain a minimum cash balance amount of up to $1.0 million.
    • ATM Offering. On April 24, 2020, we entered into a Controlled Equity OfferingSM Sales Agreement with Cantor Fitzgerald under which we may offer and sell, from time to time, shares of our Class A common stock having an aggregate offering price of up to $13.0 million.

    First Quarter 2020 Financial Results

    • Cash Position: The Company's cash position as of March 31, 2020, was $2.9 million compared to $4.3 million as of December 31, 2019. Of these amounts, $2.5 million was restricted due to the requirements of its Loan Agreement. However, the requirement to maintain this level of minimum cash was temporarily eliminated effective April 1, 2020 in connection with the Second Amendment to the Loan Agreement discussed above.
    • Revenue: Revenues were insignificant for both the first quarter of 2020 and the fourth quarter of 2019.
    • R&D Expenses: Research and development expenses were relatively consistent between periods with $4.2 million in the first quarter of 2020 and $4.4 million in the fourth quarter of 2019.
    • G&A Expenses: General and administrative expenses were $2.5 million for the first quarter of 2020 and $2.0 million for the fourth quarter of 2019, respectively. The increase in these costs was primarily attributable to increased professional and legal fees incurred in the first quarter of 2020.
    • Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $7.2 million for the first quarter of 2020 compared to $6.9 million for the fourth quarter of 2019.
    • Net Loss Per Share: GAAP net loss per share was $0.11 and $0.13 for the three months ended March 31, 2020 and December 31, 2019, respectively, based on weighted-average shares of 43.5 million and 38.0 million for the three-month periods ended March 31, 2020 and December 31, 2019, respectively. Non-GAAP net loss per fully exchanged share was $0.11 for each of the three months ended March 31, 2020 and December 31, 2019, respectively, based on non-GAAP fully exchanged weighted-average shares of 66.6 million and 61.0 million for the three months ended March 31, 2020 and December 31, 2019, respectively.


    vTv Therapeutics Inc.
    Condensed Consolidated Balance Sheets
    (in thousands)

        March 31,     December 31,  
        2020     2019  
        (Unaudited)          
    Assets                
    Current assets:                
    Cash and cash equivalents   $ 406     $ 1,777  
    Restricted cash and cash equivalents     2,500        
    Accounts receivable, net     5       5  
    Prepaid expenses and other current assets     591       806  
    Current deposits           250  
    Total current assets     3,502       2,838  
    Restricted cash and cash equivalents, long-term           2,500  
    Property and equipment, net     434       461  
    Operating lease right-of-use assets     529       543  
    Long-term investments     2,480       2,480  
    Long-term deposits     444       444  
    Total assets   $ 7,389     $ 9,266  
    Liabilities, Redeemable Noncontrolling Interest and Stockholders' Deficit                
    Current liabilities:                
    Accounts payable and accrued expenses   $ 7,395     $ 7,068  
    Operating lease liabilities     136       110  
    Current portion of contract liabilities     31       31  
    Current portion of notes payable     4,408       6,172  
    Total current liabilities     11,970       13,381  
    Contract liabilities, net of current portion     1,025       1,033  
    Operating lease liabilities, net of current portion     795       831  
    Warrant liability, related party     2,964       2,601  
    Other liabilities     260       260  
    Total liabilities     17,014       18,106  
    Commitments and contingencies                
    Redeemable noncontrolling interest     52,196       40,183  
    Stockholders' deficit:                
    Class A Common Stock     447       409  
    Class B Common Stock     232       232  
    Additional paid-in capital     190,200       183,858  
    Accumulated deficit     (252,700 )     (233,522 )
    Total stockholders' deficit attributable to vTv Therapeutics Inc.     (61,821 )     (49,023 )
    Total liabilities, redeemable noncontrolling interest and stockholders' deficit   $ 7,389     $ 9,266  


    vTv Therapeutics Inc.
    Condensed Consolidated Statements of Operations - Unaudited
    (in thousands, except per share data)


      Three Months Ended  
        March 31, 2020     December 31, 2019  
    Revenue   $ 8     $ 7  
    Operating expenses:                
    Research and development     4,204       4,406  
    General and administrative     2,450       1,989  
    Total operating expenses     6,654       6,395  
    Operating loss     (6,646 )     (6,388 )
    Interest income     12       12  
    Interest expense     (168 )     (283 )
    Other (expense) income, net     (363 )     (223 )
    Loss before income taxes and noncontrolling interest     (7,165 )     (6,882 )
    Income tax provision            
    Net loss before noncontrolling interest     (7,165 )     (6,882 )
    Less: net loss attributable to noncontrolling interest     (2,441 )     (2,483 )
    Net loss attributable to vTv Therapeutics Inc.   $ (4,724 )   $ (4,399 )
    Net loss attributable to vTv Therapeutics Inc. common shareholders   $ (4,724 )   $ (5,033 )
    Net loss per share of vTv Therapeutics Inc. Class A Common Stock, basic and diluted   $ (0.11 )   $ (0.13 )
    Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, basic and diluted     43,462,551       37,955,449  


    vTv Therapeutics Inc.
    Condensed Consolidated Statements of Operations
    (in thousands, except per share data)

        Three Months Ended March 31,  
        2020     2019  
                 
        (Unaudited)  
    Revenue   $ 8     $ 921  
    Operating expenses:                
    Research and development     4,204       2,822  
    General and administrative     2,450       2,386  
    Total operating expenses     6,654       5,208  
    Operating loss     (6,646 )     (4,287 )
    Interest income     12       10  
    Interest expense     (168 )     (626 )
    Other (expense) income, net     (363 )     921  
    Loss before income taxes and noncontrolling interest     (7,165 )     (3,982 )
    Income tax provision            
    Net loss before noncontrolling interest     (7,165 )     (3,982 )
    Less: net loss attributable to noncontrolling interest     (2,441 )     (1,827 )
    Net loss attributable to vTv Therapeutics Inc.   $ (4,724 )   $ (2,155 )
    Net loss attributable to vTv Therapeutics Inc. common shareholders   $ (4,724 )   $ (2,155 )
    Net loss per share of vTv Therapeutics Inc. Class A Common Stock, basic and diluted   $ (0.11 )   $ (0.26 )
    Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, basic and diluted     43,462,551       22,862,907  


    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  
        March 31, 2020     December 31, 2019  
    Numerator:                
    Net loss attributable to vTv Therapeutics Inc. common shareholders   $ (4,724 )   $ (5,033 )
    Other income - related party     (363 )     (223 )
    Share-based compensation expense     380       423  
    Deemed distribution to related party           634  
    Reallocation of net income attributable to noncontrolling interest from the assumed exchange of Class B shares (1)     (2,441 )     (2,483 )
    Adjusted net loss before noncontrolling interest   $ (7,148 )   $ (6,682 )
    Denominator:                
    Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, basic and diluted     43,462,551       37,955,449  
    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     66,556,772       61,049,670  
    Adjusted net loss per fully exchanged share, basic and diluted   $ (0.11 )   $ (0.11 )


        Three Months Ended March 31,  
        2020     2019  
    Numerator:                
    Net loss attributable to vTv Therapeutics Inc. common shareholders   $ (4,724 )   $ (5,883 )
    Other income - related party     (363 )     921  
    Share-based compensation expense     380       281  
    Deemed distribution to related party           3,728  
    Reallocation of net income attributable to noncontrolling interest from the assumed exchange of Class B shares (1)     (2,441 )     (1,827 )
    Adjusted net loss before noncontrolling interest   $ (7,148 )   $ (2,780 )
    Denominator:                
    Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, basic and diluted     43,462,551       22,862,907  
    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     66,556,772       45,957,128  
    Adjusted net loss per fully exchanged share, basic and diluted   $ (0.11 )   $ (0.06 )

    (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

    or

    Media:
    Glenn Silver
    Lazar FINN Partners
    646-871-8485

    Primary Logo

    View Full Article Hide Full Article
  4. HIGH POINT, N.C., Feb. 20, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) today reported financial results for the fourth quarter and year ended December 31, 2019, and provided an update on recent clinical achievements.

    "Our success in enrolling and executing clinical trials for our lead development candidates in 2019 positions us for significant pipeline advancement in the year ahead," said Steve Holcombe, chief executive officer, vTv Therapeutics. "The promising top-line data presented earlier this month from the SimpliciT-1 Study suggest that TTP399 has significant potential to benefit and improve outcomes for patients with type 1 diabetes. We believe this therapy could positively impact the lives of type 1 diabetes patients…

    HIGH POINT, N.C., Feb. 20, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) today reported financial results for the fourth quarter and year ended December 31, 2019, and provided an update on recent clinical achievements.

    "Our success in enrolling and executing clinical trials for our lead development candidates in 2019 positions us for significant pipeline advancement in the year ahead," said Steve Holcombe, chief executive officer, vTv Therapeutics. "The promising top-line data presented earlier this month from the SimpliciT-1 Study suggest that TTP399 has significant potential to benefit and improve outcomes for patients with type 1 diabetes. We believe this therapy could positively impact the lives of type 1 diabetes patients by addressing some of the most critical challenges they face, including decreasing the amount of insulin needed during the day and increasing their time in range. Rapidly advancing this program to the next stage of clinical development will be a key priority as we move through 2020. We are also focused on continuing to enroll patients with mild Alzheimer's disease and type 2 diabetes in the Elevage study of azeliragon, in order to confirm and expand the promising, previously reported data showing improved cognition in this patient population. We believe that the anticipated attainment of additional clinical milestones and data readouts from the SimpliciT-1 and Elevage studies in 2020 and 2021 will validate our clinical development expertise and provide additional inflection points for value creation."

    Recent Achievements and Outlook

    Type 1 Diabetes Study

    • Announcement of Positive Results for Part 2 of the SimpliciT-1 Study. In February 2020, the Company announced that Part 2 of the SimpliciT-1 Study of TTP399 as an adjunct to insulin in type 1 diabetes achieved its primary objective by demonstrating a statistically significant and clinically meaningful improvement in HbA1C (a measure of long-term glucose control) for TTP399 compared with placebo. TTP399 also improved patients' daily time in glycemic range, without increasing hypoglycemia or ketoacidosis, relative to placebo. For the full announcement, please refer to the press release available here.
       
    • Full results from the SimpliciT-1 Study will be presented later this year. We plan to initiate discussions with the FDA regarding the design of the next six-month trial to test TTP399 in patients with type 1 diabetes. We expect the next trial to be initiated this year and that it will support potential registration of TTP399 for the treatment of patients with type 1 diabetes.

    Alzheimer's Disease Study

    • Enrollment continues for Phase 2 Elevage Study of azeliragon. vTv Therapeutics continues to enroll patients in the Phase 2 part of the Elevage Study to evaluate the efficacy and safety of azeliragon in patients with mild Alzheimer's disease (AD) and type 2 diabetes.
                   
      The Company expects to report topline results from the Phase 2 proof of concept study in the first half of 2021.

    Fourth Quarter 2019 Financial Results

    • Cash Position: The Company's cash position as of December 31, 2019, was $4.3 million compared to $4.2 million as of September 30, 2019. Of these amounts, $2.5 million is restricted due to the requirements of its Loan Agreement.
       
    • Revenue: Revenues were insignificant for both the third and fourth quarters of 2019.
       
    • R&D Expenses: Research and development expenses were $4.4 million in the fourth quarter of 2019 and $3.7 million in the third quarter of 2019. The increase in these costs was driven primarily by recognition of an offset to research and development expense in the third quarter for a milestone payment received under the collaboration agreement with JDRF International.
       
    • G&A Expenses: General and administrative expenses were relatively consistent between the fourth and third quarters of 2019 at $2.0 million and $1.8 million, respectively.
       
    • Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $6.9 million for the fourth quarter of 2019 compared to $6.0 million for the third quarter of 2019.
       
    • Net Loss Per Share: GAAP net loss per share was $0.13 for each of the three months ended December 31, 2019 and September 30, 2019, based on weighted-average shares of 38.0 million and 32.1 million for the three-month periods ended December 31, 2019 and September 30, 2019, respectively. Non-GAAP net loss per fully exchanged share was $0.11 and $0.10 for the three months ended December 31, 2019 and September 30, 2019, respectively, based on non-GAAP fully exchanged weighted-average shares of 61.0 million and 55.2 million for the three months ended December 31, 2019 and September 30, 2019, respectively.

    Full Year 2019 Financial Results

    • Revenue: Revenues were $2.8 million and $12.4 million for the years ended December 31, 2019 and 2018, respectively. The decrease in revenue between years was primarily driven by the recognition of revenue related to the Huadong license agreement in 2018 based on the completion of the technology transfer obligations under the agreement in late 2018.
       
    • R&D Expenses: Research and development expenses were $15.1 million and $23.0 million for the years ended December 31, 2019 and 2018, respectively. Costs in 2018 were higher due to the STEADFAST Study and related open label extension which were ongoing and were wound down in the first half of 2018. The decrease in costs for these studies was offset by increases in cost for the SimpliciT-1 Study, Part 2 of which was conducted in 2019. Further, the corporate restructuring announced at the end of 2018 resulted in lower compensation costs for R&D personnel in 2019.
       
    • G&A Expenses: General and administrative expenses were $8.5 million and $9.2 million for the years ended December 31, 2019 and 2018, respectively. Such decreases were primarily driven by lower professional fees and the impact of gains recognized on the sale of equipment in connection with the Company's corporate restructuring.
       
    • Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $21.9 million and $23.8 million for the years ended December 31, 2019 and 2018, respectively.
       
    • Net Loss Per Share: GAAP net loss per share was $0.59 and $0.69 for the years ended December 31, 2019 and 2018, respectively, based on weighted-average shares of 30.3 million and 12.4 million for the years ended December 31, 2019 and 2018, respectively. Non-GAAP net loss per fully exchanged share was $0.37 and $0.62 for the years ended December 31, 2019 and 2018, respectively, based on non-GAAP fully exchanged weighted-average shares of 53.4 million and 35.5 million for the years ended December 31, 2019 and 2018, respectively.


    vTv Therapeutics Inc.
    Condensed Consolidated Balance Sheets
    (in thousands)

      December 31,     September 30,  
      2019     2019  
              (Unaudited)  
    Assets              
    Current assets:              
    Cash and cash equivalents $ 1,777     $ 2,436  
    Accounts receivable, net   5       10  
    Prepaid expenses and other current assets   806       870  
    Current deposits   250       251  
    Total current assets   2,838       3,567  
    Restricted cash and cash equivalents, long-term   2,500       2,500  
    Property and equipment, net   461       46  
    Operating lease right-of-use assets   543       85  
    Long-term investments   2,480       2,480  
    Long-term deposits   444       444  
    Total assets $ 9,266     $ 9,122  
    Liabilities, Redeemable Noncontrolling Interest and Stockholders' Deficit              
    Current liabilities:              
    Accounts payable and accrued expenses $ 7,068     $ 6,898  
    Operating lease liabilities   110       91  
    Current portion of deferred revenue   31       31  
    Current portion of notes payable   6,172       7,442  
    Total current liabilities   13,381       14,462  
    Notes payable, net of current portion   -       1,363  
    Deferred revenue, net of current portion   1,033       1,040  
    Operating lease liabilities, net of current portion   831        
    Warrant liability, related party   2,601       1,878  
    Other liabilities   260       260  
    Total liabilities   18,106       19,003  
    Commitments and contingencies              
    Redeemable noncontrolling interest   40,183       37,268  
    Stockholders' deficit:              
    Class A Common Stock   409       354  
    Class B Common Stock   232       232  
    Additional paid-in capital   183,858       175,990  
    Accumulated deficit   (233,522 )     (223,725 )
    Total stockholders' deficit attributable to vTv Therapeutics Inc.   (49,023 )     (47,149 )
    Total liabilities, redeemable noncontrolling interest and stockholders' deficit $ 9,266     $ 9,122  


    vTv Therapeutics Inc.
    Condensed Consolidated Statements of Operations - Unaudited
    (in thousands, except per share data)

      Three Months Ended  
      December 31, 2019     September 30,
    2019
     
    Revenue $ 7     $ 8  
    Operating expenses:              
    Research and development   4,406       3,663  
    General and administrative   1,989       1,770  
    Total operating expenses   6,395       5,433  
    Operating loss   (6,388 )     (5,425 )
    Interest income   12       15  
    Interest expense   (283 )     (404 )
    Other (expense) income, net   (223 )     (146 )
    Loss before income taxes and noncontrolling interest   (6,882 )     (5,960 )
    Income tax provision          
    Net loss before noncontrolling interest   (6,882 )     (5,960 )
    Less:  net loss attributable to noncontrolling interest   (2,483 )     (2,352 )
    Net loss attributable to vTv Therapeutics Inc. $ (4,399 )   $ (3,608 )
    Net loss attributable to vTv Therapeutics Inc. common shareholders $ (5,033 )   $ (4,115 )
    Net loss per share of vTv Therapeutics Inc. Class A
      Common Stock, basic and diluted
    $ (0.13 )   $ (0.13 )
    Weighted-average number of vTv Therapeutics Inc.
      Class A Common Stock, basic and diluted
      37,955,449       32,126,130  


    vTv Therapeutics Inc.
    Condensed Consolidated Statements of Operations
    (in thousands, except per share data)

      Three Months Ended
    December 31,
        For the Year Ended
    December 31,
     
      2019     2018     2019     2018  
                           
      (Unaudited)                  
    Revenue $ 7     $ 4,522     $ 2,764     $ 12,434  
    Operating expenses:                              
    Research and development   4,406       2,800       15,119       23,035  
    General and administrative   1,989       2,073       8,537       9,223  
    Total operating expenses   6,395       4,873       23,656       32,258  
    Operating loss   (6,388 )     (351 )     (20,892 )     (19,824 )
    Interest income   12       14       53       61  
    Interest expense   (283 )     (743 )     (1,827 )     (3,290 )
    Other (expense) income, net   (223 )     (1,248 )     828       (592 )
    Loss before income taxes and noncontrolling interest   (6,882 )     (2,328 )     (21,838 )     (23,645 )
    Income tax provision               100       200  
    Net loss before noncontrolling interest   (6,882 )     (2,328 )     (21,938 )     (23,845 )
    Less:  net loss attributable to noncontrolling interest   (2,483 )     (1,237 )     (8,894 )     (15,934 )
    Net loss attributable to vTv Therapeutics Inc. $ (4,399 )   $ (1,091 )   $ (13,044 )   $ (7,911 )
    Net loss attributable to vTv Therapeutics Inc. common shareholders $ (5,033 )   $ (1,091 )   $ (17,913 )   $ (7,911 )
    Net loss per share of vTv Therapeutics Inc. Class A Common
      Stock, basic and diluted
    $ (0.13 )   $ (0.10 )   $ (0.59 )   $ (0.69 )
    Weighted-average number of vTv Therapeutics Inc. Class A
      Common Stock, basic and diluted
      37,955,449       17,635,159       30,292,030       12,449,236  

    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  
      December 31,
    2019
        September 30,
    2019
     
    Numerator:              
    Net loss attributable to vTv Therapeutics Inc. common shareholders $ (5,033 )   $ (4,115 )
    Other income - related party   (223 )     (146 )
    Share-based compensation expense   423       413  
    Deemed distribution to related party   634       507  
    Reallocation of net income attributable to noncontrolling
      interest from the assumed exchange of Class B shares (1)
      (2,483 )     (2,352 )
    Adjusted net loss before noncontrolling interest $ (6,682 )   $ (5,693 )
    Denominator:              
    Weighted-average number of vTv Therapeutics Inc.
      Class A Common Stock, basic and diluted
      37,955,449       32,126,130  
    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
      61,049,670       55,220,351  
    Adjusted net loss per fully exchanged share,
      basic and diluted
    $ (0.11 )   $ (0.10 )


      Three Months Ended
    December 31,
        Twelve Months Ended
    December 31,
     
      2019     2018     2019     2018  
    Numerator:                              
    Net loss attributable to vTv Therapeutics Inc. common shareholders $ (5,033 )   $ (1,830 )   $ (17,913 )   $ (8,650 )
    Other income - related party   (223 )     (1,248 )     827       (638 )
    Share-based compensation expense   423       579       1,518       2,345  
    Deemed distribution to related party   634       739       4,869       739  
    Reallocation of net income attributable to noncontrolling
      interest from the assumed exchange of Class B shares (1)
      (2,483 )     (1,237 )     (8,894 )     (15,934 )
    Adjusted net loss before noncontrolling interest $ (6,682 )   $ (2,997 )   $ (19,593 )   $ (22,138 )
    Denominator:                              
    Weighted-average number of vTv Therapeutics Inc.
      Class A Common Stock, basic and diluted
      37,955,449       17,635,159       30,292,030       12,449,236  
    Assumed exchange of Class B Common Stock (1)   23,094,221       23,094,221       23,094,221       23,099,500  
    Adjusted proforma fully exchanged weighted-average
      shares of Class A common stock outstanding,
      basic and diluted
      61,049,670       40,729,380       53,386,251       35,548,736  
    Adjusted net loss per fully exchanged share,
      basic and diluted
    $ (0.11 )   $ (0.07 )   $ (0.37 )   $ (0.62 )

    (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

    or

    Media:
    Glenn Silver
    Lazar FINN Partners
    646-871-8485
     

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  5. - TTP399, a novel glucokinase activator, achieves primary objective of a statistically significant reduction in HbA1c, without increases in hypoglycemia or ketoacidosis

    - Company to host investor conference call today at 8:30 a.m. ET

    HIGH POINT, N.C., Feb. 10, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) today announced positive results from Part 2 of the Phase 2 Simplici-T1 trial assessing TTP399 as an oral adjunctive therapy to insulin in adults with type 1 diabetes (T1D). TTP399 is a novel, liver-selective glucokinase activator taken once a day. The 12-week trial investigated the efficacy and safety of 800 mg of TTP399 compared with placebo in 85 people with type 1 diabetes on optimized insulin therapy. The study was conducted…

    - TTP399, a novel glucokinase activator, achieves primary objective of a statistically significant reduction in HbA1c, without increases in hypoglycemia or ketoacidosis

    - Company to host investor conference call today at 8:30 a.m. ET

    HIGH POINT, N.C., Feb. 10, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) today announced positive results from Part 2 of the Phase 2 Simplici-T1 trial assessing TTP399 as an oral adjunctive therapy to insulin in adults with type 1 diabetes (T1D). TTP399 is a novel, liver-selective glucokinase activator taken once a day. The 12-week trial investigated the efficacy and safety of 800 mg of TTP399 compared with placebo in 85 people with type 1 diabetes on optimized insulin therapy. The study was conducted with support from JDRF International (JDRF), the leading provider of T1D research funding globally.

    The trial successfully achieved its primary objective analyzed using two statistical approaches to evaluating the effect of TTP399. The primary statistical analysis evaluated the effect on HbA1c regardless of treatment adherence or notable changes in insulin administration. Under the primary statistical analysis, the trial achieved its primary objective by demonstrating statistically significant improvements in HbA1c (long-term blood sugar) for TTP399 compared to placebo at week 12 (p=0.03).

    TTP399 was well tolerated with similar incidences of treatment-emergent adverse events overall and by system organ class in both treatment groups. The study had no report of diabetic ketoacidosis in either treatment group. There was no incidence of severe hypoglycemia in the treated group and one incident in the placebo group. Patients taking TTP399 experienced fewer symptomatic hypoglycemic episodes: two subjects taking TTP399 reported at least one event compared to eight subjects taking placebo.

    "I am very pleased that part 2 of the study confirmed the positive results and effects we saw in part 1.  A once-a-day pill that reduces HbA1c and improves time in range with continuous glucose monitoring, without increasing hypoglycemia or any signal for adverse events, is a big win for the future care of type 1 diabetes," said Dr. John Buse, Director of the North Carolina Translational and Clinical Sciences Institute and of the Diabetes Center at the University of North Carolina School of Medicine and principal investigator for this study.

    To eliminate the possibility that the reduction in HbA1c was driven by the administration of excess insulin (3 or more units per day), a second estimand analysis was performed.1 Based upon this analysis, people treated with TTP399 achieved a statistically-significant placebo-subtracted reduction in HbA1c of 0.32% (p=0.001). Patients taking TTP399 experienced a 0.21% reduction in HbA1c, while patients taking placebo experienced a 0.11% increase in HbA1c, from a mean study baseline HbA1c of 7.6% following a multi-week insulin optimization period prior to the administration of study treatment.

    Daily Time in Range was improved by approximately two hours in patients treated with TTP399 relative to placebo (p=0.03). TTP399 treatment reduced the total daily mealtime bolus insulin dose by 11% relative to baseline (p=0.02) whereas the placebo-treated group experienced a 3% decrease relative to baseline.

    "The development of a safe and effective therapy that improves glucose control is a critical step toward eliminating the dangerous highs and lows associated with type 1 diabetes," said Sanjoy Dutta, Ph.D., JDRF Vice President of Research. "The results from the Simplici-T1 trial indicate that TTP339 is a promising oral treatment option to help people with type 1 diabetes keep their HbA1c levels within a healthy range, and stay in a desirable glucose range for most of the day, while simplifying the daily management of the disease."

    Despite advances in insulin and its administration, people with T1D continue to have difficulty achieving optimal glucose control (HbA1c of less than 7.0%), warranting the need for adjunctive therapies. TTP399 selectively activates glucokinase (GK), a key regulator of glucose metabolism, in the liver. This activation has been shown to increase glucose utilization, which in turn lowers blood glucose. Simplici-T1 is the first study to test activation of GK in patients with T1D, evaluating daily oral TTP399 as an adjunct to insulin therapy.

    "Roughly 1.5 million people in the US are living with type 1 diabetes and the burdensome, around the clock disease management it requires to avoid life-threatening complications. These patients and their families are demanding new treatment options that offer simple, predictable diabetes management to improve HbA1c and time in range. Consistent with FDA guidance, a 0.3% improvement in HbA1c is considered clinically meaningful, and coupled with the well-controlled population of patients and favorable safety data from our clinical trials to date, this provides a strong basis for moving this potential first-in-class program forward," said Steve Holcombe, President and CEO of vTv Therapeutics. "We intend to engage with the FDA as soon as possible to plan an efficient development pathway for TTP399 and hope to initiate a registration trial this year."

    About the Simplici-T1 Study
    Simplici-T1 is 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 the same 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 Phase 2 - Part 1 were reported in June, 2019. 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.

    Investor Call and Webcast Dial-In Information
    Domestic:  877-423-9813
    International: 201-689-8573
    Conference ID: 13699047
    Webcast: http://public.viavid.com/index.php?id=138082

    About Type 1 Diabetes
    Type 1 diabetes (T1D) 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 JDRF
    JDRF is the leading global organization funding T1D research. Its mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, JDRF has invested more than $2.2 billion in research funding since its inception. JDRF is an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact, and uniting on a national stage to pool resources, passion, and energy. It collaborates with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. JDRF's staff and volunteers throughout the United States and its six international affiliates are dedicated to advocacy, community engagement and a vision of a world without T1D. For more information, please visit jdrf.org or on Twitter: @JDRF.

    About vTv Therapeutics
    vTv Therapeutics Inc. is a clinical-stage pharmaceutical company focused on treating metabolic diseases to minimize their long-term complications through end-organ protection. vTv has an innovative pipeline of first-in-class small molecule clinical and pre-clinical drug candidates for the treatment of a wide range of metabolic diseases and their long term complications such as type 1 diabetes and Alzheimer's disease. 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.

    Contacts
    Investors:
    Michael Wood
    LifeSci Advisors

    or

    Media:
    Glenn Silver
    Lazar FINN Partners
    646-871-8485

    Ayana Young
    JDRF International
    212-859-7895

    1 The second estimand analysis evaluated the effect on HbA1c for patients without evidence of noncompliance with prescribed treatment who did not administer increases of bolus insulin of three or more units per day. This second estimand analysis was conducted consistent with current regulatory guidance.

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