VTVT vTv Therapeutics Inc.

1.77
-0.03  -2%
Previous Close 1.8
Open 1.8
52 Week Low 1.3491
52 Week High 4.23
Market Cap $125,764,171
Shares 71,053,204
Float 13,709,990
Enterprise Value $123,393,106
Volume 140,353
Av. Daily Volume 567,652
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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 - Simplici-T1
Type 1 Diabetes
Phase 1/2
Phase 1/2
Pivotal trial to commence 4Q 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. HIGH POINT, N.C., Sept. 23, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) yesterday presented data from the completed Phase 2 Simplici-T1 study (NCT03335371) that support the clinical potential of TTP399 as an oral adjunctive therapy in type 1 diabetes (T1D). Newly reported data provide additional evidence suggesting that TTP399 does not increase the risk of diabetic ketoacidosis (DKA), a serious and potentially life-threatening complication that occurs in patients with T1D, due to its unique mechanism of action. DKA is a known side-effect and shortcoming of several investigational oral therapies that have been advanced for T1D, and TTP399's positive impact on ketone levels is a point of important differentiation. The company…

    HIGH POINT, N.C., Sept. 23, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) yesterday presented data from the completed Phase 2 Simplici-T1 study (NCT03335371) that support the clinical potential of TTP399 as an oral adjunctive therapy in type 1 diabetes (T1D). Newly reported data provide additional evidence suggesting that TTP399 does not increase the risk of diabetic ketoacidosis (DKA), a serious and potentially life-threatening complication that occurs in patients with T1D, due to its unique mechanism of action. DKA is a known side-effect and shortcoming of several investigational oral therapies that have been advanced for T1D, and TTP399's positive impact on ketone levels is a point of important differentiation. The company also presented additional data from the Simplici-T1 study confirming that treatment with TTP399 resulted in significant improvements in HbA1c, with reduction in bolus insulin dose, without increasing the risk of hypoglycemia or DKA.

    "The data presented at EASD add to the growing body of evidence supporting the potential of TTP399 to meet the urgent yet still unmet need for an adjunctive therapy for patients living with T1D that improves disease management and health outcomes," said Steve Holcombe, president and CEO of vTv Therapeutics. "The development of adjunctive oral therapies for T1D has been limited by unacceptable rates of hypoglycemia and ketoacidosis, so the absence of these events in the Simplici-T1 study is an important advance not only for vTv Therapeutics but for the T1D research community as a whole. This body of evidence provides a robust foundation on which to initiate our first pivotal study of TTP399, which we expect will commence by the end of 2020."

    The data was presented in two oral presentations at the 56th Annual Meeting of the European Association for the Study of Diabetes, which is being held virtually September 21-25, 2020, and are available for download at https://vtvtherapeutics.com/pipeline/ttp399/.

    "People with T1D are dependent on insulin for survival, yet are unable to achieve the recommended glycemic targets or avoid long-term complications with current insulin regimens," said Esther Latres, Ph.D., Assistant Vice President of Research at JDRF, which provided funding to support the Simplici-T1 study. "An adjunctive therapy that could enhance glucose control, reduce the need for insulin, and improve long-term health outcomes would transform the lives of individuals living with T1D. We believe that these data support the continued development of TTP399 as an oral adjunctive therapy in this population, and look forward to seeing the results from the planned pivotal trial."

    EASD Virtual Presentation Information

    Oral Presentation Title: "The Simplici-T1 Trial: Activation of Glucokinase by TTP399 Improves Glycaemic Control in Patients with Type 1 Diabetes"

    Presentation Number: 50

    Category: OP 09 Novel Agents in Type 1 Diabetes

    Date and Time: Tuesday, September 22, 2020, 8:45 AM - 9:00 AM ET



    Oral Presentation Title: "Mechanism Matter: Preliminary Evidence That Activation of Glucokinase by TTP399 Does Not Increase Plasma or Urine Ketones in Type 1 Diabetes"

    Presentation Number: 51

    Category: OP 09 Novel Agents in Type 1 Diabetes

    Date and Time: Tuesday, September 22, 2020, 9:00 AM - 9:15 AM ET



    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.

    About Type 1 Diabetes

    Type 1 diabetes is an autoimmune disease in which a person's pancreas stops producing insulin, a hormone that enables people to get energy from food. It occurs when the body's immune system attacks and destroys the insulin-producing cells in the pancreas, called beta cells. While its causes are not yet entirely understood, scientists believe that both genetic factors and environmental triggers are involved. Its onset has nothing to do with diet or lifestyle. There is nothing you can do to prevent T1D, and—at present—nothing you can do to cure it.

    About vTv Therapeutics

    vTv Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing oral small molecule drug candidates. vTv has a pipeline of clinical drug candidates led by programs for the treatment of type 1 diabetes, Alzheimer's disease, and inflammatory disorders. vTv's development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease (COPD), and genetic mitochondrial diseases. For more information, please visit www.vtvtherapeutics.com or follow us on Twitter: @vTvTherapeutics.

    Forward-Looking Statements

    This release contains forward-looking statements, which involve risks and uncertainties. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and, in each case, their negative or other various or comparable terminology. All statements other than statements of historical facts contained in this release, including statements regarding the timing of our clinical trials, our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause our results to vary from expectations include those described under the heading "Risk Factors" in our Annual Report on Form 10-K and our other filings with the SEC. These forward-looking statements reflect our views with respect to future events as of the date of this release and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements represent our estimates and assumptions only as of the date of this release and, except as required by law, we undertake no obligation to update or review publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this release. We anticipate that subsequent events and developments will cause our views to change. Our forward-looking statements do not reflect the potential impact of any future acquisitions, merger, dispositions, joint ventures or investments we may undertake. We qualify all of our forward-looking statements by these cautionary statements.

    Contacts

    Investors:

    Corey Davis

    LifeSci Advisors

    or

    Media:

    Glenn Silver

    Lazar FINN Partners

    646-871-8485

    Primary Logo

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  2. HIGH POINT, N.C., Sept. 16, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) today announced it will deliver two oral presentations emphasizing the potential of TTP399 as an oral adjunctive therapy in type 1 diabetes at the 56th Annual Meeting of the European Association for the Study of Diabetes, held virtually September 21-25, 2020.

    In June 2020 at the American Diabetes Association's 80th Virtual Scientific Sessions, the Company presented positive clinical data from the Phase 2 Simplici-T1 Study confirming that treatment with TTP399 resulted in significant improvements in HbA1c, with reduction in bolus insulin dose, without increasing the risk of hypoglycemia or diabetic ketoacidosis (DKA).

    Details of the EASD virtual presentations…

    HIGH POINT, N.C., Sept. 16, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) today announced it will deliver two oral presentations emphasizing the potential of TTP399 as an oral adjunctive therapy in type 1 diabetes at the 56th Annual Meeting of the European Association for the Study of Diabetes, held virtually September 21-25, 2020.

    In June 2020 at the American Diabetes Association's 80th Virtual Scientific Sessions, the Company presented positive clinical data from the Phase 2 Simplici-T1 Study confirming that treatment with TTP399 resulted in significant improvements in HbA1c, with reduction in bolus insulin dose, without increasing the risk of hypoglycemia or diabetic ketoacidosis (DKA).

    Details of the EASD virtual presentations follow:

    Oral Presentation Title: "The Simplici-T1 Trial: Activation of Glucokinase by TTP399 Improves Glycaemic Control in Patients with Type 1 Diabetes"

    Presentation Number: 50

    Category: OP 09 Novel Agents in Type 1 Diabetes

    Date and Time: Tuesday, September 22, 2020, 8:45 AM - 9:00 AM ET

    Oral Presentation Title: "Mechanism Matter: Preliminary Evidence That Activation of Glucokinase by TTP399 Does Not Increase Plasma or Urine Ketones in Type 1 Diabetes"

    Presentation Number: 51

    Category: OP 09 Novel Agents in Type 1 Diabetes

    Date and Time: Tuesday, September 22, 2020, 9:00 AM - 9:15 AM ET

    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.

    About Type 1 Diabetes

    Type 1 diabetes is an autoimmune disease in which a person's pancreas stops producing insulin, a hormone that enables people to get energy from food. It occurs when the body's immune system attacks and destroys the insulin-producing cells in the pancreas, called beta cells. While its causes are not yet entirely understood, scientists believe that both genetic factors and environmental triggers are involved. Its onset has nothing to do with diet or lifestyle. There is nothing you can do to prevent T1D, and—at present—nothing you can do to cure it.

    About vTv Therapeutics

    vTv Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing oral small molecule drug candidates. vTv has a pipeline of clinical drug candidates led by programs for the treatment of type 1 diabetes, Alzheimer's disease, and inflammatory disorders. vTv's development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease (COPD), and genetic mitochondrial diseases. For more information, please visit www.vtvtherapeutics.com or follow us on Twitter: @vTvTherapeutics.

    Forward-Looking Statements

    This release contains forward-looking statements, which involve risks and uncertainties. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and, in each case, their negative or other various or comparable terminology. All statements other than statements of historical facts contained in this release, including statements regarding the timing of our clinical trials, our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause our results to vary from expectations include those described under the heading "Risk Factors" in our Annual Report on Form 10-K and our other filings with the SEC. These forward-looking statements reflect our views with respect to future events as of the date of this release and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements represent our estimates and assumptions only as of the date of this release and, except as required by law, we undertake no obligation to update or review publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this release. We anticipate that subsequent events and developments will cause our views to change. Our forward-looking statements do not reflect the potential impact of any future acquisitions, merger, dispositions, joint ventures or investments we may undertake. We qualify all of our forward-looking statements by these cautionary statements.

    Contact

    Investors:

    Corey Davis

    LifeSci Advisors

    Primary Logo

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  3. HIGH POINT, N.C., Sept. 15, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) announced the appointment of Edward P. Taibi, Executive Vice President of MacAndrews & Forbes Incorporated ("MacAndrews"), to the vTv Board of Directors. Effective August 31, 2020, Mr. Taibi will serve a term through the date of the next annual meeting of the Company's stockholders.

    "Ed will add significant value as a vTv board member and will be a tremendous asset in helping to drive our near-and long-term goals," said Steve Holcombe, CEO of vTv Therapeutics. "As a member of the senior leadership team at MacAndrews, we look forward to leveraging his keen insights and future contributions."

    Mr. Taibi has gained extensive business leadership experience…

    HIGH POINT, N.C., Sept. 15, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) announced the appointment of Edward P. Taibi, Executive Vice President of MacAndrews & Forbes Incorporated ("MacAndrews"), to the vTv Board of Directors. Effective August 31, 2020, Mr. Taibi will serve a term through the date of the next annual meeting of the Company's stockholders.

    "Ed will add significant value as a vTv board member and will be a tremendous asset in helping to drive our near-and long-term goals," said Steve Holcombe, CEO of vTv Therapeutics. "As a member of the senior leadership team at MacAndrews, we look forward to leveraging his keen insights and future contributions."

    Mr. Taibi has gained extensive business leadership experience over the course of his sixteen-year tenure at MacAndrews, advising on transformative business development opportunities, as well as large and complex capital markets and financing transactions.  Prior to joining MacAndrews, Mr. Taibi served as a lawyer in the Mergers and Acquisitions group at Skadden, Arps, Slate, Meagher & Flom LLP.

    "I am honored to join vTv Therapeutics' Board of Directors," said Edward P. Taibi. "I look forward to collaborating with vTv's management team as we progress the development of the company's pipeline of innovative clinical drug candidates that have the potential to significantly improve the lives of patients suffering with type 1 diabetes and Alzheimer's disease."

    MacAndrews is a holding company with a portfolio of public and private companies in diverse industries.  MacAndrews has been a significant investor in vTv and its predecessor companies for more than 20 years.  

    About vTv Therapeutics

    vTv Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing oral small molecule drug candidates. vTv has a pipeline of clinical drug candidates led by programs for adjunctive treatment for type 1 diabetes, Alzheimer's disease, and inflammatory disorders. vTv's development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease (COPD), and genetic mitochondrial diseases. For more information, please visit www.vtvtherapeutics.com or follow us on Twitter: @vTvTherapeutics.

    Forward-Looking Statements

    This release contains forward-looking statements, which involve risks and uncertainties. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and, in each case, their negative or other various or comparable terminology. All statements other than statements of historical facts contained in this release, including statements regarding the timing of our clinical trials, our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause our results to vary from expectations include those described under the heading "Risk Factors" in our Annual Report on Form 10-K and our other filings with the SEC. These forward-looking statements reflect our views with respect to future events as of the date of this release and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements represent our estimates and assumptions only as of the date of this release and, except as required by law, we undertake no obligation to update or review publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this release. We anticipate that subsequent events and developments will cause our views to change. Our forward-looking statements do not reflect the potential impact of any future acquisitions, merger, dispositions, joint ventures or investments we may undertake. We qualify all of our forward-looking statements by these cautionary statements.

    Contact

    Investors:

    Corey Davis

    LifeSci Advisors

    Primary Logo

    View Full Article Hide Full Article
  4. HIGH POINT, N.C., Aug. 03, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) today reported financial results for the second quarter ended June 30, 2020, and provided an update on the progress of its clinical programs.

    "Building on the successful phase 2 study completed earlier this year with TTP399, we have been highly focused on advancing this promising candidate as an adjunct to insulin for type 1 diabetes into the next stage of clinical development," said Steve Holcombe, president and CEO. "To this end, we have been engaging with the FDA to determine the development path for TTP399 and are in the planning stages for our first pivotal study, which we anticipate commencing by the end of 2020.  We have also continued to enroll…

    HIGH POINT, N.C., Aug. 03, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) today reported financial results for the second quarter ended June 30, 2020, and provided an update on the progress of its clinical programs.

    "Building on the successful phase 2 study completed earlier this year with TTP399, we have been highly focused on advancing this promising candidate as an adjunct to insulin for type 1 diabetes into the next stage of clinical development," said Steve Holcombe, president and CEO. "To this end, we have been engaging with the FDA to determine the development path for TTP399 and are in the planning stages for our first pivotal study, which we anticipate commencing by the end of 2020.  We have also continued to enroll patients in our phase 2 study of azeliragon for the treatment of Alzheimer's disease in patients with type 2 diabetes, despite the clinical challenges posed by COVID-19."

    Recent Achievements and Outlook

    Type 1 Diabetes

    • FDA Engagement and Pivotal Study Planning.  Following a Type C Meeting request, vTv received written feedback from the FDA in June regarding the design of the Company's proposed pivotal studies.  vTv expects to commence the next study for TTP399 by the end of 2020 with a six-month treatment period and a six-month open label extension.  A second study with a 6-month treatment period would be initiated within 12 months after initiation of the first trial.

       
    • Two Presentations at ADA of Simplici-T1 Study Results.  Dr. John Buse, University of North Carolina at Chapel Hill, and Dr. Carmen Valcarce, chief scientific officer, made separate presentations at the American Diabetes Association's 80th Scientific Sessions on the results of the Simplici-T1 Study in which TTP399 improved HbA1c in patients with type 1 diabetes, while reducing insulin dose and lowering the incidence of hypoglycemia and diabetic ketoacidosis.

    Dementia with Diabetes

    • Enrollment continues for Phase 2 Elevage Study of azeliragon. vTv continues to enroll patients in the Elevage Study to evaluate the efficacy and safety of azeliragon in patients with probable mild Alzheimer's disease (AD) and type 2 diabetes. Recruitment for the study will conclude by September 30, 2020 with a target of approximately 50 patients enrolled. The Company expects to report topline results from this study in the second quarter of 2021.

       
    • Additional Clinical Data from STEADFAST Presented at AAIC. Dr. Aaron Burstein, SVP clinical development, presented additional clinical data at the Alzheimer's Association International Conference of the impact of azeliragon on the individual components of CDR-sb and ADAS-cog, the two primary instruments used to evaluate Alzheimer's disease.

    Financing Activities

    During the second quarter, vTv entered into agreements in order to provide additional financial flexibility and availability of additional capital to fund its near-term operations.

    • Amendment to the Loan Agreement. On July 29, 2020, vTv entered into the Third Amendment to the Company's existing Loan Agreement to allow monthly, interest-only payments on the outstanding principal balance for two additional months beginning July 1, 2020 and to extend the maturity date of the first tranche from August 1 to September 1, 2020.  The Third Amendment also eliminates the requirement for the Company to maintain a minimum cash balance.

       
    • ATM Sales. Under the Controlled Equity OfferingSM Sales Agreement with Cantor Fitzgerald, vTv sold shares of its Class A common stock having an aggregate offering price of $7.6 million as of the end of the second quarter.

    Second Quarter 2020 Financial Results

    • Cash Position: The Company's cash position as of June 30, 2020, was $6.4 million compared to $0.4 million as of March 31, 2020.

       
    • Revenue: Revenues were insignificant for both the first and second quarter of 2020.

       
    • R&D Expenses: Research and development expenses were $2.5 million and $4.2 million for the three months ended June 30, 2020 and March 31, 2020, respectively.  This decrease of $1.7 million was driven primarily by a decrease of $0.5 million related to the development of TTP399, as the Simplici-T1 Study was completed in early 2020. Further, costs related to the development of azeliragon decreased approximately $0.8 million related to lower costs incurred for the Elevage Study due to a slowdown in enrollment caused, in part, by COVID-19.

       
    • G&A Expenses: General and administrative expenses were $1.7 million for the second quarter of 2020 and $2.5 million for the first quarter, respectively. The decrease of $0.8 million was driven by lower professional fees, an adjustment made to the Company's asset retirement obligation recorded in connection with a leased facility, and overall expense curtailment.

       
    • Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $5.0 million for the second quarter of 2020 compared to $7.2 million for the first quarter of 2020.

       
    • Net Loss Per Share: GAAP net loss per share was $0.07 and $0.11 for the three months ended June 30, 2020 and March 31, 2020, respectively, based on weighted-average shares of 45.7 million and 43.5 million for the three-month periods ended June 30, 2020 and March 31, 2020, respectively. Non-GAAP net loss per fully exchanged share was $0.08 and $0.11 for the three months ended June 30, 2020 and March 31, 2020, respectively, based on non-GAAP fully exchanged weighted-average shares of 68.8 million and 66.6 million for the three months ended June 30, 2020 and March 31, 2020, respectively.



    vTv Therapeutics Inc.

    Condensed Consolidated Balance Sheets

    (in thousands)

     June 30,  March 31 
     2020  2020 
     (Unaudited)  (Unaudited) 
    Assets       
    Current assets:       
    Cash and cash equivalents$6,392  $406 
    Restricted cash and cash equivalents    2,500 
    Accounts receivable, net    5 
    Prepaid expenses and other current assets 299   591 
    Current deposits 87    
    Total current assets 6,778   3,502 
    Property and equipment, net 412   434 
    Operating lease right-of-use assets 514   529 
    Long-term investments 2,480   2,480 
    Long-term deposits 444   444 
    Total assets$10,628  $7,389 
    Liabilities, Redeemable Noncontrolling Interest and Stockholders' Deficit       
    Current liabilities:       
    Accounts payable and accrued expenses$6,697  $7,395 
    Operating lease liabilities 143   136 
    Current portion of contract liabilities 31   31 
    Current portion of notes payable 4,543   4,408 
    Total current liabilities 11,414   11,970 
    Contract liabilities, net of current portion 1,025   1,025 
    Operating lease liabilities, net of current portion 756   795 
    Warrant liability, related party 3,529   2,964 
    Other liabilities 54   260 
    Total liabilities 16,778   17,014 
    Commitments and contingencies       
    Redeemable noncontrolling interest 63,378   52,196 
    Stockholders' deficit:       
    Class A Common Stock 479   447 
    Class B Common Stock 232   232 
    Additional paid-in capital 198,634   190,200 
    Accumulated deficit (268,873)  (252,700)
    Total stockholders' deficit attributable to vTv Therapeutics Inc. (69,528)  (61,821)
    Total liabilities, redeemable noncontrolling interest and stockholders' deficit$10,628  $7,389 





    vTv Therapeutics Inc.

    Condensed Consolidated Statements of Operations - Unaudited

    (in thousands, except per share data)

     Three Months Ended 
     June 30, 2020  March 31, 2020 
    Revenue$  $8 
    Operating expenses:       
    Research and development 2,509   4,204 
    General and administrative 1,695   2,450 
    Total operating expenses 4,204   6,654 
    Operating loss (4,204)  (6,646)
    Interest income    12 
    Interest expense (222)  (168)
    Other (expense) income, net (565)  (363)
    Loss before income taxes and noncontrolling interest (4,991)  (7,165)
    Income tax provision     
    Net loss before noncontrolling interest (4,991)  (7,165)
    Less:  net loss attributable to noncontrolling interest (1,623)  (2,441)
    Net loss attributable to vTv Therapeutics Inc.$(3,368) $(4,724)
    Net loss attributable to vTv Therapeutics Inc. common shareholders$(3,368) $(4,724)
    Net loss per share of vTv Therapeutics Inc. Class A

      Common Stock, basic and diluted
    $(0.07) $(0.11)
    Weighted-average number of vTv Therapeutics Inc.

      Class A Common Stock, basic and diluted
     45,661,221   43,462,551 





    vTv Therapeutics Inc.

    Condensed Consolidated Statements of Operations

    (in thousands, except per share data)

     Three Months Ended June 30,  For the Six Months Ended June 30, 
     2020  2019  2020  2019 
     (Unaudited)  (Unaudited) 
    Revenue$  $1,828  $8  $2,749 
    Operating expenses:               
    Research and development 2,509   4,228   6,713   7,050 
    General and administrative 1,695   2,392   4,145   4,778 
    Total operating expenses 4,204   6,620   10,858   11,828 
    Operating loss (4,204)  (4,792)  (10,850)  (9,079)
    Interest income    16   12   26 
    Interest expense (222)  (514)  (390)  (1,140)
    Other (expense) income, net (565)  276   (928)  1,197 
    Loss before income taxes and noncontrolling interest (4,991)  (5,014)  (12,156)  (8,996)
    Income tax provision    100      100 
    Net loss before noncontrolling interest (4,991)  (5,114)  (12,156)  (9,096)
    Less:  net loss attributable to noncontrolling interest (1,623)  (2,232)  (4,064)  (4,059)
    Net loss attributable to vTv Therapeutics Inc.$(3,368) $(2,882) $(8,092) $(5,037)
    Net loss attributable to vTv Therapeutics Inc. common shareholders$(3,368) $(2,882) $(8,092) $(8,765)
    Net loss per share of vTv Therapeutics Inc. Class A Common

      Stock, basic and diluted
    $(0.07) $(0.10) $(0.18) $(0.34)
    Weighted-average number of vTv Therapeutics Inc. Class A

      Common Stock, basic and diluted
     45,661,221   28,037,628   44,561,886   25,464,562 



    About vTv Therapeutics

    vTv Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing oral small molecule drug candidates. vTv has a pipeline of clinical drug candidates led by programs for the treatment of type 1 diabetes, Alzheimer's disease, and inflammatory disorders. vTv's development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease (COPD), and genetic mitochondrial diseases.

    Forward-Looking Statements

    This release contains forward-looking statements, which involve risks and uncertainties. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and, in each case, their negative or other various or comparable terminology. All statements other than statements of historical facts contained in this release, including statements regarding the timing of our clinical trials, our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause our results to vary from expectations include those described under the heading "Risk Factors" in our Annual Report on Form 10-K and our other filings with the SEC. These forward-looking statements reflect our views with respect to future events as of the date of this release and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements represent our estimates and assumptions only as of the date of this release and, except as required by law, we undertake no obligation to update or review publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this release. We anticipate that subsequent events and developments will cause our views to change. Our forward-looking statements do not reflect the potential impact of any future acquisitions, merger, dispositions, joint ventures or investments we may undertake. We qualify all of our forward-looking statements by these cautionary statements.

    Non-GAAP Financial Measures

    To supplement our consolidated financial statements, which are prepared and presented in accordance with generally accepted accounting principles in the U.S. ("GAAP"), we use non-GAAP adjusted net loss per fully exchanged share, which is a non-GAAP financial measure. Non-GAAP adjusted net loss per fully exchanged share adjusts the net loss attributable to vTv common shareholders for the impact of adjustments related to outstanding warrants, share-based compensation expense and the portion of net loss attributable to the noncontrolling interest. It also assumes the exchange of all the Class B common stock of vTv Therapeutics Inc. and an equal number of non-voting common units of vTv Therapeutics LLC ("vTv Units") for shares of Class A common stock of vTv Therapeutics Inc. We believe that this measure provides useful information to investors as it eliminates the variability of non-controlling interest resulting from the exchanges of Class B common stock and vTv Units into Class A common stock and other items of a non-cash nature. This measure is not intended to be considered in isolation or as a substitute for, or superior to, financial measures prepared and presented in accordance with GAAP.

    The following is a reconciliation of non-GAAP adjusted net loss per fully exchanged share, basic and diluted to its most directly comparable GAAP measure, net loss per share of vTv Therapeutics Inc. Class A common stock, basic and diluted and the computation of the components of this non-GAAP measure:

     Three Months Ended 
     June 30, 2020  March 31,2020 
    Numerator:       
    Net loss attributable to vTv Therapeutics Inc. common shareholders$(3,368) $(4,724)
    Other income - related party (565)  (363)
    Share-based compensation expense 186   380 
    Deemed distribution to related party     
    Reallocation of net income attributable to noncontrolling

      interest from the assumed exchange of Class B shares (1)
     (1,623)  (2,441)
    Adjusted net loss before noncontrolling interest$(5,370) $(7,148)
    Denominator:       
    Weighted-average number of vTv Therapeutics Inc.

      Class A Common Stock, basic and diluted
     45,661,221   43,462,551 
    Assumed exchange of Class B Common Stock (1) 23,094,221   23,094,221 
    Adjusted proforma fully exchanged weighted-average

      shares of Class A common stock outstanding,

      basic and diluted
     68,755,442   66,556,772 
    Adjusted net loss per fully exchanged share,

      basic and diluted
    $(0.08) $(0.11)



     Three Months Ended June 30,  Six Months Ended June 30, 
     2020  2019  2020  2019 
    Numerator:               
    Net loss attributable to vTv Therapeutics Inc. common shareholders$(3,368) $(2,882) $(8,092) $(8,765)
    Other income - related party (565)  275   (928)  1,196 
    Share-based compensation expense 186   401   566   682 
    Deemed distribution to related party          3,728 
    Reallocation of net income attributable to noncontrolling

      interest from the assumed exchange of Class B shares (1)
     (1,623)  (2,232)  (4,064)  (4,059)
    Adjusted net loss before noncontrolling interest$(5,370) $(4,438) $(12,518) $(7,218)
    Denominator:               
    Weighted-average number of vTv Therapeutics Inc.

      Class A Common Stock, basic and diluted
     45,661,221   28,037,628   44,561,886   25,464,562 
    Assumed exchange of Class B Common Stock (1) 23,094,221   23,094,221   23,094,221   23,094,221 
    Adjusted proforma fully exchanged weighted-average

      shares of Class A common stock outstanding,

      basic and diluted
     68,755,442   51,131,849   67,656,107   48,558,783 
    Adjusted net loss per fully exchanged share,

      basic and diluted
    $(0.08) $(0.09) $(0.19) $(0.15)



    (1) Assumes the exchange of all outstanding Class B common stock, resulting in the elimination of the noncontrolling interest and recognition of the net income attributable to noncontrolling interests.

    Contacts

    Investors:

    Corey Davis

    LifeSci Advisors

    or



    Media:

    Glenn Silver

    Lazar FINN Partners

    646-871-8485

    Primary Logo

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  5. HIGH POINT, N.C., July 27, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) today announced that the Company will present at the upcoming 2020 Alzheimer's Association International Conference (AAIC), held virtually, July 27–31, 2020.

    The poster presentation will highlight additional analyses of the clinical data from the STEADFAST Study of azeliragon showing the relative contribution of the effects on individual test items, as well as on the higher level cognitive and/or function domains, to the potential benefits of azeliragon on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) and Clinical Dementia Rating Scale (CDR), tools used by doctors to assess someone's Alzheimer's disease.

    Details of the virtual…

    HIGH POINT, N.C., July 27, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) today announced that the Company will present at the upcoming 2020 Alzheimer's Association International Conference (AAIC), held virtually, July 27–31, 2020.

    The poster presentation will highlight additional analyses of the clinical data from the STEADFAST Study of azeliragon showing the relative contribution of the effects on individual test items, as well as on the higher level cognitive and/or function domains, to the potential benefits of azeliragon on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) and Clinical Dementia Rating Scale (CDR), tools used by doctors to assess someone's Alzheimer's disease.

    Details of the virtual presentation are below:

    Presentation Title: Effects of azeliragon on ADAS-cog and CDR domains and individual items in patients with mild Alzheimer's disease and type 2 diabetes (T2D).

    Poster Number: 41198

    Category: [Posters: Drug Development] Human/Human Trials: Other

    Date and Time:
    Wednesday, July 29, 2020, (released Tuesday, July 28, 2020 at 5:00 pm CT, 6:00 pm ET)

    The STEADFAST study was comprised of two independent and identical randomized, double-blind, placebo-controlled Phase 3 trials designed to investigate the safety and efficacy of azeliragon as a potential treatment for patients with mild Alzheimer's disease. Positive data from post-hoc analyses of the STEADFAST study indicating a potential benefit of treatment with azeliragon in patients with Alzheimer's disease who also have type 2 diabetes were reported at the 11th Clinical Trials on Alzheimer's Disease (CTAD) conference in 2018.

    About Azeliragon

    Azeliragon is an orally active small-molecule antagonist of the receptor for advanced glycation end products, RAGE. vTv Therapeutics discovered and developed azeliragon using its proprietary drug discovery platform. A broad range of human pathologic and experimental biologic investigation suggests that RAGE ligand interactions lead to sustained inflammatory states that play a role in chronic diseases such as diabetes, inflammation, and Alzheimer's disease. vTv is currently screening patients for a phase 2, randomized, double-blind, placebo-controlled 6-month proof of concept study evaluating azeliragon in patients with mild Alzheimer's disease and type 2 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, Alzheimer's disease, and inflammatory disorders. vTv's development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease (COPD), and genetic mitochondrial diseases. For more information, please visit www.vtvtherapeutics.com or follow us on Twitter: @vTvTherapeutics.

    Forward-Looking Statements

    This release contains forward-looking statements, which involve risks and uncertainties. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and, in each case, their negative or other various or comparable terminology. All statements other than statements of historical facts contained in this release, including statements regarding the timing of our clinical trials, our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause our results to vary from expectations include those described under the heading "Risk Factors" in our Annual Report on Form 10-K and our other filings with the SEC. These forward-looking statements reflect our views with respect to future events as of the date of this release and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements represent our estimates and assumptions only as of the date of this release and, except as required by law, we undertake no obligation to update or review publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this release. We anticipate that subsequent events and developments will cause our views to change. Our forward-looking statements do not reflect the potential impact of any future acquisitions, merger, dispositions, joint ventures or investments we may undertake. We qualify all of our forward-looking statements by these cautionary statements.

    Contacts

    Investors:

    Corey Davis

    LifeSci Advisors

    or

    Media:

    Glenn Silver

    Lazar FINN Partners

    646-871-8485

    Primary Logo

    View Full Article Hide Full Article
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