VTVT vTv Therapeutics Inc.

2.75
+0.03  (+1%)
Previous Close 2.72
Open 2.74
52 Week Low 1.44
52 Week High 4.75
Market Cap $221,823,976
Shares 80,663,264
Float 20,916,905
Enterprise Value $214,572,077
Volume 244,602
Av. Daily Volume 3,671,383
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Upcoming Catalysts

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

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

Latest News

  1. HIGH POINT, N.C., March 23, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) announced today that the U.S. Patent and Trademark Office has issued a patent with claims protecting methods of treatment using TTP399, the company's oral glucokinase activator. The patent number is 10,952,993 (‘993 Patent).

    The ‘993 Patent, expiring in 2039, includes claims covering a method of lowering HbA1c and also reducing the incidence of hypoglycemia in patients with type 1 diabetes by orally administering between 400 mg to 1200 mg of TTP399 per day as an adjunct to insulin therapy.

    vTv expects that the ‘993 Patent will be Orange Book-listable. The ‘993 Patent adds to the portfolio of US patents covering TTP399, including a composition of matter…

    HIGH POINT, N.C., March 23, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) announced today that the U.S. Patent and Trademark Office has issued a patent with claims protecting methods of treatment using TTP399, the company's oral glucokinase activator. The patent number is 10,952,993 (‘993 Patent).

    The ‘993 Patent, expiring in 2039, includes claims covering a method of lowering HbA1c and also reducing the incidence of hypoglycemia in patients with type 1 diabetes by orally administering between 400 mg to 1200 mg of TTP399 per day as an adjunct to insulin therapy.

    vTv expects that the ‘993 Patent will be Orange Book-listable. The ‘993 Patent adds to the portfolio of US patents covering TTP399, including a composition of matter patent that is expected to expire as late as 2030. vTv continues to prosecute additional patent applications to further enhance its existing patent portfolio covering TTP399.

    "This newly-issued patent is an important addition to the intellectual property portfolio that serves as the underpinnings for our strategy with TTP399 as an oral adjunctive treatment in type 1 diabetes," said Steve Holcombe, CEO of vTv Therapeutics.

    As vTv recently announced, TTP399 is currently being studied in a randomized, double blind, mechanistic study in patients with type 1 diabetes evaluating the drug's effect on the risk of diabetic ketoacidosis. In addition, the company is planning to initiate its first pivotal study with TTP399 in patients with type 1 diabetes later this year, along with other NDA supporting studies.

    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 and inflammatory disorders, including psoriasis. vTv's development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease (COPD), renal disease, and primary mitochondrial myopathy. For more information, please visit https://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:



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  2. HIGH POINT, N.C., March 18, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) a clinical-stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes and inflammatory diseases, today announced the initiation of a mechanistic study exploring the effects of TTP399 on ketone body formation during a period of insulin withdrawal in people with type 1 diabetes. The phase 1 study will test the hypothesis that treatment with vTv's TTP399, a liver-selective glucokinase activator, will not result in the increased production of ketones, a precursor to ketoacidosis, which can lead to hospitalization in patients with type 1 diabetes.

    Despite advances in insulin therapy and monitoring technologies…

    HIGH POINT, N.C., March 18, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) a clinical-stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes and inflammatory diseases, today announced the initiation of a mechanistic study exploring the effects of TTP399 on ketone body formation during a period of insulin withdrawal in people with type 1 diabetes. The phase 1 study will test the hypothesis that treatment with vTv's TTP399, a liver-selective glucokinase activator, will not result in the increased production of ketones, a precursor to ketoacidosis, which can lead to hospitalization in patients with type 1 diabetes.

    Despite advances in insulin therapy and monitoring technologies, many patients with type 1 diabetes still do not achieve acceptable glycemic control. Poor glycemic control has resulted in a global increase in hospitalizations for people with type 1 diabetes caused by hypoglycemia or diabetic ketoacidosis. TTP399 previously demonstrated improvement in glycemic control without increased incidence of diabetic ketoacidosis or hypoglycemia in a three-month phase 2 study in patients with type 1 diabetes.

    "Developing a drug that does not increase the risk of diabetic ketoacidosis or, even better, has the potential to reduce that risk while improving glycemic control and reducing the risk of hypoglycemia would be a win for patients with type 1 diabetes," said Steve Holcombe, chief executive officer, vTv Therapeutics. "This would represent a substantial improvement over insulin administration alone."

    The Company continues to push forward with the development of TTP399 in type 1 diabetes and is on track to initiate the first pivotal study later this year.

    About Diabetic Ketoacidosis

    Diabetic ketoacidosis is a serious condition that occurs when the body produces high levels of blood acids called ketones. It occurs most commonly in patients with type 1 diabetes and has been reported to be the cause for 14% of all hospital admissions of these patients and 16% of all diabetes-related fatalities.

    About vTv Therapeutics

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

    Forward-Looking Statements

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

    Contacts

    Investors:

    Corey Davis

    LifeSci Advisors





    or



    Media:

     



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  3. HIGH POINT, N.C., March 08, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) a clinical-stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes and inflammatory diseases, today announced its participation in the H.C. Wainwright Global Life Sciences Conference held virtually March 9-10, 2021.

    The company will be providing a general company update through a virtual presentation that will be available on demand for conference attendees beginning on March 9, 2021. Company management will also be meeting with members of the investment community during one-on-one virtual meetings.

    About vTv Therapeutics
    vTv Therapeutics Inc. is a clinical-stage biopharmaceutical company focused…

    HIGH POINT, N.C., March 08, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) a clinical-stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes and inflammatory diseases, today announced its participation in the H.C. Wainwright Global Life Sciences Conference held virtually March 9-10, 2021.

    The company will be providing a general company update through a virtual presentation that will be available on demand for conference attendees beginning on March 9, 2021. Company management will also be meeting with members of the investment community during one-on-one virtual meetings.

    About vTv Therapeutics

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

    Forward-Looking Statements

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

    Contacts

    Investors:

    Corey Davis

    LifeSci Advisors





    or



    Media:

     

    Source: vTv Therapeutics Inc.



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  4. Initiation of Mechanistic Study of TTP399 expected during Q1 2021

    Announcement of First-Patient First-Visit in Multiple Ascending Dose Phase 1 Study of HPP737

    Publication of Phase 2 SimpliciT-1 Results of TTP399 in ADA's Diabetes Care Journal

    HIGH POINT, N.C., Feb. 24, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) today reported financial results for the fourth quarter and year ended December 31, 2020, and provided an update on the progress of its clinical programs.

    "Despite the challenges of operating through a global pandemic, 2020 was a successful year for vTv Therapeutics," said Steve Holcombe, president and CEO. "We had positive results in the Phase 2 SimpliciT-1 Study with our lead compound, TTP399, paving the way…

    Initiation of Mechanistic Study of TTP399 expected during Q1 2021

    Announcement of First-Patient First-Visit in Multiple Ascending Dose Phase 1 Study of HPP737

    Publication of Phase 2 SimpliciT-1 Results of TTP399 in ADA's Diabetes Care Journal

    HIGH POINT, N.C., Feb. 24, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) today reported financial results for the fourth quarter and year ended December 31, 2020, and provided an update on the progress of its clinical programs.

    "Despite the challenges of operating through a global pandemic, 2020 was a successful year for vTv Therapeutics," said Steve Holcombe, president and CEO. "We had positive results in the Phase 2 SimpliciT-1 Study with our lead compound, TTP399, paving the way for our continued development of this asset in patients with type 1 diabetes. In addition, we strengthened our current and future financial position with the initiation of our ATM, agreement with Lincoln Park Capital, and licensing agreement with Anteris Bio."

    "In 2021, we look forward to building on these successes as we advance our two lead programs for the treatment of type 1 diabetes and psoriasis. We plan to initiate our first pivotal study of TTP399 along with other supporting studies to demonstrate our unique glucokinase activator's potential to reduce the incidence of hypoglycemia in people with type 1 diabetes. Furthermore, we have commenced a multiple ascending dose study with HPP737 to be followed by a phase 2 study in patients with psoriasis in order to demonstrate HPP737's potential to be a well-tolerated, next-generation PDE4 inhibitor."

    Recent Achievements and Outlook

    Type 1 Diabetes

    • Mechanistic Study of Ketoacidosis with TTP399. To further support the hypothesis that TTP399 may help reduce the incidence of ketoacidosis, vTv will begin dosing of a mechanistic study of TTP399 in patients with type 1 diabetes during Q1 of 2021 to determine the impact of TTP399 on ketone body formation during a period of acute insulin withdrawal. The FDA agreed with the Company's recommendation that such a mechanistic study be performed in support of the Company's planned pivotal trials. vTv expects to report topline results from the mechanistic study in Q2/Q3 2021.
    • Pivotal Study Planning. The Company is planning to initiate the first of two pivotal, placebo-controlled, six-month clinical trials of TTP399 in approximately 400 subjects with type 1 diabetes in 2H 2021. The studies will be designed to assess TTP399's ability to reduce the incidence of hypoglycemia when administered as an oral adjunct to insulin therapy.
    • Publication of SimpliciT-1 Results. Diabetes Care, the American Diabetes Association's journal of clinical research, published the positive results of the Phase 2 SimpliciT-1 Study of TTP399 as an adjunct therapy to insulin in patients with type 1 diabetes, which showed statistically significant reductions in HbA1c and clinically meaningful reductions in hypoglycemia.

    Psoriasis

    • First-Patient First-Visit of Multiple Ascending Dose Study with HPP737. The Company has begun dosing of a phase 1 multiple ascending dose study to assess the safety, tolerability, and pharmacokinetic profile of HPP737, a PDE4 inhibitor, in healthy volunteers. The phase 1 study will inform dose selection for the planned phase 2 study in psoriasis that the Company expects to begin later this year.

    Strategic Partnership with Anteris Bio

    • License Agreement for Nrf2 Activator HPP971. In December 2020, the Company announced a new license agreement with Anteris Bio for worldwide rights to vTv's novel, clinical-stage Nrf2 activator compound, HPP971. Anteris will be pursuing indications in renal disease with HPP971.

    Azeliragon (TTP488)

    • Discontinuation of azeliragon for Alzheimer's disease. On December 15, 2020, vTv announced that the phase 2 Elevage Study of azeliragon did not meet its primary objective. vTv has discontinued development of azeliragon for Alzheimer's disease, but the Company is evaluating potential alternative indications in partnership with other interested parties.

    Capital Raising

    • At-the-Market (ATM) Offering. In January, the Company filed a prospectus supplement for $5.5 million of additional capacity under the Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co. As of the date of this release, the full $5.5 million remains available.
    • Lincoln Park. The Company continues to leverage its partnership with Lincoln Park to raise capital to fund its on-going and planned clinical trials and corporate operations on an opportunistic basis.

    Fourth Quarter 2020 Financial Results

    • Cash Position: The Company's cash position as of December 31, 2020, was $5.7 million compared to $1.8 million as of September 30, 2020.
    • Revenue: Revenue for the fourth quarter was $6.4 million and was insignificant for the third quarter of 2020. The revenue for the fourth quarter was primarily attributable to the upfront consideration, consisting of cash and an equity interest, received in connection with the Company's license agreement with Anteris Bio.
    • R&D Expenses: Research and development expenses were $2.5 million and $1.8 million for the three months ended December 31, 2020 and September 30, 2020, respectively. This increase of $0.8 million was driven primarily by the reversal of certain performance-based compensation accruals which occurred in the third quarter.
    • G&A Expenses: General and administrative expenses were $2.0 million for the fourth quarter of 2020 and $1.1 million for the third quarter, respectively. The increase of $1.0 million was driven by the reversal of certain performance-based compensation accruals in the third quarter.
    • Net Income/(Loss) Before Non-Controlling Interest: Net income before non-controlling interest was $1.6 million for the fourth quarter of 2020 compared to a net loss of $2.3 million for the third quarter of 2020.
    • Net Income/(Loss) Per Share: Diluted net income per share was $0.02 for the three months ended December 31, 2020 compared to a diluted net loss per share of ($0.03) for the three months ended September 30, 2020, based on weighted-average diluted shares of 74.4 million and 48.2 million for the three-month periods ended December 31, 2020 and September 30, 2020, respectively. Non-GAAP net income per fully exchanged share was $0.02 for the three months ended December 31, 2020 compared to a net loss per fully exchanged share of ($0.02) at September 30, 2020, based on non-GAAP fully exchanged weighted-average shares of 74.4 million and 71.3 million for the three months ended December 31, 2020 and September 30, 2020, respectively.

    Full Year 2020 Financial Results

    • Revenue: Revenues were $6.4 million and $2.8 million for the years ended December 31, 2020 and 2019, respectively. The 2020 revenue is attributable to the upfront payment and fair value of the equity interest received by the Company in connection with the license agreement with Anteris Bio. The revenue earned during 2019 primarily relates to the recognition of amounts deferred for the license agreement with Reneo and a milestone received under the license agreement with Newsoara.
    • R&D Expenses: Research and development expenses were $11.0 million and $15.1 million for the years ended December 31, 2020 and 2019, respectively. This decrease was attributable primarily to lower spending on clinical trials for azeliragon and TTP399 in 2020 coupled with the impact of reversals of performance-based compensation accruals in 2020.
    • G&A Expenses: General and administrative expenses were $7.3 million and $8.5 million for the years ended December 31, 2020 and 2019, respectively. Such decreases were primarily driven by lower compensation costs related to a reversal of accruals for performance-based compensation and lower share-based compensation expense in 2020.
    • Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $12.8 million and $21.9 million for the years ended December 31, 2020 and 2019, respectively.
    • Net Loss Per Share: GAAP net loss per share was $0.18 and $0.59 for the years ended December 31, 2020 and 2019, respectively, based on weighted-average shares of 47.1 million and 30.3 million for the years ended December 31, 2020 and 2019, respectively. Non-GAAP net loss per fully exchanged share was $0.17 and $0.37 for the years ended December 31, 2020 and 2019, respectively, based on non-GAAP fully exchanged weighted-average shares of 70.2 million and 53.4 million for the years ended December 31, 2020 and 2019, respectively.



    vTv Therapeutics Inc.

    Condensed Consolidated Balance Sheets

    (in thousands)

      December 31,  September 30, 
      2020  2020 
          (Unaudited) 
    Assets        
    Current assets:        
    Cash and cash equivalents $5,747  $1,827 
    Accounts receivable, net  158   14 
    Prepaid expenses and other current assets  939   1,306 
    Current deposits  371   531 
    Total current assets  7,215   3,678 
    Property and equipment, net  367   389 
    Operating lease right-of-use assets  482   499 
    Long-term investments  6,725   2,480 
    Total assets $14,789  $7,046 
    Liabilities, Redeemable Noncontrolling Interest and Stockholders' Deficit        
    Current liabilities:        
    Accounts payable and accrued expenses $6,120  $5,747 
    Operating lease liabilities  155   149 
    Current portion of contract liabilities  31   31 
    Current portion of notes payable  84   2,369 
    Total current liabilities  6,390   8,296 
    Contract liabilities, net of current portion  1,009   1,017 
    Operating lease liabilities, net of current portion  676   717 
    Warrant liability, related party  2,871   2,715 
    Other liabilities  50   82 
    Total liabilities  10,996   12,827 
    Commitments and contingencies        
    Redeemable noncontrolling interest  83,895   45,591 
    Stockholders' deficit:        
    Class A Common Stock  541   492 
    Class B Common Stock  232   232 
    Additional paid-in capital  209,161   201,243 
    Accumulated deficit  (290,036)  (253,339)
    Total stockholders' deficit attributable to vTv Therapeutics Inc.  (80,102)  (51,372)
    Total liabilities, redeemable noncontrolling interest and stockholders' deficit $14,789  $7,046 



    vTv Therapeutics Inc.

    Condensed Consolidated Statements of Operations - Unaudited

    (in thousands, except per share data)

      Three Months Ended 
      December 31, 2020  September 30, 2020 
    Revenue $6,399  $7 
    Operating expenses:        
    Research and development  2,534   1,768 
    General and administrative  2,035   1,071 
    Total operating expenses  4,569   2,839 
    Operating income/(loss)  1,830   (2,832)
    Interest expense  (67)  (235)
    Other (expense) income, net  (156)  814 
    Loss before income taxes and noncontrolling interest  1,607   (2,253)
    Income tax provision      
    Net loss before noncontrolling interest  1,607   (2,253)
    Less: net income/(loss) attributable to noncontrolling interest  481   (720)
    Net income/(loss) attributable to vTv Therapeutics Inc. $1,126  $(1,533)
    Net income/(loss) attributable to vTv Therapeutics Inc. common shareholders $1,126  $(1,533)
             
    Net income/(loss) per share:        
    Basic net income/(loss) per share of vTv Therapeutics Inc. Class A Common Stock $0.02  $(0.03)
    Diluted net income/(loss) per share of vTv Therapeutics Inc. Class A Common Stock $0.02  $(0.03)
             
    Weighted average shares used in calculating:        
    Basic net income/(loss) per share of vTv Therapeutics Inc. Class A Common Stock  51,133,609   48,238,285 
    Diluted net income/(loss) per share of vTv Therapeutics Inc. Class A Common Stock  74,397,085   48,238,285 



    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, 
      2020  2019  2020  2019 
                 
      (Unaudited)    
    Revenue $6,399  $7  $6,414  $2,764 
    Operating expenses:                
    Research and development  2,534   4,406   11,015   15,119 
    General and administrative  2,035   1,989   7,251   8,537 
    Total operating expenses  4,569   6,395   18,266   23,656 
    Operating income/(loss)  1,830   (6,388)  (11,852)  (20,892)
    Interest income     12   12   53 
    Interest expense  (67)  (283)  (692)  (1,827)
    Other (expense) income, net  (156)  (223)  (270)  828 
    Income/(loss) before income taxes and noncontrolling interest  1,607   (6,882)  (12,802)  (21,838)
    Income tax provision           100 
    Net income/(loss) before noncontrolling interest  1,607   (6,882)  (12,802)  (21,938)
    Less: net income/(loss) attributable to noncontrolling interest  481   (2,483)  (4,303)  (8,894)
    Net income/(loss) attributable to vTv Therapeutics Inc. $1,126  $(4,399) $(8,499) $(13,044)
    Net income/(loss) attributable to vTv Therapeutics Inc. common shareholders $1,126  $(5,033) $(8,499) $(17,913)
                     
    Net income/(loss) per share:                
    Basic net income/(loss) per share of vTv Therapeutics Inc. Class A Common Stock $0.02  $(0.13) $(0.18) $(0.59)
    Diluted net income/(loss) per share of vTv Therapeutics Inc. Class A Common Stock $0.02  $(0.13) $(0.18) $(0.59)
                     
    Weighted average shares used in calculating:                
    Basic net income/(loss) per share of vTv Therapeutics Inc. Class A Common Stock  51,133,609   37,955,449   47,137,917   30,292,030 
    Diluted net income/(loss) per share of vTv Therapeutics Inc. Class A Common Stock  74,397,085   37,955,449   47,137,917   30,292,030 



    About vTv Therapeutics

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

    Forward-Looking Statements

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

    Non-GAAP Financial Measures

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

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

      Three Months Ended 
      December 31, 2020  September 30, 2020 
    Numerator:        
    Net income/(loss) attributable to vTv Therapeutics Inc. common shareholders $1,126  $(1,533)
    Other income - related party  (156)  814 
    Share-based compensation expense  272   171 
    Deemed distribution to related party      
    Reallocation of net income attributable to noncontrolling interest from the assumed exchange of Class B shares (1)  481   (720)
    Adjusted net income/(loss) before noncontrolling interest $1,723  $(1,268)
    Denominator:        
    Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, diluted  74,397,085   48,238,285 
    Assumed exchange of Class B Common Stock (1)     23,094,221 
    Adjusted proforma fully exchanged weighted-average shares of Class A common stock outstanding, diluted  74,397,085   71,332,506 
    Adjusted net income/(loss) per fully exchanged share, diluted $0.02  $(0.02)



      Three Months Ended

    December 31,
      Twelve Months Ended

    December 31,
     
      2020  2019  2020  2019 
    Numerator:                
    Net income/(loss) attributable to vTv Therapeutics Inc. common shareholders $1,126  $(5,033) $(8,499) $(17,913)
    Other income - related party  (156)  (223)  (270)  827 
    Share-based compensation expense  272   423   1,009   1,518 
    Deemed distribution to related party     634      4,869 
    Reallocation of net income attributable to noncontrolling interest from the assumed exchange of Class B shares (1)  481   (2,483)  (4,303)  (8,894)
    Adjusted net income/(loss) before noncontrolling interest $1,723  $(6,682) $(12,063) $(19,593)
    Denominator:                
    Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, diluted  74,397,085   37,955,449   47,137,917   30,292,030 
    Assumed exchange of Class B Common Stock (1)     23,094,221   23,094,221   23,094,221 
    Adjusted proforma fully exchanged weighted-average shares of Class A common stock outstanding, diluted  74,397,085   61,049,670   70,232,138   53,386,251 
    Adjusted net income/(loss) per fully exchanged share, diluted $0.02  $(0.11) $(0.17) $(0.37)



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



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  5. HIGH POINT, N.C., Feb. 23, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT), a clinical-stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes (T1D) and inflammatory diseases, today announced that the results from the JDRF-supported SimpliciT-1 Study were published in the American Diabetes Association's Diabetes Care journal. The SimpliciT-1 Study was a multi-center, randomized, double-blind, adaptive study assessing the safety and efficacy of TTP399 as an adjunct to insulin therapy in adults with T1D. TTP399 is a novel, hepatoselective glucokinase activator in development for the reduction of hypoglycemic events in patients with T1D.

    The Phase 2 study was conducted in…

    HIGH POINT, N.C., Feb. 23, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT), a clinical-stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes (T1D) and inflammatory diseases, today announced that the results from the JDRF-supported SimpliciT-1 Study were published in the American Diabetes Association's Diabetes Care journal. The SimpliciT-1 Study was a multi-center, randomized, double-blind, adaptive study assessing the safety and efficacy of TTP399 as an adjunct to insulin therapy in adults with T1D. TTP399 is a novel, hepatoselective glucokinase activator in development for the reduction of hypoglycemic events in patients with T1D.

    The Phase 2 study was conducted in two parts under a treat-to-target protocol to evaluate the safety and efficacy of TTP399 in T1D patients over 12 weeks of daily dosing following a multi-week insulin optimization and placebo run-in period.

    Published results from the study showed that treatment with 800mg of TTP399 demonstrated statistically significant reductions in HbA1c, as previously announced. Interestingly, it also resulted in a clinically relevant (~40%) reduction in the frequency of severe or symptomatic hypoglycemia, as compared to placebo. Abnormal serum and urine ketones were detected less frequently in participants in the TTP399 group than in the placebo group. These data suggest the potential of TTP399 to lower HbA1c and reduce hypoglycemia without increasing the risk of ketosis and should be further evaluated as an adjunctive therapy for the treatment of type 1 diabetes. vTv looks forward to initiation of its first pivotal study of TTP399 later this year.

    "An adjunctive therapy that protects against the main acute, life-threatening complications of type 1 diabetes while maintaining or improving glycemic control would represent a substantial advancement in clinical standard of care," said Dr. Carmen Valcarce, vTv's chief scientific officer. "The data presented in this publication support our enthusiasm and our commitment to continuing the development of TTP399 as an oral adjunctive therapy to insulin in T1D."

    Dr. Klara Klein, MD, PhD, Division of Endocrinology and Metabolism at the University of North Carolina at Chapel Hill, and lead author stated, "The significant improvement in HbA1c, under a stringent treat-to-target design, without an increase in hypoglycemia or blood ketones is a unique observation that, if confirmed in larger studies, reinforces the potential for TTP399 to help people with T1D achieve optimal glycemic control safely."

    The publication, titled "The SimpliciT1 study: A randomized, double-blind placebo-controlled, Phase 1b/2 adaptive study of TTP399, a hepatoselective glucokinase activator, for adjunctive treatment of type 1 diabetes mellitus", is published online ahead of print at https://care.diabetesjournals.org/lookup/doi/10.2337/dc20-2684.

    About vTv Therapeutics

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

    Forward-Looking Statements

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

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    Investors:

    Corey Davis

    LifeSci Advisors





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    Source: vTv Therapeutics Inc.



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