1. HIGH POINT, N.C., Aug. 04, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) today reported financial results for the second quarter ended June 30, 2021, and provided an update on the progress of its clinical programs.

    "We held our first, highly-productive meeting with the FDA following the designation of Breakthrough Therapy for TTP399 as a potential adjunct treatment for type 1 diabetes," said Steve Holcombe, president and CEO, vTv Therapeutics. "Based upon the outcome of this meeting, we are planning to conduct two pivotal studies of TTP399 starting in the first half of 2022. We are appreciative of the ongoing dialogue that the Breakthrough Designation affords us and look forward to continuing to work closely with the agency…

    HIGH POINT, N.C., Aug. 04, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) today reported financial results for the second quarter ended June 30, 2021, and provided an update on the progress of its clinical programs.

    "We held our first, highly-productive meeting with the FDA following the designation of Breakthrough Therapy for TTP399 as a potential adjunct treatment for type 1 diabetes," said Steve Holcombe, president and CEO, vTv Therapeutics. "Based upon the outcome of this meeting, we are planning to conduct two pivotal studies of TTP399 starting in the first half of 2022. We are appreciative of the ongoing dialogue that the Breakthrough Designation affords us and look forward to continuing to work closely with the agency as we refine the design of these studies in the coming weeks."

    Recent Achievements and Outlook

    Type 1 Diabetes

    • Breakthrough Therapy Designation Type B Meeting. As announced in April, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for TTP399 as an adjunctive therapy to insulin for the treatment of type 1 diabetes. The Company held its first Type B meeting with the FDA pursuant to the Breakthrough Therapy designation to discuss the development of TTP399.



    • Mechanistic Study of Ketoacidosis with TTP399. The Company completed enrollment in the mechanistic study of TTP399 in people with type 1 diabetes. This phase 1 study is designed to assess the impact of TTP399 on ketone body formation, and therefore the risk of diabetic ketoacidosis, during a period of acute insulin withdrawal. vTv expects to report topline results from this mechanistic study in late third quarter or early fourth quarter of 2021.



    • Pivotal Study Planning. The Company is planning two pivotal, placebo-controlled clinical trials of TTP399 in subjects with type 1 diabetes that are expected to begin in the first half of 2022.

    Psoriasis

    • Multiple Ascending Dose Study with HPP737. The Company completed dosing healthy subjects in a phase 1 multiple ascending dose study to assess the safety, tolerability, and pharmacokinetic profile of HPP737, an oral PDE4 inhibitor. We expect to report the results from this study in the third quarter.



    • Phase 2 Study Planning. The Company is planning a phase 2 clinical trial of HPP737 in patients with psoriasis. We are discussing the proposed study design with the FDA during the third quarter and expect to begin the study late in the fourth quarter of 2021 or early in the first quarter of 2022.

    License Partner Updates

    • vTv and Cantex Entered into a Strategic Licensing Agreement for Azeliragon. In June, the Company announced a new strategic collaboration with Cantex Pharmaceuticals under which Cantex will continue the development of azeliragon for the treatment of the complications associated with cancer, including cachexia and pain from bone metastasis. Cantex will be responsible for the development and commercialization of azeliragon and the companies will allocate profits under a tiered arrangement.



    • Reneo Dosed the First Patient in Phase 2b STRIDE Study. In July, Reneo Pharmaceuticals dosed the first patient in the phase 2b STRIDE Study, designed to assess the efficacy and safety of REN001 for the treatment of patients with primary mitochondrial myopathies.

    Funding Updates

    • $50 Million ATM Program. The Company added an additional $50 million of capacity to its at-the-market equity program with Cantor Fitzgerald to fund the ongoing and planned development of TTP399 and HPP737.



    • Registration of Additional Shares to Support Equity Line. The Company registered an additional 9.4 million shares of Class A Common Stock to provide the continued flexibility to raise capital with share sales to Lincoln Park Capital under the Purchase Agreement entered into in November of 2020.

    First Quarter 2021 Financial Results

    • Cash Position: The Company's cash position as of June 30, 2021, was $10.8 million compared to $8.4 million as of March 31, 2021.



    • Revenue: Revenue for the second quarter of 2021 was an insignificant amount. For the first quarter of 2021 revenue was $1.0 million. The revenue for the first quarter was non-cash and related to the recognition of revenue pertaining to the Huadong license agreement.



    • R&D Expenses: Research and development expenses were $2.4 million and $3.1 million for the three months ended June 30, 2021 and March 31, 2021, respectively. This decrease of $0.7 million was driven primarily by the decreases in spending for the Elevage study as the analysis and close out of this study largely occurred in the first quarter as well as a decrease in spending for our study of HPP737 in psoriasis.



    • G&A Expenses: General and administrative expenses were consistent between periods at $2.2 million for each of the three months ended June 30, 2021 and March 31, 2021.



    • Other Income/(Expense): Other income for the three months ended June 30, 2021 was $3.8 million and was attributable to the changes in the fair value of our investment in Reneo Pharmaceuticals, Inc. which completed its initial public offering in the second quarter of 2021 as well as gains related to a reduction in fair value of the warrants to purchase shares of our own stock issued to a related party (the "Related Party Warrants"). Other expense for the three months ended March 31, 2021 was driven by losses related to an increase in the fair value of the Related Party Warrants.



    • Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $0.8 million for the second quarter of 2021 compared to net loss of $5.9 million for the first quarter of 2021.



    • Net Loss Per Share: Diluted net loss per share was ($0.01) for the three months ended June 30, 2021 compared to diluted net loss per share of ($0.08) for the three months ended March 31, 2021, based on weighted-average diluted shares of 58.6 million and 56.5 million for the three-month periods ended June 30, 2021 and March 31, 2021, respectively.





    vTv Therapeutics Inc.

    Condensed Consolidated Balance Sheets

    (in thousands)

     June 30,  March 31, 
     2021  2021 
     (Unaudited)  (Unaudited) 
    Assets       
    Current assets:       
    Cash and cash equivalents$10,835  $8,449 
    Accounts receivable, net    2 
    Prepaid expenses and other current assets 313   710 
    Current deposits 124   60 
    Total current assets 11,272   9,221 
    Property and equipment, net 322   344 
    Operating lease right-of-use assets 444   464 
    Long-term investments 9,622   6,725 
    Total assets$21,660  $16,754 
    Liabilities, Redeemable Noncontrolling Interest and Stockholders' Deficit       
    Current liabilities:       
    Accounts payable and accrued expenses$4,855  $4,965 
    Operating lease liabilities 169   162 
    Current portion of contract liabilities 35   35 
    Current portion of notes payable     
    Total current liabilities 5,059   5,162 
    Contract liabilities, net of current portion 9   18 
    Operating lease liabilities, net of current portion 587   633 
    Warrant liability, related party 3,588   4,519 
    Other liabilities 50   50 
    Total liabilities 9,293   10,382 
    Commitments and contingencies       
    Redeemable noncontrolling interest 60,190   62,647 
    Stockholders' deficit:       
    Class A Common Stock 602   576 
    Class B Common Stock 232   232 
    Additional paid-in capital 224,457   217,647 
    Accumulated deficit (273,114)  (274,730)
    Total stockholders' deficit attributable to vTv Therapeutics Inc. (47,823)  (56,275)
    Total liabilities, redeemable noncontrolling interest and stockholders' deficit$21,660  $16,754 





    vTv Therapeutics Inc.


    Condensed Consolidated Statements of Operations - Unaudited

    (in thousands, except per share data)

     Three Months Ended 
     June 30, 2021  March 31, 2021 
    Revenue$9  $987 
    Operating expenses:       
    Research and development 2,437   3,103 
    General and administrative 2,242   2,164 
    Total operating expenses 4,679   5,267 
    Operating loss (4,670)  (4,280)
    Interest income    1 
    Interest expense     
    Other income (expense), net 3,829   (1,648)
    Loss before income taxes and noncontrolling interest (841)  (5,927)
    Income tax provision    15 
    Net loss before noncontrolling interest (841)  (5,942)
    Less: net loss attributable to noncontrolling interest (233)  (1,701)
    Net loss attributable to vTv Therapeutics Inc.$(608) $(4,241)
    Net loss attributable to vTv Therapeutics Inc. common shareholders$(608) $(4,241)
    Net loss per share of vTv Therapeutics Inc. Class A

      Common Stock, basic and diluted
    $(0.01) $(0.08)
    Weighted-average number of vTv Therapeutics Inc.

      Class A Common Stock, basic and diluted
     58,615,137   56,472,535 
            



    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, 
     2021  2020  2021  2020 
     (Unaudited)  (Unaudited)  
    Revenue$9  $  $996  $8 
    Operating expenses:               
    Research and development 2,437   2,509   5,540   6,713 
    General and administrative 2,242   1,695   4,406   4,145 
    Total operating expenses 4,679   4,204   9,946   10,858 
    Operating loss (4,670)  (4,204)  (8,950)  (10,850)
    Interest income       1   12 
    Interest expense    (222)     (390)
    Other income (expense), net 3,829   (565)  2,181   (928)
    Loss before income taxes and noncontrolling interest (841)  (4,991)  (6,768)  (12,156)
    Income tax provision       15    
    Net loss before noncontrolling interest (841)  (4,991)  (6,783)  (12,156)
    Less: net loss attributable to noncontrolling interest (233)  (1,623)  (1,934)  (4,064)
    Net loss attributable to vTv Therapeutics Inc.$(608) $(3,368) $(4,849) $(8,092)
    Net loss attributable to vTv Therapeutics Inc. common

    shareholders
    $(608) $(3,368) $(4,849) $(8,092)
    Net loss per share of vTv Therapeutics Inc. Class A

      Common Stock, basic and diluted
    $(0.01) $(0.07) $(0.08) $(0.18)
    Weighted-average number of vTv Therapeutics Inc.

      Class A Common Stock, basic and diluted
     58,615,137   45,661,221   57,549,755   44,561,886 

    About vTv Therapeutics

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

    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

    CDavis@LifeSciAdvisors.com

    or



    Media:

    PR@vtvtherapeutics.com 

     



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

    Poster Details:

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

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

    Poster Details:

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

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

    About HPP737

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

    About vTv Therapeutics

    vTv Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing oral, small molecule drug candidates. vTv has a pipeline of clinical drug candidates led by programs for the treatment of type 1 diabetes (T1D) and psoriasis. vTv's development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease (COPD), renal disease, and primary mitochondrial myopathy.

    For more information, please visit www.vtvtherapeutics.com or follow us on Twitter: @vTvTherapeutics.

    Forward-Looking Statements

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

    Contacts

    Investors:

    Corey Davis

    LifeSci Advisors

    CDavis@LifeSciAdvisors.com



    or



    Media:

    PR@vtvtherapeutics.com 

    Source: vTv Therapeutics Inc.



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

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

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

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

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

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

    About Azeliragon

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

    About vTv Therapeutics

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

    About Cantex Pharmaceuticals

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

    Forward-Looking Statements

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

    vTv Contacts

    Investors:

    Corey Davis

    LifeSci Advisors

    CDavis@LifeSciAdvisors.com



    or



    Media:

    PR@vtvtherapeutics.com

    Cantex Contacts

    Investors:

    Stephen G. Marcus, M.D.

    (954) 315-3660

    smarcus@cantex.com

    or

    Media:

    Barbara Lindheim

    BLL Partners, LLC

    (917) 355-9234

    blindheim@bllbiopartners.com



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

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

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

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

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

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

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

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

    Recent Achievements and Outlook

    Type 1 Diabetes

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



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



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

    Psoriasis

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

    License Partner Updates

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

    First Quarter 2021 Financial Results

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



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



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



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



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



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





    vTv Therapeutics Inc.

    Condensed Consolidated Balance Sheets

    (in thousands)

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

    vTv Therapeutics Inc.

    Condensed Consolidated Statements of Operations - Unaudited

    (in thousands, except per share data)

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

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

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

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

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

    vTv Therapeutics Inc.

    Condensed Consolidated Statements of Operations

    (in thousands, except per share data)

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

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

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

    About vTv Therapeutics

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

    Forward-Looking Statements

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

    Non-GAAP Financial Measures

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

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

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

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

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

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



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

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

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

    shares of Class A common stock outstanding,

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

    diluted
    $(0.09) $(0.11)



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

    Contacts

    Investors:

    Corey Davis

    LifeSci Advisors

    CDavis@LifeSciAdvisors.com

    or



    Media:

    PR@vtvtherapeutics.com 



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

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

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

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

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

    About FDA Breakthrough Therapy Designation

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

    About Type 1 Diabetes

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

    About vTv Therapeutics

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

    Forward-Looking Statements

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

    Contacts

    Investors:

    Corey Davis

    LifeSci Advisors

    CDavis@LifeSciAdvisors.com



    or



    Media:



    PR@vtvtherapeutics.com  



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

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

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

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

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

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

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

    About the SimpliciT-1 Study

    The SimpliciT-1 Study was a multi-center, randomized, double-blind, adaptive study assessing the safety and efficacy of TTP399 as an adjunct to insulin therapy in adults with T1D. The Phase 2 study was conducted in two parts under a treat-to-target protocol to evaluate the safety and efficacy of TTP399 in T1D patients over 12 weeks of daily dosing following a multi-week insulin optimization and placebo run-in period.

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

    About vTv Therapeutics

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

    Forward-Looking Statements

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

    Contacts

    Investors:

    Corey Davis

    LifeSci Advisors

    CDavis@LifeSciAdvisors.com



    or



    Media:

    PR@vtvtherapeutics.com 

    Source: vTv Therapeutics Inc. 



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  7. 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

    CDavis@LifeSciAdvisors.com

    or

    Media:

    PR@vTvTherapeutics.com



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  8. 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

    CDavis@LifeSciAdvisors.com



    or



    Media:

    PR@vtvtherapeutics.com 



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  9. 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

    CDavis@LifeSciAdvisors.com



    or



    Media:

    PR@vtvtherapeutics.com 

    Source: vTv Therapeutics Inc.



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  10. 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.



    Contacts

    Investors:

    Corey Davis

    LifeSci Advisors

    CDavis@LifeSciAdvisors.com

    or

    Media:

    PR@vtvtherapeutics.com



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  11. 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.

    Contacts

    Investors:

    Corey Davis

    LifeSci Advisors

    CDavis@LifeSciAdvisors.com



    or



    Media:

    PR@vtvtherapeutics.com 

    Source: vTv Therapeutics Inc.



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  12. Phase 1 multiple ascending dose study to evaluate safety of HPP737 in healthy volunteers and inform dose selection for phase 2 planned for 2H 2021

    Strategic Partner in Asia and Pacific Rim, Newsoara Biopharma, has initiated a phase 2 study in COPD in China

    HIGH POINT, N.C., Feb. 17, 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 phase 1 multiple ascending dose study evaluating an orally administered phosphodiesterase type 4 ("PDE4") inhibitor, HPP737, to assess the pharmacokinetics, pharmacodynamics, safety and tolerability of HPP737 in healthy…

    Phase 1 multiple ascending dose study to evaluate safety of HPP737 in healthy volunteers and inform dose selection for phase 2 planned for 2H 2021

    Strategic Partner in Asia and Pacific Rim, Newsoara Biopharma, has initiated a phase 2 study in COPD in China

    HIGH POINT, N.C., Feb. 17, 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 phase 1 multiple ascending dose study evaluating an orally administered phosphodiesterase type 4 ("PDE4") inhibitor, HPP737, to assess the pharmacokinetics, pharmacodynamics, safety and tolerability of HPP737 in healthy adult volunteers. The Company expects to complete the study in Q2 2021.

    This randomized, double-blind, placebo-controlled, multiple ascending dose study will evaluate up to 3 doses of HPP737 administered for 14 days in healthy volunteers. The goal of this study is to determine the maximum tolerated dose with minimal or no gastrointestinal intolerance to inform dose selection for a phase 2 study in psoriasis which is planned for later this year.

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

    Additionally, the company's strategic partner, Newsoara Biopharma, has advanced HPP737 into phase 2 with the initiation of a proof of concept study in chronic obstructive pulmonary disease (COPD) in China. The phase 2 study in COPD follows the completion of a phase 1 pharmacokinetic bridging study in which HPP737 was well tolerated with no dose limiting safety or tolerability findings and little or no gastrointestinal distress. Newsoara is also initiating phase 2 studies in psoriasis and atopic dermatitis, respectively, in 2021.

    "The initiation of this study with HPP737 is an important next step for our company and we hope to demonstrate HPP737's potential to be a well-tolerated, next-generation PDE4 inhibitor," said Steve Holcombe, chief executive officer, vTv Therapeutics. "We are also very pleased with Newsoara's clinical advancements in China and plan to leverage the data generated in these studies to complement our development efforts in the rest of the world."

    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.

    About Newsoara Biopharma

    Newsoara is a biotech company based in Shanghai, China with research laboratories in the Suzhou BioBAY focusing on novel drug research and development to address unmet medical needs in patients with respiratory, metabolic, autoimmune and oncology 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.

    Contacts

    Investors:

    Corey Davis

    LifeSci Advisors

    CDavis@LifeSciAdvisors.com

    or

    Media:

    PR@vtvtherapeutics.com 

    Source: vTv Therapeutics Inc.



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  13. HIGH POINT, N.C., Jan. 06, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) a clinical-stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes and inflammatory diseases, today announced that it is participating in the LifeSci Partners 10th Annual Healthcare Corporate Access Event held virtually from January 11-14 2021.

    Company management will be conducting one-on-one virtual meetings during the week of the conference concurrently with J.P. Morgan's 39th Annual Healthcare Conference. To request a meeting, please visit the following registration link http://lifesci.events/LifeSci2021.

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

    HIGH POINT, N.C., Jan. 06, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) a clinical-stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes and inflammatory diseases, today announced that it is participating in the LifeSci Partners 10th Annual Healthcare Corporate Access Event held virtually from January 11-14 2021.

    Company management will be conducting one-on-one virtual meetings during the week of the conference concurrently with J.P. Morgan's 39th Annual Healthcare Conference. To request a meeting, please visit the following registration link http://lifesci.events/LifeSci2021.

    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. vTv's development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease (COPD), renal disease 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

    CDavis@LifeSciAdvisors.com



    or



    Media:

    PR@vtvtherapeutics.com 

    Source: vTv Therapeutics Inc.



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  14. HIGH POINT, N.C., Dec. 15, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) today announced that the Phase 2 Elevage study of azeliragon in people with mild Alzheimer's disease and type 2 diabetes did not meet its primary objective of demonstrating an improvement in cognition as assessed by the 14-item Alzheimer's Disease Assessment Scale – Cognitive Subscale (ADAS-cog14) relative to placebo. The 6-month trial investigated the efficacy and safety of 5 mg azeliragon administered orally once daily compared to placebo in 43 people with mild probable Alzheimer's disease and type 2 diabetes. The azeliragon treated group (n=21) had a 1.8 point decline from baseline in ADAS-cog14 compared to a placebo (n=22) decline of 0.35. These differences…

    HIGH POINT, N.C., Dec. 15, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) today announced that the Phase 2 Elevage study of azeliragon in people with mild Alzheimer's disease and type 2 diabetes did not meet its primary objective of demonstrating an improvement in cognition as assessed by the 14-item Alzheimer's Disease Assessment Scale – Cognitive Subscale (ADAS-cog14) relative to placebo. The 6-month trial investigated the efficacy and safety of 5 mg azeliragon administered orally once daily compared to placebo in 43 people with mild probable Alzheimer's disease and type 2 diabetes. The azeliragon treated group (n=21) had a 1.8 point decline from baseline in ADAS-cog14 compared to a placebo (n=22) decline of 0.35. These differences were not statistically significant. Consistent with previous studies, azeliragon was generally well-tolerated with similar incidences of treatment-emergent adverse events overall and by system organ class in both treatment groups.

    "We will continue to analyze the data to determine if there are potential benefits or future applications for azeliragon in Alzheimer's, dementia or related indications that we or other interested parties may seek to pursue," said Steve Holcombe, chief executive officer, vTv Therapeutics. "On behalf of vTv Therapeutics, we would like to extend our most sincere and heartfelt gratitude to study participants, their families, physicians and caregivers for their commitment to this important study despite the challenging circumstances created by the COVID-19 pandemic."

    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 and related dementia, and inflammatory disorders. vTv's development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease (COPD), genetic mitochondrial diseases, and chronic kidney disease. 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

    CDavis@LifeSciAdvisors.com



    or



    Media:

    Glenn Silver

    Lazar FINN Partners

    646-871-8485

    gsilver@lazarpartners.com 

    Source: vTv Therapeutics Inc. 



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  15. OAKLAND, Calif., Dec. 15, 2020 /PRNewswire/ -- Aditum Bio, the biotech investment firm co-founded in 2019 by former Novartis CEO Joe Jimenez and former President of the Novartis Institutes for BioMedical Research (NIBR) Dr. Mark Fishman, today announced the formation of Anteris Bio, a portfolio company developing a new therapy for the treatment of renal disease. Anteris Bio is being formed following the successful in-licensing of ANT-401 from vTv Therapeutics (NASDAQ:VTVT).   

    Anteris Bio is the third independent company launched by Aditum Bio, whose mission is to give large patient populations access to medicines which otherwise may not be developed. To speed these drugs to market, Aditum Bio fosters an incubator model, focusing on the translational phase of drug development. The "spin out" model enables a nimble, start-up culture with its own dedicated team of managers.

    "We are excited to announce the formation of Anteris Bio, with its focus on renal disease. Unmet medical need is high, with few therapies in development that have the potential to be disease modifying," said Joe Jimenez, Co-Founder and Managing Director of Aditum Bio. Dr. Mark Fishman, Co-Founder and Chair of the Medical and Scientific Advisory Boards added, "The relentless progression of renal disease has been largely refractory to medical therapies.  We hope the fundamental mechanism exemplified by ANT-401 will change that for the better." 

    Chronic kidney disease (CKD) is one of the most significant global health challenges and a leading cause of mortality, both directly and as a key risk factor for cardiovascular disease. Globally, it is estimated that nearly 700 million individuals suffer from CKD, and CKD is directly responsible for over 1 million deaths annually. Clear unmet medical need exists in renal disease as therapies have traditionally revolved around treatment of symptoms (e.g. hypertension, renal failure). ANT-401 is a small molecule activator of Nrf2, a mechanism which has disease modifying potential across multiple etiologies of renal disease. Nrf2 is a transcription factor required for the expression of many antioxidant genes regulated by the ARE promoter sequence. ANT-401 activates Nrf2 through the inhibition of Bach1, a transcription repressor that prevents Nrf2 activity in the nucleus.

    Aditum Bio has partnered with TrialSpark, a technology driven research company that can complete clinical trials faster and at a lower cost than traditional trials. TrialSpark partners with doctors to create trial and referral sites within their existing practices. Their digital platform enables faster patient recruitment, together with common data entry and analysis across sites which leads to speed, quality, and standardization.

    About Aditum Bio

    Aditum Bio is committed to improving public health by accelerating R&D in disease areas with both large and more targeted patient populations, where medical innovation can have a huge impact. Aditum Bio focuses on basic mechanisms of disease, in-licenses promising drug candidates directed at such pathophysiologies, and spins-out individual companies dedicated to bringing each candidate through Phase II clinical trials. In partnership with TrialSpark, Aditum Bio uses data, software and technology to help bring innovative medicines through the clinical trial phase more quickly and with lower costs than traditional pharmaceutical companies.

    For more information, please visit www.aditumbio.com.

    About TrialSpark

    TrialSpark is a technology company that runs end-to-end clinical trials as an alternative to a traditional CRO. TrialSpark has built a technology platform that optimizes all aspects of a clinical trial, enabling faster trial completion, higher data quality, and a more patient-centric experience. TrialSpark also empowers doctors in the community setting to participate in clinical trials, unlocking the 99% of patients the industry has traditionally struggled to reach, accelerating recruitment rates, and democratizing access to clinical trials. TrialSpark is backed by leading investors such as Michael Moritz, John Doerr, Thrive Capital, and Sequoia Capital.

    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.

    Media

    For inquiries, please contact:

    Susie Phillips

    Aditum Bio

    (510) 227-2096

    public.relations@aditumbio.com

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/aditum-bio-announces-formation-of-third-company-anteris-bio-301193067.html

    SOURCE Aditum Bio

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  16. HIGH POINT, N.C., Dec. 15, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) today announced that vTv Therapeutics LLC ("vTv") has entered into a licensing agreement with Anteris Bio for worldwide rights to vTv's novel clinical-stage Nrf2 activator compound, HPP971. Anteris Bio, a newly-formed portfolio company of Aditum Bio, the biotech investment firm co-founded in 2019 by former Novartis CEO Joe Jimenez and former President of the Novartis Institutes for BioMedical Research (NIBR) Dr. Mark Fishman, will focus on developing HPP971 as a new therapy for the treatment of renal disease.

    HPP971 is vTv's most advanced oral, small molecule activator of the Nrf2 pathway (nuclear factor erythroid 2-related factor 2) within its portfolio…

    HIGH POINT, N.C., Dec. 15, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) today announced that vTv Therapeutics LLC ("vTv") has entered into a licensing agreement with Anteris Bio for worldwide rights to vTv's novel clinical-stage Nrf2 activator compound, HPP971. Anteris Bio, a newly-formed portfolio company of Aditum Bio, the biotech investment firm co-founded in 2019 by former Novartis CEO Joe Jimenez and former President of the Novartis Institutes for BioMedical Research (NIBR) Dr. Mark Fishman, will focus on developing HPP971 as a new therapy for the treatment of renal disease.

    HPP971 is vTv's most advanced oral, small molecule activator of the Nrf2 pathway (nuclear factor erythroid 2-related factor 2) within its portfolio of promising Nrf2 compounds. HPP971 has completed two phase 1 studies to date. Under the terms of the agreement, Anteris will pay vTv an upfront payment of $2 million and vTv may be eligible for up to $151 million of future development, regulatory and commercial sales milestones, as well as royalties on annual net sales at a low double-digit rate in exchange for worldwide development and commercialization rights to the compound. In addition, vTv will receive a minority equity interest in Anteris Bio.

    "The Nrf2 pathway is a promising, novel target for combating many diseases related to oxidative stress, including renal disease," said Steve Holcombe, president and chief executive officer of vTv Therapeutics. "We're thrilled to partner with Anteris to further the development of HPP971. With a focus in renal disease and a strategic partnership with TrialSpark, they will have the ability to efficiently develop HPP971 to ultimately bring a potential new treatment option to patients suffering from kidney disease."

    Chronic kidney disease (CKD) is one of the most significant global health challenges and a leading cause of mortality, both directly and as a key risk factor for cardiovascular disease. Globally, it is estimated that nearly 700 million individuals suffer from CKD, and CKD is directly responsible for over 1 million deaths annually. Clear unmet medical need exists in renal disease as therapies have traditionally revolved around treatment of symptoms (e.g. hypertension, renal failure). HPP971, to be renamed ANT-401, is a small molecule activator of Nrf2, a mechanism which has disease modifying potential across multiple etiologies of renal disease. Nrf2 is a transcription factor required for the expression of many antioxidant genes regulated by the ARE promoter sequence. ANT-401 activates Nrf2 through the inhibition of Bach1, a transcription repressor that prevents Nrf2 activity in the nucleus.

    vTv will continue to explore further internal development and partnership opportunities for the remaining molecules in its portfolio of Nrf2 activators.

    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.

    About Aditum Bio

    Aditum Bio is committed to improving public health by accelerating R&D in disease areas with both large and more targeted patient populations, where medical innovation can have a huge impact. Aditum Bio focuses on basic mechanisms of disease, in-licenses promising drug candidates directed at such pathophysiologies, and spins-out individual companies dedicated to bringing each candidate through Phase II clinical trials. In partnership with TrialSpark, a technology driven research company that can complete clinical trials faster and at a lower cost than traditional trials, Aditum Bio uses data, software and technology to help bring innovative medicines through the clinical trial phase more quickly and with lower costs than traditional pharmaceutical companies.

    For more information, please visit www.aditumbio.com.

    Forward-Looking Statements

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

    Contacts

    Investors:

    Corey Davis

    LifeSci Advisors

    CDavis@LifeSciAdvisors.com



    or



    Media:

    Glenn Silver

    Lazar FINN Partners

    646-871-8485

    gsilver@lazarpartners.com 

     



    Primary Logo

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  17. HIGH POINT, N.C., Nov. 24, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) today announced it has entered into a common stock purchase agreement ("Purchase Agreement") for up to $47 million with Lincoln Park Capital Fund, LLC ("LPC"), a Chicago-based institutional investor.

    "The LPC financing will help us reach a number of potential value-driving events over the next six to nine months, including the upcoming topline results of our phase 2 Elevage Study in patients with Alzheimer's disease and type 2 diabetes in December," said Steve Holcombe, President and CEO of vTv Therapeutics. "In addition, these funds will help us conduct a mechanistic study of TTP399, our oral treatment for patients with type 1 diabetes focused on its…

    HIGH POINT, N.C., Nov. 24, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) today announced it has entered into a common stock purchase agreement ("Purchase Agreement") for up to $47 million with Lincoln Park Capital Fund, LLC ("LPC"), a Chicago-based institutional investor.

    "The LPC financing will help us reach a number of potential value-driving events over the next six to nine months, including the upcoming topline results of our phase 2 Elevage Study in patients with Alzheimer's disease and type 2 diabetes in December," said Steve Holcombe, President and CEO of vTv Therapeutics. "In addition, these funds will help us conduct a mechanistic study of TTP399, our oral treatment for patients with type 1 diabetes focused on its impact on diabetic ketoacidosis, and additionally a multiple-ascending dose study of HPP737 as a potential oral treatment for psoriasis."

    vTv will have the option, but not the obligation, to sell to LPC up to $47.0 million in shares of Class A common stock over a thirty-six-month period subject to certain conditions, including a registration statement being filed and declared effective by the SEC. There are no upper limits to the price LPC may pay to purchase Class A common stock from vTv and the purchase price of the shares will be based on the prevailing market prices of vTv's shares at the time of each sale to LPC.

    LPC has agreed not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of vTv's shares of Class A common stock. No warrants, derivatives, or other share classes are associated with this agreement. In consideration for entering into the agreement, vTv has issued shares of Class A common stock to LPC as a commitment fee. The Purchase Agreement may be terminated by vTv at any time, at its sole discretion, without any additional cost or penalty.

    vTv intends to use the net proceeds from the transaction for general corporate purposes and to support its clinical development strategy, including finalizing and reporting topline results from the Company's ongoing Elevage Study of azeliragon for the treatment of Alzheimer's disease in patients with type 2 diabetes in December 2020, conducting a mechanistic study of TTP399 in patients with type 1 diabetes, and conducting a multiple-ascending dose study of HPP737 as part of a development program of the product as an oral therapy for psoriasis.

    A more detailed description of the agreement is set forth in vTv's Current Report on Form 8-K to be filed with the SEC.

    This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor will there be any sale of these securities in any jurisdiction in which such offer solicitation or sale are unlawful prior to registration or qualification under securities laws of any such jurisdiction.

    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 psoriasis. 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

    CDavis@LifeSciAdvisors.com



    or



    Media:

    Glenn Silver

    Lazar FINN Partners

    646-871-8485

    gsilver@lazarpartners.com



    Primary Logo

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  18. HIGH POINT, N.C., Nov. 05, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) today reported financial results for the third quarter ended September 30, 2020, and provided an update on the progress of its clinical programs.

    "Following our decision to conclude enrollment in the Elevage Study at the end of September, we look forward to announcing topline results from this phase 2 study of azeliragon in December," said Steve Holcombe, president and CEO.  "In addition, we are planning a mechanistic study of TTP399 to start early in the new year to better understand its impact on diabetic ketoacidosis.  Finally, we are planning a phase 1 study of our PDE4 inhibitor compound, HPP737, as an initial step towards a proof-of-concept study…

    HIGH POINT, N.C., Nov. 05, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) today reported financial results for the third quarter ended September 30, 2020, and provided an update on the progress of its clinical programs.

    "Following our decision to conclude enrollment in the Elevage Study at the end of September, we look forward to announcing topline results from this phase 2 study of azeliragon in December," said Steve Holcombe, president and CEO.  "In addition, we are planning a mechanistic study of TTP399 to start early in the new year to better understand its impact on diabetic ketoacidosis.  Finally, we are planning a phase 1 study of our PDE4 inhibitor compound, HPP737, as an initial step towards a proof-of-concept study in psoriasis.  We expect to report topline results from both the mechanistic study of TTP399 and the phase 1 study of HPP737 during the second quarter of 2021."

    Recent Achievements and Outlook

    Type 1 Diabetes

    • FDA Engagement and Pivotal Study Planning.  vTv continued its dialogue with the FDA during the third quarter surrounding the design and endpoints of its planned pivotal studies of TTP399 as an adjunct to insulin therapy for type 1 diabetes.  Based upon the FDA's feedback, the Company plans to conduct a placebo-controlled six-month clinical trial in approximately 400 subjects, followed by a second placebo-controlled six-month clinical trial to be initiated nine to twelve months after initiation of the first pivotal trial.  The FDA also confirmed that the effect size of TTP399 on events of hypoglycemia as demonstrated in the Phase 2 SimpliciT-1 Study are clinically meaningful and that a reduction in events of hypoglycemia would be an acceptable clinical endpoint for evaluation of a therapy for the treatment of type 1 diabetes.

       
    • Development of Mechanistic Study of Ketoacidosis.  To further support the hypothesis that TTP399 may help reduce the incidence of ketoacidosis, vTv plans to conduct a mechanistic study in a small number of patients with type 1 diabetes to determine the impact of TTP399 on ketone body formation during a period of acute insulin withdrawal.  The Company proposed the mechanistic study to the FDA, and the FDA recommended that the study be performed in support of the planned pivotal trials. vTv expects the mechanistic study to be initiated in the first quarter of 2021 and to report topline results in the second quarter of 2021.

       
    • Two Oral Presentations at EASD of SimpliciT-1 Study Results.  Members of vTv's TTP399 clinical development team, including Chief Scientific Officer Dr. Carmen Valcarce, presented additional data at the 56th Annual European Association for the Study of Diabetes on the effects of TTP399 on hypoglycemia and ketone body formation from the positive SimpliciT-1 Study.             

    Dementia with Diabetes

    • Enrollment concluded for Phase 2 Elevage Study of azeliragon. On September 30, vTv concluded enrollment of patients in the Elevage Study. Forty-three (43) patients with mild probable Alzheimer's disease and type 2 diabetes were enrolled in the study.  The study is designed to evaluate the effect of six-months of treatment with azeliragon on cognitive performance. The Company plans to report top-line results for substantially all of the enrolled patients during December 2020, earlier than previously expected.  The objective of the Elevage Study is to replicate in a randomized double-blind, placebo controlled study the results observed in a post hoc analysis of the phase 3 STEADFAST trial A-Study in which a subgroup of forty-seven (47) patients with mild Alzheimer's disease and type 2 diabetes treated with azeliragon demonstrated nominally statistically significant improvements in cognition on the ADAS-cog11 scale of 5.5 points (p=0.006) at month 18 compared to the same subgroup of patients treated with placebo.  Azeliragon associated improvement was nominally significant as early as month 6 on the ADAS-cog11 scale (4.9 points, p<0.001).

       
    • Elevage Study Update to be Presented at CTAD. Dr. Ann Gooch presented an update on the Elevage Study focusing on the demographic and baseline characteristics data of enrolled subjects at the 13th Clinical Trials on Alzheimer's Disease conference on November 4, 2020.

    Psoriasis

    • Multiple Ascending Dose Study with HPP737.  The Company is planning a phase 1 multiple ascending dose study to assess the safety, tolerability, and pharmacokinetic profile of HPP737, a PDE4 inhibitor, in healthy volunteers.  vTv expects to initiate the study in the first quarter of 2021 and to report topline results in the second quarter of 2021.

    Third Quarter 2020 Financial Results

    • Cash Position: The Company's cash position as of September 30, 2020, was $1.8 million compared to $6.4 million as of June 30, 2020.

       
    • Revenue: Revenues were insignificant for both the second and third quarters of 2020.

       
    • R&D Expenses: Research and development expenses were $1.8 million and $2.5 million for the three months ended September 30, 2020 and June 30, 2020, respectively.  This decrease of $0.7 million was driven primarily by the reversal of certain performance-based compensation accruals that are no longer expected to be paid.

       
    • G&A Expenses: General and administrative expenses were $1.1 million for the third quarter of 2020 and $1.7 million for the second quarter, respectively. The decrease of $0.6 million was driven by the reversal of certain performance-based compensation accruals that are no longer expected to be paid.

       
    • Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $2.3 million for the third quarter of 2020 compared to $5.0 million for the second quarter of 2020.

       
    • Net Loss Per Share: GAAP net loss per share was $0.03 and $0.07 for the three months ended September 30, 2020 and June 30, 2020, respectively, based on weighted-average shares of 48.2 million and 45.7 million for the three-month periods ended September 30, 2020 and June 30, 2020, respectively. Non-GAAP net loss per fully exchanged share was $0.02 and $0.08 for the three months ended September 30, 2020 and June 30, 2020, respectively, based on non-GAAP fully exchanged weighted-average shares of 71.3 million and 68.8 million for the three months ended September 30, 2020 and June 30, 2020, respectively.



    vTv Therapeutics Inc.


    Condensed Consolidated Balance Sheets

    (in thousands)

     September 30,  June 30 
     2020  2020 
     (Unaudited)  (Unaudited) 
    Assets       
    Current assets:       
    Cash and cash equivalents$1,827  $6,392 
    Accounts receivable, net 14    
    Prepaid expenses and other current assets 1,306   299 
    Current deposits 531   87 
    Total current assets 3,678   6,778 
    Property and equipment, net 389   412 
    Operating lease right-of-use assets 499   514 
    Long-term investments 2,480   2,480 
    Long-term deposits    444 
    Total assets$7,046  $10,628 
    Liabilities, Redeemable Noncontrolling Interest and Stockholders' Deficit       
    Current liabilities:       
    Accounts payable and accrued expenses$5,747  $6,697 
    Operating lease liabilities 149   143 
    Current portion of contract liabilities 31   31 
    Current portion of notes payable 2,369   4,543 
    Total current liabilities 8,296   11,414 
    Contract liabilities, net of current portion 1,017   1,025 
    Operating lease liabilities, net of current portion 717   756 
    Warrant liability, related party 2,715   3,529 
    Other liabilities 82   54 
    Total liabilities 12,827   16,778 
    Commitments and contingencies       
    Redeemable noncontrolling interest 45,591   63,378 
    Stockholders' deficit:       
    Class A Common Stock 492   479 
    Class B Common Stock 232   232 
    Additional paid-in capital 201,243   198,634 
    Accumulated deficit (253,339)  (268,873)
    Total stockholders' deficit attributable to vTv Therapeutics Inc. (51,372)  (69,528)
    Total liabilities, redeemable noncontrolling interest and stockholders' deficit$7,046  $10,628 



    vTv Therapeutics Inc.

    Condensed Consolidated Statements of Operations - Unaudited

    (in thousands, except per share data)

     Three Months Ended 
     September 30,

    2020
      June 30,

    2020
     
    Revenue$7  $ 
    Operating expenses:       
    Research and development 1,768   2,509 
    General and administrative 1,071   1,695 
    Total operating expenses 2,839   4,204 
    Operating loss (2,832)  (4,204)
    Interest expense (235)  (222)
    Other income (expense), net 814   (565)
    Loss before income taxes and noncontrolling interest (2,253)  (4,991)
    Income tax provision     
    Net loss before noncontrolling interest (2,253)  (4,991)
    Less:  net loss attributable to noncontrolling interest (720)  (1,623)
    Net loss attributable to vTv Therapeutics Inc.$(1,533) $(3,368)
    Net loss attributable to vTv Therapeutics Inc. common shareholders$(1,533) $(3,368)
    Net loss per share of vTv Therapeutics Inc. Class A

       Common Stock, basic and diluted
    $(0.03) $(0.07)
    Weighted-average number of vTv Therapeutics Inc.

       Class A Common Stock, basic and diluted
     48,238,285   45,661,221 



    vTv Therapeutics Inc.

    Condensed Consolidated Statements of Operations

    (in thousands, except per share data)

     Three Months Ended

    September 30,
      For the Nine Months Ended

    September 30,
     
     2020  2019  2020  2019 
                
     (Unaudited)  (Unaudited) 
    Revenue$7  $8  $15  $2,757 
    Operating expenses:               
    Research and development 1,768   3,663   8,481   10,713 
    General and administrative 1,071   1,770   5,216   6,548 
    Total operating expenses 2,839   5,433   13,697   17,261 
    Operating loss (2,832)  (5,425)  (13,682)  (14,504)
    Interest income    15   12   41 
    Interest expense (235)  (404)  (625)  (1,544)
    Other income (expense), net 814   (146)  (114)  1,051 
    Loss before income taxes and noncontrolling interest (2,253)  (5,960)  (14,409)  (14,956)
    Income tax provision          100 
    Net loss before noncontrolling interest (2,253)  (5,960)  (14,409)  (15,056)
    Less:  net loss attributable to noncontrolling interest (720)  (2,352)  (4,784)  (6,411)
    Net loss attributable to vTv Therapeutics Inc.$(1,533) $(3,608) $(9,625) $(8,645)
    Net loss attributable to vTv Therapeutics Inc. common shareholders$(1,533) $(3,608) $(9,625) $(12,880)
    Net loss per share of vTv Therapeutics Inc. Class A Common Stock, basic and diluted$(0.03) $(0.13) $(0.21) $(0.46)
    Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, basic and diluted 48,238,285   32,126,130   45,796,298   27,709,486 

    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 psoriasis. 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 
     September 30,

    2020
      June 30,

    2020
     
    Numerator:       
    Net loss attributable to vTv Therapeutics Inc. common shareholders$(1,533) $(3,368)
    Other income - related party 814   (565)
    Share-based compensation expense 171   186 
    Deemed distribution to related party     
    Reallocation of net income attributable to noncontrolling interest from the assumed exchange of Class B shares (1) (720)  (1,623)
    Adjusted net loss before noncontrolling interest$(1,268) $(5,370)
    Denominator:       
    Weighted-average number of vTv Therapeutics Inc.

       Class A Common Stock, basic and diluted
     48,238,285   45,661,221 
    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
     71,332,506   68,755,442 
    Adjusted net loss per fully exchanged share,

       basic and diluted
    $(0.02) $(0.08)



     Three Months Ended

    September 30,
      Nine Months Ended

    September 30,
     
     2020  2019  2020  2019 
    Numerator:               
    Net loss attributable to vTv Therapeutics Inc. common shareholders$(1,533) $(4,115) $(9,625) $(12,880)
    Other income - related party 814   (146)  (114)  1,050 
    Share-based compensation expense 171   413   737   1,095 
    Deemed distribution to related party    507      4,235 
    Reallocation of net income attributable to noncontrolling interest from the assumed exchange of Class B shares (1) (720)  (2,352)  (4,784)  (6,411)
    Adjusted net loss before noncontrolling interest$(1,268) $(5,693) $(13,786) $(12,911)
    Denominator:               
    Weighted-average number of vTv Therapeutics Inc.

       Class A Common Stock, basic and diluted
     48,238,285   32,126,130   45,796,298   27,709,486 
    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
     71,332,506   55,220,351   68,890,519   50,803,707 
    Adjusted net loss per fully exchanged share,

       basic and diluted
    $(0.02) $(0.10) $(0.20) $(0.25)

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

    Contacts

    Investors:

    Corey Davis

    LifeSci Advisors

    CDavis@LifeSciAdvisors.com

    or



    Media:

    Glenn Silver

    Lazar FINN Partners

    646-871-8485

    gsilver@lazarpartners.com



     

     

    Primary Logo

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  19. HIGH POINT, N.C., Nov. 04, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) today reported baseline characteristics for the enrolled subjects in the ongoing Elevage clinical study of azeliragon as a potential treatment for mild Alzheimer's disease (AD) in people with type 2 diabetes (NCT03980730). The data demonstrate that the patients enrolled in Elevage (n=43) have similar baseline characteristics to those in the STEADFAST A-study type 2 diabetes (T2D) subgroup (NCT02080364) (n=47). As the company reported in October 2018, data from this subgroup demonstrated nominally significant differences favoring azeliragon compared with placebo on the ADAS-cog11, an instrument used to evaluate cognition. The goal of the Elevage study is…

    HIGH POINT, N.C., Nov. 04, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) today reported baseline characteristics for the enrolled subjects in the ongoing Elevage clinical study of azeliragon as a potential treatment for mild Alzheimer's disease (AD) in people with type 2 diabetes (NCT03980730). The data demonstrate that the patients enrolled in Elevage (n=43) have similar baseline characteristics to those in the STEADFAST A-study type 2 diabetes (T2D) subgroup (NCT02080364) (n=47). As the company reported in October 2018, data from this subgroup demonstrated nominally significant differences favoring azeliragon compared with placebo on the ADAS-cog11, an instrument used to evaluate cognition. The goal of the Elevage study is to confirm the results of these retrospective analyses in a 6-month Phase 2 study prior to initiating a Phase 3 study.

    The Elevage data are being presented today at the 13th Clinical Trials on Alzheimer's Disease (CTAD) Conference - Digital Event, which is being held virtually November 4-7, 2020.

    "We have completed enrollment in Part 1 of Elevage and are pleased that the baseline characteristics are consistent with those of the STEADFAST T2D subgroup in which we saw benefit for azeliragon compared with placebo," said Steve Holcombe, President and CEO of vTv Therapeutics. "The Elevage study for azeliragon in this patient population is designed as sequential Phase 2 and 3 trials operationally conducted under one protocol. If the Phase 2 data are positive, this design would allow us to move quickly to a Phase 3 trial with the potential to support product approval. Approximately 35% of patients with AD have T2D, with associated increased advanced glycation endproducts and increased expression of the Receptor for Advanced Glycation Endproducts, the target for azeliragon. We believe that azeliragon could potentially be an important advance for addressing dementia in this population."

    Baseline characteristic data presented today demonstrate that the Elevage patient population is similar to that of the STEADFAST T2D subgroup with respect to age, height, weight, body-mass index, ApoE status, background AD medication, HbA1c, and scores on multiple cognitive assessments including Mini-Mental State Exam (MMSE), ADAS-cog11, CDR Global, and CDR Sum of Boxes. The company expects to report topline safety and efficacy data from Part 1 of the Elevage study in December 2020, earlier than previously anticipated.

    Details of the CTAD digital presentation are:

    Oral Presentation Title: "The Azeliragon Elevage Study: Study Update and Preliminary Data on Baseline Characteristics of Participants with Mild Alzheimer's Disease and Type 2 Diabetes Randomized in Part 1"

    Presentation Number: LB5

    Category: On Demand, Late Breaking Communications

    Date and Time: Wednesday, November 4, 2020, Available from 1 am US EST



    About the Elevage Study

    The Elevage Study is a randomized, double-blind, placebo-controlled clinical trial evaluating azeliragon in individuals ages 50 – 85 with probable mild-Alzheimer's disease and type 2 diabetes. The objective of the Elevage Study is to replicate in a randomized double-blind, placebo controlled study the results observed in a post hoc analysis of the phase 3 STEADFAST trial A-Study in which a subgroup of forty-seven (47) patients with mild Alzheimer's disease and type 2 diabetes treated with azeliragon demonstrated nominally statistically significant improvements in cognition on the ADAS-cog11 scale of 5.5 points (p=0.006) at month 18 compared to the same subgroup of patients treated with placebo. Azeliragon associated improvement was nominally significant as early as month 6 on the ADAS-cog11 scale (4.9 points, p<0.001).

    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

    CDavis@LifeSciAdvisors.com



    or



    Media:

    Glenn Silver

    Lazar FINN Partners

    646-871-8485

    gsilver@lazarpartners.com 

    Primary Logo

    View Full Article Hide Full Article
  20. HIGH POINT, N.C., Oct. 29, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) today announced that it will make an oral presentation at the 13th Clinical Trials on Alzheimer's Disease (CTAD) Digital Event on November 4, 2020. The presentation will provide a general study update and data on the baseline characteristics of patients enrolled in the ongoing phase 2 Elevage Study of azeliragon as a potential treatment for mild-probable Alzheimer's disease (AD) in adult patients who also have type 2 diabetes. Patient enrollment in the Elevage Study concluded as of September 2020 and vTv expects to report topline results in December 2020.

    Details of the CTAD digital presentation are:

    Oral Presentation Title: "The Azeliragon Elevage Study…

    HIGH POINT, N.C., Oct. 29, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (NASDAQ:VTVT) today announced that it will make an oral presentation at the 13th Clinical Trials on Alzheimer's Disease (CTAD) Digital Event on November 4, 2020. The presentation will provide a general study update and data on the baseline characteristics of patients enrolled in the ongoing phase 2 Elevage Study of azeliragon as a potential treatment for mild-probable Alzheimer's disease (AD) in adult patients who also have type 2 diabetes. Patient enrollment in the Elevage Study concluded as of September 2020 and vTv expects to report topline results in December 2020.

    Details of the CTAD digital presentation are:

    Oral Presentation Title: "The Azeliragon Elevage Study: Study Update and Preliminary Data on Baseline Characteristics of Participants with Mild Alzheimer's Disease and Type 2 Diabetes Randomized in Part 1"

    Presentation Number: LB5

    Category: On Demand, Late Breaking Communications

    Date and Time: Wednesday, November 4, 2020, Available from 1 am US EST



    About the Elevage Study

    The Elevage Study is a randomized, double-blind, placebo-controlled clinical trial evaluating azeliragon in individuals ages 50 – 85 with probable mild-Alzheimer's disease and type 2 diabetes. The objective of the Elevage Study is to replicate in a randomized double-blind, placebo controlled study the results observed in a post hoc analysis of the phase 3 STEADFAST trial A-Study in which a subgroup of forty-seven (47) patients with mild Alzheimer's disease and type 2 diabetes treated with azeliragon demonstrated nominally statistically significant improvements in cognition on the ADAS-cog11 scale of 5.5 points (p=0.006) at month 18 compared to the same subgroup of patients treated with placebo. Azeliragon associated improvement was nominally significant as early as month 6 on the ADAS-cog11 scale (4.9 points, p<0.001).

    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

    CDavis@LifeSciAdvisors.com

    or

    Media:

    Glenn Silver

    Lazar FINN Partners

    646-871-8485

    gsilver@lazarpartners.com

    Primary Logo

    View Full Article Hide Full Article
  21. 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

    CDavis@LifeSciAdvisors.com

    or

    Media:

    Glenn Silver

    Lazar FINN Partners

    646-871-8485

    gsilver@lazarpartners.com

    Primary Logo

    View Full Article Hide Full Article
  22. 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

    CDavis@LifeSciAdvisors.com

    Primary Logo

    View Full Article Hide Full Article
  23. 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

    CDavis@LifeSciAdvisors.com

    Primary Logo

    View Full Article Hide Full Article
  24. 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

    CDavis@LifeSciAdvisors.com

    or



    Media:

    Glenn Silver

    Lazar FINN Partners

    646-871-8485

    gsilver@lazarpartners.com

    Primary Logo

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  25. 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

    CDavis@LifeSciAdvisors.com

    or

    Media:

    Glenn Silver

    Lazar FINN Partners

    646-871-8485

    gsilver@lazarpartners.com

    Primary Logo

    View Full Article Hide Full Article
  26. - 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

    nstrong@vtvtherapeutics.com

    Primary Logo

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  27. 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
    CDavis@LifeSciAdvisors.com

    or

    Media:
    Glenn Silver
    Lazar FINN Partners
    646-871-8485
    gsilver@lazarpartners.com

    Primary Logo

    View Full Article Hide Full Article
  28. 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
    CDavis@LifeSciAdvisors.com

    or

    Media:
    Glenn Silver
    Lazar FINN Partners
    646-871-8485
    gsilver@lazarpartners.com

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  29. 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
    CDavis@LifeSciAdvisors.com

    or

    Media:
    Glenn Silver
    Lazar FINN Partners
    646-871-8485
    gsilver@lazarpartners.com 

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  30. - 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
    MWood@LifeSciAdvisors.com

    or

    Media:
    Glenn Silver
    Lazar FINN Partners
    646-871-8485
    gsilver@lazarpartners.com

    Ayana Young
    JDRF International
    212-859-7895
    ayoung@jdrf.org

    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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