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