vTv Therapeutics Announces 2019 First Quarter Financial Results and Update

HIGH POINT, N.C.–(BUSINESS WIRE)–vTv
Therapeutics Inc. (Nasdaq:VTVT) today reported financial results for
the first quarter that ended March 31, 2019, and provided an update on
recent achievements and upcoming events.

“We continue to make significant progress with our operational plans and
look forward to announcing in the second quarter results from part 1 of
our phase 2 Simplici-T₁ trial in patients with type 1
diabetes, and the initiation of a phase 2 clinical trial of azeliragon
in patients with mild-Alzheimer’s disease (AD) and type 2 diabetes,”
said Steve Holcombe, chief executive officer, vTv Therapeutics.

Recent Achievements and Outlook

• Simplici-T₁ Study enrolling patients with
  type 1 diabetes. We completed enrollment of part 1 of the phase 2
  Simplici-T₁ Study, a 12-week study to evaluate TTP399 as an
  add-on to insulin therapy for patients with type 1 diabetes, and
  expect to report results in June 2019. We also began screening
  patients in the part 2 confirmatory phase 2 and expect to report
  results for that portion of the study in the latter part of the first
  quarter of 2020. In the previous AGATA Study, a phase 2 study in type
  2 diabetes patients, TTP399 demonstrated statistically significant
  reductions in HbA1c levels. Importantly, TTP399 has been well
  tolerated in all clinical studies to date with negligible incidences
  of hypoglycemia and hyperlipidemia and no occurrences of ketoacidosis.
• Screening for Phase 2 clinical trial of azeliragon expected to
  begin in June 2019. We are performing start-up activities for a
  clinical trial to evaluate azeliragon as a potential treatment of
  mild-AD in patients with type 2 diabetes that consists of sequential
  phase 2 and phase 3 studies operationally conducted under a single
  clinical trial protocol. The phase 2 study is designed to enroll
  approximately 100 patients to evaluate the impact of six months of
  treatment with azeliragon on cognitive performance as measured by the
  change from baseline in the Alzheimer’s Disease Assessment Scale –
  Cognitive Subscale (“ADAS-COG₁₄”). We expect to begin
  screening patients in June 2019 for the phase 2 clinical trial and to
  report top-line results from the phase 2 study by the end of the
  fourth quarter of 2020. The phase 3 study is designed to enroll
  approximately 200 patients to evaluate the efficacy of 18 months of
  treatment with azeliragon on cognition and global function as measured
  by the change from baseline in the ADAS-COG₁₄ and Clinical
  Dementia Rating Scale Sum of Boxes. The design of the phase 3 study
  may be adapted based on the results of the phase 2 study.
• Publication of paper discussing the discovery and development of
  TTP399. In the first quarter, we announced the publication of a
  paper in Science Translational Medicine showcasing the
  discovery and development of TTP399. The paper reviewed the scientific
  rationale underpinning the development of TTP399 and detailed its
  progression from preclinical to clinical development.

First Quarter 2019 Financial Results

• Cash Position: Cash and cash equivalents as of March 31, 2019,
  were $5.0 million compared to $1.7 million as of December 31, 2018.
• R&D Expenses: Research and development expenses were $2.8
  million in each of the first quarter of 2019 and the fourth quarter of
  2018.
• G&A Expenses: General and administrative expenses were $2.4
  million and $2.1 million in the first quarter of 2019 and the fourth
  quarter of 2018, respectively.
• Net Loss Before Non-Controlling Interest: Net loss before
  non-controlling interest was $4.0 million for the first quarter of
  2019 compared to net loss before non-controlling interest of $2.3
  million for the fourth quarter of 2018.
• Net Loss Per Share: GAAP net loss per share was $0.26 and $0.10
  for the three months ended March 31, 2019 and December 31, 2018,
  respectively, based on weighted-average shares of 22.9 million and
  17.6 million for the three month periods ended March 31, 2019 and
  December 31, 2018, respectively. Adjusted pro forma net loss per fully
  exchanged share was $0.09 and $0.06 for the three months ended March
  31, 2019 and December 31, 2018, respectively, based on adjusted pro
  forma fully exchanged weighted-average shares of 46.0 million and 40.7
  million for the three months ended March 31, 2019 and December 31,
  2018, respectively.

About vTv Therapeutics

vTv Therapeutics Inc. is a clinical-stage biopharmaceutical company
engaged in the discovery and development of orally administered small
molecule drug candidates to fill significant unmet medical needs. vTv
has a pipeline of clinical drug candidates led by programs for the
treatment of Alzheimer’s disease, diabetes, and inflammatory disorders.

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 adjusted pro forma earnings per
fully exchanged share, which is a non-GAAP financial measure. Adjusted
pro forma earnings per fully exchanged share is defined as net loss
attributable to vTv Therapeutics Inc. common shareholders including the
loss attributable to the non-controlling interest and assuming 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.
Additionally, we have adjusted this metric for the non-cash deemed
distributions that were made in connection with our letter agreements
with MacAndrews & Forbes Group LLC. 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
excludes the impact of the non-cash deemed distribution. 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 adjusted pro forma earnings per
fully exchanged share, basic and diluted to its most directly comparable
GAAP measure, net loss attributable to vTv Therapeutics Inc. common
shareholders, basic and diluted and the computation of the components of
this non-GAAP measure:

Contacts

Investors:
vTv Therapeutics Inc.
[email protected]

or

Media:
Josh Vlasto, 212-572-5969
[email protected]