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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
____________________________
FORM 10-Q
_____________________________
(Mark One)
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x |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2022
Or
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o |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
For the transition period
from to
Commission file number: 001-37524
_____________________________
vTv Therapeutics Inc.
(Exact name of registrant as specified in its charter)
_____________________________
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Delaware |
47-3916571 |
(State or other jurisdiction of
incorporation or organization) |
(I.R.S. Employer
Identification No.) |
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3980 Premier Dr, Suite 310
High Point, NC
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27265
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(Address of principal executive offices) |
(Zip Code) |
(336) 841-0300
(Registrant’s telephone number, including area code)
(Former name, former address and former fiscal year, if changed
since last report)
_____________________________
Securities registered pursuant to Section 12(b) of the
Act:
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Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
Class A common stock, par value $0.01 per share |
VTVT |
NASDAQ Capital Market
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Indicate by check mark whether the registrant (1) has filed all
reports required to be filed by Section 13 or 15(d) of the
Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file
such reports), and (2) has been subject to such filing requirements
for the past 90 days. Yes
x
No
o
Indicate by check mark whether the registrant has submitted
electronically every Interactive Data File required to be submitted
pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter)
during the preceding 12 months (or for such shorter period that the
registrant was required to submit such files). Yes
x
No
o
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer, a
smaller reporting company, or an emerging growth company. See the
definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule
12b-2 of the Exchange Act.
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Large accelerated filer |
o |
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Accelerated filer |
o |
Non-accelerated filer |
o |
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Smaller reporting company |
x |
Emerging growth company |
o |
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If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange
Act.
o
Indicate by check mark whether the registrant is a shell company
(as defined in Rule 12b-2 of the Exchange Act). Yes
o
No
x
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Class of Stock |
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Shares Outstanding as of November 10, 2022
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Class A common stock, par value $0.01 per share |
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81,483,600 |
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Class B common stock, par value $0.01 per share |
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23,093,860 |
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vTv THERAPEUTICS INC. AND SUBSIDIARIES
INDEX TO FORM 10-Q
FOR THE QUARTER ENDED SEPTEMBER 30, 2022
PART I – FINANCIAL INFORMATION
The financial statements and other disclosures contained in this
report include those of vTv Therapeutics Inc. (“we”, the “Company”
or the “Registrant”), which is the registrant, and those of vTv
Therapeutics LLC (“vTv LLC”), which is the principal operating
subsidiary of the Registrant. Unless the context suggests
otherwise, references in this Quarterly Report on Form 10-Q to the
“Company”, “we”, “us” and “our” refer to vTv Therapeutics Inc. and
its consolidated subsidiaries.
vTv Therapeutics Inc.
Condensed Consolidated Balance Sheets
(in thousands, except number of shares and per share
data)
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|
September 30,
2022 |
|
December 31,
2021 |
|
(Unaudited) |
|
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
15,339 |
|
|
$ |
13,415 |
|
Accounts receivable |
57 |
|
|
57 |
|
Promissory note receivable |
12,091 |
|
|
— |
|
Prepaid expenses and other current assets |
1,281 |
|
|
2,049 |
|
Current deposits |
15 |
|
|
100 |
|
Total current assets |
28,783 |
|
|
15,621 |
|
Property and equipment, net |
230 |
|
|
278 |
|
Operating lease right-of-use assets |
328 |
|
|
402 |
|
Long-term investments |
6,175 |
|
|
9,173 |
|
Total assets |
$ |
35,516 |
|
|
$ |
25,474 |
|
Liabilities, Redeemable Noncontrolling Interest and Stockholders’
Deficit |
|
|
|
Current liabilities: |
|
|
|
Accounts payable and accrued expenses |
$ |
6,676 |
|
|
$ |
8,023 |
|
Current portion of operating lease liabilities |
208 |
|
|
184 |
|
Current portion of contract liabilities |
26 |
|
|
35 |
|
Current portion of notes payable |
557 |
|
|
256 |
|
Total current liabilities |
7,467 |
|
|
8,498 |
|
Contract liabilities, net of current portion |
18,669 |
|
|
— |
|
Operating lease liabilities, net of current portion |
333 |
|
|
492 |
|
Warrant liability, related party |
1,409 |
|
|
1,262 |
|
Total liabilities |
27,878 |
|
|
10,252 |
|
Commitments and contingencies |
|
|
|
Redeemable noncontrolling interest |
24,207 |
|
|
24,962 |
|
Stockholders’ deficit: |
|
|
|
Class A common stock, $0.01 par value; 200,000,000 shares
authorized, 81,483,600 and 66,942,777 shares outstanding as of
September 30, 2022, and December 31, 2021
|
815 |
|
|
669 |
|
Class B common stock, $0.01 par value; 100,000,000 shares
authorized, and 23,093,860 outstanding as of September 30,
2022, and December 31, 2021
|
232 |
|
|
232 |
|
Promissory note receivable for common stock |
(4,000) |
|
|
— |
|
Additional paid-in capital |
253,446 |
|
|
238,193 |
|
Accumulated deficit |
(267,062) |
|
|
(248,834) |
|
Total stockholders’ deficit attributable to vTv Therapeutics
Inc. |
(16,569) |
|
|
(9,740) |
|
Total liabilities, redeemable noncontrolling interest and
stockholders’ deficit |
$ |
35,516 |
|
|
$ |
25,474 |
|
The accompanying notes are an integral part of the unaudited
condensed consolidated financial statements.
vTv Therapeutics Inc.
Condensed Consolidated Statements of Operations -
Unaudited
(in thousands, except number of shares and per share
data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Revenue |
$ |
— |
|
|
$ |
3,000 |
|
|
$ |
2,009 |
|
|
$ |
3,996 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
3,055 |
|
|
2,382 |
|
|
8,393 |
|
|
7,922 |
|
General and administrative |
2,634 |
|
|
2,221 |
|
|
9,813 |
|
|
6,627 |
|
Total operating expenses |
5,689 |
|
|
4,603 |
|
|
18,206 |
|
|
14,549 |
|
Operating loss |
(5,689) |
|
|
(1,603) |
|
|
(16,197) |
|
|
(10,553) |
|
Other income (expense) |
403 |
|
|
(1,084) |
|
|
(2,998) |
|
|
1,814 |
|
Other income (expense) – related party |
(324) |
|
|
1,328 |
|
|
221 |
|
|
611 |
|
Interest income |
150 |
|
|
— |
|
|
200 |
|
|
1 |
|
Interest expense |
(8) |
|
|
(6) |
|
|
(9) |
|
|
(6) |
|
Loss before income taxes and noncontrolling interest |
(5,468) |
|
|
(1,365) |
|
|
(18,783) |
|
|
(8,133) |
|
Income tax provision |
— |
|
|
100 |
|
|
200 |
|
|
115 |
|
Net loss before noncontrolling interest |
(5,468) |
|
|
(1,465) |
|
|
(18,983) |
|
|
(8,248) |
|
Less: net loss attributable to noncontrolling interest |
(1,207) |
|
|
(378) |
|
|
(4,564) |
|
|
(2,312) |
|
Net loss attributable to vTv Therapeutics Inc. |
$ |
(4,261) |
|
|
$ |
(1,087) |
|
|
$ |
(14,419) |
|
|
$ |
(5,936) |
|
Net loss attributable to vTv Therapeutics Inc. common
shareholders |
$ |
(4,261) |
|
|
$ |
(1,087) |
|
|
$ |
(14,419) |
|
|
$ |
(5,936) |
|
Net loss per share of vTv Therapeutics Inc. Class A common stock,
basic and diluted |
$ |
(0.05) |
|
|
$ |
(0.02) |
|
|
$ |
(0.20) |
|
|
$ |
(0.10) |
|
Weighted average number of vTv Therapeutics Inc. Class A common
stock, basic and diluted |
80,490,121 |
|
|
61,073,280 |
|
|
72,649,531 |
|
|
58,737,170 |
|
The accompanying notes are an integral part of the unaudited
condensed consolidated financial statements.
vTv Therapeutics Inc.
Condensed Consolidated Statement of Changes in Redeemable
Noncontrolling Interest and Stockholders’ Deficit -
Unaudited
(in thousands, except number of shares)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended September 30, 2022 |
|
|
|
|
Class A Common Stock |
|
Class B Common Stock |
|
|
|
|
|
|
|
|
|
Redeemable
Noncontrolling
Interest |
|
|
Shares |
|
Amount |
|
Shares |
|
Amount |
|
Note Receivable for Common Stock |
|
Additional
Paid-in
Capital |
|
Accumulated Deficit |
|
Total Stockholders' Deficit |
Balances at June 30, 2022 |
$ |
15,916 |
|
|
|
77,329,051 |
|
|
$ |
773 |
|
|
23,093,860 |
|
|
$ |
232 |
|
|
$ |
— |
|
|
$ |
243,772 |
|
|
$ |
(253,303) |
|
|
$ |
(8,526) |
|
Net loss |
(1,207) |
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(4,261) |
|
|
(4,261) |
|
Share-based compensation |
— |
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
338 |
|
|
— |
|
|
338 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of Class A common stock under CinRx purchase agreement,
net of offering cost |
— |
|
|
|
4,154,549 |
|
|
42 |
|
|
— |
|
|
— |
|
|
(4,000) |
|
|
9,336 |
|
|
— |
|
|
5,378 |
|
Change in redemption value of noncontrolling interest |
9,498 |
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(9,498) |
|
|
(9,498) |
|
Balances at September 30, 2022 |
$ |
24,207 |
|
|
|
81,483,600 |
|
|
$ |
815 |
|
|
23,093,860 |
|
|
$ |
232 |
|
|
$ |
(4,000) |
|
|
$ |
253,446 |
|
|
$ |
(267,062) |
|
|
$ |
(16,569) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended September 30, 2021 |
|
|
|
|
Class A Common Stock |
|
Class B Common Stock |
|
|
|
|
|
|
|
Redeemable
Noncontrolling
Interest |
|
|
Shares |
|
Amount |
|
Shares |
|
Amount |
|
Additional
Paid-in
Capital |
|
Accumulated Deficit |
|
Total Stockholders' Deficit |
Balances at June 30, 2021 |
$ |
60,190 |
|
|
|
60,193,967 |
|
|
$ |
602 |
|
|
23,093,860 |
|
|
$ |
232 |
|
|
$ |
224,457 |
|
|
$ |
(273,114) |
|
|
$ |
(47,823) |
|
Net loss |
(378) |
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(1,087) |
|
|
(1,087) |
|
Share-based compensation |
— |
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
474 |
|
|
— |
|
|
474 |
|
Issuance of Class A common stock under ATM offering |
— |
|
|
|
6,277,209 |
|
|
63 |
|
|
— |
|
|
— |
|
|
11,626 |
|
|
— |
|
|
11,689 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in redemption value of noncontrolling interest |
(15,202) |
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
15,202 |
|
|
15,202 |
|
Balances at September 30, 2021 |
$ |
44,610 |
|
|
|
66,471,176 |
|
|
$ |
665 |
|
|
23,093,860 |
|
|
$ |
232 |
|
|
$ |
236,557 |
|
|
$ |
(258,999) |
|
|
$ |
(21,545) |
|
The accompanying notes are an integral part of the unaudited
condensed consolidated financial statements.
vTv Therapeutics Inc.
Condensed Consolidated Statement of Changes in Redeemable
Noncontrolling Interest and Stockholders’ Deficit -
Unaudited
(in thousands, except number of shares)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the nine months ended September 30, 2022 |
|
|
|
|
Class A Common Stock |
|
Class B Common Stock |
|
|
|
|
|
|
|
|
|
Redeemable
Noncontrolling
Interest |
|
|
Shares |
|
Amount |
|
Shares |
|
Amount |
|
Note Receivable for Common Stock |
|
Additional
Paid-in
Capital |
|
Accumulated Deficit |
|
Total Stockholders' Deficit |
Balances at December 31, 2021 |
$ |
24,962 |
|
|
|
66,942,777 |
|
|
$ |
669 |
|
|
23,093,860 |
|
|
$ |
232 |
|
|
$ |
— |
|
|
$ |
238,193 |
|
|
$ |
(248,834) |
|
|
$ |
(9,740) |
|
Net loss |
(4,564) |
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(14,419) |
|
|
(14,419) |
|
Share-based compensation |
— |
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
981 |
|
|
— |
|
|
981 |
|
Issuance of Class A common stock to collaboration partner, net of
offering costs |
— |
|
|
|
10,386,274 |
|
|
104 |
|
|
— |
|
|
— |
|
|
— |
|
|
4,936 |
|
|
— |
|
|
5,040 |
|
Issuance of Class A common stock under CinRx purchase agreement,
net of offering costs |
— |
|
|
|
4,154,549 |
|
|
42 |
|
|
— |
|
|
— |
|
|
(4,000) |
|
|
9,336 |
|
|
— |
|
|
5,378 |
|
Change in redemption value of noncontrolling interest |
3,809 |
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(3,809) |
|
|
(3,809) |
|
Balances at September 30, 2022 |
$ |
24,207 |
|
|
|
81,483,600 |
|
|
$ |
815 |
|
|
23,093,860 |
|
|
$ |
232 |
|
|
$ |
(4,000) |
|
|
$ |
253,446 |
|
|
$ |
(267,062) |
|
|
$ |
(16,569) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the nine months ended September 30, 2021 |
|
|
|
|
Class A Common Stock |
|
Class B Common Stock |
|
|
|
|
|
|
|
Redeemable
Noncontrolling
Interest |
|
|
Shares |
|
Amount |
|
Shares |
|
Amount |
|
Additional
Paid-in
Capital |
|
Accumulated Deficit |
|
Total Stockholders' Deficit |
Balances at December 31, 2020 |
$ |
83,895 |
|
|
|
54,050,710 |
|
|
$ |
541 |
|
|
23,094,221 |
|
|
$ |
232 |
|
|
$ |
209,161 |
|
|
$ |
(290,036) |
|
|
$ |
(80,102) |
|
Net loss |
(2,312) |
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(5,936) |
|
|
(5,936) |
|
Share-based compensation |
— |
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
1,362 |
|
|
— |
|
|
1,362 |
|
Issuance of Class A common stock under ATM offering |
— |
|
|
|
8,457,546 |
|
|
85 |
|
|
— |
|
|
— |
|
|
16,939 |
|
|
— |
|
|
17,024 |
|
Exchange of Class B common stock for Class A common
stock |
— |
|
|
|
361 |
|
|
— |
|
|
(361) |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
Exercise of stock options |
— |
|
|
|
20,833 |
|
|
— |
|
|
— |
|
|
— |
|
|
47 |
|
|
— |
|
|
47 |
|
Issuance of Class A common stock under LPC Agreement |
— |
|
|
|
3,941,726 |
|
|
39 |
|
|
— |
|
|
— |
|
|
9,048 |
|
|
— |
|
|
9,087 |
|
Change in redemption value of noncontrolling interest |
(36,973) |
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
36,973 |
|
|
36,973 |
|
Balances at September 30, 2021 |
$ |
44,610 |
|
|
|
66,471,176 |
|
|
$ |
665 |
|
|
23,093,860 |
|
|
$ |
232 |
|
|
$ |
236,557 |
|
|
$ |
(258,999) |
|
|
$ |
(21,545) |
|
The accompanying notes are an integral part of the unaudited
condensed consolidated financial statements.
vTv Therapeutics Inc.
Condensed Consolidated Statements of Cash Flows -
Unaudited
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
2022 |
|
2021 |
Cash flows from operating activities: |
|
|
|
Net loss before noncontrolling interest |
$ |
(18,983) |
|
|
$ |
(8,248) |
|
Adjustments to reconcile net loss before noncontrolling interest to
net cash used in operating activities: |
|
|
|
Depreciation expense |
69 |
|
|
67 |
|
Non-cash interest income |
(200) |
|
|
— |
|
Interest expense |
9 |
|
|
— |
|
Share-based compensation expense |
981 |
|
|
1,362 |
|
Change in fair value of investments |
2,998 |
|
|
(1,814) |
|
Change in fair value of warrants, related party |
(221) |
|
|
(611) |
|
Changes in assets and liabilities: |
|
|
|
Accounts receivable |
— |
|
|
(770) |
|
Prepaid expenses and other assets |
853 |
|
|
(367) |
|
|
|
|
|
Accounts payable and accrued expenses |
(1,417) |
|
|
(1,514) |
|
Contract liabilities |
6,769 |
|
|
(996) |
|
Net cash used in operating activities |
(9,142) |
|
|
(12,891) |
|
Cash flows from investing activities: |
|
|
|
Purchases of property and equipment |
(21) |
|
|
— |
|
Net cash used in investing activities |
(21) |
|
|
— |
|
Cash flows from financing activities: |
|
|
|
Proceeds from sale of Class A common stock to collaboration
partner, net of offering costs |
5,040 |
|
|
— |
|
Proceeds from sale of Class A common stock and warrants, net of
offering costs |
5,746 |
|
|
— |
|
Proceeds from sale of Class A common stock, net of offering
costs |
— |
|
|
26,111 |
|
Proceeds from exercise of stock options |
— |
|
|
47 |
|
Proceeds from debt issuance |
776 |
|
|
887 |
|
Repayment of notes payable |
(475) |
|
|
(335) |
|
Net cash provided by financing activities |
11,087 |
|
|
26,710 |
|
Net increase in cash and cash equivalents |
1,924 |
|
|
13,819 |
|
Total cash and cash equivalents, beginning of period |
13,415 |
|
|
5,747 |
|
Total cash and cash equivalents, end of period |
$ |
15,339 |
|
|
$ |
19,566 |
|
|
|
|
|
Non-cash activities: |
|
|
|
Change in redemption value of noncontrolling interest |
$ |
3,809 |
|
|
$ |
(36,973) |
|
Notes receivable recorded at fair value from collaboration
partner |
$ |
11,891 |
|
|
$ |
— |
|
Notes receivable for common stock from CinRx purchase
agreement |
$ |
4,000 |
|
|
$ |
— |
|
The accompanying notes are an integral part of the unaudited
condensed consolidated financial statements.
vTv Therapeutics Inc.
Notes to Condensed Consolidated Financial Statements –
Unaudited
(dollar amounts are in thousands, unless otherwise
noted)
Note 1: Description of Business, Basis of Presentation and Going
Concern
Description of Business
vTv Therapeutics Inc. (the “Company,” the “Registrant,” “we” or
“us”) was incorporated in the state of Delaware in April 2015. The
Company is a clinical stage pharmaceutical company focused on
treating metabolic diseases to minimize their long-term
complications through end-organ protection.
Principles of Consolidation
vTv Therapeutics Inc. is a holding company, and its principal asset
is a controlling equity interest in vTv Therapeutics LLC (“vTv
LLC”), the Company’s principal operating subsidiary, which 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.
The Company has determined that vTv LLC is a variable-interest
entity (“VIE”) for accounting purposes and that vTv Therapeutics
Inc. is the primary beneficiary of vTv LLC because (through its
managing member interest in vTv LLC and the fact that the senior
management of vTv Therapeutics Inc. is also the senior management
of vTv LLC) it has the power and benefits to direct all of the
activities of vTv LLC, which include those that most significantly
impact vTv LLC’s economic performance. vTv Therapeutics Inc. has
therefore consolidated vTv LLC’s results pursuant to Accounting
Standards Codification Topic 810, “Consolidation” in its Condensed
Consolidated Financial Statements. As of September 30, 2022,
various holders own non-voting interests in vTv LLC, representing a
22.1% economic interest in vTv LLC, effectively restricting vTv
Therapeutics Inc.’s interest to 77.9% of vTv LLC’s economic
results, subject to increase in the future, should vTv Therapeutics
Inc. purchase additional non-voting common units (“vTv Units”) of
vTv LLC, or should the holders of vTv Units decide to exchange such
units (together with shares of Class B common stock) for shares of
Class A common stock (or cash) pursuant to the Exchange Agreement
(as defined in Note 9). vTv Therapeutics Inc. has provided
financial and other support to vTv LLC in the form of its purchase
of vTv Units with the net proceeds of the Company’s initial public
offering (“IPO”) in 2015, its registered direct offering in March
2019, and its agreeing to be a co-borrower under the Venture Loan
and Security Agreement (the “Loan Agreement”) with Horizon
Technology Finance Corporation and Silicon Valley Bank (together,
the “Lenders”) which was entered into in 2016. vTv Therapeutics
Inc. entered into the letter agreements with MacAndrews and Forbes
Group LLC (“M&F Group”), a related party and an affiliate of
MacAndrews & Forbes Incorporated (together with its affiliates
“MacAndrews”) in December 2017, July 2018, December 2018, March
2019, September 2019, and December 2019 (each a “Letter Agreement”
and collectively, the “Letter Agreements”). In addition, vTv
Therapeutics Inc. also entered into the Controlled Equity
OfferingSM
Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald
& Co. (“Cantor Fitzgerald”) (the “ATM Offering”), the purchase
agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”) (the
“LPC Purchase Agreement”), the common stock purchase agreement with
G42 Investments AI Holding RSC Ltd (“G42 Investments”) (the “G42
Purchase Agreement”) and the common stock and warrant purchase
agreement with CinPax, LLC and CinRx, LLC, respectively (the “CinRx
Purchase Agreement”). vTv
Therapeutics Inc. will not be required to provide financial or
other support for vTv LLC.
However, vTv Therapeutics Inc. will control its business and other
activities through its managing member interest in vTv LLC, and its
management is the management of vTv LLC. Nevertheless, because vTv
Therapeutics Inc. will have no material assets other than its
interests in vTv LLC, any financial difficulties at vTv LLC could
result in vTv Therapeutics Inc. recognizing a loss.
Going Concern and Liquidity
To date, the Company has not generated any product revenue and has
not achieved profitable operations. The continuing development of
our drug candidates will require additional financing. From its
inception through September 30, 2022, the Company has funded
its operations primarily through a combination of private
placements of common and preferred equity, research collaboration
agreements, upfront and milestone payments for license agreements,
debt and equity financings and the completion of its IPO in August
2015. As of September 30, 2022, the Company had an accumulated
deficit of $267.1 million and has generated net losses in each
year of its existence.
As of September 30, 2022, the Company’s liquidity sources
included cash and cash equivalents of $15.3 million. To meet our
future funding requirements into the fourth quarter of 2023,
including funding the on-going and future clinical trials of
TTP399,
we are evaluating several financing strategies, including direct
equity investments and the potential licensing and
monetization of other Company programs such as
HPP737.
The Company also has promissory notes of $12.5 million and $4.0
million under the G42 Purchase Agreement and CinRx Purchase
Agreement payable to the Company, respectively. The G42 promissory
note is due on or before May 31, 2023, and the CinRx promissory
note is due on or before November 22, 2022 (see Note
9).
The Company may also use its remaining availability of $37.3
million under our Sales Agreement with Cantor Fitzgerald pursuant
to which the Company may offer and sell, from time to time shares
of the Company’s Class A common stock (the “ATM Offering”)
and
the ability to sell an additional 9,437,376 shares of Class A
common stock under the LPC Purchase Agreement based on the
remaining number of registered shares. However, the ability to use
these sources of capital is dependent on a number of factors,
including the prevailing market price of and the volume of trading
in the Company’s Class A common stock.
See Note 9 for further details.
These conditions raise substantial doubt about the Company’s
ability to continue as a going concern. If we are unable to raise
additional capital as and when needed, or upon acceptable terms,
such failure would have a significant negative
impact on our financial condition.
The Company’s financial statements have been prepared assuming the
Company will continue as a going concern, which contemplates, among
other things, the realization of assets and satisfaction of
liabilities in the normal course of business. The
Condensed Consolidated Financial Statements do not include
adjustments to reflect the possible future effects on the
recoverability and classification of recorded assets or the amounts
of liabilities that might be necessary should the Company be unable
to continue as a going concern.
Note 2: Summary of Significant Accounting Policies
Unaudited Interim Financial Information
The accompanying financial statements have been prepared in
accordance with accounting principles generally accepted in the
United States of America (“GAAP”). The accompanying Condensed
Consolidated Balance Sheet as of September 30, 2022, Condensed
Consolidated Statements of Operations for the three and nine months
ended September 30, 2022, and 2021, Condensed Consolidated
Statement of Changes in Redeemable Noncontrolling Interest and
Stockholders’ Deficit for the three and nine months ended
September 30, 2022, and 2021 and Condensed Consolidated
Statements of Cash Flows for the nine months ended
September 30, 2022, and 2021 are unaudited. These unaudited
financial statements have been prepared in accordance with the
rules and regulations of the United States Securities and Exchange
Commission (“SEC”) for interim financial information. Accordingly,
they do not include all of the information and footnotes required
by GAAP for complete financial statements. These financial
statements should be read in conjunction with the audited financial
statements and the accompanying notes for the year ended
December 31, 2021, contained in the Company’s Annual Report on
Form 10-K. The unaudited interim financial statements have been
prepared on the same basis as the annual financial statements and,
in the opinion of management, reflect all adjustments (consisting
of normal recurring adjustments) necessary to state fairly the
Company’s financial position as of September 30, 2022, the
results of operations for the three and nine months ended
September 30, 2022, and 2021 and cash flows for the nine
months ended September 30, 2022, and 2021. The
December 31, 2021 Condensed Consolidated Balance Sheet
included herein was derived from the audited financial statements
but does not include all disclosures or notes required by GAAP for
complete financial statements.
The financial data and other information disclosed in these notes
to the financial statements related to the three and nine months
ended September 30, 2022, and 2021 are unaudited. Interim
results are not necessarily indicative of results for an entire
year.
The Company does not have any components of other comprehensive
income recorded within its Condensed Consolidated Financial
Statements, and, therefore, does not separately present a statement
of comprehensive income in its Condensed Consolidated Financial
Statements.
Use of Estimates
The preparation of financial statements in conformity with
accounting principles generally accepted in the United States of
America requires the Company to make estimates and assumptions that
affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities as of the date of
the financial statements and the reported amounts of revenues and
expenses during the reporting period. Actual results could differ
from those estimates.
On an ongoing basis, the Company evaluates its estimates, including
those related to the grant date fair value of equity awards, the
fair value of warrants to purchase shares of its Class A common
stock, the fair value of the Class B common stock, the useful lives
of property and equipment, the fair value of derivative
liabilities, the fair value of the promissory note
receivable, and the fair value of the Company’s debt, among others.
The Company bases its estimates on historical experience and on
various other assumptions that it believes to be reasonable, the
results of which form the basis for making judgments about the
carrying value of assets and liabilities.
Concentration of Credit Risk
Financial instruments that potentially expose the Company to
concentrations of credit risk consist principally of cash on
deposit with one financial institution. The balances of these cash
accounts frequently exceed insured limits.
One customer represented 100% of the revenue earned during the nine
months ended September 30, 2022, two customers represented
100% of the revenue earned during the three months ended September
30, 2021 and three customers represented 100% of the revenue earned
during the nine months ended September 30, 2021.
Cash and Cash Equivalents
The Company considers any highly liquid investments with an
original maturity of three months or less to be cash and cash
equivalents.
Investments
Investments in entities in which the Company has no control or
significant influence, is not the primary beneficiary, and have a
readily determinable fair value are classified as equity
investments with readily determinable fair value. The investments
are measured at fair value based on a quoted market price per unit
in active markets multiplied by the number of units held without
consideration of transaction costs (Level 1). Gains and losses are
recorded in other income (expense), net on the Consolidated
Statements of Operations.
Equity investments without readily determinable fair value include
ownership rights that do not provide the Company with control or
significant influence and these investments do not have readily
determinable fair values. The Company has elected to measure its
equity investments without readily determinable fair values at cost
minus impairment, if any, plus or minus changes resulting from
observable price changes in orderly transactions for the identical
or similar investment.
Revenue Recognition
The Company uses the revenue recognition guidance established by
ASC Topic 606,
Revenue From Contracts With Customers
(“ASC 606”). When an agreement falls under the scope of other
standards, such as ASC Topic 808,
Collaborative Arrangements
(“ASC 808”), the Company will apply the recognition, measurement,
presentation, and disclosure guidance in ASC 606 to the performance
obligations in the agreements if those performance obligations are
with a customer. Revenue recognized by analogizing to ASC 606, is
recorded as collaboration revenue on the statements of
operations.
The majority of the Company’s revenue results from its license and
collaboration agreements associated with the development of
investigational drug products. The Company accounts for a contract
when it has approval and commitment from both parties, the rights
of the parties are identified, payment terms are identified, the
contract has commercial substance and collectability of
consideration is probable. For each contract meeting these
criteria, the Company identifies the performance obligations
included within the contract. A performance obligation is a promise
in a contract to transfer a distinct good or service to the
customer. The Company then recognizes revenue under each contract
as the related performance obligations are satisfied.
The transaction price under the contract is determined based on the
value of the consideration expected to be received in exchange for
the transferred assets or services. Development, regulatory and
sales milestones included in the Company’s collaboration agreements
are considered to be variable consideration. The amount of variable
consideration expected to be received is included in the
transaction price when it becomes probable that the milestone will
be met. For contracts with multiple performance obligations, the
contract’s transaction price is allocated to each performance
obligation using the Company’s best estimate of the standalone
selling price of each distinct good or service in the contract. The
primary method used to estimate standalone selling price is the
expected cost-plus margin approach.
Research and Development
Major components of research and development costs include cash and
share-based compensation, costs of preclinical studies, clinical
trials and related clinical manufacturing, costs of drug
development, costs of materials and supplies, regulatory and
compliance costs, fees paid to consultants and other entities that
conduct certain research and development
activities on the Company’s behalf, facilities costs, and overhead
costs. Research and development costs are expensed as
incurred.
The Company records accruals based on estimates of the services
received, efforts expended, and amounts owed pursuant to contracts
with numerous contract research organizations. In the normal course
of business, the Company contracts with third parties to perform
various clinical study activities in the ongoing development of
potential products. The financial terms of these agreements are
subject to negotiation and variation from contract to contract and
may result in uneven payment flows. Payments under the contracts
depend on factors such as the achievement of certain events and the
completion of portions of the clinical study or similar conditions.
The objective of the Company’s accrual policy is to match the
recording of expenses in its financial statements to the actual
services received and efforts expended. As such, expense accruals
related to clinical studies are recognized based on the Company’s
estimate of the degree of completion of the event or events
specified in the specific clinical study.
The Company records nonrefundable advance payments it makes for
future research and development activities as prepaid expenses.
Prepaid expenses are recognized as expense in the Condensed
Consolidated Statements of Operations as the Company receives the
related goods or services.
Research and development costs that are reimbursed under a
cost-sharing arrangement are reflected as a reduction of research
and development expense.
Recently Issued Accounting Pronouncements
Fair Value Measurements:
In June 2022, the Financial Accounting Standards Board (FASB)
issued Accounting Standards Update (ASU) No. 2022-03
“Fair Value Measurements (Topic 820): Fair Value Measurement of
Equity Securities Subject to Contractual Sale Restrictions.”
These amendments clarify that a contractual restriction on the sale
of an equity security is not considered part of the unit of account
of the equity security and, therefore, is not considered in
measuring fair value. This guidance is effective for public
business entities for fiscal years, including interim periods
within those fiscal years, beginning after December 15, 2023. Early
adoption is permitted. The Company has assessed ASU 2022-03 and
early adopted the guidance during the second quarter of 2022. The
adoption did not have a material impact on the Company's Condensed
Consolidated Financial Statements.
Note 3: Collaboration Agreements
G42 Purchase Agreement and Cogna Collaborative and License
Agreement
The Company and G42 Investments AI Holding RSC Ltd, a private
limited company (“G42 Investments”), entered into a Common Stock
Purchase Agreement (the “G42 Purchase Agreement”), pursuant to
which the Company sold to G42 Investments 10,386,274 shares of the
Company’s Class A common stock, par value $0.01 per share (the “G42
Common Stock) at a price per share of approximately $2.41, for an
aggregate purchase price of $25.0 million, which was paid (i) $12.5
million in cash at the closing and (ii) $12.5 million in the form
of a promissory note of G42 Investments to be paid at the one-year
anniversary of the execution of the G42 Purchase Agreement. As part
of the G42 Purchase Agreement, G42 Investments put forward a
director as appointee and the Company’s board of directors approved
appointing the new director to the Company’s board.
G42 Investments has agreed to certain transfer restrictions
(including restrictions on short sales or similar transactions) and
restrictions on further acquisitions of shares, in each case
subject to specified exceptions. Following the expiration of a lock
up period, from the period May 31, 2022 until December 31, 2024 (or
if earlier, the date of receipt of U.S. Food and Drug
Administration (“FDA”) approval in the U.S. for
TTP399
(the “FDA Approval”) of
TTP399),
the Company has granted to G42 Investments certain shelf and
piggyback registration rights with respect to those shares of Class
A common stock issued to G42 Investments pursuant to the G42
Purchase Agreement, including the ability to conduct an
underwritten offering to resell such shares under certain
circumstances. The registration rights include customary
cooperation, cut-back, expense reimbursement, and indemnification
provisions.
Contemporaneously with the G42 Purchase Agreement, effective on May
31, 2022, the Company entered into a collaboration and license
agreement (the “Cogna Agreement”) with Cogna Technology Solutions
LLC, an affiliate of G42 Investments (“Cogna”) (“Collaboration
Partner”), which requires Cogna to work with the Company in
performing Phase 3 clinical trials for the Company’s
TTP399
compound (the “Licensed Product”) as well as jointly creating a
global development plan to develop, market, and
commercialize
TTP399
in certain countries in the Middle East, Africa, and Central Asia
(the “Partner Territory”). Under the terms of the Cogna Agreement,
Cogna will obtain rights to the Company’s license of
TTP399,
for purposes of performing Phase 3 clinical trials in the Partner
Territory, but will not have access to the various intellectual
property (“IP”) related to the license and
TTP399.
Specifically, the Company will share various protocols with Cogna
related to conducting the clinical trials and will provide the
patient dosages and placebo of
TTP399
needed to conduct
the trials. Separately, the Company will conduct its Phase 3
clinical trials for
TTP399
in the U.S. at its own cost that similarly will not be reimbursed.
The results of each party’s Phase 3 clinical trials will be
combined by the Company to seek FDA approval in the U.S. for
TTP399.
Under the Cogna Agreement, Cogna has the right to develop and
commercialize the Licensed Product in the Partner Territory at its
own cost once restrictions on the use of the IP have been lifted by
the Company. The Cogna Agreement determined which specific
countries in the Partner Territory that Cogna may pursue
development and commercialization and provides the Company with the
ability to determine when Cogna can benefit from this IP through
the powers granted to the Company to approve the global development
plan. Further, the Company may supply at cost, or Cogna may
manufacture,
TTP399
for commercial sale under terms to be agreed upon by the parties at
a later date.
The G42 Purchase Agreement also provides for, following the receipt
of FDA approval of the Licensed Product, at the option of G42
Investments, either (a) the issuance of the Company’s Class A
common stock (the “Milestone Shares”) having an aggregate value
equal to $30.0 million or (b) the payment by the Company of $30.0
million in cash (the “Milestone Cash Payment”). The issuance of the
Milestone Shares or the payment of the Milestone Cash Payment, as
applicable, are conditioned upon receipt of the FDA Approval and
subject to certain limitations and conditions set forth in the G42
Purchase Agreement. There can be no assurance that the FDA Approval
will be granted or as to the timing thereof.
Once commercialization takes place in the Partner Territories, the
Company will receive royalties of 8% from Cogna on the sale of the
Licensed Product for ten years after the first commercial sale of
the Licensed Product.
Common stock is generally recorded at fair value at the date of
issuance. In determining the fair value of the Class A common stock
issued to G42 Investments, the Company considered the closing price
of the common stock on the effective date. The Company did not make
an adjustment to the fair value for sale restrictions on the stock
in accordance with guidance recently adopted in ASU 2022-03. See
the “Recently Issued Accounting Guidance” in this 10-Q for details
of the ASU. Accordingly, the Company determined that cash
consideration of $5.7 million should be recorded as fair value of
the Class A common stock at the effective date, utilizing the Class
A common stock closing price of $0.55 at the effective
date.
A premium was paid on the Class A common stock by G42 Investments
of $18.7 million, net of a note receivable discount of $0.6
million. This premium is determined to be the transaction price for
all remaining obligations under the agreements, which will be
accounted for under ASC 808 or ASC 606 based on determination of
the unit of account.
The Company determined that certain commitments under the
agreements are in the scope of ASC 808 as both the Company and
Cogna are active participants in the clinical trials of the
Licensed Product, and both are exposed to significant risks and
rewards based on the success of the clinical trials and subsequent
FDA approval. Cogna is determined to be a vendor of the Company
during the clinical trial phase, working on the Company’s behalf to
complete R&D activities, and not in a customer capacity. The
Company accounted for the commitments related to the clinical
trials, which includes transfer of trial protocols, supply of
clinical trial dosages, and collaboration on the joint development
committee (“JDC”) as an ASC 808 unit of account, applying the
recognition and measurement principles of ASC 606 by analogy. The
Company will recognize collaboration revenue for its development
activities under ASC 808 over time based on the estimated period of
performance.
By applying the principals in ASC 606 by analogy, the Company
identified the performance obligation and considered the timing of
satisfaction of the obligation to account for the pattern of
revenue recognition. In order to recognize collaboration revenue,
generally, the Company would begin satisfying its performance
obligation and Cogna would need to be able to use and benefit from
delivery of the assets or services. The performance obligation
under the agreements that fall within the 808 unit of account are
concentrated in the Phase 3 clinical trials. As of
September 30, 2022, the Phase 3 clinical trials had not
commenced. Accordingly, no collaboration revenue was recognized for
the ASC 808 unit of account during the three and nine months ended
September 30, 2022.
The Company identified certain commitments that are in the scope of
ASC 606 as Cogna’s relationship is that of a customer for these
commitments. The significant performance obligations that are in
the scope of ASC 606 are (1) the development, commercialization and
manufacturing license of the IP once restrictions on the use of the
IP have been lifted by the Company and (2) a potential material
right to a commercial supply agreement. The Company will recognize
revenue from the development, commercial and manufacturing license
at a point in time when the Company releases the restrictions on
the use of the IP, which is expected to be after the Licensed
Product is approved by the FDA. The Company will recognize revenue
from the material right related to Cogna’s ability to purchase the
commercial supply at cost as Cogna purchases the commercial supply
from the Company, which will occur after the completion of the
initial clinical trials (if Cogna decides to purchase the clinical
supply from the Company). As a result, the Company has not
recognized any revenue under the ASC 606 unit of account during the
three and nine months ended September 30, 2022.
As of September 30, 2022, the Company has recognized the cash
and a non-interest bearing promissory note receivable of with a
principal balance of $12.5 million. The promissory note receivable
was classified and accounted for under ASC 310 and was initially
measured at its fair value of $11.9 million and will be
subsequently remeasured at its amortized cost through its maturity
date. The Company also recorded the $18.7 million as deferred
revenue in the Consolidated Balance Sheets, as none of the
underlying performance obligations had been satisfied as of and for
the three and nine months ended September 30,
2022.
Reneo License Agreement
The Company is party to a license agreement with Reneo
Pharmaceuticals, Inc. (“Reneo”) (the “Reneo License Agreement”),
under which Reneo obtained an exclusive, worldwide, sublicensable
license to develop and commercialize the Company’s peroxisome
proliferation activated receptor delta (PPAR-δ) agonist program,
including the compound
HPP593,
for therapeutic, prophylactic or diagnostic application in
humans.
The Company has fully allocated the transaction price to the
license and the technology transfer services, which represents a
single combined performance obligation because they were not
capable of being distinct on their own. The revenue related to this
performance obligation was recognized on a straight-line basis over
the technology transfer service period.
The revenue related to this performance obligation has been fully
recognized and no revenue related to this performance obligation
was recognized for the three and nine months ended
September 30, 2022. There have been no adjustments to the
transaction price for the performance obligations under the Reneo
License Agreement during the three and nine months ended
September 30, 2022. In the third quarter of 2021, the
transaction price for this performance obligation was increased by
$2.0 million due to the satisfaction of a development milestone
under the Reneo License Agreement. This amount was fully recognized
as revenue during the three and nine months ended September 30,
2021, as the related performance obligation was fully
satisfied.
Huadong License Agreement
The Company is party to a license agreement with Hangzhou Zhongmei
Huadong Pharmaceutical Co., Ltd. (“Huadong”) (the “Huadong License
Agreement”), under which Huadong obtained an exclusive and
sublicensable license to develop and commercialize the Company’s
glucagon-like peptide-1 receptor agonist (“GLP-1r”) program,
including the compound
TTP273,
for therapeutic uses in humans or animals, in China and certain
other pacific rim countries, including Australia and South Korea
(collectively, the “Huadong License Territory”). Additionally,
under the Huadong License Agreement, the Company obtained a
non-exclusive, sublicensable, royalty-free license to develop and
commercialize certain Huadong patent rights and know-how related to
the Company’s GLP-1r program for therapeutic uses in humans or
animals outside of the Huadong License Territory.
On January 14, 2021, the Company entered into the first
amendment to the Huadong License Agreement ( the “First Huadong
Amendment”) which eliminated the Company’s obligation to sponsor a
multi-region clinical trial (the “Phase 2 MRCT”), and corresponding
obligation to contribute up to $3.0 million in support of such
trial. The amendment also reduced the total potential development
and regulatory milestone payments by $3.0 million.
Prior to the First Amendment, the Company had allocated a portion
of the transaction price to the obligation to sponsor and conduct a
portion of the Phase 2 MRCT. Upon the removal of this performance
obligation, the Company evaluated the impact of the modification
under the provisions of ASC Topic 606 and performed a reallocation
of the transaction price among the remaining performance
obligations. This resulted in the recognition of approximately $1.0
million of revenue on a cumulative catch-up basis during the nine
months ended September 30, 2021. The majority of the
transaction price originally allocated to the Phase 2 MRCT
performance obligation was reallocated to the license and
technology transfer services combined performance obligation
discussed below, which had already been completed. The reallocation
of the purchase price in connection with the First Huadong
Amendment was made based on the relative estimated selling prices
of the remaining performance obligations.
The significant performance obligations under the Huadong License
Agreement, as amended, were determined to be (i) the exclusive
license to develop and commercialize the Company’s GLP-1r program,
(ii) technology transfer services related to the chemistry and
manufacturing know-how for a defined period after the effective
date, (iii) the Company’s obligation to participate on a joint
development committee (the “JDC”), and (iv) other obligations
considered to be de minimis in nature.
The Company has determined that the license and technology transfer
services related to the chemistry and manufacturing know-how
represent a combined performance obligation because they were not
capable of being distinct on
their own. The Company also determined that there was no
discernible pattern in which the technology transfer services would
be provided during the transfer service period. As such, the
Company recognized the revenue related to this combined performance
obligation using the straight-line method over the transfer service
period. This combined performance obligation was considered
complete as of September 30, 2021. The Company recognized $1.0
million of revenue related to this combined performance obligation
during the nine months ended September 30, 2021. During the
nine months ended September 30, 2022, the transaction price
for this performance obligation was increased by $2.0 million due
to the satisfaction of a development milestone under the Huadong
License Agreement, as amended. This amount was fully recognized as
revenue during the nine months ended September 30, 2022, as
the related performance obligation was fully
satisfied.
A portion of the transaction price allocated to the obligation to
participate in the JDC to oversee the development of products and
the Phase 2 MRCT in accordance with the development plan remained
deferred as of September 30, 2022, and revenue will be
recognized using the proportional performance model over the period
of the Company’s participation on the JDC. The unrecognized amount
of the transaction price allocated to this performance obligation
as of September 30, 2022, was de minimis. An immaterial amount
of revenue for this performance obligation has been recognized
during nine months ended September 30, 2022, and
2021.
Newsoara License Agreement-
The Company is party to a license agreement with Newsoara Biopharma
Co., Ltd., (“Newsoara”) (the “Newsoara License Agreement”) under
which Newsoara obtained an exclusive and sublicensable license to
develop and commercialize the Company’s phosphodiesterase type 4
inhibitors (“PDE4”) program, including the compound
HPP737,
in China, Hong Kong, Macau, Taiwan and other pacific rim countries
(collectively, the “Newsoara License Territory”). Additionally,
under the Newsoara License Agreement, the Company obtained a
non-exclusive, sublicensable, royalty-free license to develop and
commercialize certain Newsoara patent rights and know-how related
to the Company’s PDE4 program for therapeutic uses in humans
outside of the Newsoara License Territory.
The Company has fully allocated the transaction price to the
license and the technology transfer services which represents a
single performance obligation because they were not capable of
being distinct on their own. The Company recognized revenue for
this performance obligation using the straight-line method over the
transfer service period. The revenue for this performance
obligation has been fully recognized as of September 30, 2022.
In the third quarter of 2021, the transaction price for this
performance obligation was increased by $1.0 million due to the
satisfaction of a development milestone under the Newsoara License
Agreement. This amount was fully recognized as revenue during the
three and nine months ended September 30, 2021, as the related
performance obligation was fully satisfied. No revenue related to
this performance obligation was recognized and there have been no
changes to the transaction price during the three and nine months
ended September 30, 2022.
JDRF Agreement
In August 2017, the Company entered into a research and
collaboration agreement with JDRF International (the “JDRF
Agreement”) to support the funding of the Simplici-T1 Study, a
Phase 2 study to explore the effects of
TTP399
in patients with type 1 diabetes.
The JDRF Agreement was amended in June 2021 to provide additional
funding for the Company’s mechanistic study exploring the effects
of
TTP399
on ketone body formation during a period of insulin withdrawal in
people with type 1 diabetes. Consistent with
the terms of the JDRF Agreement, JDRF provided research funding of
$3.4 million based on the achievement of research and development
milestones, with the total funding provided by JDRF not to exceed
approximately one-half of the total cost of the project.
Additionally, the Company has the obligation to make certain
milestone payments to JDRF upon the commercialization, licensing,
sale or transfer of
TTP399
as a treatment for type 1 diabetes.
Payments that the Company receives from JDRF under this agreement
were recorded as restricted cash and current liabilities and
recognized as an offset to research and development expense, based
on the progress of the project, and only to the extent that the
restricted cash is utilized to fund such development activities. As
of September 30, 2022, the Company had received funding under
this agreement of $3.4 million. Research and development costs have
been offset by the $3.4 million of cash received over the course of
this agreement.
Contract Liabilities
Contract liabilities related to the Company’s collaboration
agreements consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2022 |
|
December 31, 2021 |
Current portion of contract liabilities |
$ |
26 |
|
|
$ |
35 |
|
Contract liabilities, net of current portion |
18,669 |
|
|
— |
|
Total contract liabilities |
$ |
18,695 |
|
|
$ |
35 |
|
Changes in short-term and long-term contract liabilities for the
nine months ended September 30, 2022, were as
follows:
|
|
|
|
|
|
|
Contract Liabilities |
Balance on January 1, 2022 |
$ |
35 |
|
Reclassification of the beginning contract liabilities to revenue,
as the result of performance obligations satisfied |
(9) |
|
Consideration received in advance and not recognized as
revenue |
18,669 |
|
Balance on September 30, 2022 |
$ |
18,695 |
|
Note 4: Share-Based Compensation
The Company has issued non-qualified stock option awards to
management, other key employees, consultants, and non-employee
directors. These option awards generally vest ratably over a
three-year period and the option awards expire after a term of ten
years from the date of grant. As of September 30, 2022, the
Company had total unrecognized stock-based compensation expense for
its outstanding stock option awards of approximately $2.6 million,
which is expected to be recognized over a weighted average period
of 2.7 years. The weighted average grant date fair value of options
granted during the nine months ended September 30, 2022, and
2021 was $0.68 and $2.21 per option, respectively. The aggregate
intrinsic value of the in-the-money awards outstanding at
September 30, 2022, was de minimis.
On February 27, 2022, Ms. Deepa Prasad notified the Board of
Directors (the “Board”) of the Company of her decision to resign
from her positions as Chief Executive Officer, President, and Board
member, effective as of March 29, 2022, and served in these
roles through March 29, 2022 (the “Effective Date”). Ms.
Prasad agreed to serve as a Strategic Advisor to the Company for
six months after the Effective Date. Ms. Prasad will retain 624,659
of the outstanding options previously granted to her, which will
vest at the end of the 15-month period following the Effective
Date. As a result of the separation agreement, these options were
modified to accelerate vesting at the Effective Date. These options
will remain exercisable for the original ten-year period and the
remaining 1,873,976 of her options were cancelled. The additional
stock compensation expense for the modification during the nine
months ended September 30, 2022, was de minimis.
The following table summarizes the activity related to the stock
option awards for the nine months ended September 30,
2022:
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of Shares |
|
Weighted
Average Exercise Price |
Awards outstanding at December 31, 2021 |
7,056,035 |
|
|
$ |
3.19 |
|
Granted |
4,047,333 |
|
|
0.78 |
|
Forfeited |
(3,384,424) |
|
|
2.37 |
|
Awards outstanding at September 30, 2022 |
7,718,944 |
|
|
$ |
2.28 |
|
Options exercisable at September 30, 2022 |
2,563,810 |
|
|
$ |
4.75 |
|
Weighted average remaining contractual term |
6.3 Years |
|
|
Options vested and expected to vest at September 30,
2022 |
6,664,874 |
|
|
$ |
2.49 |
|
Weighted average remaining contractual term |
8.2 Years |
|
|
Compensation expense related to the grants of stock options is
included in research and development and general and administrative
expense as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
2022 |
|
2021 |
|
|
2022 |
|
2021 |
Research and development |
$ |
109 |
|
|
$ |
186 |
|
|
|
$ |
289 |
|
|
$ |
542 |
|
General and administrative |
229 |
|
|
288 |
|
|
|
692 |
|
|
820 |
|
Total share-based compensation expense |
$ |
338 |
|
|
$ |
474 |
|
|
|
$ |
981 |
|
|
$ |
1,362 |
|
Note 5: Investments
In connection with the Reneo License Agreement and the Anteris
License Agreement, the Company has received equity ownership
interests of less than 20% of the voting equity of the investee.
Further, the Company does not have the ability to exercise
significant influence over the investees. The investments are
classified as long-term investments in the Company’s Consolidated
Balance Sheets.
Reneo completed its initial public offering in April 2021. Prior to
Reneo becoming a publicly traded company, the Company’s investment
in Reneo did not have a readily determinable fair value and was
measured at cost less impairment, adjusted for any changes in
observable prices, under the measurement alternative. Subsequent to
Reneo’s initial public offering, the Company’s investment in Reneo
is considered to have a readily determinable fair value and, as
such, is adjusted to its fair value each period with changes in
fair value recognized as a component of net loss.
The Company’s investment in Anteris does not have a readily
determinable fair value and is measured at cost less impairment,
adjusted for any changes in observable prices.
The Company’s investments consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2022 |
|
December 31, 2021 |
Equity investment with readily determinable fair value: |
|
|
|
Reneo common stock |
$ |
1,930 |
|
|
$ |
4,928 |
|
|
|
|
|
Equity investment without readily determinable fair values assessed
under the measurement alternative: |
|
|
|
Anteris preferred stock |
4,245 |
|
|
4,245 |
|
Total |
$ |
6,175 |
|
|
$ |
9,173 |
|
No adjustments have been made to the value of the Company’s
investment in Anteris since its initial measurement either due to
impairment or based on observable price changes. The Company
recognized an unrealized gain on its investment in Reneo of
$0.4 million and an unrealized loss of $3.0 million for the
three and nine months ended September 30, 2022, respectively.
The Company recognized an unrealized loss on its investment in
Reneo of $1.1 million and an unrealized gain of $1.8 million for
the three months and nine months ended September 30, 2021,
respectively. These adjustments were recognized as a component of
other income/(expense) in the Company’s Condensed Consolidated
Statements of Operations.
Note 6: Commitments and Contingencies
Legal Matters
From time to time, the Company is involved in various legal
proceedings arising in the normal course of business. If a specific
contingent liability is determined to be probable and can be
reasonably estimated, the Company accrues and discloses the amount.
The Company is not currently a party to any material legal
proceedings.
Novo Nordisk
In February 2007, the Company entered into an Agreement Concerning
Glucokinase Activator Project with Novo Nordisk A/S (the “Novo
License Agreement”) whereby the Company obtained an exclusive,
worldwide, sublicensable license under certain Novo Nordisk
intellectual property rights to discover, develop, manufacture,
have manufactured, use and commercialize products for the
prevention, treatment, control, mitigation or palliation of human
or animal diseases or conditions. As part of this license grant,
the Company obtained certain worldwide rights to Novo Nordisk’s GKA
program, including rights to preclinical and clinical compounds
such as
TTP399.
This agreement was amended in May 2019 to create
milestone payments applicable to certain specific and non-specific
areas of therapeutic use. Under the terms of the amended Novo
License Agreement, the Company has potential developmental and
regulatory milestone payments totaling up to $9.0 million for
approval of a product for the treatment of type 1 diabetes, $50.5
million for approval of a product for the treatment of type 2
diabetes, or $115.0 million for approval of a product in any other
indication. The Company may also be obligated to pay an additional
$75.0 million in potential sales-based milestones, as well as
royalty payments, at mid-single digit royalty rates, based on
tiered sales of commercialized licensed products. During the fourth
quarter of 2021, the Company made a payment of $2.0 million related
to the satisfaction of the milestone to complete the phase 2 trials
for
TTP399
under this agreement.
Note 7: Leases
The Company leases office space for its headquarters location under
an operating lease. This lease commenced in November 2019 after the
completion of certain tenant improvements made by the lessor. The
lease includes an option to renew for a five-year term as well as
an option to terminate after three years, neither of which have
been recognized as part of its related right of use assets or lease
liabilities as their election was not considered reasonably
certain. The Company has notified the lessor that it intends to
exercise the early termination option and is negotiating an
amendment to the lease. Further, this lease does not include any
material residual value guarantee or restrictive
covenants.
At each of September 30, 2022, and December 31, 2021, the
weighted average incremental borrowing rate for the operating
leases held by the Company was 13.1%. At September 30, 2022,
and December 31, 2021, the weighted average remaining lease
terms for the operating leases held by the Company were 2.3 years
and 3.1 years, respectively.
Maturities of lease liabilities for the Company’s operating leases
as of September 30, 2022, were as follows (in
thousands):
|
|
|
|
|
|
2022 (remaining three months) |
$ |
65 |
|
2023 |
268 |
|
2024 |
275 |
|
2025 |
23 |
|
2026 |
— |
|
Thereafter |
— |
|
Total lease payments |
631 |
|
Less: imputed interest |
(90) |
|
Present value of lease liabilities |
$ |
541 |
|
Operating lease cost and the related operating cash flows for the
nine months ended September 30, 2022, and 2021 were immaterial
amounts.
Note 8: Redeemable Noncontrolling Interest
The Company is subject to the Exchange Agreement with respect to
the vTv Units representing the 22.1% noncontrolling interest in vTv
LLC outstanding as of September 30, 2022 (see Note 9). The
Exchange Agreement requires the surrender of an equal number of vTv
Units and Class B common stock for (i) shares of Class A common
stock on a one-for-one basis or (ii) cash (based on the fair market
value of the Class A common stock as determined pursuant to the
Exchange Agreement), at the Company’s option (as the managing
member of vTv LLC), subject to customary conversion rate
adjustments for stock splits, stock dividends and
reclassifications. The exchange value is determined based on a
20-day volume weighted average price of the Class A common stock as
defined in the Exchange Agreement, subject to customary conversion
rate adjustments for stock splits, stock dividends and
reclassifications.
The redeemable noncontrolling interest is recognized at the higher
of (1) its initial fair value plus accumulated earnings/losses
associated with the noncontrolling interest or (2) the redemption
value as of the balance sheet date. At September 30, 2022, and
December 31, 2021, the redeemable noncontrolling interest was
recorded based on the redemption value as of the balance sheet date
of $24.2 million and $25.0 million, respectively.
Changes in the Company’s ownership interest in vTv LLC while the
Company retains its controlling interest in vTv LLC are accounted
for as equity transactions, and the Company is required to adjust
noncontrolling interest and equity for
such changes. The following is a summary of net income attributable
to vTv Therapeutics Inc. and transfers to noncontrolling
interest:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended September 30, |
|
For the Nine Months Ended September 30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Net loss attributable to vTv Therapeutics Inc. common
shareholders |
$ |
(4,261) |
|
|
$ |
(1,087) |
|
|
$ |
(14,419) |
|
|
$ |
(5,936) |
|
(Increase) in vTv Therapeutics Inc. accumulated deficit for
purchase of LLC Units as a result of common stock
issuances |
(1,174) |
|
|
(2,773) |
|
|
(103) |
|
|
(5,298) |
|
Change from net loss attributable to vTv Therapeutics Inc. common
shareholders and transfers to noncontrolling interest |
$ |
(5,435) |
|
|
$ |
(3,860) |
|
|
$ |
(14,522) |
|
|
$ |
(11,234) |
|
Note 9: Stockholders’ Deficit
Amendment to Certificate of Incorporation
On May 4, 2021, the Company filed an amendment to its Amended
and Restated Certificate of Incorporation (the “Charter Amendment”)
to increase the number of shares of Class A common stock that the
Company is authorized to issue from 100,000,000 shares of Class A
common stock to 200,000,000 shares of Class A common stock,
representing an increase of 100,000,000 shares of authorized Class
A common stock, with a corresponding increase in the total
authorized common stock, which includes Class A common stock and
Class B common stock, from 200,000,000 to 300,000,000, and a
corresponding increase in the total authorized capital stock, which
includes common stock and preferred stock, from 250,000,000 shares
to 350,000,000 shares.
G42 Investments Transaction
On May 31, 2022, the Company and G42 Investments entered in to the
G42 Purchase Agreement (see Note 3), pursuant to which the Company
agreed to sell to G42 Investments 10,386,274 shares of the
Company's Class A common stock, par value $0.01 per share at a
price per share of approximately $2.41, for an aggregate purchase
price of $25.0 million, consisting of (i) $12.5 million in cash at
the closing of the transaction and (ii) $12.5 million in the form
of a promissory note of G42 Investments to be paid at the one-year
anniversary of the execution of the G42 Purchase
Agreement.
CinPax and CinRx Transaction
On July 22, 2022 (the “Transaction Date”), the Company entered into
the CinRx Purchase Agreement with CinPax and CinRx, pursuant to
which the Company agreed to sell to CinPax 4,154,549 shares of the
Company’s Class A common stock, par value $0.01 per share (the
“Common Stock” and such shares, the “Closing Shares”) at a price
per share of approximately $2.41, for an aggregate purchase price
of $10.0 million, which was paid (i) $6.0 million in cash at the
closing of the transaction and (ii) $4.0 million in the form of a
non-interest-bearing promissory note with CinPax to be paid at the
four-month anniversary of the execution of the CinRx Purchase
Agreement. The promissory note receivable was classified and
accounted for under ASC 505 as contra-equity. The CinRx Purchase
Agreement provides CinPax the right to put forward a director to be
approved to sit on vTv’s Board of Directors and a board observer,
which was subsequently approved by the Company’s
board.
Common stock is generally recorded at fair value at the date of
issuance. In determining the fair value of the Class A common stock
issued to CinPax, the Company considered the closing price of the
common stock on the Transaction Date. The Company did not make an
adjustment to the fair value for sale restrictions on the stock in
accordance with guidance recently adopted in ASU 2022-03. See the
“Recently Issued Accounting Guidance” in this 10-Q for details of
the ASU.
Accordingly, the Company determined that cash consideration of $3.0
million should be recorded as fair value of the Class A common
stock at the effective date, utilizing the Class A common stock
closing price of $0.72 at the effective date.
The CinRx Purchase Agreement also provides CinRx warrants to
purchase up to 1,200,000 shares of Common Stock at an initial
exercise of price of approximately $0.72 per share (the “CinRx
Warrants”). The CinRx Warrants were initially measured at fair
value of $0.4 million using the Black Scholes option model at the
time of issuance and will be recorded in Warrant liability related
party in the Condensed Consolidated Balance Sheets and will be
subsequently remeasured at fair value through earnings on a
recurring basis. (see Note 13)
The CinRx Warrants will become exercisable by CinRx only if (i) the
Company receives approval from the U.S. Food and Drug
Administration (“FDA Approval”) to market and distribute the
pharmaceutical product containing the Company’s proprietary
candidate,
TTP399
(the “Product”), or (ii) the Company is acquired by a third party,
sells all or substantially all of its assets related to the Product
to a third party or grants a third party an exclusive license to
develop, commercialize and manufacture the Product in the United
States (an “Exit Event”). If neither of these events happen within
five years of the date of the issuance of the CinRx Warrants, the
CinRx Warrants will expire and not be exercisable by CinRx. The
exercise price of the CinRx Warrants and the number of shares
issuable upon exercise of the CinRx Warrants are subject to
adjustments in accordance with the terms of the CinRx
Warrants.
Additionally, in conjunction with the CinRx Purchase Agreement the
Company and CinRx entered into a Master Service Agreement (“CinRx
MSA”) whereby CinRx provides the Company with consulting,
pre-clinical and clinical trial services, as enumerated in project
proposals negotiated between the Company and CinRx from time to
time. (see Note 10)
The Company did not identify any other promises in the CinRx
Purchase Agreement (aside from the issuance of common shares and
the CinRx Warrants) and determined since there is no value ascribed
to the CinRx MSA, the right to appoint a member and observer to the
board of directors, that the remaining unallocated amount meets the
definition of contributed equity and represents the amount in
excess of par.
ATM Offering
In April 2020, the Company entered into the Sales Agreement with
Cantor Fitzgerald as the sales agent, pursuant to which the Company
may offer and sell, from time to time, through Cantor, shares of
its Class A common stock, par value $0.01 per share, having an
aggregate offering price of up to $13.0 million by any method
deemed to be an “at the market offering” as defined in Rule
415(a)(4) under the Securities Act (the “ATM Offering”). The shares
are offered and sold pursuant to the Company’s shelf registration
statement on Form S-3. In no event will the Company sell Class A
common stock under this registration statement with a value
exceeding more than one-third of the “public float” (the market
value of our Class A common stock and any other equity securities
that we may issue in the future that are held by non-affiliates) in
any 12-calendar month period so long as our public float remains
below $75 million.
On January 14, 2021, and June 25, 2021, the Company filed
a prospectus supplement in connection with the ATM Offering to
increase the size of the at-the-market offering pursuant to which
the Company may offer and sell, from time to time, through or to
Cantor, as sales agent or principal, shares of the Company’s Class
A common stock, by an aggregate offering price of
$5.5 million
and $50.0 million, respectively.
During the three and nine months ended September 30, 2021, the
Company sold 8,457,546 shares of its Class A common stock under the
ATM Offering for net proceeds of $17.0 million.
During the three and nine months ended September 30, 2022, the
Company did not sell any shares under the ATM
Offering.
Lincoln Park Capital Transaction
On November 24, 2020, the Company entered into the LPC
Purchase Agreement and a registration rights agreement (the
“Registration Rights Agreement”), pursuant to which the Company has
the right to sell to Lincoln Park shares of the Company’s Class A
common stock having an aggregate value of up to $47.0 million,
subject to certain limitations and conditions set forth in the LPC
Purchase Agreement. The Company will control the timing and amount
of any sales of shares to Lincoln Park. pursuant to the LPC
Purchase Agreement. During the three and nine months ended
September 30, 2022, the Company did not sell any shares under the
LPC Purchase Agreement. During the nine months ended
September 30, 2021, the Company sold 3,941,726 shares under
the LPC Purchase Agreement for total proceeds of $9.1
million.
Note 10: Related-Party Transactions
MacAndrews & Forbes Incorporated
As of September 30, 2022, subsidiaries and affiliates of
MacAndrews & Forbes Incorporated (collectively “MacAndrews”)
indirectly controlled 23,084,267 shares of the Company’s Class B
common stock and 36,519,212 shares of the Company’s Class A common
stock. As a result, MacAndrews’ holdings represent approximately
57.0% of the combined voting power of the Company’s outstanding
common stock.
The Company has entered into several agreements with MacAndrews or
its affiliates as further detailed below:
Letter Agreements
The Company has previously entered into the Letter Agreements with
MacAndrews. Under the terms of the Letter Agreements, during the
one year commitment period beginning on the date of each License
Agreement, the Company had the right to sell to MacAndrews shares
of its Class A common stock at a specified price per share, and
MacAndrews had the right (exercisable up to three times) to require
the Company to sell to it shares of Class A common stock at the
same price. The commitment period of each of the Letter Agreements
has now expired. In addition, in connection with and as a
commitment fee for the entrance into certain of these Letter
Agreements, the Company also issued MacAndrews warrants (the
“Letter Agreement Warrants”) to purchase additional shares of the
Company’s Class A common stock.
The Letter Agreement Warrants have been recorded as warrant
liability, related party within the Company’s Condensed
Consolidated Balance Sheets based on their fair value. The issuance
of the Letter Agreement Warrants was considered to be a cost of
equity recorded as a reduction to additional paid-in
capital.
Exchange Agreement
The Company and MacAndrews are party to an exchange agreement (the
“Exchange Agreement”) pursuant to which the vTv Units (along with a
corresponding number of shares of the Class B common stock) are
exchangeable for (i) shares of the Company’s Class A common stock
on a one-for-one basis or (ii) cash (based on the fair market value
of the Class A common stock as determined pursuant to the Exchange
Agreement), at the Company’s option (as the managing member of vTv
LLC), subject to customary conversion rate adjustments for stock
splits, stock dividends and reclassifications. Any decision to
require an exchange for cash rather than shares of Class A common
stock will ultimately be determined by the entire board of
directors of vTv Therapeutics Inc. (the “Board of Directors”). As
of September 30, 2022, MacAndrews had not exchanged any shares
under the provisions of the Exchange Agreement.
Tax Receivable Agreement
The Company and MacAndrews are party to a tax receivable agreement
(the “Tax Receivable Agreement”), which provides for the payment by
the Company to M&F TTP Holdings Two LLC (“M&F”), as
successor in interest to vTv Therapeutics Holdings, LLC (“vTv
Therapeutics Holdings”), and M&F TTP Holdings LLC (or certain
of its transferees or other assignees) of 85% of the amount of cash
savings, if any, in U.S. federal, state and local income tax or
franchise tax that the Company actually realizes (or, in some
circumstances, the Company is deemed to realize) as a result of (a)
the exchange of Class B commons stock, together with the
corresponding number of vTv Units, for shares of the Company’s
Class A common stock (or for cash), (b) tax benefits related to
imputed interest deemed to be paid by the Company as a result of
the Tax Receivable Agreement and (c) certain tax benefits
attributable to payments under the Tax Receivable
Agreement.
As no shares have been exchanged by MacAndrews pursuant to the
Exchange Agreement (discussed above), the Company has not
recognized any liability, nor has it made any payments pursuant to
the Tax Receivable Agreement as of September 30,
2022.
Investor Rights Agreement
The Company is party to an investor rights agreement with M&F,
as successor in interest to vTv Therapeutics Holdings (the
“Investor Rights Agreement”). The Investor Rights Agreement
provides M&F with certain demand, shelf, and piggyback
registration rights with respect to its shares of Class A common
stock and also provides M&F with certain governance rights,
depending on the size of its holdings of Class A common stock.
Under the Investor Rights Agreement, M&F was initially entitled
to nominate a majority of the members of the Board of Directors and
designate the members of the committees of the Board of
Directors.
CinRx Pharma, LLC
Master Services Agreement
On July 22, 2022, the Company entered into a Master Services
Agreement with CinRx Pharma, LLC (“CinRx”) (the “CinRx MSA”). Under
the CinRx MSA, CinRx provides the Company with consulting,
pre-clinical and clinical trial services, as enumerated in project
proposals negotiated between the Company and CinRx from time to
time. As of October 10, 2022, the Company has agreed to pay CinRx
fees of up to $0.2 million per month until approximately December
2024 in respect of ongoing agreed project proposals under the CinRx
MSA, plus out-of-pocket expenses incurred by CinRx on the Company’s
behalf. Dr. Jonathan Isaacsohn, who was appointed as chair of the
Company’s board of directors on August 9, 2022, is the President
and Chief Executive Officer of CinRx. CinPax, LLC, a subsidiary of
CinRx, currently holds 4,154,549 shares of the Company’s Class A
Common Stock.
Note 11: Income Taxes
The Company is subject to U.S. federal income taxes as well as
state taxes. The Company did not record an income tax provision for
the three months ended September 30, 2022. The Company’s
income tax provision for the nine months ended September 30,
2022, was $0.2 million related to foreign withholding taxes. The
Company’s income tax provision for the three and nine months ended
September 30, 2021 was $0.1 million related to foreign withholding
taxes.
Management has evaluated the positive and negative evidence
surrounding the realization of its deferred tax assets, including
the Company’s history of losses, and under the applicable
accounting standards determined that it is more-likely-than-not
that the deferred tax assets will not be realized. The difference
between the effective tax rate of the Company and the U.S.
statutory tax rate of 21% on September 30, 2022, is due to the
valuation allowance against the Company’s expected net operating
losses.
As discussed in Note 10, the Company is party to a tax receivable
agreement with a related party which provides for the payment by
the Company to M&F (or certain of its transferees or other
assignees) of 85% of the amount of cash savings, if any, in U.S.
federal, state and local income tax or franchise tax that the
Company actually realizes (or, in some circumstances, the Company
is deemed to realize) as a result of certain transactions. As no
transactions have occurred which would trigger a liability under
this agreement, the Company has not recognized any liability
related to this agreement as of September 30,
2022.
Note 12: Net Loss per Share
Basic loss per share is computed by dividing net loss attributable
to vTv Therapeutics Inc. by the weighted average number of shares
of Class A common stock outstanding during the period. Diluted loss
per share is computed giving effect to all potentially dilutive
shares. Diluted loss per share for all periods presented is the
same as basic loss per share as the inclusion of potentially
issuable shares would be antidilutive.
A reconciliation of the numerator and denominator used in the
calculation of basic and diluted net loss per share of Class A
common stock is as follows (in thousands, except share and per
share amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended September 30, |
|
For the Nine Months Ended September 30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Numerator: |
|
|
|
|
|
|
|
Net loss |
$ |
(5,468) |
|
|
$ |
(1,465) |
|
|
$ |
(18,983) |
|
|
$ |
(8,248) |
|
Less: Net loss attributable to noncontrolling interests |
(1,207) |
|
|
(378) |
|
|
(4,564) |
|
|
(2,312) |
|
Net loss attributable to common shareholders of vTv Therapeutics
Inc., basic and diluted |
(4,261) |
|
|
(1,087) |
|
|
(14,419) |
|
|
(5,936) |
|
Denominator: |
|
|
|
|
|
|
|
Weighted average vTv Therapeutics Inc. Class A common stock, basic
and diluted |
80,490,121 |
|
|
61,073,280 |
|
|
72,649,531 |
|
|
58,737,170 |
|
Net loss per share of vTv Therapeutics Inc. Class A common stock,
basic and diluted |
$ |
(0.05) |
|
|
$ |
(0.02) |
|
|
$ |
(0.20) |
|
|
$ |
(0.10) |
|
Potentially dilutive securities not included in the calculation of
diluted net loss per share are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2022 |
|
September 30, 2021 |
Class B common stock
(1)
|
23,093,860 |
|
|
23,093,860 |
|
Common stock options granted under the Plan |
7,718,944 |
|
|
4,474,403 |
|
Common stock warrants |
3,214,503 |
|
|
2,014,503 |
|
Total |
34,027,307 |
|
|
29,582,766 |
|
_____________________________
|
|
|
|
|
|
|
|
|
|
(1) |
Shares of Class B common stock do not share in the Company’s
earnings and are not participating securities. Accordingly,
separate presentation of loss per share of Class B common stock
under the two-class method has not been provided. Each share of
Class B common stock (together with a corresponding vTv Unit) is
exchangeable for one share of Class A common stock. |
Note 13: Fair Value of Financial Instruments
The carrying amount of certain of the Company’s financial
instruments, including cash and cash equivalents, net accounts
receivable, note receivable, accounts payable, and other accrued
liabilities, approximate fair value due to their short-term
nature.
Assets and Liabilities Measured at Fair Value on a Recurring
Basis
The Company evaluates its financial assets and liabilities subject
to fair value measurements on a recurring basis to determine the
appropriate level in which to classify them for each reporting
period. This determination requires significant judgments. The
Company determined that the promissory note receivable was level 2
and the fair value measurement was based on the market yield
curves. The following table summarizes the conclusions reached
regarding fair value measurements as of September 30, 2022,
and December 31, 2021 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2022 |
|
Quoted Prices in Active
Markets for Identical Assets
(Level 1) |
|
Significant Other Observable
Inputs
(Level 2) |
|
Significant Unobservable Inputs
(Level 3) |
Assets: |
|
|
|
|
|
|
|
Equity securities with readily determinable fair value |
$ |
1,930 |
|
|
$ |
1,930 |
|
|
$ |
— |
|
|
$ |
— |
|
Total |
$ |
1,930 |
|
|
$ |
1,930 |
|
|
$ |
— |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
|
|
|
|
Warrant liability, related party
(1)
|
$ |
1,409 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
1,409 |
|
Total |
$ |
1,409 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
1,409 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2021 |
|
Quoted Prices in Active
Markets for Identical Assets
(Level 1) |
|
Significant Other Observable
Inputs
(Level 2) |
|
Significant Unobservable Inputs
(Level 3) |
Assets: |
|
|
|
|
|
|
|
Equity securities with readily determinable fair value |
$ |
4,928 |
|
|
$ |
4,928 |
|
|
$ |
— |
|
|
$ |
— |
|
Total |
$ |
4,928 |
|
|
$ |
4,928 |
|
|
$ |
— |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
|
|
|
|
Warrant liability, related party
(1)
|
$ |
1,262 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
1,262 |
|
Total |
$ |
1,262 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
1,262 |
|
_____________________________
|
|
|
|
|
|
(1) |
Fair value determined using the Black-Scholes option pricing model.
Expected volatility is based on the historical volatility of the
Company’s common stock over the most recent period. The risk-free
rate is based on the U.S. Treasury yield curve in effect at the
time of valuation. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes in Level 3 instruments for the nine months ended September
30, |
|
Balance at January 1 |
|
Net Change in
fair value included in
earnings |
|
Purchases /
Issuance |
|
Sales /
Repurchases |
|
Balance at September 30, |
2022 |
|
|
|
|
|
|
|
|
|
Warrant liability, related party |
$ |
1,262 |
|
|
$ |
(221) |
|
|
$ |
368 |
|
|
$ |
— |
|
|
$ |
1,409 |
|
Total |
$ |
1,262 |
|
|
$ |
(221) |
|
|
$ |
368 |
|
|
$ |
— |
|
|
$ |
1,409 |
|
|
|
|
|
|
|
|
|
|
|
2021 |
|
|
|
|
|
|
|
|
|
Warrant liability, related party |
$ |
2,871 |
|
|
$ |
(611) |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
2,260 |
|
Total |
$ |
2,871 |
|
|
$ |
(611) |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
2,260 |
|
During the nine months ended September 30, 2021, Reneo completed
its initial public offering. As a result, the fair value of the
Company’s investment in Reneo’s common stock now has a readily
determinable market value and is no longer eligible for the
practical expedient for investments without readily determinable
fair market values. As such, the Company’s investment in Reneo is
adjusted each reporting period to its fair value based on its most
recent closing price, which is considered a Level 1 fair value
measurement under the fair value hierarchy.
There were no transfers into or out of level 3 instruments and/or
between level 1 and level 2 instruments during the three and nine
months ended September 30, 2022. Gains and losses recognized
due to the change in fair value of the warrant liability, related
party are recognized as a component of other (expense) income,
related party in the Condensed Consolidated Statements of
Operations.
The fair value of the Letter Agreement Warrants was determined
using the Black-Scholes option pricing model or option pricing
models based on the Company’s current capitalization. Expected
volatility is based on the historical volatility of the Company’s
common stock over the most recent period. The risk-free rate is
based on the U.S. Treasury yield curve in effect at the time of
valuation. Significant inputs utilized in the valuation of the
Letter Agreement Warrants as of September 30, 2022, and
December 31, 2021, were:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2022 |
|
December 31, 2021 |
|
Range |
Weighted Average |
|
Range |
Weighted Average |
Expected volatility |
81.70% - 109.73%
|
95.51% |
|
82.68% - 142.86%
|
128.13% |
Risk-free interest rate |
4.13% - 4.25%
|
4.20% |
|
0.95% - 1.26%
|
1.15% |
The fair value of the CinRx Warrants was determined using the
Black-Scholes option pricing model. Expected volatility is based on
the historical volatility of the Company’s common stock over the
most recent period. The risk-free rate is based on the U.S.
Treasury yield curve in effect at the time of valuation.
Significant inputs utilized in the valuation of the CinRx Warrants
as of September 30, 2022, were:
|
|
|
|
|
|
Expected volatility |
85.2 |
% |
Expected life of options in years |
3.1 |
Risk-free interest rate |
4.3 |
% |
Expected dividend yield |
— |
% |
The weighted average expected volatility and risk-free interest
rate was based on the relative fair values of the
warrants.
Changes in the unobservable inputs noted above would impact the
amount of the liability for the Letter Agreement and CinRx
Warrants. Increases (decreases) in the estimates of the Company’s
annual volatility would increase (decrease) the liability and an
increase (decrease) in the annual risk-free rate would increase
(decrease) the liability.
Note 14: Subsequent Events
The Company evaluated subsequent events through November 10, 2022,
and determined that there have been no events that have occurred
that would require adjustments to our disclosures or the unaudited
condensed consolidated financial statements.
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
As used in this Quarterly Report on Form 10-Q, the “Company”, the
“Registrant”, “we” or “us” refer to vTv Therapeutics Inc. and “vTv
LLC” refers to vTv Therapeutics LLC. The following discussion and
analysis of our financial condition and results of operations
should be read in conjunction with our financial statements and
related notes that appear elsewhere in this report. In addition to
historical financial information, the following discussion contains
forward-looking statements that reflect our plans, estimates,
assumptions and beliefs. Our actual results could differ materially
from those discussed in the forward-looking statements. Factors
that could cause or contribute to these differences include those
discussed below and elsewhere in this report under “Part II, Other
Information—Item 1A, Risk Factors.” Forward-looking statements
include information concerning our possible or assumed future
results of operations, business strategies and operations,
financing plans, potential growth opportunities, potential market
opportunities, potential results of our drug development efforts or
trials, and the effects of competition. Forward-looking statements
include all statements that are not historical facts and can be
identified by terms such as “anticipates,” “believes,” “could,”
“seeks,” “estimates,” “expects,” “intends,” “may,” “plans,”
“potential,” “predicts,” “projects,” “should,” “will,” “would” or
similar expressions and the negatives of those terms. Given these
uncertainties, you should not place undue reliance on these
forward-looking statements. Also, forward-looking statements
represent our management’s plans, estimates, assumptions and
beliefs only as of the date of this report. Except as required by
law, we assume no obligation to update these forward-looking
statements publicly or to update the reasons actual results could
differ materially from those anticipated in these forward-looking
statements, even if new information becomes available in the
future.
Company Overview
We are a clinical stage pharmaceutical company focused on treating
metabolic and inflammatory diseases to minimize their long-term
complications and improve the lives of patients. We have an
innovative pipeline of first-in-class small molecule clinical and
preclinical drug candidates. Our lead program is
TTP399,
an orally administered, small molecule, liver-selective glucokinase
activator (“GKA”) for the treatment of type 1
diabetes.
Recent Developments
On July 27, 2022, the Company appointed Paul Sekhri as President,
Chief Executive Officer (CEO) effective August 1, 2022, and was
confirmed as a member of the board of directors on August 9, 2022.
Mr. Sekhri brings nearly 30 years of healthcare experience,
including serving as President and CEO of several healthcare
companies, experience in several senior business development and
strategy roles and he has been a director on more than 30 private,
public company and non-profit boards.
Based upon the positive results of our Simplici-T1 Study, we
requested Breakthrough Therapy Designation (“BTD”) with the FDA
which was granted in April 2021. In October 2021, we began to
implement a strategy to focus our efforts on the continued
development of
TTP399
as a potential treatment for patients with type 1 diabetes
(“T1D”).
After several meetings with the FDA BTD-team, the Company is
planning two pivotal, placebo-controlled clinical trials of
TTP399
in subjects with T1D. The studies will recruit a total of
approximately 1,000 patients and at least one of the studies will
be one year of treatment. The FDA confirmed that the effect size
of
TTP399
on events of hypoglycemia as demonstrated in the Phase 2
SimpliciT-1 Study is clinically meaningful and has agreed on the
primary endpoint for the studies as the difference between placebo
and
TTP399-treated
group in number of hypoglycemia events.
The results of the mechanistic study provided additional evidence
to support the idea that treatment with
TTP399
will not increase the risk of diabetic ketoacidosis (“DKA”) in
patients with T1D. The data demonstrate that in contrast to agents
such as SGLT2 inhibitors and GLP‐1RAs,
TTP399
does not increase the risk of ketoacidosis when used as an
adjunctive therapy to insulin in individuals with T1D. Moreover,
these findings support prior studies that demonstrate that
TTP399
improves glucose control and reduces hypoglycemia and suggests a
protective effect of
TTP399
against acidosis in people with T1D. Thus, accumulating data
suggest that
TTP399
has robust potential as an adjunctive therapy for T1D. Full study
results were published in the
Diabetes Obesity and Metabolism
journal in conjunction with the 82nd American Diabetes Association
Scientific Sessions on June 6, 2022.
The following table summarizes our drug candidates, their
partnership status, and their respective stages of
development:
Our Type 1 Diabetes Program –
TTP399
The Company is planning two pivotal, placebo-controlled clinical
trials of
TTP399
in subjects with T1D and has engaged with the FDA on the optimal
clinical trial designs for these studies. The studies will recruit
a total of approximately 1000 patients and at least one of the
studies will be one year of treatment. The FDA and the company have
agreed on the primary endpoint for the studies as the difference
between placebo and
TTP399-treated
group in number of hypoglycemia events. We expect site-specific
startup activities and patient enrollment for these pivotal studies
to begin in the first quarter of 2023.
In October 2021, we announced positive results of a mechanistic
study of
TTP399
in patients with T1D. The study demonstrated that patients with T1D
taking
TTP399
experienced no increase in ketone levels relative to placebo during
a period of acute insulin withdrawal, indicating no increased risk
of ketoacidosis. Consistent with previous clinical studies,
improved fasting plasma glucose levels and fewer hypoglycemic
events were observed in the
TTP399
treated group during the week of treatment prior to the insulin
withdrawal test. The FDA has declined to approve SGLT2 inhibitors
as an adjunctive therapy in T1D, with concerns over the potential
risks of diabetic ketoacidosis (“DKA”) in focus. DKA can lead to
hospitalization and, if untreated, death. To address these
concerns, vTv, following the FDA’s recommendation, conducted this
mechanistic study to demonstrate that treatment with
TTP399,
a liver-selective glucokinase activator, will not result in
increased production of ketones, a precursor to
ketoacidosis.
In April 2021, we announced that the FDA granted BTD for
TTP399
as an adjunctive therapy to insulin for the treatment of T1D. This
designation provides a sponsor with added support and the potential
to expedite development and review timelines for a promising new
investigational medicine.
G42 Investments
On May 31, 2022, the Company announced entry into agreements that
include a $25.0 million investment by G42 Investments. Under the
terms of the agreements, the Company agreed to sell G42 Investments
10,386,274 shares of the Company’s Class A common stock at an issue
price of $2.41 per share, with $12.5 million paid in cash at
closing, and the remaining amount of $12.5 million payable on May
31, 2023. The agreements also provide for the potential issuance of
$30.0 million in additional shares of Class A common stock to G42
Investments (or cash in lieu of such issuance at the option of G42
Investments) if the FDA approves the marketing and sale of a
pharmaceutical product containing
TTP399,
a liver selective glucokinase activator, as the active ingredient
for treatment of T1D in the United States. The agreements set
forth
the terms under which the Company and Cogna, an affiliate of G42
Investments, plan to collaborate on clinical trials for
pharmaceutical products that contain
TTP399,
including Cogna funding a portion of the Phase 3 clinical trials
for
TTP399,
and the Company granting Cogna an exclusive license to develop and
commercialize pharmaceutical products containing
TTP399
in a specified territory, principally consisting of the Middle
East, Africa and Central Asia.
CinRx Purchase Agreement
On July 25, 2022, the Company announced entry into agreements that
include a $10 million investment by CinPax, LLC (“CinPax”), a
subsidiary of CinRx Pharma, LLC (“CinRx”). Under the terms of the
agreements, CinPax acquired 4,154,549 shares of Class A Common
Stock of vTv at an issue price of approximately $2.41 per share,
with $6.0 million paid in cash at closing, and the remaining amount
of $4.0 million payable on November 22, 2022. The agreements also
provide for the issuance of 1,200,000 warrants to CinRx to acquire
additional shares of Class A common stock that become exercisable
upon agreed vesting triggers (including FDA approval of
TTP399).
In addition to the investment, the Company and CinRx entered into a
Master Service Agreement (“MSA”) whereby CinRx provides the Company
with consulting, pre-clinical and clinical trial services, as
enumerated in project proposals negotiated between the Company and
CinRx from time to time.
Holding Company Structure
vTv Therapeutics Inc. is a holding company, and its principal asset
is a controlling equity interest in vTv Therapeutics LLC, the
principal operating subsidiary. We have determined that vTv LLC is
a variable-interest entity (“VIE”) for accounting purposes and that
vTv Therapeutics Inc. is the primary beneficiary of vTv LLC because
(through its managing member interest in vTv LLC and the fact that
the senior management of vTv Therapeutics Inc. is also the senior
management of vTv LLC) it has the power to direct all of the
activities of vTv LLC, which include those that most significantly
impact vTv LLC’s economic performance. vTv Therapeutics Inc. has
therefore consolidated vTv LLC’s results under the VIE accounting
model in its consolidated financial statements.
Financial Overview
Revenue
To date, we have not generated any revenue from drug sales. Our
revenue has been primarily derived from up-front proceeds,
milestones and research fees under collaboration and license
agreements.
In the future, we may generate revenue from a combination of
product sales, license fees, milestone payments and royalties from
the sales of products developed under licenses of our intellectual
property. We expect that any revenue we generate will fluctuate
from quarter to quarter as a result of the timing and amount of
license fees, milestone and other payments, and the amount and
timing of payments that we receive upon the sale of our products,
to the extent any are successfully commercialized. If we fail to
complete the development of our drug candidates in a timely manner
or obtain regulatory approval for them, our ability to generate
future revenue and our results of operations and financial position
will be materially adversely affected.
Research and Development Expenses
Since our inception, we have focused our resources on our research
and development activities, including conducting preclinical
studies and clinical trials, manufacturing development efforts, and
activities related to regulatory filings for our drug candidates.
We recognize research and development expenses as they are
incurred. Our direct research and development expenses consist
primarily of external costs such as fees paid to investigators,
consultants, central laboratories, and clinical research
organizations (“CRO(s)”) in connection with our clinical trials,
and costs related to acquiring and manufacturing clinical trial
materials. Our indirect research and development costs consist
primarily of cash and share-based compensation costs, the cost of
employee benefits, and related overhead expenses for personnel in
research and development functions. Since we typically use our
employee and infrastructure resources across multiple research and
development programs such costs are not allocated to the individual
projects.
From our inception, including our predecessor companies, through
September 30, 2022, we have incurred approximately $608.5
million in research and development expenses.
Our research and development expenses by project for the three and
nine months ended September 30, 2022, and 2021 were as follows
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Direct research and development expense: |
|
|
|
|
|
|
|
TTP399 |
$ |
2,309 |
|
|
$ |
729 |
|
|
$ |
6,438 |
|
|
$ |
1,365 |
|
HPP737 |
(111) |
|
|
482 |
|
|
(66) |
|
|
2,249 |
|
Azeliragon |
52 |
|
|
— |
|
|
— |
|
|
887 |
|
Other projects |
232 |
|
|
97 |
|
|
483 |
|
|
329 |
|
Indirect research and development expense |
573 |
|
|
1,074 |
|
|
1,538 |
|
|
3,092 |
|
Total research and development expense |
$ |
3,055 |
|
|
$ |
2,382 |
|
|
$ |
8,393 |
|
|
$ |
7,922 |
|
We plan to continue to incur significant research and development
expenses for the foreseeable future as we continue the development
of
TTP399
and further advance the development of our other drug candidates,
subject to the availability of additional funding.
The successful development of our clinical and preclinical drug
candidates is highly uncertain. At this time, we cannot reasonably
estimate the nature, timing, or costs of the efforts that will be
necessary to complete the remainder of the development of any of
our clinical or preclinical drug candidates or the period, if any,
in which material net cash inflows from these drug candidates may
commence. This is due to the numerous risks and uncertainties
associated with the development of our drug candidates,
including:
•the
uncertainty of the scope, rate of progress, and expense of our
ongoing, as well as any additional, clinical trials and other
research and development activities;
•the
potential benefits of our candidates over other
therapies;
•our
ability to market, commercialize, and achieve market acceptance for
any of our drug candidates that we are developing or may develop in
the future;
•future
clinical trial results;
•our
ability to enroll patients in our clinical trials;
•the
timing and receipt of any regulatory approvals; and
•the
filing, prosecuting, defending, and enforcing of patent claims and
other intellectual property rights, and the expense of doing
so.
A change in the outcome of any of these variables with respect to
the development of a drug candidate could mean a significant change
in the costs and timing associated with the development of that
drug candidate. For example, if the FDA or another regulatory
authority were to require us to conduct clinical trials beyond
those that we currently anticipate will be required for the
completion of clinical development of a drug candidate, or if we
experience significant delays in enrollment in any of our clinical
trials, we could be required to expend significant additional
financial resources and time with respect to the development of
that drug candidate.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries,
benefits, and related costs for employees in executive, finance,
corporate development, human resources, and administrative support
functions. Other significant general and administrative expenses
include accounting and legal services, expenses associated with
obtaining and maintaining patents, cost of various consultants,
occupancy costs, and information systems.
Interest Income
The Company’s interest expense is immaterial.
Interest Expense
The Company’s interest expense is immaterial.
Other Income (Expense), Net
Other income/expense primarily consists of unrealized gains or
losses attributable to the changes in fair value of the equity
investments held by our licensees, as well as the recognition of
changes in fair value of the warrants to purchase shares of our
Class A common stock held by related parties.
Results of Operations
Comparison of the three months ended September 30, 2022, and
2021
The following table sets forth certain information concerning our
results of operations for the periods shown:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(dollars in thousands) |
Three Months Ended September 30, |
Statement of operations data: |
2022 |
|
2021 |
|
Change |
Revenue |
$ |
— |
|
$ |
3,000 |
|
$ |
(3,000) |
Operating expenses: |
|
|
|
|
|
Research and development |
3,055 |
|
2,382 |
|
673 |
General and administrative |
2,634 |
|
2,221 |
|
413 |
Total operating expenses |
5,689 |
|
4,603 |
|
1,086 |
Operating loss |
(5,689) |
|
(1,603) |
|
(4,086) |
Interest income |
150 |
|
— |
|
150 |
Interest expense |
(8) |
|
(6) |
|
(2) |
Other income, net |
79 |
|
244 |
|
(165) |
Loss before income taxes |
(5,468) |
|
(1,365) |
|
(4,103) |
Income tax provision |
— |
|
100 |
|
(100) |
Net loss before noncontrolling interest |
(5,468) |
|
(1,465) |
|
(4,003) |
Less: Net loss attributable to noncontrolling interest |
(1,207) |
|
(378) |
|
(829) |
Net loss attributable to vTv Therapeutics Inc. |
$ |
(4,261) |
|
$ |
(1,087) |
|
$ |
(3,174) |
Revenue
There was no revenue for the three months ended September 30,
2022. Revenue for the three months ended September 30, 2021,
included increases to the transaction prices for the license
performance obligations under the license agreement with Newsoara
Biopharma Co., Ltd., (“Newsoara”) (the “Newsoara License
Agreement”) and Reneo Pharmaceuticals, Inc. (“Reneo) (the “Reneo
License agreement”) due to the satisfaction of development
milestones.
Research and Development Expenses
Research and development expenses were $3.1 million and $2.4
million for the three months ended September 30, 2022, and
2021, respectively. The increase in research and development
expenses during this period of $0.7 million or 28.3%, was primarily
driven by i) higher spending on
TTP399
of $1.6 million, due to increases in drug product related costs as
well as higher spending on trial preparation costs, partially
offset by ii) decreased spending of $0.6 million related to the
multiple ascending dose study for
HPP737,
due to its completion in 2021 and iii) decreases in indirect costs
and other projects of $0.3 million.
General and Administrative Expenses
General and administrative expenses were $2.6 million and $2.2
million for the three months ended September 30, 2022, and
2021, respectively. The increase in general and administrative
expenses during this period of $0.4 million, or 18.6%, was
primarily driven by i) increases of $0.5 million in legal expense,
ii) increases of $0.4 million other general and administrative
costs, partially offset by iii) decreases in payroll costs of $0.5
million due to the reduction in workforce at year-end
2021.
Interest income
Interest income for the three months ended September 30, 2022,
of $0.2 million is related to imputed interest on the promissory
notes. Interest income for the three months ended
September 30, 2021, was insignificant.
Interest Expense
Interest expense for the three months ended September 30,
2022, and 2021, was insignificant.
Other (Expense) / Income
Other expense was $0.1 million for the three months ended
September 30, 2022, and was driven by an unrealized gain
related to our investment in Reneo as well as the
losses related
to the change in the fair value of the outstanding warrants to
purchase shares of our own stock issued to related parties
(“Related Party Warrants”). Other income was $0.2 million for the
three months ended September 30, 2021, and was related to the
unrealized loss recognized related to our investment in Reneo as
well as gains related to the change in the fair value of the
outstanding warrants in our own stock held by a related
party.
Comparison of the nine months ended September 30, 2022, and
2021
The following table sets forth certain information concerning our
results of operations for the periods shown:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(dollars in thousands) |
Nine Months Ended September 30, |
Statement of operations data: |
2022 |
|
2021 |
|
Change |
Revenue |
$ |
2,009 |
|
$ |
3,996 |
|
$ |
(1,987) |
Operating expenses: |
|
|
|
|
|
Research and development |
8,393 |
|
7,922 |
|
471 |
General and administrative |
9,813 |
|
6,627 |
|
3,186 |
Total operating expenses |
18,206 |
|
14,549 |
|
3,657 |
Operating loss |
(16,197) |
|
(10,553) |
|
(5,644) |
Interest income |
200 |
|
1 |
|
199 |
Interest expense |
(9) |
|
(6) |
|
(3) |
Other (expense) income, net |
(2,777) |
|
2,425 |
|
(5,202) |
Loss before income taxes |
(18,783) |
|
(8,133) |
|
(10,650) |
Income tax provision |
200 |
|
115 |
|
85 |
Net loss before noncontrolling interest |
(18,983) |
|
(8,248) |
|
(10,735) |
Less: Net loss attributable to noncontrolling interest |
(4,564) |
|
(2,312) |
|
(2,252) |
Net loss attributable to vTv Therapeutics Inc. |
$ |
(14,419) |
|
$ |
(5,936) |
|
$ |
(8,483) |
Revenue
Revenue for the nine months ended September 30, 2022, includes
a $2.0 million increase to the transaction price for the license
performance obligations under the amended license agreement with
Huadong due to the satisfaction of a development milestone. Revenue
for the nine months ended September 30, 2021, relates to the
reallocation of revenue to the license and technology transfer
performance obligation made in connection with the First Huadong
Amendment as well as increases to the transaction prices for the
license performance obligations under the Newsoara License
Agreement and the Reneo License Agreement due to the satisfaction
of development milestones.
Research and Development Expenses
Research and development expenses were $8.4 million and $7.9
million for the nine months ended September 30, 2022, and
2021, respectively. The increase in research and development
expenses during the period of $0.5 million, or 5.9%, was primarily
driven by i) higher spending on
TTP399
of $5.1 million due to increases in drug product related costs as
well as higher spending on trial preparation costs, partially
offset by ii) a decrease in clinical trial costs of $0.8 million
for
azeliragon
which was driven by discontinuance of its development as a
potential treatment of Alzheimer’s disease in patients with type 2
diabetes, iii) decreased spending of $2.3 million related to the
multiple ascending dose study for
HPP737,
due to its completion in 2021, and iii)
decreases in indirect costs of $1.5 million primarily related to
payroll costs due to the reduction in workforce at year-end of
2021.
General and Administrative Expenses
General and administrative expenses were $9.8 million and $6.6
million for the nine months ended September 30, 2022, and
2021, respectively. The increase of $3.2 million has been primarily
driven by i) increases of $3.2 million in legal
expense, ii) increases of $0.8 million in severance costs, iii)
increases of $1.0 million in other general and administrative
costs, partially offset by iv) decreases of $0.1 million in shared
based expense, and v) decreases of $1.7 million in payroll costs
due to the reduction in workforce at year-end of 2021.
Interest income
Interest income for the nine months ended September 30, 2022,
of $0.2 million is related to imputed interest on the promissory
note. Interest income for the nine months ended September 30,
2021, was insignificant.
Interest Expense
Interest expense for the nine months ended September 30, 2022,
and 2021, was insignificant.
Other Income / (Expense)
Other expense was $2.8 million for the nine months ended
September 30, 2022, and is driven by an unrealized loss
recognized related to the Company’s investment in Reneo as well as
the losses related to the change in the fair value of the
outstanding warrants to purchase shares of our own stock issued to
related parties. Other income was $2.4 million for the nine months
ended September 30, 2021, and was driven by an unrealized gain
recognized related to the Company’s investment in Reneo as well as
gains related to the change in fair value of the outstanding
warrants in our own stock held by a related party.
Liquidity and Capital Resources
Liquidity and Going Concern
As of September 30, 2022, we have an accumulated deficit of
$267.1 million as well as a history of negative cash flows from
operating activities. We anticipate that we will continue to incur
losses for the foreseeable future as we continue our clinical
trials. Further, we expect that we will need additional capital to
continue to fund our operations. As of September 30, 2022, our
liquidity sources included cash and cash equivalents of $15.3
million. In addition to available cash and cash equivalents
discussed above, we are evaluating several financing strategies to
fund the on-going and future clinical trials of
TTP399,
including direct equity investments and the potential licensing and
monetization of other Company programs such as
HPP737.
The Company has a promissory note of $12.5 million under the G42
Purchase Agreement payable to the Company on or before May 31,
2023, and a promissory note of $4.0 million under the CinRx
Purchase Agreement payable to the Company on November 22, 2022 (see
Note 9).
Based on our current operating plan, we may use the remaining
availability of $37.3 million under our Sales Agreement with Cantor
Fitzgerald pursuant to which we could offer and sell, from time to
time, shares of our Class A common stock under the ATM Offering and
our ability to sell approximately 9.4 million shares of Class A
common stock to Lincoln Park pursuant and subject to the
limitations of the LPC Purchase Agreement. However, the ability to
use these sources of capital is dependent on a number of factors,
including the prevailing market price of and the volume of trading
in our Class A common stock. These factors raise substantial doubt
about our ability to continue as a going concern.
ATM Offering
We have entered into the Sales Agreement with Cantor Fitzgerald
pursuant to which we may offer and sell, from time to time, through
or to Cantor Fitzgerald, as sales agent or principal, shares of our
Class A common stock having an aggregate offering price of up to
$68.5 million. We are not obligated to sell any shares under the
Sales Agreement. Under the terms of the Sales Agreement, we will
pay Cantor Fitzgerald a commission of up to 3% of the aggregate
proceeds from the sale of shares and reimburse certain legal fees
or other disbursements. As of September 30, 2022, we have sold
$31.2 million worth of Class A common stock under the ATM Offering
for net proceeds of $30.3 million, leaving $37.3 million available
to be sold. The shares are offered and sold pursuant to the
Company’s shelf registration statement on Form S-3. In no event
will we sell Class A common stock under this registration statement
with a value exceeding more than one-third of the “public float”
(the market value of our Class A common stock and any other equity
securities that we may issue in the future that are held by
non-affiliates) in any 12-calendar month period so long as our
public float remains below $75 million.
Lincoln Park Purchase Agreement
We have entered into the LPC Purchase Agreement, pursuant to which
we have the right to sell to Lincoln Park shares of the Company’s
Class A common stock having an aggregate value of up to $47.0
million. As of September 30, 2022, we have issued 5,331,306 of
these shares for gross proceeds of approximately $11.1 million,
leaving $35.9 million available to be sold.
Over the 36-month term of the LPC Purchase Agreement, we have the
right, but not the obligation, from time to time, in our sole
discretion, to direct Lincoln Park to purchase up to 250,000 shares
per day (the “Regular Purchase Share Limit”) of the Class A common
stock (each such purchase, a “Regular Purchase”). The Regular
Purchase Share Limit will increase to 275,000 shares per day if the
closing price of the Class A common stock on the applicable
purchase date is not below $4.00 per share and will further
increase to 300,000 shares per day if the closing price of the
Class A common stock on the applicable purchase date is not below
$5.00 per share. In any case, Lincoln Park’s maximum obligation
under any single Regular Purchase will not exceed $2,000,000. The
purchase price for shares of Class A common stock to be purchased
by Lincoln Park under a Regular Purchase will be equal to the lower
of (in each case, subject to the adjustments described in the LPC
Purchase Agreement): (i) the lowest sale price for the Class A
common stock on the applicable purchase date and (ii) the
arithmetic average of the three lowest closing sales prices for the
Class A common stock during the 10 consecutive trading days prior
to the purchase date.
If we direct Lincoln Park to purchase the maximum number of shares
of Class A common stock that we may sell in a Regular Purchase,
then in addition to such Regular Purchase, and subject to certain
conditions and limitations in the LPC Purchase Agreement, we may
direct Lincoln Park to make an “accelerated purchase” and an
“additional accelerated purchase”, each of an additional number of
shares of Class A common stock which may not exceed the lesser of:
(i) 300% of the number of shares purchased pursuant to the
corresponding Regular Purchase and (ii) 30% of the total number of
shares of the common stock traded during a specified period on the
applicable purchase date as set forth in the LPC Purchase
Agreement. The purchase price for such shares will be the lesser of
(i) 97% of the volume weighted average price of the Class A common
stock over a certain portion of the date of sale as set forth in
the LPC Purchase Agreement and (ii) the closing sale price of the
Class A common stock on the date of sale (an “Accelerated
Purchase”). Under certain circumstances and in accordance with the
LPC Purchase Agreement, we may direct Lincoln Park to purchase
shares in multiple Accelerated Purchases on the same trading
day.
The LPC Purchase Agreement also prohibits us from directing Lincoln
Park to purchase any shares of its Class A common stock if those
shares, when aggregated with all other shares of Class A common
stock then beneficially owned by Lincoln Park and its affiliates,
would result in Lincoln Park and its affiliates having beneficial
ownership, at any single point in time, of more than 9.99% of the
then total outstanding shares of Class A common stock as calculated
pursuant to Section 13(d) of the Securities Exchange Act of 1934,
as amended, and Rule 13d-3 thereunder.
Cash Flows
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
2022 |
|
2021 |
(dollars in thousands) |
|
|
|
Net cash used in operating activities |
$ |
(9,142) |
|
|
$ |
(12,891) |
|
Net cash used in investing activities |
(21) |
|
|
— |
|
Net cash provided by financing activities |
11,087 |
|
|
26,710 |
|
Net increase in cash and cash equivalents |
$ |
1,924 |
|
|
$ |
13,819 |
|
Operating Activities
For the nine months ended September 30, 2022, our net cash
used in operating activities decreased by $3.7 million from the
nine months ended September 30, 2021.
The significant contributor to the change in cash used during the
year was
driven by working capital changes offset by $6.8 million of cash
received in excess of the fair value of the Class A common stock
issued to G42 investments.
Investing Activities
For the nine months ended September 30, 2022, net cash used in
investing activities was insignificant. There were no cash flows
from investing activities for the nine months ended
September 30, 2021.
Financing Activities
For the nine months ended September 30, 2022, net cash
provided by financing activities was driven by sales of our Class A
common stock to a collaboration partner and from the CinRx Purchase
Agreement. For the nine months ended September 30, 2021, net
cash provided by financing activities was driven by sales of shares
of our Class A common stock during the nine months ended
September 30, 2021.
Future Funding Requirements
To date, we have not generated any revenue from drug product sales.
We do not know when, or if, we will generate any revenue from drug
product sales. We do not expect to generate revenue from drug sales
unless and until we obtain regulatory approval of and commercialize
any of our drug candidates. At the same time, we expect our
expenses to continue or to increase in connection with our ongoing
development activities, particularly as we continue the research,
development, and clinical trials of, and seek regulatory approval
for, our drug candidates. In addition, subject to obtaining
regulatory approval of any of our drug candidates, we expect to
incur significant commercialization expenses for product sales,
marketing, manufacturing, and distribution. We anticipate that we
will need substantial additional funding in connection with our
continuing operations.
We plan to finance our operations into the third quarter of 2023
through the use of our cash and cash equivalents and based on
current operating plans, we are evaluating several financing
strategies to fund the on-going and future clinical trials
of
TTP399,
including direct equity investments and the potential licensing and
monetization of other Company programs such as
HPP737.
The Company has a promissory note of $12.5 million under the G42
Purchase Agreement payable to the Company on or before May 31,
2023, and a promissory note of $4.0 million under the CinRx
Purchase Agreement payable to the Company on November 22, 2022 (see
Note 9). The timing of any such transactions is not certain, and we
may not be able to complete such transactions on acceptable terms,
or at all. Even if we are able to complete such transactions, it
may contain restrictions on our operations or cause substantial
dilution to our stockholders. We have based our estimates on
assumptions that may prove to be wrong, and we may use our
available capital resources sooner than we currently expect. We
have based our estimates on assumptions that may prove to be wrong,
and we may use our available capital resources sooner than we
currently expect. Because of the numerous risks and uncertainties
associated with the development and commercialization of our drug
candidates, we are unable to estimate the amounts of increased
capital outlays and operating expenditures necessary to complete
the development of our drug candidates. Additionally, we may rely
on our ability to sell shares of our Class A common stock pursuant
to the ATM Offering and LPC Purchase Agreement. However, the
ability to use these sources of capital is dependent on a number of
factors, including the prevailing market price of and the volume of
trading in the Company’s Class A common stock, and we may use our
available capital resources sooner than we currently
expect.
Our future capital requirements will depend on many factors,
including:
•The
progress, costs, results, and timing of our planned trials to
evaluate
TTP399
as a potential treatment of T1D;
•the
willingness of the FDA to rely upon our completed and planned
clinical and preclinical studies and other work, as the basis for
review and approval of our drug candidates;
•the
outcome, costs, and timing of seeking and obtaining FDA and any
other regulatory approvals;
•the
number and characteristics of drug candidates that we pursue,
including our drug candidates in preclinical
development;
•the
ability of our drug candidates to progress through clinical
development successfully;
•our
need to expand our research and development
activities;
•the
costs associated with securing, establishing, and maintaining
commercialization capabilities;
•the
costs of acquiring, licensing, or investing in businesses,
products, drug candidates and technologies;
•our
ability to maintain, expand and defend the scope of our
intellectual property portfolio, including the amount and timing of
any payments we may be required to make, or that we may receive, in
connection with the licensing, filing, prosecution, defense and
enforcement of any patents or other intellectual property
rights;
•our
need and ability to hire additional management and scientific and
medical personnel;
•the
effect of competing technological and market
developments;
•our
need to implement additional internal systems and infrastructure,
including financial and reporting systems;
•the
economic and other terms, timing and success of our existing
licensing arrangements and any collaboration, licensing, or other
arrangements into which we may enter in the future;
•the
amount of any payments we are required to make to M&F TTP
Holdings Two LLC in the future under the Tax Receivable Agreement;
and
•the
impact and duration of the COVID-19 outbreak /
pandemic.
Until such time, if ever, as we can generate substantial revenue
from drug sales, we expect to finance our cash needs through a
combination of equity offerings, debt financings, marketing and
distribution arrangements and other collaborations, strategic
alliances, and licensing arrangements. We currently have committed
external source of funds available through the ATM Offering, LPC
Purchase Agreement and Promissory Notes under the G42 Purchase
Agreement and the CinRx Purchase Agreement.
To the extent that we raise additional capital through the sale of
equity or convertible debt securities, the ownership interests of
our common stockholders will be diluted, and the terms of these
securities may include liquidation or other preferences that
adversely affect the rights of our common stockholders. Debt
financing and preferred equity financing, if available, may involve
agreements that include covenants that will further limit or
restrict our ability to take specific actions, such as incurring
additional debt, making capital expenditures, or declaring
dividends. If we raise additional funds through collaborations,
strategic alliances or marketing, distribution, or licensing
arrangements with third parties, we may be required to relinquish
valuable rights to our technologies, future revenue streams or drug
candidates or grant licenses on terms that may not be favorable to
us. If we are unable to obtain additional funding, we could be
forced to delay, reduce, or eliminate our research and development
programs or commercialization efforts, or pursue one or more
alternative strategies, such as restructuring, any of which could
adversely affect our business prospects.
Off-Balance Sheet Arrangements
As of September 30, 2022, we did not have outstanding any
off-balance sheet arrangements as defined under SEC
rules.
Discussion of Critical Accounting Policies
For a discussion of our critical accounting policies and estimates,
please refer to Part II, Item 7. “Management’s Discussion and
Analysis of Financial Condition and Results of Operations” in our
Annual Report on Form 10-K for the year ended December 31,
2021. There have been no material changes to our critical
accounting policies and estimates in 2022.
Forward-Looking Statements
This quarterly report includes certain forward-looking statements
within the meaning of the federal securities laws regarding, among
other things, our management’s intentions, plans, beliefs,
expectations, or predictions of future events, which are considered
forward-looking statements. You should not place undue reliance on
those statements because they are subject to numerous uncertainties
and factors relating to our operations and business environment,
all of which are difficult to predict and many of which are beyond
our control. Forward-looking statements include information
concerning our possible or assumed future results of operations,
including descriptions of our business strategy. These statements
often include words such as “may,” “will,” “should,” “believe,”
“expect,” “outlook”, “anticipate,” “intend,” “plan,” “estimate” or
similar expressions. These statements are based upon assumptions
that we have made in light of our experience in the industry, as
well as our perceptions of historical trends, current conditions,
expected future developments and other factors that we believe are
appropriate under the circumstances. As you read this quarterly
report, you should understand that these statements are not
guarantees of performance or results. They involve known and
unknown risks, uncertainties, and assumptions, including those
described under the heading “Risk Factors” under Item 1A of Part I
in our Annual Report on Form 10-K and under Item 1A of Part II of
this Quarterly Report on Form 10-Q. Although we believe that these
forward-looking statements are based upon reasonable assumptions,
you should be aware that many factors, including those described
under the heading “Risk Factors” under Item 1A of Part I in our
Annual Report on Form 10-K and under Item 1A of Part II of this
Quarterly Report on Form 10-Q, could affect our actual financial
results or results of operations and could cause actual results to
differ materially from those in the forward-looking
statements.
Our forward-looking statements made herein are made only as of the
date of this quarterly report. We expressly disclaim any intent,
obligation or undertaking to update or revise any forward-looking
statements made herein to reflect any change in our expectations
with regard thereto or any change in events, conditions, or
circumstances on which any such statements are based. All
subsequent written and oral forward-looking statements attributable
to us or persons acting on our behalf are expressly qualified in
their entirety by the cautionary statements contained in this
quarterly report.
Effect of Recent Accounting Pronouncements
See discussion of recent accounting pronouncements in Note 2,
“Summary of Significant Accounting Policies”, to the Condensed
Consolidated Financial Statements in this Form 10-Q.
ITEM 3. QUANTITATIVE AND QUALITATIVE
DISCLOSURES ABOUT MARKET RISK
Interest Rate Risk
We do not currently have any material interest rate
exposure.
Market Risk
Our exposure to market risk is limited to our cash and cash
equivalents, all of which have maturities of one year or less. The
goals of our investment strategy are preservation of capital,
fulfillment of liquidity needs and fiduciary control of cash and
investments. We also seek to maximize income from our investments
without assuming significant risk. To achieve our goals, we
maintain a portfolio of cash equivalents in a financial institution
that management believes to be of high credit quality. Because of
the short-term maturities of our investments, we do not believe
that an increase in market rates would have a material negative
impact on the value of our investment portfolio.
Foreign Currency Risk
We do not have any material foreign currency exposure.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Under the supervision and with the participation of our Chief
Executive Officer and Chief Accounting Officer, management has
evaluated the effectiveness of the design and operation of our
disclosure controls and procedures (as defined in Rules 13a-15(e)
or 15d-15(e) of the Securities Exchange Act of 1934) as of
September 30, 2022. Based upon that evaluation, our Chief
Executive Officer and Chief Accounting Officer concluded that, as
of September 30, 2022, our disclosure controls and procedures
were effective in causing material information relating to us
(including our consolidated subsidiaries) to be recorded,
processed, summarized, and reported by management on a timely basis
and to ensure the quality and timeliness of our public disclosures
pursuant to SEC disclosure obligations.
Our management, including our Chief Executive Officer and Chief
Accounting Officer, does not expect that our disclosure controls
and procedures will prevent all errors and all fraud. A control
system, no matter how well conceived and operated, can provide only
reasonable, not absolute, assurance that the objectives of the
control system are met. Further, the design of a control system
must reflect the fact that there are resource constraints, and the
benefits of controls must be considered relative to their costs.
Because of the inherent limitations in all control systems, no
evaluation of controls can provide absolute assurance that all
control issues and instances of fraud, if any, with the Company
have been detected. These inherent limitations include the
realities that judgments in decision-making can be faulty and that
breakdowns can occur because of simple error and mistake.
Additionally, controls can be circumvented by the individual acts
of some persons, by collusion of two or more people or by
management override of controls.
The design of any system of controls also is based in part upon
certain assumptions about the likelihood of future events, and
there can be no assurance that any design will succeed in achieving
its stated goals under all potential future conditions. Over time,
a control may become inadequate because of changes in conditions or
because the degree of compliance with the policies or procedures
may deteriorate. Because of the inherent limitations in a
cost-effective control system, misstatements due to error or fraud
may occur and may not be detected.
Changes to Internal Control over Financial Reporting
There have been no changes in our internal control over financial
reporting during our most recent fiscal quarter that have
materially affected, or are reasonably likely to materially affect,
our internal control over financial reporting.
Website Availability of Reports and other Corporate Governance
Information
The Company maintains a comprehensive corporate governance program,
including Corporate Governance Guidelines for its Board of
Directors, Board Guidelines for Assessing Director Independence,
and charters for its Audit Committee, Nominating and Corporate
Governance Committee and Compensation Committee. The Company
maintains a corporate investor relations website,
www.vtvtherapeutics.com, where stockholders and other interested
persons may review, without charge, among other things, corporate
governance materials and certain SEC filings, which are generally
available on the same business day as the filing date with the SEC
on the SEC’s website http://www.sec.gov. The contents of our
website are not made a part of this Quarterly Report on Form
10-Q.
PART II – OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
We are not currently a party to any material legal
proceedings.
ITEM 1A. RISK FACTORS
Our risk factors are set forth under the heading “Risk Factors”
under Item 1A of Part I in our Annual Report on Form 10-K for the
year ended December 31, 2021. There have been no material
changes to our risk factors from those previously disclosed in our
Annual Report on Form 10-K for the year ended December 31,
2021.
ITEM 2. UNREGISTERED SALES OF EQUITY
SECURITIES AND USE OF PROCEEDS
During the three months ended September 30, 2022, the Company
issued the following unregistered securities:
In July 2022, the Company sold 4,154,549 shares of the Company’s
Class A common stock at a price per share of approximately $2.41,
for an aggregate purchase price of $10.0 million.
ITEM 3. DEFAULTS UPON SENIOR
SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURES
None.
ITEM 5. OTHER INFORMATION
None.
ITEM 6. EXHIBITS
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Exhibit
Number |
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Description |
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31.1* |
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31.2* |
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32.1* |
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32.2* |
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101.INS |
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Inline XBRL Instance Document |
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101.SCH |
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Inline XBRL Taxonomy Extension Schema |
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101.CAL |
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Inline XBRL Taxonomy Extension Calculation Linkbase |
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101.DEF |
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Inline XBRL Taxonomy Extension Definition Document |
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101.LAB |
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Inline XBRL Taxonomy Extension Label Linkbase |
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101.PRE |
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Inline XBRL Taxonomy Extension Presentation Linkbase |
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104 |
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Cover Page Interactive Data File (formatted as inline XBRL and
contained in Exhibit 101) |
___________________________
†† Confidential treatment received with
respect to portions of this exhibit.
* Filed herewith
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on
its behalf by the undersigned thereunto duly
authorized.
Date: November 10, 2022
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VTV THERAPEUTICS INC. |
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(Registrant) |
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By: |
/s/ Paul J. Sekhri |
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Paul J. Sekhri |
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President and Chief Executive Officer |
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By: |
/s/ Barry Brown |
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Barry Brown |
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Chief Accounting Officer |
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