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2022-09-30
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
☒
|
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
☐
|
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: 001-39306
APPLIED MOLECULAR TRANSPORT INC.
(Exact Name of Registrant as Specified in its Charter)
Delaware
|
81-4481426
|
(State or other jurisdiction of
incorporation or organization)
|
(I.R.S. Employer
Identification No.)
|
450 East Jamie Court
South San Francisco, California
|
94080
|
(Address of principal executive offices)
|
(Zip Code)
|
Registrant’s telephone number, including area code:
650-392-0420
(Former name, former address and
former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the
Act:
Title of each class
|
|
Trading
Symbol(s)
|
|
Name of each exchange on which registered
|
Common Stock, par value $0.0001 per share
|
|
AMTI
|
|
The Nasdaq Global Select Market
|
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 ☒ No ☐
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
☒ No ☐
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.
Large accelerated filer
|
|
☒
|
|
Accelerated filer
|
|
☐
|
|
|
|
|
Non-accelerated filer
|
|
☐
|
|
Smaller reporting company
|
|
☐
|
|
|
|
|
|
|
|
Emerging growth company
|
|
☐
|
|
|
|
|
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. ☐
Indicate by check mark whether the registrant is a shell company
(as defined in Rule 12b-2 of the Exchange
Act). Yes ☐ No ☒
As of October 31, 2022, the registrant had 38,943,097 shares of
common stock, $0.0001 par value per share, outstanding.
Table of Contents
Table of Contents
Table of Contents
Special Note Regarding Forward-Looking Statements
This report contains forward-looking statements that are based on our beliefs and assumptions and
on information currently available to us. Forward-looking
statements include information regarding our expectations on the
timing of clinical study initiation and results and the timing and
success of future development of our product candidates, potential
regulatory approval of our product candidates, our possible or
assumed future results of operations and expenses, business
strategies and plans, trends, market sizing, competitive position,
industry environment, potential growth opportunities, reliance on
third parties, financing needs, the sufficiency of the Company’s
existing cash and cash equivalents, our ability to protect our
intellectual property position, the impact on our business of
certain geo-political events, the development of macroeconomic
conditions, the impact of the COVID-19 pandemic on our business,
and impact of the Affordable Care Act and other legislation and
regulation, among other things. Forward-looking statements include
all statements that are not historical facts and, in some cases,
can be identified by terms such as “anticipates,” “believes,”
“could,” “estimates,” “expects,” “intends,” “may,” “plans,”
“potential,” “predicts,” “projects,” “seeks,” “should,” “will,”
“would” or similar expressions and the negatives of those
terms.
Forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause our actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements, including those described in “Risk
Factors” and elsewhere in this report. Given these uncertainties,
you should not place undue reliance on these forward-looking
statements.
Any forward-looking statement made by us in this report speaks only
as of the date on which it is made. Except as required by law, we
disclaim any 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.
Table of Contents
PART
I—FINANCIAL INFORMATION
Item 1.
Condensed Financial Statements (Unaudited)
Applied Molecular Transport Inc.
Condensed
Balance Sheets
(unaudited)
(in thousands, except share and per share data)
|
|
September 30,
|
|
|
December 31,
|
|
|
|
2022
|
|
|
2021
|
|
Assets
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
76,020
|
|
|
$
|
159,821
|
|
Prepaid expenses
|
|
|
3,210
|
|
|
|
6,685
|
|
Other current assets
|
|
|
1,047
|
|
|
|
594
|
|
Total current assets
|
|
|
80,277
|
|
|
|
167,100
|
|
Property and equipment, net
|
|
|
8,780
|
|
|
|
6,998
|
|
Operating lease ROU assets, net
|
|
|
33,446
|
|
|
|
38,142
|
|
Finance lease ROU assets, net
|
|
|
639
|
|
|
|
652
|
|
Restricted cash
|
|
|
916
|
|
|
|
1,025
|
|
Other assets
|
|
|
549
|
|
|
|
121
|
|
Total assets
|
|
$
|
124,607
|
|
|
$
|
214,038
|
|
Liabilities and stockholders’ equity
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
1,374
|
|
|
$
|
2,211
|
|
Accrued expenses
|
|
|
8,043
|
|
|
|
8,226
|
|
Lease liabilities, operating lease - current
|
|
|
4,449
|
|
|
|
3,584
|
|
Lease liabilities, finance lease - current
|
|
|
258
|
|
|
|
237
|
|
Total current liabilities
|
|
|
14,124
|
|
|
|
14,258
|
|
Lease liabilities, operating lease
|
|
|
31,785
|
|
|
|
35,785
|
|
Lease liabilities, finance lease
|
|
|
59
|
|
|
|
167
|
|
Other liabilities
|
|
|
244
|
|
|
|
241
|
|
Total liabilities
|
|
|
46,212
|
|
|
|
50,451
|
|
Commitments and contingencies (Note 6)
|
|
|
|
|
|
|
|
|
Stockholders’ equity:
|
|
|
|
|
|
|
|
|
Common stock, $0.0001 par value, 450,000,000 shares authorized as
of September 30, 2022 and December 31, 2021; 38,943,097 and
38,619,957 shares issued and outstanding as of September 30, 2022
and December 31, 2021, respectively
|
|
|
4
|
|
|
|
4
|
|
Additional paid-in capital
|
|
|
421,762
|
|
|
|
403,228
|
|
Accumulated deficit
|
|
|
(343,371
|
)
|
|
|
(239,645
|
)
|
Total stockholders’ equity
|
|
|
78,395
|
|
|
|
163,587
|
|
Total liabilities and stockholders’ equity
|
|
$
|
124,607
|
|
|
$
|
214,038
|
|
The accompanying notes are an integral part of these condensed
financial statements.
2
Table of Contents
Applied Molecular Transport Inc.
Condensed Statements of Operations and Comprehensive Loss
(unaudited)
(in thousands, except share and per share data)
|
|
Three Months Ended
|
|
|
Nine Months Ended
|
|
|
|
September 30,
|
|
|
September 30,
|
|
|
|
2022
|
|
|
2021
|
|
|
2022
|
|
|
2021
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
18,238
|
|
|
$
|
18,350
|
|
|
$
|
75,386
|
|
|
$
|
49,765
|
|
General and administrative
|
|
|
7,288
|
|
|
|
7,641
|
|
|
|
28,738
|
|
|
|
20,333
|
|
Total operating expenses
|
|
|
25,526
|
|
|
|
25,991
|
|
|
|
104,124
|
|
|
|
70,098
|
|
Loss from operations
|
|
|
(25,526
|
)
|
|
|
(25,991
|
)
|
|
|
(104,124
|
)
|
|
|
(70,098
|
)
|
Interest income, net
|
|
|
321
|
|
|
|
5
|
|
|
|
393
|
|
|
|
104
|
|
Other income (expense), net
|
|
|
(1
|
)
|
|
|
(6
|
)
|
|
|
5
|
|
|
|
(90
|
)
|
Net loss
|
|
$
|
(25,206
|
)
|
|
$
|
(25,992
|
)
|
|
$
|
(103,726
|
)
|
|
$
|
(70,084
|
)
|
Net loss per share, basic and diluted
|
|
$
|
(0.65
|
)
|
|
$
|
(0.68
|
)
|
|
$
|
(2.68
|
)
|
|
$
|
(1.88
|
)
|
Weighted-average shares of common stock outstanding, basic and
diluted
|
|
|
38,914,570
|
|
|
|
38,437,096
|
|
|
|
38,769,226
|
|
|
|
37,273,178
|
|
Comprehensive loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(25,206
|
)
|
|
$
|
(25,992
|
)
|
|
$
|
(103,726
|
)
|
|
$
|
(70,084
|
)
|
Other comprehensive loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized loss on investments
|
|
|
—
|
|
|
|
(5
|
)
|
|
|
—
|
|
|
|
(26
|
)
|
Total comprehensive loss
|
|
$
|
(25,206
|
)
|
|
$
|
(25,997
|
)
|
|
$
|
(103,726
|
)
|
|
$
|
(70,110
|
)
|
The accompanying notes are an integral part of these condensed
financial statements.
3
Table of Contents
Applied Molecular Transport Inc.
Condensed Statements of Stockholders’ Equity
(unaudited)
(in thousands, except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional
|
|
|
Other
|
|
|
|
|
|
|
Total
|
|
|
|
Common Stock
|
|
|
Paid-In
|
|
|
Comprehensive
|
|
|
Accumulated
|
|
|
Stockholders'
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Income (Loss)
|
|
|
Deficit
|
|
|
Equity
|
|
As of December 31, 2021
|
|
|
38,619,957
|
|
|
$
|
4
|
|
|
$
|
403,228
|
|
|
$
|
—
|
|
|
$
|
(239,645
|
)
|
|
$
|
163,587
|
|
Exercise of common stock options
|
|
|
34,206
|
|
|
|
—
|
|
|
|
60
|
|
|
|
—
|
|
|
|
—
|
|
|
|
60
|
|
Stock-based compensation expense
|
|
|
—
|
|
|
|
—
|
|
|
|
6,773
|
|
|
|
—
|
|
|
|
—
|
|
|
|
6,773
|
|
Net loss
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(42,575
|
)
|
|
|
(42,575
|
)
|
As of March 31, 2022
|
|
|
38,654,163
|
|
|
$
|
4
|
|
|
$
|
410,061
|
|
|
$
|
-
|
|
|
$
|
(282,220
|
)
|
|
$
|
127,845
|
|
Issuance of common stock from employee stock purchase plan
|
|
|
66,497
|
|
|
|
—
|
|
|
|
231
|
|
|
|
—
|
|
|
|
—
|
|
|
|
231
|
|
Exercise of common stock options
|
|
|
16,073
|
|
|
|
—
|
|
|
|
31
|
|
|
|
—
|
|
|
|
—
|
|
|
|
31
|
|
Issuance of common stock upon vesting of restricted stock units
|
|
|
161,962
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
Stock-based compensation expense
|
|
|
—
|
|
|
|
—
|
|
|
|
5,590
|
|
|
|
—
|
|
|
|
—
|
|
|
|
5,590
|
|
Net loss
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(35,945
|
)
|
|
|
(35,945
|
)
|
As of June 30, 2022
|
|
|
38,898,695
|
|
|
$
|
4
|
|
|
$
|
415,913
|
|
|
$
|
-
|
|
|
$
|
(318,165
|
)
|
|
$
|
97,752
|
|
Exercise of common stock options
|
|
|
3,430
|
|
|
|
—
|
|
|
|
7
|
|
|
|
—
|
|
|
|
—
|
|
|
|
7
|
|
Issuance of common stock upon vesting of restricted stock units
|
|
|
40,972
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
Stock-based compensation expense
|
|
|
—
|
|
|
|
—
|
|
|
|
5,842
|
|
|
|
—
|
|
|
|
—
|
|
|
|
5,842
|
|
Net loss
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(25,206
|
)
|
|
|
(25,206
|
)
|
As of September 30, 2022
|
|
|
38,943,097
|
|
|
$
|
4
|
|
|
$
|
421,762
|
|
|
$
|
-
|
|
|
$
|
(343,371
|
)
|
|
$
|
78,395
|
|
The accompanying notes are an integral part of these condensed
financial statements.
4
Table of Contents
Applied Molecular Transport Inc.
Condensed Statements of Stockholders’ Equity (continued)
(unaudited)
(in thousands, except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional
|
|
|
Other
|
|
|
|
|
|
|
Total
|
|
|
|
Common Stock
|
|
|
Paid-In
|
|
|
Comprehensive
|
|
|
Accumulated
|
|
|
Stockholders'
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Income (Loss)
|
|
|
Deficit
|
|
|
Equity
|
|
As of December 31, 2020
|
|
|
35,121,360
|
|
|
$
|
4
|
|
|
$
|
271,000
|
|
|
$
|
27
|
|
|
$
|
(139,358
|
)
|
|
$
|
131,673
|
|
Exercise of common stock options
|
|
|
129,290
|
|
|
|
—
|
|
|
|
397
|
|
|
|
—
|
|
|
|
—
|
|
|
|
397
|
|
Stock-based compensation expense
|
|
|
—
|
|
|
|
—
|
|
|
|
1,951
|
|
|
|
—
|
|
|
|
—
|
|
|
|
1,951
|
|
Unrealized loss on investments
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(2
|
)
|
|
|
—
|
|
|
|
(2
|
)
|
Net loss
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(20,462
|
)
|
|
|
(20,462
|
)
|
As of March 31, 2021
|
|
|
35,250,650
|
|
|
$
|
4
|
|
|
$
|
273,348
|
|
|
$
|
25
|
|
|
$
|
(159,820
|
)
|
|
$
|
113,557
|
|
Issuance of common stock upon follow-on offering, net of
underwriters' commission and issuance costs of $7,947
|
|
|
2,875,000
|
|
|
|
—
|
|
|
|
112,801
|
|
|
|
—
|
|
|
|
—
|
|
|
|
112,801
|
|
Issuance of common stock from employee stock purchase plan
|
|
|
10,549
|
|
|
|
—
|
|
|
|
276
|
|
|
|
—
|
|
|
|
—
|
|
|
|
276
|
|
Exercise of common stock options
|
|
|
214,791
|
|
|
|
—
|
|
|
|
772
|
|
|
|
—
|
|
|
|
—
|
|
|
|
772
|
|
Stock-based compensation expense
|
|
|
—
|
|
|
|
—
|
|
|
|
4,333
|
|
|
|
—
|
|
|
|
—
|
|
|
|
4,333
|
|
Unrealized loss on investments
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(19
|
)
|
|
|
—
|
|
|
|
(19
|
)
|
Net loss
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(23,630
|
)
|
|
|
(23,630
|
)
|
As of June 30, 2021
|
|
|
38,350,990
|
|
|
$
|
4
|
|
|
$
|
391,530
|
|
|
$
|
6
|
|
|
$
|
(183,450
|
)
|
|
$
|
208,090
|
|
Exercise of common stock options
|
|
|
124,170
|
|
|
|
—
|
|
|
|
491
|
|
|
|
—
|
|
|
|
—
|
|
|
|
491
|
|
Stock-based compensation expense
|
|
|
—
|
|
|
|
—
|
|
|
|
4,937
|
|
|
|
—
|
|
|
|
—
|
|
|
|
4,937
|
|
Unrealized loss on investments
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(5
|
)
|
|
|
—
|
|
|
|
(5
|
)
|
Net loss
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(25,992
|
)
|
|
|
(25,992
|
)
|
As of September 30, 2021
|
|
|
38,475,160
|
|
|
$
|
4
|
|
|
$
|
396,958
|
|
|
$
|
1
|
|
|
$
|
(209,442
|
)
|
|
$
|
187,521
|
|
The accompanying notes are an integral part of these condensed
financial statements.
5
Table of Contents
Applied Molecular Transport Inc.
Condensed Statements of Cash Flows
(unaudited)
(in thousands)
|
|
Nine Months Ended
September 30,
|
|
|
|
2022
|
|
|
2021
|
|
Operating activities
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(103,726
|
)
|
|
$
|
(70,084
|
)
|
Adjustments to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Stock-based compensation expense
|
|
|
18,205
|
|
|
|
11,221
|
|
Depreciation and amortization
|
|
|
2,468
|
|
|
|
2,403
|
|
Non-cash operating lease expense
|
|
|
6,433
|
|
|
|
2,117
|
|
Loss on impairment of property and equipment
|
|
|
80
|
|
|
|
—
|
|
Loss on disposal of property and equipment
|
|
|
—
|
|
|
|
71
|
|
Net accretion of discounts on investments
|
|
|
—
|
|
|
|
(69
|
)
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Prepaid expenses
|
|
|
3,475
|
|
|
|
(3,192
|
)
|
Other current assets
|
|
|
336
|
|
|
|
(313
|
)
|
Other assets
|
|
|
(428
|
)
|
|
|
75
|
|
Accounts payable
|
|
|
(837
|
)
|
|
|
(1,807
|
)
|
Accrued expenses
|
|
|
(221
|
)
|
|
|
1,520
|
|
Operating lease liabilities
|
|
|
(4,872
|
)
|
|
|
(2,071
|
)
|
Other liabilities
|
|
|
3
|
|
|
|
—
|
|
Net cash used in operating activities
|
|
|
(79,084
|
)
|
|
|
(60,129
|
)
|
Investing activities
|
|
|
|
|
|
|
|
|
Purchases of property and equipment
|
|
|
(4,146
|
)
|
|
|
(906
|
)
|
Proceeds from sales and maturities of investments
|
|
|
—
|
|
|
|
94,000
|
|
Net cash (used in) provided by investing activities
|
|
|
(4,146
|
)
|
|
|
93,094
|
|
Financing activities
|
|
|
|
|
|
|
|
|
Payments of deferred offering costs for “at-the-market”
offering
|
|
|
(806
|
)
|
|
|
—
|
|
Principal payments on finance lease liabilities
|
|
|
(203
|
)
|
|
|
(173
|
)
|
Proceeds from issuance of common stock from employee stock purchase
plan
|
|
|
231
|
|
|
|
276
|
|
Proceeds from exercise of common stock options
|
|
|
98
|
|
|
|
1,660
|
|
Proceeds from follow-on offering, net of underwriters'
commission
|
|
|
—
|
|
|
|
113,505
|
|
Payments of issuance costs for follow-on offering
|
|
|
—
|
|
|
|
(704
|
)
|
Net cash (used in) provided by financing activities
|
|
|
(680
|
)
|
|
|
114,564
|
|
Net (decrease) increase in cash, cash equivalents and restricted
cash
|
|
|
(83,910
|
)
|
|
|
147,529
|
|
Cash, cash equivalents and restricted cash, beginning of period
|
|
|
160,846
|
|
|
|
5,951
|
|
Cash, cash equivalents and restricted cash, end of period
|
|
$
|
76,936
|
|
|
$
|
153,480
|
|
Supplemental cash flow data:
|
|
|
|
|
|
|
|
|
Cash paid for interest on finance lease liabilities
|
|
$
|
21
|
|
|
$
|
25
|
|
Supplemental disclosure of non-cash investing and financing
activities:
|
|
|
|
|
|
|
|
|
Property and equipment included in accounts payable and accrued
expenses
|
|
$
|
23
|
|
|
$
|
266
|
|
Deferred offering costs included in accounts payable and accrued
expenses
|
|
$
|
15
|
|
|
$
|
—
|
|
The accompanying notes are an integral part of these condensed
financial statements.
6
Table of Contents
Applied Molecular Transport Inc.
Notes to the Condensed Financial Statements
(unaudited)
1. Business and Principal Activities
Description of Business
Applied Molecular Transport Inc. (the Company) is a clinical-stage
biopharmaceutical company leveraging its proprietary technology
platform to design and develop a pipeline of novel oral and
respiratory biologic product candidates to treat autoimmune,
inflammatory, metabolic, and other diseases. The Company’s
principal operations are in the United States with its headquarters
in South San Francisco, California.
Since the date of incorporation in Delaware on November 21, 2016,
the Company has devoted substantially all of its resources to
research and development activities, including research activities
such as drug discovery, preclinical studies, and clinical trials as
well as development activities such as the manufacturing of
clinical and research material, establishing and maintaining an
intellectual property portfolio, hiring personnel, raising capital,
and providing general and administrative support for these
operations.
Liquidity and Capital Resources
Management believes that its existing cash and cash equivalents as
of September 30, 2022 will be sufficient to allow the Company to
fund its current operating plan through at least 12 months from the
date that this Quarterly Report on Form 10-Q is filed with the U.S.
Securities and Exchange Commission (SEC).
The Company has incurred significant losses and negative cash flows
from operations since its inception. As of September 30, 2022, the
Company had an accumulated deficit of $343.4 million and does not
expect positive cash flows from operations in the foreseeable
future. The Company expects to incur significant and increasing
losses until regulatory approval is granted and successful
commercialization is achieved for any of its product candidates.
Regulatory approval is not guaranteed and may never be obtained.
The Company has historically financed its operations primarily
through private placements of its convertible preferred stock and
sale of common stock upon the completion of the Initial Public
Offering (IPO) and follow-on equity offering. In addition, on
January 27, 2022, the Company entered into a Sales Agreement with
SVB Securities LLC and JMP Securities LLC, as the Company’s sales
agents (Agents), pursuant to which the Company may offer and sell
from time to time through the Agents up to $150.0 million in shares
of the Company’s common stock through an “at-the-market” program
(ATM facility). As of September 30, 2022, the Company had not yet
sold any shares of common stock under the ATM facility. The Company
may seek to raise additional capital through debt financings,
private or public equity financings, license agreements,
collaborative agreements or other arrangements with other
companies, or other sources of financing. There can be no assurance
that such financing will be available or will be at terms
acceptable to the Company.
Strategic Plan Announcement
In May 2022, the Company implemented a strategic plan to focus the
business on its clinical program for AMT-101 (Strategic Plan). The
Strategic Plan is intended to preserve capital, ensuring that the
Company is appropriately resourced to advance AMT-101 through key
development milestones.
Employment Related Agreements
Under the Strategic Plan, the Company reduced its workforce by
approximately 40%. Impacted employees received notice that their
positions were eliminated on May 16, 2022. Impacted employees were
eligible to receive severance benefits and Company funded COBRA
premiums, contingent upon an impacted employee’s execution (and
non-revocation) of a customary separation agreement, which included
a general release of claims against the Company. For certain
employees, the Company accelerated vesting of restricted stock
units (“RSUs”) to May 16, 2022 from the original vesting date of
June 1, 2022.
In connection with the Strategic Plan, the Company recognized
restructuring charges of approximately $3.8 million in the nine
months ended September 30, 2022. These restructuring charges were
primarily related to severance payments and other employee-related
separation costs of $3.3 million, contract termination fees of $0.5
million, a lease termination fee of $0.3 million, impairment of
property and equipment of $0.1 million and insignificant legal
expenses, partially offset by a $0.4 million reduction in
stock-based compensation expense as a result of applying
modification accounting for accelerated vesting of RSUs. As of
September 30, 2022, accrued contract termination fees of $0.4
million remained unpaid and are expected to be paid within one
year.
7
Table of Contents
Risks and Uncertainties
The COVID-19 virus has spread extensively throughout the world,
resulting in the World Health Organization characterizing COVID-19
as a pandemic. While significant progress in addressing the
pandemic has been made with multiple vaccines and treatment options
now available, the emergence of highly transmissible variants of
the virus have resulted in periodic surges in infection rates
around the world and a cycle of fluctuating public health
restrictions designed to mitigate the spread of the virus. The
extent to which the COVID-19 pandemic impacts the Company’s
business will depend on future developments, which are highly
uncertain and cannot be predicted, such as the spread or emergence
of new variants, the duration and severity of surges in outbreaks,
travel restrictions and social distancing in the United States and
other countries, business closures or business disruptions, and the
effectiveness of actions taken in the United States and other
countries to contain and treat the disease and to address its
impact, including on financial markets or otherwise. The Company
continues to have a hybrid work environment with a majority of the
Company’s workforce either working exclusively from home or working
from home for part of their work week. The Company’s financial
results could be affected by the COVID-19 pandemic in various ways.
As a result of the COVID-19 pandemic, the Company has experienced
and could experience disruptions that could severely impact the
Company’s business, current and planned critical trials and
preclinical studies. For example, the COVID-19 pandemic could
result in delays to the Company’s clinical trials and preclinical
studies for numerous reasons including difficulties in enrolling
patients or healthy volunteers, diversion of healthcare resources
away from the conduct of clinical trials, delays in receiving
regulatory authorities to initiate clinical trials, and delays in
receiving supplies to conduct clinical trials and preclinical
studies. There has also been an increase in infections from
COVID-19 variants which has impacted patient recruitment at certain
of the Company’s clinical trial sites and could result in increased
costs and delays. In addition, as a result of ongoing COVID-19
research and the current global supply chain issues, there is
currently limited availability for certain resources required to
conduct some of the Company’s preclinical studies and clinical
trials, which may result in longer lead times, increased costs, and
delays in completing preclinical studies and clinical trials. As a
result, research and development expenses and general and
administrative expenses may vary significantly if there is an
increased impact from COVID-19 on the costs and timing associated
with the conduct of the clinical trial and other related business
activities. The Company is carefully monitoring the pandemic and
the potential length and depth of the resulting economic impact on
the Company’s financial condition and results of operations as of
September 30, 2022.
In addition, currently there is a conflict involving Russia and
Ukraine. The Company’s AMT-101 Phase 2 LOMBARD trial currently
includes clinical trial sites located in Ukraine, Russia, and other
Eastern European countries. The Board of Directors of the Company
(Board of Directors) is receiving management reports and discusses
with management at board meetings macro-economic and geopolitical
developments, including the Russia/Ukraine conflict and the impact
on the Company’s personnel, cybersecurity, sanctions and the
Company’s clinical trial sites located in the region so that the
Company can be prepared to react to new developments as they arise.
This conflict has and may continue to impact the Company’s ability
to conduct certain of our trials in Ukraine, Russia and other
Eastern European countries, and may prevent the Company from
obtaining data on patients already enrolled at sites in these
countries. This could negatively impact the completion of the
Company’s clinical trials and/or analyses of clinical results or
result in increased costs, all of which could materially harm the
Company’s business. The Board of Directors is monitoring and
continues to assess and monitor risks related to the Russia/Ukraine
conflict.
The extent of the ongoing impact of macroeconomic events on the
Company’s business and on global economic activity is uncertain and
the related financial impact cannot be reasonably estimated with
any certainty at this time, although the impacts are expected to
continue and may significantly affect the Company’s business. The
Company expects that the impacts on its business will continue
through this period of economic uncertainty as supply chain issues,
inflation and other factors continue to worsen or emerge.
Accordingly, management is carefully evaluating its liquidity
position, communicating with and monitoring the actions of its
suppliers and continuing to review its near-term operating expenses
as the uncertainty related to these factors continues to unfold.
The risks related to the Company’s business, including further
discussion of the impact and possible future impacts of the
COVID-19 pandemic and current economic conditions on the Company’s
business, are further described in the section titled “Risk
Factors” in Part II, Item 1A of this Quarterly Report on Form
10-Q.
8
Table of Contents
2. Summary of Significant Accounting Policies
Condensed Financial Statements (Unaudited)
The financial statements have been prepared in accordance with
accounting principles generally accepted in the United States of
America (GAAP) and applicable rules and regulations of the SEC
for interim reporting. As permitted under those rules and
regulations, certain footnotes or other financial information
normally included in financial statements prepared in accordance
with GAAP have been condensed or omitted. The interim condensed
financial statements have been prepared on the same basis as the
annual financial statements and, in the opinion of management,
reflect all adjustments, which include only normal, recurring
adjustments that are necessary to present fairly the Company’s
results for the interim periods presented. The condensed balance
sheet as of December 31, 2021 was derived from the Company’s
audited financial statements. The results of operations for the
three and nine months ended September 30, 2022 are not necessarily
indicative of the results to be expected for the year ending
December 31, 2022 or for any other interim periods or future
years.
The accompanying interim unaudited condensed financial statements
should be read in conjunction with the audited financial statements
and the related notes thereto for the year ended December 31, 2021,
which are included in the Company’s Annual Report on Form 10-K,
originally filed with the SEC on February 24, 2022, as amended by
Form 10-K/A (Amendment No. 1) filed on March 25, 2022.
Use of Estimates
The preparation of financial statements in conformity with GAAP
requires management to make estimates and assumptions that affect
the amounts reported in the financial statements and accompanying
notes. The Company bases its estimates on historical experience and
market-specific or other relevant assumptions that it believes are
reasonable under the circumstances. Assets and liabilities reported
in the Company’s condensed balance sheets and expenses and income
reported are affected by estimates and assumptions, which are used
for, but are not limited to, recording research and development
expenses and related accruals, and determining the fair value of
stock options for stock-based compensation expense. The Company
assessed certain accounting matters that generally require
consideration of forecasted financial information in context with
the information reasonably available to the Company and the unknown
future impacts of the COVID-19 pandemic. Actual results could
differ from such estimates or assumptions.
Concentration of Credit Risk and Other Risks and Uncertainties
Financial instruments that potentially subject the Company to
significant concentrations of credit risk consist primarily of
cash, cash equivalents, and investments. From time to time, the
Company invests in U.S. Treasury securities. The Company maintains
bank deposits in federally insured financial institutions and these
deposits may exceed federally insured limits. The Company is
exposed to credit risk in the event of default by the financial
institutions holding its cash, cash equivalents, and investments to
the extent recorded in the condensed balance sheets. The Company
has not experienced any losses on its deposits of cash, cash
equivalents, and investments. The Company is subject to a number of
risks similar to other clinical-stage biopharmaceutical companies,
including, but not limited to, the need to obtain adequate
additional funding, possible failure of current or future
preclinical studies or clinical trials, its reliance on third
parties to conduct its clinical trials, the need to obtain
regulatory and marketing approvals for its product candidates,
competitors developing new technological innovations, the need to
successfully commercialize and gain market acceptance of the
Company’s product candidates, protection of its proprietary
technology, and the need to secure and maintain adequate
manufacturing arrangements with third parties or develop internal
manufacturing capabilities. The Company’s product candidates will
require approval from the U.S. Food and Drug Administration (FDA)
and/or comparable foreign regulatory agencies prior to
commercialization in their respective jurisdictions. If the Company
does not successfully commercialize or partner any of its product
candidates, it will be unable to generate product revenue or
achieve profitability.
Operating Segment
The Company operates and manages its business as one reportable and
operating segment, which is the business of designing and
developing a pipeline of novel oral and respiratory biologic
product candidates to treat autoimmune, inflammatory, metabolic,
and other diseases. The Company’s chief executive officer, who is
the chief operating decision maker, reviews financial information
on an aggregate basis for allocating and evaluating financial
performance.
Cash and Cash Equivalents
Cash and cash equivalents are held in accounts at financial
institutions. Such deposits have and will continue to exceed
federally insured limits in the foreseeable future. The Company
considers all highly liquid investments purchased with original
maturities of 90 days or less from the purchase date to be cash
equivalents. Cash equivalents consist of amounts invested in money
market funds exclusively composed of U.S. government
obligations.
9
Table of Contents
Restricted Cash
As of September 30, 2022, the Company had $0.9 million in
restricted cash, which was classified as long-term on the Company’s
condensed balance sheets. The restricted cash was attributable to a
letter of credit issued by the Company in connection with the
operating lease for the Company’s headquarters (See Note 5). The
letter of credit will expire 90 days after the expiration of the
lease in 2029.
During the nine months ended September 30, 2022, the Company
collected its $0.1 million letter of credit associated with the
expiration of an operating lease.
The following table provides a reconciliation of cash, cash
equivalents and restricted cash reported within the condensed
statements of cash flows (in thousands):
|
|
September 30,
|
|
|
September 30,
|
|
|
|
2022
|
|
|
2021
|
|
Cash and cash equivalents
|
|
$
|
76,020
|
|
|
$
|
152,455
|
|
Restricted cash
|
|
|
916
|
|
|
|
1,025
|
|
Total cash, cash equivalents and restricted cash
|
|
$
|
76,936
|
|
|
$
|
153,480
|
|
Property and Equipment, Net
Property and equipment are presented at cost, net of accumulated
depreciation. Depreciation is recorded using the straight-line
method. Depreciation begins at the time the asset is placed in
service. Maintenance and repairs are charged to expense as incurred
and costs of major replacement or improvement are capitalized. The
Company’s estimated useful lives of its property and equipment are
as follows:
Laboratory and manufacturing equipment
|
|
5 years
|
Computer and office equipment
|
|
3 years
|
Leasehold improvements
|
|
Shorter of remaining lease term or estimated useful life
|
Impairment of Long-Lived Assets
The Company evaluates the carrying amount of its long-lived assets
whenever events or changes in circumstances indicate that the
assets may not be recoverable. An impairment loss is recognized
when the remaining book value of an asset is not recoverable. The
Company recorded impairment charges of $0.1 million related to
laboratory and manufacturing equipment in connection with the
Strategic Plan during the nine months ended September 30, 2022.
There was no other impairment to the Company’s long-lived assets
during the nine months ended September 30, 2021.
Leases
In February 2016, the Financial Accounting Standards Board (FASB)
issued an Accounting Standard Update (ASU) No. 2016-02, Leases (ASC
842), and its associated amendments, that establishes a
right-of-use (ROU) model that requires a lessee to recognize a ROU
asset and lease liability on the balance sheet for all leases with
a term longer than 12 months and disclose key information about
leasing arrangements. The Company adopted ASC 842 on January 1,
2021 using the modified retrospective approach. Leases have been
classified as either finance or operating, with classification
affecting the pattern and classification of expense recognition in
the condensed statements of operations and comprehensive loss.
At the inception of an arrangement, the Company determines if an
arrangement is, or contains, a lease based on the facts and
circumstances present in that arrangement. Lease classification,
recognition, and measurement are then determined at the lease
commencement date. For arrangements that contain a lease, the
Company (i) identifies lease and non-lease components, (ii)
determines the consideration in the contract, (iii) determines
whether the lease is an operating or finance lease; and (iv)
recognizes lease ROU assets and liabilities. Lease liabilities and
their corresponding ROU assets are recorded based on the present
value of lease payments over the expected lease term. The interest
rate implicit in lease contracts is typically not readily
determinable. Accordingly, the Company uses the incremental
borrowing rate based on the information available at the lease
commencement date, which represents an internally developed rate
that would be incurred to borrow, on a collateralized basis, over a
similar term, an amount equal to the lease payments
10
Table of Contents
in a similar economic environment.
Building improvements continue to be capitalized as leasehold
improvements and are included in property and equipment, net in
the
condensed
balance sheets.
Most leases include options to renew and/or terminate the lease,
which can impact the lease term. The exercise of these options is
at the Company’s discretion. The Company’s lease terms may include
options to extend or terminate the lease when it is reasonably
certain that the Company will exercise such options.
The Company has operating leases for its corporate offices,
laboratory, and manufacturing and warehouse facilities. Fixed lease
payments on operating leases are recognized as lease expense over
the expected term of the lease on a straight-line basis. The
Company’s real estate operating leases require payment of common
area maintenance, real estate taxes, and insurance. These
components are recognized as variable lease expense in the period
in which the obligation is incurred. As these costs are generally
variable in nature, they are not included in the measurement of the
operating lease ROU asset and related lease liability. Fixed and
variable lease expense on operating leases is recognized within
operating expenses within the Company’s condensed statements of
operations and comprehensive loss. Sublease income is recognized on
a straight-line basis over the sublease term and is recorded net
against the head lease expense.
The Company has various finance leases for laboratory and
manufacturing equipment. Interest expense from fixed payments on
finance leases is recognized using the effective interest method.
Finance lease ROU asset amortization and interest expense are
recorded within operating expenses and interest income, net,
respectively, within the Company’s condensed statements of
operations and comprehensive loss.
The Company has elected the short-term lease exemption and,
therefore, does not recognize an ROU asset or corresponding
liability for lease arrangements with an original term of 12 months
or less.
Research and Development Expenses
Research and development expenses are expensed as incurred.
Research and development expenses include personnel costs related
to research and development activities, materials costs, external
clinical product candidate manufacturing and clinical trial costs,
outside services costs, repair, maintenance and depreciation costs
for research and development equipment, as well as facility costs
for laboratory space used for research and development
activities.
Accrued Research and Development Expenses
The Company accrues for estimated costs of research, preclinical
studies, clinical trials, and manufacturing development services
performed but not yet invoiced and such accruals are included
within accrued expenses which are significant components of
research and development expenses. A substantial portion of the
Company’s ongoing research and development activities is conducted
by third-party service providers including contract research
organizations (CROs) and contract development and manufacturing
organizations (CDMOs). The Company’s contracts, amendments thereto,
statements of work and change orders with the CROs and CDMOs
generally include fees such as initiation fees, reservation fees,
costs related to animal studies and safety tests, verification run
costs, materials and reagents expenses, and taxes. Payments made to
third parties under these arrangements in advance of the
performance of the related services are recorded as prepaid
expenses and are expensed as services are rendered. The financial
terms of these arrangements are subject to negotiations, which vary
from contract to contract and may result in the timing of payments
that do not match the periods over which materials or services are
provided to the Company under such contracts. The Company accrues
the costs incurred under agreements with these third parties and/or
adjusts the prepaid expenses based on estimates of work completed
in accordance with the respective agreements. The Company
determines the estimated costs through information obtained from
third-party providers as to the progress, stage of completion or
actual timeline (start-date and end-date) of the services and the
agreed-upon fees to be paid for such services and corroboration
with internal personnel responsible for the oversight of the
research and development activities.
If the actual timing of the performance of services or the level of
effort varies from the estimate, the Company adjusts accrued
expenses or prepaid expenses accordingly, which impact research and
development expenses. Although the Company does not expect its
estimates to be materially different from amounts actually
incurred, the Company’s understanding of the status and timing of
services performed relative to the actual status and timing of
services performed may vary and may result in reporting amounts
that are too high or too low in any particular period. To date,
there have not been any material adjustments to the Company’s prior
estimates of research and development expenses.
11
Table of Contents
Stock-Based Compensation Expense
The Company maintains both an equity incentive plan and an employee
stock purchase plan (ESPP) as long-term incentives for its
employees, consultants, and non-employee directors. Under the
equity incentive plan, the Company is authorized to grant various
equity-based incentives including stock options and restricted
stock units (RSUs). The ESPP provides for 24-month offering periods
and each offering period may contain up to four six-month purchase
periods. The ESPP allows employees to purchase shares of the
Company’s common stock each purchase period based on a percentage
of their compensation subject to certain limits.
The Company accounts for stock-based compensation expense by
measuring and recognizing compensation expense for all share-based
payments made to employees and non-employees based on estimated
grant-date fair values. The grant-date fair values for options are
recorded as stock-based compensation expense on a straight-line
basis over each recipient’s requisite service period, which is
generally the vesting period. The grant-date fair values for
purchase rights granted under the ESPP are recorded as stock-based
compensation expense on a straight-line basis over the applicable
offering period. Actual forfeitures of unvested equity awards are
recognized as they occur by reversing any expense previously
recorded for the award.
The Company estimates the fair value of stock options granted to
employees and non-employees using the Black-Scholes model. The
Company estimates the fair value of purchase rights granted under
the ESPP for an offering period using the Black-Scholes model. The
Black-Scholes model requires the input of subjective assumptions,
including expected volatility, expected dividend yield, expected
term and the risk-free rate of return.
Fair Value Measurements
Fair value is defined as the exchange price that would be received
for an asset or paid to transfer a liability, or an exit price, in
the principal or most advantageous market for that asset or
liability in an orderly transaction between market participants on
the measurement date. Fair value measurement establishes a fair
value hierarchy that requires an entity to maximize the use of
observable inputs, where available, and minimize the use of
unobservable inputs when measuring fair value.
The Company determined the fair value of financial assets and
liabilities using the fair value hierarchy that describes three
levels of inputs that may be used to measure fair value, as
follows:
▪
|
Level 1—Quoted
prices in active markets for identical assets and
liabilities;
|
▪
|
Level 2—Inputs
other than Level 1 that are observable, either directly or
indirectly, such as quoted prices for similar assets or
liabilities, quoted prices in markets that are not active, or other
inputs that are observable or can be corroborated by observable
market data for substantially the full term of the assets or
liabilities; and
|
▪
|
Level 3—Unobservable inputs
that are supported by little or no market activity and that are
significant to the fair value of the assets or
liabilities.
|
Financial instruments consist of cash and cash equivalents,
restricted cash, other current assets, accounts payable and accrued
expenses. As of September 30, 2022 and December 31, 2021, the
Company’s financial instruments carried at fair value on a
recurring basis consists of money market funds, which are included
in cash and cash equivalents. Other financial instruments are
recorded at carrying amounts that approximate their fair value due
to their short-term nature.
Comprehensive Loss
Comprehensive loss includes net loss and other comprehensive income
(loss) for the period. Other comprehensive income (loss) represents
unrealized gains on investments and amounts recognized for net
realized gain included in net loss.
Commitments and Contingencies
Liabilities for loss contingencies arising from claims,
assessments, litigation, fines, penalties and other sources are
recorded if and when it is probable that a liability has been
incurred and the amount can be reasonably estimated. Legal costs
incurred in connection with loss contingencies are expensed as
incurred.
12
Table of Contents
Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the
FASB or other standard setting bodies and adopted by the Company as
of the specified effective date. Unless otherwise discussed, the
impact of recently issued standards that are not yet effective may
not have a material impact on the Company’s financial position or
results of operations upon adoption.
Recently Adopted Accounting Pronouncements
In February 2016, the FASB issued Accounting Standards Update (ASU)
2016-02, Leases
(Topic 842) that requires a
lessee to recognize leases of greater than 12 months on the balance
sheet and disclose key information about leasing arrangements.
The Company adopted the new standard on January 1, 2021 using the
modified retrospective approach. The Company has elected to apply
the transition method that allows companies to continue applying
the guidance under the lease standard in effect at that time in the
comparative periods presented in the condensed financial statements
and recognize a cumulative-effect adjustment to the opening balance
of accumulated deficit on the date of adoption. The Company has
lease agreements that contain both lease components (for example
fixed rent payments) and non-lease components (for example,
common-area maintenance costs), and has elected to combine lease
and non-lease components for all classes of assets. The Company
also elected the “package of practical expedients”, which permits
the Company not to reassess under the new standard its prior
conclusions about lease identification, lease classification and
initial direct costs. Lastly, the Company elected a practical
expedient to use hindsight in determining the lease term for all
its leases.
Results for reporting periods beginning after January 1, 2021 are
presented under the new standard, while prior period amounts have
not been adjusted and continue to be reported under the accounting
standards in effect for the prior period. Upon adoption of the new
lease standard on January 1, 2021, the Company capitalized
operating lease ROU assets of $6.0 million, with opening
adjustments of $0.5 million related to deferred rent existing as of
the transition date, and $6.5 million of operating lease
liabilities, within the Company’s condensed balance sheets. There
was no impact to the finance lease ROU asset and the finance lease
liabilities upon adoption. In connection with operating and finance
leases, there was no impact to the accumulated deficit upon the
adoption of the new standard on January 1, 2021.
3. Fair Value Measurements
The Company follows guidance provided in ASC 820, Fair Value
Measurement, for valuation of financial assets and financial
liabilities and for nonfinancial items that are recognized or
disclosed at fair value in the financial statements on a recurring
basis. Fair value is defined as the price that would be received to
sell an asset or paid to transfer a liability in an orderly
transaction between market participants at the measurement date.
This guidance also establishes a framework for measuring fair value
and expands disclosures about fair value measurements.
In determining fair value, the Company utilizes valuation
techniques that maximize the use of observable inputs and minimize
the use of unobservable inputs to the extent possible as well as
considers counterparty credit risk in its assessment of fair
value.
The following tables summarize the Company’s financial assets
measured at fair value on a recurring basis by level within the
fair value hierarchy (in thousands):
|
|
|
|
September 30, 2022
|
|
|
|
Fair Value
|
|
|
|
|
|
Gross
|
|
|
Gross
|
|
|
|
|
|
|
|
Hierarchy
Level
|
|
Amortized
Cost
|
|
|
Unrealized
Gains
|
|
|
Unrealized
Losses
|
|
|
Fair Value
|
|
Cash equivalents:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds invested in U.S. government
obligations(1)
|
|
Level 1
|
|
$
|
75,242
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
75,242
|
|
Total
|
|
|
|
$
|
75,242
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
75,242
|
|
|
(1)
|
Included in cash and
cash equivalents on the condensed balance sheets
|
13
Table of Contents
|
|
|
|
December 31, 2021
|
|
|
|
Fair Value
|
|
|
|
|
|
Gross
|
|
|
Gross
|
|
|
|
|
|
|
|
Hierarchy
Level
|
|
Amortized
Cost
|
|
|
Unrealized
Gains
|
|
|
Unrealized
Losses
|
|
|
Fair Value
|
|
Cash equivalents:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds invested in U.S. government
obligations(1)
|
|
Level 1
|
|
$
|
159,010
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
159,010
|
|
Total
|
|
|
|
$
|
159,010
|
|