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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

 

 

 

 

Page

PART I.

FINANCIAL INFORMATION

 

Item 1.

Condensed Financial Statements (Unaudited)

2

 

Condensed Balance Sheets

2

 

Condensed Statements of Operations and Comprehensive Loss

3

 

Condensed Statements of Stockholders’ Equity

4

 

Condensed Statements of Cash Flows

6

 

Notes to Condensed Financial Statements (Unaudited)

7

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

21

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

30

Item 4.

Controls and Procedures

30

 

 

 

PART II.

OTHER INFORMATION

 

Item 1.

Legal Proceedings

31

Item 1A.

Risk Factors

31

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

81

Item 3.

Defaults Upon Senior Securities

82

Item 4.

Mine Safety Disclosures

82

Item 5.

Other Information

82

Item 6.

Exhibits

83

Signatures

84

 

 

 


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.

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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.

 

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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.

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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.

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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.  

 

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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.

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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

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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.

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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.

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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

 

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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