10-Q
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 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 March 31, 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: 001-41331

 

AN2 Therapeutics, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

82-0606654

( State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer
Identification No.)


1800 El Camino Real, Suite D

Menlo Park, California

94027

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (650) 331-9090

 

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

 

ANTX

 

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, 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 May 6, 2022, the registrant had 19,402,658 shares of common stock, $0.00001 par value per share, outstanding.

 

 

 

 


 

Table of Contents

 

 

 

Page

 

 

Special Note Regarding Forward Looking Statements

1

 

 

 

PART I.

FINANCIAL INFORMATION

 

 

 

 

Item 1.

Financial Statements (Unaudited)

3

 

Condensed Balance Sheets

3

 

Condensed Statements of Operations and Comprehensive Loss

4

 

Condensed Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)

5

 

Condensed Statements of Cash Flows

7

 

Notes to Unaudited Condensed Financial Statements

8

Item 2.

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

24

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

34

Item 4.

Controls and Procedures

35

 

 

 

PART II.

OTHER INFORMATION

37

 

 

 

Item 1.

Legal Proceedings

37

Item 1A.

Risk Factors

37

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

84

Item 3.

Defaults Upon Senior Securities

85

Item 4.

Mine Safety Disclosures

85

Item 5.

Other Information

85

Item 6.

Exhibits

86

Signatures

87

 

i


 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q (“Form 10-Q”), including statements regarding our future results of operations and financial position, business strategy, product candidates, planned preclinical and nonclinical studies and clinical trials, results of preclinical and nonclinical studies, clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. These statements involve known and unknown risks, uncertainties, and other important factors that are in some cases beyond our control and 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.

In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “believe,” “estimate,” “predict,” “potential,” or “continue,” or the negative of these terms or other similar expressions. Forward-looking statements contained in this Form 10-Q include, but are not limited to, statements about:

our use of the net proceeds from the initial public offering (“IPO”);
the initiation, timing, progress, and results of our preclinical and nonclinical studies and clinical trials, and our research and development programs, including the manufacture of clinical trial material and drug product for launch;
the ability of our planned Phase 2/3 pivotal clinical trial in MAC lung disease to be sufficient for regulatory approval in the United States;
our ability to retain the continued service of our key professionals and to identify, hire, and retain additional qualified professionals;
our ability to advance product candidates into, and successfully complete, clinical trials;
the timing of and our ability to obtain and maintain regulatory approvals for our product candidates;
the commercialization of our product candidates, if approved;
the ability of epetraborole, if approved, to successfully compete with other therapies, including therapies currently in development;
the pricing, coverage, and reimbursement of our product candidates, if approved;
the implementation of our business model, strategic plans for our business, and product candidates;
the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates;
our ability to identify additional product candidates and advance them into clinical development;
our estimates regarding expenses, capital requirements, and needs for additional financing;
our financial performance; and
developments relating to our competitors and our industry.

 

 

1

 

 


 

We have based these forward-looking statements largely on our current expectations and projections about our business, the industry in which we operate and financial trends that we believe may affect our business, financial condition, results of operations, and prospects and these forward-looking statements are not guarantees of future performance or development. These forward-looking statements speak only as of the date of this Form 10-Q and are subject to a number of risks, uncertainties, and assumptions described in the section titled “Risk Factors” and elsewhere in this Form 10-Q. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein until after we distribute this Form 10-Q, whether as a result of any new information, future events, or otherwise.

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Form 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and you are cautioned not to unduly rely upon these statements.

 

 

2

 

 


 

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

AN2 THERAPEUTICS, INC.

CONDENSED BALANCE SHEETS

(in thousands, except share and per share amounts)

(unaudited)

 

 

 

March 31,
2022

 

 

December 31,
2021

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

82,519

 

 

$

12,097

 

Short-term investments

 

 

35,835

 

 

 

46,458

 

Prepaid expenses and other current assets

 

 

1,397

 

 

 

1,551

 

Right-of-use asset, net

 

 

32

 

 

 

 

Total current assets

 

 

119,783

 

 

 

60,106

 

Deferred offering costs

 

 

 

 

 

1,724

 

Long-term investments

 

 

 

 

 

3,486

 

Other assets, long-term

 

 

720

 

 

 

 

Total assets

 

$

120,503

 

 

$

65,316

 

Liabilities, redeemable convertible preferred stock, and stockholders’
   equity (deficit)

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

Accounts payable

 

$

2,609

 

 

$

1,063

 

Accrued compensation

 

 

335

 

 

 

916

 

Accrued liabilities

 

 

2,101

 

 

 

1,399

 

Operating lease liabilities, short-term

 

 

32

 

 

 

 

Options subject to repurchase, short-term

 

 

10

 

 

 

17

 

Total current liabilities

 

 

5,087

 

 

 

3,395

 

Options subject to repurchase, long-term

 

 

6

 

 

 

13

 

Total liabilities

 

 

5,093

 

 

 

3,408

 

Commitments and contingencies (Note 6)

 

 

 

 

 

 

Redeemable convertible preferred stock: $0.00001 par value; 10,000,000 and
   
11,409,536 shares authorized at March 31, 2022 and December 31,
    2021, respectively,
0 and 11,409,488 shares issued and outstanding at
    March 31, 2022 and December 31, 2021; aggregate liquidation preference
    $
0 and $103,064 at March 31, 2022 and December 31, 2021, respectively

 

 

 

 

 

109,319

 

Stockholders’ equity (deficit):

 

 

 

 

 

 

Common stock, $0.00001 par value; 500,000,000 and 17,166,642 shares authorized at March 31, 2022 and December 31, 2021, respectively; 18,712,658 and 2,730,298 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively

 

 

 

 

 

 

Additional paid-in capital

 

 

171,990

 

 

 

 

Accumulated other comprehensive loss

 

 

(158

)

 

 

(27

)

Accumulated deficit

 

 

(56,422

)

 

 

(47,384

)

Total stockholders’ equity (deficit)

 

 

115,410

 

 

 

(47,411

)

Total liabilities, redeemable convertible preferred stock, and stockholders’
   equity (deficit)

 

$

120,503

 

 

$

65,316

 

 

The accompanying notes are an integral part of these unaudited interim condensed financial statements.

 

 

3

 

 


 

AN2 THERAPEUTICS, INC.

CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(in thousands, except share and per share amounts)

(unaudited)

 

 

 

Three Months Ended March 31,

 

 

 

2022

 

 

2021

 

Operating expenses:

 

 

 

 

 

 

Research and development

 

$

5,633

 

 

$

1,649

 

General and administrative

 

 

2,050

 

 

 

401

 

Total operating expenses

 

 

7,683

 

 

 

2,050

 

Loss from operations

 

 

(7,683

)

 

 

(2,050

)

Interest income

 

 

27

 

 

 

2

 

Other income (expense)

 

 

1

 

 

 

 

Net loss

 

 

(7,655

)

 

 

(2,048

)

Accretion to redemption value and cumulative dividends on preferred stock

 

 

(1,820

)

 

 

(761

)

Net loss attributable to common stockholders

 

$

(9,475

)

 

$

(2,809

)

Net loss per share attributable to common stockholders, basic and diluted

 

$

(2.98

)

 

$

(1.07

)

Weighted-average number of shares used in computing net loss per
   share, basic and diluted

 

 

3,180,717

 

 

 

2,620,670

 

Other comprehensive loss:

 

 

 

 

 

 

Unrealized loss on investments

 

 

(131

)

 

 

 

Comprehensive loss

 

$

(7,786

)

 

$

(2,048

)

 

The accompanying notes are an integral part of these unaudited interim condensed financial statements.

 

 

4

 

 


 

AN2 THERAPEUTICS, INC.

CONDENSED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)

(in thousands, except share and per share amounts)

(unaudited)

 

 

 

Redeemable
Convertible
Preferred Stock

 

 

 

Common Stock

 

 

Additional
Paid-In

 

 

Accumulated
Other
Comprehensive

 

 

Accumulated

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Equity (Deficit)

 

Balances at December 31, 2021

 

 

11,409,488

 

 

$

109,319

 

 

 

 

2,730,298

 

 

$

 

 

$

 

 

$

(27

)

 

$

(47,384

)

 

$

(47,411

)

Accretion to redemption value and cumulative
   dividends on preferred stock

 

 

 

 

 

1,820

 

 

 

 

 

 

 

 

 

 

(437

)

 

 

 

 

 

(1,383

)

 

 

(1,820

)

Conversion of convertible preferred stock into common stock

 

 

(11,409,488

)

 

 

(111,139

)

 

 

 

11,409,488

 

 

 

 

 

 

111,139

 

 

 

 

 

 

 

 

 

111,139

 

Issuance of common stock upon initial public offering, net of underwriters' commission and offering costs of $8.1 million

 

 

 

 

 

 

 

 

 

4,600,000

 

 

 

 

 

 

60,836

 

 

 

 

 

 

 

 

 

60,836

 

Vesting of early exercised stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

14

 

 

 

 

 

 

 

 

 

14

 

Repurchase of early exercised stock options

 

 

 

 

 

 

 

 

 

(27,128

)

 

 

 

 

 

(11

)

 

 

 

 

 

 

 

 

(11

)

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

449

 

 

 

 

 

 

 

 

 

449

 

Unrealized gain (loss) on available-for-sale investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(131

)

 

 

 

 

 

(131

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(7,655

)

 

 

(7,655

)

Balances at March 31, 2022

 

 

 

 

$

 

 

 

 

18,712,658

 

 

$

 

 

$

171,990

 

 

$

(158

)

 

$

(56,422

)

 

$

115,410

 

 

The accompanying notes are an integral part of these unaudited interim condensed financial statements.

 

 

5

 

 


 

AN2 THERAPEUTICS, INC.

CONDENSED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ Equity (DEFICIT)

(in thousands, except share and per share amounts)

(unaudited)

 

 

 

Redeemable
Convertible
Preferred Stock

 

 

 

Common Stock

 

 

Additional
Paid-In

 

 

Accumulated
Other
Comprehensive

 

 

Accumulated

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Equity (Deficit)

 

Balance at December 31, 2020

 

 

6,076,196

 

 

$

23,070

 

 

 

 

2,707,468

 

 

$

 

 

$

 

 

$

 

 

$

(20,319

)

 

$

(20,319

)

Issuance of Series B redeemable convertible
   preferred stock at $
15 per share for cash,
   net of issuance costs of $
266

 

 

5,333,292

 

 

 

79,734

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock upon the exercise
   of stock options

 

 

 

 

 

 

 

 

 

22,830

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vesting of early exercised stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6

 

 

 

 

 

 

 

 

 

6

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

8

 

 

 

 

 

 

 

 

 

8

 

Accretion to redemption value and cumulative
   dividends on preferred stock

 

 

 

 

 

761

 

 

 

 

 

 

 

 

 

 

(14

)

 

 

 

 

 

(747

)

 

 

(761

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(2,048

)

 

 

(2,048

)

Balances at March 31, 2021

 

 

11,409,488

 

 

$

103,565

 

 

 

 

2,730,298

 

 

$

 

 

$

 

 

$

 

 

$

(23,114

)

 

$

(23,114

)

 

The accompanying notes are an integral part of these unaudited interim condensed financial statements.

 

 

6

 

 


 

AN2 THERAPEUTICS, INC.

CONDENSED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)

 

 

 

Three Months Ended
March 31,

 

 

 

2022

 

 

2021

 

Cash flows used in operating activities

 

 

 

 

 

 

Net loss

 

$

(7,655

)

 

$

(2,048

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Stock-based compensation expense

 

 

449

 

 

 

8

 

Non-cash operating lease expense

 

 

18

 

 

 

 

Amortization of net investment premium

 

 

1

 

 

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

(Increase) decrease in prepaid expenses and other assets

 

 

(566

)

 

 

102

 

Increase in accounts payable

 

 

1,546

 

 

 

379

 

Decrease in accrued compensation

 

 

(581

)

 

 

(316

)

Increase in accrued liabilities

 

 

64

 

 

 

332

 

Decrease in operating lease liabilities

 

 

(18

)

 

 

 

Net cash used in operating activities

 

 

(6,742

)

 

 

(1,543

)

Cash flows from investing activities

 

 

 

 

 

 

Purchase of investments

 

 

(998

)

 

 

 

Proceeds upon maturities of investments

 

 

14,975

 

 

 

 

Net cash provided by investing activities

 

 

13,977

 

 

 

 

Cash flows from financing activities

 

 

 

 

 

 

Proceeds from issuance of redeemable convertible preferred stock, net of
   issuance costs

 

 

 

 

 

79,734

 

Proceeds from exercise of stock options

 

 

 

 

 

10

 

Repurchase of early exercised stock options

 

 

(11

)

 

 

 

Proceeds from issuance of common stock from the initial public offering, net of underwriting discounts, commissions and offering expenses

 

 

63,198

 

 

 

 

Net cash provided by financing activities

 

 

63,187

 

 

 

79,744

 

Net increase in cash and cash equivalents

 

 

70,422

 

 

 

78,201

 

Cash and cash equivalents at the beginning of the period

 

 

12,097

 

 

 

4,070

 

Cash and cash equivalents at the end of the period

 

$

82,519

 

 

$

82,271

 

Supplemental disclosure of noncash financing items

 

 

 

 

 

 

Conversion of redeemable convertible preferred stock into common stock

 

$

111,139

 

 

$

 

Accretion to redemption value and cumulative dividends on preferred stock

 

 

1,820

 

 

 

761

 

Issuance costs for initial public offering included in accounts payable and accrued liabilities

 

 

1,151

 

 

 

 

 

The accompanying notes are an integral part of these unaudited interim condensed financial statements.

 

 

7

 

 


 

AN2 Therapeutics, Inc.

Notes to Unaudited Condensed Financial Statements

Note 1. Organization and Description of the Business

Description of Business

AN2 Therapeutics, Inc. (the “Company”) is a clinical-stage biopharmaceutical company focused on developing treatments for rare, chronic, and serious infectious diseases with high unmet needs. The Company’s initial product candidate, epetraborole, is under development as a once-daily, oral treatment for patients with non-tuberculous mycobacterial (NTM) lung disease with an initial focus on treatment-refractory Mycobacterium avium complex (MAC) lung disease. The Company was incorporated in the state of Delaware in February 2017, began operations in November 2019, began trading on the Nasdaq Global Select Market on March 25, 2022 under the symbol “ANTX”, and is based in Menlo Park, California.

Since launching operations in November 2019, the Company has devoted substantially all of its resources to performing research and development activities, including with respect to its initial product candidate, epetraborole, business planning, hiring personnel, raising capital and providing general and administrative support for these operations.

Initial Public Offering

On March 24, 2022, the Company’s registration statement on Form S-1 (File No. 333-263295) relating to its initial public offering (“IPO”) of common stock became effective. The IPO closed on March 29, 2022, at which time the Company issued an aggregate of 4,600,000 shares of its common stock at a price to the public of $15.00 per share. In addition, immediately prior to the closing of the IPO, all outstanding shares of the Company’s redeemable convertible preferred stock automatically converted into 11,409,488 shares of common stock. The aggregate offering proceeds for shares sold in the IPO was $69.0 million. After deducting underwriting discounts and commissions of $4.8 million and offering costs paid or payable by the Company of $3.3 million, the net proceeds from the offering were approximately $60.9 million.

Note 2. Basis of Presentation and Summary of Significant Accounting Policies

Basis of Presentation

The Company’s financial statements have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”).

Unaudited Interim Condensed Financial Information

The accompanying condensed balance sheets as of March 31, 2022, the condensed statements of operations and comprehensive loss, the condensed statements of redeemable convertible preferred stock and stockholders’ equity (deficit) and condensed statements of cash flows for the three months ended March 31, 2022 and 2021 are unaudited. The unaudited interim condensed financial statements have been prepared on the same basis as the audited annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of March 31, 2022 and the results of its operations and its cash flows for the three months ended March 31, 2022 and 2021. The financial data and other information disclosed in these notes related to the three months ended March 31, 2022 and 2021 are also unaudited. The results for the three months ended March 31, 2022 are not necessarily indicative of results to be expected for the year ending December 31, 2022, any other interim periods, or any future year or period. The balance sheet as of December 31, 2021 included herein was derived from the audited financial statements as of that date. Certain disclosures have been condensed or omitted from the interim condensed financial statements. These unaudited interim condensed financial

 

 

8

 

 


 

statements should be read in conjunction with the Company’s audited financial statements included in the prospectus filed with the U.S. Securities and Exchange Commission (“SEC”), dated March 24, 2022.

Risks and Uncertainties

Liquidity

Prior to the Company’s IPO in March 2022, the Company’s operations have historically been financed through the issuance of redeemable convertible preferred stock. Since inception, the Company has incurred significant losses and negative net cash flows from operations. During the three months ended March 31, 2022 and 2021, the Company incurred a net loss of $7.7 million and $2.0 million, respectively and had cash flows used in operating activities of $6.7 million and $1.5 million, respectively. The Company has an accumulated deficit as of March 31, 2022 and December 31, 2021 of $56.4 million and $47.4 million, respectively, and will require substantial additional capital for research and development activities. The Company anticipates incurring additional losses until such time, if ever, that it can generate significant sales of its product candidate currently in development.

As of March 31, 2022, the Company had cash, cash equivalents and investments of $118.4 million. Management believes that its cash, cash equivalents and investments as of March 31, 2022 will be sufficient to fund its current operating plan through at least 12 months from the issuance date of these condensed financial statements. Future capital requirements will depend on many factors, including the timing and extent of spending on research and development, including costs for preclinical and nonclinical studies, clinical trials and clinical trial material manufacturing. There can be no assurance that, in the event the Company requires additional financing, such financing will be available at terms acceptable to the Company if at all. Failure to generate sufficient cash flows from operations, raise additional capital, and reduce discretionary spending should additional capital not become available could have a material adverse effect on the Company’s ability to achieve its intended business objectives.

Other Risks and Uncertainties

The Company is subject to a number of risks similar to those of other clinical-stage biopharmaceutical companies, including, but not limited to: dependence on key individuals, the need to develop commercially viable therapeutics, competition from other companies, many of which are larger and better capitalized, protection of intellectual property rights, litigation or claims against the Company based on intellectual property rights, regulatory clearance, market acceptance of the Company’s products and the need to obtain adequate additional financing to fund the development of its products.

In March 2020, the World Health Organization declared the global novel coronavirus disease (“COVID-19”) outbreak a pandemic. To date, the Company’s business has not been materially impacted by the COVID-19 pandemic. However, the Company has experienced certain slowing of its preclinical and clinical trials and cannot at this time predict the specific extent, duration, or full impact that the COVID-19 pandemic will have on its financial condition and operations, including ongoing and planned preclinical and nonclinical studies, clinical trials and clinical trial material manufacturing. The impact of the COVID-19 pandemic on the financial performance of the Company will depend on future developments, including the duration and spread of the outbreak and related governmental advisories and restrictions. These developments and the impact of COVID-19 on the financial markets and the overall economy are highly uncertain. If the financial markets and/or the overall economy are impacted for an extended period, the Company’s results may be adversely affected.

In February 2022, Russia commenced a military invasion of Ukraine. The ongoing geopolitical turmoil and continuing military action in the region, together with widening sanctions imposed on Russia, have caused disruptions in the global economy, related to trade and shipping, and increased costs of transportation, as well as potentially affecting the availability of European clinical sites. The duration and impact of the conflict between Russia and Ukraine is highly unpredictable and the extent to which the conflict may impact certain of the Company's clinical development and regulatory efforts remains uncertain. While the Company does not currently conduct any trials in Russia or Ukraine that are impacted by the present conflict, any disruptions or increased costs related to the shipping of supplies and drug

 

 

9

 

 


 

necessary to conduct the Company's trials, as well as the continued availability of European clinical sites, could negatively impact the Company's liquidity and cash flows.

Segments

The Company operates and manages its business as one reportable and operating segment. The Company’s chief executive officer, who is the chief operating decision maker, reviews financial information on a company-wide basis for purposes of allocating resources and assessing financial performance.

Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and judgments that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities as of the date of the financial statements and the reported amounts of expenses during the reporting period. On an ongoing basis, management evaluates its estimates, including those related to research and development accruals, fair value of assets and liabilities and stock-based compensation. Management bases its estimates on historical experience and on various other market-specific and relevant assumptions that management believes to be reasonable under the circumstances. Actual results could differ from those estimates.

Stock Split

On March 17, 2022, the Board of Directors and stockholders approved, and, on March 18, 2022, the Company filed, an amended and restated certificate of incorporation effecting a 2.352936-for-1 forward stock split of common stock and all redeemable convertible preferred stock. The par value of the common and redeemable convertible preferred stock was not adjusted as a result of the stock split. All authorized, issued and outstanding common stock, redeemable convertible preferred stock, stock options and per share amounts contained in the financial statements have been retroactively adjusted to reflect this stock split for all periods presented.

Deferred Offering Costs

The Company capitalizes certain legal, accounting and other third-party fees that are directly related to the Company’s equity financings, including its IPO, until such financings are consummated. After consummation of the equity financing, these costs are recorded as a reduction of the proceeds received as a result of the financing. The Company capitalized certain legal, accounting and other third-party fees that were directly related to the Company’s IPO. After the completion of the IPO in March 2022, the total deferred offering costs of $3.3 million were offset against the proceeds from the IPO and reclassified to additional paid-in capital in the accompanying condensed balance sheets. At December 31, 2021, deferred offering costs totaling $1.7 million were included as non-current assets in the accompanying balance sheet.

Research and Development Expenses

All research and development costs, including work performed by third parties, are expensed as incurred. Research and development costs consist of salaries and other personnel-related expenses, including associated stock-based compensation, consulting fees, and facility costs, as well as fees paid to other entities that conduct certain research and development activities on behalf of the Company. Payments made prior to the receipt of goods or services to be used in research and development are capitalized until the goods are received or services are rendered.

As part of the process of preparing its financial statements, the Company estimates its accrued expenses. This process involves reviewing quotations and contracts, identifying services that have been performed on the Company’s behalf and estimating the level of services performed and the associated cost incurred for services for which the Company has not yet been invoiced or otherwise notified of the actual cost. The majority of the Company’s service providers invoice monthly in arrears for services performed or when contractual milestones are met. The Company makes estimates of its accrued expenses at the end of each reporting period based on the facts and circumstances known to the Company at that time. The significant estimates in the Company’s accrued research and development expenses relate to expenses

 

 

10

 

 


 

incurred with respect to contract manufacturing and research organizations, academic research centers and other vendors in connection with research and development activities for which the Company has not yet been invoiced.

Redeemable Convertible Preferred Stock

The Company recorded the redeemable convertible preferred stock at fair value on the dates of issuance, net of issuance costs. The carrying value of the redeemable convertible preferred stock was accreted to its redemption value. Immediately prior to the closing of the IPO, all outstanding shares of the Company’s redeemable convertible preferred stock were converted into shares of common stock and the related carrying value was reclassified to common stock and additional paid-in capital. There were no shares of redeemable convertible preferred stock outstanding as of March 31, 2022.

Stock-Based Compensation

The Company measures and recognizes compensation expense for equity-classified stock-based awards made to employees, directors and non-employees based on the grant date estimated fair value of each award. Compensation expense for employee and director awards is recognized on a straight- line basis over the requisite service period which is generally the vesting period for the entire award. Expense is adjusted for forfeitures as they occur. Compensation expense for non-employee awards is recognized in the same period and manner as if the Company had paid cash for the goods or services provided.

The valuation model used for calculating the fair value of stock options for stock compensation expense is the Black-Scholes option-pricing model (the Black-Scholes model). The Black-Scholes model requires management to make assumptions and judgments about the variables used in the calculation, including the expected term, the expected volatility of common stock, an assumed risk-free interest rate, and expected dividends the Company may pay. Management elected to apply the practical expedient for private companies and used the simplified method to determine the awards’ expected term. Volatility is based on an average of the historical volatilities of the common stock of entities with characteristics similar to the Company’s. The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant for periods corresponding with the expected life of the option. The Company uses an assumed dividend yield of zero as the Company has never paid dividends and has no current plans to pay any dividends on its common stock.

For awards that contain performance conditions, compensation cost is recognized in the period in which it becomes probable that the performance condition will be satisfied. The grant date fair value of these awards is equal to the fair value of the underlying shares as determined by the price other investors paid for such shares in recent transactions. For awards that vest upon a liquidity event or a change in control, the performance condition is not probable of being achieved until the event occurs. As a result, no compensation expense would be recognized until the performance-based vesting condition is achieved.

Fair Value of Common Stock

Prior to the Company's IPO, the absence of an active market for the Company’s common stock required the Company’s board of directors to determine the fair value of its common stock for purposes of granting stock options. The fair value of the Company’s common stock was determined by the Company’s board of directors with assistance from management and an independent third-party valuation firm. Management’s approach to estimating the fair value of the Company’s common stock was consistent with the methods outlined in the American Institute of Certified Public Accountants’ Practice Aid, Valuation of Privately-Held- Company Equity Securities Issued as Compensation. Determining the best estimated fair value of the Company’s common stock requires significant judgement and management considers several factors, including the Company’s stage of development, equity market conditions affecting comparable public companies, significant milestones and progress in research and development efforts. Following the completion of its IPO, the Company uses its stock price traded on the Nasdaq Global Select Market to determine its fair value.

Cash and Cash Equivalents

The Company considers all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. Cash equivalents, which consist of money market funds, corporate debt securities and corporate

 

 

11

 

 


 

commercial paper, are stated at fair value. As of March 31, 2022 and December 31, 2021, the Company had cash equivalents of $82.5 million and $12.1 million, respectively.

Investments

Investments consist of U.S. Treasuries, asset-backed securities, corporate debt securities and corporate commercial paper. All of the Company’s investments are classified as available-for-sale and are carried at estimated fair values and reported in cash equivalents, short-term investments or long- term investments. Management determines the appropriate classification of the investments at the time they are acquired and evaluates the appropriateness of such classifications at each balance sheet date. Investments with contractual maturities greater than 12 months are considered long-term investments.

Unrealized gains and losses on available-for-sale investments are reported in accumulated other comprehensive gain (loss) as a separate component of stockholders’ equity (deficit). Investments are regularly reviewed for other-than-temporary declines in fair value. The review includes consideration of the cause of impairment, including the creditworthiness of the security issuers, the number of investments in an unrealized loss position, the severity and duration of the unrealized losses, and whether it is more likely than not that the Company will be required to sell the investments before the recovery of their amortized cost basis. The cost of investments sold, if any, is based on the specific identification method. To date, the Company has not recorded any impairment charges on its investments related to other-than-temporary declines in market value. As of March 31, 2022 and December 31, 2021, the Company had investments of $35.8 million and $49.9 million, respectively.

Concentrations of Credit Risk

Financial instruments that potentially subject the Company to concentrations of credit risk consist of cash, cash equivalents and investments. The Company’s cash is invested through financial institutions in the United States. The Company’s investments consist of debt securities, issued by highly rated corporate entities or the U.S. government, and asset-backed securities. The Company’s exposure to any individual corporate entity is limited by its investment policy. Deposits may at times, exceed federally insured limits, but minimal credit risk exists. The Company invests its cash equivalents in highly rated money market funds. The Company has not experienced any credit losses in such accounts and does not believe it is exposed to any significant credit risk on these funds.

The Company is exposed to credit risk in the event of a default by the financial institution holding its cash to the extent recorded on the condensed balance sheets. Through March 31, 2022, the Company has no off-balance sheet concentrations of credit risk.

Comprehensive Loss

Comprehensive loss includes net loss and certain changes in stockholders’ equity (deficit) that are excluded from net loss. The Company’s other comprehensive loss consists of net changes in unrealized gains and losses on its available-for-sale investments. For the three months ended March 31, 2022 the Company had $0.1 million of net unrealized loss on available-for-sale investments, and no net unrealized gain or loss on available-for-sale investments for the three months ending March 31, 2021.

Net Loss Per Share

Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common stock and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, redeemable convertible preferred stock, stock options, common stock subject to repurchase related to unvested early exercise of stock options are considered to be potentially dilutive securities. Basic and diluted net loss attributable to common stockholders per share is presented in conformity with the two-class method required for participating securities as the redeemable convertible preferred stock is considered a participating security because it participates in dividends with common stock. The Company also considers the shares issued upon the early exercise of stock options subject to

 

 

12

 

 


 

repurchase to be participating securities because holders of such shares have non-forfeitable dividend rights in the event a dividend is paid on common stock. The holders of all series of redeemable convertible preferred stock and the holders of early exercised shares subject to repurchase do not have a contractual obligation to share in the Company’s losses. As such, the net loss was attributed entirely to common stockholders. Because the Company has reported a net loss for all periods presented, diluted net loss per share is the same as basic net loss per share for those periods because the impact of potentially dilutive securities would be anti-dilutive.

JOBS Act Accounting Election

The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. The Company has elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date the Company (i) is no longer an emerging growth company or (ii) affirmatively and irrevocably opts out of the extended transition period provided in the JOBS Act. As a result, these financial statements may not be comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates.

Recently Adopted Accounting Pronouncements

In July 2018, the FASB issued ASU No. 2018-11, Leases (Topic 842): Targeted Improvements (“ASU 2018-11”). ASU 2018-11 provided an alternative method in addition to the modified retrospective transition method for ASU No. 2016-02, Leases: Amendments to the FASB Accounting Standards Codification (“ASU 2016-02”), issued in February 2016. Under ASU 2018-11, an entity may elect to initially apply the new lease standard at the adoption date and recognize a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption. Under ASU 2016-02, a lease is required to recognize assets and liabilities with lease terms of more than twelve months. ASU 2016-02 is effective for nonpublic business entities and public entities eligible to be Smaller Reporting Companies for fiscal years beginning after December 15, 2021.

The Company adopted the new standard on January 1, 2022 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 elected to combine lease components (for example fixed rent payments) with non-lease components (for example, common-area maintenance costs) on its facility and CRO embedded lease asset classes. The Company also elected the “package of practical expedients”, which permits the Company not to reassess under the new standard the Company’s prior conclusions about lease identification, lease classification and initial direct costs. The Company also elected the short-term lease practical expedients allowed under the standard. Lastly, the Company did not elect the practical expedient allowing the use-of-hindsight which would require the Company to reassess the lease term of its leases based on all facts and circumstances through the effective date.

Results for reporting period beginning after January 1, 2022 are presented under the new standard, while prior period amounts are not 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, 2022, the Company capitalized operating lease right-of-use (ROU) assets of $0.05 million and $0.05 million of operating lease liabilities, within the condensed balance sheets upon adoption.

Recent Accounting Pronouncements Not Yet Adopted

Since the Company's IPO, it has been the Company’s intention to take advantage of certain temporary exemptions from various reporting requirements and the Company is taking advantage of additional transitional relief available to emerging growth companies. The Company may take advantage of these provisions for up to five years (which should be through March 2027), unless the Company ceases to be an emerging growth company at an earlier date.

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326) Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), which requires an entity to utilize a new impairment model

 

 

13

 

 


 

known as the current expected credit loss (“CECL”) model to estimate its lifetime “expected credit loss” and record an allowance that, when deducted from the amortized cost basis of the financial assets and certain other instruments, including but not limited to available-for-sale debt securities. Credit losses relating to available-for-sale debt securities will be recorded through an allowance for credit losses rather than as a direct write-down to the security. ASU 2016-13 requires a cumulative effect adjustment to the balance sheet as of the beginning of the first reporting period in which the guidance is effective. In November 2019, the FASB issued ASU 2019-10, Financial Instruments—Credit Losses (Topic 326), Derivatives and Hedging (Topic 815) and Leases (Topic 842): Effective Dates, which defers the effective date of ASU 2016-13 to fiscal years beginning after December 15, 2022 for SEC reporting companies that are smaller reporting companies such as the Company. The Company is currently evaluating the impact of the adoption of ASU 2016-13 on its financial statements, and will consider the extended transition period available to “emerging growth" companies.

Note 3. Fair Value Measurements

The Company records its financial assets and liabilities at fair value. The accounting guidance for fair value provides a framework for measuring fair value, clarifies the definition of fair value, and expands disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows:

Level 1: Inputs which include quoted prices in active markets for identical assets and liabilities.
Level 2: Inputs other than Level I 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.
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.

The Company’s primary financial instruments include cash, cash equivalents, short- and long-term investments, prepaid expenses, accounts payable, and accrued liabilities. The carrying amounts of the Company’s financial instruments, other than cash equivalents, short- and long-term investments, approximate fair value due to their relatively short maturities.

The following table presents the Company’s financial assets, which consist of cash equivalents and investments classified as available-for-sale investments, that are measured at fair value on a recurring basis (in thousands):

 

 

March 31, 2022

 

 

 

Level

 

Amortized Cost

 

 

Unrealized Gain

 

 

Unrealized Loss

 

 

Estimated Fair Value

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

Level 1

 

$

67,572

 

 

$

 

 

$

 

 

$

67,572

 

Commercial paper

 

Level 2

 

 

5,493

 

 

 

 

 

 

(1

)

 

 

5,492

 

Short-term investments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

U.S. treasury securities

 

Level 1

 

 

7,995

 

 

 

 

 

 

(79

)

 

 

7,916

 

Commercial paper

 

Level 2

 

 

24,980

 

 

 

 

 

 

(65

)

 

 

24,915

 

Asset-backed securities

 

Level 2

 

 

3,019

 

 

 

 

 

 

(13

)

 

 

3,006

 

Total

 

 

 

$

109,059

 

 

$

 

 

$

(158

)

 

$

108,901

 

 

 

 

14

 

 


 

 

 

December 31, 2021

 

 

 

Level

 

Amortized Cost

 

 

Unrealized Gain

 

 

Unrealized Loss

 

 

Estimated Fair Value

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

Level 1

 

$

3,567

 

 

$

 

 

$

 

 

$

3,567

 

Commercial paper

 

Level 2

 

 

2,999

 

 

 

 

 

 

 

 

 

2,999

 

Corporate debt securities

 

Level 2

 

 

1,501

 

 

 

 

 

 

 

 

 

1,501

 

Short-term investments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

U.S. treasury securities