Table of Contents

33

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 September 30, 2020

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 No. 001-38944


Akero Therapeutics, Inc.

(Exact name of registrant as specified in its charter)


Delaware

    

81-5266573

(State or other jurisdiction of
incorporation or organization)

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

601 Gateway Boulevard, Suite 350

South San Francisco, CA 94080

(650) 487-6488


(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

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

AKRO

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 and post 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 November 6, 2020, the registrant had 34,721,845 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 Consolidated Financial Statements

6

Condensed Consolidated Balance Sheets (Unaudited)

6

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)

7

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

8

Condensed Consolidated Statements of Cash Flows (Unaudited)

9

Notes to Unaudited Condensed Consolidated Financial Statements

10

Item 2.

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

27

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

36

Item 4.

Controls and Procedures

36

PART II.

OTHER INFORMATION

Item 1.

Legal Proceedings

37

Item 1A.

Risk Factors

37

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

83

Item 3.

Defaults Upon Senior Securities

83

Item 4.

Mine Safety Disclosures

83

Item 5.

Other Information

83

Item 6.

Exhibits

84

Signatures

85

2


Table of Contents

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. All statements, other than statements of historical facts, contained in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans and objectives of management and expected market growth are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

These forward-looking statements include, among other things, statements about:

the success, cost and timing of our product development activities and clinical trials, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, and our research and development programs;
our ability to complete Cohort C in our ongoing Phase 2a clinical trial of Efruxifermin (“EFX”), formerly known as AKR-001, in NASH patients, known as the BALANCED study, including the ability to obtain data and maintain our expected timelines during the ongoing COVID-19 pandemic;
our ability to submit information to regulatory authorities that supports initiation of our planned Phase 2b clinical trial of EFX during the ongoing COVID-19 pandemic;
our ability to initiate and complete enrollment and collect sufficient data in our planned Phase 2b/3 clinical trial of EFX for the treatment of NASH during the ongoing COVID-19 pandemic;
the potential for COVID-19 or other pandemic, epidemic or outbreak of an infectious disease, including COVID-19, to disrupt our business plans, product development activities, ongoing clinical trials, including the timing and enrollment of patients, the health of our employees and the strength of our supply chain;
our ability to advance any product candidate into or successfully complete any clinical trial;
our ability to successfully manufacture our product candidates for future clinical trials or for commercial use, if approved;
the potential for our identified research priorities to advance our technologies;
our ability to obtain and maintain regulatory approval, if obtained, of EFX or any future product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate;
the ability to license additional intellectual property relating to any future product candidates and to comply with our existing license agreement;
our ability to commercialize our products in light of the intellectual property rights of others;
the success of competing therapies that are or become available;
our ability to obtain funding for our operations, including funding necessary to complete further development and commercialization of our product candidates;
the commercialization of our product candidates, if approved;
our plans to research, develop and commercialize our product candidates;
our ability to attract collaborators with development, regulatory and commercialization expertise;
future agreements with third parties in connection with the commercialization of our product candidates and any other approved product;
the size and growth potential of the markets for our product candidates, and our ability to serve those markets;
the rate and degree of market acceptance of our product candidates;
regulatory developments in the United States and foreign countries;
our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately;
our ability to attract and retain key scientific or management personnel;
the accuracy of our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
the impact of laws and regulations; and

3


Table of Contents

our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates.

We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this Quarterly Report on Form 10-Q, particularly in the “Risk Factors” section, that could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, collaborations, joint ventures or investments that we may make or into which we may enter.

You should read this Quarterly Report on Form 10-Q and the documents that we reference herein and have filed or incorporated by reference as exhibits hereto completely and with the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

NOTE REGARDING TRADEMARKS

Akero Therapeutics, Inc. is the owner of the AKERO trademark, as well as certain other trademarks, including design versions of some of these trademarks.  The symbols ™ and ® are not used in connection with the presentation of these trademarks in this report and their absence does not indicate a lack of trademark rights.  Certain other trademarks used in this report are the property of third-party trademark owners and may be presented with or without trademark references.

All brand names or trademarks appearing in this report are the property of their respective owners. Unless the context requires otherwise, references in this report to “Akero,” the “Company,” “we,” “us” and “our” refer to Akero Therapeutics, Inc. and its subsidiary.

4


Table of Contents

SUMMARY OF THE MATERIAL RISKS ASSOCIATED WITH OUR BUSINESS

Our business is subject to numerous risks and uncertainties, including those described in Part II, Item 1A. “Risk Factors” in this Quarterly Report on Form 10-Q. The principal risks and uncertainties affecting our business include the following:

Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control, including difficulties in identifying patients with NASH and significant competition for recruiting such patients in clinical trials.
We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than us.
Failures or delays in the commencement or completion of, or ambiguous or negative results from, our planned clinical trials of our product candidates could result in increased costs to us and could delay, prevent, or limit our ability to generate revenue and continue our business.
Clinical development is uncertain and our clinical trials for EFX and any future product candidates may experience delays, which would adversely affect our ability to obtain regulatory approvals or commercialize these programs on a timely basis or at all, which would have an adverse effect on our business.
We rely and will continue to rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval of or commercialize any potential product candidates.
The manufacture of our product candidates is complex and we may encounter difficulties in production. If we or any of our third-party manufacturers encounter such difficulties, or fail to meet rigorously enforced regulatory standards, our ability to provide supply of our product candidates for clinical trials or our products for patients, if approved, could be delayed or stopped, or we may be unable to maintain a commercially viable cost structure.
We are heavily dependent on the success of EFX, our only product candidate.
If we fail to develop and successfully commercialize other product candidates, our business and future prospects may be harmed and our business will be more vulnerable to any problems that we encounter in developing and commercializing our product candidate.
We may develop EFX, and potentially future product candidates, in combination with other therapies, which exposes us to additional risks.
If we are not successful in discovering, developing, receiving regulatory approval for and commercializing EFX and any future product candidates, our ability to expand our business and achieve our strategic objectives would be impaired.
We may be required to make significant payments under our license agreement for EFX.
The regulatory approval processes of the FDA and comparable foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable. Our inability to obtain regulatory approval for EFX or any future product candidate would substantially harm our business.
Even if we are able to obtain regulatory approvals for our product candidate or any future product candidates, if they exhibit harmful side effects after approval, our regulatory approvals could be revoked or otherwise negatively impacted, and we could be subject to costly and damaging product liability claims.
Our relationships with customers and third-party payors will be subject to applicable anti-kickback, fraud and abuse, transparency and other healthcare laws and regulations, which, if violated, could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.
We have incurred significant losses since our inception and we expect to incur losses for the foreseeable future.
We currently have a limited operating history, have not generated any revenue to date, and may never become profitable.
We will require additional capital to finance our operations, which may not be available to us on acceptable terms, or at all. As a result, we may not complete the development and commercialization of our product candidate or develop any future product candidates.
Business interruptions resulting from the coronavirus disease (COVID-19) outbreak or similar public health crises could cause a disruption of the development of our product candidates and adversely impact our business.

5


Table of Contents

PART I—FINANCIAL INFORMATION

Item 1. Condensed Consolidated Financial Statements

Akero Therapeutics, Inc.

Condensed Consolidated Balance Sheets

(In thousands, except share and per share amounts)

(Unaudited)

    

September 30, 2020

    

December 31, 2019

Assets

 

  

 

  

Current assets:

  

  

Cash and cash equivalents

$

192,679

$

64,788

Short-term marketable securities

99,191

71,612

Prepaid expenses and other current assets

 

6,163

 

1,649

Total current assets

 

298,033

 

138,049

Property and equipment, net

137

Right of use asset

1,710

Other assets, noncurrent

156

69

Total assets

$

300,036

$

138,118

Liabilities and Stockholders’ Equity

 

 

  

Current liabilities:

 

  

 

  

Accounts payable

$

4,636

$

947

Accrued expenses and other current liabilities

 

7,378

 

8,422

Total current liabilities

 

12,014

 

9,369

Operating lease liability, noncurrent

1,564

Other liabilities, noncurrent

23

Total liabilities

13,578

9,392

Commitments and contingencies (Note 11)

 

  

 

  

Stockholders’ equity:

 

  

 

  

Common stock, $0.0001 par value, 150,000,000 shares authorized as of September 30, 2020 and December 31, 2019; 34,720,675 and 28,567,837 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively

 

4

 

3

Additional paid-in capital

 

466,254

 

259,049

Accumulated other comprehensive gain (loss)

16

(6)

Accumulated deficit

 

(179,816)

 

(130,320)

Total stockholders’ equity

 

286,458

 

128,726

Total liabilities and stockholders’ equity

$

300,036

$

138,118

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

6


Table of Contents

Akero Therapeutics, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share amounts)

(Unaudited)

Three Months Ended September 30, 

Nine Months Ended September 30, 

    

2020

    

2019

    

2020

    

2019

Operating expenses:

 

  

 

  

 

  

 

  

Research and development

$

17,379

$

13,885

$

39,207

$

23,908

General and administrative

 

4,159

 

2,424

 

11,164

 

5,522

Total operating expenses

 

21,538

 

16,309

 

50,371

 

29,430

Loss from operations

 

(21,538)

 

(16,309)

 

(50,371)

 

(29,430)

Other income:

 

  

 

  

 

  

 

  

Interest income

135

755

875

1,286

Total other income

 

135

 

755

 

875

 

1,286

Net loss

 

(21,403)

 

(15,554)

 

(49,496)

 

(28,144)

Net unrealized gain (loss) on short-term marketable securities

(74)

22

Comprehensive loss

$

(21,477)

$

(15,554)

$

(49,474)

$

(28,144)

Net loss per common share, basic and diluted

$

(0.63)

$

(0.56)

$

(1.63)

$

(2.66)

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

 

34,002,769

 

28,024,779

 

30,381,671

 

10,589,119

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

7


Table of Contents

Akero Therapeutics, Inc.

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

(In thousands, except share amounts)

(Unaudited)

Accumulated

Redeemable Convertible Preferred

Additional

Other

Total

Stock

Common Stock

Paid-In-

Comprehensive

Accumulated

Stockholders’

    

Shares

    

Amount

  

  

Shares

    

Amount

    

Capital

    

Gain (Loss)

Deficit

    

Equity (Deficit)

Balances at December 31, 2019

$

28,567,837

$

3

$

259,049

$

(6)

$

(130,320)

$

128,726

Exercise of stock options

103,385

112

112

Vesting of restricted stock

30

30

Stock-based compensation expense

1,238

1,238

Disgorgement of stockholders' short-swing profits, net

52

52

Net unrealized gain on short-term marketable securities

51

51

Net loss

(11,886)

(11,886)

Balances at March 31, 2020

28,671,222

3

260,481

45

(142,206)

118,323

Exercise of stock options

3,202

9

9

Vesting of restricted stock

13

13

Issuance of common stock pursuant to ESPP purchases

9,255

158

158

Stock-based compensation expense

1,322

1,322

Net unrealized gain on short-term marketable securities

45

45

Net loss

(16,207)

(16,207)

Balances at June 30, 2020

28,683,679

3

261,983

90

(158,413)

103,663

Issuance of common stock upon closing of secondary public offering, net of issuance costs and underwriting fees of $906

6,012,390

1

202,553

202,554

Exercise of stock options

24,606

163

163

Vesting of restricted stock

9

9

Stock-based compensation expense

1,546

1,546

Net unrealized loss on short-term marketable securities

(74)

(74)

Net loss

(21,403)

(21,403)

Balances at September 30, 2020

 

$

 

34,720,675

$

4

$

466,254

$

16

$

(179,816)

$

286,458

Balances at December 31, 2018

64,730,410

$

124,728

238,986

$

$

36,646

$

$

(86,565)

$

(49,919)

Stock-based compensation expense

 

 

 

 

 

215

 

 

 

215

Net loss

 

 

 

 

 

 

 

(5,362)

 

(5,362)

Balances at March 31, 2019

64,730,410

124,728

238,986

36,861

(91,927)

(55,066)

Conversion of convertible preferred stock into common stock upon closing of public offering

 

(64,730,410)

 

(124,728)

 

21,056,136

 

2

 

124,726

 

 

 

124,728

Issuance of common stock upon closing of initial public offering, net of issuance costs and underwriting fees of $10,348

 

 

 

6,612,500

 

1

 

95,452

 

 

 

95,453

Issuance of restricted common stock upon early exercise of stock options

487,933

Exercise of stock options

159,824

100

100

Stock-based compensation expense

402

402

Net loss

(7,228)

(7,228)

Balances at June 30, 2019

28,555,379

3

257,541

(99,155)

158,389

Issuance of restricted common stock upon early exercise of stock options

3,274

Vesting of restricted stock

66

66

Stock-based compensation expense

483

483

Net loss

(15,554)

(15,554)

Balances at September 30, 2019

$

28,558,653

$

3

$

258,090

$

$

(114,709)

$

143,384

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


Table of Contents

Akero Therapeutics, Inc.

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

Nine Months Ended September 30, 

    

2020

    

2019

CASH FLOWS FROM OPERATING ACTIVITIES

 

  

 

  

Net loss

$

(49,496)

$

(28,144)

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

 

 

  

Stock-based compensation expense

 

4,106

 

1,100

Depreciation

6

Non-cash lease expense

147

Net amortization of premiums and discounts on short-term investments

(41)

Changes in operating assets and liabilities:

 

 

  

Prepaid expenses and other assets

 

(4,539)

 

(1,097)

Accounts payable

 

3,689

 

(1,280)

Accrued expenses and other current liabilities

 

(1,183)

 

5,443

Other liabilities

(2)

Operating lease liability

(96)

Net cash used in operating activities

 

(47,409)

 

(23,978)

CASH FLOWS FROM INVESTING ACTIVITIES

 

  

 

  

Purchase of short-term marketable securities

 

(106,041)

 

Proceeds from sales of short-term marketable securities

9,864

Proceeds from maturities of short-term marketable securities

 

68,660

 

Purchase of property and equipment

(143)

Net cash used in investing activities

 

(27,660)

 

CASH FLOWS FROM FINANCING ACTIVITIES

 

  

 

  

Proceeds from the issuance of common stock in follow-on public offering, net of issuance costs and underwriting fees

202,554

Proceeds from the issuance of common stock in initial public offering, net of issuance costs and underwriting fees

 

 

95,452

Proceeds from the exercise of stock options

 

284

 

100

Proceeds from the issuance of common stock pursuant to employee stock purchase plan purchases

158

Proceeds from the disgorgement of stockholders' short-swing profits, net

52

Proceeds from the early exercise of stock options in exchange for restricted common stock

 

 

321

Net cash provided by financing activities

 

203,048

 

95,873

Net increase in cash, cash equivalents and restricted cash

 

127,979

 

71,895

Cash, cash equivalents and restricted cash at the beginning of the period

 

64,848

 

76,000

Cash, cash equivalents and restricted cash at the end of the period

$

192,827

$

147,895

SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING INFORMATION:

 

  

 

  

ROU asset obtained in exchange for operating lease liability

$

1,751

$

Net unrealizable gain on marketable securities

$

22

$

Remeasurement of ROU asset and lease liability

$

173

$

Conversion of convertible preferred stock into common stock

$

$

124,728

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

9


Table of Contents

Akero Therapeutics, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

(Amounts in thousands, except share and per share data)

1.           Nature of the business and basis of presentation

Akero Therapeutics, Inc., together with its wholly owned subsidiary Akero Securities Corporation, (“Akero” or the “Company”) is a cardio-metabolic non-alcoholic steatohepatitis (“NASH”) company developing pioneering medicines designed to restore metabolic balance and improve the overall health of patients with NASH. NASH is a severe form of nonalcoholic fatty liver disease (“NAFLD”) characterized by inflammation and fibrosis in the liver that can progress to cirrhosis, liver failure, cancer and death. Our lead product candidate is Efruxifermin (“EFX”), formerly known as AKR-001, an analog of fibroblast growth factor 21 (“FGF21”). We completed the main study portion of a Phase 2a randomized, double-blind, placebo-controlled clinical trial, the BALANCED study, which evaluated EFX in the treatment of adult NASH patients with F1-F3 fibrosis, in the second quarter of 2020. An additional study cohort evaluating EFX in the treatment of patients with compensated cirrhosis is ongoing, with enrollment completed in the third quarter of 2020.

The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, completion and success of clinical testing, development by competitors of new technological innovations, compliance with governmental regulations, dependence on key personnel and protection of proprietary technology and the ability to secure additional capital to fund operations. EFX will require extensive clinical testing prior to regulatory approval and commercialization. These efforts require significant amounts of additional capital, adequate personnel, and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s drug development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.

Basis of presentation

The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and include the accounts of the Company after elimination of all intercompany accounts and transactions. All adjustments necessary for the fair presentation of the Company’s condensed consolidated financial statements for the periods have been reflected.

The Company’s significant accounting policies are disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, dated and filed on March 16, 2020 with the U.S. Securities and Exchange Commission. Since the date of those financial statements, other than the adoption of Accounting Standards Update No. 2016-02, Leases (Topic 842) as discussed in Note 2, there have been no changes to the Company’s significant accounting policies.

Liquidity

In accordance with Accounting Standards Update (“ASU”) No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40), the Company has evaluated whether there are certain conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the condensed consolidated financial statements are issued.

Since its inception, the Company has funded its operations primarily with proceeds from sales of redeemable convertible preferred stock and common stock, proceeds from its initial public offering (“IPO”) of common stock in June 2019 and most recently with proceeds from a secondary public offering of common stock in July 2020. The Company has incurred recurring losses since its inception, including a net loss of $49,496 and $28,144 for the nine months ended September 30, 2020 and 2019, respectively and net losses of $43,755 and $81,714 for the years ended December 31, 2019 and 2018, respectively. In addition, as of September 30, 2020, the Company had an

10


Table of Contents

Akero Therapeutics, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

(Amounts in thousands, except share and per share data)

accumulated deficit of $179,816. The Company expects to continue to generate operating losses for the foreseeable future. As of November 12, 2020, the issuance date of these condensed consolidated financial statements, the Company expects that its existing cash, cash equivalents and short-term marketable securities of $291,870 as of September 30, 2020 will be sufficient to fund its operating expenses and capital expenditure requirements for at least 12 months from the issuance date of these condensed consolidated financial statements. The Company expects that it will require additional funding to complete the clinical development of EFX, commercialize EFX if it receives regulatory approval, and pursue in-licenses or acquisitions of other product candidates.

If the Company is unable to obtain funding, the Company will be forced to delay, reduce or eliminate some or all of its research and development programs, product portfolio expansion or commercialization efforts, which could adversely affect its business prospects, or the Company may be unable to continue operations. Although management continues to pursue these plans, there is no assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to the Company to fund continuing operations, if at all.

2.           Summary of significant accounting policies

Unaudited interim financial statements

The accompanying unaudited condensed consolidated financial statements have been prepared by the Company in accordance with GAAP for interim financial reporting and as required by Regulation S-X, Rule 10-01. The unaudited condensed consolidated financial statements have been prepared on the same basis as the Company’s audited annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for a fair statement of the Company’s financial position as of September 30, 2020 and the results of its operations and its cash flows for the three and nine months ended September 30, 2020 and 2019 and the condensed consolidated statement of stockholders’ equity (deficit) as of September 30, 2020. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2020 and 2019 are unaudited. The results for the three and nine months ended September 30, 2020 are not necessarily indicative of results to be expected for the year ending December 31, 2020, any other interim periods, or any future year or period.

Use of estimates

The preparation of the Company's condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of expenses during the reporting period. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, the accrual of research and development expenses, the valuations of common stock and the valuation allowance for deferred tax assets. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates when there are changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates.

Cash and cash equivalents

The Company considers all highly liquid investments with original maturities of three months or less at the time of purchase to be cash equivalents. Cash equivalents consist primarily of amounts invested in money market accounts.

11


Table of Contents

Akero Therapeutics, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

(Amounts in thousands, except share and per share data)

Short-term marketable securities

The Company invests in short-term marketable securities, primarily money market funds, commercial paper, U.S. treasury securities and corporate debt securities. The Company classifies its short-term marketable securities as available-for-sale securities and reports them at fair value in short-term marketable securities on the consolidated balance sheets with related unrealized gains and losses included within accumulated other comprehensive gain (loss) on the consolidated balance sheets. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity, which is included in other income (expense), net on the condensed consolidated statements of operations and comprehensive loss. Realized gains and losses and declines in value judged to be other-than-temporary, if any, on available-for-sale securities are included in other income (expense), net. The cost of securities sold is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are included in other income (expense), net.

The Company regularly reviews all its investments for other-than-temporary declines in estimated fair value. This review includes the consideration of the cause of the impairment, including the creditworthiness of the security issuers, the number of securities in an unrealized loss position, the severity and duration of the unrealized losses, whether the Company has the intent to sell the securities and whether it is more likely than not that the Company will be required to sell the securities before the recovery of their amortized cost basis. When the Company determines that the decline in estimated fair value of an investment is below the amortized cost basis and the decline is other-than-temporary, the carrying value of the security will be reduced and a loss will be recorded for the amount of such decline.

Restricted cash

As of September 30, 2020 and December 31, 2019, the Company was required to maintain a separate cash balance of $40 to collateralize corporate credit cards with a bank, which are classified within other assets (non-current) on the condensed consolidated balance sheets.

As of September 30, 2020 the Company was required to maintain a separate cash balance of $108 for the benefit of the landlord in connection with an office space lease in South San Francisco, California, which is classified within other assets (non-current) on the condensed consolidated balance sheet (see Note 11). As of December 31, 2019 the Company was required to maintain a separate cash balance of $20 for the benefit of the landlord in connection with an office space lease in South San Francisco, California, which is classified within other assets (non-current) on the condensed consolidated balance sheet (see Note 11).

Concentrations of credit risk

Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents and short-term marketable securities. Periodically, the Company maintains deposits in accredited financial institutions in excess of federally insured limits. The Company deposits its cash investments in financial institutions that it believes have high credit quality and has not experienced any losses on such accounts and does not believe it is exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships.

Property and equipment, net

Property and equipment are stated cost, less accumulated depreciation and amortization. Depreciation is provided using the straight-line method over the estimated useful lives of the assets, which is three years for furniture and equipment. Leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the improvements. Depreciation and amortization begins at the time the asset is placed in service.

12


Table of Contents

Akero Therapeutics, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

(Amounts in thousands, except share and per share data)

Leases

Leases (Topic 842) Effective January 1, 2020

The Company determines whether an arrangement is or contains a lease at inception by assessing whether the arrangement contains an identified asset and whether the Company has the right to control the identified asset. Right-of-use, or ROU, assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Lease liabilities are recognized at the lease commencement date based on the present value of future lease payments over the lease term. ROU assets are based on the measurement of the lease liability and are further adjusted by any lease payments made prior to or on lease commencement, lease incentives received and initial direct costs incurred, as applicable. The Company elected, as allowed under Topic 842 (or “ASC 842”), to not recognize leases with a lease term of one year or less on its balance sheet. Operating lease costs included in the measurement of the lease are recognized on a straight-line basis over the lease term. Variable lease costs are expensed as incurred as an operating expense.

In accordance with ASC 842, components of a lease should be split into three categories: lease components, non-lease components, and non-components. The fixed and in-substance fixed contract consideration (including any consideration related to non-components) must be allocated, based on the respective relative fair values, to the lease components and non-lease components.

Entities may elect not to separate lease and non-lease components. Accordingly, entities making this election would account for each lease component and related non-lease component together as a single lease component. The Company has elected to account for lease and non-lease components together as a single lease component for all underlying assets and allocate all of the contract consideration to the lease component only.

ASC 842 allows for the use of judgment in determining whether the assumed lease term is for a major part of the remaining economic life of the underlying asset and whether the present value of lease payments represents substantially all of the fair value of the underlying asset. The Company applies the bright line thresholds referenced in ASC 842-10-55-2 to assist in evaluating leases for appropriate classification. The aforementioned bright lines are applied consistently to the Company’s leases.

The Company determines the lease classification and the present value of future lease payments at the time of the lease commencement using an incremental borrowing rate that it estimates based upon the Company’s credit risk and term of the lease. The interest rate implicit in lease contracts has not historically been readily determinable and the Company must therefore use the appropriate incremental borrowing rate to measure its leases. To estimate the incremental borrowing rate, a credit rating applicable to the Company is estimated using a synthetic credit rating analysis since the Company does not currently have a rating agency-based credit rating.

Leases (Topic 840) Prior to the Adoption of Topic 842

The Company enters into lease agreements for office facilities which are classified as operating leases. Rent expense is recognized on a straight-line basis over the noncancelable term of the lease and, accordingly, the Company records the difference between cash rent payments and the recognition of rent expense as a deferred rent liability, which is included within accrued expenses and other current liabilities (short-term portion) and other liabilities (long-term portion) on the condensed consolidated balance sheet.

13


Table of Contents

Akero Therapeutics, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

(Amounts in thousands, except share and per share data)

Research and development costs

Research and development costs are expensed as incurred. Research and development expenses consist of costs incurred to discover, research and develop drug candidates, including personnel expenses, stock-based compensation expense, third-party license fees and external costs including fees paid to consultants and clinical research organizations ("CROs"), in connection with drug product manufacturing, nonclinical studies and clinical trials, and other related clinical trial fees, such as for investigator grants, patient screening, laboratory work, clinical trial database management, clinical trial material management and statistical compilation and analysis. Non-refundable prepayments for goods or services that will be used or rendered for future research and development activities are recorded as prepaid expenses. Such amounts are recognized as an expense as the goods are delivered or the related services are performed, or until it is no longer expected that the goods will be delivered or the services rendered.

Costs incurred in obtaining technology licenses are charged immediately to research and development expense if the technology licensed has not reached technological feasibility and has no alternative future uses.

Research contract costs and accruals

The Company has entered into various research and development and other agreements with commercial firms, researchers and others for provisions of goods and services. These agreements are generally cancelable, and the related costs are recorded as research and development expenses as incurred. The Company records accruals for estimated ongoing research and development costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the studies or clinical trials, including the phase or completion of events, invoices received and contracted costs. Significant judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ materially from the Company's estimates.

Stock-based compensation

The Company measures all stock-based awards granted to employees and nonemployees based on the fair value on the date of the grant and recognizes compensation expense for those awards over the requisite service period, which is generally the vesting period of the respective award, on a straight-line basis. The Company accounts for forfeitures as they occur. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model. Prior to the Company’s initial public offering, the exercise price for all stock options granted was at the estimated fair value of the underlying common stock as determined on the date of grant by the Company’s board of directors.

The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model, which requires inputs based on certain subjective assumptions, including the expected stock price volatility, the expected term of the option, the risk-free interest rate for a period that approximates the expected term of the option, and the Company's expected dividend yield. The Company completed its initial public offering in June 2019 and accordingly, lacks sufficient company-specific historical and implied volatility information for its shares traded in the public markets. Therefore, it estimates its expected share price volatility based on the historical volatility of publicly traded peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded share price. The expected term of the Company's stock options has been determined utilizing the "simplified" method for awards that qualify as "plain-vanilla" options. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends on common stock and does not expect to pay any cash dividends in the foreseeable future. The fair value of each restricted common stock award is estimated on the date of grant based on the fair value of the Company's common stock on that same date.

14


Table of Contents

Akero Therapeutics, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

(Amounts in thousands, except share and per share data)

Compensation expense for purchases under the Employee Stock Purchase Plan is recognized based on the fair value of the common stock estimated based on the closing price of our common stock as reported on the date of offering, less the purchase discount percentage provided for in the plan.

The Company classifies stock-based compensation expense in its consolidated statement of operations and comprehensive loss in the same manner in which the award recipient's payroll costs are classified or in which the award recipient's service payments are classified.

Comprehensive loss

Comprehensive loss includes net loss as well as other changes in stockholders' equity (deficit) that result from transactions and economic events other than those with stockholders. Our comprehensive loss is comprised of net loss and unrealized gains and losses on our short-term marketable securities.

Emerging growth company

The Company is an emerging growth company as defined in the Jumpstart Our Business Startups Act of 2012, as amended (the “JOBS Act”). Under the JOBS Act, companies have extended transition periods available for complying with new or revised accounting standards. The Company has elected this exemption to delay adopting new or revised accounting standards until such time as those standards apply.

Recently adopted accounting pronouncements

In February 2016 the FASB issued ASU 2016-02, Leases (Topic 842, ASC 842 or ASU 2016-02). ASU 2016-02 amends several aspects of lease accounting, including requiring lessees to recognize almost all leases with a term greater than one year as a ROU asset and corresponding liability, measured at the present value of the lease payments. On January 1, 2020, the Company adopted Topic 842 using the modified retrospective approach and the adoption date as the initial date of application. Results prior to the adoption effective date are presented under Topic 840. No prior period amounts were adjusted and continue to be reported in accordance with previous lease guidance, Accounting Standards Codification Topic 840, Leases, or Topic 840.

Topic 842 provides a number of optional practical expedients in transition. The Company elected the short-term lease expedient for leases with a term of one year or less, which permits a lessee to not recognize lease assets and lease liabilities for those leases. The Company elected the practical expedients to not reassess its prior conclusions about lease identification under the new standard, to not reassess lease classification, and to not reassess initial direct costs for its existing leases at adoption.

Operating lease liabilities and their corresponding ROU assets are recorded based on the present value of future lease payments over the expected remaining lease term at lease commencement. In transition to ASC 842, the Company utilized the remaining lease term of its leases, as of the effective date, in determining the appropriate incremental

15


Table of Contents

Akero Therapeutics, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

(Amounts in thousands, except share and per share data)

borrowing rate. Lease cost for operating leases is recognized on a straight-line basis over the lease term as an operating expense.

The impact of the Company’s adoption of Topic 842 on the accompanying condensed consolidated balance sheet as of January 1, 2020 was as follows:

    

    

Adjustments

Due to the

December 31, 

Adoption of

January 1,

2019

Topic 842

2020

Assets:

Operating lease ROU asset

$

$

280

$

280

Liabilities:

Operating lease liabilities, current (included in accrued expenses and other current liabilities)

224

224

Deferred rent, current (included in accrued expenses and other current liabilities)

 

2

 

(2)

 

Operating lease liabilities, noncurrent (included in other liabilities)

 

 

60

 

60

Deferred rent, noncurrent (included in other liabilities)

 

2

 

(2)

 

3.            Fair value of financial assets and liabilities

Certain assets and liabilities of the Company are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:

Level 1—Quoted prices in active markets for identical assets or liabilities.
Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.
Level 3—Unobservable inputs that are supported by little or no market activity that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.

16


Table of Contents

Akero Therapeutics, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

(Amounts in thousands, except share and per share data)

The following is a summary of our financial assets measured at fair value on a recurring basis as of September 30, 2020 and December 31, 2019:

Fair Value Measurements as of September 30, 2020 Using:

 

Total

 

Level 1

Level 2

Level 3

Money market funds

    

$

140,039

$

140,039

$

$

Commercial paper

 

49,327

49,327

 

U.S. treasury securities

 

11,998

11,998

 

Corporate debt securities

 

37,867

37,867

 

$

239,231

$

152,037

$

87,194

$

Fair Value Measurements as of December 31, 2019 Using:

 

Total

 

Level 1

Level 2

Level 3

Money market funds

    

$

49,948

    

$

49,948

$

$

Commercial paper

 

49,114

 

 

49,114

 

U.S. treasury securities

 

6,048

 

6,048

 

 

Corporate debt securities

 

20,143

 

 

20,143

 

$

125,253

$

55,996

$

69,257

$

Commercial paper and corporate debt securities were valued by the Company using quoted prices in active markets for similar securities, which represent a Level 2 measurement within the fair value hierarchy. The carrying values of the Company’s prepaid expenses and other current assets, accounts payable and accrued expenses approximate their fair values due to the short-term nature of these assets and liabilities. During the nine months ended September 30, 2020 and the twelve months ended December 31, 2019, there were no transfers between Level 1, Level 2 and Level 3.

17


Table of Contents

Akero Therapeutics, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

(Amounts in thousands, except share and per share data)

4.           Cash equivalents and short-term marketable securities

The following is a summary of cash equivalents and short-term marketable securities as of September 30, 2020 and December 31, 2019:

September 30, 2020

Amortized cost

Gross unrealized gains

Gross unrealized losses

Fair value

Money market funds

    

$

140,039

    

$

$

$

140,039

Commercial paper

 

49,326

 

 

 

49,326

U.S. treasury securities

 

11,997

 

1

 

 

11,998

Corporate debt securities

 

37,852

 

15

 

 

37,867

$

239,214

$

16

$

$

239,230

Cash equivalents

$

140,039

Short-term marketable securities

99,191

$

239,230

December 31, 2019

 

Amortized cost

 

Gross unrealized gains

Gross unrealized losses

Fair value

Money market funds

    

$

49,948

    

$

$

$

49,948

Commercial paper

 

49,114

 

 

 

49,114

U.S. treasury securities

 

6,048

 

 

 

6,048

Corporate debt securities

 

20,149

 

 

(6)

 

20,143

$

125,259

$

$

(6)

$

125,253

Cash equivalents

$

53,641

Short-term marketable securities

71,612

$

125,253

5.           Accrued expenses and other current liabilities

The following is a summary of accrued expenses and other current liabilites as of September 30, 2020 and December 31, 2019:

    

September 30, 

    

December 31, 

2020

2019

Accrued external research and development expenses

$

5,159

$

6,361

Accrued employee compensation and benefits

1,442

1,606

Accrued legal and professional fees

 

474

 

370

Short-term lease liability and other

 

303

 

85

$

7,378

$

8,422

18


Table of Contents

Akero Therapeutics, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

(Amounts in thousands, except share and per share data)

6.           Stockholder’s equity (deficit)

Common stock

As of September 30, 2020 and December 31, 2019, the Company’s certificate of incorporation, as amended and restated, authorized the Company to issue 150,000,000 shares of $0.0001 par value common stock. Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. The holders of common stock, voting exclusively and as a separate class, have the exclusive right to vote for the election of directors of the Company. Common stockholders are entitled to receive dividends, as may be declared by the board of directors. Through September 30, 2020, no cash dividends had been declared or paid.

On June 24, 2019, the Company completed its IPO at which time the Company issued 6,612,500 shares of common stock, including the exercise in full by the underwriters of their option to purchase up to 862,500 additional shares of common stock, at a public offering price of $16.00 per share. The Company received $98,394, net of underwriting discounts and commissions, but before deducting offering costs paid by the Company, which were $2,942. Upon the closing of the IPO, all outstanding shares of convertible preferred stock converted into 21,056,136 shares of common stock.

On July 10, 2020, the Company completed a follow-on public offering at which time the Company issued 6,012,390 shares of common stock, including the exercise in full by the underwriters of their option to purchase up to 784,224 additional shares of common stock, at a public offering price of $36.00 per share. The Company received $203,460 net of underwriting discounts and commissions, but before deducting offering costs paid by the Company, which were $906.

As of September 30, 2020 and December 31, 2019, there were 34,720,675 and 28,567,837 shares of common stock issued and outstanding, respectively.

The following shares of common stock were reserved for issuance as follows:

September 30, 2020

December 31, 2019

Options outstanding under the 2018 Stock Option and Grant Plan

 

2,167,169

 

2,296,029

Options outstanding under the 2019 Stock Option and Incentive Plan

 

991,473

 

800,526

Options available for future grant

 

2,721,364

 

1,771,931

2019 Employee Stock Purchase Plan

 

545,787

 

269,364

 

6,425,793

 

5,137,850

Undesignated preferred stock

The Company’s fourth amended and restated certificate of incorporation authorizes the Company to issue up to 10,000,000 shares of undesignated preferred stock, par value $0.0001 per share. There were no undesignated preferred shares issued or outstanding as of September 30, 2020.

Restricted common stock

In March 2017, the Company issued an aggregate of 226,400 shares of restricted common stock under restricted stock agreements with the founders. Pursuant to the terms of the agreements, the restricted common stock was initially subject to a vesting schedule over a four-year period commencing in January 2017 and culminating in January 2021. In March 2018, the Company amended the restricted stock agreements such that the restricted common stock became

19


Table of Contents

Akero Therapeutics, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

(Amounts in thousands, except share and per share data)

subject to a vesting schedule over a two-year period commencing in May 2018 and culminating in June 2020. As of September 30, 2020, all restricted stock issued to the founders is fully vested.

In April, June and July 2019, the Company amended certain option grant agreements granted under the Company’s 2018 Stock Option and Grant Plan to allow the holders the right to early exercise unvested options, subject to a repurchase right held by the Company equal to the lesser of the original exercise price per share or the fair value of the shares on the repurchase date. The unvested shares issued as a result of the early exercise are deemed restricted stock pursuant to a restricted stock agreement and a vesting schedule identical to the vesting schedule of the original grant agreement. The proceeds related to unvested restricted common stock are recorded as liabilities until the stock vests, at which point they are reclassified to additional paid-in capital. Common shares issued for the early exercise of options are included in issued and outstanding shares.

The following table summarizes restricted stock activity since December 31, 2019:

Grant-Date Fair

    

Number of Shares

    

 Value

Unvested restricted common stock as of December 31, 2019

155,149

$

0.52

Shares vesting

(106,648)

0.48

Unvested restricted common stock as of September 30, 2020

 

48,501

$

0.62

As of September 30, 2020, there were 48,501 shares of unvested restricted common stock from the early exercise of stock options.

7.           Stock-based awards

2018 Stock option and grant plan

The Company’s 2018 Stock Option and Grant Plan (the “2018 Plan”) provided for the Company to grant incentive stock options or nonqualified stock options, restricted stock awards and other stock-based awards to employees, directors and consultants of the Company. The 2018 Plan was administered by the board of directors or, at the discretion of the board of directors, by a committee of the board of directors. The exercise prices, vesting and other restrictions were determined at the discretion of the board of directors, or its committee if so delegated.

The total number of shares of common stock that could have been issued under the 2018 Plan was 3,071,960 shares, of which 107,635 shares remained available for grant on June 18, 2019, the date that the Company’s 2019 Stock Option and Incentive Plan (the “2019 Plan”) became effective. Upon the effectiveness of the 2019 Plan, the 107,635 remaining shares available under the 2018 Plan were transferred and became available for issuance under the 2019 Plan. Shares of common stock underlying outstanding awards under the 2018 Plan that are forfeited, cancelled, held back upon exercise or settlement of an award to satisfy the exercise price or tax withholding, reacquired by the Company prior to vesting, satisfied without the issuance of stock, expire or are otherwise terminated (other than by exercise) will be added to the shares of common stock available for issuance under the 2019 Plan.

2019 Stock option and incentive plan

The 2019 Plan was adopted and approved by the Company’s board of directors in May 2019 and by the Company’s stockholders in June 2019. The 2019 Plan became effective on June 18, 2019 and replaced the Company’s 2018 Plan on that date. The 2019 Plan allows the board of directors or the compensation committee of the board of directors to make equity-based incentive awards to the Company’s officers, employees, directors or other key persons (including consultants). The number of shares initially reserved for issuance under the 2019 Plan was 2,572,457, which

20


Table of Contents

Akero Therapeutics, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

(Amounts in thousands, except share and per share data)

included the 107,635 shares transferred from the 2018 Plan, and shall be cumulatively increased on each January 1 by 4% of the number of shares of the Company’s common stock outstanding on the immediately preceding December 31 or such lesser number of shares determined by the Company’s board of directors or compensation committee of the board of directors. The 2019 Plan was increased by 1,142,713 shares on January 1, 2020.

The 2019 Plan is administered by the board of directors or, at the discretion of the board of directors, by a committee of the board of directors. The exercise prices, vesting and other restrictions are determined at the discretion of the board of directors, or its committee if so delegated, except that the exercise price per share of stock options may not be less than 100% of the fair market value of the share of common stock on the date of grant and the term of stock option may not be greater than ten years. All incentive options granted to any person possessing more than 10% of the total combined voting power of all classes of shares may not have an exercise price of less than 110% of the fair market value of the common stock on the grant date. Stock options granted to employees, officers, members of the board of directors and consultants will typically vest over a four-year period.

Shares that are expired, terminated, surrendered or canceled under the 2019 Plan without having been fully exercised will be available for future awards.

2019 Employee stock purchase plan

The 2019 Employee Stock Purchase Plan (the “2019 ESPP”) was adopted and approved by the Company’s board of directors in May 2019 and by the Company’s stockholders in June 2019. The 2019 ESPP became effective on June 18, 2019, at which time 273,869 shares were reserved for issuance. The 2019 ESPP provides that the number of shares reserved and available for issuance will automatically increase each January 1, beginning on January 1, 2020 and each January 1 through January 1, 2029, by the least of (i) 1% of the outstanding number of shares of the Company’s common stock on the immediately preceding December 31, (ii) 410,803 shares or (iii) such number of shares as determined by the compensation committee. The 2019 ESPP was increased by 285,678 shares on January 1, 2020.

Stock option valuation

The assumptions that the Company used to determine the grant-date fair value of stock options granted to employees, directors and consultants as follows, presented on a weighted average basis:

Three Months Ended

Nine Months Ended

September 30, 

September 30, 

    

2020

2019

2020

2019

Expected term (in years)

 

n/a

 

n/a

5.81

6.04

Volatility

 

n/a

n/a

77.70

%

69.80

%

Risk-free interest rate

 

n/a

n/a

1.07

%

2.39

%

Dividend yield

 

n/a

n/a

0.00

%

0.00

%

The Company did not grant any stock options during the three months ended September 30, 2020 or 2019.

21


Table of Contents

Akero Therapeutics, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

(Amounts in thousands, except share and per share data)

Stock options

The following table summarizes the Company’s stock option activity since December 31, 2019:

    

    

Weighted-

    

Weighted-

    

Average

Average

Aggregate

Exercise

remaining

Intrinsic

Number

Price per

contractual

Value

of Options

Share

term (years)

(000's)

Balance outstanding, December 31, 2019

 

3,096,555

$

7.89

 

9.19

$

44,323

Options granted

 

194,500

$

22.45

 

  

 

  

Options exercised

(131,193)

$

2.16

Options cancelled

 

(1,220)

$

0.61

 

  

 

  

Balance outstanding, September 30, 2020

3,158,642

$

9.03

8.52

$

68,735

Exercisable, September 30, 2020

 

836,701

$

7.63

 

8.43

$

19,383

Vested and expected to vest, September 30, 2020

 

3,158,642

$

9.03

 

8.52

$

68,735

The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common stock for those stock options that had exercise prices lower than the fair value of the Company’s common stock.

The weighted average grant-date fair value per share of stock options granted during the nine months ended September 30, 2020 was $14.76. There were no stock options granted during the three months ended September 30, 2020.

Stock-based compensation

The following table summarizes the Company’s stock-based compensation expense during the three and nine months ended September 30, 2020 and 2019:

Three Months Ended

Nine Months Ended

September 30, 2020

September 30, 2019

September 30, 2020

September 30, 2019

Stock-based compensation expense:

Classified within research and development expense

$

378

$

125

$

1,115

$

301

Classified within general and administrative expense

1,168

358

2,991

799

Total stock-based compensation expense

$

1,546

$

483

$

4,106

$

1,100

As of September 30, 2020, total unrecognized compensation cost related to unvested stock options was $14,470, which is expected to be recognized over a weighted average period of 2.3 years.

In April, June and July 2019, certain option holders early exercised options to purchase 491,207 shares of common stock, at an average exercise price of $0.65 per share, for cash proceeds of $321 (See Note 6). Stock-based compensation expense related to these options will continue to be recognized over the requisite service period of the awards based on the grant-date fair value which was determined using the Black-Scholes option-pricing model.

22


Table of Contents

Akero Therapeutics, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

(Amounts in thousands, except share and per share data)

8.           Amgen license agreement

In June 2018, the Company entered into a license agreement (the “Amgen Agreement”) with Amgen pursuant to which the Company was granted an exclusive license to certain patents and intellectual property related to a long-acting FGF21 analog in order to commercially develop, manufacture, use and distribute FGF21 as a treatment for NASH and other serious metabolic diseases. The Amgen Agreement provides the Company with exclusive global rights to the licensed products and the right to grant sublicenses that cover EFX to third parties.

In exchange for these rights, the Company made an upfront payment of $5,000 and issued 2,653,333 shares of Series A Preferred Stock with a fair value of $1,353 to Amgen. The Company accounted for the acquisition of technology as an asset acquisition because it did not meet the definition of a business. The Company recorded the total consideration transferred to Amgen as research and development expense in the condensed consolidated statements of operations and comprehensive loss because the acquired technology represented in-process research and development and had no alternative future use.

In addition, under the Amgen Agreement, Amgen was entitled to maintain a 10% ownership interest of the outstanding shares of the Company’s common stock, on a fully diluted and converted basis, through the second closing of the Company’s Series A Preferred Stock financing. The Company assessed the Amgen anti-dilution right and determined that the right (i) met the definition of a freestanding financial instrument that was not indexed to the Company’s own stock and (ii) met the definition of a derivative and did not qualify for equity classification. The anti-dilution right liability was initially valued at $1,639 which the Company recorded as research and development expense in June 2018. Changes in the fair value of the anti-dilution right liability continued to be recognized until the Company satisfied the obligation which occurred in November 2018. In November 2018, in connection with the second closing of the Company’s Series A Preferred Stock financing, the Company issued 3,205,128 shares of Series A Preferred Stock to Amgen for a total value of $7,404 satisfying its anti-dilution obligation under the Amgen Agreement.

Under the Amgen Agreement, the Company made a milestone payment in August 2019 of $2,500 in connection with dosing the first patient in the BALANCED study and is obligated to make aggregate remaining milestone payments to Amgen of up to $37,500 upon the achievement of specified clinical and regulatory milestones and aggregate milestone payments of up to $75,000 upon the achievement of specified commercial milestones for all products licensed under the Amgen Agreement.

Under the Amgen Agreement, the Company is obligated to pay Amgen tiered royalties ranging from a low to high single-digit percentages on annual net sales of the licensed products, beginning on the first commercial sale of such licensed products in each country and expiring on a country-by-country basis on the latest of (i) the expiration of the last valid patent claim covering such licensed products in such country, (ii) the loss of regulatory exclusivity in such country, and (iii) ten years after the first commercial sale of such licensed product in such country. The royalty payments are subject to reduction under specified conditions set forth in the Amgen Agreement.

 

The Company is solely responsible for all development, manufacturing, and commercial activities and costs of the licensed products, including clinical studies or other tests necessary to support the use of a licensed product. The Company is also responsible for costs related to the filing, prosecution and maintenance of the licensed patent rights.

 

The Amgen Agreement will remain in effect until the expiration of the royalty term in all countries for all licensed products. The Amgen Agreement may be terminated by either party with at least 90 days' notice in the event of material breach by the other party that remains uncured for 90 days, by either party for insolvency or bankruptcy of the other party and immediately by Amgen if the Company challenges the licensed patents. The Company may also

23


Table of Contents

Akero Therapeutics, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

(Amounts in thousands, except share and per share data)

terminate the Amgen Agreement with 90 days' written notice for discretionary reasons such as scientific, technical, regulatory or commercial issues, as defined in the Amgen Agreement.

During the three and nine months ended September 30, 2020 and 2019, the Company did not record any research and development expense in connection with the Amgen Agreement.

9.           Income taxes

During the three and nine months ended September 30, 2020 and 2019, the Company did not record any income tax benefits for the net operating losses incurred or for the research and development tax credits generated in each period due to its uncertainty of realizing a benefit from those items. All of the Company’s operating losses since inception have been generated in the United States.

On March 27, 2020, the Coronavirus Aid, Relief and Economic Security (CARES) Act, (the “Act”) was signed into law. The Act includes provisions relating to refundable payroll tax credits, deferment of the employer portion of certain payroll taxes, net operating loss carryback periods, alternative minimum tax credit refunds, modifications to the net interest deduction limitations and technical corrections to tax depreciation methods for qualified improvement property. The Company analyzed the provisions of the Act and determined there was no significant impact to its income tax provision for the three and nine months ended September 30, 2020.

10.           Net loss per share

Basic and diluted net loss per share attributable to common stockholders was calculated as follows:

Three Months Ended September 30, 

Nine Months Ended September 30, 

    

2020

    

2019

    

2020

    

2019

Numerator:

 

  

 

  

 

  

 

  

Net loss

$

(21,403)

$

(15,554)

$

(49,496)

$

(28,144)

Denominator:

 

 

Weighted average common shares outstanding, basic and diluted

 

34,002,769

 

28,024,779

30,381,671

10,589,119

Net loss per share, basic and diluted

$

(0.63)

$

(0.56)

$

(1.63)

$

(2.66)

The Company excluded 53,679 shares and 42,667 shares of restricted common stock, presented on a weighted average basis, from the calculations of basic net loss per share for the three months ended September 30, 2020 and 2019, respectively, because those shares had not vested. The Company excluded 41,938 shares and 56,679 shares of restricted common stock, presented on a weighted average basis, from the calculations of basic net loss per share for the nine months ended September 30, 2020 and 2019, respectively, because those shares had not vested.

The Company’s potentially dilutive securities, which include stock options, unvested restricted common stock and redeemable convertible preferred stock, have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted average number of common shares outstanding used to calculate both basic and diluted net loss per share is the same. The Company excluded the following potential

24


Table of Contents

Akero Therapeutics, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

(Amounts in thousands, except share and per share data)

common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect:

Three and nine months ended September 30, 

    

2020

    

2019

Options to purchase common stock

 

3,158,642

 

2,417,234

Unvested restricted common stock

 

48,501

 

421,066

 

3,207,143

 

2,838,300

11.         Commitments and contingencies

COVID-19 Pandemic

In December 2019, a novel strain of coronavirus (“COVID-19”) was reported to have surfaced in Wuhan, China. As of May 2020, COVID-19 has spread to other countries, including Europe and the United States, and has been declared a pandemic by the World Health Organization. Efforts to contain the spread of COVID-19 have intensified and the United States, Europe and Asia have implemented severe travel restrictions, social distancing requirements, stay-at-home orders and have delayed the commencement of non-COVID-19-related clinical trials, among other restrictions. The Company’s financial results for the three and nine months ended September 30, 2020 were not significantly impacted by COVID-19, however, the Company cannot at this time predict the specific extent, duration, or full impact that the COVID-19 pandemic will have on its financial condition, operations, and business plans for 2020, including the timing and enrollment of patients in its planned clinical trials and other expected milestones of its product candidate.

Operating leases

In October 2018, the Company entered into a lease agreement for office space in South San Francisco, California. In March 2019, the Company amended this lease agreement (the “First Amendment”) to extend the term of the lease and expand the square footage of the existing leased office space. On May 7, 2020, the Company entered into an agreement to effectuate an early termination of the 2018 office lease agreement in South San Francisco, California, without penalty, resulting in a non-cash reduction to the ROU asset and corresponding lease liability of $173 at that time. This early termination was effective on June 30, 2020 and had reduced the Company’s future minimum lease payments by approximately $180.

In September 2019, the Company entered into an agreement to use office space in Cambridge, Massachusetts. The agreement was for an initial six-month term, which was extended until September 2020, and provides for rolling six-month extensions. The Company has determined this lease to be short term, as the Company is not obligated at any time for more than a six-month term. The Company made monthly payments of $4 under the agreement until the agreement was terminated on September, 30, 2020.

In February 2020, the Company entered into a seven-year agreement to occupy 6,647 square feet of office space in South San Francisco, California. The lease commenced on July 10, 2020 when the Company took occupancy of the leased space and the lease was determined to be operating classified. Under the agreement, the Company is required to make approximately $2,300 in total minimum payments during the term. The Company is also required to pay its proportionate share of building operating and tax costs after the first year under lease which are not included in the measurement of the lease and treated as variable lease cost and expense when incurred.

25


Table of Contents

Akero Therapeutics, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

(Amounts in thousands, except share and per share data)

As of September 30, 2020, maturities of the Company’s operating lease liabilities were as follows:

2020 (remainder)

$

75

2021

303

2022

312

2023

321

2024

331

2025 and thereafter

900

Total future minimum lease payments

2,242

Less imputed interest

(501)

Present value of operating lease liabilities

$

1,741

As of September 30, 2020, the total lease liability was $1,741, of which $1,564 was noncurrent and $177 was short-term and classified within “Accrued expenses and other current liabilities” on the balance sheet.

For the three and nine months ended September 30, 2020, the components of operating lease cost were as follows:

Three Months Ended

Nine Months Ended

September 30, 2020

September 30, 2020

Lease cost:

Statement of Operations Classification:

Operating lease cost

General and administrative expense

$

73

$

186

Variable operating lease cost

General and administrative expense

43

Short-term lease cost

Research and development expense

8

32

Total operating lease cost

$

81

$

261

Other information:

Cash paid for amounts included in the measurement of operating lease liability

$

18

$

135

Weighted average remaining lease term

 

6.8

 

6.8

Weighted average discount rate

 

7.6%

 

7.6%

Prior to the Company’s adoption of ASC 842 on January 1, 2020, the Company recognized rent expense on a straight-line basis over the respective lease periods and recorded rent expense of $305 for the year ended December 31, 2019. As of December 31, 2019, future minimum commitments due under the Company’s leases totaled $401, of which $321 was due in 2020 and $80 was due in 2021.

Research and manufacturing commitments

The Company has entered into agreements with contract research organizations and contract manufacturing organizations to provide services in connection with its nonclinical studies and clinical trials and to manufacture clinical development materials. As of September 30, 2020, the Company had non-cancelable purchase commitments under these agreements totaling $14,171.

26


Table of Contents

Akero Therapeutics, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

(Amounts in thousands, except share and per share data)

Indemnification agreements

In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its board of directors and its executive officers that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnifications. The Company is not currently aware of any indemnification claims and has not accrued any liabilities related to such obligations in its condensed consolidated financial statements as of September 30, 2020.

Legal proceedings

The Company is not a party to any litigation and does not have contingency reserves established for any litigation liabilities. At each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting for contingencies. The Company expenses as incurred the costs related to such legal proceedings.

12.         Related parties

Atlas Venture Life Science Advisors, LLC

A partner of Atlas Venture Life Science Advisors, LLC (“Atlas”), a significant investor in the Company, has served on the Company’s board of directors since 2018. In August 2018, the Company entered into a use and occupancy agreement for office space with Atlas in Cambridge, Massachusetts (see Note 11). The parties terminated the agreement in September 2019. As of September 30, 2020 and December 31, 2019, the Company did not owe any amounts to Atlas.

13.         Subsequent event

The Company evaluated subsequent events through November 12, 2020, the date on which these financial statements were issued. Based on this evaluation, it was determined that no subsequent events occurred that require recognition or disclosure in its financial statements for the three and nine months ended September 30, 2020.

27


Table of Contents

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion should be read in conjunction with our financial statements and accompanying footnotes appearing elsewhere in this Quarterly Report on Form 10-Q and the audited financial statements and related notes contained in our Annual Report on Form 10-K for the year ended December 31, 2019. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. See “Special Note Regarding Forward-Looking Statements.” Because of many factors, including those factors set forth in the “Risk Factors” section of this Quarterly Report on Form 10-Q, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Overview

We are a cardio-metabolic nonalcoholic steatohepatitis, or NASH, company developing pioneering medicines designed to restore metabolic balance and improve overall health for NASH patients. Our lead product candidate, Efruxifermin, or EFX, formerly known as AKR-001, is a proprietary fibroblast growth factor 21, or FGF21, analog with unique properties that we believe has the potential to address the core processes underlying NASH pathogenesis, with the potential to restore healthy fat metabolism in the liver, reduce hepatocyte stress, mitigate inflammation and resolve fibrosis. FGF21 is an endocrine hormone that acts on the liver, pancreas, muscle and adipose tissue to regulate the metabolism of lipids, carbohydrates and proteins. Acting as a paracrine hormone, FGF21 also plays a critical role in protecting cells against stress. These attributes make FGF21 agonism a compelling therapeutic mechanism, but native FGF21 is limited by its short half-life in the bloodstream. EFX has been engineered with the objective of increasing human FGF21's half-life sufficiently to enable dosing once-weekly or once every two weeks, while seeking to retain the native biological activity of FGF21.

In the second quarter of 2020 we reported data from the main portion of the BALANCED study, which enrolled 80 patients with biopsy-confirmed NASH. This main study was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study that evaluated three EFX dose groups after 16 weeks of treatment. A separate cohort evaluating treatment of 30 patients with compensated cirrhosis (F4), Child-Pugh Class A, is ongoing, with enrollment completed in September 2020.

In March 2020, we reported primary and secondary endpoint results related to liver fat reduction and ALT reduction for the main study. All EFX groups met the primary and secondary endpoints related to reductions in liver fat, as measured by magnetic resonance imaging-proton density fat fraction, or MRI-PDFF, and ALT, with 63% to 72% relative reductions in liver fat across EFX dose groups, compared to 0% for placebo. In addition, all EFX patients with week 12 MRI-PDFF results were designated treatment responders, having achieved at least a 30% relative reduction in liver fat. In June 2020, we announced additional results of a 16-week analysis of secondary and exploratory endpoints, including histological results from paired biopsies for treatment responders. Of the 40 EFX treatment responders who had end-of-treatment biopsies, we observed that 48% achieved improvement in liver fibrosis of at least one stage and no worsening of NASH and 28% achieved at least a two-stage improvement in liver fibrosis. Sixty-two percent of treatment responders in the 50mg dose group achieved one-stage improvement in liver fibrosis and no worsening of NASH. In addition, 48% of EFX patients achieved NASH resolution and no worsening of liver fibrosis, including 54% of patients in the 50mg dose group.

In September 2020, we received written guidance from the U.S. Food and Drug Administration, or FDA, in response to our Type C Meeting Request, which enables us to implement an innovative combined Phase 2b/3 study design for pivotal EFX trials in NASH patients. Under the planned adaptive trial design, we will evaluate the 28 and 50mg EFX doses in a 24-week Phase 2b portion of the trial to inform selection of a single dose for evaluation in the Phase 3 portion of the study. We are in the process of updating the EFX IND to enable the planned Phase 2b portion of our Phase 2b/3 adaptive clinical trial in biopsy-confirmed NASH patients. These ongoing updates have included, or will include, reports covering chronic toxicology studies as well as comparability assessments, release and stability testing for drug substance and drug product. We remain on track to initiate this study in the first half of 2021. In October 2020,

28


Table of Contents

the European Medicines Agency, or EMA, granted Priority Medicines, or PRIME, designation to EFX. This designation was granted based on the positive efficacy data from the BALANCED study. Based on available published data, we believe that EFX is the first drug candidate to receive a PRIME designation for treatment of NASH.

We believe EFX holds the potential to be a promising monotherapy for the treatment of NASH, if approved. NASH is a complex disease, and its treatment ideally would include intervening at all of the various stages of its pathogenesis. Based on the results of the BALANCED study to date, we believe EFX could potentially address all of the various stages of NASH pathogenesis in a single treatment: reducing steatohepatitis, resolving fibrosis and helping restore healthy metabolism to the whole body. Pending consultation with FDA we expect to begin the next clinical trial during the first half of 2021.

We were incorporated in January 2017 and have devoted substantially all of our efforts to organizing and staffing our company, business planning, raising capital, in-licensing rights to EFX, research and development activities for EFX, building our intellectual property portfolio and providing general and administrative support for these operations. To date, we have principally raised capital through the issuance of convertible preferred stock, the initial public offering of our common stock in June 2019 and an underwritten public offering of our common stock in July 2020.

We have incurred significant operating losses since inception. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of EFX and any future product candidates. Our net losses were $21.4 million and $49.5 million for the three and nine months ended September 30, 2020, respectively, and $15.6 million and $28.1 million for the three and nine months ended September 30, 2019, respectively. As of September 30, 2020, we had an accumulated deficit of $179.8 million. We expect to continue to incur significant expenses for at least the next several years as we advance EFX through later-stage clinical development, develop additional product candidates and seek regulatory approval of any product candidates that complete clinical development. In addition, if we obtain marketing approval for any product candidates, we expect to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution. We may also incur expenses in connection with the in-licensing or acquisition of additional product candidates.

As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the sale of equity, debt financings, or other capital sources, which may include collaborations with other companies or other strategic transactions. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, reduce or eliminate the development and commercialization of one or more of our product candidates or delay our pursuit of potential in-licenses or acquisitions.

Because of the numerous risks and uncertainties associated with product development, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.

As of September 30, 2020, we had cash, cash equivalents and short-term marketable securities of $291.9 million which we believe will be sufficient to fund our operating expenses and capital expenditure requirements for at least 12 months from the issuance date of these condensed consolidated financial statements.

Impact of the COVID-19 Pandemic

As of November 2020, a novel strain of coronavirus, or COVID-19, has spread globally. Efforts to contain the spread of COVID-19 have intensified and the United States, Europe and Asia have implemented severe travel restrictions, social distancing requirements, and stay-at-home orders, among other restrictions, which have led to delays in the commencement of non-COVID-19-related clinical trials. As a result, the COVID-19 pandemic has caused

29


Table of Contents

significant disruptions to the U.S., regional and global economies and has contributed to significant volatility and negative pressure in financial markets.

We have been carefully monitoring the COVID-19 pandemic and its potential impact on our business and have taken important steps to help ensure the safety of employees and their families and to reduce the spread of COVID-19. We have established, and maintained without interruption, a work-from-home policy for all employees. We have also maintained efficient communication with our manufacturing and supply partners as the COVID-19 situation has progressed. We have taken these precautionary steps while maintaining business continuity so that we can continue to progress our programs. Our financial results for the three and nine months ended September 30, 2020 were not significantly impacted by COVID-19, and the COVID-19 pandemic did not materially impact data collection for the main portion of the BALANCED study, which has been completed. To date, data collection in a separate cohort of the BALANCED study evaluating patients with compensated cirrhosis (F4), Child-Pugh Class A, and preparations for our upcoming Phase 2b/3 trial, have not been materially impacted by the COVID-19 pandemic.

Commercial-scale manufacture of GMP drug substance, or API, was completed in April 2020 without any impact from COVID-19. Manufacture of GMP drug product for our Phase 2b clinicial trial was completed in September 2020, also without any impact from COVID-19.

Notwithstanding the foregoing, the future impact of the COVID-19 pandemic on our industry, the healthcare system and our current and future operations and financial condition will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the scope, severity and duration of the pandemic, the actions taken to contain the pandemic or mitigate its impact, and the direct and indirect economic effects of the pandemic and containment measures, among others. See “Item 1A. Risk Factors” for a discussion of the potential adverse impact of COVID-19 on our business, results of operations and financial condition.

Components of our results of operations

Revenue

We have not generated any revenue since our inception and do not expect to generate any revenue from the sale of products in the near future, if at all. If our development efforts for EFX or additional product candidates that we may develop in the future are successful and result in marketing approval or if we enter into collaboration or license agreements with third parties, we may generate revenue in the future from a combination of product sales or payments from such collaboration or license agreements.

Operating expenses

Research and development expenses

Research and development expenses consist primarily of costs incurred in connection with the development of EFX, as well as unrelated discovery program expenses. We expense research and development costs as incurred. These expenses include:

employee-related expenses, including salaries, related benefits and stock-based compensation expense, for employees engaged in research and development functions;