10-Q
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 10-Q

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2023

OR

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File Number: 001-39617

Aligos Therapeutics, Inc.

(Exact Name of Registrant as Specified in its Charter)

Delaware

82-4724808

(State or other jurisdiction of

incorporation or organization)

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

One Corporate Drive, 2nd Floor

South San Francisco, California

94080

(Address of principal executive offices)

(Zip Code)

 

Registrant’s telephone number, including area code: (800) 466-6059

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

 

ALGS

 

The Nasdaq Stock Market LLC

(Nasdaq Global Select Market)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer

 

 

Accelerated filer

 

 

 

 

Non-accelerated filer

 

 

Smaller reporting company

 

 

 

 

 

 

 

 

Emerging growth company

 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No

As of July 31, 2023, the registrant had 43,502,582 shares of common stock, $0.0001 par value per share, outstanding, comprised of 40,410,244 shares of voting common stock, $0.0001 par value per share and 3,092,338 shares of non-voting common stock, $0.0001 par value per share.

 

 

 


Special note regarding forward-looking statements

This Quarterly Report on Form 10-Q contains forward-looking statements concerning our business, operations and financial performance and condition, as well as our plans, objectives and expectations for our business, operations and financial performance and condition. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that are in some cases beyond our control and may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.

In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would,” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about:

the scope, progress, results and costs of developing our drug candidates or any other future drug candidates, and conducting nonclinical studies and clinical trials, including our ALG-055009, ALG‑000184 and ALG-125755 clinical trials;
the scope, progress, results and costs related to the research and development of our pipeline;
the timing of, and costs involved in, obtaining and maintaining regulatory approval for any of our current or future drug candidates, and any related restrictions or limitations;
our expectations regarding the potential market size and size of the potential patient populations for ALG‑055009, ALG‑000184 and ALG-125755, our other drug candidates and any future drug candidates, if approved for commercial use;
our ability to maintain existing, and establish new, collaborations, licensing or other arrangements and the financial terms of any such agreements;
our commercialization, marketing and manufacturing capabilities and expectations;
the rate and degree of market acceptance of our drug candidates, as well as the pricing and reimbursement of our drug candidates, if approved;
the implementation of our business model and strategic plans for our business, drug candidates and technology, including additional indications for which we may pursue;
the scope of protection we are able to establish and maintain for intellectual property rights covering our drug candidates, including the projected term of patent protection;
any lawsuits related to our drug candidates or commenced against us, including the costs associated with our current litigation with Janssen Biopharma, LLC (Janssen);
estimates of our expenses, future revenue, capital requirements, our needs for additional financing and our ability to obtain additional capital;
developments and projections relating to our competitors and our industry, including competing therapies and procedures;
regulatory and legal developments in the United States and foreign countries;
the performance of our third-party suppliers and manufacturers;
our ability to attract and retain key management, scientific and medical personnel;
our expectations regarding the period during which we will qualify as an emerging growth company under the Jumpstart Our Business Startups Act of 2012;
our expectations regarding our ability to obtain, maintain, enforce and defend our intellectual property protection for our drug candidates; and
other risks and uncertainties, including those listed under the caption “Risk Factors.”

These forward-looking statements are based on management’s current expectations, estimates, forecasts and projections about our business and the industry in which we operate and management’s beliefs and assumptions and are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control. As a result, any or all of our forward-looking statements in this Quarterly Report on Form 10-Q may turn out to be inaccurate. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under the

i


section titled “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements contained herein for any reason after the date of this report to conform these statements to new information, actual results or changes in our expectations, except as required by applicable law.

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

Investors and others should note that we may announce material business and financial information to our investors using our investor relations website, Securities and Exchange Commission, or SEC, filings, webcasts, press releases and conference calls. We use these mediums, including our website, to communicate with the public about our company, our business and other issues. It is possible that the information that we make available may be deemed to be material information. We therefore encourage investors and others interested in our company to review the information that we make available on our website.

Summary of material risks associated with our business

The principal risks and uncertainties affecting our business include the following:

We are a clinical-stage biopharmaceutical company with a limited operating history and no products approved for commercial sale. We have incurred significant losses since inception. We expect to incur losses for at least the next several years and may never achieve or maintain profitability, which, together with our limited operating history, makes it difficult to assess our future viability.
We have never generated revenue from product sales and may never be profitable.
We will require substantial additional financing to achieve our goals, which may not be available on acceptable terms, or at all. A failure to obtain this necessary capital when needed could force us to delay, limit, reduce or terminate our product development or commercialization efforts.
We are early in our development efforts, and our business is dependent on the successful development of our current and future drug candidates. If we are unable to advance our current or future drug candidates through clinical trials, obtain marketing approval and ultimately commercialize any drug candidates we develop, or experience significant delays in doing so, our business will be materially harmed.
Our current or future drug candidates may cause undesirable side effects or have other properties when used alone or in combination with other approved products or investigational new drugs that could delay or halt their clinical development, prevent their marketing approval, limit their commercial potential or result in significant negative consequences.
We depend on collaborations with third parties for the development of certain of our potential drug candidates, and we may depend on additional collaborations in the future for the development and commercialization of these or other potential candidates. If our collaborations are not successful, we may not be able to capitalize on the market potential of these drug candidates.
We intend to develop our current drug candidates, and expect to develop other future drug candidates, in combination with other therapies, which exposes us to additional risks.
We face significant competition, and if our competitors develop and market products that are more effective, safer or less expensive than the drug candidates we develop, our commercial opportunities will be negatively impacted.
If we and our collaborators are unable to obtain, maintain, protect and enforce sufficient patent and other intellectual property protection for our drug candidates and technology, our competitors could develop and commercialize products and technology similar or identical to ours, and we may not be able to compete effectively in our market or successfully commercialize any drug candidates we may develop.
Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could negatively impact the success of our business.

ii


We have entered into licensing and collaboration agreements with third parties. If we fail to comply with our obligations in the agreements under which we license intellectual property rights to or from third parties, or these agreements are terminated, or we otherwise experience disruptions to our business relationships with our licensors or licensees, our competitive position, business, financial condition, results of operations and prospects could be harmed.
We are highly dependent on our key personnel, and if we are not successful in attracting, motivating and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.

The summary risk factors described above should be read together with the text of the full risk factors below in the section entitled “Risk Factors” and the other information set forth in this Quarterly Report on Form 10-Q, including our consolidated financial statements and the related notes, as well as in other documents that we file with the SEC. The risks summarized above or described in full below are not the only risks that we face. Additional risks and uncertainties not precisely known to us or that we currently deem to be immaterial may also materially adversely affect our business, financial condition, results of operations, and future growth prospects.

 

iii


Table of Contents

Page

PART I.

FINANCIAL INFORMATION

1

 

Item 1.

Financial Statements (Unaudited)

1

 

Condensed Consolidated Balance Sheets as of June 30, 2023 and December 31, 2022

1

 

Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Six Months Ended June 30, 2023 and 2022

2

 

Condensed Consolidated Statements of Changes in Stockholders’ Equity for the Three and Six Months Ended June 30, 2023 and 2022

3

 

Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2023 and 2022

5

 

Notes to Unaudited Condensed Consolidated Financial Statements

7

 

Item 2.

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

18

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

25

 

Item 4.

Controls and Procedures

26

 

PART II.

OTHER INFORMATION

27

 

Item 1.

Legal Proceedings

27

 

Item 1A.

Risk Factors

27

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

81

 

Item 3.

Defaults Upon Senior Securities

81

 

Item 4.

Mine Safety Disclosures

81

 

Item 5.

Other Information

81

 

Item 6.

Exhibits

82

 

Signatures

83

 

iv


 

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

ALIGOS THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share data)

 

 

 

 

June 30,
2023

 

 

December 31,
2022

 

 

 

(Unaudited)

 

 

 

 

ASSETS

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

90,828

 

 

$

81,347

 

Restricted cash

 

 

42

 

 

 

115

 

Short-term investments

 

 

10

 

 

 

44,480

 

Other current assets

 

 

3,363

 

 

 

7,603

 

Total current assets

 

 

94,243

 

 

 

133,545

 

Operating lease right-of-use assets

 

 

7,312

 

 

 

7,698

 

Property and equipment, net

 

 

3,951

 

 

 

4,816

 

Other assets

 

 

624

 

 

 

634

 

Total assets

 

$

106,130

 

 

$

146,693

 

 

 

 

 

 

 

LIABILITIES AND

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

3,241

 

 

$

4,737

 

Accrued liabilities

 

 

13,795

 

 

 

16,039

 

Operating lease liabilities, current

 

 

3,173

 

 

 

3,035

 

Finance lease liabilities, current

 

 

64

 

 

 

108

 

Deferred revenue from customers, current

 

 

2,849

 

 

 

467

 

Deferred revenue from collaborations, current

 

 

4,103

 

 

 

8,743

 

Total current liabilities

 

 

27,225

 

 

 

33,129

 

Operating lease liabilities, net of current portion

 

 

8,974

 

 

 

9,201

 

Finance lease liabilities, net of current portion

 

 

203

 

 

 

230

 

Deferred revenue from customers, net of current portion

 

 

93

 

 

 

233

 

Total liabilities

 

 

36,495

 

 

 

42,793

 

Commitments and contingencies (Note 10)

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Preferred Stock, $0.0001 par value; 10,000,000 shares authorized as of June 30, 2023 (unaudited) and December 31, 2022, respectively; no shares issued and outstanding as of June 30, 2023 (unaudited) and December 31, 2022, respectively.

 

 

-

 

 

 

-

 

Common stock, $0.0001 par value; 320,000,000 shares authorized as of June 30, 2023 (unaudited) and December 31, 2022, respectively; 43,502,582 and 42,922,980 shares issued and outstanding as of June 30, 2023 (unaudited) and December 31, 2022, respectively.

 

 

4

 

 

 

4

 

Additional paid-in capital

 

 

509,998

 

 

 

502,613

 

Accumulated deficit

 

 

(440,864

)

 

 

(399,118

)

Accumulated other comprehensive income

 

 

497

 

 

 

401

 

Total stockholders’ equity

 

 

69,635

 

 

 

103,900

 

Total liabilities and stockholders’ equity

 

$

106,130

 

 

$

146,693

 

 

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

1


 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)

(In thousands, except share and per share data)

 

 

 

 

 

 

Three Months Ended
June 30,

 

 

Six Months Ended
June 30,

 

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Revenue from collaborations

 

 

$

2,592

 

 

$

3,693

 

 

$

5,175

 

 

$

6,264

 

Revenue from customers

 

 

 

4,294

 

 

 

 

 

 

4,434

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

 

16,781

 

 

 

16,510

 

 

 

34,916

 

 

 

48,186

 

General and administrative

 

 

 

9,246

 

 

 

7,576

 

 

 

17,752

 

 

 

14,028

 

Total operating expenses

 

 

 

26,027

 

 

 

24,086

 

 

 

52,668

 

 

 

62,214

 

Loss from operations

 

 

 

(19,141

)

 

 

(20,393

)

 

 

(43,059

)

 

 

(55,950

)

Interest and other income, net

 

 

 

1,107

 

 

 

516

 

 

 

2,109

 

 

 

510

 

Loss before income tax expense

 

 

 

(18,034

)

 

 

(19,877

)

 

 

(40,950

)

 

 

(55,440

)

Income tax expense

 

 

 

(757

)

 

 

(47

)

 

 

(796

)

 

 

(99

)

Net loss

 

 

 

(18,791

)

 

 

(19,924

)

 

 

(41,746

)

 

 

(55,539

)

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

(2

)

 

 

(154

)

 

 

96

 

 

 

(402

)

Other comprehensive income (loss)

 

 

 

(2

)

 

 

(154

)

 

 

96

 

 

 

(402

)

Comprehensive loss

 

 

$

(18,793

)

 

$

(20,078

)

 

$

(41,650

)

 

$

(55,941

)

Net loss per share, basic and diluted

 

 

$

(0.43

)

 

$

(0.47

)

 

$

(0.97

)

 

$

(1.30

)

Weighted average shares of common stock, basic and diluted

 

 

 

43,215,478

 

 

 

42,665,598

 

 

 

43,063,615

 

 

 

42,590,479

 

 

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

2


 

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

(Unaudited)

(In thousands, except share and per share data)

 

 

 

Three Months Ended June 30, 2023

 

 

 

Common Stock

 

 

Additional
Paid-in

 

 

Accumulated

 

 

Accumulated
Other
Comprehensive

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Income

 

 

Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance as of March 31,2023

 

 

42,940,089

 

 

$

4

 

 

$

506,320

 

 

$

(422,073

)

 

$

499

 

 

$

84,750

 

Issuance of common stock upon
   exercise of stock options

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Issuance of common stock related
   to ESPP purchase

 

 

562,493

 

 

 

-

 

 

 

461

 

 

 

-

 

 

 

-

 

 

 

461

 

Stock-based compensation expense related to employee stock awards

 

 

-

 

 

 

-

 

 

 

2,975

 

 

 

-

 

 

 

-

 

 

 

2,975

 

Stock-based compensation expense related to employee stock purchases

 

 

-

 

 

 

-

 

 

 

222

 

 

 

-

 

 

 

-

 

 

 

222

 

Vesting of early exercised
   common stock options

 

 

-

 

 

 

-

 

 

 

20

 

 

 

-

 

 

 

-

 

 

 

20

 

Other comprehensive loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(2

)

 

 

(2

)

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(18,791

)

 

 

-

 

 

 

(18,791

)

Balance as of June 30, 2023

 

 

43,502,582

 

 

$

4

 

 

$

509,998

 

 

$

(440,864

)

 

$

497

 

 

$

69,635

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Six Months Ended June 30, 2023

 

 

 

Common Stock

 

 

Additional
Paid-in

 

 

Accumulated

 

 

Accumulated
Other
Comprehensive

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Income

 

 

Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance as of December 31, 2022

 

 

42,922,980

 

 

$

4

 

 

$

502,613

 

 

$

(399,118

)

 

$

401

 

 

$

103,900

 

Issuance of common stock upon
   exercise of stock options

 

 

17,109

 

 

 

-

 

 

 

23

 

 

 

-

 

 

 

-

 

 

 

23

 

Issuance of common stock related
   to ESPP purchase

 

 

562,493

 

 

 

-

 

 

 

461

 

 

 

-

 

 

 

-

 

 

 

461

 

Stock-based compensation expense related to employee stock awards

 

 

-

 

 

 

-

 

 

 

6,478

 

 

 

-

 

 

 

-

 

 

 

6,478

 

Stock-based compensation expense related to employee stock purchases

 

 

-

 

 

 

-

 

 

 

382

 

 

 

-

 

 

 

-

 

 

 

382

 

Vesting of early exercised
   common stock options

 

 

-

 

 

 

-

 

 

 

41

 

 

 

-

 

 

 

-

 

 

 

41

 

Other comprehensive income

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

96

 

 

 

96

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(41,746

)

 

 

-

 

 

 

(41,746

)

Balance as of June 30, 2023

 

 

43,502,582

 

 

$

4

 

 

$

509,998

 

 

$

(440,864

)

 

$

497

 

 

$

69,635

 

 

3


 

 

 

 

Three Months Ended June 30, 2022

 

 

 

 

Common Stock

 

 

Additional
Paid-in

 

 

Accumulated

 

 

Accumulated
Other
Comprehensive

 

 

Total
Stockholders’

 

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Income (Loss)

 

 

Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance as of March 31,2022

 

 

 

42,695,195

 

 

$

4

 

 

$

491,365

 

 

$

(338,687

)

 

$

204

 

 

$

152,886

 

Issuance of common stock upon
   exercise of stock options

 

 

 

625

 

 

 

-

 

 

 

1

 

 

 

-

 

 

 

-

 

 

 

1

 

Issuance of common stock related
   to ESPP purchase

 

 

 

112,468

 

 

 

-

 

 

 

111

 

 

 

-

 

 

 

-

 

 

 

111

 

Stock-based compensation expense related to employee stock awards

 

 

 

-

 

 

 

-

 

 

 

3,554

 

 

 

-

 

 

 

-

 

 

 

3,554

 

Stock-based compensation expense related to employee stock purchases

 

 

 

-

 

 

 

-

 

 

 

447

 

 

 

-

 

 

 

-

 

 

 

447

 

Vesting of early exercised
   common stock options

 

 

 

-

 

 

 

-

 

 

 

60

 

 

 

-

 

 

 

-

 

 

 

60

 

Other comprehensive loss

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(154

)

 

 

(154

)

Net loss

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(19,924

)

 

 

-

 

 

 

(19,924

)

Balance as of June 30, 2022

 

 

 

42,808,288

 

 

$

4

 

 

$

495,538

 

 

$

(358,611

)

 

$

50

 

 

$

136,981

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Six Months Ended June 30, 2022

 

 

 

 

Common Stock

 

 

Additional
Paid-in

 

 

Accumulated

 

 

Accumulated
Other
Comprehensive

 

 

Total
Stockholders’

 

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Income (Loss)

 

 

Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance as of December 31, 2021