10-Q 1 algs-20240930.htm 10-Q 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 September 30, 2024

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 Capital 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 November 4, 2024, the registrant had 3,587,892 shares of common stock, $0.0001 par value per share, outstanding, comprised of 3,464,199 shares of voting common stock, $0.0001 par value per share and 123,693 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;
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 our 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;
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 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 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

i


 

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 (the 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 for a full fiscal year, 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 for a full fiscal year.
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.
If we fail to comply with the continued listing requirements of the Nasdaq Stock Market LLC (Nasdaq) our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted.
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 September 30, 2024 and December 31, 2023

1

 

Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) for the Three and Nine Months Ended September 30, 2024 and 2023

2

 

Condensed Consolidated Statements of Changes in Stockholders’ Equity for the Three and Nine Months Ended September 30, 2024 and 2023

3

 

Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2024 and 2023

5

 

Notes to Unaudited Condensed Consolidated Financial Statements

7

 

Item 2.

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

21

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

30

 

Item 4.

Controls and Procedures

30

 

PART II.

OTHER INFORMATION

31

 

Item 1.

Legal Proceedings

31

 

Item 1A.

Risk Factors

31

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

85

 

Item 3.

Defaults Upon Senior Securities

85

 

Item 4.

Mine Safety Disclosures

85

 

Item 5.

Other Information

85

 

Item 6.

Exhibits

86

 

Signatures

87

 

iv


 

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

ALIGOS THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share data)

 

 

 

 

September 30,
2024

 

 

December 31,
2023

 

 

 

 

 

 

 

 

ASSETS

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

35,331

 

 

$

135,704

 

Restricted cash

 

 

110

 

 

 

70

 

Short-term investments

 

 

39,591

 

 

 

-

 

Other current assets

 

 

4,790

 

 

 

5,310

 

Total current assets

 

 

79,822

 

 

 

141,084

 

Operating lease right-of-use assets

 

 

5,394

 

 

 

6,559

 

Property and equipment, net

 

 

2,575

 

 

 

3,259

 

Other assets

 

 

635

 

 

 

625

 

Total assets

 

$

88,426

 

 

$

151,527

 

 

 

 

 

 

 

LIABILITIES AND

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

2,740

 

 

$

2,517

 

Accrued liabilities

 

 

14,161

 

 

 

16,842

 

Operating lease liabilities, current

 

 

3,387

 

 

 

3,229

 

Finance lease liabilities, current

 

 

13

 

 

 

10

 

Deferred revenue from customers, current

 

 

655

 

 

 

1,224

 

Deferred revenue from collaborations, current

 

 

-

 

 

 

84

 

Total current liabilities

 

 

20,956

 

 

 

23,906

 

Operating lease liabilities, net of current portion

 

 

5,545

 

 

 

7,668

 

Finance lease liabilities, net of current portion

 

 

188

 

 

 

231

 

Warrant liability

 

 

11,595

 

 

 

27,596

 

Long term liability

 

 

46

 

 

 

46

 

Total liabilities

 

 

38,330

 

 

 

59,447

 

Commitments and contingencies (Note 12)

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Preferred Stock, $0.0001 par value; 10,000,000 shares authorized as of September 30, 2024 and December 31, 2023, respectively; no shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively.

 

 

-

 

 

 

-

 

Common stock, $0.0001 par value; 20,800,000 shares and 12,800,000 shares authorized as of September 30, 2024 and December 31, 2023, respectively; 3,324,780 and 3,003,855 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively.

 

 

8

 

 

 

7

 

Additional paid-in capital

 

 

585,369

 

 

 

578,325

 

Accumulated deficit

 

 

(535,858

)

 

 

(486,797

)

Accumulated other comprehensive income

 

 

577

 

 

 

545

 

Total stockholders’ equity

 

 

50,096

 

 

 

92,080

 

Total liabilities and stockholders’ equity

 

$

88,426

 

 

$

151,527

 

 

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
September 30,

 

 

Nine Months Ended
September 30,

 

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Revenue from collaborations

 

 

$

19

 

 

$

2,154

 

 

$

311

 

 

$

7,329

 

Revenue from customers

 

 

 

1,250

 

 

 

1,085

 

 

 

3,005

 

 

 

5,519

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

 

16,774

 

 

 

15,867

 

 

 

54,238

 

 

 

50,783

 

General and administrative

 

 

 

4,626

 

 

 

6,443

 

 

 

17,669

 

 

 

24,195

 

Total operating expenses

 

 

 

21,400

 

 

 

22,310

 

 

 

71,907

 

 

 

74,978

 

Loss from operations

 

 

 

(20,131

)

 

 

(19,071

)

 

 

(68,591

)

 

 

(62,130

)

Interest and other income, net

 

 

 

963

 

 

 

1,059

 

 

 

19,834

 

 

 

3,168

 

Loss before income tax expense

 

 

 

(19,168

)

 

 

(18,012

)

 

 

(48,757

)

 

 

(58,962

)

Income tax expense

 

 

 

(91

)

 

 

(29

)

 

 

(304

)

 

 

(825

)

Net loss

 

 

 

(19,259

)

 

 

(18,041

)

 

 

(49,061

)

 

 

(59,787

)

Other comprehensive income:

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain on available-for-sale securities

 

 

 

83

 

 

 

-

 

 

 

32

 

 

 

96

 

Other comprehensive income

 

 

 

83

 

 

 

-

 

 

 

32

 

 

 

96

 

Comprehensive loss

 

 

$

(19,176

)

 

$

(18,041

)

 

$

(49,029

)

 

$

(59,691

)

Net loss per share, basic and diluted

 

 

$

(3.07

)

 

$

(10.37

)

 

$

(7.84

)

 

$

(34.59

)

Weighted average shares of common stock, basic and diluted

 

 

 

6,272,291

 

 

 

1,739,847

 

 

 

6,258,706

 

 

 

1,728,282

 

 

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 September 30, 2024

 

 

 

Common Stock

 

 

Additional
Paid-in

 

 

Accumulated

 

 

Accumulated
Other
Comprehensive

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Income

 

 

Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance as of June 30, 2024

 

 

3,191,425

 

 

$

8

 

 

$

583,326

 

 

$

(516,599

)

 

$

494

 

 

$

67,229

 

Issuance of common stock upon
   exercise of stock options

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Issuance of common stock related
   to ESPP purchase

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Issuance of common stock upon
   exercise of pre-funded warrants

 

 

128,578

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Stock-based compensation expense related to employee stock awards

 

 

4,777

 

 

 

-

 

 

 

1,904

 

 

 

-

 

 

 

-

 

 

 

1,904

 

Stock-based compensation expense related to employee stock purchases

 

 

-

 

 

 

-

 

 

 

139

 

 

 

-

 

 

 

-

 

 

 

139

 

Vesting of early exercised
   common stock options

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Other comprehensive income

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

83

 

 

 

83

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(19,259

)

 

 

-

 

 

 

(19,259

)

Balance as of September 30, 2024

 

 

3,324,780

 

 

$

8

 

 

$

585,369

 

 

$

(535,858

)

 

$

577

 

 

$

50,096

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Nine Months Ended September 30, 2024

 

 

 

Common Stock

 

 

Additional
Paid-in

 

 

Accumulated

 

 

Accumulated
Other
Comprehensive

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Income

 

 

Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance as of December 31, 2023

 

 

3,003,855

 

 

$

7

 

 

$

578,325

 

 

$

(486,797

)

 

$

545

 

 

$

92,080

 

Issuance of common stock upon
   exercise of stock options

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Issuance of common stock related
   to ESPP purchase

 

 

22,438

 

 

 

-

 

 

 

297

 

 

 

-

 

 

 

-

 

 

 

297

 

Issuance of common stock upon
   exercise of pre-funded warrants

 

 

293,613

 

 

 

1

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

1

 

Issuance of common stock from
   RSU vesting

 

 

4,874

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Stock-based compensation expense related to employee stock awards

 

 

-

 

 

 

-

 

 

 

6,321

 

 

 

-

 

 

 

-

 

 

 

6,321

 

Stock-based compensation expense related to employee stock purchases

 

 

-

 

 

 

-

 

 

 

426

 

 

 

-

 

 

 

-

 

 

 

426

 

Other comprehensive loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

32

 

 

 

32

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(49,061

)

 

 

-

 

 

 

(49,061

)

Balance as of September 30, 2024

 

 

3,324,780

 

 

$

8

 

 

$

585,369

 

 

$

(535,858

)

 

$

577

 

 

$

50,096

 

 

3


 

 

 

 

Three Months Ended September 30, 2023

 

 

 

 

Common Stock

 

 

Additional
Paid-in

 

 

Accumulated

 

 

Accumulated
Other
Comprehensive

 

 

Total
Stockholders’

 

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Income

 

 

Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance as of June 30, 2023

 

 

 

1,740,084

 

 

$

4

 

 

$

509,998

 

 

$

(440,864

)

 

$

497

 

 

$

69,635

 

Issuance of common stock related
   to ESPP purchase

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Stock-based compensation expense related to employee stock awards

 

 

 

-

 

 

 

-

 

 

 

2,883

 

 

 

-

 

 

 

-

 

 

 

2,883

 

Stock-based compensation expense related to employee stock purchases

 

 

 

-

 

 

 

-

 

 

 

326

 

 

 

-

 

 

 

-

 

 

 

326

 

Vesting of early exercised
   common stock options

 

 

 

-

 

 

 

-

 

 

 

18

 

 

 

-

 

 

 

-

 

 

 

18

 

Other comprehensive loss

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Net loss

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(18,041

)

 

 

-

 

 

 

(18,041

)

Balance as of September 30, 2023

 

 

 

1,740,084

 

 

$

4

 

 

$

513,225

 

 

$

(458,905

)

 

$

497

 

 

$

54,821

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Nine Months Ended September 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

 

 

 

1,716,923

 

 

$

4

 

 

$

502,613

 

 

$

(399,118

)

 

$

401

 

 

$

103,900

 

Issuance of common stock upon
   exercise of stock options

 

 

 

680

 

 

 

-

 

 

 

23

 

 

 

-

 

 

 

-

 

 

 

23

 

Issuance of common stock related
   to ESPP purchase

 

 

 

22,481

 

 

 

-

 

 

 

461

 

 

 

-

 

 

 

-

 

 

 

461

 

Stock-based compensation expense related to employee stock awards

 

 

 

-

 

 

 

-

 

 

 

9,361

 

 

 

-

 

 

 

-

 

 

 

9,361

 

Stock-based compensation expense related to employee stock purchases

 

 

 

-

 

 

 

-

 

 

 

708

 

 

 

-

 

 

 

-

 

 

 

708

 

Vesting of early exercised
   common stock options

 

 

 

-

 

 

 

-

 

 

 

59

 

 

 

-

 

 

 

-

 

 

 

59

 

Other comprehensive income

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

96

 

 

 

96

 

Net loss

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(59,787

)

 

 

-

 

 

 

(59,787

)

Balance as of September 30, 2023

 

 

 

1,740,084

 

 

$

4

 

 

$

513,225

 

 

$

(458,905

)

 

$

497

 

 

$

54,821

 

 

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

4


 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

(In thousands)

 

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(49,061

)

 

$

(59,787

)

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

 

 

 

 

 

 

Accretion of discount on investments

 

 

(1,411

)

 

 

(424

)

Amortization of right of use assets

 

 

1,165

 

 

 

1,129

 

Impairment of right of use assets

 

 

-

 

 

 

724

 

Change in fair value of warrant liability

 

 

(16,001

)

 

 

-

 

Loss on disposal of assets

 

 

-

 

 

 

17

 

Depreciation expense

 

 

786

 

 

 

1,165

 

Stock-based compensation including ESPP

 

 

6,747

 

 

 

10,069

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Other assets

 

 

512

 

 

 

3,472

 

Accounts payable

 

 

223

 

 

 

(1,796

)

Accrued liabilities

 

 

(2,681

)

 

 

(3,657

)

Operating lease liabilities

 

 

(1,966

)

 

 

(1,805

)

Other liabilities

 

 

-

 

 

 

46

 

Deferred revenue from collaborations

 

 

(84

)

 

 

(6,650

)

Deferred revenue from customers

 

 

(569

)

 

 

1,158

 

Net cash and cash equivalents used in operating activities

 

 

(62,340

)

 

 

(56,339

)

Cash flows from investing activities:

 

 

 

 

 

 

Activities in available-for-sale investments:

 

 

 

 

 

 

Maturities of short-term investments

 

 

70,000

 

 

 

45,011

 

Purchase of short-term investments

 

 

(108,149

)

 

 

(11

)

Purchases of property and equipment

 

 

(102

)

 

 

(12

)

Net cash and cash equivalents (used in) provided by investing activities

 

 

(38,251

)

 

 

44,988

 

Cash flows from financing activities:

 

 

 

 

 

 

Proceeds from issuance of common stock upon exercise of pre funded warrants

 

 

1

 

 

 

-

 

Payments on finance lease

 

 

(40

)

 

 

(92

)

Proceeds from the ESPP purchase

 

 

297

 

 

 

461

 

Proceeds from the exercise of common stock option

 

 

-

 

 

 

23

 

Net cash and cash equivalents provided by financing activities

 

 

258

 

 

 

392

 

Net decrease in cash, cash equivalents, and restricted cash

 

 

(100,333

)

 

 

(10,959

)

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

 

 

135,774

 

 

 

81,462

 

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

 

$

35,441

 

 

$

70,503

 

 

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

5


 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

(In thousands)

 

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

Reconciliation to amounts on the Consolidated Balance Sheets:

 

 

 

 

 

 

   Cash and cash equivalents

 

$

35,331

 

 

$

70,429

 

   Restricted cash

 

 

110

 

 

 

74

 

Total cash, cash equivalents, and restricted cash

 

$

35,441

 

 

$

70,503

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Supplemental disclosures of noncash financing and investing activities:

 

 

 

 

 

 

   Mark to market adjustment for available-for-sale investments

 

$

32

 

 

$

96

 

   Acquisition of right of use asset through operating lease obligation

 

 

-

 

 

 

1,094

 

   Vesting of early exercised options

 

 

-

 

 

 

59

 

 

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

6


 

ALIGOS THERAPEUTICS, INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

 

1.
Organization

Description of business

Aligos Therapeutics, Inc. (Aligos-US) was incorporated in the state of Delaware on February 5, 2018 (inception). On September 10, 2018, the Company formed Aligos Belgium BVBA (Aligos-Belgium), a limited liability company organized under the laws of Belgium. On March 30, 2020, the Company formed as a wholly owned subsidiary, Aligos Australia Pty LTD (Aligos-Australia), a proprietary limited company. On May 18, 2021, the Company formed as a wholly owned subsidiary, Aligos Therapeutics (Shanghai) Co. Ltd. (Aligos-Shanghai) and together with Aligos-US, Aligos-Belgium, and Aligos-Australia being the “Company” or “Aligos”.

Aligos is a clinical-stage biopharmaceutical company developing novel therapeutics to address unmet medical needs in viral and liver diseases, including for chronic hepatitis B (CHB), metabolic dysfunction associated steatohepatitis (MASH), and coronaviruses.

The Company is devoting substantially all of its efforts to the research and development of its drug candidates. The Company has not generated any product revenue to date. The Company is also subject to a number of risks similar to other companies in the biotechnology industry, including the uncertainty of success of its nonclinical studies and clinical trials, regulatory approval of drug candidates, uncertainty of market acceptance of products, competition from substitute products and larger companies, the need to obtain additional financing, compliance with government regulations, protection of proprietary technology, dependence on third-parties, product liability, and dependence on key individuals.

Liquidity

The Company has incurred losses and negative cash flows from operations in each fiscal year since its inception. As of September 30, 2024 and December 31, 2023, the Company had an accumulated deficit of $535.9 million and $486.8 million, respectively. Management expects to continue to incur additional substantial losses in future fiscal years in the foreseeable future as a result of its research and development activities.

As of September 30, 2024, the Company has cash, cash equivalents and investments of approximately $74.9 million which is available to fund future operations. The Company expects to continue to spend substantial amounts to continue the nonclinical and clinical development of its current and future programs. If the Company is able to gain marketing approval for drug candidates that are being developed, it will require significant additional amounts of cash in order to launch and commercialize such drug candidates. In addition, other unanticipated costs may arise. Because the design and outcome of the Company’s planned and anticipated clinical trials is highly uncertain, the Company cannot reasonably estimate the actual amounts necessary to successfully complete the development and commercialization of any drug candidate the Company may develop.

7


 

The Company expects to finance its cash needs through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and/or other marketing or distribution arrangements. In addition, the Company may seek additional capital to take advantage of favorable market conditions or strategic opportunities even if the Company believes it has sufficient funds for its current or future operating plans. Based on the Company’s research and development plans, the Company expects its existing cash, cash equivalents and investments, will enable it to fund its operations for at least 12 months following the date the condensed consolidated financial statements are issued. However, the Company’s operating plan may change as a result of many factors currently unknown, and the Company may need to seek additional funds sooner than planned. Moreover, it is particularly difficult to estimate with certainty the Company’s future expenses given the dynamic nature of its business and the macro-economic environment generally.

The Company’s ability to raise additional funds depends on financial, economic and other factors, many of which are beyond its control. For example, if there is a disruption of global financial markets, the Company could be unable to access additional capital, which could negatively affect its ability to consummate certain corporate development transactions or other important, beneficial or opportunistic investments. If additional funds are not available to the Company when needed, on terms that are acceptable to the Company, or at all, the Company may be required to: delay, limit, reduce or terminate nonclinical studies, clinical trials or other research and development activities or eliminate one or more of its development programs altogether; or delay, limit, reduce or terminate its efforts to establish manufacturing and sales and marketing capabilities or other activities that may be necessary to commercialize any future approved products, or reduce the Company’s flexibility in developing or maintaining its sales and marketing strategy.

Periodically, the Company maintains deposits in accredited financial institutions in excess of federally insured limits. The Company deposits its cash 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. The Company has always maintained a dual banking system to limit its credit and liquidity risk.

2.
Summary of significant accounting policies

Basis of presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) and applicable rules and regulations of the Securities and Exchange Commission (the SEC) regarding interim financial reporting. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. Any reference in these notes to applicable accounting guidance is meant to refer to the authoritative U.S. GAAP included in the Accounting Standards Codification (ASC), and Accounting Standards Update (ASU) issued by the Financial Accounting Standards Board (FASB).

The condensed consolidated balance sheet as of December 31, 2023 included herein was derived from the audited consolidated financial statements as of that date but does not include all of the information and notes required by U.S. GAAP for complete financial statements. Certain information and note disclosures normally included in the financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to requirements for interim financial statements. As such, the information included in this Quarterly Report on Form 10-Q should be read in conjunction with the audited consolidated financial statements and the related notes thereto as of and for the year ended December 31, 2023, included in the Company’s Annual Report on Form 10-K filed with the SEC on March 12, 2024.

Unaudited interim financial information

The accompanying consolidated balance sheet as of September 30, 2024, the consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2024 and 2023, the consolidated statements of stockholders’ equity for the three and nine months ended September 30, 2024 and 2023, and the consolidated statements of cash flows for the nine months ended September 30, 2024 and 2023 are unaudited. The unaudited consolidated interim financial statements have been prepared on the same basis as the audited annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the Company’s consolidated financial position as of September 30, 2024 and the consolidated results of its operations and cash flows for the nine months ended September 30, 2024 and 2023. The consolidated financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2024 and 2023 are unaudited. The consolidated results for the three and nine months ended September 30, 2024 are not necessarily indicative of results to be expected for the year ending December 31, 2024, any other interim periods, or any future year or period.

 

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Significant accounting policies and estimates

No material changes were made to the Company’s significant accounting policies disclosed in Note 2, Summary of significant accounting policies, in its Annual Report on Form 10-K, filed with the SEC on March 12, 2024, for the year ended December 31, 2023.

Reverse Stock Split

In June 2024, the Company’s stockholders approved a reverse stock split of its authorized, issued and outstanding voting and non-voting common stock at a range of ratios between 1-for-5 to 1-for-30, and the Company’s board of directors subsequently approved the implementation of the reverse stock split at a ratio of 1-for-25 (the Reverse Stock Split). The Reverse Stock Split was effective as of August 19, 2024.

As of the effective time of the Reverse Stock Split, every 25 issued and outstanding shares of the Company’s common stock was automatically reclassified into one issued and outstanding share of the Company’s common stock. This reduced the number of shares outstanding from 79.9 million shares to 3.3 million shares. The Reverse Stock Split did not affect the par value of the common stock. No fractional shares of common stock were issued in connection with the Reverse Stock Split and all fractional shares were rounded down to the nearest whole share with respect to outstanding shares of common stock. Any holders of common stock who would have otherwise received a fractional share of common stock pursuant to the Reverse Stock Split, received cash in lieu of the fractional share. All prior period share and per share amounts of the Company's common stock presented have been retroactively adjusted to reflect the 1-for-25 Reverse Stock Split.

Recently issued accounting standards

From time to time, new accounting pronouncements are issued by FASB that the Company adopts as of the specified effective date. The Company qualifies as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 and has the option to not “opt out” of the extended transition related to complying with new or revised accounting standards. This means that when a standard is issued or revised and it has different application dates for public and nonpublic companies, the Company has the option to adopt the new or revised standard at the time nonpublic companies adopt the new or revised standard and can do so until such time that the Company either (i) irrevocably elects to “opt out” of such extended transition period or (ii) no longer qualifies as an emerging growth company.

In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280) (ASU 2023-07). The guidance improves reportable segment disclosures requirements, primarily through enhanced disclosures about significant segment expenses. The standard is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted. The Company is evaluating the potential impact of this standard on its consolidated financial statements.

The Company has considered all recent accounting pronouncements issued, but not yet effective, and does not expect any to have a material effect on the Company’s condensed consolidated financial statements other than those discussed in its Annual Report on Form 10-K, filed with the SEC on March 12, 2024, for the year ended December 31, 2023.

3.
Property and equipment

The components of property and equipment as of September 30, 2024 and December 31, 2023 were as follows (in thousands):

 

 

 

September 30,
2024

 

 

December 31,
2023

 

Leasehold improvements

 

$

6,101

 

 

$

6,101

 

Lab equipment

 

 

5,932

 

 

 

5,830

 

Computer equipment

 

 

1,051

 

 

 

1,051

 

Furniture and office equipment

 

 

732

 

 

 

732

 

Vehicles and equipment

 

 

296

 

 

 

296

 

Asset under construction

 

 

4

 

 

 

4

 

Total, at cost

 

 

14,116

 

 

 

14,014

 

Accumulated depreciation

 

 

(11,541

)

 

 

(10,755

)

Total, net

 

$

2,575

 

 

$

3,259

 

 

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Depreciation expense was $0.3 million and $0.8 million, respectively, for the three and nine months ended September 30, 2024 and $0.3 million and $1.2 million for the three and nine months ended September 30, 2023, respectively. Finance leases are also included in property and equipment as vehicles and lab equipment on the condensed consolidated balance sheets.

4.
Investments

As of September 30, 2024, amortized cost, gross unrealized gains and losses, and estimated fair values of total fixed-maturity securities were as follows (in thousands):

 

 

 

September 30, 2024

 

 

 

 

 

 

Gross

 

 

Gross

 

 

 

 

 

 

Amortized

 

 

Unrealized

 

 

Unrealized

 

 

Estimated

 

 

 

Cost

 

 

Gain

 

 

Loss

 

 

Fair Value

 

Available-for-sale securities:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. Treasury bonds

 

$

39,559

 

 

$

32

 

 

$

-

 

 

$

39,591

 

 

 

 

 

 

 

 

 

 

 

 

 

 

As of December 31, 2023, the Company did not hold any available for sale securities.

 

Changes in fair value are related to changes in market interest rates. The Company expects to collect all contractual principal and interest payments.

The following is a summary of maturities of securities available-for-sale as of September 30, 2024 (in thousands):

 

 

 

Available-for-sale

 

 

Amortized Cost

 

 

Estimated
Fair Value

 

Amounts maturing in:

 

 

One year or less

$

39,559

 

$

39,591

 

Total investments

$

39,559

 

$

39,591

 

 

The Company recorded interest income of $0.5 million and $1.4 million for the three and nine months ended September 30, 2024, respectively, and $1.0 million and $2.7 million for the three and nine months ended September 30, 2023, respectively, as a component of interest and other income, net on the Company’s condensed consolidated statements of operations and comprehensive loss.

5.
Accrued liabilities

Accrued liabilities consisted of the following (in thousands):

 

 

 

September 30,

 

 

December 31,

 

 

 

2024

 

 

2023

 

Accrued compensation

 

$

4,407

 

 

$

6,673

 

Accrued payables

 

 

7,007

 

 

 

7,144

 

Other

 

 

2,747

 

 

 

3,025

 

Total

 

$

14,161

 

 

$

16,842

 

 

 

6. Capital stock

Common stock

On October 20, 2020, the Company amended its certificate of incorporation to increase the total shares of common stock authorized for issuance to 12,800,000 and decrease the total shares of preferred stock authorized for issuance to 10,000,000 with a par value of $0.0001 per share. 12,000,000 shares of the common stock were designated as “Voting Common Stock” and 800,000 shares of the common stock were designated as “Non-Voting Common Stock”.

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On June 27, 2024, the Company amended its certificate of incorporation to increase the total shares of voting common stock authorized for issuance from 12,000,000 to 20,000,000.

The holders of shares of voting common stock are entitled to one vote for each share of common stock at all meetings of stockholders.