UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_________________
FORM 8-K
_________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 6, 2025
_______________________________
ALIGOS THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
_______________________________
| Delaware | 001-39617 | 82-4724808 |
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |
One Corporate Dr., 2nd Floor
South San Francisco, California 94080
(Address of Principal Executive Offices) (Zip Code)
(800) 466-6059
(Registrant's telephone number, including area code)
(Former name or former address, if changed since last report)
_______________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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, $0.0001 par value per share | ALGS | The Nasdaq Stock Market LLC (Nasdaq Capital Market) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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. ☐
On May 6, 2025, the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
The information in this Item 2.02 and the attached Exhibit 99.1 are being furnished and shall not be deemed to be "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall they be deemed to be incorporated by reference in any filing made by the Registrant under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
| 99.1 | Press Release dated May 6, 2025 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Aligos Therapeutics, Inc. | ||
| Date: May 6, 2025 | By: | /s/ Lesley Ann Calhoun |
| Lesley Ann Calhoun | ||
| Executive Vice President, Chief Operating Officer and Chief Financial Officer | ||
EXHIBIT 99.1
Aligos Therapeutics Reports Recent Business Progress and First Quarter 2025 Financial Results
SOUTH SAN FRANCISCO, Calif., May 06, 2025 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biotechnology company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today reported recent business progress and financial results for the first quarter 2025.
“We continued to make progress towards our corporate development plans aimed at advancing life-saving therapies for viral and liver diseases,” stated Lawrence Blatt, Ph.D., M.B.A., Chairman, President, and Chief Executive Officer of Aligos Therapeutics. “Over the past few months, we raised over $100M to begin our important Phase 2 study of ALG-000184 in chronic hepatitis B virus infection and we are on track to begin dosing by mid-2025 following recent positive correspondence with the FDA. Our data presentation at the APASL meeting showcased the extension of dosing to 96 weeks. These data continue to support our belief that ALG-000184 has the potential to be first line standard of care treatment for chronic suppression of HBV infection as well as the drug of choice to combine with other agents aimed at functional cure. Additionally, recent data presented at the APASL meeting for ALG-055009, our THR-β agonist for the treatment of MASH, further demonstrated best-in-class potential. We are continuing our partnering discussions for ALG-055009 with several multinational pharmaceutical companies that have strong interests in MASH and other metabolic diseases.”
Recent Business Progress
Pipeline Updates
ALG-000184: Potential first-/best-in-class small molecule CAM-E for chronic hepatitis B virus (HBV) infection
ALG-055009: Potential best-in-class small molecule THR-β agonist for metabolic dysfunction-associated steatohepatitis (MASH)
ALG-097558: Potential best-in-class ritonavir-free small molecule pan-coronavirus protease inhibitor
Financial Results for the First Quarter 2025
Cash, cash equivalents and investments totaled $137.9 million as of March 31, 2025, compared with $56.9 million as of December 31, 2024. Our cash, cash equivalents and investments are expected to provide sufficient funding of planned operations into the second half of 2026.
Net income for the three months ended March 31, 2025 was $43.1 million or basic net income per common share of $5.12, and diluted net loss per common share of $(2.11), compared to net loss of $34.9 million or basic and diluted net loss per common share of $(5.58) for the three months ended March 31, 2024.
Research and development (R&D) expenses for the three months ended March 31, 2025 were $14.5 million, compared with $16.4 million for the same period of 2024. The decrease was primarily due to a decrease in third-party expenses for the clinical trials. Total R&D stock-based compensation expense incurred for the three months ended March 31, 2025 was $0.5 million, compared with $1.4 million for the same period of 2024.
General and administrative (G&A) expenses for the three months ended March 31, 2025 were $5.1 million, compared with $6.7 million for the same period of 2024. The decrease in G&A expenses for this comparative period is primarily due to a decrease in third-party expenses including legal expenses. Total G&A stock-based compensation expense incurred for the three months ended March 31, 2025 was $0.4 million, compared with $1.2 million for the same period of 2024.
Interest and other income, net, for the three months ended March 31, 2025 was income of $0.9 million compared with income of $1.6 million for the same period of 2024. The decrease was primarily due to a decrease in the accretion of short-term investments.
Change in fair value of 2023 common warrants for the three months ended March 31, 2025 was income of $61.5 million compared with a loss of $14.4 million for the same period of 2024.
About Aligos
Aligos Therapeutics, Inc. (NASDAQ: ALGS) is a clinical stage biotechnology company founded with the mission to improve patient outcomes by developing best-in-class therapies for the treatment of liver and viral diseases. Aligos applies its science driven approach and deep R&D expertise to advance its purpose-built pipeline of therapeutics for high unmet medical needs such as chronic hepatitis B virus infection, metabolic dysfunction-associated steatohepatitis (MASH), and coronaviruses.
For more information, please visit www.aligos.com or follow us on LinkedIn or X.
Forward-Looking Statement
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation, statements with respect to Aligos being positioned for success; the expectation that a Phase 2 clinical study for ALG-000184 will begin in mid-2025 and begin dosing in mid-2025; the potential of CAM-E and ALG-000184; the planned presentation at upcoming scientific conferences for ALG-000184; the expectation of continued development and potential out-licensing for ALG-055009 and future development of ALG-097558; the expectations regarding ALG-055009 and ALG-097558 funding; and the company’s continued belief its cash, cash equivalents and investments provide sufficient funding of fund planned operations into the second half of 2026. Forward-looking statements are typically, but not always, identified by the use of words such as “may,” “will,” “would,” “believe,” “intend,” “plan,” “anticipate,” “estimate,” “expect,” and other similar terminology indicating future results. Such forward looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties inherent in the drug development process, including Aligos’ clinical-stage of development, the process of designing and conducting clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Aligos’ ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of Aligos’ capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape and the impact of global events and other macroeconomic conditions on Aligos’ business. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Aligos in general, see Aligos’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 6, 2025 and Aligos’ Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 10, 2025 and its future periodic reports to be filed or submitted with the Securities and Exchange Commission. Except as required by law, Aligos undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.
Investor Contact
Jordyn Tarazi
Vice President, Investor Relations & Corporate Communications
+1 (650) 910-0427
jtarazi@aligos.com
| Aligos Therapeutics, Inc | ||||||||
| Condensed Consolidated Statements of Operations | ||||||||
| (In thousands, except share and per share amounts) | ||||||||
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2025 | 2024 | |||||||
| (Unaudited) | (Unaudited) | |||||||
| Revenue from Collaborations | $ | - | $ | 292 | ||||
| Revenue from Customers | 311 | 694 | ||||||
| Operating Expenses: | ||||||||
| Research and development | 14,502 | 16,366 | ||||||
| General and administrative | 5,052 | 6,666 | ||||||
| Total operating expenses | 19,554 | 23,032 | ||||||
| Loss from operations | (19,243 | ) | (22,046 | ) | ||||
| Interest and other income, net | 880 | 1,579 | ||||||
| Change in fair value of 2023 common warrants | 61,494 | (14,372 | ) | |||||
| Income (loss) before income tax provision | 43,131 | (34,839 | ) | |||||
| Income tax provision | (43 | ) | (24 | ) | ||||
| Net income (loss) | $ | 43,088 | $ | (34,863 | ) | |||
| Net income (loss) per share, basic | $ | 5.12 | $ | (5.58 | ) | |||
| Net loss per share, diluted | $ | (2.11 | ) | $ | (5.58 | ) | ||
| Weighted-average shares of common stock, basic | 8,408,481 | 6,246,113 | ||||||
| Weighted-average shares of common stock, diluted | 8,709,693 | 6,246,113 | ||||||
| Aligos Therapeutics, Inc. Condensed Consolidated Balance Sheets (In thousands) | |||||||
| March 31, 2025 | December 31, 2024 | ||||||
| (Unaudited) | (audited) (1) | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 73,763 | $ | 36,997 | |||
| Short-term investments | 64,098 | 19,942 | |||||
| Prepaid expenses and other current assets | 5,344 | 5,202 | |||||
| Total current assets | 143,205 | 62,141 | |||||
| Other assets | 7,494 | 7,953 | |||||
| Total assets | $ | 150,699 | $ | 70,094 | |||
| Liabilities and Stockholders’ Equity (Deficit) | |||||||
| Current liabilities | $ | 18,948 | $ | 21,737 | |||
| Other liabilities, noncurrent | 15,306 | 77,330 | |||||
| Total liabilities | 34,254 | 99,067 | |||||
| Total stockholders’ equity (deficit) | 116,445 | (28,973 | ) | ||||
| Total liabilities and stockholders’ equity (deficit) | $ | 150,699 | $ | 70,094 | |||
| _____________________________________________ | |
| (1) | The condensed consolidated balance sheet as of December 31, 2024 has been derived from the audited consolidated financial statements at that date included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024. |