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 10, 2021
Aligos Therapeutics, Inc.
(Exact Name of Registrant as Specified in Charter)
| Delaware | 001-39617 | 82-4724808 |
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification Number) |
| One Corporate Dr., 2nd Floor South San Francisco, CA 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 Global Select Market) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company [ X ]
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. [ ]
Item 2.02. Results of Operations and Financial Condition.
On May 10, 2021, 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.
Item 9.01. Financial Statements and Exhibits.
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 10, 2021 | By: | /s/ Lesley Ann Calhoun |
| Lesley Ann Calhoun | ||
| Executive Vice President, Chief Financial Officer | ||
EXHIBIT 99.1
Aligos Therapeutics Reports Recent Business Progress and First Quarter 2021 Financial Results
Advancement of Aligos’ drug candidates continues to be on track
SOUTH SAN FRANCISCO, Calif., May 10, 2021 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today reported recent business progress and financial results for the first quarter March 31, 2021.
"Despite the many challenges posed by the ongoing pandemic, Aligos’ 2021 activities remain on track,” said Lawrence Blatt, PhD, MBA, CEO of Aligos. “Our clinical stage programs continue to advance, with dosing in CHB patients commencing for both our STOPS™ and CAM programs. Additionally, our ASO and thyroid hormone receptor beta agonist programs remain on track to start clinical trials in the second half of this year. Everyone at Aligos remains focused on advancing these and our various non-clinical programs towards the next stage of development.”
Recent Business Progress
Aligos Portfolio of Drug Candidates:
Evaluation of ALG-000184, a small molecule class II capsid assembly modulator (CAM), was initiated in patients with CHB. The study (NCT04536337) is evaluating 28 days of once daily oral dosing of ALG-000184 or placebo in treatment naïve/currently not treated patients with CHB. Safety and antiviral data from the initial cohort(s) are expected in the second half of 2021.
Aligos’ CAM program represents one of several in the company’s chronic hepatitis B (CHB) portfolio that target different clinically validated mechanisms of action in the hepatitis B virus life cycle. The portfolio also includes ALG-010133, an S-antigen Transport-inhibiting Oligonucleotide Polymers (STOPSTM) molecule, ALG-020572, an antisense oligonucleotide (ASO), and ALG-020755, a small interfering RNA (siRNA) drug candidate. The properties of these candidates indicate that their use in combination could yield potentially best-in-class treatment regimens that may achieve higher rates of functional cure than current standard of care. For each of these drug candidates, Aligos plans to initially establish proof of concept as monotherapy in Phase 1 umbrella trials before evaluating them in combination in subsequent trials.
Financial Results for the First Quarter 2021
Net losses for the three months ended March 31, 2021 were $27.7 million or basic and diluted net loss per common share of $0.74 compared to net losses of $20.0 million or basic and diluted net loss per common share of $7.56 for the three months ended March 31, 2020.
Research and development (R&D) expenses for the three months ended March 31, 2021, were $22.9 million compared with $17.3 million for the same period of 2020. The increase in R&D expenses for this comparative period is primarily attributable to increased expenses related to the Company’s continued development of ALG-010133 and ALG-000184 clinical trial activities, as well as increases in salaries and employee-related expenses and preclinical programs. Total R&D stock-based compensation expense incurred for the three months ended March 31, 2021, was $1.7 million compared with $0.2 million for the same period for 2020.
General and administrative (G&A) expenses for the three months ended March 31, 2021, were $5.8 million compared with $3.4 million for the same periods of 2020. The increase in G&A expenses for this comparative period is primarily attributable to higher employee-related costs associated with the growth of the Company’s operations and additional professional and consulting services related to being a public company. Total G&A stock-based compensation expense incurred for the three months ended March 31, 2021, was $1.0 million compared with $0.2 million for the same period for 2020.
Cash, cash equivalents and marketable securities totaled $213.4 million as of March 31, 2021 compared with $243.5 million as of December 31, 2020.
About Aligos
Aligos Therapeutics, Inc. is a clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of viral infections and liver diseases. Aligos is focused on the discovery and development of targeted antiviral therapies for chronic hepatitis B (CHB) and coronaviruses as well as leveraging its expertise in liver diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH). Aligos’ strategy is to harness the deep expertise and decades of drug development experience its team has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.
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 regarding the continued advancement of Aligos’s clinical stage STOPS and CAM programs; the ASO and thyroid hormone receptor beta agonist programs remaining on track to start clinical trials in the second half of 2021; the advancement of these and various non-clinical programs towards the next stage of development; expectations that safety and antiviral data from the initial cohort(s) of the ALG-000184 study (NCT04536337) being available in the second half of 2021; the use of the candidates in Aligos’s CHB portfolio in combination yielding potentially best-in-class treatment regimens that may achieve higher rates of functional cure than current standard of care; and Aligos’s plans to initially establish proof of concept as monotherapy in Phase 1 umbrella trials for each of these CHB drug candidates before evaluating them in combination in subsequent trials.. 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’s 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’s ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of Aligos’s capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape and the effects on our business of the worldwide COVID-19 pandemic. 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’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 23, 2021 and as well as other documents Aligos files from time to time 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.
| Aligos Therapeutics, Inc | |||||
| Condensed Consolidated Statements of Operations | |||||
| (In thousands, except share and per share amounts) | |||||
| Three Months Ended March 31, | |||||
| 2021 | 2020 | ||||
| (Unaudited) | (Unaudited) | ||||
| Revenue from Collaborations | $ | 910 | $ | -- | |
| Operating Expenses: | |||||
| Research and development | 22,869 | 17,302 | |||
| Selling, general and administrative | 5,781 | 3,419 | |||
| Total operating expenses | 28,650 | 20,721 | |||
| Loss from operations | (27,740) | (20,721) | |||
| Interest and other income (expense), net | 111 | 692 | |||
| Loss before income tax expense | (27,629) | (20,029) | |||
| Income tax expense | (45) | -- | |||
| Net loss | $ | (27,674) | $ | (20,029) | |
| $ | (0.74) | $ | (7.56) | ||
| Weighted-average number of shares used in computing basic and diluted net loss per common share | 37,434,261 | 2,648,885 | |||
| Aligos Therapeutics, Inc | |||||
| Condensed Consolidated Balance Sheets | |||||
| (in thousands) | |||||
| March 31, 2021 | December 31, 2020 | ||||
| (Unaudited) | (1) | ||||
| Assets | |||||
| Current assets: | |||||
| Cash and cash equivalents | $ | 200,362 | $ | 220,383 | |
| Short-term marketable securities | 13,053 | 23,130 | |||
| Prepaid expenses and other current assets | 6,411 | 6,504 | |||
| Total current assets | 219,826 | 250,017 | |||
| Other assets | 14,714 | 15,285 | |||
| Total assets | $ | 234,540 | $ | 265,302 | |
| Liabilities and Stockholders’ Equity | |||||
| Current liabilities | $ | 25,231 | $ | 30,274 | |
| Other liabilities, noncurrent | 14,089 | 14,989 | |||
| Total liabilities | 39,320 | 45,263 | |||
| Total stockholders’ equity | 195,220 | 220,039 | |||
| Total liabilities and stockholders’ equity | $ | 234,540 | $ | 265,302 | |
(1) The condensed, consolidated balance sheet at December 31, 2020 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, 2020.
Media Contact
Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
ajobe@lifescicomms.com
Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com