On August 5, 2021 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, reported recent business progress and financial results for the second quarter, June 30, 2021 (Press release, Aligos Therapeutics, AUG 5, 2021, View Source [SID1234591815]).

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"Over the past few months, in addition to completing our recent financing, we have made significant strides in advancing our CHB and NASH drug candidates," commented Lawrence Blatt, PhD, MBA, Chairman and CEO of Aligos. "At recent scientific conferences, healthy volunteer data from our STOPS program and initial antiviral data in CHB subjects from our CAM program, were presented. For both the STOPS and CAM programs, enrollment in the first CHB cohort is complete and is ongoing in the second cohort. Additionally, we recently filed the first clinical trial application (CTA) for our ASO drug candidate, ALG-020572, which is anticipated to begin dosing in healthy volunteers in Q4 2021. We are also on track to file a CTA in Q3 for ALG-055009, our NASH drug candidate, and start dosing in healthy volunteers in Q4 2021. We look forward to continuing to advance these important development programs."

Recent Business Progress

Aligos Portfolio of Drug Candidates:

Preliminary safety and pharmacokinetic data in healthy volunteers (HVs) from the ongoing Phase 1a/b multi-part dose range finding trial (NCT04485663) of our S-antigen Transport-inhibiting Oligonucleotide Polymers (STOPS) compound, ALG-010133, were presented at the European Association for the Study of the Liver (EASL) Digital International Liver Congress 2021 (ILC 2021) in June. These data showed that single and multiple doses up to 200 mg and 180 mg, respectively, were generally well tolerated.

Enrollment and dosing in our Phase 1b trial evaluating subjects with CHB is ongoing and we continue to initiate more clinical trial centers to support this study. However, recent delays to enrollment of chronic hepatitis B subjects have been encountered due to COVID-19 related logistical challenges and an increasing number of competitive phase 2 clinical trials. Consequently, data from the planned 3 cohorts, evaluating a range of doses, are expected to be available in the first half of 2022.

Given that STOPS molecules work by a novel mechanism and patient antiviral response characteristics are unknown, we believe it is important to generate a dataset from multiple cohorts. This should enable us to refine the PK-PD model to optimize dosing for evaluation in subsequent cohorts and studies. We plan to unblind virological data, including HBsAg, once dosing in the first three cohorts has been completed.

In addition, evaluation of ALG-000184, a small molecule class II capsid assembly modulator (CAM), was initiated in patients with CHB in April. This dose range finding study (NCT04536337) is evaluating 28 days of once daily oral dosing of ALG-000184 or placebo in treatment naïve/currently not treated CHB patients. Initial 14-day data from the first cohort demonstrated that a 100 mg dose was well tolerated and resulted in significant antiviral activity. These 14-day data were presented at the HBV-TAG 2021 meeting in June. Data from additional cohorts are expected to be presented at one or more scientific conferences in the second half of 2021.

The initial CTA for our third CHB drug candidate, ALG-020572, an antisense oligonucleotide (ASO), was recently filed. We expect to begin evaluating ALG-020572 in HVs in the fourth quarter of 2021.

The CTA for our first nonalcoholic steatohepatitis (NASH) drug candidate, ALG-055009, a thyroid hormone receptor beta agonist, remains on track to be filed in the third quarter of 2021 to enable evaluation in HVs to commence in the fourth quarter of 2021.

Aligos has a broad CHB portfolio that targets different clinically validated mechanisms of action in the hepatitis B virus life cycle. The portfolio includes ALG-000184, a class II CAM, ALG-010133, a STOPS molecule, ALG-020572, an 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 dose range finding trials before evaluating them in combination in subsequent trials.

Corporate:

The company announced the pricing of its underwritten public offering of 4,400,000 shares of common stock at a public offering price of $19.00 per share. In addition, the company granted the underwriters a 30-day option to purchase up to an additional 660,000 shares of common stock at the same terms and conditions. All of the shares of common stock were offered by the company.

The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Aligos, were $83.6 million, excluding any exercise of the underwriters’ option to purchase additional shares. The offering closed on July 6, 2021, subject to customary closing conditions.

Financial Results for the Second Quarter 2021

Net losses for the three months ended June 30, 2021 were $29.8 million or basic and diluted net loss per common share of $(0.79) compared to net losses of $20.8 million or basic and diluted net loss per common share of $(7.40) for the three months ended June 30, 2020.

Research and development (R&D) expenses for the three months ended June 30, 2021, were $24.6 million compared with $17.2 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 June 30, 2021, was $2.0 million compared with $0.2 million for the same period for 2020.

General and administrative (G&A) expenses for the three months ended June 30, 2021, were $6.6 million compared with $4.1 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 June 30, 2021, was $1.5 million compared with $0.1 million for the same period for 2020.

Cash, cash equivalents and short-term investments totaled $190.7 million as of June 30, 2021 compared with $243.5 million as of December 31, 2020.