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Aligos Therapeutics, Inc. (NASDAQ: ALGS) is a clinical-stage biopharmaceutical company headquartered in South San Francisco, California, and founded in 2018. The company is dedicated to developing novel therapeutics to address unmet medical needs in liver and viral diseases. Aligos is particularly focused on treatments for chronic hepatitis B (CHB) and metabolic dysfunction-associated steatohepatitis (MASH), as well as for coronaviruses.
The company’s lead candidate, ALG-010133, is a synthetic oligonucleotide currently in Phase I clinical trial for the treatment of CHB. Other promising candidates in their pipeline include ALG-000184, a capsid assembly modulator also targeting CHB, and ALG-055009, a small molecule thyroid hormone receptor beta (THR-ß) agonist for MASH. Initial studies on ALG-055009 have demonstrated enhanced potency and favorable pharmacokinetics.
Aligos is advancing its clinical programs, including the Phase 2a HERALD study of ALG-055009, which will assess the safety and efficacy of the drug in subjects with MASH, with topline data expected in Q4 2024. The study aims to enroll about 100 subjects and will evaluate multiple non-invasive biomarkers to track liver health improvements.
The company is also actively engaged in collaborations and partnerships to bolster its research efforts. Recently, Aligos presented positive data at the European Association for the Study of the Liver (EASL) Congress 2024, showcasing the sustained antiviral activity of ALG-000184 in both HBeAg-positive and HBeAg-negative CHB subjects. This data represents a significant advancement in viral load suppression and demonstrates Aligos' potential to deliver best-in-class treatments.
Besides its focus on liver diseases, Aligos is developing ALG-097558, a pan-coronavirus protease inhibitor showing promise in preclinical and early clinical trials. ALG-097558 has been well tolerated and does not require ritonavir boosting, addressing a critical need for effective, easily administered antiviral therapies.
Financially, Aligos reported cash, cash equivalents, and investments totaling $112.7 million as of March 31, 2024. The company continues to secure funding to support its operations and further its research projects, with a belief that its current cash balance will sustain operations through the end of 2025.
Aligos’ mission is to leverage its deep expertise and innovative approaches in drug development to become a leader in treating liver and viral diseases, ultimately improving patient outcomes and addressing high unmet medical needs worldwide.
Aligos Therapeutics (Nasdaq: ALGS) has appointed Dr. Hardean Achneck as Chief Medical Officer, effective immediately. Dr. Achneck, a seasoned clinical development executive with expertise in hepatology and infectious diseases, will lead the company's global clinical development efforts and join the Senior Leadership Team. This appointment follows Aligos' recent positive topline data for ALG-055009 in MASH subjects.
Dr. Achneck brings extensive experience from previous roles, including Senior Vice President and Head of Clinical Development at Pliant Therapeutics, and Vice President of Clinical Development and Clinical Research at Dicerna Therapeutics. He has successfully advanced liver-targeted oligonucleotide assets and has a strong background in hepatic diseases. Dr. Achneck holds an M.D. from Yale University School of Medicine and is licensed to practice medicine in the U.S. and EU.
Aligos Therapeutics (Nasdaq: ALGS) announced positive topline results from the Phase 2a HERALD study of ALG-055009, a thyroid hormone receptor beta agonist, for treating metabolic-dysfunction associated steatohepatitis (MASH). The study met its primary endpoint with statistically significant reductions in liver fat at Week 12, measured by MRI-PDFF. Key findings include:
1. Placebo-adjusted median relative reductions in liver fat up to 46.2% with a clear dose response
2. ALG-055009 was well-tolerated with no serious adverse events
3. Significant reductions in atherogenic lipids, including LDL-C, lipoprotein (a), and apolipoprotein B
4. Up to 70% of subjects achieved ≥30% relative reduction in liver fat compared to baseline
The company is evaluating options for further development, including potential partnerships.
Aligos Therapeutics (Nasdaq: ALGS) is set to announce topline results from its Phase 2a HERALD study of ALG-055009, a thyroid hormone receptor beta (THR-β) agonist for the treatment of metabolic-dysfunction associated steatohepatitis (MASH), on September 19, 2024. The company, focused on developing therapies for liver and viral diseases, will release the results before market open and host a conference call and webcast at 8:30am ET/5:30am PT to discuss the findings.
Investors and interested parties can access the live webcast with slides on the Aligos website's Presentation & Events page. A replay of the webcast will be available for 90 days following the live presentation.
Aligos Therapeutics (Nasdaq: ALGS), a clinical stage biopharmaceutical company specializing in liver and viral diseases, has announced an inducement grant under Nasdaq Listing Rule 5635(c)(4). The company's Compensation Committee granted a non-qualified stock option to purchase 3,500 shares to a newly hired employee on September 10, 2024. This grant, made under Aligos' 2024 Inducement Plan, serves as an inducement for employment.
The stock option's exercise price equals the closing price of Aligos' common stock on the grant date. The shares will vest over four years, with 25% vesting on the first anniversary and the remainder vesting in equal monthly installments, contingent on continued employment.
Aligos Therapeutics (Nasdaq: ALGS) has announced a 1-for-25 reverse stock split effective August 19, 2024. The company's common stock will continue trading on the Nasdaq Capital Market under the same symbol with a new CUSIP number. This move primarily aims to regain compliance with Nasdaq's $1.00 minimum bid price requirement. The reverse split will affect all outstanding stock options, warrants, and equity incentive plans proportionally. No fractional shares will be issued, with stockholders receiving cash payments instead. The split was approved by stockholders on June 27, 2024, and subsequently by the Board of Directors. Continental Stock Transfer & Trust Company is acting as the exchange and transfer agent for the process.
Aligos Therapeutics (Nasdaq: ALGS) has appointed two new independent directors to its Board: Dr. Heather Preston and Margarita Chavez, J.D. Dr. Preston, with over 30 years of healthcare industry experience, will chair the Nominating and Corporate Governance Committee. Ms. Chavez, bringing 25 years of dealmaking expertise, will join the Audit Committee. Both appointments are effective August 7, 2024.
Dr. Preston, currently a Senior Advisor to TPG Biotech, has a background in investing and medical practice. Ms. Chavez, a Venture Partner at Wellington Partners, has extensive experience in biopharmaceutical dealmaking. These appointments aim to strengthen Aligos's Board as the company progresses its drug candidates for liver and viral diseases through clinical trials.
Aligos Therapeutics (Nasdaq: ALGS) reported Q2 2024 financial results and business progress. Key highlights include:
1. Completed enrollment for Phase 2a HERALD study of ALG-055009 (THR-β agonist for MASH), with topline data expected in early Q4 2024.
2. Presented promising data for ALG-000184 (CAM-E for CHB) at EASL Congress 2024, showing sustained HBV DNA suppression.
3. Received positive FDA feedback for ALG-000184, supporting future studies with sustained HBV DNA suppression as the primary endpoint.
4. Q2 2024 net income of $5.1 million ($0.03 per share), primarily due to a decrease in warrant liability.
5. Cash balance of $94.5 million as of June 30, 2024, expected to fund operations through end of 2025.
Aligos Therapeutics (Nasdaq: ALGS), a clinical stage biopharmaceutical company specializing in liver and viral diseases, has announced that it will release its second quarter 2024 financial results on Tuesday, August 6, 2024. The report will be made available after the close of U.S. financial markets. This announcement is significant for investors and analysts who closely follow the company's financial performance and progress in developing novel therapeutics for unmet medical needs in liver and viral diseases.
Aligos Therapeutics (Nasdaq: ALGS) has announced a clinical trial collaboration with Xiamen Amoytop Biotech to evaluate the combination of ALG-000184 and PEGBING® (Mipeginterferon alfa-2b) in chronic hepatitis B (CHB) patients in China. Amoytop will sponsor a Phase 1b exploratory study to assess the efficacy and safety of this combination.
ALG-000184 is a potent oral capsid assembly modulator (CAM-E) designed to disrupt hepatitis B cccDNA levels and reduce viral markers. It has shown promising results in Phase 1a and 1b studies. PEGBING®, developed by Amoytop, is a 40kD pegylated interferon α-2b injection used in viral hepatitis treatment.
The 48-week Phase 1b study will compare ALG-000184 + PEGBING® + entecavir (ETV) with ALG-000184 + ETV or PEGBING® + ETV in HBeAg-positive and HBeAg-negative CHB subjects.
Aligos Therapeutics announced a virtual KOL event on July 18, 2024, featuring Dr. Mark Sulkowski to discuss positive Phase 1b data for ALG-000184 in treating chronic hepatitis B (CHB). The event will cover the unmet needs in CHB treatment, current landscape, and future development plans following positive FDA feedback. Aligos' CEO, Lawrence Blatt, highlighted the promising results of ALG-000184 monotherapy, showing significant viral suppression without breakthrough, and its superior efficacy compared to existing treatments. The KOL event aims to provide further insights into the regulatory pathway for chronic suppression.
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