Aligos Therapeutics(US:ALGS)2025-11-06 13:37Drug Development - The company is developing three potential best-in-class drug candidates for chronic hepatitis B virus (HBV) infection, obesity, and coronavirus infections, with promising clinical data reported[95][96]. - Pevifoscorvir sodium has shown multi-log10 reductions in HBV DNA and RNA in Phase 1 studies, with 60% of HBeAg+ subjects achieving sustained HBV DNA suppression at Week 48[100][101]. - The ongoing Phase 2 B-SUPREME study aims to evaluate the safety and efficacy of pevifoscorvir sodium compared to tenofovir disoproxil fumarate in approximately 200 subjects with chronic HBV infection[105]. - The company has received positive feedback from the FDA and other regulatory bodies supporting the chronic suppressive therapy pathway for pevifoscorvir sodium[103]. - ALG-055009 has been designed to exhibit approximately 50-fold greater potency compared to resmetirom, positioning it as a strong candidate for treating obesity and metabolic dysfunction-associated steatohepatitis (MASH)[108]. - The Phase 1 study of ALG-055009 showed that it was well tolerated, with no evidence of clinical thyroid dysfunction and low intersubject variability in pharmacokinetics[109][110]. - The company is exploring an antisense oligonucleotide (ASO) platform to potentially treat chronic HBV infection and hepatitis delta virus (HDV) co-infection[106][107]. - Pevifoscorvir sodium has demonstrated a favorable pharmacokinetic profile and antiviral activity, suggesting its potential as a best-in-class treatment for chronic HBV infection[99][104]. - The company plans to present 96-week safety and antiviral activity data for pevifoscorvir sodium at upcoming scientific conferences[104]. - ALG-055009 demonstrated significant synergistic effects in preclinical studies when combined with semaglutide or tirzepatide, showing enhanced antihyperlipidemic effects compared to monotherapy[114]. - The Phase 2 study of ALG-097558 began in 2024, evaluating its efficacy in high-risk COVID-19 patients[118]. Financial Performance - Revenue from collaborations was $0 for the three and nine months ended September 30, 2025, due to the termination of the Merck collaboration agreement[135]. - Revenue from customers decreased by $0.5 million (41%) and $1.0 million (33%) for the three and nine months ended September 30, 2025, compared to the same periods in 2024[136]. - Research and development expenses increased by $7.2 million (43%) for the three months ended September 30, 2025, compared to the same period in 2024[134]. - The total operating expenses for the three months ended September 30, 2025, were $29.1 million, a 36% increase compared to $21.4 million in the same period in 2024[134]. - The net loss for the nine months ended September 30, 2025, was $4.3 million, a 91% decrease compared to a net loss of $49.1 million for the same period in 2024[132]. - The company has incurred net losses since its formation in February 2018, with an accumulated deficit of $622.3 million as of September 30, 2025[132]. - The change in fair value of 2023 common warrants showed a significant increase of 3905% for the three months ended September 30, 2025, compared to the same period in 2024[134]. - Research and development expenses increased by $7.2 million to $23.9 million for the three months ended September 30, 2025, compared to $16.8 million in the same period of 2024[138]. - Total research and development expenses decreased by $1.8 million to $52.4 million for the nine months ended September 30, 2025, compared to $54.2 million in the same period of 2024[139]. - General and administrative expenses increased by $0.5 million to $5.0 million for the three months ended September 30, 2025, compared to $4.5 million in the same period of 2024[141]. - General and administrative expenses decreased by $1.9 million to $14.1 million for the nine months ended September 30, 2025, compared to $16.0 million in the same period of 2024[142]. - Net cash used in operating activities was $60.8 million for the nine months ended September 30, 2025, compared to $62.3 million in the same period of 2024[157]. - The company incurred a net loss of $4.3 million for the nine months ended September 30, 2025, compared to a net loss of $49.1 million in the same period of 2024[146][159]. - The company had an accumulated deficit of $622.3 million as of September 30, 2025, compared to $618.0 million as of December 31, 2024[149]. - The company raised gross proceeds of $105.0 million from a securities purchase agreement in February 2025[148]. - Cash, cash equivalents, and short-term investments totaled $99.1 million as of September 30, 2025, compared to $56.9 million as of December 31, 2024[149]. - The company expects research and development expenses to increase in future periods as it continues to advance clinical trials for pevifoscorvir sodium and MASH[140]. - During the nine months ended September 30, 2024, investing activities used $38.3 million of cash, primarily due to $108.1 million of purchase of short-term investments[161]. - Net cash provided by financing activities during the nine months ended September 30, 2025, was $101.5 million, primarily due to proceeds from the 2025 PIPE financing[162]. - Net cash provided by financing activities during the nine months ended September 30, 2024, was $0.3 million, consisting primarily of proceeds from the ESPP purchase[162]. Contractual Obligations and Accounting Policies - There have been no material changes to contractual obligations and commitments as of September 30, 2025[163]. - The company does not have any off-balance sheet arrangements during the periods presented[164]. - The maximum potential amount of future payments under indemnification agreements is not determinable, and the fair value of these agreements is considered minimal[165]. - There have been no material changes to critical accounting policies and estimates through September 30, 2025, from those discussed in the Form 10-K[167]. - There have been no material changes in market risk during the three and nine months ended September 30, 2025[169].