SOUTH SAN FRANCISCO, Calif., Aug. 08, 2024 (GLOBE NEWSWIRE) --  Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”, the “Company”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced the appointment of Heather Preston, M.D. and Margarita Chavez, J.D. as Class II Independent Directors to the Board of Directors, effective August 7, 2024. Dr. Preston will join the Nominating and Corporate Governance Comm ...

Cash and Cash Equivalents - Cash and cash equivalents decreased from $135,704 thousand to $45,078 thousand, a significant drop of 66.8%[26] - Cash and cash equivalents decreased by $90.6 million to $45.1 million as of June 30, 2024[38] - Fair value of cash equivalents as of June 30, 2024: $45.1 million[82] - Unrestricted cash, cash equivalents, and investments totaled $94.5 million as of June 30, 2024[47] - As of June 30, 2024, the company had cash, cash equivalents, and investments of $94.5 million[139] - As of June 30, 2024, the company had total stockholders' equity of $67.2 million and cash, cash equivalents, and investments of $94.5 million[168][172] Total Current Assets and Liabilities - Total current assets declined from $141,084 thousand to $99,570 thousand, a decrease of 29.4%[26] - Total liabilities decreased from $59,447 thousand to $41,582 thousand, a reduction of 30.1%[26] - Accrued liabilities decreased from $16.842 million as of December 31, 2023 to $12.064 million as of June 30, 2024[63] Research and Development Expenses - Research and development expenses increased from $16,781 thousand to $21,099 thousand, up 25.7% for the three months ended June 30, 2024[28] - Research and development expenses increased by $4.3 million during the three months ended June 30, 2024, compared to the same period in 2023[134] - Total direct research and development expenses for the six months ended June 30, 2024 were $20.13 million, compared to $14.73 million in 2023[125] Net Income and Loss - Net income for the three months ended June 30, 2024 was $5,061 thousand, compared to a net loss of $18,791 thousand in the same period last year[28] - Net loss for the six months ended June 30, 2023, was $41.7 million[38] - Net income for the three months ended June 30, 2024, was $5.06 million, compared to a net loss of $18.79 million for the same period in 2023[106] - Net loss for the six months ended June 30, 2024, was $29.80 million, compared to a net loss of $41.75 million for the same period in 2023[106] - The company incurred net losses of $29.8 million and $41.7 million for the six months ended June 30, 2024 and 2023, respectively[119] - The company incurred a net loss of $29.8 million for the six months ended June 30, 2024, and $87.7 million for the year ended December 31, 2023[168] Stock-Based Compensation - Stock-based compensation expense related to employee stock awards was $1,918 thousand for the three months ended June 30, 2024[31] - Stock-based compensation expense for the six months ended June 30, 2023, was $6.9 million[38] - Stock option compensation expense was $4.4 million for the six months ended June 30, 2024, down from $6.5 million in the same period of 2023[72] - Employee stock purchase plan stock-based compensation expense for the six months ended June 30, 2024: $0.3 million[77] - Total stock-based compensation expense for the six months ended June 30, 2024: $4.7 million[78] Revenue and Collaborations - Revenue from collaborations for the six months ended June 30, 2024 was $292 thousand, down 94.4% from $5,175 thousand in the same period last year[28] - Revenue from collaborations decreased by $2.6 million and $4.9 million, respectively, for the three and six months ended June 30, 2024[132] - Revenue from customers decreased by $3.2 million and $2.7 million, respectively, for the three and six months ended June 30, 2024[133] - The company recognized $0.3 million in revenue from collaborative arrangements related to upfront payments during the three months ended June 30, 2024[93] - The company recognized $1.8 million in revenue from customers related to upfront payments during the three months ended June 30, 2024[101] Accumulated Deficit - Accumulated deficit increased from $486,797 thousand to $516,599 thousand, reflecting a 6.1% increase in losses[26] - Accumulated deficit increased to $516.6 million as of June 30, 2024[46] - The company has an accumulated deficit of $516.6 million as of June 30, 2024[119] Stock and Equity - Weighted average shares of common stock, basic increased from 43,215,478 to 156,444,408, a significant rise of 261.9%[28] - Total stockholders' equity decreased from $92,080 thousand to $67,229 thousand, a decline of 27.0%[26] - The company increased authorized voting common stock from 300 million to 500 million shares on June 27, 2024[64] - In October 2023, the company raised $92.1 million through a PIPE offering, issuing common stock, pre-funded warrants, and common warrants[66] - Pre-funded warrants outstanding decreased from 81,054,686 at January 1, 2024 to 76,929,155 at June 30, 2024 due to exercises[68] - Common warrant liability decreased from $27.596 million at January 1, 2024 to $11.490 million at June 30, 2024 due to fair value changes[69] - Outstanding options as of June 30, 2024: 10,041,963 with a weighted average exercise price of $2.04 and a remaining contractual term of 8.20 years[73] - Options vested and exercisable as of June 30, 2024: 3,436,608 with a weighted average exercise price of $3.70 and a remaining contractual term of 5.97 years[73] - Weighted-average grant date fair value of options granted during the six months ended June 30, 2024: $0.74 per share[73] - Stock option exchange program in January 2024: 3,880,332 eligible options canceled and 1,906,153 replacement options granted[74] - Restricted stock units unamortized expense balance as of June 30, 2024: $43 thousand to be amortized over 3.0 years[75] - The company raised $92.1 million in gross proceeds from a private placement in October 2023[172] Property and Equipment - Total property and equipment net value decreased from $3.259 million as of December 31, 2023 to $2.797 million as of June 30, 2024[57] - Depreciation expense for the six months ended June 30, 2024 was $0.5 million, compared to $0.9 million for the same period in 2023[57] Interest Income and Expense - The company recorded interest income of $0.9 million for the six months ended June 30, 2024, down from $1.7 million in the same period of 2023[61] - Interest income, net decreased by $0.6 million and $0.8 million for the three and six months ended June 30, 2024, respectively, due to a general decrease in market interest rates[138] Other Income and Expenses - Other income, net increased by $31.2 million and $17.6 million for the three and six months ended June 30, 2024, respectively, due to the change in fair value of Common Warrants[138] - The company recorded income tax expense of $213.0 thousand for the six months ended June 30, 2024, primarily related to international operations[104] Cash Flow - Operating activities utilized $42.2 million of cash during the six months ended June 30, 2024, primarily due to a net loss of $29.8 million[150] - Investing activities used $48.6 million of cash during the six months ended June 30, 2024, primarily due to $88.6 million in purchases of short-term investments[151] - Net cash provided by financing activities was $262.0 thousand during the six months ended June 30, 2024, primarily from ESPP purchases[152] - Maturities of short-term investments provided $45.0 million in cash during the six months ended June 30, 2023[38] Future Funding and Capital Requirements - The company expects its existing cash and investments to fund operations for at least 12 months[49] - The company may seek additional funding through equity offerings, debt financings, or collaborations[49] - The company believes its existing cash, cash equivalents, and investments will fund planned operating expenses and capital expenditures for at least the next twelve months[143] - The company may raise additional capital on an opportunistic basis to fund operations[143] - The company's existing cash, cash equivalents, and investments are expected to fund operations for at least 12 months following the report date[175] - The company's future capital requirements depend on factors such as clinical trial costs, regulatory approval timelines, and commercialization expenses[173] - The company's ability to raise additional funds may be limited by market conditions and SEC regulations, potentially impacting its development and commercialization efforts[176][177] Clinical Trials and Drug Development - The company is focused on developing therapeutics for viral and liver diseases, including MASH, CHB, and coronaviruses[44] - The company has not generated any product revenue to date[45] - ALG-055009, the company's potential best-in-class THR-β agonist for MASH, completed Phase 1 studies and initiated Phase 2a HERALD study with topline data expected in early Q4 2024[113] - ALG-000184, the company's CAM-E for CHB, demonstrated sustained HBV DNA suppression in 90% of HBeAg-positive CHB subjects and complete suppression in 100% of HBeAg-negative CHB subjects in Phase 1b studies[116] - The company received supportive feedback from the FDA regarding chronic suppressive therapy with ALG-000184, with the potential for superiority to standard of care in future clinical studies[116] - The company selected two lead molecules for small molecule inhibitors of PD-L1 and completed scale-up for further advancement towards clinical development[116] - ALG-097558 is at least 6-fold more potent than nirmatrelvir and other PIs in clinical development against SARS-CoV-2 variants, including Omicron[117] - The projected efficacious dose range for ALG-097558 to treat SARS-CoV-2 is 200-600 mg Q12 x 5 days[117] - The company expects to receive approximately $13.8 million in funds from NIH awards and contracts to support coronavirus-related activities[118] - The company entered into a clinical trial collaboration and supply agreement with Amoytop in July 2024 to evaluate the efficacy and safety of ALG-000184 in combination with PEGBING® in CHB patients in China[111] - The company halted development of ALG‑010133 in January 2022 due to insufficient HBsAg reduction at projected efficacious doses, and discontinued ALG‑020572 in March 2022 due to serious adverse events[210] - The siRNA drug candidate ALG-125755 showed evidence of HBsAg lowering in Phase 1 studies, but further advancement requires additional external funding[211] - The company is investing significant resources in developing treatments for MASH, including ALG-055009, currently in Phase 2a trials, but success is not guaranteed[220] Regulatory and Compliance - The company has not previously submitted a new drug application (NDA) to the FDA, and regulatory approval for drug candidates is uncertain[197] - The company plans to seek regulatory approval for drug candidates in the United States and select foreign countries, requiring compliance with varying regulatory requirements[199] - Regulatory approval processes by the FDA, EMA, and other authorities are lengthy, unpredictable, and may require additional studies or trials beyond initial plans[204][206] - The company may fail to obtain regulatory approval if clinical trial results do not meet statistical significance or if manufacturing processes are deemed deficient[206] - Even if approved, regulatory authorities may limit indications, require costly post-marketing trials, or restrict labeling claims, impacting commercialization prospects[208] - The company has not yet obtained regulatory approval for any drug candidate, and there is no guarantee that current or future candidates will be approved[205] - Delays or failures in clinical trials could significantly harm the company's business, financial condition, and ability to generate revenue[209] - Failure to comply with Nasdaq's continued listing requirements could result in delisting, negatively impacting the company's stock price and access to capital markets[181][182] - The company's common stock began trading on the Nasdaq Capital Market on March 6, 2024, with a compliance period ending on September 3, 2024, to regain the minimum bid price requirement of $1.00 per share[183] - A reverse stock split is expected to be completed in August 2024, aiming to achieve a share price exceeding $1.00 to comply with Nasdaq listing standards[185] - The company faces potential delisting from Nasdaq, which could negatively impact stock liquidity, trading volume, and the ability to raise capital[187] Risks and Uncertainties - The company expects to continue incurring significant losses for the foreseeable future and may never achieve profitability[166][168] - The company's ability to generate revenue depends on successful completion of clinical trials, regulatory approvals, and commercialization of drug candidates[169][170] - The company's operating results may fluctuate significantly due to factors such as clinical trial enrollment, regulatory approvals, and manufacturing costs[178][179] - Health pandemics or epidemics could materially adversely affect the company's business, particularly in regions with significant manufacturing facilities or clinical trial sites[188] - COVID-19-related restrictions, including shelter-in-place orders, have previously disrupted the company's operations and could continue to impact productivity and clinical programs[189] - Supply chain disruptions due to health pandemics or epidemics may delay or limit the company's ability to obtain materials for drug candidates[190] - Clinical trials may be delayed due to health pandemics, affecting site initiation, patient enrollment, and the ability to recruit and retain investigators[191] - The company's drug candidates are in early-stage development, with clinical trials initiated in multiple countries, but there is no guarantee of efficacy or safety[194] - Clinical trials for drug candidates are being conducted in multiple countries including New Zealand, Hong Kong, and the United Kingdom, with potential future trials in additional regions[214] - Delays in clinical trials could harm the commercial prospects of drug candidates, increase costs, and allow competitors to bring products to market first[215] - Potential disruptions from another pandemic or epidemic could affect clinical trial sites, patient enrollment, and supply chain for materials, particularly impacting trials for ALG‑055009, ALG-000184, and ALG-097558[216] - The BIOSECURE Act, if enacted, could restrict the company's ability to collaborate with certain Chinese biotechnology companies, potentially impacting contractual relationships[217] - Principal investigators for clinical trials may have financial relationships with the company, which could raise concerns about data integrity and regulatory approval[218] Licensing and Collaboration Agreements - License agreement with Emory University: potential milestone payments up to $125.0 million and tiered single-digit royalties on net sales[86] - License agreement with Luxna Biotech: potential milestone payments up to $55.5 million and low-single digit royalty percentage on net sales[90] - The company entered into a Research, Licensing and Commercialization Agreement with KU Leuven, with potential payments totaling up to $62.0 million for commercial sales and development milestones, and a low-to-mid-single digit royalty percentage on net sales[91] - The company received an upfront payment of $12 million from Merck and is eligible for up to $458.0 million in development and commercialization milestones, plus tiered royalties on net sales[92] - The company received an additional upfront payment of $15 million from Merck for a second MASH target, with potential payments of up to $460.0 million in milestones and tiered royalties[93] - The company received an upfront payment of $7.0 million from Amoytop, with potential payments of up to $109.0 million in development and commercialization milestones and tiered royalties[100] - The company received an additional upfront payment of $1.5 million from Amoytop in May 2024 for a nine-month extension of the Development Agreement[100] Grants and Awards - The company was awarded a $1.1 million grant by the NIH in 2022, with additional grants of $1.4 million in 2023 and $1.5 million in 2024[95][97] - The company was awarded an $8.5 million contract by the NIAID in 2023, with an additional $1.3 million awarded in 2024, bringing the total contract value to $9.8 million[97] - The company expects to receive approximately $13.8 million in funds from NIH awards and contracts to support coronavirus-related activities[118] General and Administrative Expenses - General and administrative expenses decreased by $2.9 million during the three months ended June 30, 2024, compared to the same period in 2023[135] - General and administrative expenses decreased by $4.7 million during the six months ended June 30, 2024, primarily due to reduced legal and IP spend, facility expenses, and employee-related costs[137] Nonclinical Development - Nonclinical development is a complex and lengthy process, often taking several years or more per program, with potential delays due to regulatory requirements, study design consensus, and global-scale events[203]

EXHIBIT 99.1 Aligos Therapeutics Reports Recent Business Progress and Second Quarter 2024 Financial Results SOUTH SAN FRANCISCO, Calif., Aug. 06, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, "Aligos"), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today reported recent business progress and financial results for the second quarter 2024. "This quarter we continued to execute on our key clini ...

Amoytop to sponsor a Phase 1b exploratory clinical study evaluating the efficacy and safety of ALG-000184 in combination with PEGBING® (Mipeginterferon alfa-2b) in CHB patients SOUTH SAN FRANCISCO, Calif., July 22, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (NASDAQ:ALGS, "Aligos"))), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced that it has entered into a clinical trial collaboration agr ...

Amoytop to sponsor a Phase 1b exploratory clinical study evaluating the efficacy and safety of ALG-000184 in combination with PEGBING® (Mipeginterferon alfa-2b) in CHB patients SOUTH SAN FRANCISCO, Calif., July 22, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced that it has entered into a clinical trial collaboration agre ...

SOUTH SAN FRANCISCO, Calif., June 05, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (NASDAQ:ALGS, "Aligos"))), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced positive data from six poster presentations at the European Association for the Study of the Liver (EASL) Congress 2024, being held June 5-8 in Milan, Italy. The clinical poster presentations highlight the continued potent antiviral act ...

SOUTH SAN FRANCISCO, Calif., June 05, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced positive data from six poster presentations at the European Association for the Study of the Liver (EASL) Congress 2024, being held June 5-8 in Milan, Italy. The clinical poster presentations highlight the continued potent antiviral acti ...

Shares of Aligos Therapeutics, Inc. (ALGS) have been struggling lately and have lost 8.1% over the past two weeks. However, a hammer chart pattern was formed in its last trading session, which could mean that the stock found support with bulls being able to counteract the bears. So, it could witness a trend reversal down the road.While the formation of a hammer pattern is a technical indication of nearing a bottom with potential exhaustion of selling pressure, rising optimism among Wall Street analysts abou ...

SOUTH SAN FRANCISCO, Calif., May 22, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced six abstracts have been accepted for poster presentations, including two Top abstracts, at the European Association for the Study of the Liver (EASL) Congress 2024, being held June 5-8 in Milan, Italy. The abstracts released today can be ...

SOUTH SAN FRANCISCO, Calif., May 22, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced six abstracts have been accepted for poster presentations, including two Top abstracts, at the European Association for the Study of the Liver (EASL) Congress 2024, being held June 5-8 in Milan, Italy. The abstracts released today can be ...