UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39617 Aligos Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 82-4724808 (State or other jurisd ...

Financial Performance - Net income for Q1 2025 was $43.1 million, with a basic net income per share of $5.12, compared to a net loss of $34.9 million in Q1 2024[6]. - The change in fair value of common warrants resulted in income of $61.5 million for Q1 2025, compared to a loss of $14.4 million in Q1 2024[11]. - Cash, cash equivalents, and investments totaled $137.9 million as of March 31, 2025, up from $56.9 million as of December 31, 2024, providing funding into the second half of 2026[5]. - Total liabilities decreased to $34.3 million as of March 31, 2025, from $99.1 million as of December 31, 2024[18]. Research and Development - Aligos raised over $100 million to initiate a Phase 2 study of ALG-000184 for chronic hepatitis B virus infection, with dosing expected to begin by mid-2025[2]. - Research and development expenses decreased to $14.5 million in Q1 2025 from $16.4 million in Q1 2024, primarily due to reduced clinical trial costs[7]. - ALG-000184 demonstrated 100% sustained HBV DNA suppression in HBeAg subjects after 48 weeks of treatment[3]. - The Phase 2 B-SUPREME study for ALG-000184 is expected to enroll approximately 200 untreated adult subjects with chronic HBV infection[3]. - ALG-055009 showed statistically significant liver fat reductions of up to 46.2% at week 12 in MASH patients, with 70% of subjects achieving a ≥30% relative reduction[10]. Operating Expenses - General and administrative expenses fell to $5.1 million in Q1 2025 from $6.7 million in Q1 2024, attributed to lower third-party expenses[8].

Core Insights - Aligos Therapeutics is advancing its clinical development plans for therapies targeting liver and viral diseases, having raised over $100 million for its Phase 2 study of ALG-000184 in chronic hepatitis B virus infection [2][3] - The company reported significant financial progress, with a net income of $43.1 million for Q1 2025, a substantial improvement from a net loss of $34.9 million in Q1 2024 [7][10] Recent Business Progress - Aligos is on track to begin dosing for the Phase 2 study of ALG-000184 by mid-2025, following positive FDA correspondence [2] - Data presented at the APASL meeting indicated that ALG-000184 has the potential to be a first-line treatment for chronic HBV infection, with a well-tolerated profile and promising antiviral activity [5][12] - The Phase 2 B-SUPREME study will evaluate ALG-000184 against tenofovir disoproxil fumarate in approximately 200 untreated adult subjects with chronic HBV infection [5] Pipeline Updates - ALG-000184 is positioned as a potential first-/best-in-class small molecule for chronic hepatitis B virus infection [3] - ALG-055009, a THR-β agonist for metabolic dysfunction-associated steatohepatitis (MASH), has shown best-in-class potential, with significant reductions in liver fat observed in clinical trials [4][12] - The company is in discussions for potential partnerships regarding ALG-055009 with multinational pharmaceutical companies [2] Financial Results for Q1 2025 - Cash, cash equivalents, and investments totaled $137.9 million as of March 31, 2025, compared to $56.9 million at the end of 2024, providing sufficient funding into the second half of 2026 [6] - Research and development expenses decreased to $14.5 million from $16.4 million year-over-year, primarily due to reduced third-party clinical trial expenses [8] - General and administrative expenses also decreased to $5.1 million from $6.7 million, reflecting lower third-party costs [9]

Core Viewpoint - Aligos Therapeutics, Inc. is set to report its first quarter 2025 financial results on May 6, 2025, before the U.S. financial markets open, indicating ongoing developments in its clinical-stage biotechnology efforts focused on liver and viral diseases [1]. Company Overview - Aligos Therapeutics, Inc. is a clinical stage biopharmaceutical company dedicated to improving patient outcomes through the development of best-in-class therapies for liver and viral diseases [2]. - The company utilizes a science-driven approach and extensive R&D expertise to advance its pipeline of therapeutics targeting high unmet medical needs, including chronic hepatitis B virus infection, metabolic dysfunction-associated steatohepatitis (MASH), and coronaviruses [2].

SOUTH SAN FRANCISCO, Calif., March 26, 2025 (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 three oral presentations at the 34th Annual Meeting of the Asian Pacific Association for the Study of the Liver (APASL) 2025, being held March 26 - 30, 2025 in Beijing, China. “We are pleased to present preliminary da ...

Financial Performance - The company incurred significant net losses of $131.2 million for the year ended December 31, 2024, and $87.7 million for the year ended December 31, 2023[181]. - As of December 31, 2024, the company had a total stockholders' deficit of $29.0 million[181]. - The company has never generated revenue from product sales and does not anticipate doing so for the next several years[182]. - The company had cash, cash equivalents, and investments of $56.9 million as of December 31, 2024[185]. - The company may require substantial additional financing to achieve its goals, which may not be available on acceptable terms[185]. Funding and Investments - In October 2023 and February 2025, the company closed private investments generating approximately $92.1 million and $105.0 million in gross proceeds, respectively[185]. - The company expects to finance its cash needs through a combination of public or private equity offerings, debt financings, and collaborations[189]. - The company filed a Registration Statement on Form S-3 covering the offering of up to $400.0 million of various securities in November 2024[188]. Drug Development Challenges - The company has invested a significant portion of its resources in research and development activities since its inception[185]. - The company anticipates incurring significant costs associated with commercializing any approved drug candidates[184]. - The company has halted further development of drug candidate ALG-010133 due to insufficient antiviral activity observed in clinical trials[202]. - Development of drug candidate ALG-020572 was discontinued following a serious adverse event involving significant increase in alanine aminotransferase (ALT) levels in patients[202]. - The company is conducting clinical trials for drug candidate ALG-125755, which showed evidence of HBsAg lowering at all evaluated dose levels, but further evaluation is not prioritized due to funding constraints[202]. Regulatory and Compliance Issues - The company has limited experience in preparing and submitting regulatory filings, having not previously submitted a new drug application (NDA) to the FDA[205]. - Regulatory approval processes are lengthy and unpredictable, with no current drug candidates having received approval[213]. - The company plans to seek regulatory approval for its drug candidates in the United States and select foreign countries, which requires compliance with varying regulatory requirements[206]. - The company may face penalties or loss of marketing approval if it fails to comply with regulatory requirements post-approval[266]. - The FDA's review and approval processes can be affected by government funding and other disruptions, potentially delaying the company's product approvals[274]. Market and Competitive Landscape - The company is pursuing treatments for CHB and MASH, with significant investments in drug candidates like ALG-000184 and ALG-055009, respectively[229][232]. - The company faces competition from other firms developing more efficacious therapies for COVID-19, which could impact demand for its products[239]. - The availability of COVID-19 vaccines and oral COVID-19 drugs may reduce the need for potential COVID-19 therapies, negatively impacting commercial opportunities[288]. - The company may face significant delays in obtaining coverage and reimbursement for newly approved drugs, impacting commercial viability[300]. Intellectual Property and Patent Risks - The ability to obtain and maintain sufficient patent protection is critical for the company to compete effectively in the market and commercialize drug candidates[366]. - The company may face challenges in enforcing intellectual property rights, which could allow competitors to develop similar products, impacting its market position[367]. - The company currently holds several U.S. provisional patent applications, which require timely filing of non-provisional applications within 12 months to maintain priority dates[370]. - The company may lose patent protection if it fails to timely file non-provisional applications or if its licensors do not fulfill their obligations under licensing agreements[378]. Operational Risks - The company relies on third parties for clinical trials and studies, and any failure by these parties could substantially harm the business and delay marketing approvals[344]. - The company does not own manufacturing facilities and relies on third parties for drug supplies, increasing the risk of insufficient quantities or delays in development and commercialization efforts[350]. - There is a risk that third-party manufacturers may not be able to scale up production in a timely or cost-effective manner, potentially delaying regulatory approval or commercial launch of drug candidates[351]. Legal and Regulatory Compliance - Compliance with evolving data privacy laws, such as GDPR and CCPA, may impose significant operational challenges and financial penalties for non-compliance[324][323]. - The company must ensure compliance with various healthcare laws, including the federal Anti-Kickback Statute and the False Claims Act, to avoid significant operational and financial risks[363]. - The company anticipates ongoing legal complexity and uncertainty regarding international personal data transfers, which could adversely affect financial results[327].

Financial Performance - Aligos Therapeutics reported a net loss of $82.2 million for Q4 2024, compared to a net loss of $27.9 million in Q4 2023, resulting in a basic and diluted net loss per share of $(13.08) versus $(5.50) in the prior year[8][20]. - For the full year 2024, the net loss was $131.2 million, compared to $87.7 million in 2023, with a basic and diluted net loss per share of $(20.94) compared to $(34.20) in 2023[9][20]. - Cash, cash equivalents, and investments totaled $56.9 million as of December 31, 2024, down from $135.7 million at the end of 2023; following a $105 million private placement completed in February 2025, funding is expected to last into the second half of 2026[7][5]. - General and administrative (G&A) expenses for Q4 2024 were $5.2 million, compared to $6.4 million in Q4 2023, with total G&A expenses for the year at $22.8 million, down from $30.6 million in 2023[12][13]. Research and Development - Research and development (R&D) expenses for Q4 2024 were $16.0 million, down from $22.3 million in Q4 2023, while total R&D expenses for the year were $70.3 million, slightly down from $73.0 million in 2023[10][11]. - Interim data from a Phase 1 study of ALG-000184 showed 100% sustained HBV DNA suppression in HBeAg-positive subjects by Week 48, with no viral breakthrough or known CAM resistant mutations observed[5][10]. - The Phase 2 clinical study for ALG-000184 is expected to begin in mid-2025, with the potential to replace standard care for chronic hepatitis B virus infection[2][5]. - ALG-055009 demonstrated statistically significant reductions in liver fat of up to 46.2% at Week 12, with 70% of subjects achieving a ≥30% relative reduction compared to baseline[5][12]. - Aligos commenced three additional clinical trials for ALG-097558 in 2024, with ongoing studies evaluating its efficacy in high-risk COVID-19 patients[6][12]. Funding and Development Strategy - The company is evaluating options for continued development funding, including potential out-licensing of its products[12][14].

Financial Performance - The company reported net losses of $49.1 million and $59.8 million for the nine months ended September 30, 2024 and 2023, respectively, with an accumulated deficit of $535.9 million as of September 30, 2024[104]. - The company has incurred net losses and negative cash flows from operations since its formation, with no revenue from product sales reported[104]. - The company expects to continue incurring significant expenses and increasing operating losses over the next several years due to ongoing research and development activities[104]. - Revenue from collaborations decreased by $2.1 million (99%) for the three months ended September 30, 2024, and by $7.0 million (96%) for the nine months ended September 30, 2024, primarily due to the completion of the Amended Agreement with Merck[114]. - General and administrative expenses decreased by $1.8 million (28%) for the three months ended September 30, 2024, compared to the same period in 2023, and decreased by $6.5 million (27%) for the nine months ended September 30, 2024[117]. - Total operating expenses for the three months ended September 30, 2024, were $21.400 million, a decrease of $0.910 million (4%) compared to $22.310 million in the same period of 2023[113]. - Interest income, net decreased by $0.548 million (55%) for the three months ended September 30, 2024, compared to the same period in 2023, primarily due to a general decrease in market interest rates[118]. - Other income, net increased by $0.452 million (838%) for the three months ended September 30, 2024, compared to the same period in 2023, due to changes in fair value of common warrants[118]. - For the nine months ended September 30, 2024, the company utilized $62.3 million in cash for operating activities, primarily due to a net loss of $49.1 million[129]. - The net cash used in operating activities for the same period in 2023 was $56.3 million, resulting from a net loss of $59.8 million[129]. - The company reported a net decrease in cash, cash equivalents, and restricted cash of $100.3 million for the nine months ended September 30, 2024[128]. - The company has no committed external sources of funds and may need to raise additional capital, which could dilute existing ownership interests[126]. - The company expects to incur substantial additional funds to achieve its business objectives, as its drug candidates may not achieve commercial success[125]. - The company’s future capital requirements will depend on various factors, including the costs of research, development, and commercialization of its drug candidates[123]. Research and Development - The company is developing ALG-000184, a Capsid Assembly Modulator for chronic hepatitis B (CHB), which demonstrated HBV DNA suppression in 60% of subjects by Week 48 and 90% in HBeAg-positive subjects by Week 72[100]. - ALG-055009, a thyroid hormone receptor beta agonist for metabolic dysfunction associated steatohepatitis (MASH), showed statistically significant reductions in liver fat of up to 46.2% at Week 12 in Phase 2a trials[102]. - The company has initiated Phase 1 clinical trials for ALG-097558, a small molecule coronavirus 3CL protease inhibitor, which has shown to be at least 6-fold more potent than nirmatrelvir against SARS-CoV-2 variants[103]. - The Phase 1b study of ALG-000184 indicated potentially best-in-class antiviral activity with no viral breakthrough observed in HBeAg-negative subjects[101]. - The company plans to submit a new Phase 2 protocol for ALG-000184 in Q1 2025, following FDA clearance for a Phase 1 drug-drug interaction study[101]. - The Phase 2a HERALD study for ALG-055009 included 102 subjects and demonstrated a favorable tolerability profile with no evidence of clinical hyper/hypothyroidism[102]. - Research and development expenses for the three months ended September 30, 2024, increased by $0.9 million to $16.774 million compared to $15.867 million in the same period of 2023, primarily due to increased clinical study costs[115]. - Total direct research and development expenses for the nine months ended September 30, 2024, were $28.529 million, up from $22.179 million in the same period of 2023, reflecting a 29% increase[109]. - The company expects research and development expenses to increase substantially in connection with ongoing clinical development activities related to its drug candidates[120]. Funding and Capital Requirements - The company is exploring external funding options, including approximately $13.8 million from NIH awards to support the development of ALG-097558[104]. - The company has no material changes to its contractual obligations and commitments as of September 30, 2024[133]. - The company did not have any off-balance sheet arrangements during the periods presented[134]. - The company may need to relinquish valuable rights to its technology or future revenue streams if it raises additional funds through collaborations or licensing arrangements[127].

Financial Performance - Aligos reported a net loss of $19.3 million for Q3 2024, with a basic and diluted net loss per share of $(3.07), compared to a net loss of $18.0 million and $(10.37) per share in Q3 2023[7]. - Cash, cash equivalents, and investments totaled $74.9 million as of September 30, 2024, down from $135.7 million as of December 31, 2023, indicating a decrease of approximately 44.8%[6]. - Total operating expenses for Q3 2024 were $21.4 million, compared to $22.3 million in Q3 2023, indicating a slight decrease[15]. - Aligos believes its current cash balance is sufficient to fund planned operations through the end of 2025[6]. Research and Development - Research and development (R&D) expenses increased to $16.8 million in Q3 2024 from $15.9 million in Q3 2023, primarily due to higher third-party expenses for clinical trials[8]. - Aligos is progressing ALG-000184 for chronic hepatitis B (CHB) towards a Phase 2 study next year, with positive feedback from the FDA regarding its primary efficacy endpoint[3]. - The company expects to begin externally funded clinical studies for ALG-097558 in COVID subjects later this year, with three additional clinical studies planned for 2024[5]. Clinical Trial Results - The company announced positive topline HERALD data for ALG-055009, showing placebo-adjusted median relative reductions in liver fat of up to 46.2%[2]. - Up to 70% of subjects treated with ALG-055009 achieved a ≥30% relative reduction in liver fat compared to baseline[4]. General and Administrative Expenses - General and administrative (G&A) expenses decreased to $4.6 million in Q3 2024 from $6.4 million in Q3 2023, reflecting a reduction in third-party expenses including legal costs[9].

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]