PART I: FINANCIAL INFORMATION [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The company reported a reduced net loss in Q1 2025, with assets decreasing and collaboration revenue increasing Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $23,413 | $38,344 | | Marketable securities | $67,615 | $73,735 | | Total Assets | $99,017 | $119,168 | | Deferred revenue (short & long-term) | $63,581 | $73,000 | | Total Liabilities | $71,884 | $85,809 | | Total Stockholders' Equity | $27,133 | $33,359 | Condensed Consolidated Statements of Operations Highlights (in thousands, except per share data) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Collaboration revenue | $9,419 | $5,785 | | Research and development | $14,851 | $11,879 | | General and administrative | $4,509 | $4,635 | | Loss from operations | $(9,941) | $(10,729) | | Net loss | $(8,818) | $(9,077) | | Net loss per share, basic and diluted | $(1.17) | $(1.66) | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(23,439) | $(18,364) | | Net cash provided by investing activities | $6,586 | $17,272 | | Net cash provided by financing activities | $1,922 | $— | | Net decrease in cash and cash equivalents | $(14,931) | $(1,092) | [Notes to Financial Statements](index=8&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) Notes detail the company's biotech focus, financial sufficiency, and key Gilead collaboration terms - The company is a biotechnology firm developing therapeutics for viral diseases including genital herpes, hepatitis B (HBV), hepatitis D (HDV), and transplant-related herpesviruses[19](index=19&type=chunk) - Management believes current funds are sufficient to meet operating requirements for **at least the next twelve months** from the report's issuance date[20](index=20&type=chunk) - The collaboration with Gilead is a significant component of operations. In Q1 2025, the company recognized **$9.4 million** in collaboration revenue, up from **$5.8 million** in Q1 2024[32](index=32&type=chunk)[58](index=58&type=chunk) - The transaction price for the Gilead agreement was amended to **$74.2 million**, consisting of the unrecognized portion of the original contract, a **$5.2 million** premium on a stock purchase, and a **$10.0 million** payment from an amendment[54](index=54&type=chunk) - During Q1 2025, the company sold **161,645 shares** of common stock under its "at-the-market" (ATM) offering, receiving net proceeds of **$1.9 million**[41](index=41&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses clinical pipeline progress, increased revenue and R&D, and future funding outlook - The company's pipeline includes clinical-stage therapies for recurrent genital herpes (HPIs), hepatitis delta virus (HDV entry inhibitor), and hepatitis B virus (HBV CAM), as well as a program for transplant-related herpesviruses[62](index=62&type=chunk) - The company expects its existing cash, cash equivalents, and marketable securities will fund operating expenses and capital expenditure requirements into the **middle of 2026**[122](index=122&type=chunk) R&D Expense Breakdown (in thousands) | Program | Q1 2025 | Q1 2024 | $ Change | | :--- | :--- | :--- | :--- | | 5366 (Herpes) | $1,680 | $377 | $1,303 | | 1179 (Herpes) | $734 | $1,040 | $(306) | | 6250 (HDV) | $2,445 | $1,027 | $1,418 | | 4334 (HBV) | $426 | $553 | $(127) | | 7423 (Transplant) | $752 | $— | $752 | | **Total R&D Expenses** | **$14,851** | **$11,879** | **$2,972** | - Net cash used in operating activities increased to **$23.4 million** in Q1 2025 from **$18.4 million** in Q1 2024, primarily due to increased operating expenses from advancing the clinical pipeline[119](index=119&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable for the registrant, as it qualifies as a smaller reporting company - The company has indicated that this item is **not applicable**[126](index=126&type=chunk) [Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Management evaluated disclosure controls and procedures, concluding they were effective with no material changes - The Chief Executive Officer and President concluded that the company's disclosure controls and procedures were **effective** at a reasonable assurance level as of the end of the period[127](index=127&type=chunk) - **No changes** in internal control over financial reporting occurred during the quarter ended March 31, 2025, that materially affected, or are reasonably likely to materially affect, internal controls[128](index=128&type=chunk) PART II: OTHER INFORMATION [Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings - The company is **not a party to any material legal proceedings**[130](index=130&type=chunk) [Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks from unapproved products, financial needs, and third-party and IP dependencies - The company has **no approved products** and its future success depends on obtaining regulatory approval for its pipeline candidates, which is uncertain[132](index=132&type=chunk) - The company has a history of **losses** and will need **additional financing** to complete development. Failure to raise capital could force it to scale back or discontinue operations[137](index=137&type=chunk)[138](index=138&type=chunk) - The collaboration with Gilead is **critical**. Risks include potential conflicts, Gilead choosing not to exercise its options, and dependence on Gilead for development and commercialization of optioned programs[140](index=140&type=chunk)[142](index=142&type=chunk) - The company relies on **third-party CROs and manufacturers**, which reduces control over clinical studies and manufacturing and introduces risks related to performance, compliance, and supply chain interruptions[146](index=146&type=chunk)[153](index=153&type=chunk) - The business depends on **protecting its intellectual property** through patents and trade secrets, but these protections may be inadequate, challenged by third parties, or difficult to enforce globally[190](index=190&type=chunk)[191](index=191&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=55&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the period covered by this report - **None**[208](index=208&type=chunk) [Exhibits](index=56&type=section&id=Item%206.%20Exhibits) The report includes exhibits such as the CEO's certifications pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002, as well as Inline XBRL documents - Filed exhibits include **CEO certifications (31.1, 32.1) and Inline XBRL data files (101.INS, 101.SCH, 104)**[212](index=212&type=chunk)

[Company Overview and Pipeline Update](index=1&type=section&id=Assembly%20Biosciences%20Reports%20First%20Quarter%202025%20Financial%20Results%20and%20Recent%20Updates) This section outlines the company's strategic focus and clinical pipeline updates, including key milestones and data readouts [Pipeline Progress and Anticipated Milestones](index=1&type=section&id=First%20Quarter%202025%20and%20Recent%20Highlights) Assembly Biosciences reports strong progress in its antiviral portfolio, with four clinical studies on track for key data readouts in 2025 - The company is on track to deliver key clinical data sets for four candidates in 2025, reinforcing progress in its antiviral portfolio[1](index=1&type=chunk)[2](index=2&type=chunk) - Key upcoming data readouts include: - **Recurrent Genital Herpes (ABI-5366 & ABI-1179):** Interim efficacy, safety, and PK data from Phase 1b studies are expected in fall 2025[5](index=5&type=chunk) - **Hepatitis D Virus (HDV - ABI-6250):** Data from a Phase 1a study in healthy participants is anticipated in Q3 2025[9](index=9&type=chunk) - **Hepatitis B Virus (HBV - ABI-4334):** Efficacy, safety, and PK data from the 400 mg cohort in a Phase 1b study are expected in the first half of 2025[7](index=7&type=chunk) [Financial Results](index=2&type=section&id=First%20Quarter%202025%20Financial%20Results) This section details Q1 2025 financial performance, covering revenue, expenses, net loss, and the company's cash and funding outlook [Q1 2025 Financial Performance](index=2&type=section&id=First%20Quarter%202025%20Financial%20Performance) Q1 2025 saw collaboration revenue increase by 62% to $9.4 million, with a net loss of $8.8 million, an improvement from the prior year Q1 2025 vs Q1 2024 Statement of Operations Highlights (in millions, except per share data) | Financial Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Collaboration Revenue | $9.4 | $5.8 | +62.1% | | R&D Expenses | $14.9 | $11.9 | +25.2% | | G&A Expenses | $4.5 | $4.6 | -2.2% | | Net Loss | $(8.8) | $(9.1) | Improvement | | Net Loss Per Share | $(1.17) | $(1.66) | Improvement | - The increase in collaboration revenue reflects higher R&D activity and increased funding from the amended Gilead agreement[10](index=10&type=chunk) - The rise in R&D expenses was largely driven by increased spending on the ABI-6250 (HDV) and ABI-5366 (herpes) programs[10](index=10&type=chunk) [Financial Position and Outlook](index=2&type=section&id=Financial%20Position) As of March 31, 2025, the company held $91.0 million in cash and marketable securities, projected to fund operations into mid-2026 - The company's cash, cash equivalents, and marketable securities totaled **$91.0 million** as of March 31, 2025[10](index=10&type=chunk) - Management projects the current cash position will fund operations into mid-2026[10](index=10&type=chunk) Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $23,413 | $38,344 | | Marketable securities | $67,615 | $73,735 | | **Total Cash & Marketable Securities** | **$91,028** | **$112,079** | | Total Assets | $99,017 | $119,168 | | Total Liabilities | $71,884 | $85,809 | | Total Stockholders' Equity | $27,133 | $33,359 | [Financial Statements](index=5&type=section&id=Financial%20Statements) This section presents the unaudited condensed consolidated financial statements, including balance sheets and statements of operations [Condensed Consolidated Balance Sheets](index=5&type=section&id=ASSEMBLY%20BIOSCIENCES,%20INC.%20CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) This section presents the unaudited condensed consolidated balance sheets as of March 31, 2025, and December 31, 2024 Condensed Consolidated Balance Sheets (In thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **ASSETS** | | | | Total current assets | $95,527 | $115,503 | | Total assets | $99,017 | $119,168 | | **LIABILITIES AND STOCKHOLDERS' EQUITY** | | | | Total current liabilities | $46,631 | $47,803 | | Total liabilities | $71,884 | $85,809 | | Total stockholders' equity | $27,133 | $33,359 | | Total liabilities and stockholders' equity | $99,017 | $119,168 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=ASSEMBLY%20BIOSCIENCES,%20INC.%20CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS%20AND%20COMPREHENSIVE%20LOSS) This section provides the unaudited condensed consolidated statements of operations and comprehensive loss for Q1 2025 and Q1 2024 Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except per share data) | | Three Months Ended March 31, | | :--- | :--- | :--- | | | **2025** | **2024** | | Collaboration revenue from a related party | $9,419 | $5,785 | | Total operating expenses | $19,360 | $16,514 | | Loss from operations | $(9,941) | $(10,729) | | Net loss | $(8,818) | $(9,077) | | Comprehensive loss | $(8,860) | $(9,235) | | Net loss per share, basic and diluted | $(1.17) | $(1.66) | | Weighted average common shares outstanding | 7,506,321 | 5,483,313 |

Core Insights - Assembly Biosciences, Inc. is progressing well with its antiviral portfolio, expecting key clinical data sets in 2025, including interim Phase 1b data for ABI-5366 and ABI-1179 in fall 2025 [2][3] Financial Results - As of March 31, 2025, the company reported cash, cash equivalents, and marketable securities totaling $91.0 million, down from $112.1 million as of December 31, 2024, with projections to fund operations into mid-2026 [12] - Revenue from collaborative research with Gilead was $9.4 million for Q1 2025, an increase from $5.8 million in Q1 2024, attributed to increased research and development spending and collaboration funding [12] - Research and development expenses rose to $14.9 million in Q1 2025 from $11.9 million in Q1 2024, primarily due to increased spending on ABI-6250 and ABI-5366 [12] - General and administrative expenses slightly decreased to $4.5 million in Q1 2025 from $4.6 million in Q1 2024 [12] - The net loss attributable to common stockholders was $8.8 million, or $1.17 per share, for Q1 2025, compared to a net loss of $9.1 million, or $1.66 per share, for the same period in 2024 [12] Clinical Development Updates - Ongoing clinical studies for four candidates are on track, with data expected in 2025, including interim Phase 1b data for ABI-5366 and ABI-1179 anticipated in fall 2025 [1][4] - The company plans to run concurrent studies for ABI-5366 and ABI-1179, evaluating weekly and monthly oral dosing in participants with recurrent genital herpes over a 28-day period [8] - In Q3 2025, data from a Phase 1a study in healthy participants for ABI-6250 will be assessed for safety and pharmacokinetic measures [8] - Efficacy, safety, and pharmacokinetic data from a Phase 1b study for ABI-4334 in chronic HBV infection is expected in the first half of 2025 [8] Upcoming Conferences - Assembly Biosciences presented multiple abstracts at various conferences, including ICAR, ESCMID, and EASL in 2025, showcasing data on its antiviral candidates [8]

Core Insights - Assembly Biosciences, Inc. presented new preclinical and in vitro data for two therapeutic candidates, ABI-6250 and ABI-4334, at the EASL Congress, highlighting their potential in treating chronic viral hepatitis [1][2] Group 1: ABI-6250 - ABI-6250 is a first-in-class oral therapeutic candidate for chronic hepatitis D virus (HDV) infection, currently in Phase 1a clinical study [3] - Preclinical results show ABI-6250 specifically inhibits both HDV and hepatitis B virus (HBV) at low nanomolar levels, with minimal effects on cell viability across multiple cell types [4] - The mechanism of ABI-6250 involves blocking the sodium taurocholate cotransporting polypeptide (NTCP), a validated target for HDV infection, which is crucial as current treatments for chronic HDV are limited [5] Group 2: ABI-4334 - ABI-4334 is a next-generation capsid assembly modulator (CAM) for HBV, with in vitro studies demonstrating sustained inhibition of HBV replication and HBsAg levels after long-term treatment in human hepatocytes [6] - The World Health Organization estimates that 254 million people are chronically infected with HBV, leading to significant health issues, highlighting the need for innovative treatments like ABI-4334 [7] Group 3: Company Overview - Assembly Biosciences is focused on developing innovative small-molecule therapeutics aimed at serious viral diseases, particularly targeting herpesvirus, HBV, and HDV infections [9]

Company Overview - Assembly Biosciences (ASMB) shares increased by 24% to close at $14.18, with notable trading volume compared to typical sessions, and a 22.9% gain over the past four weeks [1][2] Development Pipeline - The company is investigating four developmental candidates in early-stage studies targeting chronic infections such as herpesvirus, hepatitis B virus, and hepatitis delta virus, with several clinical data readouts expected in 2025 [2] Financial Expectations - Assembly Biosciences is projected to report a quarterly loss of $2.01 per share, reflecting a year-over-year decline of 21.1%, while revenues are anticipated to be $7.76 million, marking a 34% increase from the previous year [3] Earnings Estimate Trends - The consensus EPS estimate for the upcoming quarter has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] Industry Context - Assembly Biosciences is part of the Zacks Medical - Generic Drugs industry, where another company, Taysha Gene Therapies, Inc. (TSHA), saw a 7.1% increase in its stock price, closing at $2.58, with a remarkable 91.3% return over the past month [4]

Core Insights - Assembly Biosciences, Inc. is developing ABI-5366, a long-acting helicase-primase inhibitor for recurrent genital herpes, with interim proof-of-concept data expected in fall 2025 [1][5] - The company presented data on ABI-5366 at the 2025 Congress of the European Society of Clinical Microbiology and Infectious Diseases, highlighting its potential as a once-weekly or once-monthly oral treatment option [1][2][8] Clinical Data - ABI-5366 was well tolerated in a Phase 1a study, with no serious adverse events reported at doses up to 350 mg, and a half-life of approximately 20 days supports infrequent dosing [3][4] - Preclinical studies demonstrated broad activity against HSV-1 and HSV-2, reinforcing the potential for weekly or monthly oral dosing [4] Genital Herpes Prevalence and Treatment Patterns - A retrospective analysis estimated 262,457 total genital herpes cases and 148,067 recurrent cases in 2023 among healthcare-engaged individuals in the U.S., with a projected 1.35 million individuals experiencing recurrent genital herpes nationwide [6][7] - Among recurrent cases, 97% received pharmacologic treatment, with 57% on suppressive therapy, indicating a significant opportunity for improved treatment strategies [7] Company Overview - Assembly Biosciences focuses on innovative therapeutics for serious viral diseases, including herpesvirus and hepatitis infections, aiming to enhance patient outcomes [12]

Core Viewpoint - Assembly Biosciences (ASMB) is experiencing significant selling pressure, with a 22.6% decline over the past four weeks, but is now positioned for a potential trend reversal due to being in oversold territory and positive earnings expectations from Wall Street analysts [1]. Group 1: Technical Indicators - The Relative Strength Index (RSI) is a key technical indicator used to identify oversold stocks, with a reading below 30 typically indicating oversold conditions [2]. - ASMB's current RSI reading is 20.23, suggesting that heavy selling may be exhausting itself, indicating a potential bounce back towards equilibrium in supply and demand [5]. Group 2: Fundamental Indicators - There is a strong consensus among sell-side analysts that ASMB's earnings estimates for the current year have increased by 11.4% over the last 30 days, which often correlates with near-term price appreciation [7]. - ASMB holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, further supporting the stock's potential for a turnaround [8].

Core Viewpoint - Assembly Biosciences (ASMB) has received a Zacks Rank 2 (Buy) upgrade due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Correlation - The Zacks rating system emphasizes the correlation between changes in earnings estimates and stock price movements, particularly influenced by institutional investors who adjust their valuations based on these estimates [4][6]. - Rising earnings estimates for Assembly Biosciences indicate an improvement in the company's underlying business, suggesting potential for stock price appreciation [5]. Recent Performance and Projections - Assembly Biosciences is projected to earn -$6.78 per share for the fiscal year ending December 2025, reflecting a year-over-year change of -1.4% [8]. - Over the past three months, the Zacks Consensus Estimate for Assembly Biosciences has increased by 11.4%, indicating positive revisions in earnings estimates [8]. Zacks Rating System Overview - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with only the top 20% receiving a 'Strong Buy' or 'Buy' rating, highlighting superior earnings estimate revisions [9][10]. - The upgrade of Assembly Biosciences to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [10].

Clinical Development - The biotechnology company is developing multiple clinical-stage investigational therapies targeting serious viral diseases, including two helicase-primase inhibitors (HPIs) for recurrent genital herpes and an orally bioavailable hepatitis delta virus (HDV) entry inhibitor [211]. - The company initiated several Phase 1 studies in 2024, including a Phase 1a/b study of 5366 and 1179, both long-acting HPIs for recurrent genital herpes, and a Phase 1a study of 6250, an orally bioavailable HDV entry inhibitor [212]. - Interim results from the Phase 1a portion of the 5366 study showed a mean half-life of approximately 20 days, supporting once-weekly oral dosing, with no serious adverse events reported [221][222]. - The company expects interim data from the Phase 1b portion of the 5366 study to be available in fall 2025 [223]. - The company nominated 6250, a novel orally bioavailable small molecule targeting NTCP, for HBV and HDV entry inhibition, demonstrating low nanomolar potency and a favorable safety profile in nonclinical studies [237]. - A Phase 1a clinical study of 6250 was initiated in Q4 2024, with interim safety and pharmacokinetic data expected in Q3 2025 [238]. - The company plans to report interim data for both 5366 and 1179 concurrently in fall 2025, as both studies are anticipated to be conducted at the same sites [228]. - The company is advancing 1179, which has shown single-digit nanomolar potency against HSV-1 and HSV-2, supporting its potential as a long-acting treatment [224]. - The Phase 1a study of the next-generation CAM, 4334, demonstrated a mean decline in HBV DNA of 2.9 log10 IU/mL in predominantly HBeAg negative participants [244]. - Interim clinical results from the initial 150 mg cohort of 4334 indicated that clinical exposures were multiple folds above those anticipated for potent viral activity [244]. - The company anticipates releasing data from the 400 mg cohort of 4334 in the first half of 2025, following strong antiviral activity observed in the first cohort [244]. Financial Performance - The company has an accumulated deficit of $825.9 million as of December 31, 2024, and expects to continue generating losses as it develops its product candidates [255]. - Collaboration revenue for the year ended December 31, 2024, was $28.5 million, a 298% increase from $7.2 million in 2023, primarily due to a full year of revenue recognition under the Gilead Collaboration Agreement [268]. - Research and development expenses increased to $55.9 million in 2024 from $48.9 million in 2023, reflecting a $7.0 million rise driven by external program expenses related to pipeline advancements [271]. - General and administrative expenses decreased to $18.0 million in 2024, down 21% from $22.9 million in 2023, mainly due to reduced legal expenses and stock-based compensation [274]. - Interest and other income, net, rose to $5.6 million in 2024, a 61% increase from $3.5 million in 2023, attributed to higher interest income from marketable securities following a $100.0 million receipt from the Gilead Collaboration [275]. - Income tax expense for 2024 was $0.3 million, a significant increase of 900% from $0.033 million in 2023, due to taxable income from upfront payments under the Gilead Collaboration [276]. - Total external program expenses for research and development increased by 40% to $28.4 million in 2024 from $20.3 million in 2023 [270]. - The company expects its existing cash, cash equivalents, and marketable securities will fund operations into mid-2026, based on current assumptions [281]. - Future operating expenses are anticipated to increase substantially as the company advances its candidates into clinical trials [280]. - The company has raised an aggregate of $648.0 million in net proceeds from equity financings and $200.9 million from strategic collaborations since its inception [279]. - Net cash used in operating activities for the year ended December 31, 2024 was $51.1 million, a decrease from net cash provided of $22.7 million in 2023 [285]. - Net cash provided by investing activities for the year ended December 31, 2024 was $40.2 million, compared to net cash used of $69.1 million in 2023 [286]. - Net cash provided by financing activities for the year ended December 31, 2024 was $29.4 million, an increase from $13.8 million in 2023 [287]. - The company experienced a net increase in cash and cash equivalents of $18.5 million in 2024, compared to a decrease of $32.6 million in 2023 [284]. Collaborations and Partnerships - Gilead made an upfront cash payment of $84.8 million as part of the collaboration agreement, with potential opt-in fees ranging from $45 million to $125 million per program [249]. - The collaboration with Gilead may yield up to $330 million in potential regulatory and commercial milestones, in addition to royalties ranging from high single-digits to high teens [250]. - Gilead's equity investment included purchasing 1,089,472 shares at $13.92 per share, with a subsequent purchase at $21.37 per share, representing a 35% premium [252]. Market Need and Impact - The World Health Organization estimates that 254 million people are chronically infected with HBV, with only approximately 33 million aware of their infection, highlighting a significant treatment gap [229]. - The current standard of care for chronic HBV infection has not seen new mechanisms of action approved in over 25 years, indicating a need for innovative therapies [230]. - Approximately 95,000 transplant patients in the U.S. and Europe were impacted by uncontrolled viral infections in 2021, highlighting the need for effective antiviral treatments [245]. - The company is developing a broad-spectrum NNPI for transplant-associated herpesvirus infections, with ongoing CTA-enabling studies for candidate 7423 [246].

Financial Performance - Assembly Biosciences reported cash, cash equivalents, and marketable securities of $112.1 million as of December 31, 2024, compared to $130.2 million as of December 31, 2023[7]. - Revenues from collaborative research increased to $28.5 million for the year ended December 31, 2024, up from $7.2 million in 2023, primarily due to a full year of revenue recognition under the collaboration with Gilead[7]. - Research and development expenses rose to $55.9 million in 2024, compared to $48.9 million in 2023, reflecting an increase in candidates under development[7]. - General and administrative expenses decreased to $18.0 million in 2024 from $22.9 million in 2023, mainly due to reductions in legal and non-cash stock-based compensation expenses[7]. - The net loss attributable to common stockholders was $40.2 million, or $6.69 per share, for the year ended December 31, 2024, compared to a net loss of $61.2 million, or $13.38 per share, in 2023[7]. - Total liabilities decreased to $85.8 million as of December 31, 2024, from $95.7 million in 2023[12]. Clinical Development - Positive Phase 1a interim data for ABI-1179 indicated it was well-tolerated, supporting potential once-weekly oral dosing at a low dose[3]. - ABI-4334 demonstrated a mean decline in HBV DNA of 2.9 log10 IU/mL in the initial 150 mg dose cohort, primarily in HBeAg negative participants[3]. - Assembly Biosciences plans to run concurrent studies for ABI-5366 and ABI-1179, with interim efficacy data expected in fall 2025[7]. - The company received approximately $20.1 million in equity investment and $10 million in accelerated funding from Gilead to advance clinical development programs[3].