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]

Financial Performance - BridgeBio Pharma reported a quarterly loss of $0.88 per share, which was better than the Zacks Consensus Estimate of a loss of $1, representing an earnings surprise of 12% [1] - The company posted revenues of $116.63 million for the quarter ended March 2025, exceeding the Zacks Consensus Estimate by 86.76%, although this is a decline from year-ago revenues of $211.12 million [2] - Over the last four quarters, BridgeBio Pharma has surpassed consensus EPS estimates three times and topped consensus revenue estimates two times [2] Stock Performance - Since the beginning of the year, BridgeBio Pharma shares have increased by approximately 30.8%, contrasting with a decline of 6% in the S&P 500 [3] - The stock's immediate price movement will largely depend on management's commentary during the earnings call [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.98 on revenues of $60.98 million, and for the current fiscal year, it is -$4.18 on revenues of $255.08 million [7] - The estimate revisions trend for BridgeBio Pharma is currently unfavorable, resulting in a Zacks Rank 4 (Sell) for the stock, indicating expected underperformance in the near future [6] Industry Context - The Medical - Generic Drugs industry, to which BridgeBio Pharma belongs, is currently ranked in the top 29% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8]

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].

Financial Performance - The net loss for the three months ended September 30, 2024, was $9,613,000, compared to a net loss of $14,420,000 for the same period in 2023, reflecting a reduction in losses of about 33.5%[7]. - The net loss for the nine months ended September 30, 2024, was $29,842,000, compared to a net loss of $50,266,000 for the same period in 2023, indicating a reduction in losses[11]. - The company reported a net loss of $9.6 million for the three months ended September 30, 2024, compared to a net loss of $14.4 million for the same period in 2023, representing a 33.5% improvement[25]. - Basic net loss per share for the nine months ended September 30, 2024, was $(5.12), an improvement from $(11.61) in the same period of 2023[25]. - Comprehensive loss for the three months ended September 30, 2024, was $9,476,000, compared to $14,370,000 for the same period in 2023, showing a 33.5% improvement[7]. Revenue and Collaboration - Collaboration revenue from a related party for the three months ended September 30, 2024, was $6,845,000, compared to $0 for the same period in 2023[7]. - The company recognized $6.8 million in collaboration revenue from the Gilead Collaboration Agreement during the three months ended September 30, 2024[27]. - Collaboration revenue recognized from the Gilead Collaboration Agreement was $6.8 million for the three months ended September 30, 2024, and $21.2 million for the nine months ended September 30, 2024[52]. - The total transaction price for the Gilead Collaboration Agreement was determined to be $90.7 million as of September 30, 2024[50]. - The Company entered into a collaboration agreement with Gilead in October 2023, receiving total proceeds of $100.0 million[46]. Assets and Liabilities - As of September 30, 2024, total assets decreased to $100,262,000 from $136,823,000 as of December 31, 2023, representing a decline of approximately 26.5%[6]. - Total liabilities decreased to $74,259,000 as of September 30, 2024, from $95,726,000 as of December 31, 2023, a decrease of approximately 22.4%[6]. - The accumulated deficit increased to $815,590,000 as of September 30, 2024, from $785,748,000 as of December 31, 2023[6]. - Total stockholders' equity decreased from $41,714,000 as of September 30, 2023, to $26,003,000 as of September 30, 2024, indicating a significant decline[10]. - Total current liabilities rose to $41.635 million from $39.225 million, an increase of about 6.1%[6]. Cash Flow and Expenses - Cash and cash equivalents increased to $28,452,000 from $19,841,000, marking a growth of about 43.3%[6]. - The company reported net cash used in operating activities of $50,710,000 for the nine months ended September 30, 2024, slightly lower than $50,904,000 for the same period in 2023[11]. - The company reported total operating expenses of $17,801,000 for the three months ended September 30, 2024, compared to $15,048,000 for the same period in 2023, an increase of approximately 18.4%[7]. - Research and development expenses rose to $13,515,000 for the three months ended September 30, 2024, up from $10,824,000 in the same period of 2023, an increase of approximately 24.9%[7]. - The company incurred $0.3 million in reimbursable expenses due to Gilead during the nine months ended September 30, 2024[52]. Stock and Equity - The weighted average common shares outstanding for the three months ended September 30, 2024, was 6,351,431, compared to 4,380,444 for the same period in 2023[7]. - The company completed a reverse stock split at a ratio of 1-for-12, reducing the number of shares outstanding from 65.8 million to 5.5 million[22]. - The exercise price of warrants sold was set at $17.00 per share, with an expiration date of June 18, 2029[41]. - The company has $2.9 million of total unrecognized stock-based compensation related to outstanding equity awards as of September 30, 2024[44]. - The weighted average number of common shares outstanding increased to 6,351,431 for the three months ended September 30, 2024, up from 4,380,444 in the same period of 2023[25]. Future Outlook - The company has not generated any revenue from product sales to date and continues to incur substantial losses as it develops its product pipeline[13]. - The company expects to continue incurring substantial losses for the next several years as it advances its product development efforts[13]. - The company has sufficient funds to meet its operating requirements for at least the next twelve months, but may need to secure additional funding through various means[13]. - The company intends to secure additional funding through strategic relationships, public or private equity or debt financings, and grants[13]. - Gilead will support the collaboration with extension fees of $75.0 million in each of the third, fifth, and seventh years of the collaboration[48].

Financial Performance - Revenue from collaborative research was $6.8 million for Q3 2024, compared to $0 for the same period in 2023, attributed to the collaboration with Gilead[4] - Net loss attributable to common stockholders was $9.6 million, or $1.51 per share, for Q3 2024, compared to a net loss of $14.4 million, or $3.29 per share, for Q3 2023[4] - Total operating expenses for Q3 2024 were $17.8 million, compared to $15.0 million for Q3 2023[4] Research and Development - Positive Phase 1a interim data for ABI-5366 showed a favorable safety profile with a half-life of approximately 20 days and well-tolerated exposures of up to 70 days[1] - ABI-5366 Phase 1b trial initiated for recurrent genital herpes, with interim data expected in the first half of 2025[1] - ABI-4334 Phase 1b trial ongoing for chronic HBV, with interim data expected by the end of 2024[1] - ABI-1179 and ABI-6250 candidates are on track to enter the clinic by the end of 2024[4] Financial Position - Cash, cash equivalents, and marketable securities totaled $95.0 million as of September 30, 2024, down from $109.2 million as of June 30, 2024, projected to fund operations into Q1 2026[4] - Total liabilities as of September 30, 2024, were $74.3 million, down from $95.7 million at the end of 2023[4] Expense Trends - Research and development expenses increased to $13.5 million in Q3 2024, up from $10.8 million in Q3 2023, due to more candidates in development[4]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.001 ASMB The Nasdaq Global Select Market FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________to_________ ...

Exhibit 99.1 Assembly Biosciences Reports Second Quarter 2024 Financial Results and Recent Updates • Dosing initiated in healthy participants in Phase 1a/b trial for ABI-5366 targeting recurrent genital herpes, with interim Phase 1a first-in-human data expected in Q3 2024 and interim Phase 1b data in participants with recurrent genital herpes expected in first half of 2025 • Dosing initiated in Phase 1b trial for ABI-4334 in participants with chronic HBV infection, with interim Phase 1b data expected by end ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.001 ASMB The Nasdaq Global Select Market5 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________to_______ ...

Exhibit 99.1 Assembly Biosciences Reports First Quarter 2024 Financial Results and Recent Highlights • Clinical trial application clearances received for a Phase 1a/1b trial for ABI-5366 targeting recurrent genital herpes, and a Phase 1b trial for ABI-4334 in chronic HBV infection; both studies on track to initiate by mid-2024 • ABI-5366 interim Phase 1a first-in-human data expected in Q3 2024 and ABI-4334 interim Phase 1b data expected by end of year SOUTH SAN FRANCISCO, Calif., May 8, 2024 (GLOBE NEWSWIRE ...