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]

Investors interested in Medical stocks should always be looking to find the best-performing companies in the group. Assembly Biosciences (ASMB) is a stock that can certainly grab the attention of many investors, but do its recent returns compare favorably to the sector as a whole? Let's take a closer look at the stock's year-to-date performance to find out.Assembly Biosciences is a member of the Medical sector. This group includes 1019 individual stocks and currently holds a Zacks Sector Rank of #5. The Zac ...

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 ...

– Data from both ABI-5366 and ABI-1179, novel long-acting helicase-primase inhibitor candidates for recurrent genital herpes, to be presented – – Poster presentation highlights key preclinical data from ABI-5366 supporting its entry into ongoing Phase 1a/b clinical trials – – Oral and poster presentations feature first data presented from ABI-1179, expected to enter the clinic by the end of 2024 – SOUTH SAN FRANCISCO, Calif., July 15, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a bi ...

– Data from both ABI-5366 and ABI-1179, novel long-acting helicase-primase inhibitor candidates for recurrent genital herpes, to be presented – – Poster presentation highlights key preclinical data from ABI-5366 supporting its entry into ongoing Phase 1a/b clinical trials – – Oral and poster presentations feature first data presented from ABI-1179, expected to enter the clinic by the end of 2024 – SOUTH SAN FRANCISCO, Calif., July 15, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (NASDAQ:ASMB), a bio ...

Core Insights - Assembly Biosciences, Inc. has initiated dosing for the Phase 1b trial of ABI-4334, a next-generation capsid assembly modulator aimed at treating chronic hepatitis B virus (HBV) infection [1][4] - Chronic HBV infection is a significant global health issue, leading to over one million deaths in 2022, with current treatments offering low cure rates [2] - ABI-4334 is designed to inhibit HBV DNA replication and prevent the formation of new cccDNA, showing promising preclinical potency [2][3] Company Overview - Assembly Biosciences is focused on developing innovative small molecule therapeutics for serious viral diseases, including HBV and hepatitis delta virus (HDV) [7] - The company is led by a team experienced in virologic drug development, aiming to improve patient outcomes [7] Clinical Trial Details - The Phase 1b study, ABI-4334-102, is a randomized, blinded, placebo-controlled trial enrolling up to 50 subjects to evaluate safety, pharmacokinetics (PK), and antiviral activity over a 28-day treatment period [5] - The trial will assess the impact of escalating doses of ABI-4334 on HBV DNA levels and gather key safety data [4][5] - Interim results from the study are expected to be reported later in the year [4]

— Funding supports advancement of antiviral portfolio, including four candidates in clinical development, and extends cash runway into Q1 2026 — — Anticipated near term interim data read outs include ABI-5366 Phase 1a in 3Q24 and Phase 1b in 1H25, and ABI-4334 Phase 1b by end of 2024 — SOUTH SAN FRANCISCO, Calif., June 17, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. ("Assembly Bio") (NASDAQ:ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today anno ...

– Phase 1a study portion of single ascending dosing in healthy participants will inform the development of ABI-5366 with interim data expected in Q3 2024 – – Phase 1b study portion of multiple ascending weekly doses in participants with recurrent genital herpes on track to initiate by end of year with interim data expected in 1H 2025 – SOUTH SAN FRANCISCO, Calif., June 10, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting ...