Assembly Biosciences Reports First Quarter 2026 Financial Results and Recent Highlights
Rhea-AI Summary
Assembly Biosciences (Nasdaq: ASMB) reported Q1 2026 results and program updates on May 7, 2026. Key development milestones include completed Phase 1b follow-up for ABI-5366 and ABI-1179, completed chronic toxicology for ABI-6250, and an expected Phase 2 start for ABI-6250 in Q4 2026.
Financials: $226.6M cash and marketable securities at March 31, 2026, projected runway into 2028; collaborative revenue with Gilead was $8.2M in Q1; net loss attributable to common stockholders was $9.1M (loss per share $0.54).
Positive
- Completed Phase 1b follow-up for ABI-5366 and ABI-1179
- Completed chronic toxicology studies supporting ABI-6250 Phase 2 dosing
- Cash and marketable securities of $226.6M as of March 31, 2026
- Projected cash runway into 2028
Negative
- Collaborative revenue from Gilead fell to $8.2M in Q1 2026 from $9.4M year-ago
- Net loss of $9.1M in Q1 2026, reflecting continued operating losses
Key Figures
Market Reality Check
Peers on Argus
ASMB gained 6.13% while peers showed mixed moves: RCKT up 7.82%, LRMR up 2.22%, BNTC up 1.94%, TECX down 1.02%, YMAB up 0.23%. No broad sector momentum flagged.
Previous Earnings Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Mar 19 | Year-end 2025 earnings | Positive | +3.5% | Full-year 2025 results, $35M Gilead option fee, strong cash of $248.1M. |
| Nov 10 | Q3 2025 earnings | Positive | +3.3% | Q3 2025 results with positive HSV and HDV data and $175M equity raise. |
| Aug 06 | Q2 2025 earnings | Positive | +9.2% | Q2 2025 results, higher Gilead revenue and improved net loss of $10.2M. |
| May 08 | Q1 2025 earnings | Positive | +5.0% | Q1 2025 results with rising collaboration revenue and narrowed net loss. |
| Mar 20 | Year-end 2024 earnings | Positive | +3.0% | 2024 results showing revenue growth, lower net loss, and pipeline advances. |
Earnings and results updates have consistently drawn positive reactions, with all past five earnings-tagged events showing gains and an average move of 4.79%.
Over the past year, Assembly Bio’s earnings updates have highlighted strengthening finances and steady pipeline progress. Cash balances rose from $75.0M at Q2 2025 to $248.1M at year-end 2025, supported by a $175M equity raise and Gilead collaboration revenue reaching $72.3M in 2025. Net loss narrowed to $6.1M for 2025. Today’s Q1 2026 report extends this narrative with continued HSV and HDV program advancement alongside controlled operating expenses.
Historical Comparison
Past earnings headlines moved ASMB about 4.79% on average. Today’s 6.13% gain sits modestly above that pattern, consistent with prior positive reactions to financial updates and pipeline progress.
Earnings updates have traced a path from 2024 revenue growth and loss reduction through 2025 cash strengthening, larger Gilead contributions and advancing HSV/HDV programs, leading into Q1 2026 with continued clinical progress and maintained operating discipline.
Regulatory & Risk Context
An effective S-3 shelf filed on 2026-03-19 registers up to $400,000,000 in securities, including an $100,000,000 at-the-market common stock program via Jefferies LLC, providing flexibility to issue equity, debt or other securities as described in the prospectus.
Market Pulse Summary
This announcement details Q1 2026 financials, with cash and securities of $226.6M, collaboration revenue of $8.2M, and a net loss of $9.1M. Management highlights completion of Phase 1b HSV studies and toxicology work supporting Phase 2 initiation for ABI-6250 in HDV by Q4 2026. The company projects funding into 2028. Investors may watch execution against these timelines, collaboration revenue trends, and utilization of the recently filed $400,000,000 shelf and $100,000,000 ATM program.
Key Terms
phase 1b medical
helicase-primase inhibitors medical
entry inhibitor medical
hepatitis delta virus medical
phase 2 medical
AI-generated analysis. Not financial advice.
– Completed Phase 1b studies for ABI-5366 and ABI-1179, helicase-primase inhibitors for recurrent genital herpes –
– Completed chronic toxicology studies for ABI-6250, an oral small-molecule entry inhibitor candidate for chronic hepatitis delta virus; Phase 2 initiation anticipated Q4 2026 –
SOUTH SAN FRANCISCO, Calif., May 07, 2026 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today reported financial results for the first quarter ended March 31, 2026, and recent highlights.
“The first quarter reflected steady progress across our portfolio as we continue advancing our discovery and development programs,” said Jason Okazaki, chief executive officer and president of Assembly Bio. “As we look ahead, we anticipate receiving Gilead’s development plan and budget for the herpesvirus program and will evaluate our cost and profit share opt-in decision by mid-2026 while continuing to advance ABI-6250 toward Phase 2 in hepatitis delta virus by year-end.”
First Quarter 2026 and Recent Highlights
- Completed follow-up period for all participants in the Phase 1b portion of the studies for ABI-5366 and ABI-1179, reinforcing continued confidence in the safety and efficacy findings previously disclosed for both candidates
- Completed chronic toxicology studies for ABI-6250, establishing support for anticipated phase 2 doses
- Presented an oral presentation and three posters, including one late-breaker, highlighting interim Phase 1b data for ABI-5366 and ABI-1179 at the 2026 Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) in Munich, Germany
Anticipated Milestones and Events
- By mid-2026, upon receipt of Gilead Sciences, Inc. (Gilead)’s development plan and budget for the helicase-primase inhibitor (HPI) program (ABI-5366 and ABI-1179) for recurrent genital herpes, Assembly Bio to determine whether to opt in to a
40% U.S. cost-profit share, in lieu of receiving U.S. milestones and royalties - Initiation of a Phase 2 clinical study for ABI-6250 in participants with chronic hepatitis delta virus (HDV) infection expected in the fourth quarter of 2026
Upcoming Conferences
- European Association for the Study of the Liver (EASL) Congress: May 27-30, 2026 – Barcelona, Spain
ABI-5366, ABI-1179 and ABI-6250 are investigational product candidates that have not been approved anywhere globally, and their safety and efficacy have not been established. ABI-5366 and ABI-1179 are exclusively licensed to Gilead under the collaboration between Assembly Bio and Gilead, and Gilead has the sole right and responsibility for further clinical development and commercialization of the HPI program.
First Quarter 2026 Financial Results
- Cash, cash equivalents and marketable securities were
$226.6 million as of March 31, 2026, compared to$248.1 million as of December 31, 2025. The company’s cash position is projected to fund operations into 2028. - Revenue from collaborative research with Gilead was
$8.2 million for the three months ended March 31, 2026, compared to$9.4 million for the same period in 2025. The decrease reflects the timing of activities performed and progress toward completion of services under the Gilead Collaboration Agreement. - Research and development expenses were
$14.9 million for the three months ended March 31, 2026, consistent with the same period in 2025, with increases in employee compensation and research and discovery activities offset by decreases in external program expenses due to the completion of clinical trials. - General and administrative expenses were
$4.7 million for the three months ended March 31, 2026, compared to$4.5 million for the same period in 2025, primarily driven by increased stock-based compensation related to performance-based awards. - Net loss attributable to common stockholders was
$9.1 million , or$0.54 per basic and diluted share, for the three months ended March 31, 2026, compared to$8.8 million , or$1.17 per basic and diluted share, for the same period in 2025, reflecting a higher weighted-average share count in 2026.
About Assembly Biosciences
Assembly Biosciences is a biotechnology company dedicated to the development of innovative small-molecule therapeutics designed to change the path of serious viral diseases and improve the lives of patients worldwide. Led by an accomplished team of leaders in virologic drug development, Assembly Bio is committed to improving outcomes for patients struggling with the serious, chronic impacts of herpesvirus, hepatitis B virus (HBV) and hepatitis delta virus (HDV) infections. For more information, visit assemblybio.com.
Forward-Looking Statements
The information in this press release contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to materially differ. These risks and uncertainties include: Assembly Bio’s ability to realize the potential benefits of its collaboration with Gilead, including all financial aspects of the collaboration and equity investments; Assembly Bio’s ability to initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio’s collaboration with Gilead, in the currently anticipated timeframes or at all; safety and efficacy data from clinical or nonclinical studies may not warrant further development of Assembly Bio’s product candidates; clinical and nonclinical data may not differentiate Assembly Bio’s product candidates from other companies’ candidates; Assembly Bio’s ability to maintain financial resources and secure additional funding necessary to continue its research activities, clinical studies, and other business operations; potential effects of changes in government regulation; results of nonclinical studies may not be representative of disease behavior in a clinical setting and may not be predictive of the outcomes of clinical studies; and other risks identified from time to time in Assembly Bio’s reports filed with the U.S. Securities and Exchange Commission (the SEC). You are urged to consider statements that include the words may, will, would, could, should, might, believes, hopes, estimates, projects, potential, expects, plans, anticipates, intends, continues, forecast, designed, goal or the negative of those words or other comparable words to be uncertain and forward-looking. Assembly Bio intends such forward-looking statements to be covered by the safe harbor provisions contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. More information about Assembly Bio’s risks and uncertainties are more fully detailed under the heading “Risk Factors” in Assembly Bio’s filings with the SEC, including its most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Except as required by law, Assembly Bio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
Contacts:
Investors:
Patrick Till
Meru Advisors
(484) 788-8560
investor_relations@assemblybio.com
Media:
Sam Brown LLC
Jamie Strachota
(703) 819-7647
ASMBMedia@sambrown.com
| ASSEMBLY BIOSCIENCES, INC. | ||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| (In thousands except for share amounts and par value) | ||||||||
| March 31, | December 31, | |||||||
| 2026 | 2025 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 31,120 | $ | 58,450 | ||||
| Marketable securities | 195,481 | 189,656 | ||||||
| Accounts receivable from collaboration with a related party | 451 | 974 | ||||||
| Prepaid expenses and other current assets | 5,561 | 5,469 | ||||||
| Total current assets | 232,613 | 254,549 | ||||||
| Property and equipment, net | 214 | 221 | ||||||
| Operating lease right-of-use assets | 2,369 | 2,508 | ||||||
| Other assets | 312 | 312 | ||||||
| Total assets | $ | 235,508 | $ | 257,590 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 1,129 | $ | 1,171 | ||||
| Accrued research and development expenses | 1,538 | 2,387 | ||||||
| Other accrued expenses | 2,664 | 7,749 | ||||||
| Deferred revenue from a related party | 29,076 | 36,904 | ||||||
| Operating lease liabilities - short-term | 590 | 569 | ||||||
| Total current liabilities | 34,997 | 48,780 | ||||||
| Operating lease liabilities - long-term | 1,901 | 2,059 | ||||||
| Total liabilities | 36,898 | 50,839 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity | ||||||||
| Preferred stock, | — | — | ||||||
| Common stock, | 16 | 16 | ||||||
| Additional paid-in capital | 1,040,088 | 1,038,823 | ||||||
| Accumulated other comprehensive loss | (368 | ) | (41 | ) | ||||
| Accumulated deficit | (841,126 | ) | (832,047 | ) | ||||
| Total stockholders' equity | 198,610 | 206,751 | ||||||
| Total liabilities and stockholders' equity | $ | 235,508 | $ | 257,590 | ||||
| ASSEMBLY BIOSCIENCES, INC. | ||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||
| (In thousands except for share and per share amounts) | ||||||||
| (Unaudited) | ||||||||
| Three Months Ended March 31, | ||||||||
| 2026 | 2025 | |||||||
| Collaboration revenue from a related party | $ | 8,213 | $ | 9,419 | ||||
| Operating expenses | ||||||||
| Research and development | 14,900 | 14,851 | ||||||
| General and administrative | 4,683 | 4,509 | ||||||
| Total operating expenses | 19,583 | 19,360 | ||||||
| Loss from operations | (11,370 | ) | (9,941 | ) | ||||
| Other income | ||||||||
| Interest and other income, net | 2,291 | 1,123 | ||||||
| Total other income | 2,291 | 1,123 | ||||||
| Net loss | $ | (9,079 | ) | $ | (8,818 | ) | ||
| Other comprehensive loss | ||||||||
| Unrealized loss on marketable securities | 327 | 42 | ||||||
| Comprehensive loss | $ | (9,406 | ) | $ | (8,860 | ) | ||
| Net loss per share, basic and diluted | $ | (0.54 | ) | $ | (1.17 | ) | ||
| Weighted average common shares outstanding, basic and diluted | 16,900,232 | 7,506,321 | ||||||
