Full Press Release Details
Assembly Biosciences Reports Fourth Quarter and Year End 2021 Financial Results and Recent Highlights
SOUTH SAN FRANCISCO, Calif., March 10, 2022 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and other viral diseases, today reported financial results and recent highlights for the fourth quarter and year ended December 31, 2021.
"Our expanded strategy and pipeline progress in 2021 have positioned us to reach a number of important milestones in 2022 with both our core inhibitor portfolio and our research programs beyond core inhibition and HBV," said John McHutchison, AO, MD, chief executive officer and president of Assembly Bio. "The Phase 2 triple combination studies evaluating our lead investigational core inhibitor candidate, vebicorvir (VBR), plus standard-of care NrtI with other complementary mechanisms are progressing, and we anticipate initial on-treatment data during the second half of the year. We also plan to begin a Phase 1b trial of ABI-H3733, with initial antiviral data anticipated before year end, and to initiate clinical development of ABI-4334, our newest core inhibitor candidate that has been optimized for potency against the formation of cccDNA. Importantly, during the first half of 2022, we intend to share more about research programs underway that leverage our team's deep virologic drug development expertise to explore new targets in HBV as well as other viral diseases. We look forward to introducing the first of these during a web event at the end this month."
Fourth Quarter 2021 and Recent Highlights
2022 Anticipated Milestones and Events
Upcoming Conferences
Fourth Quarter 2021 and Year End Financial Results
About Assembly Biosciences
Assembly Bio is a clinical-stage biotechnology company committed to bringing finite and curative therapies to the 296 million people living with hepatitis B virus (HBV) worldwide. A pioneer in the development of a new class of potent, oral core inhibitor drug candidates, Assembly Bio's approach aims to break the complex viral replication cycle of HBV to free patients from a lifetime of therapy. Assembly Bio's strategy includes a leading portfolio of more potent, next-generation core inhibitors, proof-of-concept combination studies for HBV cure and research programs focused on the discovery of additional novel antiviral mechanisms for HBV, and other viral diseases. 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 initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio's clinical collaboration agreements, in the currently anticipated timeframes; safety and efficacy data from clinical studies may not warrant further development of Assembly Bio's product candidates; clinical and nonclinical data presented at conferences may not differentiate Assembly Bio's product candidates from other companies' candidates; 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; continued development and commercialization of
Assembly Bio's HBV product candidates, if successful, in the China territory will be dependent on, and subject to, Assembly Bio's collaboration agreement governing its HBV-related activity in the China territory; Assembly Bio's ability to maintain financial resources necessary to continue its clinical studies and fund business operations; any impact that the COVID-19 pandemic may have on Assembly Bio's business and operations, including initiation, enrollment and continuation of its clinical studies or timing of discussions with regulatory authorities; 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.
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ASSEMBLY BIOSCIENCES, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands except for share amounts and par value)
| December 31, | December 31, | |||||||
| 2021 | 2020 | |||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 45,627 | $ | 59,444 | ||||
| Marketable securities - short-term | 101,000 | 156,969 | ||||||
| Accounts receivable from collaborations | 336 | 1,230 | ||||||
| Prepaid expenses and other current assets | 7,241 | 6,850 | ||||||
| Total current assets | 154,204 | 224,493 | ||||||
| Marketable securities - long-term | 27,972 | - | ||||||
| Property and equipment, net | 1,139 | 1,600 | ||||||
| Operating lease right-of-use (ROU) assets | 6,042 | 9,131 | ||||||
| Other assets | 1,703 | 6,392 | ||||||
| Indefinite-lived intangible asset | - | 29,000 | ||||||
| Goodwill | - | 12,638 | ||||||
| Total assets | $ | 191,060 | $ | 283,254 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 2,659 | $ | 4,598 | ||||
| Accrued research and development expenses | 3,400 | 4,444 | ||||||
| Other accrued expenses | 6,863 | 11,987 | ||||||
| Operating lease liabilities - short-term | 3,151 | 3,404 | ||||||
| Total current liabilities | 16,073 | 24,433 | ||||||
| Deferred tax liabilities | - | 2,531 | ||||||
| Deferred revenue | 2,733 | 8,987 | ||||||
| Operating lease liabilities - long-term | 3,325 | 6,725 | ||||||
| Total liabilities | 22,131 | 42,676 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity | ||||||||
| Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares issued or outstanding | - | - | ||||||
| Common stock, $0.001 par value; 100,000,000 shares authorized as of December 31, 2021 and December 31, 2020; 48,120,437 and 34,026,680 shares issued and outstanding as of December 31, 2021 and December 31, 2020, respectively | 48 | 34 | ||||||
| Additional paid-in capital | 800,728 | 742,387 | ||||||
| Accumulated other comprehensive loss | (419 | ) | (270 | ) | ||||
| Accumulated deficit | (631,428 | ) | (501,573 | ) | ||||
| Total stockholders' equity | 168,929 | 240,578 | ||||||
| Total liabilities and stockholders' equity | $ | 191,060 | $ | 283,254 |
ASSEMBLY BIOSCIENCES, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands except for share and per share amounts)
| Year Ended December 31, | ||||||||
| 2021 | 2020 | |||||||
| Collaboration revenue | $ | 6,254 | $ | 79,105 | ||||
| Operating expenses: | ||||||||
| Research and development | 68,524 | 106,823 | ||||||
| General and administrative | 28,780 | 37,058 | ||||||
| Impairment of goodwill and indefinite-lived intangible asset | 41,638 | - | ||||||
| Total operating expenses | 138,942 | 143,881 | ||||||
| Loss from operations | (132,688 | ) | (64,776 | ) | ||||
| Other income | ||||||||
| Interest and other income, net | 302 | 2,624 | ||||||
| Total other income | 302 | 2,624 | ||||||
| Loss before income taxes | (132,386 | ) | (62,152 | ) | ||||
| Income tax benefit | 2,531 | - | ||||||
| Net Loss | $ | (129,855 | ) | $ | (62,152 | ) | ||
| Other comprehensive loss | ||||||||
| Unrealized loss on marketable securities | (149 | ) | (69 | ) | ||||
| Comprehensive loss | $ | (130,004 | ) | $ | (62,221 | ) | ||
| Net loss per share, basic and diluted | $ | (3.00 | ) | $ | (1.75 | ) | ||
| Weighted average common shares outstanding, basic and diluted | 43,280,383 | 35,427,120 |