Full Press Release Details
Assembly Biosciences Reports Second Quarter 2022 Financial Results and Recent Highlights
SOUTH SAN FRANCISCO, Calif., August 9, 2022 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage biotechnology company developing innovative, investigational therapeutics targeting hepatitis B virus (HBV) and other viral diseases, today announced financial results and recent highlights for the second quarter ended June 30, 2022.
"We are excited to advance clinical development of our next-generation, more potent core inhibitors and to continue the expansion of our pipeline. Our recently introduced small molecule interferon- receptor agonist research program provides a complementary immunomodulatory approach to our HBV and HDV strategy that we believe can engage interferon- 's validated mechanism while limiting its substantial side effect profile. We also look forward to introducing our new viral targets outside of HBV in the third quarter of 2022, leveraging the deep antiviral expertise and experience of our research organization against diseases with significant unmet medical need," said John McHutchison, AO, MD, chief executive officer of Assembly Bio. "Additionally, we recently announced our data-driven decision to discontinue clinical development of our first-generation core inhibitor vebicorvir (VBR) and have restructured the organization to support our refocused clinical and pre-clinical pipeline, which has also extended our projected cash runway into the first half of 2024."
Anticipated Milestones and Events
Upcoming Conferences
Second Quarter 2022 Financial Results
About Assembly Biosciences
Assembly Bio is a clinical-stage biotechnology company pioneering the development of therapeutics for viral diseases, including pursuing finite and potentially curative therapies for the 296 million people living with hepatitis B virus (HBV) worldwide. Assembly Bio is advancing a leading portfolio of more potent, next-generation core inhibitor drug candidates that aim to break the complex viral replication cycle of HBV 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 successfully execute its reprioritization and restructuring activities; potential adverse legal, reputational, operational and financial effects on Assembly Bio resulting from the reprioritization and restructuring activities; Assembly Bio's ability to initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio's 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 ABI-H3733, if successful, in the China territory will be dependent on, and subject to, Assembly Bio's collaboration agreement governing this 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.
Investor and Corporate:
SVP, Investor Relations, Corporate Affairs and Alliance Management
ASSEMBLY BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands except for share amounts and par value)
| June 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 43,063 | $ | 45,627 | ||||
| Marketable securities - short-term | 73,626 | 101,000 | ||||||
| Accounts receivable from collaborations | 523 | 336 | ||||||
| Prepaid expenses and other current assets | 7,082 | 7,241 | ||||||
| Total current assets | 124,294 | 154,204 | ||||||
| Marketable securities - long-term | 11,908 | 27,972 | ||||||
| Property and equipment, net | 899 | 1,139 | ||||||
| Operating lease right-of-use (ROU) assets | 4,711 | 6,042 | ||||||
| Other assets | 1,635 | 1,703 | ||||||
| Total assets | $ | 143,447 | $ | 191,060 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 2,454 | $ | 2,659 | ||||
| Accrued research and development expenses | 4,446 | 3,400 | ||||||
| Other accrued expenses | 4,750 | 6,863 | ||||||
| Operating lease liabilities - short-term | 3,311 | 3,151 | ||||||
| Total current liabilities | 14,961 | 16,073 | ||||||
| Deferred revenue | 2,733 | 2,733 | ||||||
| Operating lease liabilities - long-term | 1,773 | 3,325 | ||||||
| Total liabilities | 19,467 | 22,131 | ||||||
| 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; 150,000,000 and 100,000,000 shares authorized as of June 30, 2022 and December 31, 2021, respectively; 48,362,736 and 48,120,437 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively | 48 | 48 | ||||||
| Additional paid-in capital | 803,910 | 800,728 | ||||||
| Accumulated other comprehensive loss | (998 | ) | (419 | ) | ||||
| Accumulated deficit | (678,980 | ) | (631,428 | ) | ||||
| Total stockholders' equity | 123,980 | 168,929 | ||||||
| Total liabilities and stockholders' equity | $ | 143,447 | $ | 191,060 |
ASSEMBLY BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands except for share and per share amounts)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 17,792 | $ | 16,749 | $ | 34,997 | $ | 35,303 | ||||||||
| General and administrative | 6,781 | 6,917 | 12,738 | 15,621 | ||||||||||||
| Total operating expenses | 24,573 | 23,666 | 47,735 | 50,924 | ||||||||||||
| Loss from operations | (24,573 | ) | (23,666 | ) | (47,735 | ) | (50,924 | ) | ||||||||
| Other income: | ||||||||||||||||
| Interest and other income, net | 112 | 71 | 183 | 129 | ||||||||||||
| Total other income | 112 | 71 | 183 | 129 | ||||||||||||
| Net loss | $ | (24,461 | ) | $ | (23,595 | ) | $ | (47,552 | ) | $ | (50,795 | ) | ||||
| Other comprehensive loss | ||||||||||||||||
| Unrealized loss on marketable securities | (90 | ) | (2 | ) | (579 | ) | (3 | ) | ||||||||
| Comprehensive loss | $ | (24,551 | ) | $ | (23,597 | ) | $ | (48,131 | ) | $ | (50,798 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.51 | ) | $ | (0.55 | ) | $ | (0.99 | ) | $ | (1.23 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 48,293,495 | 42,876,268 | 48,208,735 | 41,286,831 |