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SOUTH SAN FRANCISCO, Calif., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV), today reported financial results and recent highlights for the fourth quarter and year ended December 31, 2020.
“Our strategy for 2021 and beyond is to focus entirely on developing finite and curative therapies that have the potential to free patients with chronic HBV infection from a lifetime of therapy. We are well positioned to do this by advancing our more potent next generation core inhibitors, which include three novel compounds in the clinic and a fourth candidate in pre-IND development, exploring multiple triple combination studies of vebicorvir with complementary mechanisms of action, and expanding our internal research efforts to discover and develop candidates against novel targets,” said John McHutchison, AO, MD, Chief Executive Officer and President of Assembly Bio.
Fourth Quarter 2020 and Recent Highlights
2021 Key Objectives and Anticipated Progress
Fourth Quarter 2020 and Year End Financial Results
About Assembly BiosciencesAssembly Bio is a clinical-stage biotechnology company committed to bringing finite and curative therapies to the 270 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 toward cure includes a leading portfolio of more potent, next-generation core inhibitors, proof-of-concept combination studies and a research program focused on the discovery of novel HBV targets. 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 HBV 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; 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 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 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.
ContactsInvestor and Corporate:Lauren GlaserSenior Vice President, Investor Relations and Corporate Affairs(415) 521-3828lglaser@assemblybio.com
Media:Sam Brown Inc. Audra Friis (917) 519-9577 ASMBMedia@sambrown.com
| ASSEMBLY BIOSCIENCES, INC. | ||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| (In thousands except for share amounts and par value) | ||||||||
| December 31, | December 31, | |||||||
| 2020 | 2019 | |||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 59,444 | $ | 46,732 | ||||
| Marketable securities | 156,969 | 227,311 | ||||||
| Accounts receivable from collaboration | 1,230 | 3,374 | ||||||
| Prepaid expenses and other current assets | 6,850 | 5,363 | ||||||
| Total current assets | 224,493 | 282,780 | ||||||
| Property and equipment, net | 1,600 | 1,830 | ||||||
| Operating lease right-of-use (ROU) assets | 9,131 | 11,975 | ||||||
| Other assets | 6,392 | 1,684 | ||||||
| Indefinite-lived intangible asset | 29,000 | 29,000 | ||||||
| Goodwill | 12,638 | 12,638 | ||||||
| Total assets | $ | 283,254 | $ | 339,907 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 4,598 | $ | 1,731 | ||||
| Accrued clinical expenses | 4,444 | 4,826 | ||||||
| Other accrued expenses | 11,987 | 8,286 | ||||||
| Deferred revenue - short-term | — | 6,411 | ||||||
| Operating lease liabilities - short-term | 3,404 | 3,186 | ||||||
| Total current liabilities | 24,433 | 24,440 | ||||||
| Deferred tax liabilities | 2,531 | 2,531 | ||||||
| Deferred revenue - long-term | 8,987 | 30,637 | ||||||
| Operating lease liabilities - long-term | 6,725 | 9,082 | ||||||
| Total liabilities | 42,676 | 66,690 | ||||||
| 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, 2020 and 2019; 34,026,680 and 32,558,307 shares issued and outstanding as of December 31, 2020 and 2019, respectively | 34 | 32 | ||||||
| Additional paid-in capital | 742,387 | 712,807 | ||||||
| Accumulated other comprehensive loss | (270 | ) | (201 | ) | ||||
| Accumulated deficit | (501,573 | ) | (439,421 | ) | ||||
| Total stockholders' equity | 240,578 | 273,217 | ||||||
| Total liabilities and stockholders' equity | $ | 283,254 | $ | 339,907 | ||||
| ASSEMBLY BIOSCIENCES, INC. | ||||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) | ||||||||||||
| (In thousands except for share and per share amounts) | ||||||||||||
| Year Ended December 31, | ||||||||||||
| 2020 | 2019 | 2018 | ||||||||||
| Collaboration revenue | $ | 79,105 | $ | 15,963 | $ | 14,804 | ||||||
| Operating expenses: | ||||||||||||
| Research and development | 106,823 | 85,757 | 72,741 | |||||||||
| General and administrative | 37,058 | 32,919 | 34,798 | |||||||||
| Total operating expenses | 143,881 | 118,676 | 107,539 | |||||||||
| Loss from operations | (64,776 | ) | (102,713 | ) | (92,735 | ) | ||||||
| Other income | ||||||||||||
| Interest and other income, net | 2,624 | 4,305 | 3,083 | |||||||||
| Total other income | 2,624 | 4,305 | 3,083 | |||||||||
| Loss before income taxes | (62,152 | ) | (98,408 | ) | (89,652 | ) | ||||||
| Income tax benefit | — | 774 | (1,099 | ) | ||||||||
| Net loss | $ | (62,152 | ) | $ | (97,634 | ) | $ | (90,751 | ) | |||
| Other comprehensive (loss) income | ||||||||||||
| Unrealized (loss) gain on marketable securities, net of tax | (69 | ) | 146 | 45 | ||||||||
| Comprehensive loss | $ | (62,221 | ) | $ | (97,488 | ) | $ | (90,706 | ) | |||
| Net loss per share, basic and diluted | $ | (1.75 | ) | $ | (3.72 | ) | $ | (3.98 | ) | |||
| Weighted average common shares outstanding, basic and diluted | 35,427,120 | 26,258,790 | 22,801,644 | |||||||||
