Full Press Release Details
Assembly Biosciences Reports First Quarter 2021 Financial Results and Recent Updates
SOUTH SAN FRANCISCO, CA, May 6, 2021 -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV), today reported financial results and recent updates for the first quarter ended March 31, 2021.
"In the first quarter of 2021, we solidified all our efforts and focus on hepatitis B and the sole pursuit of finite and curative therapies to replace burdensome life-long treatment regimens for the more than 250 million people living with this disease," said John McHutchison, AO, MD, Chief Executive Officer and President of Assembly Bio. "Our strategy is clear and we have made significant progress, continuing to advance all our clinical programs while expanding and accelerating our novel discovery efforts. We are particularly excited that our first Phase 2 proof-of-concept triple combination studies - key drivers of our clinical strategy - are now underway."
Anticipated Milestones and Events
Upcoming Conferences
First Quarter 2021 Financial Results
About Assembly Biosciences
Assembly 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 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 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.
Investor and Corporate:
Senior Vice President, Investor Relations and Corporate Affairs
ASSEMBLY BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands except for share amounts and par value)
| March 31, | December 31, | |||||||
| 2021 | 2020 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 78,253 | $ | 59,444 | ||||
| Marketable securities | 136,631 | 156,969 | ||||||
| Accounts receivable from collaborations | 203 | 1,230 | ||||||
| Prepaid expenses and other current assets | 6,547 | 6,850 | ||||||
| Total current assets | 221,634 | 224,493 | ||||||
| Property and equipment, net | 1,493 | 1,600 | ||||||
| Operating lease right-of-use (ROU) assets | 8,104 | 9,131 | ||||||
| Other assets | 6,034 | 6,392 | ||||||
| Indefinite-lived intangible asset | 29,000 | 29,000 | ||||||
| Goodwill | 12,638 | 12,638 | ||||||
| Total assets | $ | 278,903 | $ | 283,254 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 3,562 | $ | 4,598 | ||||
| Accrued clinical expenses | 4,342 | 4,444 | ||||||
| Other accrued expenses | 3,659 | 11,987 | ||||||
| Operating lease liabilities - short-term | 2,934 | 3,404 | ||||||
| Total current liabilities | 14,497 | 24,433 | ||||||
| Deferred tax liabilities | 2,531 | 2,531 | ||||||
| Deferred revenue | 8,987 | 8,987 | ||||||
| Operating lease liabilities - long-term | 5,644 | 6,725 | ||||||
| Total liabilities | 31,659 | 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 March 31, 2021 and December 31, 2020; 40,104,684 and 34,026,680 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively | 40 | 34 | ||||||
| Additional paid-in capital | 776,248 | 742,387 | ||||||
| Accumulated other comprehensive loss | (271 | ) | (270 | ) | ||||
| Accumulated deficit | (528,773 | ) | (501,573 | ) | ||||
| Total stockholders' equity | 247,244 | 240,578 | ||||||
| Total liabilities and stockholders' equity | $ | 278,903 | $ | 283,254 |
ASSEMBLY BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands except for share and per share amounts)
| Three Months Ended March 31, | ||||||||
| 2021 | 2020 | |||||||
| Collaboration revenue | $ | - | $ | 4,081 | ||||
| Operating expenses: | ||||||||
| Research and development | 18,554 | 23,046 | ||||||
| General and administrative | 8,704 | 8,729 | ||||||
| Total operating expenses | 27,258 | 31,775 | ||||||
| Loss from operations | (27,258 | ) | (27,694 | ) | ||||
| Other income: | ||||||||
| Interest and other income, net | 58 | 1,039 | ||||||
| Total other income | 58 | 1,039 | ||||||
| Net loss | $ | (27,200 | ) | $ | (26,655 | ) | ||
| Other comprehensive (loss) income | ||||||||
| Unrealized (loss) gain on marketable securities | (1 | ) | 115 | |||||
| Comprehensive loss | $ | (27,201 | ) | $ | (26,540 | ) | ||
| Net loss per share, basic and diluted | $ | (0.69 | ) | $ | (0.76 | ) | ||
| Weighted average common shares outstanding, basic and diluted | 39,679,734 | 35,079,756 |