Full Press Release Details
Assembly Biosciences Reports Updates on Corporate Progress and
First Quarter 2020 Financial Results
-- Advancing the development of three clinical-stage core inhibitor candidates in
-- Cash position of $249 million projected to fund operations into 2022 --
-- Company to host HBV portfolio progress update call / webcast
today at 1:30 pm PT / 4:30 pm ET --
SOUTH SAN FRANCISCO, CA, May 7, 2020 -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and diseases associated with the microbiome, today reported financial results for the first quarter ended March 31, 2020 and provided an update on recent corporate progress.
"I am proud of the exceptional commitment and focus that our team has demonstrated during the first quarter, in light of the unprecedented events unfolding throughout the world and the healthcare sector with the COVID-19 pandemic. We have managed to achieve our key business objectives while keeping the health and safety of patients, study staff, and employees top of mind, and continuing to assess and adapt to this environment," said John McHutchison, AO, MD, Chief Executive Officer and President. "Importantly, we have finalized the stopping criteria by which patients with chronic HBV infection in Study 211 will be transitioned off combination therapy with our core inhibitor candidate ABI-H0731 and a nucleos(t)ide therapy later this year. This is a critical next step in the development of hepatitis B therapies, as ours would be the first trial of a core inhibitor to stop therapy and monitor patients for potential sustained virologic response."
First Quarter 2020 and Recent Highlights
Microbiome Portfolio
Corporate Highlights
Microbiome Portfolio
First Quarter 2020 Financial Results
Conference Call / Webcast Today
Assembly Biosciences is hosting a conference call and webcast today at 1:30 pm PT / 4:30 pm ET. The live audio webcast with accompanying slide presentation may be accessed through the "Events & Presentations" page in the "Investors" section of the Company's website at https://investor.assemblybio.com/events-presentations. Alternatively, participants may dial (866) 438-0453 (domestic) or (409) 220-9366 (international) and refer to conference ID 5156737. Due to current high volume accessing virtual events, participants are encouraged to connect at 1:15 pm PT / 4:15 pm ET to ensure a timely connection to the call or to utilize the webcast link for listen-only access.
The archived webcast will be available on Assembly's website beginning approximately two hours after the event and will be archived and available for replay for at least 30 days after the event.
About Assembly Biosciences
Assembly Biosciences, Inc. is a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and diseases associated with the microbiome. The HBV program is focused on advancing a new class of potent, oral core inhibitors that have the potential to increase cure rates for chronically infected patients. The microbiome program is developing novel oral live microbial biotherapeutic candidates with Assembly's fully integrated platform, including a robust process for strain identification and selection, GMP manufacturing expertise and targeted delivery to the lower gastrointestinal tract with the GEMICEL technology. 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's ability to initiate and complete clinical trials involving its HBV Cure and Microbiome therapeutic product candidates in the currently anticipated timeframes; safety and efficacy data from clinical studies may not warrant further development of Assembly's product candidates; clinical and nonclinical data presented at conferences may not differentiate Assembly's product candidates from other companies' candidates; Assembly may not observe sustained virologic response in patients who stop therapy in Study 211; Assembly's ability to maintain financial resources necessary to continue its clinical trials and fund business operations; any impact that the spread of the coronavirus and resulting COVID-19 pandemic may have on Assembly's business and operations, including initiation and continuation of its clinical trials or timing of discussions with regulatory authorities; and other risks identified from time to time in Assembly'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 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's risks and uncertainties are more fully detailed under the heading "Risk Factors" in Assembly'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 assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
Assembly Biosciences, Inc.
Investor Relations Consultant
ASSEMBLY BIOSCIENCES, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands except for share and per share amounts)
| March 31, | December 31, | |||||||
| 2020 | 2019 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 42,326 | $ | 46,732 | ||||
| Marketable securities | 206,803 | 227,311 | ||||||
| Accounts receivable from collaboration | 3,055 | 3,374 | ||||||
| Prepaid expenses and other current assets | 4,568 | 5,363 | ||||||
| Total current assets | 256,752 | 282,780 | ||||||
| Property and equipment, net | 1,780 | 1,830 | ||||||
| Operating lease right-of-use assets | 11,479 | 11,975 | ||||||
| Other assets | 1,661 | 1,684 | ||||||
| Indefinite-lived intangible asset | 29,000 | 29,000 | ||||||
| Goodwill | 12,638 | 12,638 | ||||||
| Total assets | $ | 313,310 | $ | 339,907 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 2,104 | $ | 1,731 | ||||
| Accrued clinical expenses | 4,633 | 4,826 | ||||||
| Other accrued expenses | 4,430 | 8,286 | ||||||
| Deferred revenue - short-term | 6,715 | 6,411 | ||||||
| Operating lease liabilities - short-term | 3,264 | 3,186 | ||||||
| Total current liabilities | 21,146 | 24,440 | ||||||
| Deferred tax liabilities | 2,531 | 2,531 | ||||||
| Deferred revenue - long-term | 29,326 | 30,637 | ||||||
| Operating lease liabilities - long-term | 8,539 | 9,082 | ||||||
| Total liabilities | 61,542 | 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 March 31, 2020 and December 31, 2019; 32,624,725 and 32,558,307 shares issued and outstanding as of March 31, 2020 and December 31, 2019, respectively | 32 | 32 | ||||||
| Additional paid-in capital | 717,898 | 712,807 | ||||||
| Accumulated other comprehensive loss | (86 | ) | (201 | ) | ||||
| Accumulated deficit | (466,076 | ) | (439,421 | ) | ||||
| Total stockholders' equity | 251,768 | 273,217 | ||||||
| Total liabilities and stockholders' equity | $ | 313,310 | $ | 339,907 |
ASSEMBLY BIOSCIENCES, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands except for share and per share amounts)
| Three Months Ended March 31, | ||||||||
| 2020 | 2019 | |||||||
| Collaboration revenue | $ | 4,081 | $ | 3,885 | ||||
| Operating expenses: | ||||||||
| Research and development | 23,046 | 22,704 | ||||||
| General and administrative | 8,729 | 9,517 | ||||||
| Total operating expenses | 31,775 | 32,221 | ||||||
| Loss from operations | (27,694 | ) | (28,336 | ) | ||||
| Other income (expenses) | ||||||||
| Interest and other income, net | 1,039 | 1,277 | ||||||
| Total other income | 1,039 | 1,277 | ||||||
| Loss before income taxes | (26,655 | ) | (27,059 | ) | ||||
| Income tax benefit | - | 7 | ||||||
| Net loss | $ | (26,655 | ) | $ | (27,052 | ) | ||
| Other comprehensive (loss) income | ||||||||
| Unrealized gain on marketable securities, net of tax | 115 | 108 | ||||||
| Comprehensive loss | $ | (26,540 | ) | $ | (26,944 | ) | ||
| Net loss per share, basic and diluted | $ | (0.76 | ) | $ | (1.05 | ) | ||
| Weighted average common shares outstanding, basic and diluted | 35,079,756 | 25,668,798 |