Full Press Release Details
Assembly Biosciences Reports Fourth Quarter and Year End 2019 Financial Results
SOUTH SAN FRANCISCO, Calif., March 4, 2020 (GLOBE NEWSWIRE) -- 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 and recent highlights for the fourth quarter and year ended December 31, 2019.
"We closed out 2019 with exciting Phase 2 data from our HBV core inhibitor program at AASLD, where ABI-H0731 showed superior antiviral activity to nucleos(t)ide therapy alone as well as significant declines in pgRNA that we believe are reflective of decreases in cccDNA levels. With these encouraging findings and input from our investigators, we are finalizing plans to this year begin transitioning patients meeting certain criteria off 731+Nrtl therapy in the ongoing extension study, to observe if viral suppression can be sustained," said John McHutchison, AO, MD, Chief Executive Officer and President. "Importantly, we begin 2020 well-resourced to advance our strategy and pipeline. During the fourth quarter we further strengthened our senior leadership team with the appointments of our Chief Financial Officer, our Chief Medical Officer and our Senior Vice President of Regulatory Affairs. With our experienced and dedicated team and a strong balance sheet following our successful December equity offering, we are well positioned to move our lead HBV candidate toward registration studies, to advance our second generation HBV candidate into Phase 2, and to further progress our microbiome program. We are also pleased to note that abstracts from both our HBV and microbiome therapeutic programs will be featured in presentations at medical meetings during the second quarter of 2020."
Fourth Quarter 2019 and Recent Highlights
Fourth Quarter 2019 and Year End Financial Results
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 regarding future events, including statements about the timing of data from our clinical studies involving our HBV and Microbiome therapeutic product candidates, the initiation of clinical studies for our HBV product candidates, the presentation of Microbiome non-clinical data at scientific conferences, adequacy of our financial resources and projected cash runway. Certain forward-looking statements may be identified by reference to a future period or by use of forward-looking terminology such as "expected," "planned," "projected," "upcoming" and "will." 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. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. These risks and uncertainties include, among others: the components, timing, cost and results of clinical trials and other development activities involving our product candidates; whether our cash resources will be sufficient to fund continuing operations for the periods and/or trials. More information about the risks and uncertainties faced by Assembly are more fully detailed under the heading "Risk Factors" in Assembly's Annual Report on Form 10-K for the year ended December 31, 2019 filed with the Securities and Exchange Commission. 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.
Assembly Biosciences, Inc.
Consolidated Balance Sheets
(In thousands except for share and per share amounts)
| As of December 31, | ||||||||
| 2019 | 2018 | |||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 46,732 | $ | 41,471 | ||||
| Marketable securities | 227,311 | 176,609 | ||||||
| Accounts receivable from collaboration | 3,374 | 2,430 | ||||||
| Prepaid expenses and other current assets | 5,363 | 1,992 | ||||||
| Total current assets | 282,780 | 222,502 | ||||||
| Property and equipment, net | 1,830 | 557 | ||||||
| Operating lease right-of-use assets | 11,975 | - | ||||||
| Other assets | 1,684 | 3,348 | ||||||
| Indefinite-lived intangible asset | 29,000 | 29,000 | ||||||
| Goodwill | 12,638 | 12,638 | ||||||
| Total assets | $ | 339,907 | $ | 268,045 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 1,731 | $ | 3,693 | ||||
| Accrued clinical expenses | 4,826 | 3,561 | ||||||
| Other accrued expenses | 8,286 | 6,118 | ||||||
| Deferred revenue - short-term | 6,411 | 5,100 | ||||||
| Operating lease liabilities - short-term | 3,186 | - | ||||||
| Total current liabilities | 24,440 | 18,472 | ||||||
| Deferred rent | - | 108 | ||||||
| Deferred tax liabilities | 2,531 | 3,252 | ||||||
| Deferred revenue - long-term | 30,637 | 35,560 | ||||||
| Operating lease liabilities - long-term | 9,082 | - | ||||||
| Total liabilities | 66,690 | 57,392 | ||||||
| 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, 2019 and 2018; 32,558,307 and 25,495,425 shares issued and outstanding as of December 31, 2019 and 2018, respectively | 32 | 25 | ||||||
| Additional paid-in capital | 712,807 | 552,762 | ||||||
| Accumulated other comprehensive loss | (201 | ) | (347 | ) | ||||
| Accumulated deficit | (439,421 | ) | (341,787 | ) | ||||
| Total stockholders' equity | 273,217 | 210,653 | ||||||
| Total liabilities and stockholders' equity | $ | 339,907 | $ | 268,045 |
Assembly Biosciences, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(In thousands except for share and per share amounts)
| Year ended December 31, | ||||||||||||
| 2019 | 2018 | 2017 | ||||||||||
| Collaboration revenue | $ | 15,963 | $ | 14,804 | $ | 9,019 | ||||||
| Operating expenses: | ||||||||||||
| Research and development | 85,757 | 72,741 | 44,225 | |||||||||
| General and administrative | 32,919 | 34,798 | 17,021 | |||||||||
| Total operating expenses | 118,676 | 107,539 | 61,246 | |||||||||
| Loss from operations | (102,713 | ) | (92,735 | ) | (52,227 | ) | ||||||
| Other income (expenses) | ||||||||||||
| Interest and other income | 4,300 | 3,083 | 983 | |||||||||
| Other income (expense), net | 5 | - | (615 | ) | ||||||||
| Total other income | 4,305 | 3,083 | 368 | |||||||||
| Loss before income taxes | (98,408 | ) | (89,652 | ) | (51,859 | ) | ||||||
| Income tax benefit (expense) | 774 | (1,099 | ) | 9,050 | ||||||||
| Net loss | $ | (97,634 | ) | $ | (90,751 | ) | $ | (42,809 | ) | |||
| Other comprehensive (loss) income | ||||||||||||
| Unrealized gain on marketable securities, net of tax | 146 | 45 | 209 | |||||||||
| Comprehensive loss | $ | (97,488 | ) | $ | (90,706 | ) | $ | (42,600 | ) | |||
| Net loss per share, basic and diluted | $ | (3.72 | ) | $ | (3.98 | ) | $ | (2.41 | ) | |||
| Weighted average common shares outstanding, basic and diluted | 26,258,790 | 22,801,644 | 17,750,380 |