Full Press Release Details
Assembly Biosciences Reports Second Quarter 2020 Financial Results and Recent Highlights
SOUTH SAN FRANCISCO, CA, August 5, 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 and recent highlights for the second quarter ended June 30, 2020.
"We have continued to advance the clinical development of our HBV core inhibitors during 2020 with the achievement of key milestones. In June, patients began coming off combination therapy in our Phase 2 open-label extension study of ABI-H0731 and will now be followed to evaluate the sustained virologic response (SVR) rate. We expect to be able to report data from these patients off treatment for 24 weeks (SVR24), early next year," said John McHutchison, AO, MD, Chief Executive Officer and President of Assembly Biosciences. "Additionally, in July we established an important collaboration with BeiGene, a premier scientific partner with key operational capabilities in China. This will allow us to accelerate the clinical development and commercialization of our core inhibitor candidates in China, where up to 90 million individuals are infected with hepatitis B."
Second Quarter 2020 and Recent Highlights
Microbiome Portfolio
Corporate Highlights
Anticipated Milestones and Events
Upcoming Events and Conferences
Second Quarter 2020 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 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; the timing and ability to implement strategic alternatives with respect to the Microbiome program; 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.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands except for share amounts and par value)
| June 30, | December 31, | ||||||
| 2020 | 2019 | ||||||
| (Unaudited) | |||||||
| ASSETS | |||||||
| Current assets | |||||||
| Cash and cash equivalents | $ | 96,709 | $ | 46,732 | |||
| Marketable securities | 130,005 | 227,311 | |||||
| Accounts receivable from collaboration | 3,315 | 3,374 | |||||
| Prepaid expenses and other current assets | 5,059 | 5,363 | |||||
| Total current assets | 235,088 | 282,780 | |||||
| Property and equipment, net | 2,063 | 1,830 | |||||
| Operating lease right-of-use (ROU) assets | 10,780 | 11,975 | |||||
| Other assets | 5,232 | 1,684 | |||||
| Indefinite-lived intangible asset | 29,000 | 29,000 | |||||
| Goodwill | 12,638 | 12,638 | |||||
| Total assets | $ | 294,801 | $ | 339,907 | |||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
| Current liabilities | |||||||
| Accounts payable | $ | 3,640 | $ | 1,731 | |||
| Accrued clinical expenses | 4,362 | 4,826 | |||||
| Other accrued expenses | 6,019 | 8,286 | |||||
| Deferred revenue - short-term | - | 6,411 | |||||
| Operating lease liabilities - short-term | 3,250 | 3,186 | |||||
| Total current liabilities | 17,271 | 24,440 | |||||
| Deferred tax liabilities | 2,531 | 2,531 | |||||
| Deferred revenue - long-term | - | 30,637 | |||||
| Operating lease liabilities - long-term | 7,884 | 9,082 | |||||
| Total liabilities | 27,686 | 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 June 30, 2020 and December 31, 2019; 32,807,519 and 32,558,307 shares issued and outstanding as of June 30, 2020 and December 31, 2019, respectively | 33 | 32 | |||||
| Additional paid-in capital | 725,784 | 712,807 | |||||
| Accumulated other comprehensive income (loss) | 104 | (201 | ) | ||||
| Accumulated deficit | (458,806 | ) | (439,421 | ) | |||
| Total stockholders' equity | 267,115 | 273,217 | |||||
| Total liabilities and stockholders' equity | $ | 294,801 | $ | 339,907 |
ASSEMBLY BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
(In thousands except for share and per share amounts)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Collaboration revenue | $ | 39,376 | $ | 3,080 | $ | 43,457 | $ | 6,966 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 23,327 | 18,700 | 46,373 | 41,405 | ||||||||||||
| General and administrative | 9,470 | 4,080 | 18,199 | 13,597 | ||||||||||||
| Total operating expenses | 32,797 | 22,780 | 64,572 | 55,002 | ||||||||||||
| Income (loss) from operations | 6,579 | (19,700 | ) | (21,115 | ) | (48,036 | ) | |||||||||
| Other income | ||||||||||||||||
| Interest and other income, net | 691 | 1,186 | 1,730 | 2,463 | ||||||||||||
| Total other income | 691 | 1,186 | 1,730 | 2,463 | ||||||||||||
| Income (loss) before income taxes | 7,270 | (18,514 | ) | (19,385 | ) | (45,573 | ) | |||||||||
| Income tax benefit | - | 11 | - | 18 | ||||||||||||
| Net income (loss) | $ | 7,270 | $ | (18,503 | ) | $ | (19,385 | ) | $ | (45,555 | ) | |||||
| Other comprehensive income | ||||||||||||||||
| Unrealized gain on marketable securities, net of tax | 190 | 52 | 305 | 160 | ||||||||||||
| Comprehensive income (loss) | $ | 7,460 | $ | (18,451 | ) | $ | (19,080 | ) | $ | (45,395 | ) | |||||
| Net income (loss) per share, basic | $ | 0.21 | $ | (0.72 | ) | $ | (0.55 | ) | $ | (1.77 | ) | |||||
| Weighted average common shares outstanding, basic | 35,307,669 | 25,740,500 | 35,229,570 | 25,690,617 | ||||||||||||
| Net income (loss) per share, diluted | $ | 0.19 | $ | (0.72 | ) | $ | (0.55 | ) | $ | (1.77 | ) | |||||
| Weighted average common shares outstanding, diluted | 37,291,474 | 25,740,500 | 35,229,570 | 25,690,617 |
Senior Vice President, Investor Relations and Corporate Affairs