Full Press Release Details
Assembly Biosciences Reports Fourth Quarter
and Year End 2018 Financial Results
SAN FRANCISCO, February 28, 2019 - 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 fourth quarter and year ended December 31,
"Assembly has achieved many significant milestones over
the past year across both our HBV and microbiome programs," stated Derek Small, President and Chief Executive Officer of
Assembly Biosciences. "Our HBV pipeline has matured to include three chemically-distinct core protein inhibitor candidates,
two of which are in clinical studies, and all of which were discovered by our research team with the goal of increasing cure rates
for HBV patients. We expect to report patient data throughout the year from our ongoing Phase 2a studies of ABI-H0731, as well
as provide updates on our Phase 1 studies of ABI-H2158 and the progress of our third core inhibitor ABI-H3733 towards initiation
of clinical studies."
Mr. Small further commented, "In addition, we are pleased
to announce the initiation of a Phase 1b study of ABI-M201, the first clinical candidate from our collaboration with Allergan,
in patients with mildly to moderately active ulcerative colitis. M201 is the first live biotherapeutic product (LBP) containing
a rationally derived consortium of bacteria to be evaluated in patients. The M201 program is an example of the fully integrated
platform Assembly has developed in-house to make rationally designed LBPs from strain isolation through CMC drug manufacture to
targeted delivery in a proprietary oral capsule. Throughout 2019, we expect to leverage these capabilities to bring forward additional
therapeutic candidates for other important disease indications."
Fourth Quarter 2018 and Recent Highlights
Anticipated Milestones and Events
Fourth Quarter 2018 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 synthetic biotherapeutic candidates
with Assembly's fully integrated platform, including a robust process for strain identification and selection, GMP banking
and production, 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
clinical and therapeutic potential of core inhibitors, including ABI-H0731, ABI-H2158 and ABI-H3733 and live biotherapeutic product
candidate ABI-M201, Assembly's development programs, the initiation, progress and results of Assembly's ongoing and
planned clinical studies and the timing of these events. Certain forward-looking statements may be identified by reference to a
future period or by use of forward-looking terminology such as "plan," "upcoming," "anticipated,"
"will," "expected," and "potential." 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. 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, 2018
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.
Condensed Consolidated Balance Sheets
| As of December 31, | ||||||||
| 2018 | 2017 | |||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 41,471 | $ | 82,033 | ||||
| Marketable securities, at fair value | 176,609 | 37,914 | ||||||
| Accounts receivable from collaboration | 2,430 | 2,274 | ||||||
| Prepaid expenses and other current assets | 1,992 | 898 | ||||||
| Total current assets | 222,502 | 123,119 | ||||||
| Long-term assets | ||||||||
| Marketable securities, at fair value | - | 3,347 | ||||||
| Property, plant and equipment, net | 557 | 860 | ||||||
| Other assets | 3,348 | 340 | ||||||
| Indefinite-lived intangible asset | 29,000 | 29,000 | ||||||
| Goodwill | 12,638 | 12,638 | ||||||
| Total long-term assets | 45,543 | 46,185 | ||||||
| Total assets | $ | 268,045 | $ | 169,304 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 3,693 | $ | 2,124 | ||||
| Accrued expenses | 9,679 | 6,139 | ||||||
| Deferred revenue - short-term | 5,100 | 5,229 | ||||||
| Total current liabilities | 18,472 | 13,492 | ||||||
| Long-term liabilities | ||||||||
| Deferred rent | 108 | - | ||||||
| Deferred tax liabilities | 3,252 | 2,136 | ||||||
| Deferred revenue - long-term | 35,560 | 40,556 | ||||||
| Total long-term liabilities | 38,920 | 42,692 | ||||||
| Total liabilities | 57,392 | 56,184 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity | ||||||||
| Preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding | - | - | ||||||
| Common stock, $0.001 par value; 100,000,000 and 50,000,000 shares authorized as of December 31, 2018 and December 31, 2017; 25,495,425 and 20,137,974 shares issued and outstanding as of December 31, 2018 and December 31, 2017, respectively | 25 | 20 | ||||||
| Additional paid-in capital | 552,762 | 364,528 | ||||||
| Accumulated other comprehensive loss | (347 | ) | (392 | ) | ||||
| Accumulated deficit | (341,787 | ) | (251,036 | ) | ||||
| Total stockholders' equity | 210,653 | 113,120 | ||||||
| Total liabilities and stockholders' equity | $ | 268,045 | $ | 169,304 |
Assembly Biosciences, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
| Year Ended December 31, | ||||||||||||
| 2018 | 2017 | 2016 | ||||||||||
| Collaboration revenue | $ | 14,804 | $ | 9,019 | $ | - | ||||||
| Operating expenses: | ||||||||||||
| Research and development | 72,741 | 44,225 | 33,093 | |||||||||
| General and administrative | 34,798 | 17,021 | 12,185 | |||||||||
| Total operating expenses | 107,539 | 61,246 | 45,278 | |||||||||
| Loss from operations | (92,735 | ) | (52,227 | ) | (45,278 | ) | ||||||
| Other income (expenses) | ||||||||||||
| Interest and other income | 3,083 | 983 | 1,539 | |||||||||
| Realized loss from marketable securities | - | (615 | ) | (1,140 | ) | |||||||
| Total other income | 3,083 | 368 | 399 | |||||||||
| Loss before income taxes | (89,652 | ) | (51,859 | ) | (44,879 | ) | ||||||
| Income tax (expenses) benefit | (1,099 | ) | 9,050 | 618 | ||||||||
| Net loss | $ | (90,751 | ) | $ | (42,809 | ) | $ | (44,261 | ) | |||
| Other comprehensive (loss) income | ||||||||||||
| Unrealized gain (loss) on marketable securities, net of tax | 45 | 209 | 221 | |||||||||
| Comprehensive loss | $ | (90,706 | ) | $ | (42,600 | ) | $ | (44,040 | ) | |||
| Net loss per share, basic and diluted | $ | (3.98 | ) | $ | (2.41 | ) | $ | (2.57 | ) | |||
| Weighted average common shares outstanding, basic and diluted | 22,801,644 | 17,750,380 | 17,226,245 |