Assembly Biosciences Reports Third Quarter 2019 Financial Results and Recent Highlights
“I’m thrilled to have joined Assembly during the third quarter; this is an exciting time as our HBV and microbiome programs are building important momentum. We have also had the opportunity to attract industry-leading talent to our team with the recent additions of
Third Quarter 2019 and Recent Highlights
- Abstracts with data highlighting safety and antiviral activity of Assembly’s first and second generation core inhibitor candidates in the treatment of chronic HBV were accepted for late-breaking posters at the upcoming
American Association for the Study of Liver Diseases(AASLD) Annual Meeting (The Liver Meeting®) in Boston.
° Phase 2a studies of ABI-H0731 + nucleos(t)ide analogs (Nrtl) in HBeAg+ patients show faster and deeper declines in HBV DNA and pgRNA with combination than Nrtl alone, as well as subsequent declines in the surrogate markers of cccDNA with long-term treatment
° Potent antiviral activity was observed in first cohort of HBeAg+ patients treated in 14-day monotherapy study of ABI-H2158
° The posters will be displayed during the
8:00am-5:30pm ETsession on Monday, November 11, 2019, with presentation scheduled from 12:30-1:30pm ET. John McHutchison, AO, MD, joined Assembly in August as Chief Executive Officer and President. Dr. McHutchison is a world-renowned hepatologist, gastroenterologist, and anti-viral drug developer who previously led the research and development of five marketed therapies for chronic hepatitis B and chronic hepatitis C.
- Further strengthened the leadership team with appointments of
Thomas Russoas Chief Financial Officer in October and Luisa Stamm, MD, PhD as Chief Medical Officer, as announced separately today.
° Mr. Russo brings 25 years of experience in the biotechnology and pharmaceutical industry, spanning finance and operations (including commercial planning and manufacturing), as well as equity research.
° Dr. Stamm is an infectious disease specialist whose industry career has focused on the development of therapeutics for hepatitis C (HCV) and liver disease, as well as HIV and other viral diseases.
Anticipated Milestones and Events
° Data from the ongoing long-term open label extension Phase 2 trial, Study 211, combining 731 with Ntrl therapy, including 48-week interim results, as well as final 24 week data from Studies 201 and 202 to be presented at AASLD on
November 11, 2019.
° Data from the initial dose cohort in the Phase 1b trial in HBV-infected subjects to be presented at AASLD on
November 11, 2019. Full study data anticipated in Q1 2020.
° Phase 1a trial expected to initiate in Q1 2020.
° Enrollment and dosing ongoing in Phase 1b trial in patients with mildly to moderately active ulcerative colitis (UC).
- Microbiome Platform
° Leveraging discovery and development capabilities and manufacturing expertise to advance new proprietary candidates for multiple other disease indications.
Upcoming Events and Conferences
- Conference call on
Monday, November 11, 2019at 8:30am ETto review AASLD data
- William Blair Biotech Focus Day Series: Boston Area Innovation on
November 12, 2019 Jefferies London Healthcare Conference, November 20-21, 2019
December 8-12, 2019in Kauai, HI
Upcoming Conference Call and Webcast Information
Assembly will host a live conference call and audio webcast on
Third Quarter 2019 Financial Results
- Cash, cash equivalents and marketable securities were approximately
$156.9 millionas of September 30, 2019, compared to approximately $173.8 millionas of June 30, 2019. This quarter-end cash position is projected to fund operations into 2021.
- Revenues from collaborative research were approximately
$4.2 millionfor the three months ended September 30, 2019compared to $4.3 millionfor the same period in 2018.
- Research and development expenses, excluding stock-based compensation expense, were approximately
$19.3 millionfor the three months ended September 30, 2019, compared to approximately $16.6 millionfor the same period in 2018. Stock-based compensation expense was approximately $2.5 millionfor the three months ended September 30, 2019and 2018.
- General and administrative expenses, excluding stock-based compensation expense, were approximately
$5.5 millionfor the three months ended September 30, 2019, compared to $4.2 millionfor the same period in 2018. Stock-based compensation expense was approximately $2.9 millionfor the three months ended September 30, 2019, compared to approximately $3.5 millionfor the same period in 2018.
- Net loss attributable to common stockholders was approximately
$25.0 million, or $0.96per basic and diluted share, for the three months ended September 30, 2019, compared to approximately $21.5 million, or $0.87per basic and diluted share, for the same period in 2018.
About Assembly Biosciences
The information in this press release contains forward-looking statements regarding future events, including statements about the clinical and therapeutic potential of core inhibitors, the timing of the initiation of and the availability of data from our ongoing and planned clinical trials and cash projections. Certain forward-looking statements may be identified by reference to a future period or by use of forward-looking terminology such as “expected,” “plans,” “potential” and “projected.” Assembly intends such forward-looking statements to be covered by the safe harbor provisions contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. These risks and uncertainties include, among others: the components, timing, cost and results of clinical trials and other development activities involving our product candidates (including those licensed by
|Assembly Biosciences, Inc.|
|For the Period Ended September 30, 2019|
|September 30,||December 31,|
|Cash and cash equivalents||$||24,867||$||41,471|
|Accounts receivable from collaboration||2,944||2,430|
|Prepaid expenses and other current assets||5,441||1,992|
|Total current assets||165,322||222,502|
|Property and equipment, net||1,931||557|
|Operating lease right-of-use assets||12,783||—|
|Indefinite-lived intangible asset||29,000||29,000|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Deferred revenue - short-term||6,151||5,100|
|Operating lease liabilities - short-term||3,208||—|
|Total current liabilities||21,498||18,472|
|Deferred tax liabilities||3,251||3,252|
|Deferred revenue - long-term||32,268||35,560|
|Operating lease liabilities - long-term||9,839||—|
|Commitments and contingencies|
|Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares issued or outstanding||—||—|
|Common stock, $0.001 par value; 100,000,000 shares authorized as of September 30, 2019 and December 31, 2018; 25,872,723 and 25,495,425 shares issued and outstanding as of September 30, 2019 and December 31, 2018, respectively||26||25|
|Additional paid-in capital||569,005||552,762|
|Accumulated other comprehensive loss||(205||)||(347||)|
|Total stockholders' equity||156,489||210,653|
|Total liabilities and stockholders' equity||$||223,345||$||268,045|
|Assembly Biosciences, Inc.|
|For the Period Ended September 30, 2019|
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Research and development||21,736||19,109||63,141||51,490|
|General and administrative||8,488||7,752||22,085||25,992|
|Total operating expenses||30,224||26,861||85,226||77,482|
|Loss from operations||(25,993||)||(22,575||)||(74,029||)||(66,413||)|
|Other income (expenses)|
|Interest and other income||983||1,116||3,441||2,015|
|Other income (expense), net||-||(82||)||5||(232||)|
|Total other income||983||1,034||3,446||1,783|
|Loss before income taxes||(25,010||)||(21,541||)||(70,583||)||(64,630||)|
|Income tax benefit||15||6||33||40|
|Other comprehensive (loss) income|
|Unrealized gain (loss) on marketable securities, net of tax||(18||)||17||142||37|
|Net loss per share, basic and diluted||$||(0.96||)||$||(0.87||)||$||(2.74||)||$||(2.95||)|
|Weighted average common shares outstanding, basic and diluted||25,912,568||24,878,413||25,765,414||21,900,943|
Source: Assembly Biosciences, Inc.