Assembly Biosciences Reports First Quarter 2019 Financial Results and Recent Highlights
“We are dedicated to increasing cure rates for individuals with chronic HBV and were honored to have data highlighting our deep pipeline of novel core inhibitor candidates featured at The International Liver Congress™ (ILC) last month, including our ABI-H0731 presentation as a ‘Best of ILC’ selection,” said
Mr. Small continued, “Our progress this year has helped us to attract development veterans to our leadership team to support both of our programs:
First Quarter 2019 and Recent Highlights
- Interim data from two ongoing Phase 2a trials of ABI-H0731 (‘731) in subjects with chronic HBV infection was presented at a late-breaker oral session at ILC, The Annual Meeting of the
European Association for the Study of the Liver(EASL) in Vienna, Austria.
-- ‘731 in combination with nucleos(t)ide therapy (Nuc) showed a favorable safety profile and the potential to eliminate residual Hepatitis B Virus (DNA), one of the gating factors to potentially reaching cure.
-- Significant HBV RNA declines were only observed in patients on ‘731 combination therapy.
-- In treatment naïve patients, accelerated and significant declines in HBV DNA were observed starting as early as Week 2.
-- In Nuc-experienced, virally-suppressed patients, HBV DNA reductions below the detectable limits of a high-sensitivity PCR assay were observed only on combination therapy with ‘731, an unprecedented finding in the field of HBV. One treatment suppressed patient that achieved rapid DNA “target not detected” and RNA decline to below the limit of quantitation also demonstrated a greater than 0.5 log10 decline in HBeAg by Week 24.
-- To prevent continual new infection and cccDNA formation, elimination of residual viremia will likely be required to increase cure rates.
- Additional data presentations at EASL included:
-- A Phase 1a study of next-generation core inhibitor ABI-H2158 (2158), which demonstrated that 2158 was well tolerated and trough liver concentrations are projected to achieve exposures in excess of the in vitro EC50 (334nM) for cccDNA establishment with once daily administration. A Phase 1b study in patients is underway.
-- Preclinical profile of ABI-H3733, the Company’s third core inhibitor, which demonstrated increased potency in blocking cccDNA formation.
-- Additional data from continuing longitudinal studies demonstrating that cccDNA population turnover can occur in as little as 3-4 months, contrary to historical estimates of up to 14 years. These results suggest relatively rapid turnover of cccDNA pools and/or infected cells and the potential to pursue cure in a defined treatment period with targeted therapeutic regimens
- Strengthened clinical and product development team:
-- Steven J. Knox joined as Senior Vice President Clinical Development. Mr. Knox is a 30-year clinical development veteran that came to Assembly from
Gilead Scienceswhere he most recently served as Vice President, Clinical Research and was responsible for global development programs in inflammation and viral hepatitis, including for sofosbuvir (Sovaldi®) and sofosbuvir/ledipasvir (Harvoni®), and tenofovir alafenamide (Vemlidy®)1.
-- David R. Houck, Ph.D. joined as Senior Vice President Product Development and Portfolio Management. Mr. Houck has more than 35 years of experience in the pharmaceutical and biotechnology industries, from drug discovery through submission of INDs and NDAs for both small molecules and biologics, to manufacturing and quality control with particular experience in anti-infective agents including HCV and HIV.
- Ongoing Phase 1b clinical trial of microbiome candidate M201 for mildly to moderately active ulcerative colitis (UC) at sites in the U.S.
Anticipated Milestones and Events
-- 24-week data from Phase 2a trials combining ‘731 with Nuc therapy expected in Q4 2019, along with an update on extended treatment of these patients in the open label Study 211.
-- Phase 1b trial in HBV-infected subjects data expected by Q1 2020.
-- Phase 1a trial expected to initiate in Q1 2020.
-- Ongoing Phase 1b trial in patients with mildly to moderately active UC.
- Microbiome Platform
-- Leveraging discovery and development capabilities and manufacturing expertise to advance new proprietary candidates for other disease indications.
Bank of America Merrill Lynch Health Care Conference2019 in Las Vegas, May 14-15, 2019.
- Jefferies 2019 Healthcare Conference in
New Yorkon June 5, 2019at 9:00am ET.
First Quarter 2019 Financial Results
- Cash, cash equivalents and marketable securities were approximately
$193.5 millionas of March 31, 2019, compared to approximately $218.1 millionas of December 31, 2018. This quarter-end cash position is projected to fund operations into 2021.
- Revenues from collaborative research were approximately
$3.9 millionfor the three months ended March 31, 2019compared to $3.6 millionfor the same period in 2018.
- Research and development expenses, excluding stock-based compensation expense, were approximately
$20.0 millionfor the three months ended March 31, 2019, compared to approximately $12.0 millionfor the same period in 2018. This increase was primarily due to an increase of approximately $6.4 millionin research and development expenses related to the HBV program and an increase of approximately $1.6 millionin research and development expenses related to the microbiome program. Stock-based compensation expense was approximately $2.7 millionfor the three months ended March 31, 2019, compared to approximately $2.5 millionfor the same period in 2018.
- General and administrative expenses, excluding stock-based compensation expense, were approximately
$5.7 millionfor the three months ended March 31, 2019, compared to $4.1 millionfor the same period in 2018. The increase was primarily due to increases in professional fees, employee-related expenses and facility expenses associated with the Company’s new offices in South San Francisco. Stock-based compensation expense was approximately $3.8 millionfor the three months ended March 31, 2019, compared to approximately $1.6 millionfor the same period in 2018.
- Net loss attributable to common stockholders was approximately
$27.1 million, or $1.05per basic and diluted share, for the three months ended March 31, 2019, compared to approximately $16.3 million, or $0.80per basic and diluted share, for the same period in 2018. The increase was primarily due to an increase in research and development expenses related to the HBV program, expenses related to non-cash, stock-based compensation, employee incentive programs and increased headcount across the organization.
About Assembly Biosciences
The information in this press release contains forward-looking statements regarding future events, including statements about the clinical and therapeutic potential of core inhibitors, the timing of the initiation of and the availability of data from our ongoing and planned clinical trials and cash projections. Certain forward-looking statements may be identified by reference to a future period or by use of forward-looking terminology such as “expected,” “may,” “will,” “projected” and “potential.” Assembly intends such forward-looking statements to be covered by the safe harbor provisions contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. These risks and uncertainties include, among others: the components, timing, cost and results of clinical trials and other development activities involving our product candidates (including those licensed by
1Sovaldi®, Harvoni® and Vemlidy® are registered trademarks of
|ASSEMBLY BIOSCIENCES, INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|($ in thousands except for share and per share amounts)|
|March 31,||December 31,|
|Cash and cash equivalents||$||29,107||$||41,471|
|Accounts receivable from collaboration||2,987||2,430|
|Prepaid expenses and other current assets||4,283||1,992|
|Total current assets||200,806||222,502|
|Property and equipment, net||2,079||557|
|Operating lease right-of-use assets||13,063||-|
|Indefinite-lived intangible asset||29,000||29,000|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Deferred revenue - short-term||9,933||5,100|
|Operating lease liabilities - short-term||2,704||-|
|Total current liabilities||25,205||18,472|
|Deferred tax liabilities||3,252||3,252|
|Deferred revenue - long-term||29,868||35,560|
|Operating lease liabilities - long-term||10,521||-|
|Commitments and contingencies|
|Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares issued or outstanding||-||-|
|Common stock, $0.001 par value; 100,000,000 shares authorized as of March 31, 2019 and December 31, 2018; 25,549,757 and 25,495,425 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively||26||25|
|Additional paid-in capital||559,453||552,762|
|Accumulated other comprehensive loss||(239||)||(347||)|
|Total stockholders' equity||190,401||210,653|
|Total liabilities and stockholders' equity||$||259,247||$||268,045|
|ASSEMBLY BIOSCIENCES, INC.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS|
|($ in thousands except for share and per share amounts)|
|Three Months Ended March 31,|
|Research and development||22,704||14,541|
|General and administrative||9,517||5,696|
|Total operating expenses||32,221||20,237|
|Loss from operations||(28,336||)||(16,672||)|
|Other income (expenses)|
|Interest and other income||1,276||446|
|Other income (expense), net||1||(23||)|
|Total other income||1,277||423|
|Loss before income taxes||(27,059||)||(16,249||)|
|Income tax benefit||7||-|
|Other comprehensive (loss) income|
|Unrealized gain (loss) on marketable securities, net of tax||108||(67||)|
|Net loss per share, basic and diluted||$||(1.05||)||$||(0.80||)|
|Weighted average common shares outstanding, basic and diluted||25,668,798||20,231,804|
Source: Assembly Biosciences, Inc.