UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
____________________________
FORM 8-K
____________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 5, 2019
____________________________
ASSEMBLY BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
____________________________
| Delaware | 001-35005 | 20-8729264 |
|
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
11711 N. Meridian St., Suite 310
Carmel, Indiana 46032
(Address of principal executive offices, including zip code)
(833) 509-4583
(Registrant’s telephone number, including area code)
____________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| Common Stock, par value $0.001 | ASMB | The Nasdaq Global Select Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.
Emerging growth company o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Item 2.02 Results of Operations and Financial Condition.
On August 5, 2019, Assembly Biosciences, Inc. issued a press release announcing its financial results for the quarter ended June 30, 2019. A copy of the press release is attached hereto as Exhibit 99.1.
The information furnished with this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits:
|
Exhibit No. |
Description |
| 99.1 | Press release dated August 5, 2019. |
EXHIBIT INDEX
|
Exhibit No. |
Description |
| 99.1 | Press release dated August 5, 2019. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: August 5, 2019 | Assembly Biosciences, Inc. | |
| By: | /s/ Derek A. Small | |
| Derek A. Small | ||
| President and Chief Executive Officer | ||
Exhibit 99.1
Assembly Biosciences Reports Second Quarter 2019 Financial Results and Recent Highlights
SOUTH SAN FRANCISCO, August 5, 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 and recent highlights for the second quarter ended June 30, 2019.
“The second quarter of 2019 has been a period of great progress as we continue our transition into later stage clinical development. Following a series of data presentations at EASL in Vienna and IASL in China, we have continued to progress our HBV clinical candidates, now on a global scale,” said Derek Small, President and Chief Executive Officer. “We are also excited that the first oral microbiome biologic drug candidate from our proprietary platform is being evaluated in patients, with our Phase 1b clinical trial of ABI-M201 for mildly to moderately active ulcerative colitis underway.”
Second Quarter 2019 and Recent Highlights
| · | Oral presentation, “New Therapies to More Effectively Eliminate Viral Replication and Increase Cure Rates in CHB Patients,” at the first International Association for the Study of the Liver (IASL) Congress on June 22, 2019 in Beijing, China by Richard Colonno, EVP and CSO of Virology Operations. |
| o | Reviewed science and strategies for utilizing HBV core inhibitors as well as interim clinical data previously reported by the company in April 2019 at The International Liver Congress™(ILC), the Annual Meeting of the European Association for the Study of the Liver (EASL). |
| · | Received Clinical Trial Application (CTA) approvals from China’s Center for Drug Evaluation (CDE), part of the National Medical Products Administration (NMPA) in China, enabling Assembly’s plans to initiate Phase 2 and Phase 1 clinical trials of both 731 and 2158, respectively, at leading HBV trial sites in China. |
| · | Dosed first patient with ABI-H2158 in Phase 1b dose escalation study in HBV patients. |
| · | Dosed first patient with ABI-M201 in a Phase 1b clinical trial for mildly to moderately active ulcerative colitis (UC). |
| o | First oral microbiome biologic drug candidate from Assembly’s proprietary microbiome platform to enter clinical trials in patients. |
| · | Steve Knox, SVP, Clinical Development and David Houck, PhD, SVP Product Development & Portfolio Management joined Assembly’s leadership team as the company transitions to a later stage development organization. |
Anticipated Milestones and Events
HBV Program
| · | ABI-H0731 |
| o | Additional data from the ongoing long-term Phase 2a trial combining 731 with Nuc therapy, including 48-week interim results, expected in Q4 2019. |
| · | ABI-H2158 |
| o | Data from Phase 1b trial in HBV-infected subjects expected in Q1 2020. |
| · | ABI-H3733 |
| o | Phase 1a trial expected to initiate in Q1 2020. |
Microbiome Program
| · | ABI-M201 |
| o | Enrollment and dosing ongoing in Phase 1b trial in patients with mildly to moderately active UC. |
| · | Microbiome Platform |
| o | Leveraging discovery and development capabilities and manufacturing expertise to advance new proprietary candidates for other disease indications. |
Upcoming Conferences
| · | Baird’s 2019 Global Healthcare Conference, in New York on September 5, 2019 at 10:15am ET |
Second Quarter 2019 Financial Results
| · | Cash, cash equivalents and marketable securities were approximately $173.8 million as of June 30, 2019, compared to approximately $193.5 million as of March 31, 2019. This quarter-end cash position is projected to fund operations into 2021. |
| · | Revenues from collaborative research were approximately $3.1 million for the three months ended June 30, 2019 compared to $3.2 million for the same period in 2018. |
| · | Research and development expenses, excluding stock-based compensation expense, were approximately $15.6 million for the three months ended June 30, 2019, compared to approximately $14.2 million for the same period in 2018. Stock-based compensation expense was approximately $3.1 million for the three months ended June 30, 2019, compared to approximately $3.7 million for the same period in 2018. |
| · | General and administrative expenses, excluding stock-based compensation expense, were approximately $5.1 million for the three months ended June 30, 2019, compared to $4.6 million for the same period in 2018. Stock-based compensation expense was approximately $(1.1) million for the three months ended June 30, 2019, compared to approximately $7.9 million for the same period in 2018. This decrease was primarily due to the reversal of previously recognized expense of $3.6 million related to forfeited awards to a former officer who departed during the most recent period coupled with a $4.3 million one-time expense related to the departure and transition to consultant of a former officer in 2018. |
| · | Net loss attributable to common stockholders was approximately $18.5 million, or $0.72 per basic and diluted share, for the three months ended June 30, 2019, compared to approximately $26.8 million, or $1.30 per basic and diluted share, for the same period in 2018. |
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 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, 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 Allergan Pharmaceuticals International Limited); the unpredictability
of the preclinical and clinical development of our product candidates and of the duration and results of regulatory review of those
candidates by the FDA and foreign regulatory authorities; our anticipated capital expenditures and our estimates regarding our
capital requirements; and the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining
such rights from third parties. More information about the risks and uncertainties faced by Assembly are more fully detailed under
the heading “Risk Factors” in Assembly's Quarterly Report on Form 10-Q for the quarter ended June 30, 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.
Contacts
Assembly Biosciences, Inc.
Investors:
Lauren Glaser
(415) 521-3828
lglaser@assemblybio.com
ASSEMBLY BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
($ in thousands except for share and per share amounts)
| June 30, | December 31, | |||||||
| 2019 | 2018 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 34,258 | $ | 41,471 | ||||
| Marketable securities | 139,553 | 176,609 | ||||||
| Accounts receivable from collaboration | 2,903 | 2,430 | ||||||
| Prepaid expenses and other current assets | 6,746 | 1,992 | ||||||
| Total current assets | 183,460 | 222,502 | ||||||
| Property and equipment, net | 2,048 | 557 | ||||||
| Operating lease right-of-use assets | 12,672 | - | ||||||
| Other assets | 1,693 | 3,348 | ||||||
| Indefinite-lived intangible asset | 29,000 | 29,000 | ||||||
| Goodwill | 12,638 | 12,638 | ||||||
| Total assets | $ | 241,511 | $ | 268,045 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 3,414 | $ | 3,693 | ||||
| Accrued expenses | 7,585 | 9,679 | ||||||
| Deferred revenue - short-term | 6,082 | 5,100 | ||||||
| Operating lease liabilities - short-term | 2,854 | - | ||||||
| Total current liabilities | 19,935 | 18,472 | ||||||
| Deferred rent | - | 108 | ||||||
| Deferred tax liabilities | 3,252 | 3,252 | ||||||
| Deferred revenue - long-term | 33,582 | 35,560 | ||||||
| Operating lease liabilities - long-term | 10,035 | - | ||||||
| Total liabilities | 66,804 | 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 June 30, 2019 and December 31, 2018; 25,646,783 and 25,495,425 shares issued and outstanding as of June 30, 2019 and December 31, 2018, respectively | 26 | 25 | ||||||
| Additional paid-in capital | 562,210 | 552,762 | ||||||
| Accumulated other comprehensive loss | (187 | ) | (347 | ) | ||||
| Accumulated deficit | (387,342 | ) | (341,787 | ) | ||||
| Total stockholders' equity | 174,707 | 210,653 | ||||||
| Total liabilities and stockholders' equity | $ | 241,511 | $ | 268,045 | ||||
ASSEMBLY BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
($ in thousands except for share and per share amounts)
(Unaudited)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Collaboration revenue | $ | 3,080 | $ | 3,218 | $ | 6,966 | $ | 6,783 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 18,700 | 17,840 | 41,405 | 32,381 | ||||||||||||
| General and administrative | 4,080 | 12,544 | 13,597 | 18,240 | ||||||||||||
| Total operating expenses | 22,780 | 30,384 | 55,002 | 50,621 | ||||||||||||
| Loss from operations | (19,700 | ) | (27,166 | ) | (48,036 | ) | (43,838 | ) | ||||||||
| Other income (expenses) | ||||||||||||||||
| Interest and other income | 1,182 | 453 | 2,458 | 899 | ||||||||||||
| Other income (expense), net | 4 | (127 | ) | 5 | (150 | ) | ||||||||||
| Total other income | 1,186 | 326 | 2,463 | 749 | ||||||||||||
| Loss before income taxes | (18,514 | ) | (26,840 | ) | (45,573 | ) | (43,089 | ) | ||||||||
| Income tax benefit | 11 | 34 | 18 | 34 | ||||||||||||
| Net loss | $ | (18,503 | ) | $ | (26,806 | ) | $ | (45,555 | ) | $ | (43,055 | ) | ||||
| Other comprehensive (loss) income | ||||||||||||||||
| Unrealized gain on marketable securities, net of tax | 52 | 87 | 160 | 20 | ||||||||||||
| Comprehensive loss | $ | (18,451 | ) | $ | (26,719 | ) | $ | (45,395 | ) | $ | (43,035 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.72 | ) | $ | (1.30 | ) | $ | (1.77 | ) | $ | (2.11 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 25,740,500 | 20,541,549 | 25,690,617 | 20,387,532 | ||||||||||||