UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
|
|
|
|
||
(Address of Principal Executive Offices) |
|
(Zip Code) |
Registrant’s Telephone Number, Including Area Code:
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
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:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
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 |
|
|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
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. ☐
Item 2.02 Results of Operations and Financial Condition.
On March 22, 2023, Assembly Biosciences, Inc. (the "Company") issued a press release (the "Press Release") announcing its financial results for the quarter and year ended December 31, 2022 and recent corporate highlights. 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 (other than the sections incorporated by reference pursuant to Item 8.01), 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 (the "Securities Act"), or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 8.01 Other Events.
In the Press Release dated March 22, 2023, the Company also announced results from its Phase 1b clinical study evaluating next-generation core inhibitor candidate ABI-H3733 and interim results from its Phase 1a clinical study evaluating next-generation core inhibitor candidate ABI-4334. The information set forth under the heading "4334 and 3733 Clinical Data Updates," including the subheadings "Phase 1a Study for 4334 (Study ABI-4334-101)" and "Phase 1b Study for 3733 (Study ABI-H3733-102)" are incorporated by reference into this Item 8.01 of this Current Report on Form 8-K.
The portions of the Press Release incorporated by reference into Item 8.01 of this Current Report on Form 8-K are being filed pursuant to Item 8.01. The remaining portions of the Press Release are being furnished pursuant to Item 2.02 of this Current Report on Form 8-K and shall not be deemed "filed" for any purposes under Section 18 of the Exchange Act or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit Number |
|
Description |
99.1 |
|
|
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
* Filed herewith.
1
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 thereunto duly authorized.
|
|
Assembly Biosciences, Inc. |
|
|
|
|
|
Date: March 22, 2023 |
|
By: |
/s/ John O. Gunderson |
|
|
|
John O. Gunderson |
|
|
|
VP, General Counsel and Corporate Secretary |
2
Exhibit 99.1
Assembly Biosciences Provides Update on its Core Inhibitor Pipeline, Reports Fourth Quarter and Year End 2022 Financial Results and Recent Highlights
SOUTH SAN FRANCISCO, Calif., March 22, 2023 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases, today provided an update on its investigational next-generation hepatitis B virus (HBV) core inhibitors, ABI-H3733 (3733) and ABI-4334 (4334), and reported financial results and recent highlights for the fourth quarter and year ended December 31, 2022.
“Last year, we accelerated our research pipeline and advanced our clinical pipeline of next-generation, highly potent HBV core inhibitors, 3733 and 4334,” said Jason Okazaki, chief executive officer and president of Assembly Bio. “While the clinical antiviral activity seen in HBV patients receiving 3733 in our Phase 1b trial is impressive, our objective has always been to prioritize the strongest candidate in a data-driven manner. Based on the data from our ongoing clinical and nonclinical studies, we are focusing on 4334 given its greater potency and encouraging clinical profile emerging from the initial cohorts in the Phase 1a study. We plan to evaluate and share data for the remaining multiple-dose cohort from that study in April.”
In the 100mg cohort of 3733 in a 28-day Phase 1b study, all seven HBeAg negative chronic HBV (cHBV) patients that have completed dosing reached the lower limit of quantification for HBV DNA by day 21. In the Phase 1a study of 4334, all single-dose cohorts and the first multiple-dose cohort of 100 mg are complete. In these cohorts, 4334’s pharmacokinetic (PK) profile continues to be supportive of once-daily oral dosing and of providing exposures sufficient to potently inhibit both HBV DNA and covalently closed circular DNA (cccDNA) formation. No serious adverse events (AEs) or patterns of clinically significant AEs or laboratory abnormalities have been observed in either clinical study. However, a time-dependent toxicity in one species was observed in a nonclinical chronic toxicology study for 3733 that was not observed in the previous 28-day toxicology study.
“Beyond core inhibitors, we also achieved important research milestones in 2022, leveraging our virology expertise to broaden our discovery pipeline to include additional mechanisms of action targeting hepatitis B and hepatitis delta, as well as two programs outside of viral hepatitis targeting herpesviruses,” continued Mr. Okazaki. “We are thrilled with the progress of these programs, including the recent nomination of 5366, our first herpesvirus development candidate which we expect to move into the clinic for the potential treatment of patients who suffer from high-recurrence genital herpes during the first half of 2024. High-recurrence genital
herpes is a disease for which current treatments are only partially effective and a new therapeutic hasn’t been approved in decades. We are excited at the opportunity to advance treatment options for this significant unmet medical need and expect to build upon our research progress with the nomination of a second development candidate from our expanded pipeline later this year.”
4334 and 3733 Clinical Data Updates
Phase 1a Study for 4334 (Study ABI-4334-101)
The Phase 1a clinical trial is a randomized, blinded and placebo-controlled study evaluating the safety, tolerability and PK of 4334 following single ascending dose and multiple ascending dose administration in healthy subjects. The objectives of the study include assessment of the proportion of subjects with AEs, premature treatment discontinuation due to AEs and abnormal laboratory results.
Dosing has been completed for all subjects in all single-dose cohorts (30 mg, 100 mg, 200 mg and 400 mg) and both multiple-dose cohorts of 100 mg and 200 mg, with data pending for the 200 mg multiple-dose cohort.
Based on data available for the single-dose and 100 mg multiple-dose cohorts through March 21, 2023, 4334 continued to show a half-life supportive of once-a-day (QD) dosing. In addition, based on PK data from these cohorts and preclinical studies, daily minimum plasma trough concentrations (Cmin) are projected to achieve double-digit multiples over protein-adjusted EC50 for both antiviral activity and against cccDNA formation within the dose range studied in the Phase 1a study.
Through March 21, 2023, treatment-emergent AEs and laboratory abnormalities were mild to moderate and there were no patterns of AEs or laboratory abnormalities noted and no clinically significant ECG abnormalities reported.
A dose of 200 mg was selected for the second and final multiple-dose cohort. Dosing for this cohort is complete and data from this cohort are anticipated in April.
4334 was internally discovered and developed by Assembly Bio and designed to optimize potency against both new virus production and formation of cccDNA, the viral reservoir, and has a distinct chemical scaffold from 3733.
Phase 1b Study for 3733 (Study ABI-H3733-102 and Nonclinical Toxicology Studies)
The ongoing Phase 1b clinical trial is a randomized, multi-center, double-blind and placebo-controlled study evaluating the safety, PK and antiviral activity of 3733, including changes in HBV DNA and other viral parameters associated with 3733 treatment in adults with cHBV infection who are treatment naïve or off treatment. Patients were randomized 8:2 between the new tablet formulation of 3733 and placebo for a period of 28 days. The patient population for the data included here consists of HBeAg negative patients. The study remains externally
blinded, so individual patient data are not provided. Initial data for the 25 and 50mg cohorts were reported in December 2022.
100 mg Cohort Efficacy (Viral Nucleic Acids), Safety and PK:
In the 3733 Phase 1b trial, as of March 21, 2023, enrollment was completed with 11 patients randomized to treatment. 10 of the 11 patients enrolled were HBeAg negative so efficacy data are not provided for the single HBeAg positive patient. Dosing has been completed for seven HBeAg negative patients receiving 100 mg 3733 and interim efficacy data are presented here for these seven patients. Interim efficacy results from this cohort include HBV DNA, HBV RNA and antigen measurements for the full 28-day dosing period.
In the 100 mg cohort, all seven HBeAg negative patients receiving 3733 who have completed treatment achieved HBV DNA less than the lower limit of quantification (<LLOQ) within 21 days. As all of these subjects achieved HBV DNA <LLOQ, the mean decline in HBV DNA over the treatment period of approximately 3.0 logs is reflective of both the baseline DNA levels and the lower limit of the quantifiable range in this cohort. Data on HBV RNA declines were limited due to low baseline levels in HBeAg negative patients. As expected given the 28-day dosing period, limited changes in viral antigens were observed.
Safety data for all 11 patients in the 100 mg cohort for 3733 through March 21, 2023 are reported. All treatment-emergent AEs and laboratory abnormalities reported were Grade 1 or Grade 2. Further, no AEs led to treatment discontinuation, and no clinically significant ECG abnormalities or patterns of AEs or lab abnormalities were noted.
Available PK data indicated that exposures exhibited dose-proportional increases in the dose range from 25 mg QD to 100 mg QD.
Nonclinical Toxicology Studies for 3733:
In parallel with the Phase 1b study, a 26-week nonclinical chronic toxicology study has been ongoing and revealed a time-dependent toxicity in one species that was not observed in the previous 28-day toxicology study. Assembly Bio continues to evaluate the data, however, proceeding with longer-term dosing of 3733 in a Phase 2 study would require further assessment and likely an additional chronic toxicology study in another species, which would add cost and time to the development timeline for 3733.
Fourth Quarter 2022 and Recent Highlights
Anticipated Milestones and Events
Fourth Quarter 2022 and Year End Financial Results
About Assembly Biosciences
Assembly Biosciences is a clinical-stage biotechnology company dedicated to the development of innovative small molecule antiviral therapeutics designed to change the path of serious viral diseases and improve the lives of patients worldwide. The company’s hepatitis B virus (HBV) pipeline includes potent, next-generation HBV core inhibitors in clinical development, which are designed to disrupt the virus’ replication cycle at several key points with the aim of achieving finite treatment and functional cures. Assembly Bio’s HBV and hepatitis delta virus (HDV) pipeline also includes two complementary approaches, a viral entry inhibitor and an oral, liver-focused, interferon-alpha receptor agonist, with potential application for both HBV and as chronic suppressive therapy for HDV, which is associated with significantly increased disease burden for HBV/HDV patients. The herpesvirus pipeline addresses two serious consequences associated with herpesvirus infections, high-recurrence genital herpes and transplant-associated herpesviruses. Led by an accomplished team of leaders in virologic drug development, Assembly Bio is committed to improving outcomes for patients struggling with
the serious, chronic impacts of HBV, HDV and herpesvirus infections. 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 Bio’s ability to initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio’s collaboration agreements, in the currently anticipated timeframes; safety and efficacy data from clinical or nonclinical studies may not warrant further development of Assembly Bio’s product candidates; clinical and nonclinical data presented at conferences may not differentiate Assembly Bio’s product candidates from other companies’ candidates; results of nonclinical studies may not be representative of disease behavior in a clinical setting and may not be predictive of the outcomes of clinical studies; continued development and commercialization of ABI-H3733, if successful, in the China territory will be dependent on, and subject to, Assembly Bio’s collaboration agreement governing this activity in the China territory; Assembly Bio’s ability to maintain financial resources necessary to continue its clinical studies and fund business operations; and other risks identified from time to time in Assembly Bio’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 Bio 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 Bio’s risks and uncertainties are more fully detailed under the heading “Risk Factors” in Assembly Bio’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 Bio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
Contacts
Investor and Corporate:
Shannon Ryan
SVP, Investor Relations, Corporate Affairs and Alliance Management
(415) 738-2992
sryan@assemblybio.com
Media:
Sam Brown Inc.
Hannah Hurdle
(805) 338-4752
ASMBMedia@sambrown.com
ASSEMBLY BIOSCIENCES, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands except for share amounts and par value)
|
|
December 30, |
|
|
December 31, |
|
||
|
|
2022 |
|
|
2021 |
|
||
ASSETS |
|
|
|
|
|
|
||
Current assets |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
52,418 |
|
|
$ |
45,627 |
|
Marketable securities - short-term |
|
|
39,192 |
|
|
|
101,000 |
|
Accounts receivable from collaborations |
|
|
944 |
|
|
|
336 |
|
Prepaid expenses and other current assets |
|
|
4,413 |
|
|
|
7,241 |
|
Total current assets |
|
|
96,967 |
|
|
|
154,204 |
|
|
|
|
|
|
|
|
||
Marketable securities - long-term |
|
|
— |
|
|
|
27,972 |
|
Property and equipment, net |
|
|
743 |
|
|
|
1,139 |
|
Operating lease right-of-use (ROU) assets |
|
|
3,195 |
|
|
|
6,042 |
|
Other assets |
|
|
889 |
|
|
|
1,703 |
|
Total assets |
|
$ |
101,794 |
|
|
$ |
191,060 |
|
|
|
|
|
|
|
|
||
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
||
Current liabilities |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
2,493 |
|
|
$ |
2,659 |
|
Accrued research and development expenses |
|
|
3,122 |
|
|
|
3,400 |
|
Other accrued expenses |
|
|
7,317 |
|
|
|
6,863 |
|
Operating lease liabilities - short-term |
|
|
3,364 |
|
|
|
3,151 |
|
Total current liabilities |
|
|
16,296 |
|
|
|
16,073 |
|
|
|
|
|
|
|
|
||
Deferred revenue |
|
|
2,733 |
|
|
|
2,733 |
|
Operating lease liabilities - long-term |
|
|
101 |
|
|
|
3,325 |
|
Total liabilities |
|
|
19,130 |
|
|
|
22,131 |
|
|
|
|
|
|
|
|
||
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; 150,000,000 and 100,000,000 shares authorized as of December 31, 2022 and December 31, 2021, respectively; 48,894,973 and 48,120,437 shares issued and outstanding as of December 31, 2022 and December 31, 2021, respectively |
|
|
49 |
|
|
|
48 |
|
Additional paid-in capital |
|
|
807,938 |
|
|
|
800,728 |
|
Accumulated other comprehensive loss |
|
|
(803 |
) |
|
|
(419 |
) |
Accumulated deficit |
|
|
(724,520 |
) |
|
|
(631,428 |
) |
Total stockholders' equity |
|
|
82,664 |
|
|
|
168,929 |
|
Total liabilities and stockholders' equity |
|
$ |
101,794 |
|
|
$ |
191,060 |
|
ASSEMBLY BIOSCIENCES, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands except for share and per share amounts)
|
|
Year Ended December 31, |
|
|||||
|
|
2022 |
|
|
2021 |
|
||
Collaboration revenue |
|
$ |
— |
|
|
$ |
6,254 |
|
|
|
|
|
|
|
|
||
Operating expenses |
|
|
|
|
|
|
||
Research and development |
|
|
69,980 |
|
|
|
68,524 |
|
General and administrative |
|
|
24,134 |
|
|
|
28,780 |
|
Impairment of goodwill and indefinite-lived intangible asset |
|
|
— |
|
|
|
41,638 |
|
Total operating expenses |
|
|
94,114 |
|
|
|
138,942 |
|
Loss from operations |
|
|
(94,114 |
) |
|
|
(132,688 |
) |
|
|
|
|
|
|
|
||
Other income |
|
|
|
|
|
|
||
Interest and other income, net |
|
|
1,022 |
|
|
|
302 |
|
Total other income |
|
|
1,022 |
|
|
|
302 |
|
Loss before income taxes |
|
$ |
(93,092 |
) |
|
$ |
(132,386 |
) |
|
|
|
|
|
|
|
||
Income tax benefit |
|
|
— |
|
|
|
2,531 |
|
Net loss |
|
$ |
(93,092 |
) |
|
$ |
(129,855 |
) |
|
|
|
|
|
|
|
||
Other comprehensive loss |
|
|
|
|
|
|
||
Unrealized loss on marketable securities |
|
|
(384 |
) |
|
|
(149 |
) |
Comprehensive loss |
|
$ |
(93,476 |
) |
|
$ |
(130,004 |
) |
|
|
|
|
|
|
|
||
Net loss per share, basic and diluted |
|
$ |
(1.92 |
) |
|
$ |
(3.00 |
) |
Weighted average common shares outstanding, basic and diluted |
|
|
48,409,265 |
|
|
|
43,280,383 |
|