ASMB Assembly Biosciences Inc.

23.63
-0.58  -2%
Previous Close 24.21
Open 25.1
52 Week Low 8.1301
52 Week High 25.45
Market Cap $773,229,485
Shares 32,722,365
Float 31,634,896
Enterprise Value $554,882,456
Volume 172,028
Av. Daily Volume 218,999
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Upcoming Catalysts

Drug Stage Catalyst Date
ABI-H2158
Hepatitis B virus (HBV)
Phase 1b
Phase 1b
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ABI-H0731
Hepatitis B virus (HBV)
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
ABI-H3733
Hepatitis B virus (HBV)
Phase 1a
Phase 1a
Phase 1a trial ongoing.
ABI-M201
Ulcerative Colitis
Phase 1b
Phase 1b
Phase 1b initiation of dosing announced June 27, 2019. Ongoing as of May 2020.
VEN 307 (diltiazem cream)
Anal fissures
Phase 3
Phase 3
Phase 3 data from second trial did not meet primary endpoint - Feb 2014. Will not pursue future development

Latest News

  1. SOUTH SAN FRANCISCO, Calif., July 09, 2020 (GLOBE NEWSWIRE) -- 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 announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ABI-H2158 (2158) for the treatment of patients with chronic HBV infection. 2158 is Assembly's second-generation core inhibitor, which is being evaluated in an ongoing global Phase 2 trial.

    The Fast Track program is intended to facilitate the development and review of drug candidates that treat serious conditions and fill an unmet medical need. A drug candidate with Fast Track designation…

    SOUTH SAN FRANCISCO, Calif., July 09, 2020 (GLOBE NEWSWIRE) -- 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 announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ABI-H2158 (2158) for the treatment of patients with chronic HBV infection. 2158 is Assembly's second-generation core inhibitor, which is being evaluated in an ongoing global Phase 2 trial.

    The Fast Track program is intended to facilitate the development and review of drug candidates that treat serious conditions and fill an unmet medical need. A drug candidate with Fast Track designation is eligible for greater access to the FDA for the purpose of expediting the drug product candidate's development, review and potential approval. The Company previously received Fast Track designation for its first-generation core inhibitor ABI-H0731, currently in Phase 2 development.

    "We are pleased to have received Fast Track designation for our second-generation core inhibitor 2158 for the treatment of chronic hepatitis B virus infection, a condition that affects over 250 million people worldwide with more than one million infected individuals in the United States," said Luisa Stamm, MD, PhD, Chief Medical Officer at Assembly Biosciences. "This designation holds several important advantages to expedite the development and regulatory review of 2158 and underscores the importance of providing novel treatments to patients."

    About Assembly Biosciences' HBV Core Inhibitor Portfolio

    Assembly's HBV portfolio includes three clinical-stage small molecules, all of which are HBV core inhibitors that target multiple steps of the HBV life cycle. In Phase 2 clinical trials, first-generation core inhibitor ABI-H0731 administered with nucleos(t)ide analogue reverse transcriptase inhibitor (NrtI) therapy has been well-tolerated, has shown statistically superior antiviral activity in HBV DNA suppression compared to NrtI therapy alone, and has demonstrated significant declines in pgRNA that may indicate decreased cccDNA levels. Assembly's HBV portfolio also includes two potent second-generation candidates, ABI-H2158 in a Phase 2 clinical trial and ABI-H3733 in Phase 1 development.

    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 manufacturing expertise and targeted delivery to the lower gastrointestinal tract with the GEMICEL® technology. For more information, visit assemblybio.com.

    Contacts

    Assembly Biosciences, Inc.

    Lauren Glaser

    Senior Vice President, Investor Relations and Corporate Affairs

    (415) 521-3828

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  2. SOUTH SAN FRANCISCO, Calif., July 02, 2020 (GLOBE NEWSWIRE) -- 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 announced grants of stock options to ten new employees to purchase an aggregate of 112,600 shares of the Company's common stock with an exercise price of $23.30 per share, the closing price of Assembly's common stock on July 1, 2020. The stock options were granted as material inducements to the new employees to accept the Company's offers of employment.

    The stock options have a ten-year term and vest over four years, with one-fourth vesting on the first anniversary of the date of…

    SOUTH SAN FRANCISCO, Calif., July 02, 2020 (GLOBE NEWSWIRE) -- 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 announced grants of stock options to ten new employees to purchase an aggregate of 112,600 shares of the Company's common stock with an exercise price of $23.30 per share, the closing price of Assembly's common stock on July 1, 2020. The stock options were granted as material inducements to the new employees to accept the Company's offers of employment.

    The stock options have a ten-year term and vest over four years, with one-fourth vesting on the first anniversary of the date of grant and the remaining three-fourths vesting in approximately equal monthly installments. The stock options are, in all cases, subject to the new employees' continued service with Assembly through the applicable vesting dates and to acceleration upon the occurrence of certain events as set forth in the award agreements evidencing the stock options. None of the new employees are executive officers.

    The stock options were granted outside of Assembly's stockholder-approved equity incentive plans pursuant to Assembly's 2020 Inducement Award Plan. The stock option awards were approved by the Compensation Committee of Assembly's Board of Directors, which is comprised solely of independent directors, as a material inducement to entering into employment with Assembly in accordance with Nasdaq Listing Rule 5635(c)(4), which requires this public announcement.

    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.

    Contacts

    Assembly Biosciences, Inc.

    Lauren Glaser

    Senior Vice President, Investor Relations and Corporate Affairs

    (415) 521-3828

    Primary Logo

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  3. SOUTH SAN FRANCISCO, Calif., June 25, 2020 (GLOBE NEWSWIRE) -- 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 announced the initiation of a Phase 2 trial of its potent, second-generation core inhibitor, ABI-H2158 (2158). The international multi-center, randomized, placebo-controlled trial will evaluate 2158 with entecavir versus placebo with entecavir in treatment-naïve patients with HBeAg positive chronic hepatitis B infection without cirrhosis.

    "We are excited to have three novel core inhibitors advancing in clinical development and to have our more potent second-generation candidate…

    SOUTH SAN FRANCISCO, Calif., June 25, 2020 (GLOBE NEWSWIRE) -- 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 announced the initiation of a Phase 2 trial of its potent, second-generation core inhibitor, ABI-H2158 (2158). The international multi-center, randomized, placebo-controlled trial will evaluate 2158 with entecavir versus placebo with entecavir in treatment-naïve patients with HBeAg positive chronic hepatitis B infection without cirrhosis.

    "We are excited to have three novel core inhibitors advancing in clinical development and to have our more potent second-generation candidate, 2158, now in a Phase 2 proof-of-concept study for chronic hepatitis B infection," said John McHutchison, AO, MD, Chief Executive Officer and President at Assembly Biosciences. "The initial Phase 2 development program with our first-generation core inhibitor, ABI-H0731, has shown us that core inhibitors combined with standard-of-care nucleos(t)ide therapy result in deeper reductions in HBV DNA and pgRNA levels than NrtI alone. The data from this trial with 2158 will further our understanding of the potential for our core inhibitors to drive deeper viral suppression in more patients more rapidly. Our hope is that this suppression will eventually bring patients with chronic hepatitis B infection closer to cure by more potently blocking the generation of new cccDNA, increasing the possibility of achieving sustained virologic response."

    In the trial, 80 patients will be randomized three-to-one to receive either 300 mg oral 2158 plus entecavir or placebo plus entecavir once daily for up to 72 weeks. Primary endpoints include change in HBV DNA following 24 weeks of treatment, and safety and tolerability throughout the study. Other endpoints include changes in pgRNA and other viral antigens. Currently, initial sites are open for patient screening, with additional sites planned. Further details may be found at https://clinicaltrials.gov/ using identifier NCT04398134.

    This proof-of-concept study builds on results from the recently completed Phase 1b dose-ranging study of 2158, where HBeAg-positive patients received doses of 2158 (100 mg, 300 mg, or 500 mg) or placebo once daily for 14 days. 2158 was well tolerated and demonstrated potent antiviral activity at the 300 mg dose. Clinical data from this trial have been selected as a late-breaker poster at the European Association for the Study of the Liver's (EASL) Digital International Liver Congress, August 27-29, 2020.

    About Assembly Biosciences' HBV Core Inhibitor Portfolio

    Assembly's HBV portfolio includes three clinical-stage small molecules, all of which are HBV core protein inhibitors that target multiple steps of the HBV life cycle. In Phase 2 clinical trials, first-generation core inhibitor ABI-H0731 administered with nucleos(t)ide analogue reverse transcriptase inhibitor (NrtI) therapy has been well-tolerated, has shown statistically superior antiviral activity in HBV DNA suppression compared to NrtI therapy alone, and has demonstrated significant declines in pgRNA that may indicate decreased cccDNA levels. Assembly's HBV portfolio also includes two potent second-generation candidates, ABI-H2158 in a Phase 2 clinical trial and ABI-H3733 in Phase 1 development.

    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 manufacturing expertise 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 that are subject to certain risks and uncertainties that could cause actual results to materially differ from those projected or implied. These risks and uncertainties include:  Assembly's ability to initiate and complete clinical trials involving ABI-H2158 in the currently anticipated timeframes; safety and efficacy data from ABI-H2158 may not warrant further development; clinical and nonclinical data may not differentiate Assembly's product candidates from other companies' candidates; and other risks identified from time to time in Assembly's reports filed with the U.S. Securities and Exchange Commission (the SEC). All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Readers are cautioned not to rely on these forward-looking statements. 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. More information about the risks and uncertainties faced by Assembly are more fully detailed under the heading "Risk Factors" in Assembly's filings with the Securities and Exchange Commission, 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 assumes no obligation to update publicly any forward-looking statements, whether resulting from new information, future events or otherwise.

    Contacts
    Assembly Biosciences, Inc.
    Lauren Glaser
    Senior Vice President, Investor Relations and Corporate Affairs
    (415) 521-3828
    

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  4. SOUTH SAN FRANCISCO, Calif., June 22, 2020 (GLOBE NEWSWIRE) -- 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 announced that preclinical data from its immuno-oncology microbiome program are currently being featured in an e-poster at the American Association for Cancer Research Virtual Annual Meeting II, June 22-24, 2020. The poster, Discovery and functional validation of a rationally selected, orally administered, live biotherapeutic consortium of commensal bacteria for the treatment of solid tumors, is also available in the Investors section of Assembly's website: https://investor.assemblybio.com/events-presentations

    SOUTH SAN FRANCISCO, Calif., June 22, 2020 (GLOBE NEWSWIRE) -- 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 announced that preclinical data from its immuno-oncology microbiome program are currently being featured in an e-poster at the American Association for Cancer Research Virtual Annual Meeting II, June 22-24, 2020. The poster, Discovery and functional validation of a rationally selected, orally administered, live biotherapeutic consortium of commensal bacteria for the treatment of solid tumors, is also available in the Investors section of Assembly's website: https://investor.assemblybio.com/events-presentations.

    "There is growing evidence supporting the role of gut commensal microbes in mediating patient responses to immune checkpoint inhibitor therapies, which provides a rationale for a live microbial biotherapeutic product (LBP) approach," said Jackie Papkoff, PhD, Assembly's Senior Vice President, Chief Scientific Officer Microbiome. "Based on data from cell-based assays and mouse tumor models, we have defined single bacterial strains and consortia with reproducible anti-tumor activity and significant potentiation of checkpoint antibody efficacy. We are pleased to present for the first time these promising preclinical data from our oral LBP program in immuno-oncology."

    Assembly's program for oncology discovers and develops defined consortia of bacteria, rationally selected based on disease-relevant immunological mechanisms, that can be encapsulated, orally administered and delivered to the gastrointestinal tract of cancer patients. As described in the poster, the research team established a biological function-based platform to identify bacterial strains with immune stimulatory activities in vitro and significant anti-tumor efficacy alone or in combination with checkpoint antibody in syngeneic tumor models:

    • Commensal microbes were isolated from well-characterized healthy human samples
    • Reproducible, tumor immunology-relevant functional activities demonstrated in validated cell-based assays

           -  e.g. production of immune-stimulatory cytokines by human PBMC or DC, T cell activation, M1 macrophage shift
    • Reproducible anti-tumor activity of strains & consortia in syngeneic mouse tumor models

           -  Defined consortia significantly enhance checkpoint antibody efficacy

           -  Immunophenotyping data supports mechanisms of interest including increase in inflammatory cytokines and immune cell infiltration in the tumor

    About Assembly Biosciences' Microbiome Platform

    From concept to clinic, Assembly has developed an integrated live biotherapeutic product (LBP) program from discovery through manufacturing and ultimately into the clinic that features a biological function-based discovery strategy, creating a broad-based platform that is capable of addressing multiple therapeutic indications. Individual bacteria and consortia are selected for development based on a platform of in silico, in vitro and in vivo capabilities. The biologic drug candidates are manufactured under scalable GMP conditions. Assembly's in-house, end-to-end capabilities also include its licensed patented Gemicel® capsule-in-capsule delivery system designed for targeted dual release oral delivery to the gastrointestinal tract (GI).

    Assembly's lead live biotherapeutic product candidate, ABI-M201, is being evaluated in a multi-center randomized, double-blind, placebo-controlled Phase 1b trial in patients with mildly to moderately active ulcerative colitis. ABI-M301 is a preclinical program for Crohn's disease.

    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 manufacturing expertise 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 that are subject to certain risks and uncertainties that could cause actual results to materially differ. These risks and uncertainties include: Assembly's ability to progress development of its oral LBP program in immuno-oncology; and preclinical data on the oral LBP program may not translate into clinical results if and when it advances to the clinic. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Readers are cautioned not to rely on these forward-looking statements. 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. More information about Assembly's risks and uncertainties are more fully detailed under the heading "Risk Factors" in Assembly'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 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.
    Amy Figueroa, CFA
    Investor Relations Consultant
    (415) 366-5158
     
    
    Solebury Trout
    Luke Brown
    (646) 378-2944
    

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  5. -- Process to explore strategic alternatives underway --

    SOUTH SAN FRANCISCO, Calif., June 18, 2020 (GLOBE NEWSWIRE) -- 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 announced that the Company will regain worldwide rights to all microbiome gastrointestinal programs licensed under its collaboration agreement with AbbVie (formerly Allergan pre-acquisition). AbbVie has decided to terminate the research, development, collaboration and license agreement. This decision was not based on any efficacy, safety, or other data related to the collaboration programs.

    "We are grateful for the opportunity…

    -- Process to explore strategic alternatives underway --

    SOUTH SAN FRANCISCO, Calif., June 18, 2020 (GLOBE NEWSWIRE) -- 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 announced that the Company will regain worldwide rights to all microbiome gastrointestinal programs licensed under its collaboration agreement with AbbVie (formerly Allergan pre-acquisition). AbbVie has decided to terminate the research, development, collaboration and license agreement. This decision was not based on any efficacy, safety, or other data related to the collaboration programs.

    "We are grateful for the opportunity to work collaboratively on the development of our microbiome gastrointestinal programs. Together, we were able to advance ABI-M201 into the clinic to evaluate this novel biotherapeutic in patients with ulcerative colitis. With the return of all rights to the program, we have now begun to explore a broader set of strategic alternatives to continue development of these programs," said John McHutchison, AO, MD, Chief Executive Officer and President of Assembly.  

    The Company will regain worldwide rights to all microbiome candidates subject to the collaboration, including ABI-M201 and ABI-M301. ABI-M201 is currently being evaluated in a multi-center, randomized, placebo-controlled Phase 1b trial in patients with mild to moderate ulcerative colitis. ABI-M301 is a preclinical program for Crohn's disease.

    The Company anticipates the transition to be completed in the fourth quarter of 2020. The agreement provides for a transition period of 120 days during which AbbVie will continue to fulfill its obligations under the contract. As Assembly explores strategic alternatives for the microbiome franchise, the Company will continue to focus on advancing the HBV portfolio, which includes three clinical-stage core inhibitors.

    The Company anticipates no change to its projected cash runway and that its cash, cash equivalents and investments will continue to be sufficient to fund operations into 2022. As of March 31, 2020, Assembly had cash, cash equivalents and investments totaling $249.1 million.

    About Assembly Biosciences' Microbiome Platform

    From concept to clinic, Assembly has developed an integrated live biotherapeutic product (LBP) program from discovery through manufacturing that features an in-house bacterial strain inventory, creating a broad-based platform that is capable of addressing multiple therapeutic indications. Individual bacteria and consortia are selected for development based on a platform of in silico, in vitro and in vivo capabilities. The biologic drug candidates are manufactured under scalable GMP conditions. Assembly's in-house, end-to-end capabilities also include its in-licensed patented GEMICEL® capsule-in-capsule oral delivery system designed for targeted dual release within the lower gastrointestinal tract (GI).

    Assembly's lead live biotherapeutic product candidate, ABI-M201, is being evaluated in a multi-center randomized, double-blind, placebo-controlled Phase 1b trial in patients with mildly to moderately active UC. Assembly's discovery and development capabilities and manufacturing expertise also are being leveraged to advance new proprietary candidates for immuno-oncology and other disease indications.

    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 development potential of our microbiome product candidates and potential strategic alternatives with respect to those candidates. Certain forward-looking statements may be identified by reference to a future period or by use of forward-looking terminology such as "will," "may," "potential," "explore," and "strategy." 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 timing and ability to implement strategic alternatives with respect to the microbiome program; timing, cost and results of clinical trials and other development activities involving our microbiome product  candidates; the impact of the coronavirus pandemic on planned and on-going clinical trials, and results of earlier preclinical and nonclinical studies may not be predictive of future clinical studies results. More information about the risks and uncertainties faced by Assembly are more fully detailed under the heading "Risk Factors" in Assembly's filings with the Securities and Exchange Commission, 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 assumes no obligation to update publicly any forward-looking statements, whether resulting from new information, future events or otherwise.

    Contacts
    Assembly Biosciences, Inc.
    Amy Figueroa, CFA
    Investor Relations Consultant
    (415) 366-5158
     
    
    Solebury Trout
    Luke Brown
    (646) 378-2944
    

    Primary Logo

    View Full Article Hide Full Article
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