Is Assembly Biosciences On Your Radar?

Shares of Assembly Biosciences Inc. (ASMB) are down nearly 69% from their 52-week high of $67.36 recorded on March 13, 2018.

Assembly Biosciences is a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and diseases associated with the microbiome.

The Company’s lead product candidate is ABI-H0731, a potent core inhibitor, for the treatment of HBV, which is under two phase IIa studies, dubbed ABI-H0731-201 and ABI-H0731-202. Patient enrollment has been completed in the ABI-H0731-201 and ABI-H0731-202 trials.

The other HBV drug candidates in the pipeline are ABI-2158, which is under a phase Ia study in healthy volunteers, and ABI-H3733, which is expected to advance into clinical trials in 2019.

The Company’s drugs for the treatment of disorders associated with the microbiome are all currently under preclinical testing. The most advanced drug candidate under the microbiome program is ABI-M201, and a phase Ib clinical study of ABI-M201 is expected to be initiated in 2019 in patients with mild to moderate ulcerative colitis.

The other preclinical drug candidates include ABI-M301 for Crohn’s disease; and a couple of yet to be identified compounds for Irritable bowel syndrome; NASH; and Immuno-oncology.

In January 2017, Allergan plc (AGN) entered into a research, development, collaboration and license agreement for the worldwide rights to Assembly’s ABI-M201 and ABI-M301, as well as two additional yet to be identified compounds. The collaboration is valued up to $2.8 billion.

In the third quarter ended September 30, 2018, net loss attributable to common stockholders widened to about $21.5 million or $0.87 per share from approximately $12.3 million or $0.71 per share for the same period in 2017.

Revenues consisting of revenue from collaborative research were approximately $4.3 million for the three months ended September 30, 2018, compared to approximately $2.7 million for the same period in 2017.

The Company ended September 30, 2018, with zero debt and cash of approximately $233.9 million.

Near-term Catalysts:

— Interim results from the two phase IIa studies of ABI-H0731 in HBV, dubbed ABI-H0731-201 and ABI-H0731-202, are expected during Q2 of 2019.
— Data from the phase Ia study of ABI-2158, another HBV drug candidate, in healthy volunteers is expected to be available in the first half of 2019.

ASMB has traded in a range of $18.58 to $67.36 over the last 1 year. The stock closed Monday’s (Jan.28) trading at $21.06, down 0.43%.

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