ASSEMBLY BIOSCIENCES, INC. (ASMB) SEC Filings & Earnings Calls

Gilead dependency

“We expect our collaboration with Gilead to be a critical part of the development, manufacture and commercialization of our product candidates.” · word for word

No approved products

“We have no approved products and depend on the future success of the product candidates in our research and development pipeline.” · word for word

Need for additional financing

“We are not currently profitable and might never become profitable, and we will need additional financing to complete the development of any product candidates and fund our activities into the future.” · word for word

Clinical trial failure risk

“Nonclinical and clinical studies required for our product candidates are expensive and time-consuming and may fail to demonstrate the level of safety and efficacy necessary for product approval.” · word for word

Reliance on CROs

“We rely on contract research organizations (CROs) to conduct some of our nonclinical and clinical studies due to our lack of suitable facilities and resources.” · word for word

Dependence on Gilead collaboration; opt-in decision mid-2026 could reduce future economics if not exercised.

“ABI-5366 and ABI-1179 are exclusively licensed to Gilead; Assembly Bio to determine whether to opt in to a 40% U.S. cost-profit share.”

No approved products; all candidates in clinical/preclinical stages; regulatory and clinical risk high.

“ABI-5366, ABI-1179 and ABI-6250 are investigational product candidates that have not been approved anywhere globally.” · word for word

Cash burn rate; net loss continues; no revenue from product sales.

“Net loss $9.1M; cash decreased from $248.1M to $226.6M in Q1.”

No approved products; history of losses; dependence on Gilead collaboration

“We have no approved products and depend on the future success of the product candidates in our research and development pipeline. We are not currently profitable and might never become profitable.” · word for word

Gilead declined option on 4334; partnering risk

“In March 2026, Gilead declined to either exercise its option to license 4334 or defer its option until completion of Phase 2 studies. We do not plan to advance 4334 further without a partner.” · word for word

Clinical development and regulatory uncertainty

“Nonclinical and clinical studies required for our product candidates are expensive and time-consuming and may fail to demonstrate the level of safety and efficacy necessary for product approval.” · word for word

Equity dilution from share increase proposals

“increase the number of shares reserved under the 2018 Plan by 1,200,000 ... overhang percentage inclusive of pre-funded warrants, assuming stockholder approval of the Plan Amendment 18.3%” · word for word

Dependence on Gilead collaboration

“Gilead Sciences, Inc. (Gilead), a beneficial holder of more than 5% of our capital stock, are parties to the following agreements: ... Gilead held approximately 28.3% of our outstanding common stock” · word for word

Gilead declined option on ABI-4334, requiring new partner for HBV program.

“Gilead declined to exercise or defer its option on ABI-4334... Initiated a structured process to find a partner for ABI-4334 after regaining sole rights to the program.” · word for word

No approved products; operating losses since inception

“As a result of our significant research and development expenditures and the lack of any FDA-approved products to generate product sales revenue, we have not been profitable and have generated operating losses since we were incorporated in October 2005.” · word for word

Dependence on Gilead collaboration

“Our ability to realize future potential benefits pursuant to the Gilead Collaboration and maintain the collaboration.” · word for word

Clinical development risks for unapproved product candidates.

“ABI-5366, ABI-1179, ABI-6250 and ABI-4334 are investigational product candidates that have not been approved anywhere globally.” · word for word

Dependence on collaboration with Gilead for certain programs.

“ABI-1179 was contributed by Gilead Sciences, Inc. under the collaboration.”

Going concern risk resolved but pre-revenue biotech remains dependent on financing

“The Company has not derived any revenue from product sales to date and currently has no approved products.” · word for word

Dependence on Gilead collaboration for revenue and development

“We expect our collaboration with Gilead to be a critical part of the development, manufacture and commercialization of our product candidates. If this collaboration is unsuccessful, our business could be adversely affected.” · word for word

Clinical development risk: product candidates may fail in later-stage trials

“The results of nonclinical studies may not be representative of disease behavior in a clinical setting and may not be predictive of the outcomes of our clinical studies.” · word for word

Regulatory approval uncertainty and potential delays

“The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable.” · word for word

Intellectual property protection may be inadequate

“We cannot be certain that we will secure any rights to any issued patents with claims that cover any of our proprietary product candidates and technologies.” · word for word