Biomolecular Life Holdings, Inc.

What they do

The company researches two core technologies: Targeted Peptide Technology (TPT), its main focus, and Metabolic Disruption Technology (MDT), its secondary focus. Its MDT therapy, a combination of hydroxychloroquine and sorafenib, is in a Physician's IND Phase I trial for solid tumors including ovarian, breast, colon, liver, lung, and pancreas. Its TPT therapy, VG1177, is pre-clinical for HIV/AIDS and requires animal toxicity studies before an IND filing. The technology is exclusively licensed from work by Dr. M. Karen Newell Rogers at the University of Colorado, University of Vermont, and Texas A&M University.

Revenue drivers

• MDT cancer therapy — Clinical-stage combination treatment; no revenue generated to date.
• TPT HIV/AIDS program (VG1177) — Pre-clinical peptide candidate; no revenue, requires significant additional work and financing.
• Grant funding — Phase I study funded in part by a $1.5 million grant to the Scott and White Foundation.

Recent performance

Annual revenue was $0.00 in both 2013 and 2014, and quarterly revenue remained $0.00 through September 30, 2015. Net loss was $7.4 million in 2013 and $6.2 million in 2014. Operating cash flow was negative $1.0 million in 2013 and negative $1.9 million in 2014. At September 30, 2015, total assets were $1.1 million and shareholders' equity was negative $4.3 million.

Strategy

The company's main focus is TPT, led by the pre-clinical VG1177 candidate for HIV/AIDS, with MDT as a secondary clinical-stage cancer program. It plans to file an IND for VG1177 after completing animal toxicity studies, then begin initial clinical trials. It is completing analysis of its Phase I MDT trial and holds an exclusive license to the use patent application for the HCQ/sorafenib combination. Management states it does not have sufficient funding to complete its work and plans to seek additional funding.

Risks

• Going concern — The independent auditors included a going-concern qualification because the company lacks enough cash to fund the next 12 months of operations.
• No commercial products — The company has no approved products and no revenue, and VG1177 is not expected to be commercially available for several years, if ever.
• Early-stage pipeline — TPT requires significant additional work, including favorable animal toxicity results and regulatory approval, before clinical trials can begin.
• Financing dependence — The company will need to raise additional capital and can provide no assurance that new financing will be available on acceptable terms.

Outlook

Management states that its MDT Phase I trial has completed dosing in all four cohorts and it is analyzing results while one cohort-four patient continues treatment. It expects to file an IND for VG1177 after animal toxicity studies and then commence initial clinical trials for HIV/AIDS. The company expects to continue incurring losses for the foreseeable future and says it does not have sufficient funding to complete its work.