BPMX : BioPharmX Corporation Stock Analysis and Research Report
2018-03-10 - by Asif , Contributing Analyst - 652 views
BioPharmX is a specialty pharmaceutical company focused on utilizing its proprietary drug delivery technologies to develop and commercialize novel prescription and over‑the‑counter, or OTC, products that address large markets in dermatology and women’s health. The company's objective is to develop products that treat health or age‑related conditions that: (1) are not presently being addressed or treated or (2) are currently treated with drug therapies or drug delivery approaches that are sub‑optimal. The company's strategy is designed to bring new products to market by identifying optimal delivery mechanisms and/or alternative applications for United States Food and Drug Administration, or FDA, approved active pharmaceutical ingredients, or APIs, and biological materials, while, in appropriate circumstances, reducing the time, cost and risk typically associated with new product development by repurposing drugs with demonstrated safety profiles and, when applicable, taking advantage of the regulatory approval pathway under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, or FDC Act. Section 505(b)(2) permits an applicant for a new product, such as a new or improved formulation or a new use of an approved product, to rely in part on literature and/or the FDA’s findings of safety and/or effectiveness for a similar previously-approved product. The company believe these approaches may reduce drug development risk and could reduce the time and resources the company spend during development. The company's current platform technologies include innovative delivery mechanisms for antibiotics, biological materials and molecular iodine (I2).
Since inception, BioPharmX has developed its product candidates, including conducting preclinical and clinical trials, and providing general and administrative support for these operations. The company recently presented comprehensive BPX01 Phase 2b clinical data and expect its BPX01 Phase 3 clinical trial to begin later this year. The company began shipping VI2OLET through online stores in December 2014. The company continue to pursue additional channel distribution expansion for VI2OLET by way of partnerships and/or sublicensing opportunities with women’s health and/or consumer companies to provide broader access to consumers. To date, BioPharmX has generated a de minimis amount of revenue from product sales while the company focus on product acceptance and partnering opportunities.
In April 2017, the company raised net proceeds of $4.4 million in a registered direct offering of 6,410,258 shares of common stock and warrants to purchase up to 3,365,385 shares of its common stock. In July 2017, the company raised net proceeds of $1.9 million in a registered direct offering of 5,500,000 shares of its common stock.
BioPharmX Corporate Highlights
Unique Drug Delivery Systems in Dermatology
Multiple platforms focused on delivery of API to precise targets optimizing safety and efficacy Hydrophilic Topical Delivery System offers sustainable pipeline of products with known API, reduces regulatory timeline, cost and risk Technology developed in-house
BPX-01 Lead Indication – Acne
Completed positive Phase 2 for acne vulgaris First non-lipophilic topical antibiotic formulation of Minocycline FDA meeting requested; planning for phase 3 ongoing
BPX-01 Second Indication - Rosacea
Established feasibility; planning for phase 2/3 Confirmed tolerability in multiple doses
For pipeline visit latest presentation http://www.biopharmx.com/wp-content/uploads/2017/09/BioPharmX-Corporate-Presentation-September-20171.pdf