A few Q2 key breakdown points
14,187,583 Outstanding Shares
10,683,167 Prior
3,504,416 Difference
Received notice from the U.S. Patent and Trademark Office granting additional patent protection for its lead candidates, BPX-01 for the treatment of inflammatory lesions of acne vulgaris and BPX-04 for the treatment of papulopustular rosacea (U.S. Patent No. 10,391,108, entitled "Pharmaceutical Tetracycline Composition For Dermatological Use").
On September 24, 2018, we received a deficiency notice by the NYSE American that we were not in compliance with the stockholders’ equity requirements set forth in the NYSE American Company Guide. The deficiency notice was based on our reported stockholders’ equity of $4.3 million as of July 31, 2018 and net losses in our five most recent fiscal years ended January 31, 2018. NYSE Regulation reviewed our plan to regain compliance with this standard and approved a plan period through September 24, 2019. We have requestied that the NYSE American grant us a six-month extension to this plan period.
As of July 31, 2019, we had cash and cash equivalents of $3.3 million and a working capital of $1.8 million.
We incurred a net loss of $2.6 million and $4.4 million for the three months ended July 31, 2019 and 2018, respectively and a net loss of $6.3 million and $8.8 million for the six months ended July 31, 2019 and 2018, respectively. We had an accumulated deficit of $84.8 million as of July 31, 2019.
In addition, common stock with an aggregate offering price of up to $8.5 million may be issued and sold pursuant to an at-the-market sales agreement entered into with JonesTrading Institutional Services LLC in May 2019. As of July 31, 2019, we received net proceeds of $3.3 million under this at-the-market sales agreement. No additional amounts were raised under the sales agreement after July 31, 2019 through the date of this report.
We filed a shelf registration statement with the SEC to allow us to sell $100 million of our securities from time to time prior to February 2022, of which $87.6 million remains available on this effective registration statement as of August 31, 2019, subject to regulatory limitations.
We are currently preparing to request an end-of-phase 2 meeting with the FDA and are actively engaged in strategic partnership discussions to advance the continued development of both late-stage product candidates, BPX01 and BPX04. In addition, in August 2019 we retained Locust Walk Partners, LLC, a global life science transaction advisory firm focused on biopharmaceutical and medical technology companies, to provide transaction advisory services to us and to support our strategic partnership discussions.
Our goal is to reduce the time, cost and risks typically associated with new product development by utilizing APIs 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 on the FDA’s findings of safety and/or effectiveness for a similar previously-approved product. Our approach is to identify the limitations of current treatment options and work to develop novel products using our proprietary HyantXTM topical drug delivery system.
BPX01 and BPX04 are a topical formulations of minocycline (Solodyn), a previously approved oral antibiotic. Reliance on safety findings made by the FDA in approving Solodyn, the antibiotic we will reference in our NDA, could expedite the development program for our product candidates by decreasing the amount of preclinical or clinical data that we would need to generate in order to obtain FDA approval.
“This was an important quarter for BioPharmX to position our late-stage product candidates for continued success. We were extremely pleased to deliver positive Phase 2b trial results for BPX-04 as well as to secure additional patent protection for the underlying technology,” said Dr. Tierney, BioPharmX CEO. “Following a strategic review of the business, we have determined that the best path forward to realize the intrinsic value in these assets will be a strategic partnership transaction. As such, I am pleased to be working with the Locust Walk team, given my longstanding relationship with the firm, to initiate a more formal process with the aim to announce a strategic transaction in Q4 2019.”
