BioPharmX Corp fka BPMX

[Whos_Who]

Zack's Report Dec. 2017

https://shar.es/1ME7aY

BPMX: Zacks Company Report

BPMX: Positive feedback from the FDA
received with respect to the Phase III design,
Positive data from Phase IIb of BPX01 for
acne announced, Phase III planned; Strong
balance sheet.

Outlook: BPMX is a specialty pharma with a focus on
women s health and dermatology. The company s
VI2OLET is a commercially available OTC for breast
discomfort associated with FBC. BPX03, a
prescription iodine for FBC, will enter Phase III trial in
2018. BPX01, a topical minocycline, for acne, will
enter Phase III trial soon. By 2019, BPMX will
become a key player in the targeted markets of
women s health and dermatology with 3 products
commercially available targeting FBC and acne
respectively.
We are optimistic about BPMX prospect.

Update on BPX-01 for Acne
BioPharmX is developing BPX01, a non-lipophilic, topical antibiotic for the treatment of acne. BPX01
utilizes a transepidermal delivery mechanism for minocycline and other APIs that has the potential to
kill p. acnes bacteria without the systemic side effects of orally-administered antibiotics.
Phase III Study Planned in early 2018
The company plans to use the completed Phase IIb data for the design and powering of Phase III trial.
In November 2017, the company received positive feedback from the FDA with respect to the design of
the planned Phase III clinical trial for BPX-01 for the treatment of inflammatory lesions of acne vulgaris.
The company also received clear guidance with respect to the requirements for clinical, non-clinical, and
chemistry, manufacturing and controls (CMC) needed to support a NDA submission.
The company plans to use an Investigator's Global Assessment (IGA) scale specific to inflammatory
lesions to measure treatment success in the co-primary efficacy endpoint. The FDA concurred with the
company's proposal to use an inflammatory lesion IGA as a co-primary endpoint along with inflammatory
lesion reduction.

Further, the company plans to pursue an intended label indication of treatment of inflammatory lesions of
acne vulgaris. An indication specific to inflammatory lesions is consistent with the indication for oral
minocycline for acne.
With the feedback from the FDA, the company continues to consider various options as it finalizes the
Phase III study design and works on additional program requirements needed for an NDA submission.
The company is also considering partnership to fund the Phase III clinical trial and expects to begin the
trial soon.