UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8‑K
CURRENT REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report: October 10, 2018
(Date of earliest event reported)
BIOPHARMX CORPORATION
(Exact Name of Registrant as Specified in Its Charter)
Delaware
(State or Other Jurisdiction of Incorporation)
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001-37411 |
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59-3843182 |
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(Commission File Number) |
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(IRS Employer Identification No.) |
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1505 Adams Drive, Suite D Menlo Park, California |
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94025 |
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(Address of Principal Executive Offices) |
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(Zip Code) |
(650) 889-5020
(Registrant’s Telephone Number, Including Area Code)
Not Applicable
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8‑K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a‑12 under the Exchange Act (17 CFR 240.14a‑12) |
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Pre‑commencement communications pursuant to Rule 14d‑2(b) under the Exchange Act (17 CFR 240.14d‑2(b)) |
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Pre‑commencement communications pursuant to Rule 13e‑4(c) under the Exchange Act (17 CFR 240.13e‑4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers
(b), (c) and (e)
Effective October 10, 2018, Anja Krammer, President of BioPharmX Corporation (the “Company”), was terminated by the Company without Cause (as defined in the Employment Agreement between Anja Krammer and the Company, dated as of April 20, 2017 (the “Employment Agreement”)). A copy of the related press release is attached to this Current Report on Form 8-K as Exhibit 99.1.
Pursuant to the Employment Agreement, Ms. Krammer is entitled to severance payments and benefits provided for under her employment agreement, including (1) continuation of her current salary for nine months from October 10, 2018, payable in lump sum, (2) premium payments for continuing COBRA coverage for the same period or until Ms. Krammer is covered under the health plan of another employer and (3) acceleration of all time-based equity awards with respect to those shares which would have vested as of the nine month anniversary of October 10, 2018.
Effective October 10, 2018, the Company’s Board of Directors (the “Board”) appointed David S. Tierney, M.D., the Company’s Chief Executive Officer and a member of the Board, to serve as the Company’s President, Principal Executive Officer and Principal Financial Officer. Dr. Tierney, age 55, has served as Chief Executive Officer and as a member of the Board since September 2018. From January 2014 to March 2018, Dr. Tierney served as President and Chief Executive Officer of Icon Bioscience, Inc., a specialty biopharmaceutical company that was acquired by EyePoint Pharmaceuticals, Inc. in March 2018. Dr. Tierney received his medical degree from the Royal College of Surgeons in Dublin, Ireland and was subsequently trained in internal medicine. There are no family relationships between Dr. Tierney and any previous or current officers or directors of the Company, and there are no related party transactions reportable under Item 404(a) of Regulation S-K.
In addition, the Board appointed Joyce Goto, age 45, the Company’s Vice President and Controller, to serve as the Principal Accounting Officer, effective October 10, 2018. Ms. Goto has served as the Company’s Vice President and Controller since April 2015. There are no family relationships between Ms. Goto and any previous or current officers or directors of the Company, and there are no related party transactions reportable under Item 404(a) of Regulation S-K.
Item 9.01 Financial Statements and Exhibits
(d)
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Exhibit No. |
Description |
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99.1 |
Press release issued by BioPharmX Corporation dated October 11, 2018 |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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BIOPHARMX CORPORATION |
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Date: October 11, 2018 |
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/s/ David Tierney |
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Name: |
David Tierney |
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Title: |
Chief Executive Officer |
BioPharmX Initiates Phase 2b Trial of BPX-04 for Rosacea
Trial will evaluate 1% concentration of minocycline carried by company’s patented HyantX™ delivery system
MENLO PARK, Calif., Oct. 11, 2018 -- BioPharmX Corporation (NYSE American: BPMX), a specialty pharmaceutical company developing products for the dermatology market, today announced that it has enrolled the first subject in a Phase 2b clinical trial of BPX-04, a novel topical gel formulation of minocycline for the treatment of rosacea.
The trial is a randomized, double-blind, vehicle-controlled study in subjects with inflammatory lesions of rosacea. The 12-week, multi-center study will evaluate BPX-04, a 1% topical minocycline, carried by the HyantX™ delivery system, a proprietary, anhydrous hydrophilic topical system developed by BioPharmX. The trial plans to enroll 176 subjects at least 18 years old with an investigator’s global assessment (IGA) score of 3 or 4 (moderate or severe), and 15 to 70 inflammatory lesions on their faces at baseline. The study allows for an optional interim analysis to adjust the study’s sample size.
Dermatologists and their patients are still searching for effective innovations in treatments for rosacea," said Neal Bhatia, M.D., director of clinical dermatology at Therapeutics Clinical Research in San Diego who was the principal investigator for the company’s Proof-of-Concept (POC) trial. "The goal is to substantiate early research conclusions that suggest BPX-04 may offer the effective treatment of rosacea while minimizing the unwanted adverse effects associated with oral forms of antibiotics."
The primary endpoint for the study is an absolute mean change in the number of inflammatory lesions of rosacea from baseline to week 12. The secondary endpoint is the proportion of subjects with at least a two-grade reduction in IGA to clear (0) or almost clear (1), from baseline to week 12.
“The enrollment of our first subject represents an important milestone for BPX-04,” said David Tierney, BioPharmX CEO. “We are optimistic the study will demonstrate that BPX-04 is safe, effective and easy to use, which should significantly improve patient compliance – a serious challenge to rosacea treatment.”
Oral minocycline has been widely used in the treatment of skin conditions like rosacea and acne since the 1970s, but the pharmaceutical industry has not previously been able to develop a stable, topical formulation of fully solubilized minocycline, which appears to induce less resistance than other tetracycline-class antibiotics commonly used for these diseases. By applying minocycline topically, a patient will likely reduce the systemic exposure of minocycline and focus the drug’s beneficial effects at the skin where they are needed most.
Termination of Anja Krammer
In addition, BioPharmX announced that Anja Krammer has been terminated as BioPharmX's President. Following Ms. Krammer’s termination, David S. Tierney, M.D., BioPharmX’s CEO, has assumed the role of President. Michael Hubbard, Chairman of the BioPharmX Board, said: “We are confident that Dr. Tierney will provide strong leadership moving forward as our Chief Executive Officer and President.”
About HyantX™
The HyantX™ delivery system is a novel, patented drug delivery platform that stabilizes and solubilizes hydrophilic molecules in an anhydrous gel environment. It is capable of carrying a variety of active ingredients – and even combinations of actives - into the skin. Research has shown that the delivery system may allow for maximum solubility for multiple actives, which is intended to enhance skin penetration and increase efficacy and tolerability, has antibacterial properties, and hydrates the skin, making the delivery system a valuable asset in pipeline development and strategic partnering.
About BioPharmX Corporation
BioPharmX Corporation (NYSE American: BPMX) is a specialty pharmaceutical company, developing prescription products through proprietary platform technologies for dermatology indications. To learn more about BioPharmX, visit www.BioPharmX.com.
Forward-Looking Statements
The information in this press release contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the "safe harbor" created by those sections. This press release contains forward-looking statements about the company's expectations, plans, intentions, and strategies, including, but not limited to, BioPharmX’s executive leadership, the commencement and results of future trials of BPX-04 and the size of such trials, the safety and medical effects of BPX-04 and the HyantX™ delivery system, the effect BPX-04 may have on the treatment of rosacea, the absence of side effects of future use of BPX-04 and BioPharmX’s ability to advance BPX-04 through a successful NDA submission and commercialization. Additional risks are set forth in our filings with the Securities and Exchange Commission, including those described in the company's Quarterly Report on Form 10-Q for the most recent fiscal quarter. The forward-looking statements included in this news release are made only as of the date hereof, and the company undertakes no obligation to publicly update such statements. BioPharmX is a registered trademark of BioPharmX, Inc.
1 Caution: BPX-04 is a new drug limited by U.S. law to investigational use.
For further information:
Media Contact
Nina Brauer, nbrauer@biopharmx.com (650) 889-5030
or
Jim Martinez, jim@rightstorygroup.com (312) 543-9026