UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 12, 2010
TRANSDEL PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 000-52998 | 45-0567010 | ||
| (State or other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
| 4275 Executive Square, Suite 230, La Jolla, California |
92037 | |
| (Address of Principal Executive Offices) | (Zip Code) |
Registrant’s telephone number, including area code: (858) 457-5300
| 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:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 2.02. Results of Operations and Financial Condition.
On August 12, 2010, Transdel Pharmaceuticals, Inc. issued a press release announcing, among other
things, its unaudited financial results for the three and six month periods ended June 30, 2010. A
copy of the press release is attached as Exhibit 99.1 to this Current Report.
The information in this Item 2.02, and Exhibit 99.1 attached hereto, is being furnished and shall
not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as
amended, or otherwise subject to the liabilities of that section, nor shall it be deemed
incorporated by reference in any filing under the Securities Act of 1933, as amended, regardless of
any general incorporation language in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
99.1 Press release issued by Transdel Pharmaceuticals, Inc. on August 12, 2010.
SIGNATURE
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 thereunto duly authorized.
Dated: August 12, 2010
| TRANSDEL PHARMACEUTICALS, INC. |
||||
| By: | /s/ John Lomoro | |||
| John Lomoro | ||||
| Acting Chief Executive Officer and Chief Financial Officer |
||||
INDEX TO EXHIBITS
Exhibit No.
|
Description | |
99.1
|
Press release issued by Transdel Pharmaceuticals, Inc. on August 12, 2010. |
Exhibit 99.1
|
News Release |
Transdel Pharmaceuticals Reports Second Quarter and Year-to-Date 2010 Results
LA JOLLA, CA — August 12, 2010 — Transdel Pharmaceuticals, Inc. (OTCBB: TDLP), a specialty
pharmaceutical company focused on developing topically administered products using its proprietary
transdermal delivery platform, today announced financial results for the three and six months ended
June 30, 2010 and other activity during the second quarter.
Recent Achievement
| • | In June 2010, Transdel and Jan Marini Skin Research, Inc. (“JMSR”) entered into a
licensing agreement providing JMSR with the exclusive U.S. rights to Transdel’s transdermal
delivery technology for use in an anti-cellulite cosmeceutical product for the
dermatological market. Under the terms of the agreement, JMSR will pay Transdel a
licensing royalty on the U.S. and worldwide sales of an anti-cellulite product using
Trandel’s delivery technology. JMSR obtained an exclusive right to promote and sell a
product in the U.S. dermatological market for approximately one year, after which time they
have a non-exclusive right. Also, JMSR obtained a non-exclusive right to promote and sell
the product in the ex-U.S. dermatological market. |
Second Quarter and Year-to-Date 2010 Financial Results
As of June 30, 2010, the Company had cash and cash equivalents of approximately $1.0 million,
compared to $1.0 million at March 31, 2010. In April 2010, the Company received proceeds from a
$1.0 million senior convertible note financing.
Second Quarter Financial Results
Transdel reported a net loss of approximately $0.5 million, or $0.03 per share, for the quarter
ended June 30, 2010, compared to a net loss of approximately $1.2 million, or $0.08 per share, for
the same period last year.
Research and development expenses totaled approximately $0.1 million and $0.9 million for the
second quarter 2010 and 2009, respectively. The decrease in research and development costs compared
to 2009 was primarily due to expenses incurred for the Phase 3 clinical study of Ketotransdel® that
was in progress during the second quarter 2009.
General and administrative expenses were consistent between the second quarter of 2010 and 2009
totaling approximately $0.4 million and $0.3 million, respectively.
Year-to-Date Financial Results
Transdel reported a net loss of approximately $1.4 million, or $0.09 per share, for the six months
ended June 30, 2010, compared to a net loss of approximately $2.8 million, or $0.18 per share, for
the same period last year.
Research and development expenses totaled approximately $0.2 million and $2.0 million for the six
months ended June 30, 2010 and 2009, respectively. The decrease in research and development costs
compared to 2009 was primarily due to expenses incurred for the Phase 3 clinical study of
Ketotransdel® that was in progress during the first six months of 2009.
General and administrative expenses totaled approximately $1.2 million and $0.8 million for the six
months ended June 30, 2010 and 2009, respectively. The increase is primarily due to a one-time
charge of approximately $0.4 million for expenses relating to the separation agreement between the
Company and our former chief executive officer who resigned in February 2010.
About Transdel Pharmaceuticals, Inc.
Transdel Pharmaceuticals, Inc. (OTCBB: TDLP) is a specialty pharmaceutical company developing
non-invasive, topically delivered products. The Company’s innovative-patented Transdel™ cream
formulation technology is designed to facilitate the effective penetration of a variety of products
through the tough skin barrier. Ketotransdel®, the Company’s lead pain product, has successfully
completed a Phase 3 clinical trial and utilizes the Transdel technology to deliver the active drug,
ketoprofen, a non-steroidal anti-inflammatory drug through the skin directly into the underlying
tissues where the drug exerts its well-known anti-inflammatory and analgesic effects. The Company
intends to leverage its Transdel™ platform technology to expand and create a portfolio of topical
products for a variety of indications. The Company is actively pursuing partnerships with
companies to expand its product portfolio for pharmaceutical and cosmetic/cosmeceutical products.
For more information, please visit http://www.transdelpharma.com.
Safe Harbor Statement
The Company cautions you that the statements included in this press release that are not a
description of historical facts are forward-looking statements. These include statements regarding:
the Company’s interpretation of the results of its Phase 3 clinical trial for
Ketotransdel®; the Company’s ability to obtain regulatory approval to market
Ketotransdel; and the Company’s ability to continue as a going concern and complete additional
development activities for products utilizing its proprietary transdermal delivery platform. Actual
results may differ materially from those set forth in this press release due to the risks and
uncertainties inherent in the Company’s business, including, without limitation: the outcome of the
final analyses of the data from the Phase 3 clinical trial may vary from the Company’s initial
conclusions; the FDA may not agree with the Company’s interpretation of such results or may
challenge the adequacy of the Company’s clinical trial design or the execution of the clinical
trial; the FDA may continue to require the Company to complete additional clinical trials for
Ketotransdel® before the Company can submit a 505(b)(2) NDA application; the results of
any future clinical trials may not be favorable and the Company may never receive regulatory
approval for Ketotransdel®; and the Company’s current need to raise additional funding
to complete its product development plans. More detailed information about the Company and the risk
factors that may affect the realization of forward-looking statements is set forth in the Company’s
filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and
its Quarterly Reports on Form 10-Q filed with the SEC. Such documents may be read free of charge on
the SEC’s web site at www.sec.gov. You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof. All forward-looking statements
are qualified in their entirety by this cautionary statement and the Company undertakes no
obligation to revise or update this press release to reflect events or circumstances after the date
hereof. This caution is made under the safe harbor provisions of Section 21E of the Private
Securities Litigation Reform Act of 1995.
Contact:
John Lomoro, Chief Financial Officer and Acting Chief Executive Officer
Transdel Pharmaceuticals, Inc.
858-457-5300
johnl@transdelpharma.com
John Lomoro, Chief Financial Officer and Acting Chief Executive Officer
Transdel Pharmaceuticals, Inc.
858-457-5300
johnl@transdelpharma.com