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): May 13, 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.) |
| 4225 Executive Square, Suite 485, 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 May 13, 2010, Transdel Pharmaceuticals, Inc. issued a press release announcing, among other things, its unaudited financial results for the three month period ended March 31, 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 May13, 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: May 13, 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 May 13, 2010. | |
Exhibit 99.1
 |
News Release |
Transdel Pharmaceuticals Reports First Quarter 2010 Results
LA JOLLA, CA – May 13, 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 quarter ended March 31, 2010. The Company also highlighted recent achievements.
“We continue to focus our efforts on licensing discussions with potential pharmaceutical partners for Ketotransdel®, our lead transdermal product for pain, and on preparing for the continuation of the clinical program for Ketotransdel®,” stated John Lomoro, Acting Chief Executive Officer and Chief Financial Officer. “We are very pleased that the full results from the first Phase 3 Ketotransdel® study will be presented at the upcoming World Congress on Pain.”
Recent Achievements
| • | The Company raised $1 million from an existing shareholder through a private debt financing. The
financing provides the Company with additional resources to continue to plan the second Phase 3 clinical study
to evaluate Ketotransdel®, as well as to continue partnering discussions. |
| • | The Company’s abstract entitled “Efficacy And Safety Of Ketoprofen 10% Cream In The Treatment Of Pain
Associated With Acute Soft Tissue Injuries (Phase 3 Study TDLP-110-001)” was accepted for presentation at the
13th World Congress on Pain to be held August 29 to September 2, 2010 in Montreal, Canada. The poster is to be
presented by lead author Dr. Evan Ekman, President of Southern Orthopaedic Sports Medicine in Columbia, SC. |
First Quarter 2010 Financial Results
As of March 31, 2010, the Company had cash and cash equivalents of approximately $1.0 million, compared to $1.6 million at December 31, 2009. The cash and cash equivalents balance as of March 31, 2010 does not include the proceeds from the recent $1 million financing completed in early April 2010.
Transdel reported a net loss of approximately $0.9 million, or $0.06 per share, for the first quarter ended March 31, 2010, compared to a net loss of approximately $1.6 million, or $0.10 per share, for the same period last year.
Research and development expenses totaled approximately $0.1 million and $1.1 million for the first 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 first quarter 2009.
General and administrative expenses totaled approximately $0.8 million and $0.5 million for the first quarter ended March 31, 2010 and 2009, respectively. The increase is due to a one-time charge of approximately $0.4 million for accrued 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 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