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 2, 2012
THERAPEUTICSMD, INC.
(Exact name of registrant as specified in its charter)
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Nevada
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000-16731
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87-0233535
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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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951 Broken Sound Parkway NW, Suite 320, Boca Raton, FL 33487
(Address of principal executive offices and Zip Code)
(561) 961-1911
(Registrant’s telephone number, including area code)
N/A
(Former Name and Address of Registrant)
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))
TABLE OF CONTENTS
| SECTION 7 – REGULATION FD | Page | |
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Item 7.01
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Regulation FD Disclosure | 3 |
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SECTION 9 – FINANCIAL STATEMENTS AND EXHIBITS
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| Item 9.01 | (d) Exhibits | 3 |
SECTION 7 – REGULATION FD
ITEM 7.01 REGULATION FD DISCLOSURE
On July 10, 2012, TherapeuticsMD™, Inc., parent company of vitaMedMD®, LLC ("vitaMedMD") ("TherapeuticsMD" or the "Company"), previously filed three Investigational New Drug applications ("INDs") with the U.S. Food and Drug Administration ("FDA"). On August 2, 2012, one of the INDs was approved by the FDA. The Company intends to initiate Phase III clinical trials in the field of hormone therapy for menopausal women before the end of the year.
The information in this Item 7.01 of this Form 8-K (the "Report") is being furnished and shall be deemed "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934 (the "Act"), or otherwise subject to the liabilities of that section. The information in this Item 7.01 of this Report also shall not be deemed to be incorporated by reference into any filing under the Act except to the extent that we specifically incorporate it by reference.
SECTION 9 – FINANCIAL STATEMENTS AND EXHIBITS
ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS
(d) Exhibits:
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Exh. No.
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Date
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Document
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____________________________
* Filed herewith.
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.
| Date: August 7, 2012 |
THERAPEUTICSMD, INC.
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By:
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/s/Robert G. Finizio
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Robert G. Finizio, Chief Executive Officer | ||
Exhibit 99.0
| FOR IMMEDIATE RELEASE | SYMBOL: TXMD |
| August 7, 2012 | TRADED: OTCQB |
THERAPEUTICSMD, INC. HAS IND FILING ACCEPTED BY FDA
FOR IMMEDIATE RELEASE – August 7, 2012 – Boca Raton, FL – TherapeuticsMD™, Inc. [OTCQB: TXMD], parent company of vitaMedMD®, LLC ("vitaMedMD"), a specialty pharmaceutical company ("TherapeuticsMD" or the "Company"), announced today the U.S. Food and Drug Administration ("FDA") accepted the Company’s Investigational New Drug application ("IND") and now the Company can proceed with Phase III clinical trials for its product TX12002HR for hormone therapy.
Robert Finizio, the Company's Chief Executive Officer, stated, "Now that our submitted IND has been accepted we are anxious to move to the clinical stage of development for our new product TX12002HR. We anticipate that these clinical trials will begin before the end of the year."
About TherapeuticsMD
TherapeuticsMD is a specialty pharmaceutical company focused on creating safe and effective therapies exclusively for women. The Company’s branded OTC and pharmaceutical products are designed to improve the health and well-being of women from pregnancy through menopause. vitaMedMD provides dietary supplements and healthcare products focused on improving women’s health, wellness, and quality of life. Questions may be directed to Daniel A. Cartwright, the Company's Chief Financial Officer, at (561) 961-1911. More information on TherapeuticsMD is available on its website at www.therapeuticsmd.com. More information on vitaMedMD and its products are available at www.vitamedmdrx.com and www.vitamedmd.com.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy securities of TherapeuticsMD, Inc. Certain statements in this release and other written or oral statements made by or on behalf of the Company are “forward-looking statements” within the meaning of the federal securities laws. Statements regarding future events and developments and our future performance, as well as management’s expectations, beliefs, plans, estimates or projections relating to the future are forward-looking statements within the meaning of these laws. The forward-looking statements are subject to a number of risks and uncertainties including FDA and market acceptance of the Company’s services and projects and the Company’s continued access to capital and other risks and uncertainties identified in the Company’s Form 10-K and other filings with the Securities and Exchange Commission.. The actual results the Company achieves may differ materially from any forward-looking statements due to such risks and uncertainties. These statements are based on our current expectations and speak only as of the date of such statements. The Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of future events, new information or otherwise.
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