Item 7.01 Regulation FD Disclosure.
Included as Exhibit 99.1 to this Form 8-K is a presentation (the Corporate Presentation) of Clarus
Therapeutics, Holdings, Inc. ( Clarus) that it intends to utilize in various meetings with securities analysts, investors and others. The Corporate Presentation is being furnished herewith and is incorporated herein by reference.
The information in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is
being furnished and shall not be deemed filed for purposes of Section 18 of the Exchange Act 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, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 8.01
Other Events.
On January 19, 2022, Clarus announced that it currently expects to initiate in the second half of 2022, (i) a Phase 4 clinical
trial to provide T therapy for female-to-male transgender individuals, (ii) a Phase 2 clinical trial to provide once daily oral testosterone undecanoate to treat male
hypogonadism, and (iii) a Phase 2 clinical trial to provide treatment of inflammatory breast disease (PDM).
The disclosure under this Item 8.01 of
this Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, you can identify forward-looking
statements by terminology such as (but not limited to) may, should, expect, intend, will, estimate, anticipate, believe, predict,
potential, could, project, budget, forecast, anticipate, plan, design or continue, or the negatives of these terms or variations of them or
similar terminology. These forward-looking statements include, without limitation, express or implied statements regarding the timing of its Phase 4 clinical trial, as well as the Clarus ability to successfully complete clinical trials for
JATENZO and receive necessary regulatory approvals. Such forward-looking statements are subject to risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed or implied by such forward-looking
statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Clarus and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not
possible to predict all risks and uncertainties. These risks and uncertainties include, but are not limited to, the risks associated with pharmaceutical development, risks associated with Clarus financial position, and those factors described
under the heading Risk Factors in the prospectus filed with the Securities and Exchange Commission (the SEC) under Rule 424(b)(3) on December 23, 2021, and those that are included in any of Clarus future filings
with the SEC. Some of these risks and uncertainties may in the future be amplified by the COVID-19 pandemic and there may be additional risks that Clarus considers immaterial, or which are unknown. It is not
possible to predict or identify all such risks. Nothing in this Current Report on Form 8-K should be regarded as a representation by any person that the forward-looking statements set forth herein will be
achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this Current Report on Form 8-K, which
speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Clarus does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements
to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based. This Current Report on Form 8-K does not purport to summarize all of the
conditions, risks and other attributes of an investment in Clarus.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
|
|
|
Exhibit
Number
|
|
Description
|
|
|
99.1
|
|
Corporate Presentation of Clarus Therapeutics, Inc. (furnished herewith)
|
|
|
104
|
|
Cover Page Interactive Data File (embedded within the Inline XBRL document).
|