Clarus Therapeutics, Inc., a specialty pharmaceutical company
dedicated to providing solutions to unmet medical needs by
advancing androgen and metabolic therapies for men and women
(“Clarus”), and Blue Water Acquisition Corp. (Nasdaq: BLUW), a
publicly traded special purpose acquisition company (“Blue Water”),
today announced the completion of their previously announced
business combination.
The resulting combined company will be renamed Clarus
Therapeutics Holdings, Inc. (“Clarus Holdings,” “we,” “our” or
“us”) and will commence trading its shares of common stock under
the symbol “CRXT” and its warrants under the symbol “CRXTW” on the
Nasdaq Global Market on September 10, 2021. The CUSIP number for
Clarus Holdings’ common stock is 18271L 107 and 18271L 115 for the
warrants.
Gross proceeds to Clarus Holdings from this business
combination totaled approximately $25.3 million. The
stockholders of Blue Water approved the business combination at a
special meeting held on August 27, 2021. Clarus stockholders also
approved the business combination. Clarus’ management team,
led by Founder, President, and Chief Executive Officer Dr. Robert
Dudley, will continue to provide executive leadership for the
combined company.
“At Clarus, our goal is to develop and commercialize androgen
and metabolic therapies for unmet medical conditions in men and
women,” said President and Chief Executive Officer Dr. Robert
Dudley. “My sincere thanks to our investors, employees, board of
directors, and advisors for supporting our vision and making this
transaction a success. We intend to use our new resources to expand
the commercialization of JATENZO® and build an innovative pipeline
of product candidates.”
“We are proud to complete this business combination with
Clarus,” said Joseph Hernandez, Chairman and Chief Executive
Officer of Blue Water. “The company’s highly experienced management
team with its focus on continued growth and expansion positions
Clarus well for success. We look forward to the fruition of Clarus’
programs and are confident in their potential to deliver value to
patients and investors.”
About This Business CombinationOn April
27, 2021, Clarus, a privately held specialty pharmaceutical
company, entered into a definitive business combination agreement
with Blue Water, a special purpose acquisition company (SPAC)
formed to effect a merger, capital stock exchange, asset
acquisition, stock purchase, reorganization or similar business
combination with one or more businesses.
As a result of the business combination, Clarus Holdings
received gross proceeds of approximately $25.3 million.
AdvisorsTruist Securities acted as a financial
advisor and Needham & Company LLC acted as a capital markets
advisor to Clarus. Cantor Fitzgerald & Co. and Oppenheimer
& Co., Inc. acted as capital markets advisors to Blue Water.
Maxim Group LLC acted as financial advisor to Blue Water. Goodwin
Procter LLP served as legal counsel to Clarus. Ellenoff Grossman
& Schole LLP served as legal counsel to Blue Water. Mayer Brown
LLP served as legal counsel to the capital markets advisors.
About Clarus Therapeutics Holdings, Inc.Clarus
Holdings is a pharmaceutical company with expertise in developing
androgen and metabolic therapies for men and women – including
potential therapies for orphan indications. The Company’s first
commercial product is JATENZO®. For more information, visit
www.clarustherapeutics.com and www.jatenzo.com. Follow us on
Twitter (@Clarus_Thera) and LinkedIn (Clarus Therapeutics).
Forward-Looking StatementsCertain statements in
this press release may constitute “forward-looking statements” for
purposes of the federal securities laws. The words “anticipate,”
“believe,” “contemplate,” “continue,” “could,” “estimate,”
“expect,” “intend,” “may,” “might,” “plan,” “possible,”
“potential,” “predict,” “project,” “should,” “will,” “would” and
similar expressions may identify forward-looking statements, but
the absence of these words does not mean that a statement is not
forward-looking. Our forward-looking statements in this press
release include, but are not limited to, statements regarding
commencement of trading on Nasdaq, the expected use of proceeds,
expansion of commercialization of JATENZO®, our pipeline, continued
growth and expansion and our ability to deliver value to patients
and investors. In addition, any statements that refer to
projections, forecasts or other characterizations of future events
or circumstances, including any underlying assumptions, are
forward-looking statements. These forward-looking statements are
based on current expectations and beliefs concerning future
developments and their potential effects. There can be no assurance
that future developments affecting us will be those that we have
anticipated. These forward-looking statements involve a number of
risks, uncertainties (some of which are beyond our control) or
other assumptions that may cause actual results or performance to
be materially different from those expressed or implied by these
forward-looking statements. These risks and uncertainties include,
but are not limited to, risks associated with our financial
position, risks associated with our indebtedness, our dependence on
JATENZO®, and risks associated with our industry, along with those
other factors described under the heading “Risk Factors” in the
proxy statement/prospectus filed with the Securities and Exchange
Commission (the “SEC”) on July 23, 2021, and those that are
included in any of our future filings with the SEC. Should one or
more of these risks or uncertainties materialize, or should any of
our assumptions prove incorrect, actual results may vary in
material respects from those projected in these forward-looking
statements. Some of these risks and uncertainties may in the future
be amplified by the COVID-19 pandemic and there may be additional
risks that we consider immaterial, or which are unknown. It is not
possible to predict or identify all such risks. Accordingly, undue
reliance should not be placed upon the forward-looking statements.
Our forward-looking statements only speak as of the date they are
made, and we do not undertake any obligation to update or revise
any forward-looking statements, whether as a result of new
information, future events or otherwise, except as may be required
under applicable securities laws.
Clarus Investor Relations Contact:Kara
StancellClarus Therapeutics, Inc.555 Skokie Blvd., Suite
340Northbrook, IL 60062(847) 562-4300 x
206kstancell@clarustherapeutics.com
Blue Water Contact:Joseph HernandezChief
Executive Officer15 E. Putnam Avenue, Suite 363Greenwich, CT
06830(646) 303-0737
About JATENZO
Indication
JATENZO® (testosterone undecanoate) capsules, CIII, is an
androgen indicated for testosterone replacement therapy in adult
males for conditions associated with a deficiency or absence of
endogenous testosterone:
Primary hypogonadism (congenital or acquired): testicular
failure due to cryptorchidism, bilateral torsion, orchitis,
vanishing testis syndrome, orchiectomy, Klinefelter syndrome,
chemotherapy, or toxic damage from alcohol or heavy metals. These
men usually have low serum testosterone concentrations and
gonadotropins (follicle-stimulating hormone [FSH], luteinizing
hormone [LH]) above the normal range.
Hypogonadotropic hypogonadism (congenital or acquired):
gonadotropin or luteinizing hormone-releasing hormone (LHRH)
deficiency or pituitary-hypothalamic injury from tumors, trauma, or
radiation. These men have low testosterone serum concentrations but
have gonadotropins in the normal or low range.
Limitation of use
Safety and efficacy of JATENZO in males less than 18 years old
have not been established.
IMPORTANT SAFETY INFORMATION
WARNING: INCREASES IN BLOOD PRESSURE
- JATENZO can cause blood pressure (BP) increases that
can increase the risk of major adverse cardiovascular events
(MACE), including non-fatal myocardial infarction, non-fatal stroke
and cardiovascular death.
- Before initiating JATENZO, consider the patient's
baseline cardiovascular risk and ensure blood pressure is
adequately controlled.
- Periodically monitor for and treat new-onset
hypertension or exacerbations of pre-existing hypertension and
re-evaluate whether the benefits of JATENZO outweigh its risks in
patients who develop cardiovascular risk factors or cardiovascular
disease on treatment.
- Due to this risk, use JATENZO only for the treatment of
men with hypogonadal conditions associated with structural or
genetic etiologies.
CONTRAINDICATIONS
JATENZO is contraindicated in men with breast cancer or known or
suspected prostate cancer. JATENZO is contraindicated in women who
are pregnant as testosterone may cause fetal harm.
WARNINGS AND PRECAUTIONS
- Check hematocrit prior to initiation and every 3 months while a
patient is on JATENZO and if hematocrit becomes elevated, stop
JATENZO until hematocrit decreases to an acceptable level. If
hematocrit increases after JATENZO is restarted, stop
permanently.
- Monitor patients with benign prostatic hyperplasia (BPH)
treated with androgens due to an increased risk for worsening signs
and symptoms of BPH.
- Venous thromboembolic events (VTE), including deep vein
thrombosis (DVT) and pulmonary embolism (PE), have been reported in
patients using testosterone replacement products like JATENZO.
Evaluate patients with signs or symptoms consistent with DVT or PE
and, if a VTE is suspected, discontinue JATENZO and initiate
appropriate workup and management.
- Testosterone has been subject to abuse, typically at doses
higher than recommended for the approved indication and in
combination with other anabolic androgenic steroids.
- Large doses of androgens can suppress spermatogenesis by
feedback inhibition of pituitary FSH. Inform patients of this risk
before prescribing JATENZO.
- Prolonged use of high doses of methyltestosterone has been
associated with serious hepatic adverse events. JATENZO is not
known to cause these adverse events; however, patients should be
instructed to report any signs of hepatic dysfunction and JATENZO
should be discontinued while the cause is evaluated.
- Edema, with or without congestive heart failure, may be a
serious complication in patients with pre-existing cardiac, renal,
or hepatic disease. In addition to discontinuation of the drug,
diuretic therapy may be required.
- Gynecomastia may develop and persist in patients being treated
for hypogonadism.
- Sleep apnea may occur in some patients, especially those with
risk factors such as obesity or chronic lung disease.
- Changes in the serum lipid profile may require dose adjustment
of lipid-lowering drugs or discontinuation of testosterone therapy.
Monitor the lipid profile periodically, particularly after starting
testosterone therapy.
- Use JATENZO with caution in cancer patients at risk of
hypercalcemia. Monitor serum calcium concentration regularly during
treatment with JATENZO in these patients.
- Androgens, including JATENZO, may decrease concentrations of
thyroxine-binding globulin, resulting in decreased total T4 serum
concentrations and increased resin uptake of T3 and T4. Free
thyroid hormone concentrations remain unchanged, however, and there
is no clinical evidence of thyroid dysfunction.
- Depression and suicidal ideation have been reported in patients
treated with JATENZO in clinical trials.
ADVERSE EVENTS
The most common adverse events of JATENZO (incidence ≥2%) are
headache (5%), increased hematocrit (5%), hypertension (4%),
decreased HDL (3%), and nausea (2%).
These are not all of the risks associated with JATENZO.
For more information, click here
for full Prescribing Information, including BOXED WARNING
on increases in blood pressure. You can also obtain information
regarding JATENZO at www.jatenzo.com.
© 2021 Clarus Therapeutics, Inc. All rights reserved.
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