NORTHBROOK, Ill. and GREENWICH, Conn., Sept. 09, 2021 (GLOBE NEWSWIRE) -- 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 Combination
On 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.
Advisors
Truist 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 Statements
Certain 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 Stancell
Clarus Therapeutics, Inc.
555 Skokie Blvd., Suite 340
Northbrook, IL 60062
(847) 562-4300 x 206
kstancell@clarustherapeutics.com
Blue Water Contact:
Joseph Hernandez
Chief Executive Officer
15 E. Putnam Avenue, Suite 363
Greenwich, 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.
