SALT LAKE CITY, UT--(Marketwired - Apr 18, 2017) - PolarityTE™, Inc. ("Polarity") (NASDAQ: COOL) announces the recruitment of six new members to its growing team with specific expertise and experience in government and defense contracts, intellectual property and FDA legal strategy, and translational research and development.
Chairman and Chief Executive Officer, Denver M. Lough, MD, PhD stated, "With such recent and significant growth, Polarity is proud to announce that we have recruited another tremendous block of talent, including Michael V. Callahan MD, DTM&H, MSPH as Director of Military and Mass Casualty Regenerative Medicine Programs. Dr. Callahan is President of United Therapeutics Corporation (NASDAQ: UTHR) Division of Cellular Therapies and faculty member of the Division of Infectious Diseases and Director of Translational Medicine for the Vaccine and Immunotherapeutics Center (VIC) at Massachusetts General Hospital/Harvard Medical School. Within this division, Dr. Callahan will be directly supported by both our newly recruited Government & Defense Contracts Coordinator and our Multi-Facility Operations Manager.
We have recruited attorney Cameron Hoyler from King & Spalding as General Counsel to join our in-house legal team to further accelerate and facilitate our growing relationship with our K&S IP and FDA legal teams.
The Department of Translational R&D at Polarity has also added on three new doctoral members. This team includes a Biomaterials Engineer, a Director of Regenerative Aesthetics, and a Director of Medical Technology and Innovation to enhance the Polarity technology product platform, as well as provide the best experience possible for health care professionals, medical institutions, payers and most importantly the patients we have set out to help."
To facilitate the new hires, Polarity announced today that it approved non-statutory stock options to purchase 105,000 shares of its common stock and the issuance of 50,000 restricted stock units to four of its new hires. The awards were made pursuant to the NASDAQ inducement grant exception as a component of these new hires' employment compensation with the Company's equity grant program. The inducement grants were approved by PolarityTE's Compensation Committee on April 2, 2017 and April 11, 2017 and are being made as an inducement material to the employees' acceptance of employment with the Company in accordance with NASDAQ Listing Rule 5635(c)(4). The stock option awards issued and to be issued have an exercise price equal to the closing price of Polarity's common stock on the applicable employee's approval for the issuance of the inducement awards by the Compensation Committee and have a 10-year term. The stock options and restricted stock units vest over two years, with 1/24th of the original number of shares vesting one month following the date of the grant and an additional 1/24th of the original number of shares vesting each month thereafter, subject to the employee's continued service with the Company through the applicable vesting dates.
About Michael V. Callahan, MD, DTM&H, MSPH
Dr. Michael Callahan will support PolarityTE by aligning the technology to better address mass-casualty burn and cutaneous chemical weapon injury and to ensure the PolarityTE technologies address the needs of the U.S. military medical systems. Dr. Callahan is a physician-scientist who is the President of United Therapeutics Corporation (UTHR) Division of Cellular Therapies. He is also a faculty member of the Division of Infectious Diseases and Director of Translational Medicine for the Vaccine and Immunotherapeutics Center (VIC) at Massachusetts General Hospital/Harvard Medical School.
Dr. Callahan's research focus is transformative therapies in regenerative medicine and in emerging infectious diseases. As of 2016 he has invented or co-developed three commercial anti-infectives, including amphotericin-encapsulated liposomes (1991; US patent 07689709) and brought four antimicrobials to clinic. From 2005-2012 he led the Defense Advanced Research Projects Agency (DARPA) $US 240M biodefense therapeutics program, which developed cPG (Pfizer), Vaxdesign's MIMIC (Sanofi Pasteur) and Nicotinia (tobacco)-expressed mAbs (e.g. generic rituxin, flavimab, ZMAP). Since 1998, Callahan has deployed over 600 days to 7 disaster outbreaks under Rescue Medicine's HASTY team 1, including Bhuj Gharat and Bam, Iran earthquakes, Typhoon Nargit, the 2004 Christmas tsunami, 2003 SARS and H5N1 outbreaks in China, five Ebola or Marburg outbreaks 3 countries. In 2012, he was recruited by Martine Rothblatt to serve as President of United Therapeutics' infectious disease subsidiary, Unither Virology, where he led translation of a novel anti-dengue therapeutic from pre-clinical lead to IND, Phase 1 and Orphan (ODA). Since 2016, Callahan has served as President of United Therapeutics Cellular Therapies where he directs an international bench to clinic program to advance regenerative and transgene cell therapy programs for chronic and acute indications.
Dr. Callahan continues federal service on past and current Institute of Medicine, President's Office of Science and Technology, National Security Council and Health and Human Services committees including the Department of Defense Joint Chiefs Ebola Task Force, the IOM Working Groups on Synthetic Biology, Gain of Function Research, Ebola and Zika, and Office of Management and Budgets Committees on Federal Research Investments. Callahan is the PI, co-PI and past PI of CDC, DARPA and Defense Threat Reduction Agency infectious disease research in tropical disease, and oversaw NIAID's $45M program to advance a dengue therapeutic to Phase 2. He is the recipient of the Klapper Award for Infectious Disease, the McCollough Award for Infectious Disease Research, the Robert Kennedy Award for National Public Health Service, the 2009 DARPA Achievement Award, the 2012 DARPA Director Award, and he is the 19th Tinsley Harrison Scholar of the University of Alabama School of Medicine.
About Cameron Hoyler, JD
Before joining PolarityTE, Mr. Hoyler was an attorney at King & Spalding LLP, an international law firm with 900 attorneys in 19 offices around the world, and whose recent accolades include Law360 naming the firm one of three "Firms of the Year" in 2016, and bestowing the Life Sciences and Product Liability groups in which Mr. Hoyler practiced with "Practice of the Year" honors. Mr. Hoyler has extensive experience representing and counseling clients involved in disputes and transactions in a variety of settings, including product liability, employment, commercial, trademark, real estate, and insurance coverage.
While at King & Spalding, Mr. Hoyler devoted the majority of his practice to representing clients in the pharmaceutical and medical device industries, including serving as counsel to Bristol-Myers Squibb Company, AstraZeneca Pharmaceuticals LP, McKesson Corporation, and others, and he has litigated numerous cases in the prescription drug and device context in state and federal courts across the country. In addition to his work for pharmaceutical and medical device manufacturers, Mr. Hoyler also represented clients in other highly-regulated industries, including Chevron U.S.A. Inc., Monsanto Company, Phillips 66 Company, and ConocoPhillips Company. While at King & Spalding, Mr. Hoyler was actively involved in multiple pro bono matters, including representing students expelled from public schools. He served as lead trial counsel in multiple expulsion cases, leading to the students' reinstatement in the school of their choice. For this work, Mr. Hoyler earned the King & Spalding Pro Bono Service Award in 2013 and 2015.
Mr. Hoyler earned his Bachelor of Arts from the University of Pennsylvania, where he majored in Political Science and English, and minored in History. He earned his Juris Doctor from the University of San Francisco School of Law, where he was the Articles Editor for the U.S.F. Journal of Law and Social Challenges, and was a member of the Judge John R. Brown Appellate Advocacy Team. He is licensed to practice law in the State of California, and is admitted before all federal courts in California and the Ninth Circuit Court of Appeals.
About PolarityTE™, Inc.
PolarityTE™, Inc. is the owner of a novel regenerative medicine and tissue engineering platform developed and patented by Denver Lough MD, PhD. This radical and proprietary technology employs a patient's own cells for the healing of full-thickness functionally-polarized tissues. If clinically successful, the PolarityTE™ platform will be able to provide medical professionals with a truly new paradigm in wound healing and reconstructive surgery by utilizing a patient's own tissue substrates for the regeneration of skin, bone, muscle, cartilage, fat, blood vessels and nerves. It is because PolarityTE™ uses a natural and biologically sound platform technology, which is readily adaptable to a wide spectrum of organ and tissue systems, that the company and its world-renowned clinical advisory board, are poised to drastically change the field and future of translational regenerative medicine. More information can be found online at www.polarityte.com.
Forward Looking Statements
Certain statements contained in this release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward looking statements contained in this release relate to, among other things, the Company's ongoing compliance with the requirements of The NASDAQ Stock Market and the Company's ability to maintain the closing bid price requirements of The NASDAQ Stock Market on a post reverse split basis. They are generally identified by words such as "believes," "may," "expects," "anticipates," "should'" and similar expressions. Readers should not place undue reliance on such forward-looking statements, which are based upon the Company's beliefs and assumptions as of the date of this release. The Company's actual results could differ materially due to risk factors and other items described in more detail in the "Risk Factors" section of the Company's Annual Reports and other filings with the SEC (copies of which may be obtained at www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. The Company specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.