8-K
PharmaCyte Biotech, Inc. (PMCB)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 8-K
Current Report
Pursuant to Section 13 or 15(d) of the SecuritiesExchange Act of 1934
Date of Report (Date of earliest event reported): March 31, 2022
PHARMACYTE
BIOTECH, INC.
(Exact Name of Registrant as Specified in its Charter)
| Nevada | 001-40699 | 62-1772151 |
|---|---|---|
| (State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |
| 3960 Howard Hughes Parkway, Suite 500 Las Vegas, Nevada | 89169 | |
| --- | --- | |
| (Address of Principal Executive Offices) | (Zip Code) |
Registrant's telephone number, including area code: (917) 595-2850
N/A
(Former name or former address, if changed since last report)
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:
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of exchange on which registered |
|---|---|---|
| Common Stock, Par Value $0.0001 Per Share | PMCB | The Nasdaq<br>Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this Chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 5.02 | Departureof Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. |
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On March 31, 2022, the Board of Directors (“Board”) of PharmaCyte Biotech, Inc., a Nevada corporation (“Company”), appointed Matthias Löhr, MD (“Dr. Löhr”) to the Board to fill a vacancy created by the recent death of Thomas C.K. Yuen. The Board has determined that Dr. Löhr is independent within the meaning of Rule 5605 of the Nasdaq Stock Market Rules.
In connection with the appointment of Dr. Löhr to the Board, the Company expects to enter into a letter agreement (“Director Agreement”) with Dr. Löhr pursuant to which the Company will pay Dr. Löhr $12,500 in cash for each calendar quarter of service on the Board and agree to issue him annually: (i) 334 fully-paid, non-assessable shares of the Company’s restricted common stock (“Shares”); and (ii) a five-year option to purchase 334 Shares at an exercise price equal to the fair market value of the Company’s Shares on the date of the grant. Each of these equity awards will be fully vested upon grant.
There are no family relationships between Dr. Löhr and other directors or executive officers of the Company. There are no related party transactions as of the date hereof between Dr. Löhr and the Company that would require disclosure under Item 404(a) of Regulation S-K. In connection with his appointment and election to the Board, the Company and Dr. Löhr will enter into the Company’s standard form of indemnification agreement.
Dr. Löhr will serve on the Board’s Compensation and Nominating Committees.
| Item 7.01 | Regulation FD Disclosure. |
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Attached hereto as Exhibit 99.1 is a copy of the Company’s press release dated April 5 , 2021, regarding the appointment of Dr. Löhr to the Board. The information furnished in this Item 7.01, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section.
| Item 9.01 | Financial Statements and Exhibits. |
|---|---|
| (d) | Exhibits. |
| --- | --- |
| Number | Description |
| --- | --- |
| 99.1 | The Company’s press release dated April 5, 2022 (furnished pursuant to Item 7.01). |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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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: April 5, 2022 | PHARMACYTE BIOTECH, INC. | |
|---|---|---|
| By: | /s/ Kenneth L. Waggoner<br><br> <br>Kenneth L. Waggoner<br><br> <br>Chief Executive Officer,<br><br> <br>President and General Counsel |
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Exhibit 99.1
PharmaCyte BiotechAppoints Dr. Matthias Löhr to Board of Directors
LAS VEGAS, NV, April 5, 2022 (BUSINESS WIRE) -- PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box^®^, announced today the appointment of Dr. Matthias Löhr to PharmaCyte’s Board of Directors.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, stated, “PharmaCyte is extremely pleased that Dr. Löhr has joined our Board of Directors. There is no one who could be more qualified. His life’s work and passion are specifically in the areas of the treatments that PharmaCyte is developing. He has held dozens of trusted leadership roles in learned societies, cancer research centers, universities, and governmental agencies. He knows all aspects of our technology and is experienced with it in a clinical setting. The entire PharmaCyte team looks forward to Dr. Löhr making our company even stronger as we move into a bright future with the Cell-in-a-Box technology^®^.”
Commenting on his appointment, Dr. Löhr said, “It is with great pleasure that I join PharmaCyte's Board of Directors. With the company being on the precipice of an FDA clinical trial in locally advanced, inoperable pancreatic cancer, I can think of no better opportunity for me to be involved with PharmaCyte’s future successes. PharmaCyte's pipeline of developing treatments for cancer and diabetes directly addresses the hard-to-treat diseases that I have been so passionately involved in over my career. It is my belief that there is real hope on the horizon for those patients suffering from these tragic diseases, and I am honored to be a part of it all."
Dr. Matthias Löhr is Professor of Gastroenterology and Hepatology at the famed Karolinska Institute in Stockholm, Sweden, and leads the Pancreatic Team at Karolinska University Hospital. He has served as Professor of Molecular Gastroenterology at the University of Heidelberg with a same-named Unit at the German Cancer Research Center in Heidelberg, Germany. He has worked as a translational scientist and Principal Investigator in clinical studies in gastrointestinal oncology for many years. In addition to being highly published, he has extensive scientific and grant review experience, and he has received multiple awards and distinctions.
Dr. Löhr is a licensed physician and board-certified internist and gastroenterologist. He has a subspeciality in GI Oncology. He is also a Fellow of the European Board of Gastroenterology (FEBG) and a Fellow of the American Gastroenterology Association (AGAF).
Dr. Löhr served as the Principal Investigator for the Phase 1/2 and Phase 2 clinical trials of PharmaCyte’s pancreatic cancer treatment that were completed in the early 2000s. Not only is he familiar with the Cell-in-a-Box^®^ live-cell encapsulation technology that forms the core of PharmaCyte’s pancreatic cancer treatment, but he has also administered PharmaCyte’s treatment (the combination of Cell-in-a-Box^®^ capsules with low doses of the anticancer drug ifosfamide) in clinical trials in patients with advanced, inoperable pancreatic cancer.
Dr. Löhr has also served as a consultant to PharmaCyte in connection with its development of treatments for pancreatic cancer and diabetes using the Cell-in-a-Box^®^ technology. He has expertise in the treatment of both diseases, in addition to thoroughly understanding PharmaCyte’s technology and its use in a clinical setting.
In 2000, Dr. Löhr was appointed Professor of Molecular Gastroenterology at the University of Heidelberg and became Head of the same-named Division at the German Cancer Research Center, which he led until 2010. In 2007, he was appointed full professor of Gastroenterology and Hepatology at Karolinska Institute. In 2017, he received the Golden Link Award from the United European Gastroenterology (UEG) to conduct the first evidence-based European guidelines for chronic pancreatitis and was in charge of the UEG guidelines for IgG4-related diseases.
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Dr. Löhr has authored more than 340 original peer-reviewed scientific papers and more than 50 reviews. He has published in all major journals, including Nature, The Lancet, Gastroenterology, and GUT. In addition, he has delivered more than 300 invited lectures at international congresses. He is the author of six books and 40 book chapters. Dr. Löhr has been granted six patents (in Germany and internationally). He is an Editorial Board Member of the Journal of Clinical Medicine, Pancreatology, Scientific Reports, and the World Journal of Gastroenterology.
Dr. Löhr holds a BA in Anthropology & Theology from the University of Kiel in Kiel, Germany, and MD and PhD degrees from the Universities of Hamburg and Rostock. Following receipt of his medical degree, he served a residency in pathology in Hamburg, Germany, and residencies in internal medicine and gastroenterology in Erlangen and Rostock, Germany, where he became chief resident and later attending physician and assistant professor at the University of Rostock. Dr. Löhr has also completed a postdoctoral fellowship at the Scripps Clinic & Research Foundation in La Jolla, California.
About PharmaCyte Biotech
PharmaCyte Biotech, Inc. is a biotechnology company developing cellular therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box^®^.” This technology is being used as a platform upon which therapies for several types of cancer and diabetes are being developed.
PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. For pancreatic cancer, these encapsulated cells are implanted in the blood supply to the patient’s tumor as close as possible to the site of the tumor. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide flows through pores in the capsules, the live cells inside function as a “bio-artificial liver” and activate the chemotherapy drug at the site of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and we believe results in little to no treatment related side effects.
PharmaCyte’s therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes involves encapsulating a human cell line that has been genetically engineered to produce and release insulin in response to the levels of blood sugar in the human body. The encapsulation of the cell line will be done using the Cell-in-a-Box^®^ technology. Once the encapsulated cells are implanted in a diabetic patient, we anticipate that they will function as a “bio-artificial pancreas” for purposes of insulin production.
Safe Harbor
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that express the current beliefs and expectations of the management of PharmaCyte. Any statements contained herein that do not describe historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results, performance, and achievements to differ materially from those discussed in such forward-looking statements. Factors that could affect our actual results include our ability to raise the necessary capital to fund our operations and to find partners to supplement our capabilities and resources, our ability to satisfactorily address the issues raised by the FDA in order to have the clinical hold on our IND removed, as well as such other factors that are included in the periodic reports on Form 10-K and Form 10-Q that we file with the U.S. Securities and Exchange Commission. These forward- looking statements are made only as of the date hereof, and we undertake no obligation to update or revise the forward-looking statements, except as otherwise required by law, whether as a result of new information, future events or otherwise.
More information about PharmaCyte Biotech can be found at www.PharmaCyte.com. Information may also be obtained by contacting PharmaCyte’s Investor Relations Department.
Contact:
Investor Relations:
Dr. Gerald W. Crabtree
PharmaCyte Biotech, Inc.
Telephone: 917.595.2856
Email: InvestorRelations@PharmaCyte.com
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