NASDAQ: PMCB
PharmaCyte Biotech, Inc.CIK 0001157075 · Health Care · SIC 2836 · Biological Products
We are a biotechnology company focused on developing cellular therapies for cancer based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” The Cell-in-a-Box® technology is intended to be used as a platform upon which therapies for several types of… About this business →
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Latest financial statements
From 10-K filed Jul 29, 2026 (period ending Apr 30, 2026). SEC XBRL (companyfacts) — not generated by the model.
Consolidated Statements of Operations
| Description | Year ended Apr 30, 2026 | Year ended Apr 30, 2025 | Year ended Apr 30, 2024 |
|---|---|---|---|
| Revenue: | |||
| Total revenue / net sales | — | — | — |
| Operating expenses: | |||
| Research and development | 0.4 | 0.4 | 0.4 |
| General and administrative | 4.9 | 3.9 | 6.1 |
| Total operating expenses | 6.9 | 4.4 | 8.5 |
| Operating income | (6.9) | (4.4) | (8.5) |
| Other income/(expense), net | (12.6) | 35.0 | 8.9 |
| Income tax expense/(benefit) | — | — | — |
| Net income | (19.4) | 30.7 | 0.3 |
| Basic earnings per share | (2.77) | 3.19 | (1.80) |
| Diluted earnings per share | (2.77) | 3.19 | (1.80) |
Consolidated Balance Sheets
| Description | Apr 30, 2026 | Apr 30, 2025 |
|---|---|---|
| Current assets: | ||
| Cash and equivalents | 18.6 | 15.2 |
| Short-term investments | 0.3 | 0.4 |
| Prepaid expenses and other current assets | 0.10 | 0.2 |
| Other current assets | 18.5 | 6.6 |
| Total current assets | 37.4 | 22.4 |
| Identifiable intangible assets, net | — | 1.5 |
| Deferred income taxes and other assets | 0.01 | 0.01 |
| Other long-term assets | 9.3 | 31.2 |
| TOTAL ASSETS | 46.8 | 55.2 |
| Current liabilities: | ||
| Accounts payable | 0.3 | 0.4 |
| Accrued liabilities | 0.5 | 2.5 |
| Other current liabilities | 0.03 | — |
| Total current liabilities | 0.8 | 2.9 |
| Other long-term liabilities | 10.9 | 0.4 |
| Total liabilities | 11.8 | 3.3 |
| Shareholders' equity: | ||
| Common stock | — | — |
| Capital in excess of stated value | 182.7 | 181.5 |
| Accumulated other comprehensive income (loss) | (0.02) | (0.02) |
| Retained earnings (deficit) | (104.4) | (85.0) |
| Treasury stock | 45.0 | 44.6 |
| Total shareholders' equity | 33.3 | 51.9 |
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | 46.8 | 55.2 |
Consolidated Statements of Cash Flows
| Description | Year ended Apr 30, 2026 | Year ended Apr 30, 2025 |
|---|---|---|
| Operating Activities: | ||
| Net cash from operating activities | (5.2) | (3.0) |
| Investing Activities: | ||
| Net cash from investing activities | 2.0 | (7.0) |
| Financing Activities: | ||
| Net cash from financing activities | 6.6 | (25.0) |
| Net increase/(decrease) in cash | 3.4 | (35.0) |
Amounts in millions USD; EPS as reported. Line labels are presentation-friendly mappings of filer XBRL tags — not a re-audit of the full statements. Use EDGAR for interactive notes and detail. Interactive statements & notes on EDGAR ↗
About PharmaCyte Biotech, Inc.
Source: Item 1 (Business) from the 10-K filed July 29, 2026. Description as filed by the company with the SEC.
ITEM 1. BUSINESS
We are a biotechnology company focused on developing
cellular therapies for cancer based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.”
The Cell-in-a-Box® technology is intended to be used as a platform upon which therapies for several types of cancer, including LAPC,
will be developed. The current generation of our product candidate is referred to as “CypCaps™.”
On November 17, 2023, the Board formed the Strategic
Scientific Committee (the “Scientific Committee”), chaired by Dr. Michael Abecassis. The Scientific Committee and our independent
consultants are reviewing many of the risks relative to our business. In addition, the Board is reviewing risks associated with our development
programs and our relationship with SG Austria Pte. Ltd. (“SG Austria”), including that all licensed patents have expired and
that know-how relating to our Cell-in-a-Box® technology solely resides with SG Austria. The Board has reduced spending on our programs,
including pre-clinical and clinical activities, until the review by the Scientific Committee and the Board is complete and the Board has
determined the actions and plans to be implemented. The Scientific Committee’s recommendations will include potentially seeking
a new framework for our relationship with SG Austria and its subsidiaries. We are reevaluating those programs which are dependent on SG
Austria and the U.S. Food and Drug Administration’s (the “FDA”) acceptance of its technologies, including our development
programs for locally advanced, inoperable, non-metastatic pancreatic cancer (“LAPC”). Our reevaluation for addressing the
FDA concerns has resulted in delays stemming from the review of the nonclinical package provided by SG Austria and changes to the FDA
review process.
Read full description ↓
The Cell-in-a-Box® encapsulation technology is
designed to present genetically engineered live human cells to targeted tissues. The technology is intended to result in the formation
of pinhead-sized cellulose-based porous capsules in which genetically modified live human cells can be encapsulated, grown to confluence
and maintained in a cryopreserved (frozen) state until shortly before they are injected into an appropriate patient. In a laboratory setting,
this proprietary live cell encapsulation technology has been shown to create a micro-environment in which encapsulated cells survive and
flourish. Encapsulated cells are protected from environmental challenges, such as the shear forces associated with bioreactors and passage
through catheters and needles, which we believe enables greater cell growth and production of the active molecules. The capsules are largely
composed of cellulose (cotton) and are bioinert. During the past year, SG Austria has generated data and reports to support submission
to the FDA concerning the safety of the microcapsules.
We have been developing therapies for pancreatic tumors
by using genetically engineered live human cells that we believe may be capable of converting a cancer prodrug into its cancer-killing
form. We encapsulate those cells using the Cell-in-a-Box® technology and place those capsules in the body as close as possible to
the tumor. In this way, we believe that when a cancer prodrug is administered to a patient with a particular type of cancer that may be
affected by the resulting active drug, the killing or shrinking the patient’s cancerous tumor may be optimized both by enhanced
potency and limited exposure away from the target tumor. We believe that the prodrug/activator technology is well suited to address the
shift from cure/enhanced survival to creating a zone of clearance around blood vessels adjacent to tumor. This zone of clearance improves
the probability of successful surgical resection of LAPC, which has been shown to improve survival.
In addition to reengaging SG Austria, we are also
identifying alternative approaches to expand the prodrug/activator technology for cancer treatment. These discussions may expand our prodrug/activation
options to use highly toxic cancer-killing drugs in tightly controlled perivascular spaces.
Until the Scientific Committee
completes its evaluation of our programs and we enter into a new framework for our relationship with SG Austria, spending on our
development programs has been curtailed.
1
Investigational New Drug Application and Clinical
Hold
On September 1, 2020, we submitted an IND to the FDA
for a planned clinical trial in LAPC. On October 1, 2020, we received notice from the FDA that it had placed our IND on clinical hold.
On October 30, 2020, the FDA sent us a letter setting forth the reasons for the clinical hold and providing specific guidance on what
we must do to have the clinical hold lifted.
In order to address the clinical hold, the FDA has
requested that we:
·
Provide additional sequencing data and genetic stability studies;
·
Conduct a stability study on our final formulated product candidate as well as the cells from our Master Cell Bank (“MCB”);
·
Evaluate the compatibility of the delivery devices (the prefilled syringe and the microcatheter used to implant the CypCaps™) with our product candidate for pancreatic cancer;
·
Provide additional detailed description of the manufacturing process of our product candidate for pancreatic cancer;
·
Provide additional product release specifications for our encapsulated cells;
·
Demonstrate comparability between the 1st and 2nd generation of our product candidate for pancreatic cancer and ensure adequate and consistent product performance and safety between the two generations;
·
Conduct a biocompatibility assessment using the capsules material;
·
Address specified insufficiencies in the Chemistry, Manufacturing and Controls information in the cross-referenced Drug Master File;
·
Conduct an additional nonclinical study in animals to assess the safety, activity, and distribution of the product candidate for pancreatic cancer; and
·
Revise the Investigators Brochure to include any additional preclinical studies conducted in response to the clinical hold and remove any statements not supported by the data we generated.
The FDA also requested that we address the following
issues as an amendment to our IND:
·
Provide a Certificate of Analysis for pc3/2B1 plasmid that includes tests for assessing purity, safety, and potency;
·
Perform qualification studies for the drug substance filling step to ensure that the product candidate for pancreatic cancer remains sterile and stable during the filling process;
·
Submit an updated batch analysis for the product candidate for the specific lot that will be used for manufacturing all future product candidates;
·
Provide additional details for the methodology for the Resorufin (CYP2B1) potency and the PrestoBlue cell metabolic assays;
·
Provide a few examples of common microcatheters that fit the specifications in our Angiography Procedure Manual;
·
Clarify the language in our Pharmacy Manual regarding proper use of the syringe fill with the product candidate for pancreatic cancer; and
·
Provide a discussion with data for trial of the potential for cellular and humoral immune reactivity against the heterologous rat CYP2B1 protein and potential for induction of autoimmune-mediated toxicities in our study population.
We assembled a scientific and regulatory team to address
the FDA requests. That team has been working diligently to complete the items requested by the FDA.
2
The following provides a detailed summary of our activities
to have the clinical hold lifted:
·
Stability Studies on Our Clinical Trial Product Candidate for Pancreatic Cancer. We have successfully completed the required product stability studies. The timepoints were 3, 6, 9, 12, 18 and 24 months of our product candidate for pancreatic cancer being stored frozen at -80C. These studies included container closure integrity testing for certain timepoints.
·
Additional Studies Requested by the FDA. We have successfully completed various additional studies requested by the FDA, including a stability study on the cells from our MCB used to make our CypCaps™.
·
Determination of the Exact Sequence of the Cytochrome P450 2B1 Gene. We have completed the determination of the exact sequence of the cytochrome P450 2B1 gene inserted at the site previously identified on chromosome 9 using state-of-the-art nanopore sequencing. This is a scalable technology that permits real-time analysis of long DNA fragments. The result of this analysis of the sequence data confirmed that the genes are intact.
·
Confirmation of the Exact Sequence of the Cytochrome P450 2B1 Gene Insert. An additional, more detailed analysis of the integration site of the cytochrome P450 2B1 gene from the augmented HEK293 cell clone that is used in our CypCaps™ was found to be intact. In this new study, we were able to confirm the previously determined structure of the integrated transgene sequence using more data points. These studies also set the stage for a next step analysis to determine the genetic stability of the cytochrome P450 2B1 gene at the DNA level after multiple rounds of cell growth. This new study has been completed in which our original Research Cell Bank (“RCB”) cells were compared with cells from the MCB. The analysis confirmed that the cytochrome P450 2B1 and the surrounding sequence has remained stable with no changes detected at the DNA level.
·
Biocompatibility Studies. We have been involved with 10 biocompatibility studies requested by the FDA, eight of which have been completed successfully. To enable the biocompatibility studies to be performed, we had Austrianova Singapore Pte. Ltd. (“Austrianova”) manufacture an additional 400 syringes of empty capsules.
·
Systemic Toxicity Testing. We evaluated the potential toxicity of the capsule component of our product candidate for pancreatic cancer and determined there is no evidence of toxicity in any of the parameters examined. The study also confirmed previous data that shows our capsule material is bioinert.
·
Micro-Compression and Swelling Testing. This testing is underway. We are developing and optimizing two reproducible methods for testing and confirming the physical stability and integrity of our CypCaps™ under extreme pressure. These studies required the acquisition of new equipment by Austrianova as well as validation and integration into Austrianova’s Quality Control laboratory.
·
Break Force and Glide Testing. We are in the process of developing a protocol to measure whether the syringe, attached to the catheter when used to expel the capsules, will still have a break and glide force that is within the specifications we have established. We are setting the specifications based on the syringe/plunger manufacturer’s measured break and glide forces, or alternatively, accepted ranges for glide forces routinely used in the clinic.
·
Capsules Compatibility with the Syringe and Other Components of the Microcatheter Delivery System. We are in the process of showing that CypCaps™ are not in any way adversely affected by the catheters used by interventional radiologists to deliver them into a patient. Compatibility data is being generated to demonstrate that the quality of the CypCaps™ is maintained after passage through the planned microcatheter systems.
·
CypCaps™ Capsules and Cell Viability after Exposure to Contrast Medium. We have commenced testing to show that exposure of CypCaps™ to the contrast medium interventional radiologists used to implant the CypCaps™ in a patient has no adverse effect on CypCaps™. Contrast medium is used to visualize the blood vessels during implantation.
·
Master Drug File Information. Austrianova is providing additional detailed confidential information on the manufacturing process, including information on the improvements and advancements made to our product candidate for pancreatic cancer since the last clinical trials were conducted with respect to reproducibility and safety. However, Austrianova has not changed the overall physical characteristics of CypCaps™ between the 1st and 2nd generations.
·
Submission of Data to FDA. We are in the process of providing these data to the FDA. The clinical hold did not reflect any deficiencies of the clinical trial proposed. We seek to resolve these nonclinical issues to enable FDA review of a new clinical protocol that reflects the standard of care for LAPC.
3
We assembled a scientific and regulatory team of experts
to address the FDA requests. During the year ended April 30, 2026, our scientific consultants have been in active dialog with the FDA.
The technology upon which the LAPC treatment will be based, intra-arterial chemotherapy The treatment may not be a treatment of pancreatic
cancer, but a method of improving and possibly enabling complete surgical resection of the tumor. We are waiting for the FDA’s responses
and hope the FDA will accept that the LAPC treatment now meets manufacturing standard requirements, which have significantly improved
since the clinical hold was first placed. The FDA may require additional preclinical studies when the meeting takes place. We are in ongoing
dialogue with SG Austria to prepare for the next steps including encapsulation of the cells, testing the glide force and pressure testing
of pushing the cells through syringes and catheters.
History of the Business
In 2013, we restructured our operations to focus on
biotechnology. On January 6, 2015, we changed our name from “Nuvilex, Inc.” to “PharmaCyte Biotech, Inc.” to reflect
the nature of our business.
We are a biotechnology company focused on developing
and preparing to commercialize cellular therapies for cancer using our live cell encapsulation technology. This resulted from entering
into the following agreements.
Commencing in May 2011, we entered into a series of
agreements and amendments with SG Austria Pte. Ltd. (“SG Austria”) to acquire certain assets from SG Austria as well as an
exclusive, worldwide license to use, with a right to sublicense, the Cell-in-a-Box® technology and trademark for the development
of therapies for cancer (“SG Austria APA”).
In June 2013, we and SG Austria entered a Third Addendum
to the SG Austria APA (“Third Addendum”). The Third Addendum materially changed the transaction contemplated by the SG Austria
APA. Under the Third Addendum, we acquired 100% of the equity interests in Bio Blue Bird and received a 14.5% equity interest in SG Austria.
We paid: (i) $500,000 to retire all outstanding debt of Bio Blue Bird; and (ii) $1.0 million to SG Austria. We also paid SG Austria $1,572,193
in exchange for a 14.5% equity interest of SG Austria. The transaction required SG Austria to return to us the 66,667 shares of our common
stock held by SG Austria and for us to return to SG Austria the 67 shares of common stock of Austrianova we held.
Effective as of the same date we entered the Third
Addendum, we and SG Austria also entered a Clarification Agreement to the Third Addendum (“Clarification Agreement”) to clarify
and include certain language that was inadvertently left out of the Third Addendum. Among other things, the Clarification Agreement confirmed
that the Third Addendum granted us an exclusive, worldwide license to use, with a right to sublicense, the Cell-in-a-Box® technology
and trademark for the development of therapies for cancer.
With respect to Bio Blue Bird, Bavarian Nordic A/S
(“Bavarian Nordic”) and GSF-Forschungszentrum für Umwelt u. Gesundheit GmbH (collectively, “Bavarian Nordic/GSF”)
and Bio Blue Bird entered into a non-exclusive License Agreement (“Bavarian Nordic/GSF License Agreement”) in July 2005, whereby
Bio Blue Bird was granted a non-exclusive license to further develop, make, have made (including services under contract for Bio Blue
Bird or a sub-licensee, by Contract Manufacturing Organizations, Contract Research Organizations, Consultants, Logistics Companies or
others), obtain marketing approval, sell and offer for sale the clinical data generated from the pancreatic cancer clinical trials that
used the cells and capsules developed by Bavarian Nordic/GSF (then known as “CapCells™”) or otherwise use the licensed
patent rights related thereto in the countries in which patents had been granted. Bio Blue Bird was required to pay Bavarian Nordic a
royalty of 3% of the net sales value of each licensed product sold by Bio Blue Bird and/or its Affiliates and/or its sub-licensees to
a buyer. The term of the Bavarian Nordic/GSF License Agreement continued on a country-by-country basis until the expiration of the last
valid claim of the licensed patent rights.
Bavarian Nordic/GSF and Bio Blue Bird amended the
Bavarian Nordic/GSF License Agreement in December 2006 (“First Amendment to Bavarian Nordic/GSF License Agreement”) to reflect
that: (i) the license granted was exclusive; (ii) a royalty rate increased from 3% to 4.5%; (iii) Bio Blue Bird assumed the patent prosecution
expenses for the existing patents; and (iv) to make clear that the license will survive as a license granted by one of the licensors if
the other licensor rejects performance under the Bavarian Nordic/GSF License Agreement due to any actions or declarations of insolvency.
4
In October 2016, Bavarian Nordic/GSF and Bio Blue
Bird further amended the Bavarian Nordic/GSF License Agreement (“Second Amendment to Bavarian Nordic/GSF License Agreement”)
in order to: (i) include the right to import in the scope of the license; (ii) reflect ownership and notification of improvements; (iii)
clarify which provisions survive expiration or termination of the Bavarian Nordic/GSF License Agreement; (iv) provide rights to Bio Blue
Bird to the clinical data after the expiration of the licensed patent rights; and (v) change the notice address and recipients of Bio
Blue Bird.
Market Opportunity and Competitive Landscape
We are developing live cell encapsulation-based therapies
for cancer.
The Cell-in-a-Box® capsules are
comprised of cotton’s natural component – cellulose. Other materials used by competitors include alginate, collagen, chitosan,
gelatin and agarose. Alginate appears to be the most widely used of these. We believe the inherent strength and durability of our cellulose-based
capsules provides us with advantages over the competition. They do so with no evidence of rupture, damage, degradation, fibrous overgrowth
or immune system response. The cells within the capsules also remained alive and functioning during these studies. Other encapsulating
materials degrade in the human body over time, leaving the encapsulated cells open to immune system attack. Damage to surrounding tissues
has also been reported to occur over time when other types of encapsulation materials begin to degrade.
The cells encapsulated using the Cell-in-a-Box® technology
can be frozen for extended periods of time. When thawed, the cells are recovered with approximately 85% viability. The implications of
this property of the Cell-in-a-Box® technology are obvious – long-term storage of encapsulated cells and shipment
of encapsulated cells over long distances.
We believe our live cell encapsulation technology
may have new opportunities for us in numerous and developing ways. For example:
·
Cancerous diseases may be treated by placing encapsulated drug-converting cells that convert a chemotherapy prodrug near the cancerous tumor;
·
Confinement and maintenance of therapeutic cells that activate a chemotherapy prodrug may be placed at the site of implantation in a blood vessel near the cancerous tumor results in “targeted chemotherapy”;
·
Increased efficacy of a chemotherapy prodrug may allow for lower doses of the prodrug to be given to a patient, significantly reducing or even eliminating side effects from the chemotherapy;
·
Multi-layered trade secret protection and marketing exclusivity for our technology exists and is being expanded;
·
Cell-in-a-Box® capsules can prevent immune system attack of functional cells inside them without the need for immunosuppressive drug therapy; and
·
Promising data with the Cell-in-a-Box® technology and the cells used with our technology from animal and initial human clinical trials.
Pancreatic cancer is increasing in most industrialized
countries. The American Cancer Society estimated that in 2025 there were 67,000 people in the U.S. diagnosed with pancreatic cancer. It
also estimated 52,000 patients with pancreatic cancer died in 2025. Pancreatic cancer accounts for about 3% of all cancers in the U.S.
and about 7% of all cancer deaths.
Our goal is to meet the medical need for patients
with LAPC whose tumors no longer respond after 4-6 months of treatment with the chemotherapy combination of Abraxane® plus
gemcitabine or the four-drug combination known as FOLFIRINOX. For these patients, there are currently only limited therapy options. We
believe there will be no therapy comparable to our Cell-in-a-Box® plus low dose of ifosfamide combination therapy
when it is used in these patients.
5
We face intense competition in the field of treating
pancreatic cancer. There are dozens of startups, smaller biotech companies, big pharma, and several academic institutions and cancer centers
all trying to improve the outcome for pancreatic cancer patients. There are several drugs already available and in the pipelines of pharmaceutical
companies worldwide, not the least of which is the combination of the drugs of Abraxane® and gemcitabine. This is
the primary FDA-approved combination of drugs for treating advanced pancreatic cancer. In Europe and in the U.S., the 4-drug combination
FOLFIRINOX has also found use as a first-line treatment for advanced pancreatic cancer. Some of our competitive strengths include the
Orphan Drug Designation we have been granted by the FDA and the European Medicines Agency for our pancreatic cancer therapy. Yet many
of our competitors have substantially greater financial and marketing resources than we do. They also have stronger name recognition,
better brand loyalty and long-standing relationships with customers and suppliers. Our future success will be dependent upon our ability
to compete.
Material Agreements
Fourth Addendum to the SG Austria APA
In May 2018, we and SG Austria entered the Fourth
Addendum to the Asset Purchase Agreement. The Fourth Addendum required us to make the following payment. The payment was timely made in
full under the payment deadlines set forth in the Fourth Addendum:
·
$900,000 to SG Austria.
The Fourth Addendum also requires us to make future
royalty payments as follows:
·
Four percent royalty on all gross sales received by us or our affiliates;
·
Twenty percent royalty on gross revenues received by us or our affiliates from a sublicense or right to use the patents or the licenses granted by us or our affiliates;
·
Fifty percent of any other financial and non-financial consideration received from sublicensees of the Cell-in-a-Box® technology; and
·
The removal of all milestone payments.
Sources and Availability of Raw Materials
The entire encapsulation process relating to the encapsulation
of the cells for the oncology is to be carried out by Austrianova. Austrianova is the sole source of our product candidates. Austrianova
is responsible for acquiring all of the necessary raw materials used in this process, including the cellulose sulfate necessary for encapsulating
the live cells, a process proprietary to Austrianova. Austrianova from time to time has experienced significant supply chain delays, and
we believe Austrianova may also be experiencing liquidity issues as well. If Austrianova is unwilling or unable to perform such manufacturing
for us, we may not be able to locate a replacement manufacturer for our product candidates.
Intellectual Property and Trade Secrets
Intellectual property and patent protection are of
paramount importance to our business, as are the trade secrets and other strategies we have employed with Austrianova to protect the proprietary
Cell-in-a-Box® technology. Although we believe we take reasonable measures to protect our intellectual property and trade secrets
and those of Austrianova, we cannot guarantee we will be able to protect and enforce our IP or obtain patent protection for our product
candidates as needed. We license technology and trademarks relating to two areas: (i) live cell encapsulation with cells that express
cytochrome P450 where the capsule is permeable to prodrug molecules and the cells are retained within the capsules and (ii) treatment
of solid cancerous tumors.
6
Litigation may be required to protect our product
candidates, intellectual property rights or to determine the validity and scope of the proprietary rights of others. Establishment, maintenance
and enforcement of our intellectual property utilizes financial and operational resources. In addition, the possibility exists that our
intellectual property could be discovered to be owned by others, be invalid or be unenforceable – potentially bringing unforeseen
challenges to us.
Human Capital
As of April 30, 2026, we had two full-time employees
and several consultants who devote substantial time to us. The consultants are physicians, scientists, regulatory experts, clinical operation
experts and cGMP experts. All of our research and development (“R&D”) work is handled by our consultants.
Our Corporate Information
We are a Nevada corporation incorporated in 1996.
In 2013, we restructured our operations to focus on biotechnology. The restructuring resulted in us focusing our efforts to develop a
novel, effective and safe way to treat cancer. In January 2015, we changed our name from Nuvilex, Inc. to PharmaCyte Biotech, Inc. to
reflect the nature of our current business.
Our corporate headquarters are located at 3960 Howard
Hughes Parkway, Suite 500, Las Vegas, Nevada 89169. Our telephone number is (917) 595-2850. We maintain a website at www.pharmacyte.com
to which we post copies of our press releases as well as additional information about us. Our filings with the Commission are available
free of charge through our website as soon as reasonably practicable after being electronically filed with or furnished to the Commission.
Information contained in our website is not a part of, nor incorporated by reference into, this Report or our other filings with the Commission,
and should not be relied upon.
Government Regulation and Product Approval
As a development-stage biotechnology company that
operates in the U.S., we are subject to extensive regulation by the FDA and other federal, state, and local regulatory agencies. The federal
Food, Drug, and Cosmetic Act (“FDCA”) and its implementing regulations set forth, among other things, requirements for the
research, testing, development, manufacture, quality control, safety, effectiveness, approval, labeling, storage, record keeping, reporting,
distribution, import, export, advertising, promotion, marketing and sale of our product candidates. Although the discussion below focuses
on regulation in the U.S., we anticipate seeking approval for, and marketing of, our product candidates in other countries. Our activities
in other countries will also be the subject of extensive regulation, although there can be important differences with the U.S. The process
of obtaining regulatory marketing approvals and the subsequent compliance with applicable federal, state, local and foreign statutes and
regulations will require the expenditure of substantial time and financial resources and may not be successful.
Regulatory approval, when obtained, may be limited
in scope which may significantly limit the uses for which a product may be placed in the market. Further, approved drugs or biologic products,
as well as their manufacturers, are subject to ongoing post-marketing review, inspection and discovery of previously unknown issues regarding
the safety and efficacy of such products or the manufacturing or quality control procedures used in their production. These may result
in restrictions on their manufacture, sale or use or in their withdrawal from the market. Any failure or delay by us, our suppliers of
manufactured drug product, collaborators or licensees in obtaining regulatory approvals could adversely affect the marketing of our product
candidates and our ability to receive product revenue, license revenue or profit-sharing payments. For more information, see