APPENDIX "C" COMPANY DEVELOPMENT PIPELINE

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1 Horse Horse APPENDIX "C" COMPANY DEVELOPMENT PIPELINE Animal Cancer Vaccines AUTOLOGOUS Preclinical Approval ALLOGENEIC Preclinical Approval DIRECT INJECTION Preclinical Approval Horse Q Human Cancer Vaccines AUTOLOGOUS Neuroblastoma Non-Hodgkin Lymphoma 2017 Leukemia ALLOGENEIC Urinary Bladder Kidney & Renal Pelvis DIRECT INJECTION Melanoma 2017 Pancreatic 2017 Breast 2018 Colon & Rectum Liver & bile duct Lung & bronchus Thyroid Monoclonal Antibodies Growth Factors Stem Cell Banks Stem Cells Cell Separation Polymer Microspheres Pre-packed columns PACS Infectious diseases Drug Development Page 1

2 Cancer Other Technology Development 1. Cancer (Vaccines) Humans (All Cancer Types) Animals (All Cancer Types) (s, s, Horses) Autologous Personalized Vaccines 2. Pre-clinical trial with mice 1 Complete 3. Canine Non-Hodgkin B-cell lymphoma trial 2 Complete 4. Human non-hodgkin B-cell lymphoma trial 3 Near Start Direct DNA Injection 2. Horse field study 5 Complete 3. Preliminary mouse melanoma pre-clinical trialcomplete 4. Pre-clinical mouse melanoma trials 6 Initiated Allogeneic Vaccines 2. Vaccine development In Development 3. Pre-clinical case study 4 Complete 2. Stem Cell Technologies Stem Cell Growth Acceleration Tissue/Organ Transplant Enhancement 3. Cell Separation Device Cancer Diagnosis for Early Treatment Stem Cell Retrieval 1. Patents Issued and in Process 2. Commercial prototype In Development 4. Drug Development Cancer Microbial Diseases 1. Patents Issued 2. Products In Development 1 Pre-clinical Mouse Neuroblastoma Study 2 Canine B Cell Lymphoma Clinical Trial 3 Phase Ib Human non-hodgkin B Cell Lymphoma Trial 4 Compassionate Care Patient: Transitional Cell Carcinoma 5 Equine Melanoma Field Study 6 Pre-clinical Mouse Melanoma Model Study Page 2

3 ImmuneFx Cancer Vaccine Development Study 1: Pre-clinical Mouse Neuroblastoma Study A pre-clinical mouse neuroblastoma study was funded by the Pediatric Cancer Society and performed at St. Joseph s Children s Hospital. The study included the introduction of highly aggressive neuroblastoma cancer cells into mice of the same cell type. Neuroblastoma is a cancer predominately found in children. The purpose of the study was to determine the safety, effectiveness and dosage effects of our ImmuneFx derived vaccine. The vaccine was prepared using the same cells that were injected to form the tumors in the mice. A total of 259 mice were included in three important studies. The process was not toxic and did not induce adverse side effects in the mice. Analyses did not detect the bacterial gene in any tissues/organs. The combined data demonstrated that this process: 1) prevented tumor formation in 100% of mice treated, 2) prophylactically increased the overall survival rate of mice challenged with tumor to 81%, and 3) mice treated therapeutically, saw 88% long term survival at the highest dose and dosage. Syngeneic A/J neuroblastoma model: Highly aggressive N = 259 (3 studies) Strong humoral and cell-mediated responses ( first and second attack ) Prevented tumor formation in 100% of mice Increased survival in challenged mice by 81% Increased long-term survival by 88% Highly specific and effective Dose-dependent therapeutic effect No bio-distribution of bacterial gene 0% Adverse effects 0% Serious adverse effects Study 2: Canine B Cell Lymphoma Clinical Trial We are also conducted a controlled clinical veterinary Phase I/II-type study in dogs with naturally occurring (vs. induced) B cell lymphoma. Our autologous (personalized) vaccine (IFx-CL) was produced for each patient. The purpose of this study was to confirm the safety, tolerability and effectiveness of ImmuneFx as seen in the previous mouse studies in order to further support the human non-hodgkin lymphoma study and strengthen the marketing efforts by VOS of ImmuneFx in the veterinary market. s of all breeds recently diagnosed with lymphoma who met certain eligibility criteria were able to join these studies. Autologous IFx-CL cancer vaccine produced and administered: Indication: Spontaneous multicentric B cell lymphoma Multi-site study N = 26 dogs of multiple breeds Enhanced survival: Baseline: historical untreated dog survival rate = 7-59 days IFx-CL treatment alone (N = 13) median ongoing survival = 104 days IFx-CL + chemotherapy (N = 13) median ongoing survival = 208 days Strong humoral and cell-mediated responses Reduced chemotherapy side-effects and improved quality of life 0% Adverse effects 0% Serious adverse effects Page 3

4 Study 3: Phase Ib Human non-hodgkin B cell Lymphoma Clinical Trial The commencement of human clinical trials is a major phase in the development of ImmuneFx. The purpose of our first, nonrandomized, open label, Phase I, human study will be to assess the safety and tolerability of ImmuneFx in humans and to evaluate the immune response in patients with multiple sub-types of indolent non-hodgkin lymphoma. The therapeutic vaccine will consist of lymph node cells derived from the patient and modified to express our patented emm55 DNA and will be the sole treatment in patients with the disease, i.e. no chemotherapy or radiation therapy will be used. This is a superior approach and a unique opportunity as we will know that improved patient outcome will be attributed solely to our treatment/technology. We designed ImmuneFx to treat all types of cancers but decided that our first human trial would include twenty patients with a cancer termed indolent non-hodgkin lymphoma. The purpose of this Phase Ib trial will be mainly to assess the safety of our vaccine for human use. The primary trial site will be the University of Nebraska Medical Center ( UNMC ) and the Principal Investigator will be Dr. Philip Bierman, MD, Professor, Internal Medicine, Division of Hematology and Oncology at UNMC. Dr. Bierman is an internationally known expert in the treatment of lymphoma. The data we derived from our mice study (Study 1), our canine study (Study 2) and from our more than three hundred dogs, cats and horses treated with ImmuneFx provided by our subsidiary Veterinary Oncology Services, Inc. give us confidence of a positive first-in-human outcome. The expected successful outcome of our first human trial will be a definitive shareholder value inflection point. We expect the acceptance by the FDA of our trial application in Q4 of year The commencement of the human trial is planned to begin shortly thereafter. Other human trials are already in the planning stage. Study 4 : Compassionate Care Patient: Transitional Cell Carcinoma Case Study What we term Study 4 was actually not a structured clinical trial but instead was the treatment under a USDA compassionate care exception. Our patient was a dog named Muffin (aka Mup ) that had advanced stage transitional cell carcinoma in his bladder. His disease was not responsive to other treatments. His prognosis was poor and it was likely that he was going to be euthanized within a few weeks. Unable to undergo surgery, Mup was not a candidate for our USDA authorized personalized autologous vaccine. As such, he qualified and was granted a compassionate care exception for our allogeneic ( off the shelf ) vaccine. His condition was so poor that his bladder was essentially 80% consumed by tumor mass. This caused urinary occlusion (the inability to urinate effectively), and often Muffin passed blood. The critical area requiring immediate improvement was the trigone area which connects the urethra with the bladder. Within just three weeks of initiating our treatment, we received the following from Muffin's veterinarian describing his status: This has truly been exciting to watch unfold. The tumor appears to be 'disintegrating' for lack of a better term. Tissue can be seen cascading off the main tumor bulk - it's pretty amazing. Thank you for introducing me to this innovation! Two weeks after the above (the fifth week of treatment), we received the following from the parents of Mup. Just a short note to say Thank You! and to let you know that Mup is doing great and we are seeing a notable (40-50% my guess) reduction in tumor size. Mup - aka Muffin feels 100% better and is urinating (and marking again) like a normal dog. The fear of inflammation around the trigone of the bladder did not occur, as the tumor appears to be shrinking from back to front. Amazing to see the weekly changes with the ultrasounds (Thank You Dr. Chapman!) Mup is urinating normally now with just occasional light bleeding. He has energy, runs around and you can tell he feels significantly better! Within two weeks of the completion of the eight-week treatment period (one vaccine dose each week for 8 weeks), we received the following from Muffin s parents:...as.of last week the trigone region has remained totally clear. We have seen very little blood in his urine, occasionally enough to give it a very light pink color - but 90% of the time (when I can see it) it s completely clear. Even with the 0.6 ml volume ID dose in a small dog he has had very little in the way of local reactions.. I can t tell you how much my family and I appreciate the extra quality life you have given our canine family member. Page 4

5 Study 5: Equine Melanoma Field Study We have also completed a study that tests the direct DNA injection (nonpersonalized form) of the ImmuneFx for use in companion animals. This nonpersonalized ImmuneFx product consists solely of the plasmid DNA which is administered directly into an accessible tumor such as a melanoma skin lesion. This product can be made in large batches and widely distributed to veterinary clinics throughout the country. Thus double-blinded, placebo controlled field study included twenty-six (26) horses with malignant melanoma. While the main purpose of this study was to obtain a conditional license from the USDA to sell this product and then a full commercial license, these data will also provide important information for the use of the direct DNA vaccine in humans with melanoma and other malignant diseases. The results will also lay the groundwork for use in other species and for other cancers in the veterinary and human markets. Our application was submitted to the USDA in November, The study was completed in the Q1 of 2016, with data pending analysis. With the conclusion of this process we will seek commercial and facility licenses and thereafter launch commercialization of this product throughout the United States. Study 6: Pre-clinical Mouse Melanoma Model Study We will capitalize upon the data we received from Study 5 (the Equine Melanoma Field Study ) along with a new pre-clinical mouse melanoma study to transition smoothly into a human study for melanoma. Specifically, during Q1 of 2016, we initiated a large-scale preclinical study in mice transplanted with melanoma tumor cells. This pre-clinical study is being conducted by Moffitt Cancer Center and follows a pilot study we have already concluded with them. In the pilot study, we used two groups of ten mice each. Each group had the induction of melanoma but only one group was treated with our direct DNA vaccine. A larger percentage of the treatment group surpassed the 30-day expected survival of the control group. Equine Melanoma Field Study (Completed: data used to develop mouse and human trials) Pre-clinical Melanoma Mouse Study (Initiated Q1 2016: data used to develop human trial) Human Phase Ib Melanoma Clinical Trial (to initiate Q2 2017) Our current study is being conducted by a clinical research team and a principle investigator from Moffitt Cancer Center. This study is much more complex than the preliminary study and includes multiple groups of mice. The purpose of the trial is to test safety, effectiveness and dosage. In addition, we will be testing our technology in three ways: 1.without any treatment (the control group ) 2.with our treatment only, and 3.with our treatment in combination with other treatments Further, with this study we are also looking to explore the treatment s mechanism of action. We expect to complete this study and begin a Phase 1 human trial within twelve months. Future Studies In addition to the human non-hodgkin lymphoma and melanoma studies, we anticipate additional trials with other cancer indications, the first being pancreatic cancer and the second being breast cancer. Upon the completion of our plans for sales of our stock, we will be positioned to expand further studies of our technologies and increase their value. Page 5

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