COVID-19:Generex/Epivax Vaccine 5M Chinese Funded/Trials Within 90 Days
World Health Org Listing: Generex-EpiVax/Li Key Peptide Vaccine/PDF File Pg 3!! |China Companies Contract Generex for Covid -19 Vaccine You Tube Media Link|  
Generex Biotechnology Initiates Peptide Manufacturing for Ii-Key- SARS-CoV-2 Peptide Vaccine Against the COVID-19 Pandemic
Submitted proposal to BARDA for start-to-finish funding to develop an approved, commercial Ii-Key peptide vaccine against the SARS-CoV-2 coronavirus
SARS-CoV-2 epitope identification and selection completed
Initiated GLP manufacturing of synthetic Ii-Key-SARS-CoV-2 peptides for screening in “Ex-vivo” human trial in blood samples from COVID-19 convalescent (recovered) patients
Obtained letters of support for BARDA Application from scientific partners, prestigious universities, major contract manufacturers, and a prominent CRO that will manage the international regulatory effort and the proposed end-to-end clinical program
Generex strategy offers ethical and safe solution to rapid vaccine development with Ii-Key-SARS-CoV-2 peptide vaccineSARS-CoV-2 mechanism of infection still largely unknown
COVID-19 disease progression remains largely undefined
Risk factors for hospitalization include age, cardiovascular disease, hypertension, obesity, and other unknown health and genetic risks
Risky strategy of viral challenge studies unnecessarily puts people’s lives in danger
Working with a team of corporate collaborators, academic advisors, and contract manufacturers to prepare contract proposals and bids for U.S. and international government health agencies to develop Ii-Key-SARS-CoV-2 peptide vaccines against COVID-19 for clinical testing and approval
Why GNBT/NGIO/Epi-Vax has an Advantage in the Covid-19 Vaccine Race
NGIO has invested over $50 million in the last 15 years to develop the Ii-Key technology for infectious disease & cancer immunotherapy. The focus of NGIO is on cancer immunotherapy, the company previously maintained a robust research and development effort for potentially pandemic viruses avian flu (H5N1),swine flu (H1N1) and SARS, creating on-demand peptide vaccines that have been extensively studied through human clinical trials NGIO’s Ii-Key antigenic peptides have been shown to supercharge the immune system up to 100 times more than peptides alone.
Note: NGIO is currently engaged in a Phase II clinical trial of its lead cancer immunotherapeutic vaccine AE37 in combination with pembrolizumab (Merck’s Keytruda®) for the treatment of triple negative breast cancer.
Rapid Path to SARS-COV-2 Vaccine: 3 Months to Human Vaccination
NuGenerex Immuno-Oncology, a Subsidiary of Generex Biotechnology (NGIO) has developed our proprietary, patented Ii-Key immune system
activation technology that holds promise for stopping pandemic viral outbreaks like the current SARS-COV-2 coronavirus epidemic in China. NGIO has invested over $50 million in the last 15 years to develop the Ii-Key technology for infectious disease & cancer immunotherapy. The
focus of NGIO is on cancer immunotherapy, the company previously maintained a robust research and development effort for potentially pandemic viruses avian flu (H5N1),swine flu (H1N1) and SARS, creating on-demand peptide vaccines that have been extensively studied through human clinical trials NGIO’s Ii-Key antigenic peptides have been shown to supercharge the immune system up to 100 times more than peptides alone. The activity and safety of Ii Key peptide vaccines has been proven in Phase I and II clinical trials involving over 300 patients or volunteers, so new Ii-Key has been proven in Phase I
and II clinical trials involving over 300 patients or volunteers, so new Ii-Key vaccines should be able to proceed directly to human studies without significant pre-clinical toxicology testing. With human clinical data in hundreds of patients that demonstrate safety and immune system activation against infectious disease and tumor antigens, as well as preclinical in vitro and in vivo studies that prove the mechanism of T-Cell activation, the Ii-Key technology offers a rapid path to humanprotection from the SARS-COV-2 and COVID-19 epidemic.
NGIO is working with EpiVax to utilize their proprietary computational vaccinology algorithms and databases to guide the rapid development of Ii-Key peptide vaccines to protect against the spread of SARS-COV-2. EpiVax has developed a suite of online computational vaccinology tools
for the accelerated design of proteome-derived, epitope-driven vaccines. NGIO and EpiVax are generating new patents and intellectual
properties from this collaborative agreement.
 Coronavirus nCOV-2019 antigenic epitopes predicted by EpiVax computational vaccinology and epitope prediction tools to be linked with Ii-Key to generate peptide vaccines against COVID-19
The terms of the contract, which have been agreed to in writing by both parties, include an upfront payment of $1 million to initiate the project work in the United States, a $5 million licensing fee for the Ii-Key technology, payment by the Chinese consortium for all costs and expenses related to the development of a COVID-19 vaccine, and a 20% royalty on each dose of vaccine produced.
China Contract Details
Generex management will be presenting the company’s data, demonstrating the technology, and finalizing work plans with those partners to produce an Patented NGIO/EpiVax Ii-Key-COVID-19 peptide vaccine that can be tested
Terms approved to proceed with collaborative effort with international consortium
MIRAMAR, Fla., Feb. 27, 2020 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) today announced that the company has received a contract from the China Technology Exchange, Beijing Zhonghua Investment Fund Management Co., LTD., Biology Institute of Shandong Academy of Sciences and Sinotek-Advocates International Industry Development (Shenzhen) Co., LTD. The terms of the contract, which have been agreed to in writing by both parties, include an upfront payment of $1 million to initiate the project work in the United States, a $5 million licensing fee for the Ii-Key technology, payment by the Chinese consortium for all costs and expenses related to the development of a COVID-19 vaccine, and a 20% royalty on each dose of vaccine produced.
Joe Moscato, President & Chief Executive Officer of Generex has signed the draft contract with deal terms and will be traveling to China next week to sign the final, official contract with its Chinese partners to develop a COVID-19 vaccine using the "patented" Ii-Key immune system activation technology. Generex management will be presenting the company’s data, demonstrating the technology, and finalizing work plans with those partners to produce an Ii-Key-COVID-19 peptide vaccine that can be tested in human studies within 90 days. Mr. Moscato is expected to sign the official agreements on behalf of Generex at a signing ceremony in China next week, at which time Generex will make further announcements.
Mr. Moscato said, “Our subsidiary NuGenerex Immuno-Oncology (NGIO) "Future NASDAQ Listing" has developed Ii-Key peptide vaccines against several potentially pandemic viruses, including bird flu, swine, flu, HIV, and a previous coronavirus, SARS. This wealth of experience has enabled us to develop a standardized protocol for rapid vaccine development, so we are positioned to respond in the event of a new, emerging pathogen. Our partners in China have recognized the power of our Ii-Key platform and have delivered this contract to establish a collaboration to combat the COVID-19 epidemic, and we are excited to begin the work.” Note: Generex has a huge head start already funded by the Chinese. They will be able to test in China with less restrictions vs the FDA. Human trials in China with prior exposure to Covid -19 will start almost immediately. The vaccine if successful will put pressure for FDA Approval and a huge upside for Generex
Generex Biotechnology Corporation has been working to develop a peptide vaccine against the new coronavirus SARS-CoV-2 using the company’s proprietary and patented Ii-Key immune system activation technology. We have built our technology to assist third party groups and government agencies in their evaluation of potential vaccines against this pandemic SARS-CoV-2 virus.
The patented NuGenerex Immuno-Oncology (Formerly Antigen Express) Ii-Key technology uses synthetic peptides that mimic essential protein regions from a virus that are chemically linked to the 4-amino acid Ii-Key to ensure robust immune system activation. In particular, the Ii-Key ensures potent activation of CD4+ T cells, which in turn facilitates antibody production to ward off infection. This Ii-Key modification can be applied to any protein fragment of any pathogen to increase the potency of immune stimulation.
Generex is working with our partners at EpiVax who have identified such protein fragments or epitopes to generate Ii-Key-SARS 2 peptide vaccines in collaboration with our peptide manufacturing partners. The peptides and Ii-Key are made from naturally occurring amino acids, ensuring an excellent safety profile for Ii-Key peptide vaccines
Biotech Stock News: Generex Biotechnology (OTCQB: GNBT) Announces Corporate Update and Investor Conference Call: Addressing the #Coronavirus Pandemic with Ii-Key Peptide Vaccines - Thursday February 13
Acquisitions: Olaregen Therapeutix, Regentys, Veneto Assets, Pantheon Medical, MediSource Partners
Completed 100% Acquisition of HDS (now NuGenerex Diagnostics) and Retired Associated Debt
NuGenerex Immuno-Oncology (NGIO) Formation and Kiromic Acquisition
Excellagen® Wound Conforming Gel Matrix
Generex Biotechnology Signs Letter of Intent to Acquire 51% in ALTuCELL, Inc. and their Cellular Therapy Product Altsulin® with Patented Microencapsulation Technology for the Treatment of Type I Diabetes Mellitis Link Generex Biotechnology Signs Letters of Intent to Establish NuGenerex Health MSO with Arizona Endocrinology Center & Paradise Valley Family Medicine Link Generex Biotechnology Announces First Patient Enrolled in the Phase II Clinical Trial of AE37 in Combination with Pembrolizumab (Keytruda®) for the Treatment of Triple Negative Breast Cancer Link Generex Now Owns 99% of Subsidiary Olaregen Therapeutix Link
Upfront license payments for AE37 by Shenzhen BioScien Pharmaceuticals for Prostate Cancer in China, Taiwan, Hong Kong and Macau.
** Proprietary buccal oral insulin delivery for $27 billion insulin market.
** Aggressive acquisition strategy of diagnostics, therapeutics, orthopedic surgical implants and patient care in play with recent closes and signed LOI’s. GNBT – Growth and Assets Biotechnology Link
Generex Biotechnology Investing DD 2020
1) The CEO Joe Moscato is a marketing guy and he knows how to get everyone to see the big picture and to take long term views. Even if it means taking less pay now for rewards later. Including himself. No big fat salary for Joe now. In fact he has pretty much deferred any salary. What CEO does that?
2) GNBT filed an S-1 registration with the SEC with the future plans all noted. When the S-1 gets approved they have financing approved for a minimum of $40M to be used if needed. Think of it as a line of credit. The S-1 could be approved ANY day.
3) The financing allows them to purchase a majority interest privately held company named Altucell who may have a treatment which may cure Type 1 Diabetes. This companies research is fairly advanced and additional trials are about ready to go once funding arrives. Why?
"as part of our due diligence process, we pinpointed specific, comparable deals that validate the huge value of the
ALTuCELL acquisition, as evidenced by the recently announced purchase of Semma
Therapeutics by Vertex Pharmaceuticals for close to a billion dollars."
4) Generex is spinning off NGIO and it should be trading on the Nasdaq within a few weeks. It will be owned by Generex shareholders as we have been awarded dividend shares and ~70% by Generex. NGIO has the coronavirus vaccine to develop and a vaccine it is currently studying for breast cancer. Prostate research is underway as well. Other research is pending the new funding. Regarding number 4, I should have mentioned Merck. No doubt you all know about Keytruda being huge in cancer. The Generex/NGIO breast cancer study is a combo of NGIO's AE37 and Merck's Keytruda.
5) One of Generex's subs has a number of test kits for various ailments is working on a coronavirus test kit NOW.
6) Another sub, Olaregen has a wound care product being sold in the VA system and producing significant NEW revenue for Generex as of the last 3 months.
7) It was just announced two of the other subs have had a 400% increse in sales of their medical products recently
Over the next few day I will tell you about the MSO, HMO,Type 2 diabetes treatment and more.
Count yourselves lucky to be here now just before the good stuff is going to come together. Flippers will look back and regret having sold quite soon.
Did I mention Generex has already filed for UPLISTING ON THE NASDAQ for GNBT? Waiting on the S-1 to be approved and the financing to be put to work.
Finally: I don't think many day traders and particularly short sellers realize what they have gotten themselves into. Any day now there will be news of significance such as the NGIO spinout and valuation details. Aside from cancer research and the rest, GNBT/NGIO is in position number one for a coronavirus vaccine in China. They are about to sign a nice deal with upfront money which is sufficient to get the initial work done in all likelihood. Milestone payment, all the costs covered and 20% of the rev's. NGIO's vaccine technology is such that it can be ready faster than traditional vaccines and can be produced in huge volumes very fast. A successful vaccine will result in an tremendous revenue stream and big pharma looking at NGIO as a buy out candidate. A coronavirus vaccine is worth billions worldwide if this disease becomes an annual contagion as many medical researchers believe.
6 Feb, 2020 Corporate Update
Generex restarts vaccine efforts, Co-Diagnostics launches coronavirus test
Generex Biotechnology Corp. said two of its subsidiaries are collaborating with third-party groups and government agencies to reactivate efforts to develop vaccines against pandemic viruses.
The company previously developed vaccines for severe acute respiratory syndrome, or SARS, which became a global epidemic in 2003.
Generex' unit NuGenerex Immuno-Oncology — formerly Antigen Express — is looking at its patented Ii-Key technology to generate peptide vaccines. The technology is clinically proven to activate the immune system against a number of viruses such as H5N1 avian influenza or bird flu virus.
NuGenerex Immuno-Oncology said clinical trials of Ii-Key peptide vaccines have shown that the vaccines are safe and have long-lasting immune responses. One early-stage trial tested a series of vaccine peptides for H5N1 bird flu virus in more than 120 participants.
The Generex unit noted that its peptide vaccines could potentially be used against the novel coronavirus infection, or 2019-nCoV, because bird flu has been identified in animals in Wuhan, China, the epicenter of the 2019-nCoV outbreak.
NuGenerex Diagnostics, or NGDx, another Generex unit, has developed the Express II rapid diagnostic testing platform, which can detect antigens, antibodies or other components found in infectious diseases, cancer and other medical conditions. NGDx is initiating a project to adopt the platform that will help develop a diagnostic test for the Wuhan coronavirus infection.
Miramar, Fla.-based Generex Biotechnology, is an integrated healthcare holding company offering patient-centric care solutions such as rapid diagnosis and personalized therapies.
NuGenerex Immuno-Oncology, which is being spun out of Generex as a separate public company, has an ongoing mid-stage clinical trial investigating its lead cancer vaccine AE37 in combination with Merck & Co. Inc.'s Keytruda cancer drug for the treatment of triple-negative breast cancer.
Meanwhile, Co-Diagnostics Inc. said its CoPrimer diagnostic test for 2019-nCoV is available for sale to laboratories, hospitals and institutions that need a solution to the pandemic.
The company announced on Jan. 23 that CoPrimer, a polymerase chain reaction test designed for research purposes only, met the requirements for detecting coronavirus.
Co-Diagnostics CEO Dwight Egan said leveraging the company's proprietary design process and software has allowed it to quickly move the product from design to commercialization.
On Jan. 30, the World Health Organization declared the novel coronavirus a global health emergency. The U.S. Food and Drug Administration on Feb. 4 authorized the emergency use of in vitro diagnostic tests for the virus — those done on samples taken from the human body — due to its potential to negatively impact national security or public health.
Salt Lake City's Co-Diagnostics is a molecular diagnostics company that offers reagents used for diagnostic tests that can detect and analyze nucleic acid molecules.
About Generex Biotechnology Corporation
Generex Biotechnology is an integrated healthcare holding company with end-to-end solutions for patient centric care from rapid diagnosis through delivery of personalized therapies. Generex is building a new kind of healthcare company that extends beyond traditional models providing support to physicians in an MSO network, and ongoing relationships with patients to improve the patient experience and access to optimal care. In addition to advancing a legacy portfolio of immune-oncology assets, medical devices, and diagnostics, the Company is focused on an acquisition strategy of strategic businesses that complement existing assets and provide immediate sources of revenue and working capital. Recent acquisitions include a management services organization, a network of pharmacies, clinical laboratory, and medical device companies with new and approved products.
NuGenerex Immuno-Oncology (formerly Antigen Express), a subsidiary of Generex Biotechnology, is a clinical stage oncology company developing immunotherapeutic peptide vaccines based on the CD-4 T-Cell activation platform, Ii-Key. NuGenerex Immuno-Oncology (NGIO) is being spun out of Generex as a separate, independent public company to advance the platform Ii-Key technology, particularly in combination with the immune checkpoint inhibitors. NGIO is currently engaged in a Phase II clinical trial of its lead cancer immunotherapeutic vaccine AE37 in combination with pembrolizumab (Merck’s Keytruda®) for the treatment of triple negative breast cancer.
 
GNBT/NGIO Uplisting to the NASDAQ  Donohoe Advisory Link
The access information for the investor conference call is as follows: Domestic US/Canada – 1-(866) 342-8588 Direct Toll / International - 1-(203) 518-9865, Program Title: Generex Biotechnology Announces Investor Conference Call Conference ID – 3654 Agenda: Update on the 2:5 GNBT stock dividend and the 2:5 NuGenerex Immuno-Oncology (NGIO) stock dividend & the FINRA approval
Share price review: Impact of irregular & illegal trading and plans to address wrongdoing
Go-forward plans to build and operate the Generex enterprise
Update on the progress toward the NuGenerex Immuno-Oncology (NGIO) spinout
Funding update
ALTuCELL closing update
As always, Generex President & Chief Executive Officer, Joseph Moscato welcomes questions from shareholders
 MIRAMAR, Fla., Dec. 05, 2019 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (OTCQB: GNBT) is pleased to announce that the company has finalized agreements to provide significant funding for ongoing operations, launching new businesses, and advancing the commercial development of new products from the NuGenerex family of companies. As discussed on the shareholder conference call last Friday, Generex yesterday signed definitive documents to secure a short-term bridge financing of $2.2 million dollars. Generex also signed documents for 40 million in an equity investment instrument that will close once the company has an effective registration statement covering the shares issued under that instrument. With these funding initiatives complete and definitive, Generex plans to move forward immediately to establish our Arizona operations for diabetes and chronic care management, including our podiatry, ophthalmology, neurology, and pharmacy practices in partnership with the Arizona Endocrinology Center and Paradise Valley Family Practice. The funds will be used to build out facilities, hire the medical and clinical staff, and to secure the licenses and accreditation for our MSO/HMO network that will make our vision a reality. Additionally, the funds will be used to complete the acquisition of Altucell and to fund human clinical trials of Altsulin® encapsulated Sertoli cells for Type I diabetes and encapsulated stem cells in Altucaps® for autoimmune and inflammatory disorders. The funds will also support the ongoing clinical development efforts with AE37 in combination with Merck’s Keytruda for the treatment of triple negative breast cancer, as well as clinical trials of Regentys ECMH for the treatment of ulcerative colitis, which are expected to begin shortly. In addition, the funds will allow us to also expand the product portfolios of our subsidiary companies, Medisource, Pantheon, and Olaregen, particularly in the regenerative medicine space, where we will be announcing new product introductions in the coming weeks. Finally, the funding will allow Generex to re-start the MSO with a new, fully compliant operating structure that will enable us to execute our strategy to provide an end-to-end patient-focused solution our partners, the orthopedic surgeons and podiatrists in the MSO. Also, in the coming days, Generex will file 8K’s on these investments, and will provide guidance on the next steps for reinstating the postponed dividend.
Joe Moscato, President & CEO of Generex stated, “These equity investments are key to building out many of our new businesses and solidifying our subsidiary partnerships to further the clinical development and commercialization of a wide array of new products. After much work, Generex is excited to receive funding for our enterprise that will enable us to realize real revenues and further the science that forms the foundation for our valuable assets to build considerable value into the future. Further, this funding is expected to cover our one-year plus operational costs, allowing the removal of the going concern by our auditors. and enabling us to once again move toward a Nasdaq listing, building value to bring our share price back to a qualifying level for the up-list. With these investments in hand that will fund Generex over the next 2 to 3 years, we are excited for 2020 and beyond.”
GNBT – GENEREX BIOTECHNOLOGY ASSEMBLING MASSIVE GROWTH MACHINE Link
Sept 2019 Generex Announces That the Process to Retire 20,375,900 GNBT “Pool Shares” is Complete Link
Mr. Moscato stated, “By retiring the Pool shares, we are returning more value to Generex shareholders as we get closer to our Nasdaq listing, the annual board meeting and our 1:1 dividend scheduled to be paid to our shareholders on October 29th.
August 2019 NASDAQ Up-Listing Details Buy One Share And Get One Free 1:1 Dividend Link
Record date for dividend is August 30, 2019
Ex-dividend date for 1:1 shareholder stock dividend set for October 30, 2019
Effect of Dividend on GNBT Shares Outstanding
Retiring 21 million “Pool Shares”
Exclusion of insiders, noteholders, pool holders, acquisitions Generex Satisfies Notes for $138,000 and $900,000 to clear debt August 2019 Generex Now Owns 99% of Subsidiary Olaregen Therapeutix Link August 2019 Plans for NuGenerex Immuno-Oncology Spinout through a Targeted Acquisition of a Public Company and Planned Merger with Kiromic. Link
August 2019 Interview CEO Joseph Moscato Wall Street Analyzer Link
Sept 2019 Generex Biotechnology Signs Letter of Intent to Acquire 51% in ALTuCELL, Inc. and their Cellular Therapy Product Altsulin® with Patented Microencapsulation Technology for the Treatment of Type I Diabetes Mellitis Link Sept 2019 Generex Biotechnology Signs Letters of Intent to Establish NuGenerex Health MSO with Arizona Endocrinology Center & Paradise Valley Family Medicine Link
Sept 2019 Generex Biotechnology Announces First Patient Enrolled in the Phase II Clinical Trial of AE37 in Combination with Pembrolizumab (Keytruda®) for the Treatment of Triple Negative Breast Cancer Link
Biotech's New Rising Star ** Generex A37 Immunotherapy Vaccine demonstrates high efficacy with low adverse side effects against many common cancers and disease ** Combination Phase II trial with MRK Keytruda and GNBT A37 for Breast Cancer enrolling 2019.
** Upfront license payments for AE37 by Shenzhen BioScien Pharmaceuticals for Prostate Cancer in China, Taiwan, Hong Kong and Macau.
** Proprietary buccal oral insulin delivery for $27 billion insulin market.
** Aggressive acquisition strategy of diagnostics, therapeutics, orthopedic surgical implants and patient care in play with recent closes and signed LOI’s.
** Plans to launch million bottles of CBD water and health products beginning 2019.
** Share price is low but in strong uptrend with near-term Nasdaq up-listing in sight.
The following press release, “Generex Biotechnology Provides Fiscal Year Overview”, published July 10, 2019 best explains why shares are quickly becoming the new Cinderella of Biotech: Acquisitions: Olaregen Therapeutix, Regentys, Veneto Assets, Pantheon Medical, MediSource Partners
Completed 100% Acquisition of HDS (now NuGenerex Diagnostics) and Retired Associated Debt
NuGenerex Immuno-Oncology (NGIO) Formation and Kiromic Acquisition
Excellagen® Wound Conforming Gel Matrix Shares of Generex Biotechnology Corporation (OTC: GNBT) have been rising and continue in a strong uptrend for several reasons. Unlike many biotech companies that are developing just one technology and have only one drug or very few drugs in their pipeline, Generex is successfully executing an aggressive acquisition strategy to own a broad spectrum of diagnostic products, therapeutic products, orthopedic implants, surgical kits, biologic products, and care delivery solutions through their MSO. "Joseph Moscoto, CEO, has thoroughly restructured Generex Biotechnology and has assembled an experienced and effective management team that has successfully architected several acquisitions that have either been closed, or that are under LOI. Each individual acquisition has the potential to generate blockbuster revenues, and each new company is either already in commercial stages or is developing attractive solutions for the $400 billion biotechnology market and the $4 trillion healthcare market" Link Conference Call June 21st Link
August 9th 2019 GNBT - Buy One Share Of Biotech’s New Fast Rising Star And Get One Free Share price in strong uptrend for past 10 months.
1 Share dividend for each share owned will only be paid the day after Generex Biotechnology is up-listed to Nasdaq.
Nasdaq Up-listing expected in 30 to 60 days.
Stock dividend will only be paid to float shareholders and not to management or insider shareholders.
Management has completely restructured company into powerful healthcare growth engine.
Generex A37 Immunotherapy Vaccine demonstrates high efficacy with low adverse side effects against breast cancer and believes it’s also effective against many common cancers and diseases.
Combination Phase II trial with MRK Keytruda and GNBT A37 for Breast Cancer enrolling 2019.
Upfront license payments for AE37 by Shenzhen BioScien Pharmaceuticals for Prostate Cancer in China, Taiwan, Hong Kong and Macau.
Proprietary buccal oral insulin delivery for $27 billion insulin market.
Aggressive acquisition strategy of diagnostics, therapeutics, orthopedic surgical implants and patient care in play with recent closes and signed LOI’s. Summary Shares of Generex Biotechnology Corporation (OTC: OTCQB:GNBT) have been rising and continue in a strong uptrend for several reasons. Unlike many biotech companies that are developing just one technology and have only one drug or very few drugs in their pipeline, Generex is successfully executing an aggressive acquisition strategy to own a broad spectrum of diagnostic products, therapeutic products, orthopedic implants, surgical kits, biologic products, and care delivery solutions through their MSO.
Joseph Moscoto, CEO, has thoroughly restructured Generex Biotechnology and has assembled an experienced and effective management team that has successfully architected several acquisitions that have either been closed, or that are under LOI. Each individual acquisition has the potential to generate blockbuster revenues, and each new company is either already in commercial stages or is developing attractive solutions for the $400 billion biotechnology market and the $4 trillion healthcare market.
Biotech companies are known for wild share price swings on drug development news and can see their shares either rocket on good news or crash on bad news. Biotech valuations tend to be substantially higher than most industries because the leverage of one single drug can create several billions of dollars in new wealth. A37 is a broad-spectrum, Immunotherapy drug of great interest because it has the potential to deliver therapeutic solutions for so many cancers and disease conditions. If successful, its value can be enormous. The demonstrated efficacy against breast cancer and the belief it works against a host of cancers and illnesses with minimal adverse side effects has motivated the drug giant, Merck to enter into a clinical trial with Generex.
MRK is conducting a Combination Trial for breast cancer with Generex A37 and their giant blockbuster PD1 Checkpoint Inhibitor Keytruda. As A37 moves forward with MRK, dramatically higher share prices appear to be in Generex future if positive outcomes are published. Generex current market cap of well under $200 million is very small by industry standards and subject to very large overnight revaluations on expected news runway.
Additionally, Generex has the potential to deliver large and fast-growing revenues from the several products and services currently offered and about to be offered. Further increases in Generex share valuations are likely and expected as the company begins enrollment for their combination trial and as the company gets closer to reporting revenues from several profit centers. Link July 29th 2019 Generex Biotechnology Provides Guidance on 1:1 Stock Dividend MIRAMAR, Fla., July 29, 2019 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) today provided guidance for investors on the company’s plans for the GNBT up-list to Nasdaq and the payment of the 1:1 share dividend to shareholders.
Joseph Moscato, Generex President & Chief Executive Officer stated, “Many thanks to our shareholders and interested parties for participating in our conference call last Thursday, July 25. Since then, I have received a number of calls pertaining to the 1:1 shareholder dividend, so I want to provide some clarity with this release. First, in regard to the timing of the dividend payment, please note that the dividend will be paid the day after Generex is up-listed to the Nasdaq stock exchange. I cannot provide a set date at this time, as our up-list application still needs to go through the review process at Nasdaq, which is expected to take 30 to 60 days.”
“Also, there seems to be confusion in the market based on a question that was asked on the conference call pertaining to dilution and free-trading stock. Please note the dividend will only be paid to shareholders in the float. Insiders will not be taking the dividend, as the management team has waived their rights to the dividend. As recently reported, Generex retired an old debt of $3.1 million that has been carried on the books for 9 years, with the note holder opting to receive the full payment in Generex stock at $2.81 per share; these are restricted shares that will not be unrestricted for at least 6 months and are not eligible for the dividend. Similarly, if any other note holders convert their stock, those shares will also be restricted with the same restrictions. There are no features in any of Generex’s current notes that allow for automatic conversion to free-trading stock, as any such transaction requires a legal process to remove the “restricted” legend. Generex does not have an S1 nor an S3 filed with SEC at this time, which means that no free-trading stock has been granted to date. Plus, as previously reported, I am retiring the roughly 21 million “Pool Shares” such that the effect of the dividend on dilution is significantly minimized.”
“Lastly, it is important to note that if anyone sells their shares between now and the ex-date, which is expected to be two days after the pay date, the dividend shares will be transferred to the purchaser of your shares.”
As I have said since our shareholders permitted us to clean up the company, I am committed to building the value of Generex and sharing our successes with our loyal shareholders through the payment of share dividends. This final 1:1 share dividend that will only be paid to shareholders but not insiders, is another demonstration of that commitment. We look forward to the next chapter of Generex on the Nasdaq national exchange.”
The full recording of the conference call , including the Q&A session is now available on the Generex corporate web site, and the transcript will be available later today.
July 16th 2019 Generex Biotechnology Announces Investor Conference Call Scheduled for July 25, 2019 Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) today announced that it will hold an investor conference call on Thursday July 25, 2019 at 4:00 pm to update investors on the company’s plans for the GNBT up-list and the previously declared 1:1 share dividend. Joseph Moscato, Generex President & Chief Executive Officer, will provide details on the up-list process and projected timing for the payment of the dividend.
Mr. Moscato stated “I look forward to discussing the GNBT up-list and the 1:1 dividend with our shareholders.”
Dial-in instructions for the investor conference call will be announced prior to the meeting date.
About Generex Biotechnology Corp.Generex Biotechnology is an integrated healthcare holding company with end-to-end solutions for patient centric care from rapid diagnosis through delivery of personalized therapies. Generex is building a new kind of healthcare company that extends beyond traditional models providing support to physicians in an MSO network, and ongoing relationships with patients to improve the patient experience and access to optimal care.
In addition to advancing a legacy portfolio of immune-oncology assets, medical devices, and diagnostics, the Company is focused on an acquisition strategy of strategic businesses that complement existing assets and provide immediate sources of revenue and working capital. Recent acquisitions include a management services organization, a network of pharmacies, clinical laboratory, and medical device companies with new and approved products.
Our newly formed, wholly-owned subsidiary, NuGenerex Distribution Solutions (NDS), integrates our MSO network with a pharmacy network, clinical diagnostic lab, durable medical equipment company (DME-IQ) and dedicated call center.
About Olaregen TherapeutixOlaregen Therapeutix, Inc. is a regenerative medicine company focused on the development, manufacturing and commercialization of products that fill unmet needs in the current wound care market. Generex aims to provide advanced healing solutions that substantially improve medical outcomes while lowering the overall cost of care. Olaregen's first product introduction, Excellagen (flowable dermal matrix) is a topically applied product for dermal wounds and other indications. Excellagen is a FDA 510K cleared device for a broad array of dermal wounds, including partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/ grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears) and draining wounds, enabling Olaregen to market Excellagen in multiple vertical markets. Additionally, Excellagen can serve as an Enabling Delivery Platform for pluripotent stem cells, antimicrobial agents, small molecule drugs, DNA-Based Biologics, conditioned cell media and peptides. Olaregen's initial focus will be in advanced wound care including diabetic foot ulcers (DFU), venous leg ulcers and pressure ulcers. Future products focusing on innovative therapies in bone and joint regeneration comprise the current pipeline. Generex's mission is to become a significant force in regenerative medicine and advance the science of healing.
About our Service-Disabled Veteran-Owned Small Business (SDVOSB)This a Service-Disabled Veteran-Owned Small Business (SDVOSB) that specializes in the sale, marketing, and distribution of innovative medical products through a nationwide network of veteran owned distribution services.About Pantheon MedicalPantheon Medical is a manufacturer of a physician friendly, “all-in-one”, integrated kit that includes plates, screws, and tools required for orthopedic surgeons and podiatrists conducting foot and ankle surgeries. Generex is developing and submitting several new product lines to the FDA which will include cannulated surgical screws, plates, and implants.
About MediSource PartnersMediSource Partners is a 10-year-old private company, currently contracted with over 25 vendors (including Pantheon Medical) for nationwide distribution of implants and devices for spine, hips, knees, foot, ankle, hand, and wrist surgeries. Additional product lines include biologics (blood, bone, tissue, stem cells), durable medical equipment, and soft goods. Generex also supplies kits to process bone marrow aspirates and platelet rich plasma biologics at the time of surgery. July 2nd 2019 Generex Engages Donohoe Advisory to Assist with Uplisting Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) is pleased to announce that Generex has engaged Donohoe Advisory Associates LLC (“Donohoe Advisory”) in connection with its efforts to seek a listing for its common shares on a national securities exchange. Donohoe Advisory was founded by Dave Donohoe in 2004, and since that time the firm has successfully represented nearly 1,000 companies in a wide range of listing matters at both The Nasdaq Stock Market (“Nasdaq”) and the New York Stock Exchange (the “NYSE”). Each professional member of Donohoe Advisory’s team previously worked for either Nasdaq or the NYSE. Prior to forming Donohoe Advisory, Dave Donohoe spent 9+ years with Nasdaq, where he ultimately served as Chief Counsel in the Listing Qualifications Department. He is joined by Bruce Poignant, a 25-year Exchange veteran, together with a team of former Exchange officials. Joe Moscato, President & Chief Executive Officer of Generex said, “Donohoe Advisory is the premier advisory firm for managing the legal requirements, regulatory issues, and application processes necessary for a successful uplisting. I have known Dave Donohoe and Bruce Poignant for years, and the success of their firm that specializes in national exchange uplists speaks for itself. We are excited about working with them to file our uplist application with Nasdaq in the coming days.” June 28th 2019 Generex Announces Update on 1:1 Dividend and NASDAQ Listing Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) today provided guidance on the previously announced 1:1 GNBT stock dividend. After discussing our listing with Nasdaq officials and our transfer agent Broadridge Financial Solutions, Inc., the dividend will be paid the day after our listing to the Nasdaq stock exchange, not on the same day as the listing as previously stated. In addition, Generex has been working on the application for the up-listing, and we have notified the Nasdaq that we will be submitting the application in the coming days. Joe Moscato, President & Chief Executive Officer of Generex stated, “We are very close to submitting our application to Nasdaq for the up-list, and we have gotten positive input and direction from Nasdaq officials. The listing on the Nasdaq exchange is the last piece in our overall plan we put forth in January 2017 and ends with our 1:1 dividend to shareholders after we are listed. We are excited about the potential listing on Nasdaq, which will ensure our future and provide Generex with a significant benefit as it relates to raising capital and investor liquidity while building sustainable value for our shareholders. We will announce to our shareholders when the application is submitted.” June 24th 2019 Generex Investor Conference Call Recording Now Available Online Detailing 1:1 Stock Dividend, Merger for NuGenerex Immuno-Oncology and Go Forward Plans Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) today announced the audio recording of its investor conference call, is now available for listening on our website www.generex.com, and the full, written transcript will be available, on Tuesday, June 25th. The call updated investors on the previously announced 1:1 dividend that will be paid to shareholders upon up-list to the NASDAQ national stock exchange. Joseph Moscato, Generex President & Chief Executive Officer, discussed the company’s accomplishments including the launch of Excellagen® wound conforming matrix by subsidiary Olaregen Therapeutix, the reorganization of NuGenerex Distribution Solutions’ MSO model, the potential merger of NuGenerex Immuno-Oncology with Kiromic, a multi-platform immunotherapeutic company, and the launch of our new businesses NuGenerex Chronic Care Solutions (NCCS) and NuGenerex Health, as well as the strategic focus of Generex for 2019 and beyond. Mr. Moscato commented, “As we discussed on Friday’s call, Generex has made significant strides toward achieving our goal of bringing Generex back to a national exchange. We have restructured our MSO, which now provides a compliant and efficient proprietary market channel for surgical, orthopedic, and podiatric products and services, including Excellagen, which is being launched for the management of hard to heal wounds in the VA, hospitals, and podiatrists’ offices. The potential merger of NuGenerex Immuno-Oncology with Kiromic offers significant value for our shareholders with the addition of three immunotherapy and AI platforms that augment our Ii-Key immunotherapeutic peptide vaccine technology. We are extremely excited to launch our new healthcare services business, NCCS and NuGenerex Health to complete our vision of Generex as an end-to-end solutions provider for physicians and patients.” Mr. Moscato continued, “We are proud of our accomplishments to date, but this is only the beginning for the future of Generex. This final dividend to our shareholders fulfils a commitment I made when taking over the company at the beginning of 2017 to reward investor loyalty, as demonstrated by retiring the remaining 20+ million Pool shares and significantly reducing the dilution associated with the dividend. Our company is poised for growth, and I remain committed to executing on our strategy to deliver value for our shareholders.”
June 21st 2019 Generex Announces That the Pool Shares for the Benefit of Generex Will Be Retired and Put Back into the Corporate Treasury Following Payment of the 1:1 Dividend
Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) today announced that the “Pool” shares controlled for the benefit of Generex by Joe Moscato, President and Chief Executive Officer of Generex, and consisting of shares contributed by Mr. Moscato and three others, will be retired; the 20,375,900 million shares remaining in the Pool will be returned to Generex and put back into the Generex treasury once Generex achieves its up-list to NASDAQ and the dividend is paid. Generex noted that Mr. Moscato previously waived the dividend for the Pool shares. For clarity, there are currently 60,307,396 shares outstanding. Of these only 34,542,338 shares are eligible for the dividend. Post dividend, there will be 69,084,676 shares in the market, as the 20,375,900 Pool shares will be retired and returned to the Generex treasury, leaving only 9 million additional shares in the market than pre-dividend. Mr. Moscato stated, “As Trustee of the Pool shares that have been set up for the benefit of Generex, and to further demonstrate my commitment to our shareholders, we have decided to retire the Pool upon payment of the 1:1 dividend and up-listing to NASDAQ, and return 20+ million shares to the Generex Treasury. The retirement of over 20 million shares is huge for shareholders, as it significantly reduces investor dilution by one-third. As we approach our goal of bringing Generex back to a national exchange, I am happy to share our success with our shareholders and provide Generex with a strong foundation for growth.”
June 20th 2019 Generex Declares 1 for 1 Stock Dividend In Conjunction NASDAQ Up-Listing With Record Date Of 24 July 2019
MIRAMAR, FL -- June 20, 2019 -- InvestorsHub NewsWire -- Generex Biotechnology Corporation (www.generex.com) (GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) is pleased to announce that the company today declared the previously announced 1:1 common stock dividend. The Record Date for the determination of the holders of the GNBT (the “Company”) common stock entitled to participate in the Company’s 1:1 common stock dividend will be Wednesday July 24, 2019. The dividend Payment Date will be the first day the Company’s common stock trades on the NASDAQ Capital Market; payment of the dividend is contingent upon the successful up-listing of the Company’s common stock on the NASDAQ Capital Market. In the event the Company is not listed on NASDAQ on or before October 31, 2019, the dividend will not be payable without further Company Board authorization and announcement.
The Company expects to file its application with NASDAQ shortly. Thirty days of process time after filing is customary. On the date of this announcement, the Company did not meet all of the initial listing criteria, such as the stock price requirement, however, the Company believes that events in process will enable it to meet the initial listing criteria at the $4, $3, or $2 stock price thresholds.
The Company believes that the ex-dividend date will be the trading day following the Payment Date, by application of FINRA Uniform Practice Code section 11140(b)(2), because the dividend is greater than 25 percent of the value of the Company’s common stock. In addition, effective September 5, 2017, the U.S. Securities and Exchange Commission shortened the settlement cycle for transactions in U.S. equities from trade date plus three business days (T+3) to T+2 (Rule 15c6-1(a) under the Securities Exchange Act of 1934 (17 CFR 240)). Company’s common stock acquired in trades settled prior to the ex-dividend date will be entitled to receive the dividend.
If shareholders of record sell stock after the record date but before the ex-dividend date, their shares will be sold with a “due bill” book entry which will denote that, although the Company will pay the dividend to the stockholder’s account, the stockholder’s account must relinquish the amount of that dividend over to the buyer of the stock. Conversely, if stock is purchased after the record date but the trade settles before the ex-dividend date, the buyer will be entitled to the dividend and will receive it via the due bill process.
The Company’s stock dividend will result in one share of common stock paid for every one share of common stock owned.
Joe Moscato, President & Chief Executive Officer of Generex commented: “I am happy and proud to have been able to fulfill my promise to reward our loyal shareholders for allowing us to reorganize and revitalize the Company. This final dividend demonstrates our commitment to share our successes with our shareholders, as we take the final steps toward achieving our goal to bring Generex back to a national stock exchange, as I will discuss on tomorrow’s teleconference. Also, on the call, my management team and I will provide a complete corporate overview, an update on the exciting commercial launch of Excellagen, details on our go-forward strategy, and an introduction to our highly valuable, restructured MSO platform.”
June 26th 2019 Generex Biotechnology Subsidiary Olaregen Therapeutix Receives American Podiatry Medical Associations “Seal of Approval” for Excellagen Wound Conforming Matrix The APMA Seal of Approval/Acceptance Program evaluates the use of therapeutic agents and their adjuncts (pharmaceuticals) and regulated medical devices. The seal is granted to a product after the Podiatric Seals Committee, a standing committee of the American Podiatric Medical Association, evaluates and determines whether the product allows normal foot function and promotes quality foot health. Additionally, evidence of usefulness and safety must be established, either by an appropriately recognized laboratory or clinical investigation, or by the products meeting certain physical standards. A detailed review is conducted by each committee member on every product. The committee then sends its recommendation to the APMA Board of Trustees, which has the authorization to either accept or reject the recommendation. Excellagen is an FDA- 510(k) cleared Cellular Tissue Product with an indication for the management of wounds including Diabetic Foot Ulcers. Excellagen is a ready to use 3-dimensional wound conforming matrix that supports a favorable wound healing environment. It is designed to accelerate granulation tissue growth by providing a structural scaffold for cellular migration and proliferation, and activates platelets, triggering the localized release of endogenous growth factors including Platelet-Derived Growth Factor (PDGF), a key biological mediator of wound healing. Joe Moscato, CEO of Generex commented, “Receiving the “APMA Seal of Approval” is tremendous news for our subsidiary, Olaregen Therapeutix. The process for receiving the seal is a rigorous evaluation of clinical utility and value, so our customers can feel confident in choosing Excellagen to manage their hard to heal wounds knowing that our best in class product meets the high standards set by the APMA. In addition, this is a great affiliation with the APMA, and we look forward to working with them and all APMA member surgeons and podiatrists to help manage their diabetic foot ulcers using Excellagen. I would love to hear from APMA members about their experience in the use of Excellagen in managing their patients hard to heal wounds.” Anthony Dolisi, CEO of Olaregen Therapeutix commented, “Our customers include surgeons, patients, their caregivers and payors. The APMA Seal of Approval strengthens our value with our customer base. With demonstrated superior clinical data and strong economic value, the seal adds additional reason on why we believe Excellagen will be a disruptive technology in the Regenerative Wound Care Market. Equally as important is the impact Excellagen makes on patients with hard to heal wounds that are difficult to manage causing a poor quality of life.”
June 25th 2019 Generex Signs Letter of Intent with Kiromic to Merge with NuGenerex Immuno-Oncology Forming a Multi-Platform Clinical Stage Immunotherapy Company
Generex Biotechnology Corporation (“Generex”) (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) today announced that Generex has signed a Letter of Intent (“LOI”) with Kiromic, Inc., a clinical stage immunotherapy company (“Kiromic”), to merge into a newly formed Generex entity, called NuGenerex Immuno-Oncology, in an all-stock transaction. With the merger, NuGenerex Immuno-Oncology will house both Kiromic and our subsidiary Antigen Express, Inc., which is developing AE37 in combination with check point inhibitors for the treatment of triple negative breast cancer. Together, the broad technology portfolio and deep pipeline opportunities provided in the merger position NuGenerex Immuno-Oncology on the forefront of cancer immunotherapy. Kiromic, which is collaborating with MD Anderson Cancer Center, has multiple patented proprietary immuno-oncology platforms, including CAR-T, CAR NK, an oral vaccine delivery system, and DIAMOND AI, an artificial intelligence system with a multifaceted predictive algorithm that combines genomic sequencing, proteomic analysis, and clinical data to identify novel tumor mutations that can be targeted with immunotherapy.
Kiromic has used the DIAMOND AI technology to identify and validate several cancer biomarkers, including SP17, which was granted an orphan indication for ovarian cancer, and is in early-stage clinical trials with the injectable formulation, and has filed an FDA IND for its oral formulation.
In addition to advancing the ovarian cancer program, we plan to advance Kiromic’s proprietary CAR-T and CAR NK technologies into proof of concept clinical trials. We also have many exciting opportunities to implement the DIAMOND AI technology in cooperation with academic partners at leading cancer research institutions across the country to not only identify new cancer antigens, but also to build out the multifaceted database with genomic, proteomic, and clinical data to guide personalized treatment regimens based on a patient’s tumor profile.
Kiromic is led by its founder, Dr. Maurizio Chiriva-Internati, who was previously a faculty member in the Department of Internal Medicine and Director of Basic/Translational Research Program at Texas Tech University Health Sciences Center, Lubbock, TX, USA, and an Associate Professor, (Adjunct) in the Department of Lymphoma and Multiple Myeloma at the University of Texas MD Anderson Cancer Center (MDACC), and who is currently a senior research scientist in the department of gastroenterology at MDACC. “We are very fortunate to have Dr. Chiriva-Internati leading our research and clinical development efforts for NuGenerex Immuno-Oncology as we build a world-class immunotherapy company with three new platforms,” said Joe Moscato, CEO of Generex. “He is world-renowned in the oncology community through his research at Texas Tech and his clinical work at M.D. Anderson Cancer Center. His discoveries, including the DIAMOND AI artificial intelligence algorithms, CAR-T and CAR NK platforms, and oral vaccine technologies have shown proof-of-concept, and we look forward to great developments in the future.” Dr. Chiriva-Internati added, “I am excited to join NuGenerex Immuno-Oncology as we build a world-class oncology company that integrates genomic, proteomic, and molecular data sets to identify and validate cancer biomarkers. The Ii-Key technology enables rapid product development and a clear regulatory path for immunotherapeutic peptides that have been proven safe and effective for eliciting immune responses for cancer therapy. The future is bright for advancing immunotherapy as the new standard of care for cancer treatment.”
Headlines Earlier 2019
Generex Launches DME-IQ, the “Smart Solution” for In-Office Management of Durable Medical Equipment - Signs contract with The Orthopaedic Center of Tulsa, OK - Expansion of end-to-end patient solutions with a customized software & service platform that will help increase compliance, optimize workflow, and maximize practice revenues MIRAMAR, FL, January 25, 2019 -- Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) announced today that its wholly owned subsidiary NuGenerex Distribution Solutions 2, LLC (NDS) has launched DME-IQ, a novel service for physicians who manage in-office distribution of durable medical equipment (DME). DME-IQ supports the development and management of compliant and profitable in-office DME programs. DME-IQ focuses on several key areas, which include negotiating on behalf of the physicians with key vendors to decrease the Cost of Goods (COG’s), increasing insurance collections by providing oversight of the coding during the billing process, providing the necessary personnel to manage the appeals processes, and ensuring compliance with state and federal regulations.
DME-IQ will automate and provide the orthopedic practices with a proprietary, tabletbased software package that immediately verifies patient benefits and eligibility. This unique system manages DME inventory, collects patient copays and deductibles, and links patient information with the DME products and necessary patient forms all in one easy to use platform.
The US market for DME is large and growing, a result of several factors including the rising prevalence of chronic diseases requiring long-term care, the rapidly growing geriatric population, and the trend toward home healthcare services. Chronic disorders such as diabetes, diabetic foot & pressure ulcers, chronic pain, and cancer that require long-term patient care and postoperative recovery are driving demand for DME. According to a 2018 market report by Grand View Research, Inc., the US DME market is expected to reach $70.8 billion by 2025, growing at a 6.0% CAGR during the forecast period.
Terry Thompson, President of NDS and COO of Generex, stated “Today we begin the process of changing the perception of DME programs. DME-IQ is excited to announce our first client agreement with The Orthopaedic Center in Tulsa, Oklahoma, a highly regarded orthopedic group practice dedicated to improving patients’ quality of life through advanced clinical and surgical excellence and patient focused compassionate care. Our commitment to transforming cost centers into profit centers will be unparalleled in the market, as we implement the DME-IQ program to enhance patient satisfaction and practice profitability.”
Justin Clary, Practice Administrator of The Orthopaedic Center of Tulsa provided his thoughts on the implementation of DME-IQ, “Previously, we had little control over our DME program, which was managed by an outside firm that rented space in our facility. With the launch of DME-IQ, we are engaging DME-IQ to provide the management services that will enable TOC to bring the DME program in-house and allow us to expand our inventory and service offerings with new products that meet the needs of our patients and lower our cost of goods. DME-IQ tracks and maintains our DME inventory to ensure an adequate supply and product mix for our patient population, and the system facilitates insurance claim submissions and adjudication to help us achieve optimal reimbursements. With the DME-IQ system, the practice gains control of our DME program from an operations and financial perspective, while our patients gain access to a wider variety of DME products that are custom fitted for their needs.”
Joseph Moscato, CEO of Generex stated, “The explosion of high deductible insurance plans has resulted in a dramatic increase of patient out-of-pocket payments for care, and the subsequent requirement that physicians spend more time as collection agents rather than doctors. DME-IQ provides practice workflow solutions for DME with custom, tabletbased software that removes the administrative burden from the practice, facilitating patient eligibility review, collection of patient co-pay and deductibles, centralized insurance adjudication, DME product procurement, and other support services that allow physician practices to increase revenue and service quality. The launch of DME-IQ advances the mission of NDS to provide physicians with end-to-end solutions for patient centric care.” Generex Subsidiary NuGenerex Diagnostics Announces CE-Mark Certification for its Rapid Point-of-Care Express II Syphilis Treponemal Assay Rapid point-of-care syphilis assay - Cleared for sale in the European Union - Addressing the emerging global syphilis resurgence
MIRAMAR, FL /January 24, 2019 / NuGenerex Diagnostics LLC, (www.nugenerexdiangostics.com) a subsidiary of Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT), announced today receipt of the CE Marking Certification for its rapid point-of-care Express II Syphilis Treponemal Assay.
Commercialization of medical devices in the European Union requires meeting the regulatory guidelines of the European Medical Devices Directive (MDD) and fulfillment of those requirements allows a device to carry the “CE-Mark” as verification of its diagnostic authenticity. After completing rigorous test validation and submission of an application to the European Union, NuGenerex Diagnostics is pleased to announce that the CE Mark Certification for its The Express II Syphilis Treponemal Assay has been granted.
The Express II Syphilis Treponemal Assay is a rapid point-of-care diagnostic assay for the detection of syphilis antibodies in primary and secondary syphilis and is based upon NuGenerex Diagnostic’s innovative patent pending point-of-care diagnostic platform, the Express II. The accuracy of the Express II Syphilis Treponemal Assay is equal to or better than standard laboratory assays for syphilis antibodies with sensitivities and specificities of over 99%.
The Express II platform is designed to be used in a broad range of clinical and laboratory medical settings and for direct use by consumers in the home. It is simple to use, with fewer steps of operation than other rapid point-of-care tests. A single drop of blood taken by a simple finger stick is added directly to the device and the assay is activated by placing a pod of buffer solution onto the device. Results can be read in as early as 5 minutes, and no longer than 30 minutes. These simple operations allow the device to be used in all medical setting which include clinics, hospitals, laboratories, and remote field facilities. Importantly, in some countries, Express II devices can be marketed for individual in-home use directly by consumers who can conduct tests by themselves in privacy, without special training or the aid of a separate individual.
There is currently a worldwide epidemic of syphilis and new infections are increasing at an alarming rate. This disease, once on the decline, has reemerged as a major sexually transmitted disease with most new cases occurring in high risk groups of gay or bisexual men. There is also a significant rise of syphilis in pregnant women, with a concomitant rise of congenital syphilis in newborns. The syphilis testing market currently makes up approximately 12-14% of the global
sexually-transmitted disease diagnostic market. However, the syphilis infection rate is rapidly trending upward and these infections are projected to rise to 20% of the sexually-transmitted disease market by 2022.
With the receipt of the CE Mark Certification for its rapid point-of-care Express II Syphilis Treponemal Assay NuGenerex Diagnostics is well situated to enter into this growing syphilis testing market and will now pursue marketing efforts in Europe and, in parallel, begin plans for the filing of a 510k application with the United States FDA for marketing clearance in the United States. To this end, NuGenerex Diagnostics is fully qualified as a diagnostic test developer and manufacturer under FDA Good Manufacturing Procedures (GMP) and is certified by the International Standards Organization for the manufacture of medical devices under ISO 134852016 regulations.
Harold G. Haines Ph.D., President of NuGenerex Diagnostics stated: “At NuGenerex Diagnostics we believe that the commercialization of the Express II Syphilis Treponemal Assay will provide a medically necessary and highly accurate test, for use by both medical professionals and individual consumers, and will significantly augment the ongoing effort to treat and control the rising worldwide epidemic of syphilis, a dangerous disease affecting the health and quality of life of millions of people. Syphilis is a curable disease if diagnosed accurately and treated appropriately. A major key to the effective treatment and elimination of syphilis is rapid and accurate diagnosis as made available by the Express II Syphilis Treponemal Assay. In this respect we are proud to be part of the international medical community’s effort to control the spread of syphilis and look forward to working with medical professionals and affected individuals worldwide in this ongoing effort.”
Dr. Jason Terrell M.D., Generex Chief Medical and Scientific Officer stated, “I’d like to extend my praise and appreciation to Dr. Haines and the NuGenerex Diagnostic team for achieving this milestone. Dr. Haines has created a culture of excitement, innovation, determination, and commitment to success. Under Dr. Haines’ leadership, I expect NuGenerex Diagnostics will continue to expand the product pipeline and deliver multiple high-impact products to patients worldwide.” Generex Announces REVISED Record Date for NuGenerex Immuno-Oncology Stock Dividend MIRAMAR, FL, January 23, 2019 / (Business Wire) / -- Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) today announced that it has REVISED the record date for the previously announced dividend to Generex shareholders of shares in our wholly-owned subsidiary NuGenerex ImmunoOncology (formerly Antigen Express).
The Record Date for the determination of the holders of the Company’s common stock entitled to participate in the dividend will now be January 30, 2019. The dividend Payment Date remains February 25, 2019.
The Company believes that the ex-dividend date will be Monday, January 28, 2019 by application of FINRA Uniform Practice Code rules which provide ex-dividend date for dividends of less than 25 percent of the value a company’s common stock is the second business day prior to the record date.
The ex-dividend date determines whether a shareholder who sells Generex stock will retain the dividend. Based on FINRA rules, Generex understands that If a shareholder holds Generex stock but sells it before the ex-dividend date, the buyer will be entitled to the dividend. If a shareholder holds Generex stock and sells it on or after the ex-dividend date the buyer will not be entitled to the dividend Generex Biotechnology Subsidiary Olaregen Therapeutix Inc. Plans Launch of FDA Cleared Excellagen® Wound Conforming Gel Matrix with Three Dosage Options 9:00 AM ET, 01/11/2019 - Business Wire Plans Commercial Launch of three dosing options for Excellagen in pre-filled syringes The 0.5 cc and 0.8 cc and 3.0 cc doses provide optimal wound coverage while reducing waste and costs 3 cc dose has utility in surgical applications for the treatment of larger wounds and surgical incisions In negotiations with major surgical wound care networks for treatment of diabetic foot ulcers, venous stasis ulcers, and difficult to heal wounds Nationally Renowned Wound Care Thought Leader, Dr. Peter A. Blume of Yale School of Medicine, provides insightMIRAMAR, Fla.--(BUSINESS WIRE)--Jan. 11, 2019-- Generex Biotechnology Corporation (OTCQB:GNBT) is pleased to announce that Olaregen Therapeutix Inc., a subsidiary of Generex Biotechnology will launch three doses of FDA 510K-Cleared Excellagen, the company’s wound conforming gel matrix that is designated as a Cellular & Tissue Based Product or CTP for wound healing. The 0.5 cc and a 0.8 cc syringes will be utilized to treat smaller wounds such as diabetic foot ulcers, venous stasis ulcers, and pressure ulcers, and in patients who have undergone MOHs surgery for removal of cancerous tissue. The 3 cc syringe has been developed for larger wounds that are most frequently seen in emergency departments, operating rooms, and surgical suites. Excellagen has a designated reimbursement code in the Healthcare Common Procedure Coding System, with a unique Q Code designation 4149 referred to as a skin substitute.The Excellagen® launch team is introducing the product in surgical centers, the Department of Defense and VA system, operating rooms, and wound care centers, as well as through podiatric practices. The company is currently in contract negotiations with major nation-wide surgical wound care centers for the use of Excellagen® for the treatment of a variety of wound types, including partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds. Additionally, NuGenerex Distribution Solutions, a wholly-owned subsidiary of Generex, will immediately launch Excellagen® through its MSO network of surgeons and podiatrists in five states.“We’ve heard time and again about the issue of waste, or the need for multiple applications per a single procedure because the existing products don’t necessarily accommodate the size of the wound. This is not only time consuming for the doctor but is cost inefficient,” said Anthony J. Dolisi, Chief Executive Officer of Olaregen. “As part of our commitment to our customers, we listen carefully to their needs. After a thorough analysis of the market, and through discussions with physicians, we determined that Olaregen will launch Excellagen with multiple dosage options that offer clinical flexibility and cost savings with improved clinical outcomes.”Dr. Peter Blume, D.P.M., F.A.C.F.A.S., Medical Director/HVC/Ambulatory Surgery, Yale New Haven Health Systems, Assistant Clinical Professor Of Surgery Anesthesia and Cardiology, Yale School of Medicine, provides his views on Excellagen®, “The average wound size in the surgical setting can be variable and quite large depending on the amount of debridement of soft tissue and bone. Olaregen’s decision to manufacture a 0.5 cc and a 0.8 cc for smaller wounds such as DFU, VSU and Pressure ulcers and a 3 cc syringe for the surgical setting will not only save doctors time but will be highly cost effective and reduce product waste. The company is collaborating with physicians and surgeons with respect to the needs of the wound care community and addressing the unmet needs.”The wound care market is extensive, with an estimated 77 million surgical wounds in the U.S., a percentage of which Excellagen is cleared for use. The wound conforming gel is also indicated to treat Diabetic Foot Ulcers (1,260,000), Venous Stasis Ulcers (1,625,000), and MOHs surgery (850,000) among the 17 wound types Excellagen is cleared to treat. Further, a recent study published in Value in Health (Volume 21, September 2018, 27 – 32) found that total Medicare spending estimates for all wound types ranged from $28.1 to $96.8 billion, as nearly 15% of Medicare beneficiaries or 8.2 million people had at least one type of wound or tissue infection. These figures do not reflect the incidence of burns, amputations, and traumatic wounds and lacerations all which Excellagen is cleared for use. With the aging population and the increase in the incidence of diabetes, these numbers are expected to grow significantly in the future.Anthony J. Dolisi, Chief Executive Officer, provided his view of the market, “We have created a wound care expert salesforce to help guide physicians on the optimal Excellagen dose for a given wound type. As an example, in the surgical setting, a 3 cc pre-filled syringe of Excellagen will cost substantially less than our CTP competitors with demonstrated improvements in healing rates. Olaregen is aggressively pursuing a 'Value Based Healthcare' strategy in line with the goals of the Centers for Medicare and Medicaid Services, which has announced that they will be assessing waste in the wound care system. Discarding unused wound care products is a tremendous cost in the wound care space, so our strategy of multiple dosing options puts Olaregen in a strong market position Generex Biotechnology Announces Acquisition of Surgical Supply and Distribution Company 9:15 AM ET, 01/10/2019 - Business WireMedisource Partners is an FDA registered distributor with an extensive portfolio of medical and surgical products including bone grafts and biologics Partnerships and contracts with hospital systems for ordering, billing, and inventory managementMIRAMAR, Fla.--(BUSINESS WIRE)--Jan. 10, 2019-- Generex Biotechnology Corporation (OTCQB:GNBT) is pleased to announce that the company has entered into a letter of intent (LOI) to acquire Medisource Partners, an FDA-registered distributor of medical and surgical products including bone grafts and biologics from a range of surgical product manufacturers. Under the terms of the deal, Generex will acquire all of the assets of Medisource including business operations, accounts receivable and inventory, contracts, and real estate, on a debt free basis, for One Million Dollars($1,000,000) worth of Generex (GNBT) stock, plus additional cash and stock consideration for achieving certain sales and profit projections.Medisource Partners is a 10-year-old private company, currently contracted with over 25 vendors (including Pantheon Medical) for nationwide distribution of implants and devices for spine, hips, knees, foot, ankle, hand, and wrist surgeries. Additional product lines include biologics (blood, bone, tissue, and stem cells), durable medical equipment, and soft goods. The company also supplies kits to process bone marrow aspirates and platelet rich plasma biologics at the time of surgery.Travis H. Bird, CEO of Medisource, commented on the deal, “MediSource Partners was founded in 2009 and designed to be unique amongst its competitors by operating as a service-focused, 'one stop shop' for the healthcare professionals it serves. With over 25,000 products in its catalogue, including thirteen (13) lines dedicated to spine, Medisource prides itself on its ability to service everything from small private practices across several disciplines, to entire hospital systems. The large and broad-based inventory allows our client physicians to 'customize' their operating environment by selecting and implementing the hardware, biologics, soft goods and ancillary tools they feel most confident in and comfortable with. In addition, the 'one stop shop' model reduces the burden placed on support staff tasked with managing multiple reps from multiple vendors and shortens the distribution chain to reduce costs and potential redundancies. The success of this model is demonstrated in Medisource’s ability to offer this client-focused, low-impact service at a pricing matrix often below even standard GPO pricing, thus increasing client profitability and productivity.”“The strategic acquisition of Medisource Partners provides Generex with a value-added service model that fits the corporate mission of NuGenerex Distribution Solutions, adding immediate revenues and profits, while providing significant upside as we integrate the medical and surgical supply business into our current and future MSO networks,” stated Joe Moscato, CEO of Generex. “The extensive lines of surgical and biological products offered in the Medisource catalogue will enable us to expand our offerings to now include hospital systems, as well as our MSO partners. Our management services will not only integrate purchasing and billing, but will provide better pricing and access to new products, especially biologics, including platelet rich plasma, bone marrow aspirate, cord blood, and bone implants. We are excited that the acquisition of Medisource will provide access to a whole new line of products that not only enhances our current MSO network in the five states, but will eventually support the expansion of our MSO network into 27 states. We are in the process of completing the due diligence on this acquisition, with plans to close the transaction in the coming weeks.” Generex Biotechnology Announces Acquisition of Surgical Device Manufacturer 9:00 AM ET, 01/09/2019 - Business WirePantheon Medical manufactures a line of FDA cleared products used in orthopedic surgeries including screws, plates, implants, and anchorsMIRAMAR, Fla.--(BUSINESS WIRE)--Jan. 9, 2019-- Generex Biotechnology Corporation (OTCQB:GNBT) is pleased to announce that the company has entered into a letter of intent (LOI) to acquire Pantheon Medical – Foot & Ankle, a manufacturer of specialty orthopedic surgery products and tools. Under the terms of the deal, Generex will acquire all of the assets of Pantheon Medical including business operations, accounts receivable and inventory, contracts, and an FDA letter related to balanced plating system, on a debt free basis, for One Million Four Hundred Thousand Dollars ($1,400,000) worth of Generex (GNBT) stock, plus additional cash and stock consideration upon achieving certain sales and profit goals.Pantheon Medical – Foot & Ankle is a multi-million dollar company that began operations in 2014 with a physician friendly, “all-in-one,” integrated kit that includes plates, screws, and tools required for orthopedic surgeons and podiatrists conducting foot and ankle surgeries. Over the next three years, the Company will be developing and submitting several new product lines to the FDA which will include cannulated surgical screws and surgical staples, as well as a proprietary Hammertoe System.Travis H. Bird, CEO of Pantheon Medical, commented on the deal, “Partnering with Generex will enable us to expedite Pantheon’s ability to build a manufacturing company with proprietary product lines that offer convenience and cost effectiveness to physicians. We are already seeing significant uptake in the marketplace with our 'one stop shop' approach to orthopedic surgery, and the new product lines will expand our market reach.”“The acquisition of Pantheon expands the commercial product portfolio of Generex into the surgical field, adding revenues and profits with their current product line and significant upside opportunities for new FDA-approved product introductions over the next several years,” stated Joe Moscato, CEO of Generex. “Our MSO partners, many of whom are orthopedic surgeons and podiatrists, will immediately benefit from Pantheon’s Foot & Ankle surgery kit. The acquisition demonstrates Generex’s commitment to providing end-to-end solutions that enhance physician’s practice and improve outcomes for patients. We are in the process of completing the due diligence on the Pantheon acquisition, with plans to close the transaction in the coming weeks. Generex Biotechnology Completes Acquisition of Olaregen Therapeutix Inc.1:29 PM ET, 01/08/2019 - GlobeNewswire Closes transaction to complete 51% acquisition of Olaregen Therapeutix - Plans Commercial Launch of FDA-cleared Excellagen® MIRAMAR, Fla., Jan. 08, 2019 (GLOBE NEWSWIRE) -- via OTC PR WIRE -- Generex Biotechnology Corporation (GNBT) is pleased to announce that the company has completed the acquisition of 51% of Olaregen Therapeutix Inc., a New York based regenerative medicine company that is preparing to launch its proprietary, patented, wound conforming gel matrix, Excellagen® an FDA 510K Cleared wound healing product cleared for the treatment of 17 types of wounds including partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds. The terms of the deal include the previously reported upfront payment of $400,000, plus $11.6 million to be paid according to a milestone-based schedule. Details of the transaction can be found in the Generex 8K filing to be filed with the SEC in the coming days.“We are pleased to close this acquisition of Olaregen, and excited about the launch of Excellagen®,” stated Joe Moscato, CEO of Generex. “This acquisition demonstrates our commitment to offering “end-to-end” solutions to improve healthcare for doctors and patients. With the acquisitions Olaregen and Regentys, Generex has established a powerful regenerative medicine company with FDA cleared products and innovative therapies in clinical development to drive value and future growth.”Anthony J. Dolisi, CEO of Olaregen commented on the deal, “Our merger with Generex enables us to accelerate the launch of Excellagen® for several indications in a number of market channels, including nationwide distribution with the Department of Defense and the VA, and through surgical wound care centers and our proprietary network of surgeons and podiatrists. We have created a wound care expert salesforce to help guide physicians on the optimal Excellagen dose for a given wound type. Our partnership with Generex will enable Olaregen to reach our potential as a world-class regenerative medicine company with innovative products in wound healing and tissue regeneration.” The wound care market is expected to reach USD 22.81 billion by 2023 from USD 18.99 billion in 2018 at a CAGR of 3.7%. The Olaregen technology has the potential to disrupt the current wound care market. Generex Biotechnology Completes Acquisition of Regentys Corporation Announces closing of 51% acquisition of regenerative medicine company Regentys™ Regentys Extracellular Matrix Hydrogel for the Treatment of Ulcerative Colitis and Other Inflammatory Bowel DiseasesMIRAMAR, Fla.--(BUSINESS WIRE)--Jan. 7, 2019-- Generex Biotechnology Corporation (OTCQB:GNBT) is pleased to announce that the company has completed the acquisition of 51% of Regentys™ Corporation, a regenerative medicine company focused on developing novel treatments for patients with gastrointestinal (GI) disorders. The terms of the deal include the previously reported upfront payment of $400,000, plus $14.6 million to be paid according to a milestone-based schedule. Details of the transaction can be found in the Generex 8K filing with the SEC.The Regentys™ Extracellular Matrix Hydrogel (“ECMH”) is a first-in-class, non-pharmacologic, non-surgical treatment option for patients suffering from Ulcerative Colitis. ECMH is a proprietary, patented UC treatment that protects damaged tissue from waste flow and promotes tissue regeneration and healing rather than suppressing the immune system as other treatments currently do. The product has been developed with polymeric characteristics that transform ECMH from a liquid to gel form upon adherence to the mucosal lining of the diseased colon, providing a “Bio-Scaffold Bandage” to the affected area. The ECMH Bio-scaffold facilitates healing and functional repair of the colon lining, first by covering the ulcer to limit the inflammatory response, then by providing a framework to mobilize the body’s tissue repair mechanisms. Regentys has received guidance from FDA that the treatment can be approved through the FDA Office of Device Evaluation as a 510K de novo application, and the company will initiate the clinical studies necessary to obtain that approval by Q4 2019.Ulcerative Colitis (“UC”), a disease that affects approximately 750,000 patients in the United States and 1.9 million patients worldwide, is a chronic, inflammatory disease that causes sores or ulcers in the lining of the large intestine (the colon). There are currently four biologics approved by FDA, including the top-selling antibody medicines Humira (adalimumab), Simponi (golimumab), Remicade (infliximab) and Entyvio (vedolizumab), all of which target the pro-inflammatory protein, TNF-α (Tumor Necrosis Factor Alpha). Even with the introduction of expensive biologics, more than half of all patients with ulcerative colitis [UC] do not achieve long-term remission. Many, because of disease progression, require colectomy surgery. Future indications for the company’s product platform include Crohn’s Disease, an inflammatory bowel disease, as well as rectal mucositis, a condition arising from cancer radiation treatments, conditions that affect millions of patients.Joe Moscato, CEO of Generex commented on the acquisition, “The completion of this Regentys acquisition demonstrates our commitment to build a world-class regenerative medicine business by acquiring great companies with cutting-edge, patented technologies and exceptional management teams. Our direct investment in the clinical development of Regentys ECMH will provide long-term value to Generex investors as we achieve milestones on the path to commercialization in the billion dollar markets for ulcerative colitis and other inflammatory bowel diseases.”Rick Bulman, CEO of Regentys™ continued, “Our partnership with Generex provides Regentys with a number of advantages, and we are happy to join the NuGenerex family of subsidiary companies. The merger agreement offers not only the financing to advance our clinical development efforts, but the Generex corporate philosophy also promotes continuity by supporting our scientific, medical, and leadership team with resources, relationships and industry knowledge that will accelerate the commercial introduction of Regentys ECMH.” Generex Biotechnology Provides Update on NuGenerex Immuno-Oncology
Update on AE37 Clinical Trial ? NuGenerex Immuno-Oncology Spin Out and Stock Dividend MIRAMAR, FL, January 4, 2019 Generex Biotechnology Corporation (OTCQB:GNBT) is pleased to provide an update on operational and strategic developments at NuGenerex Immuno-Oncology (previously Antigen Express), a wholly-owned subsidiary. The protocol for the Phase II clinical trial of pembrolizumab (Keytruda?) in combination with the AE37 Peptide Vaccine in patients with metastatic triple negative breast cancer is under review at the Institutional Review Board (IRB) with oversight of this NSABP Foundation managed study. Site selection has begun, and study drugs are being packaged for shipment to study sites. “With the initiation of the AE37/PD-1 Inhibitor combination trial and the advancement of the company’s clinical development partnership with Shenzhen BioScien for AE37 in prostate cancer, we have validated the Ii-Key technology, as a viable immunotherapy platform,” said Richard Purcell, SVP of R&D at Generex. “The Ii-Key can activate a CD-4 T-cell immune response against any peptide to which it is linked. Given the advances in immunotherapy in the last couple of years, and the potential combinations with checkpoint inhibitors like pembrolizumab, NuGenerex Immuno-Oncology is positioned, with years of clinical experience in immunotherapy of cancer, to explore a range of opportunities for the Ii-Key technology in personalized medicine using tumor-associated antigens and neoantigens for tumor-specific cancer therapy. To that end, Generex has initiated partnering discussions with synergistic companies to explore co-development and collaborative R&D opportunities for immunotherapeutic product development.”
NuGenerex Immuno-Oncology Spin-Out & Stock Dividend
Generex President & Chief Executive Officer Joe Moscato stated, “NuGenerex Immuno-Oncology is being established to not only to advance the NuGenerex Immuno-Oncology core technology, but also to expand the Company’s portfolio in the field of immunotherapy and personalized medicine through partnerships and acquisitions. As part of our strategy, we are exploring opportunities to spin-out NuGenerex Immuno-Oncology as a separate DTC-eligible SEC registered company. Mr. Moscato stated that following the spin-out, NuGenerex ImmunoOncology is expected to seek to list its common stock on a national stock exchange. "The spin-out of NuGenerex Immuno-Oncology into a separate, publicly traded entity has been the focus of the Generex strategic development plan in cancer drug development," Mr. Moscato indicated. "The Ii-Key technology has been underappreciated for too long, as we have advanced the immunotherapy field with the largest breast cancer vaccine study ever conducted, and now the results of that trial have led to an exciting combination Phase II trial with AE37 plus Ketruda? in triple negative breast cancer. We believe this spin-out will help to unlock the true value of the Ii-Key technology for our stockholders as it creates a pure play in immunotherapy, which will foster investment and collaboration.” The spin-out will be accomplished by the issuance of one or more dividends of NuGenerex Immuno-Oncology stock to Generex stockholders. The record dates in respect of such dividends are yet to be determined and will be announced in due course. The stock dividends will enable Generex stockholders to directly participate in the promising future of NuGenerex Immuno-Oncology as well as create a large shareholder base with the potential for substantial liquidity on an immediate basis. That liquidity will be further enhanced should NuGenerex Immuno-Oncology be successful in attaining a national stock exchange listing, and should provide NuGenerex Immuno-Oncology with ready access to the capital markets to finance its on-going clinical and regulatory initiatives. Following the issuance of stock dividends, Generex expects to retain a controlling interest in NuGenerex Immuno-Oncology, but the exact proportion of the shares to be held by Generex has not yet been determined. Subject to market conditions and the satisfaction of regulatory requirements, it is expected that the NuGenerex Immuno-Oncology spin-out will occur sometime following the upcoming Annual Meeting of the Generex stockholders. Generex has formed a committee to seek qualified professionals to populate NuGenerex Immuno-Oncology's Board of Directors, Scientific Advisory Board, and executive management team. Further announcements in respect of the status of the spinout are expected to be made over the course of the coming months.
About Generex Biotechnology Corporation Generex is a strategic, diversified healthcare holdings company with offerings in a variety of services, diagnostics, medical devices, and pharmaceutical development. The Company’s direct-to-patient services support its strategy of allinclusive access to doctors, diagnostics, therapeutics, and additional healthrelated services to greatly improve the patient experience in receiving care. On the provider side, Generex’s management services remove administrative burdens in multiple provider settings, including private practice and hospital, allowing doctors to devote more time to patient care. Revenue from the Company’s subsidiaries will support clinical advancement of its wholly owned therapeutic products with a focus in immunotherapeutics based on stimulating critical members of the immune response, known as T helper cells, and its proprietary buccal administration of insulin.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Welcome to Generex
Generex Biotechnology is an integrated healthcare holding company with end-to-end solutions for patient centric care from rapid diagnosis through delivery of personalized therapies. Generex is building a new kind of healthcare company that extends beyond traditional models providing support to physicians in an MSO network, and ongoing relationships with patients to improve the patient experience and access to optimal care.
In addition to advancing a legacy portfolio of immune-oncology assets, medical devices, and diagnostics, the Company is focused on an acquisition strategy of strategic businesses that complement existing assets and provide immediate sources of revenue and working capital. Recent acquisitions include a management services organization, a network of pharmacies, clinical laboratory, and medical device companies with new and approved products.
Our newly formed, wholly-owned subsidiary, NuGenerex Distribution Solutions (NDS), integrates our MSO network with a pharmacy network, clinical diagnostic lab, durable medical equipment company (DME-IQ) and dedicated call center. Generex Biotechnology has been engaged primarily in the research and development of drug delivery systems and technologies. Our primary focus has been our proprietary technology for the administration of formulations of large molecule drugs to the oral (buccal) cavity using a handheld aerosol applicator. Generex Biotechnology has a two business focuses: 1) implementing an acquisition strategy and 2) financing sponsored clinical trials. We are positioning ourselves as a diversified holding company involved in increasing our "pipeline" of compounds, therapies, treatments, diagnostics, and technologies in all stages in the FDA process through accretive acquisitions. We are also strategically aligning ourselves with the global biopharmaceutical companies by providing a financing solution to them as sponsors of clinical trials, which are conducted by patient care providers (PCPs) such as hospitals, medical research institutes, centers.
OUR MISSION To provide physicians, hospitals, and healthcare providers an end-to-end solution for patient centric care from rapid diagnosis through delivery of personalized therapies, streamlining care processes, minimizing expenses, and delivering transparency for payers
CORPORATE OFFICERS Joseph Moscato - Chief Executive Officer, President and Chairman of the Board
Mr. Moscato has over 30 years of experience in healthcare, sales and marketing, distribution management, and finance. Mr. Moscato brings his marketing and advertising acumen to drug discovery and diagnostic & treatment development and commercialization. Since 2009, Mr. Moscato has been working as an exclusive consultant to the Company. Mr. Moscato has originated and negotiated several licensing deals with the top biopharmaceutical companies; has advised on equity financings totaling over $300 million, and has implemented the broad strategic vision for the Company. Mr. Moscato has worked and consulted for Pfizer in several capacities from sales and marketing to new drug discovery & development for licensing. He has worked with other biopharmaceutical companies such as GlaxoSmithKline, Johnson & Johnson, Parke-Davis, Amgen and others. Mr. Moscato has consulted for several healthcare focused private equity, hedge funds and family offices.
Mr. Moscato also owned several advertising and marketing agencies focused on media, entertainment, and healthcare with clients ranging from Motorola, Chadmoore Wireless, Nextel, Cannon, Sharp, GlaxoSmithKline, Pfizer, and other biopharmaceutical companies. Mr. Moscato’s agency was acquired by William Douglas McAdams, one of the largest independent healthcare advertising and marketing agencies.
Terry Thompson - Chief Operating Officer
Terry Thompson brings a wealth of experience and expertise in healthcare, providing executive leadership in pharmacy benefits management, network administration, claims processing, and distribution & logistics for drugs, durable medical equipment (DME), and infusion therapy, as illustrated by his impressive 35-year career.
Mr. Thompson started his career working with FedEx, one of the most successful startups of our era, from the company’s pre-IPO infancy to its proven “changing the way the world does business” outcome. After leaving FedEx, he used his expertise in healthcare, focusing on the pharmacy sector, to participate in the creation of the nation’s first Pharmacy Benefits Manager (PBM), Medco Containment Services, ultimately serving as Executive Vice President of Merck-Medco post-acquisition, and President of National Rx Services and Paid Prescriptions. Following his work with Medco, Mr. Thompson was COO of Synetic, Inc.’s Institutional Pharmacies, where he assimilated numerous acquired full service companies. Additionally, he brings relevant experience as Chief Operating Officer of Merit Behavioral Care Corp., a KKR buyout and largest Specialty HMO at the time, Chief Executive Officer of Closer HealthCare, Inc., a DME and Diabetic Supply Company, supporting the NIH’s ACCORD and BARI IID clinical trials, and Independent Director of ProVantage Health, a billion dollar publicly traded PBM. For the last several years, Mr. Thompson has provided consulting services to C-Level executives and their teams, primarily in healthcare.
Andrew Ro - Chief Investment Officer and a Director
Mr. Ro has over 20 years’ experience in the financial markets ranging from trading global futures and equity markets, senior secured debt, convertible securities, private investments in public equities (PIPEs) and investing. Mr. Ro was a Consultant and Registered Representative with boutique investment and merchant banks where he consulted and advised US and international companies on capital markets, operational, and regulatory issues as well as being involved in capital raising, mergers & acquisitions, and strategic implementation. Mr. Ro was a Partner with an active Investment Fund where he was involved in originating, structuring, negotiating and closing financing transactions providing growth capital, acquisition financing, recapitalization, restructuring and general working capital to late-stage venture, distressed and middle market companies across all industries and sectors. Mr. Ro originated and structured over $2 billion in total commitments and managed a portfolio of over $650 million in investments. Mr. Ro graduated from George Mason University with a Bachelor in Science in Economics. He also held Series 3, Series 7, and Series 63 licenses.
Mark Corrao - Chief Financial Officer and Treasurer
Mr. Corrao has experience in financial management with a proven track record of raising capital and extraordinary bottom line management. He has been involved in the initial registration of numerous public companies and subsequent SEC quarterly and annual reporting and has developed, authored and presented numerous business plans and models inclusive of budgets, forecasts, cash flow, cash management and investment strategies. From 2012 to present he has been a Managing Director and CFO of The Mariner Group LLC, which has merged with the CFO Squad, creating a much larger and diverse multi-talented organization. The CFO Squad is a financial and business advisory firm providing outsourced and part-time CFO services for emerging to midsized companies (both private and public) in a wide range of businesses and industries. He is the Chief Financial Officer for a pharmaceutical company specializing in the research and development of novel and new therapeutic agents designed to reduce oxidative stress and act as immune modulators and Neuroprotectants. From 2010-12, he served as Chief Financial Officer of New York Business Efficiency Experts, Inc. which provides professional services in the financial areas of accounting, taxation, auditing, venture capital and SEC registrations (reporting). He served as a Director and Chief Financial Officer for a manufacturer of proprietary software for the prevention of identity theft and the protection of computer systems from unauthorized access. Additionally, Mr. Corrao is currently the CFO for a software company.
Dr. Jason B. Terrell, MD. - Chief Scientific Officer and Chief Medical Officer
Dr. Terrell has extensive expertise in the pharmaceutical and medical diagnostic device industry in the areas of business development, clinical trial organization, regulatory affairs and commercialization strategies. Dr. Terrell has served as medical director and chief medical officer for several public and private companies like VolitionRx, a NYSE traded international medical diagnostic company. Dr. Terrell previously served as a Corporate Medical Director for Any Lab Test Now, the nation’s largest direct to consumer medical testing franchise, where he supervised clinical operations for over 70 locations throughout the United States. Dr. Terrell is a summa cum laude graduate from Hardin-Simmons University with a degree in Biochemistry. He graduated as recipient of the Holland Medal of Honor for the top graduate in the School of Science and Mathematics. Dr. Terrell was honored with the Hardin-Simmons University Outstanding Young Alumni Award and currently serves on the University’s Board of Development. Dr. Terrell is an Assistant Clinical Professor of Oncology at the University of Texas Dell Medical School in Austin, Texas, he attended The University of Texas School of Medicine in Houston and received General Medicine Internship and Pathology Residency training at the Texas Tech University Health Sciences Center.
Richard Purcell - Senior Vice-President of Research & Drug Development
Mr. Purcell has over 30 years of experience in consulting and advising emerging biopharmaceutical and technology companies on new business strategy, operations management, clinical development of novel compounds, data solutions for clinical and medical applications, patient engagement & communication, medical education for professionals and consumers, and data analytics for outcomes research. Mr. Purcell oversaw strategic planning, clinical operations, data management, regulatory filings, and R&D and was involved with business development and out-licensing activities for the company’s technology platform.
He started his career as a molecular biologist, where he developed and patented a second generation TPA with increased half-life. He also worked at a major pharmaceutical company where he conducted primary research and published several manuscripts on the topics of AIDS and immunomodulators. Mr. Purcell also headed the Life Sciences Consulting Group for Kline and Company, where he conducted market, technology and business analysis for the commercial development of pharmaceutical and biotechnology products for therapeutic and diagnostic applications.
Rich graduated with a degree in Biochemical Sciences from Princeton University, and attended Rutgers Graduate School of Management majoring in marketing and finance. He is a member of NJTC, HIMSS, the Patient-Centered Primary Care Collaborative, the Drug Information Association and the Licensing Executives Society. He is also an Adjunct Professor of Biology at Monmouth University where he developed and teaches The Business of Biotechnology.
Dick Suedkamp - Executive Vice President, Finance and Accounting
Dick Suedkamp is the EVP of Finance at Nugenerex, where he manages the company's finance and accounting functions. Prior to Nugenerex, Dick spent two years in finance and accounting leadership roles at Veneto Holdings and most recently served as Chief Financial Officer. During his tenure, Dick was instrumental in building out the finance and accounting business support capabilities and function at Veneto. Dick also spent almost 12 years in public accounting in the Big 4. He received his bachelor of business administration and master of professional accounting degrees from the University of Texas at Austin and is licensed as a CPA in the state of Texas.
Steve Worster - Chief Compliance Officer
Mr. Worster has more than fifteen years of healthcare compliance experience including holding executive level positions with Cardinal Health and HMS. As part of his prior compliance rolls Mr. Worster has also been responsible for managing data security, physical security and business continuity programs. In addition to leading the compliance function, Mr. Worster will also act as the company’s Chief Privacy Officer. Prior to working in Compliance, Mr. Worster worked as a police officer for six years in suburban Columbus, Ohio and is a Veteran of the Air Force. He earned BA from The Ohio State University and his Juris Doctorate from Villanova University’s Charles Widger School of Law.
Brad Guy - Chief Human Resource Officer
Mr. Guy brings deep domain knowledge and experience in the areas of HR Strategy, Compensation and Benefits, Recruitment & Selection and Organization Design. He was previously the Vice President of Human Resources at Veneto Holdings, LLC before joining Generex as our Chief Human Resources Officer. Mr. Guy brings a wealth of experience in Healthcare, Financial Services, Strategy Consulting and Consumer Products having worked for publicly traded companies such as, Alcon Laboratories, a subsidiary of Novartis Pharmaceuticals, Yum! Brands, Inc., CapitalOne as well as diversified money managers like Highland Capital Management, LLC and strategy consulting firms. Mr. Guy began his career in management consulting and executive search. He earned his MBA with distinction from the University of Dallas and his BBA from the University of North Texas.
Antigen Express, Inc. is a wholly owned subsidiary of Generex. Antigen Express is a platform and product-based company developing proprietary vaccine formulations for large, unmet medical needs. Our focus is on stimulating critical members of the immune response, known as T helper cells. The technology allows for antigen-specific stimulation or suppression of a T-helper response to virtually any antigen of known pathogenic potential. Consequential, Antigen Express is building a deep pipeline of therapeutics aimed at a variety of major diseases, including cancer, infectious diseases and autoimmune-based syndromes. Antigen Express therapies are based on highly selective modulation of the immune response, in contrast to most current immunomodulation strategies that are in general non-specific. This lack of specificity is the prime source for unwanted side effects. The therapies developed at Antigen Express intervene at the critical stage of antigen presentation to modulate the immune response. This targeted approach results in a potent up or down regulation of critical members of the immune system. The technologies developed at Antigen Express are novel and highly complementary to existing approaches of immune modification. Therefore, the company is uniquely positioned to develop partnerships where Antigen Express technology enhances or augments the corporate partners’ technology or product portfolios. Antigen Expres Antigen Express is a platform technology and product-based company developing proprietary vaccine formulations for active immunotherapy as well as disease prevention. In contrast to traditional therapies, the goal of active immunotherapy is to amplify the patients' ability to fight specific disease rather than targeting the diseased tissue or pathogenic agent directly. The novel technologies being developed at Antigen Express allows for robust and antigen-specific stimulation of CD4+ T cells, a cell type critical in the recognition of pathogens and modulation of the immune response. Antigen Express is developing these technologies for application to the treatment of cancer, infectious diseases, and other serious diseases. Our most advanced vaccine utilizes a self-potentiating peptide as an off-the-shelf product for active immunotherapy of breast and prostate cancer To find out more on Antigen Express please go to www.antigenexpress.com.  | {C} |  
Eric von Hofe, PhD
President Dr. von Hofe joined Antigen Express in November of 2003. Prior to this time he held two positions at Millennium Pharmaceuticals; first as Program Director for Target Validation, where he presided over technology development efforts for Aventis and Cereon, and second as Director of Programs and Operations, Discovery Research. He received his Ph.D. from the University of Southern California and was a postdoctoral fellow at the University Hospital of Zurich and Harvard. From 1989 to 1992 he was Assistant Professor of Pharmacology at the University of Massachusetts Medical School.
Scientific Advisory Board
Gabriel Hortobagyi, MD
The University of Texas MD Anderson Cancer Center
Dr. Hortobagyi chairs the department of breast medical oncology and directs the Breast Cancer Research Program at the University of Texas M.D. Anderson Cancer Center, where he also serves as professor of medicine and holds the Nellie B. Connally Chair in Breast Cancer.
Dr. Hortobagyi's research includes combination chemotherapy regimens, presurgical chemotherapy, and targeted therapies for all stages of breast cancer. He has contributed more than 800 articles to scientific journals, authored and co-authored 13 books, and contributed over 130 chapters to textbooks.
For his efforts in breast cancer research, Dr. Hortobagyi has received worldwide honors. In 2001, President Jacques Chirac named him Chevalier of the Order of la Legion d'Honneur de France. In 2003, Dr. Hortobagyi received the Glen Robbins Award in Breast Cancer Research from the New York Cancer Society and the Metropolitan Breast Cancer Group, and the Bristol-Myers Squibb 2003 Horizon Scientific Award. The Mexican Society of Oncology named him the 2005 World Leader in Oncology.
Dr. Hortobagyi was elected President of the American Society of Clinical Oncology (ASCO) for the 2006-2007 term. He chairs the Breast Committee of the Southwest Oncology Group as well as the Data and Safety Monitoring Committee of the National Surgical Adjuvant Breast and Bowel Project.
Nuhad Ibrahim, MD
The University of Texas MD Anderson Cancer Center
Dr. Nuhad Ibrahim is a Professor in the Department of Breast Medical Oncology, Division of Cancer Medicine at the University of Texas MD Anderson Cancer Center. He is a leader on the US-Middle East Breast Cancer Awareness & Research Committee, and is on the Steering committee for the Sister Institution relationship between M. D. Anderson Cancer Center and the Faculty of Medicine and Medical Center of the American University of Beirut. He is also a Member of the Institutional Research Grants Program Study Section Review Committee for Clinical Translational and Population-Based Research Projects at MD Anderson. Dr. Ibrahim focuses his research efforts on vaccines in breast cancer, breast geriatric oncology, and treatment of resistant breast cancer. He has published extensively on his research to improve outcomes for the most difficult to treat breast cancers. Dr. Ibrahim has been recognized as one of America’s Top Doctors annually since 2003.
Dr. Ibrahim received a dual undergraduate degree in Biology and Chemistry, from American University of Beirut, Lebanon, and his MD in Medicine at the Baghdad Medical College, Baghdad, Iraq. He completed surgical residencies and his Fellowship in Clinical Hematology-Oncology at the American University of Beirut Medical Center, Beirut, Lebanon. Dr, Ibrahim completed residencies in Internal Medicine at SUNY Health Science Center, Brooklyn, NY and at St. Luke's-Roosevelt Hospital, New York, NY, and a Postdoctoral Fellowship in Medical Oncology at The University of Texas MD Anderson Cancer Center.
Samuel Jacobs, MD
NSABP, University of Pittsburgh Hillman Cancer Center
Samuel Jacobs, MD is a Clinical Professor in the Department of Medicine, University of Pittsburgh School of Medicine, and the Director of Medical Affairs for the National Surgical Adjuvant Breast and Bowel Project (NSABP). Dr. Jacobs has a long and distinguished career as a clinical researcher in the fields of breast oncology and lymphoma, with a focus on adjuvant and neo-adjuvant therapy.
For the last four years, Dr. Jacobs has been intimately involved with the research efforts of the NSABP Foundation, Inc., which has more than 700 research sites in North America and an international network of oncology and research professionals. The NSABP pioneered breast cancer studies that led to the establishment of lumpectomy plus radiation over mastectomy as the standard surgical treatment for breast cancer and was also the first group to demonstrate that adjuvant therapy (treatment in addition to surgery) could alter the natural history of breast cancer, increase survival rates, and prevent recurrence using tamoxifen and raloxifene.
In addition to his work in oncology treatment protocols, Dr. Jacobs has also conducted considerable research on the logistics and management of the clinical trial process, particularly in oncology. He has led the efforts at the University of Pittsburgh Clinical Research Service to provide study development and implementation assistance, IRB processing, patient recruitment, study coordination, and specimen and data collection for all investigators conducting cancer-related studies at all UPMC Cancer Centers.
Dr. Jacobs received his MD from the University of Rochester, and has spent his career making the University of Pittsburgh Medical Center a leading institution in the field of oncology and cancer management.
Keith Knutson, PhD
Mayo Clinic
Dr. Knutson's current interests and research focuses on the immunology and immunotherapy of breast and ovarian cancers, both the basic immunobiology and clinical translation, including clinical trials. The laboratory conducts research on cancer vaccines focuses on augmenting CD4 helper T cell immunity using peptide epitopes. These vaccine strategies are aimed at preventing the patients from relapsing after optimal conventional therapies. Adoptive T cell therapy is also being examined, a strategy that involves infusing high numbers of T cells into patients with active bulky malignancy.
In addition to his research, Dr. Knutson participates in and chairs several study sections; is Director of the Mayo Clinic Cancer Center Immunology and Immunotherapy Program; Co-director, Mayo Clinic Immune Monitoring Core; and Director, Ovarian Cancer Immunotherapy Program at Mayo Clinic.
Dr. Knutson received his Ph.D. from the University of Georgia in Physiology and Pharmacology in 1995 and completed two post-doctoral fellowships in immunology: One at the University of British Columbia; and the other at the University of Washington. He was a 2004 recipient of a Howard Temin Award from the National Cancer Institute.
Ian Krop, MD, PhD
Dana-Farber Cancer Institute
Ian Krop, MD is Assistant Professor, Department of Medicine, at the Dana Farber Cancer Institute at Harvard Medical School. He is a renowned leader in the field of breast cancer, with an extensive publication record focused on biomarker targeting for the improvement of clinical outcomes. Dr. Krop’s research goal is to identify novel predictive markers and therapeutic targets in breast cancer and translate these discoveries into clinically useful reagents. To accomplish this goal, he has established an ongoing collaboration with Dr Kornelia Polyak to use SAGE (Serial Analysis of Gene Expression) to identify genes important in the interaction between cancerous breast epithelial cells and tumor associated stromal cells. This technology has yielded a number of potential therapeutic targets including two chemokine receptor/ chemokine ligand pairs as well as several cathepsin family members, the expression of which is markedly dysregulated in either tumor epithelial cells and/or tumor associated stromal cells. His research laboratory is currently validating these proteins as potential targets through the use of small molecule inhibitors in in vitro and in vivo models of tumor-stromal interaction. In addition to this ongoing project, Dr. Krop is directing directing or co-directing several clinical trials with the aim of identifying novel molecular predictors of response to conventional chemotherapeutic and molecularly targeted therapies.
Dr. Krop is Board Certified in Internal Medicine and Medical Oncology. He received his medical training and conducted his residency at Johns Hopkins University School of Medicine, and completed his Fellowship in Hematology & Oncology at Dana-Farber/Partners CancerCare.
Gary Lyman, MD
Duke University School of Medicine
Gary H. Lyman MD, MPH, FASCO, FRCP(Edin) is Professor of Medicine and Director of Comparative Effectiveness and Outcomes Research – Oncology at Duke University and the Duke Cancer Institute. Dr Lyman is also a Senior Fellow at the Duke Center for Clinical Health Policy Research. Dr Lyman previously served as Professor of Medicine, Director of Medical Oncology and Chief of Medicine at the H Lee Moffitt Cancer Center and Research Institute.
Dr. Lyman’s research interests include personalized cancer supportive care, comparative effectiveness studies of targeted therapies and biomarkers, mathematical and statistical prognostic and predictive models, advanced methods of evidence synthesis in support of clinical practice guidelines and population studies of patterns of cancer treatment and the impact of health disparities on the quality of cancer care.
Dr Lyman is active with the American Society of Clinical Oncology, serving as Chair-Elect of the ASCO Clinical Practice Guideline Committee having chaired the Methodology Subcommittee for several years. Dr Lyman also Chairs several ASCO guideline panels including those related to Prevention and Treatment of Venous Thromboembolism in Cancer, Sentinel Node Biopsy in Early-Stage Breast Cancer and Melanoma, Use of Antiemetics in Patients Receiving Cancer Chemotherapy and Weight-Based Chemotherapy Dosing. Dr Lyman is also a member of the ASCO Biomarkers Guideline Working Group, the Comparative Effectiveness Research Task Force and the Cost of Care Task Force and in 2010, Dr Lyman received the prestigious ASCO Statesman Award and was recently elected to the ASCO Board of Directors. Dr Lyman is an advisor to the US Food and Drug Administration and the Oncology Drug Advisory Committee (ODAC). He is Editor-In-Chief of Cancer Investigation and the Peer Review Editor for ASCO’s Journal of Oncology Practice and on the Editorial Board of the Journal of Clinical Oncology and several other subspecialty journals. In addition to serving as a Fellow of ASCO, Dr Lyman is a Fellow of the Royal College of Physicians (Edinburgh), the American College of Physicians, the American College of Preventive Medicine and the American College of Clinical Pharmacology.
Dr Lyman received his undergraduate and medical degree from the State University of New York in Buffalo and completed internal medicine residency at the University of North Carolina in Chapel Hill. He subsequently completed a Clinical Hematology/Oncology Fellowship at the Roswell Park Memorial Institute and a Postdoctoral Fellowship in Biostatistics at the Harvard School of Public Health and the Dana Farber Cancer Center.
Kathy D Miller, MD
Indiana University Melvin and Bren Simon Cancer Center
Dr. Miller’s career combines both laboratory and clinical research in breast cancer. She has served as co-chair of the Hoosier Oncology Group Breast Committee since early 2002 and became co-chair of the Eastern Cooperative Oncology Group Breast Core Committee in 2010. In these roles she has worked with community oncologists to develop trials that combine clinical and biologic endpoints yet remain feasible in non-academic settings. Dr. Miller first honed her ability to coordinate multi-center trials as principal investigator for E2100, the first phase III trial to confirm the benefits of antiangiogenic therapy in patients with metastatic breast cancer. Dr. Miller currently leads E5103, an international phase III trial investigating antiangiogenic therapy in the adjuvant setting.
Dr. Miller received her MD in 1991 from the Johns Hopkins School of Medicine in Baltimore, MD. Dr. Miller completed internal medicine training at Hopkins, then returned to her native Midwest for fellowship training at Indiana University, serving as Chief Fellow in 1997. She returned to Indiana University in 1999, attaining the rank of Associate Professor and Sheila D Ward Scholar in 2005.
James Mulé, PhD
H. Lee Moffitt Cancer Center & Research Institute
Dr. Mulé is the Executive Vice President and Associate Center Director for Translational Research, the Michael McGillicuddy Endowed Chair for Melanoma Research and Treatment, and the Co-Director of the Donald A. Adam Comprehensive Melanoma Center at the Moffitt Cancer Center.
He serves on the Board of Directors of Medicine in Need, Cambridge, MA (a non-profit spin-out of Harvard University), and is a member of the Scientific and Medical Advisory Board of Aura Biosciences (a for-profit spin-out of MIT); both selected as 2010 Technology Pioneers by the World Economic Forum, Davos). Dr. Mulé remains a long-standing special government employee to the FDA and the NCI. He was Chair of the Cellular, Tissue, and Gene Therapy Advisory Committee of CBER, FDA.
Dr. Mulé currently serves on the advisory boards of several NCI-designated Cancer Centers and was a member of the NCI Director’s Board of Scientific Counselors (BSC-A, clinical).
Dr. Mulé has or is currently serving on the Scientific/Medical Advisory Boards of numerous privately or publicly held companies (e.g., Celgene, Genesis Biopharma), and has been or is a consultant to many others. Dr. Mulé is recognized for his research and clinical contributions to cancer immunotherapy, particularly in solid tumors. His clinical research group is involved in vaccine strategies and other approaches to stimulate the immune system to recognize and destroy tumors. Dr. Mulé has published nearly 200 articles in the areas of cancer vaccines and cancer immunotherapy. He is a 2012 nominee to the Institute of Medicine, National Academy of Sciences.
Dr. Mulé serves on the Board of Directors of Medicine in Need, Cambridge, MA (a non-profit spin-out of Harvard University), and is a member of the Scientific and Medical Advisory Board of Aura Biosciences (a for-profit spin-out of MIT); both selected as 2010 Technology Pioneers by the World Economic Forum, Davos). Dr. Mulé remains a long-standing special government employee to the FDA and the NCI. He was Chair of the Cellular, Tissue, and Gene Therapy Advisory Committee of CBER, FDA.
Dr. Mulé received his post-graduate degrees from the University of Washington and the Fred Hutchinson Cancer Research Center, Seattle, Washington. He then received his formal post-graduate training at the Division of Cancer Treatment, National Cancer Institute, NIH, Bethesda, Maryland, and soon became a tenured, Senior Investigator there at the Surgery Branch.
Hope Rugo, MD
University of California, Division of Hematology and Oncology
Dr. Rugo is a clinical professor of medicine in the division of hematology and oncology at the University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center, where she directs the Breast Oncology Clinical Trials Program. Her research interests include innovative new therapies for women with advanced breast cancer, evaluation of special circulating cells to help figure out response to therapy, complementary medicine, and supportive care.
Dr. Rugo is an investigator in the Bay Area Spore at UCSF's Carol Franc Buck Breast Cancer Center and the principal investigator of a number of clinical trials. She has published many peer-reviewed papers and has given presentations on a variety of cancer-related topics. Dr. Rugo is a member of the Cancer and Leukemia Group B, a national clinical research group sponsored by the National Cancer Institute.
With a summa cum laude undergraduate degree from Tufts University, Dr. Rugo received her M.D. from the University of Pennsylvania School of Medicine and completed both a residency in internal medicine and a fellowship in hematology and oncology at the UCSF. Additionally, she completed a two-year post-doctoral fellowship in immunology at Stanford University.
Robert E. Humphreys, MD, PhD Founder (retired)
Dr. Humphreys was the Chief Scientific Officer of Antigen Express from it's inception, and at the time of his retirement held the position of Executive Vice President. Prior to joining Antigen Express, he was Professor of Pharmacology and Medicine, and interim Chair of Pharmacology at the University of Massachusetts Medical School. He received his BS, PhD and MD at Yale, and served in the US Navy at the US Naval Hospital and Naval Medical Research Institute in Bethesda. He was a postdoctoral fellow of Dr. Jack Strominger at Harvard. He has published over 140 peer-reviewed papers and has served 10 years on NIH study sections. | | |