- 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 Corporation9:15 AM ET, 01/07/2019 - Business Wire
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, and clinics.
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
Joseph Moscato - Chief Executive Officer, PresiCalifornia and Texas.
Mark Corrao - Chief Financial Officer and Treasurer
Dr. Terrell has extensive expertise in the pharmacapplications.
Rich graduated with a degree in Biochemical Sciences from Princeton U
Dick Suedkamp - Executive Vice President, Finance and Accounting
Dick Suedkamp is the EVP of Finance at Nugenerex, where he
Roger Ivey - Executive Vice President and General Counsel
Mr. Ivey brings deep and varied experience as in-house, healthc
Brad Guy - Chief Human Resource Officer
Mr. Guy brings deep domain knowledge and experience in the
Lawrence Salvo - Director
agency was acquired by William Douglas McAdams, one of the largest
Terry Thompson - Chief Operat
Roger Ivey - Executive Vice President, General Counsel
Mr. Ivey brings dee3, Series 7, and Series 63 licenses.
Mark Corrao - Chief Financial Officer and Treasurer
Dick Suedkamp - Executive Vice President, Finance
Roger Ivey - Executive Vice President and General Counsel
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 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
Eric von Hofe, PhD
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
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.