Generex Biotechnology Announces Organizational Roadmap & Investor Conference Call: Update on Product Launch, New Acquisitions, Financing, Expansion Initiatives & Strategic Plans

MIRAMAR, Florida, April 29, 2019 /PRNewswire/ --

• Launch of ExcellagenÒ for Wound Healing by subsidiary Olaregen Therapeutix
• Pending completion of acquisitions:
• Pantheon Medical, MediSource Partners, and Fuse Medical,
• Financing initiatives 
• S1 Filing
• Application for up-list to national exchange
• Conference call scheduled for May 15, 2019

Generex Biotechnology Corporation (www.generex.com) (OTCQB: GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) today announced that the company has scheduled an investor conference call for May 15, 2019 with Joseph Moscato, President & Chief Executive Officer of Generex who will present an organizational roadmap outlining Generex Biotechnology's operational, strategic and financial plans, as outlined herein.

Generex is pleased to announce that in the coming week, the company will finalize a financing commitment to advance the strategic goals of the company. The financing will be used to fund manufacturing of commercial products, launch a clinical trial of Regentys ECMH in ulcerative colitis, complete the acquisitions of revenue generating companies, and to launch new service lines for the NuGenerex Distribution Solutions MSO network.

On a commercial front, Generex is pleased to report that the first orders of ExcellagenÒ wound conforming collagen matrix from the company's subsidiary Olaregen Therapeutix has been delivered, and the product has begun to generate revenues. ExcellagenÒ is FDA cleared for the management of wounds, including surgical wounds, diabetic foot ulcers, venous leg ulcers, and post-MOHS surgery, among other types of dermal wounds.

As previously reported, Generex has agreements to acquire Fuse Medical, Pantheon Medical, and MediSource Partners in all-stock transactions using the Generex Pool Shares priced at $2.50 per share. The Pool Shares are already accounted for in the total outstanding shares and no new shares will be issued for these transactions. The Pantheon and MediSource acquisitions are expected to be completed shortly after the close of this fiscal quarter (April 30), followed by the acquisition of Fuse Medical, which will take additional time to close. These profitable, innovative, and growing companies in the medical, surgical, and biologic manufacturing and distribution business will add significant revenue and EBITDA to the Generex balance sheet.

Fuse is a manufacturer and national distributor of medical devices, providing a broad portfolio of Orthopedic Implants and a wide array of osteobiologics, regenerative tissues, and amniotic tissue, including human allografts, substitute bone materials and tendons, and regenerative tissues and fluids ('Biologics').

Pantheon manufactures integrated surgical kits that include plates, screws, and tools required for orthopedic surgeons and podiatrists to perform foot and ankle surgeries. 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. Fuse Medical is a publicly-traded manufacturer and supplier of a broad portfolio of specialty surgical products, including orthopedic implants, and a complete line of regenerative medicine products and biologics.

The acquisitions of Patheon, MediSource, and Fuse demonstrate the synergies among the NuGenerex family of subsidiary companies in advancing the Generex mission to deliver innovative end-to-end solutions to our healthcare partners, physicians, and patients. These companies' products will also be distributed through the NuGenerex Distribution Solutions MSO. Additionally, Anthony J. Dolisi, President & Chief Executive Officer of Olaregen, and Generex Chief Commercial Officer is working with renowned surgeons and wound care experts at a major medical center who are advisors on ExcellagenÒ. The advisors have developed a robotic surgical supply cabinet, and Mr. Dolisi is working with the NuGenerex partner companies to equip the cabinet with surgical plates, screws and tools for distribution as an integrated, computerized inventory management system for the operating room. The companies are also working on the development and distribution of new Regenerative Medicine Advanced Therapy (RMAT) products combining ExcellagenÒ with stem cells and exosomes.

Joe Moscato stated, "For the last two and a half years, our management team has worked diligently to transform Generex with a new vision for healthcare. We have been successful in building value for our investors, as clearly demonstrated by our recently reported financials, as well as by projections for the soon to close acquisitions, which when incorporated under Generex, will yield an estimated total of $98 million in shareholder equity. Following the end of this quarter, we plan to finalize the financing, complete the previously announced acquisitions of Pantheon Medical and MediSource Partners, followed by Fuse Medical in all-stock transactions, file an S1 Registration statement with the SEC, and file a request for up-list to a national exchange. It is also important to point out that the Fuse Medical acquisition will provide Generex with a public vehicle for the spin-out of our wholly-owned subsidiary NuGenerex Immuno-Oncology (previously Antigen Express). We are proud of the progress we have made to get Generex back on a national exchange, and we are excited about our future opportunities as we continue to execute on our commercial operations, growth plans, and strategic initiatives, as outlined in this announcement. I look forward to speaking with our investors on May 15."

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 immuno-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 Therapeutics

Olaregen 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. The company 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. The company'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 Fuse Medical, Inc.

Fuse is a manufacturer and national distributor of medical devices, providing a broad portfolio of internal and external fixation products; upper and lower extremity plating and total joint reconstruction; soft tissue fixation and augmentation for sports medicine procedures; full spinal implants for trauma, degenerative disc disease, and deformity indications, (collectively, "Orthopedic Implants") and a wide array of osteobiologics, regenerative tissues, and amniotic tissue, including human allografts, substitute bone materials and tendons, and regenerative tissues and fluids ("Biologics"). The Company's broad portfolio of Orthopedic Implants and Biologics provide high-quality products that assist surgeons in providing positive patient outcomes and cost-effective solutions. For more information about the Company, please visit: www.fusemedical.com.

About MediSource Partners

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, 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.

About Pantheon Medical

Pantheon 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. The Company is developing and submitting several new product lines to the FDA which will include cannulated surgical screws, plates, and implants.

Cautionary Note Regarding Forward-Looking Statements

This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as 'expects,' 'plan,' 'believes,' 'will,' 'achieve,' 'anticipate,' 'would,' 'should,' 'subject to' or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.  Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

Generex Contact:
Generex Biotechnology Corporation
Joseph Moscato
646-599-6222

Todd Falls
800-391-6755 Extension 222
[email protected]

SOURCE Generex Biotechnology Corporation.