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Generex Biotechnology Announces Plans for NuGenerex Immuno-Oncology Spinout through a Targeted Acquisition of a Public Company and Planned Merger with Kiromic

1054 Days ago

  • Filing of up-list application to Nasdaq
  • Record date for dividend is August 30, 2019
  • Pay date for 1:1 shareholder stock dividend set for October 29, 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

MIRAMAR, Fla., Aug. 16, 2019 (GLOBE NEWSWIRE) -- Generex Biotechnology (www.generex.com) (OTCQB:GNBT) today announced that the Company has identified a public, development stage company that is fully reporting and current on its filings with the SEC, and DTC eligible that will serve as a vehicle for the spin-out of its subsidiary NuGenerex Immuno-Oncology (NGIO) as a separate public company. Generex is in final negotiations to retain the controlling interest of the outstanding shares of the acquisition target and expects to complete the contracts and file a super 8K in the coming weeks. Generex and its shareholders who have received the 1:4 NGIO dividend will initially hold 100% of the NGIO shares following the acquisition, which will set the stage for the subsequent planned merger with Kiromic.

Generex has renamed its wholly-owned subsidiary Antigen Express as NuGenerex Immuno-Oncology in preparation for the planned spin-out, which will include the Ii-Key technology and AE37 immunotherapeutic vaccine program. NGIO is currently working in a research collaboration with Merck on a phase II trial, Establishing the Recommended Biologic Dose for AE37 Peptide Vaccine in Combination with Pembrolizumab (Keytruda) That Will Enhance the Tumor-specific Immune Response and Demonstrate Efficacy in Patients With Advanced Triple-negative Breast Cancer (NSABP FB-14); the trial is currently screening patients for enrollment. Additionally, Antigen Express signed a licensing agreement with Shenzhen Bioscien, a Chinese biopharmaceutical company, to develop AE37 for the treatment of prostate cancer. Further, the Ii-Key technology is being expanded to additional therapeutic cancer biomarker targets, an effort that will expand following the merger with Kiromic.

Kiromic is a clinical-stage immuno-oncology company with multiple, patented proprietary platforms, including CAR-T, CAR NK, an oral vaccine delivery system, and DIAMOND AI, an artificial intelligence system with a multifaceted predictive algorithm. Kiromic has used the DIAMOND AI technology to identify and validate several cancer biomarkers, including SP17, which was granted the last orphan indication for ovarian cancer by FDA. In addition to advancing the ovarian cancer program, NGIO plans to advance Kiromic’s proprietary CAR-T and CAR NK technologies into proof of concept clinical trials.

Joseph Moscato, Generex President & Chief Executive Officer, stated, “Spinning out our immuno-therapy platform assets—AE37 and Ii-Key—and combining them with Kiromic’s multiple, patented proprietary immuno-oncology platforms, we are excited about the possibilities for this new cutting-edge immunotherapy company, NuGenerex Immuno-Oncology. We are also evaluating additional companies, technologies, and immunotherapy platforms that will augment the NGIO spin-out. I am also delighted that our GNBT shareholders will be the shareholders of NGIO, and as we fully fund the development of our combined platforms, NGIO will also be eventually trading on the Nasdaq like GNBT.”

Mr. Moscato continued, “In other news, I would like to report that Generex has come to terms with the shareholders of Olaregen Therapeutix to acquire the remaining 38% of the company for a total Generex ownership of approximately 99% after the share exchange at $2.50 a share for GNBT. Further details will be provided in a press release next week together with an 8k filing on the transaction. Also, we are pleased that today we paid and satisfied a note with a note holder using $900,000 in cash to further strengthen our balance sheet as the Nasdaq listing application is being processed.”

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

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. Generex also supplies kits to process bone marrow aspirates and platelet rich plasma biologics at the time of surgery.

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

Todd Falls
1-800-391-6755 Extension 222

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