- Filing up-list application to Nasdaq
- Details on 1:1 Shareholder stock dividend
- Spin-out of NuGenerex Immuno-Oncology as a separately-traded public company
- Merger of NGIO with Kiromic
- Payoff of notes
- Recording available at www.generex.com
MIRAMAR, Fla., July 26, 2019 (GLOBE NEWSWIRE) — Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) today provided a summary of the investor conference call held yesterday, July 25, 2019 at 4:00 pm during which Joseph Moscato, Generex President & Chief Executive Officer updated investors on the company’s plans for the GNBT up-list and the previously declared 1:1 share dividend. He also provided guidance on the proposed timing for the NuGenerex Immuno-Oncology (NGIO) spinout and subsequent planned merger with Kiromic.
Mr. Moscato stated: “Many thanks to our shareholders and interested parties for calling in yesterday to hear about our progress in achieving stage 3 of our plan to bring Generex back to the Nasdaq. For those who could not join the call, I am providing this summary. The full recording of the call is now available on our corporate web site, and the transcript will be available early next week.”
“First, I am happy to report that Generex has paid the Nasdaq up-list application fee, and we expect the review process to take 30 to 60 days. As announced, we have worked with Donahoe Associates on our up-list application, and we will keep our shareholders apprised of our progress. Following a successful up-list of GNBT to the Nasdaq national market, the 1:1 share dividend will be paid the following day, with the ex-date two days following payment of the dividend. Note that the record date for the dividend was July 24, 2019, so anyone who held shares on that date is eligible for the dividend. If anyone sells shares between the record date and the ex-date, the purchaser of the shares is entitled to the dividend. The Company will provide further guidance on the treatment of the dividend shares through a future press release.”
“As a reminder, Generex renamed its wholly-owned cancer subsidiary Antigen Express as NuGenerex Immuno-Oncology (NGIO), which we plan to build into a multi-platform cancer immunotherapy company. Generex has identified a public company into which we plan to merge NGIO and launch a new research effort to expand the oncology indications and applications for AE37 to complement our research partnership agreement with Merck to study the combination of AE37 in combination with Merck’s checkpoint inhibitor, Ketruda® (pembrolizumab) for the treatment of triple negative breast cancer; the trial is currently screening patients for enrollment. Additionally, NGIO is working with our licensing partner Shenzhen Bioscien, a Chinese biopharmaceutical company, to develop AE37 for the treatment of prostate cancer. Under terms of the agreement, Shenzhen is to pay for the commercial development of AE37, conducting clinical trials in the EU and in China under ICH guidelines. Shenzhen holds the exclusive license for the use of AE37 for the treatment of prostate cancer only in China; Generex retains rights to the clinical data as well as global market rights for AE37 in the prostate cancer market outside of China.”
“On February 25, 2019 Generex paid a dividend in our new cancer company, whereby Generex shareholders received 1 share of NGIO for every 4 shares of GNBT. Those shares are now book-shared with Generex’s transfer agent, which is holding them in GNBT shareholders accounts; the shares will have value once we take NGIO public. The Company is working with the auditors and legal to coordinate the documentation, applications, and regulatory filings necessary for the spin-out. We are planning to execute the NGIO spin-out in the next 60 to 90 days and we will inform shareholders as we proceed through the process.”
Once the spin-out is accomplished, we plan to finalize a merger agreement with Kiromic, 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 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.”
“Finally, I am happy to announce that we have paid off two note holders and will pay off the third noteholder early next week to clean up the balance sheet and add further value that will be a benefit for our up-list application to Nasdaq.”
In closing, Generex is nearing the final steps in our three-stage plan to return the Company to Nasdaq, and we are proud to have returned value to our loyal shareholders. We plan to continue executing our plan to build a new Generex that provides end to end solutions for physicians and patients. As always, if shareholders have questions or comments, please feel free to contact me.”
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 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. 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.