docj
3 months ago
Experienced Leadership & Small Management Team: Gene Bioโs management team is led by Christopher
J. Reinhard, the founder of Gene Bio who has been a driving force responsible for advancing the Generx product
candidate from a pre-clinical lab study at the University of California-San Diego into this current FDA-cleared
Generx Phase 3 clinical study program. Mr. Reinhard was also instrumental in raising over $200 million to lead
and support the Generx development effort. He has also been responsible for three other successful FDA product
registrations.
Nostrum Pharmaceuticals operates multiple manufacturing facilities, supported by sales, marketing and
distribution activities. Nostrum sells generic drug products to hospitals and retail drug stores, by prescription
only, throughout the United States. Nostrum has facilitated the companyโs recent financial restructuring and was
responsible for the development of a new Phase 3 clinical plan for FDA registration, and the commercial biologics
manufacturing plan for the Generx product candidate at FujiFilm Bio in Texas.
Nostrum currently owns approximately 75% of Gene Biotherapeutics and approximately 25% is owned by Gene
Bioโs formerly public company shareholders. Following completion of his funding, these shareholders will be
issued contingent value rights (โCVRโ) for their proportional share from the net cash distribution entitlements
from the sale of Generx. Gene Bio investors currently own an 85% interest in Generx, and Huapont Life Sciences,
a Chinese-based, publicly traded, pharmaceutical company, owns a 15% equity interest in Generx, and Huapont
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has an exclusive right to manufacture (under certain conditions) market and sell Generx in mainland China
following FDA approval of Generx in the United States.
Nostrum has had some financial setbacks and challenges with its core business, which is why we are now seeking this financial strategic joint venture offering to secure external financial resources to accelerate the clinical developement and commercialization of our Generx product candidate at this time.
docj
3 months ago
Business Strategy: Gene Bio is a small biotechnology research and development boutique, located in San
Diego, that operates with a near-virtual, cost-conserved operating structure. We have a small, highly
experienced team that is currently singularity focused on the successful clinical development and strategic sale
of Generx. This team has worked together on the scientific, medical and clinical development of Generx over the
past 15 years. Set forth below are the key contractors that will be utilized to complete the FDA-cleared Phase 3
Generx study:
(1) FujiFilm Diosynth Biotechnologies: FujiFilm Bio is a world scale operation located in College Park,
Texas. They have expertise in process development and cGMP manufacture of cell and gene therapy
products oncolytic viruses and virial vaccines. We have entered into a manufacturing agreement with
FujiFilm Bio to manufacture Generx supplies for the planned Phase 3 clinical study, and they also have
the current capability to commercially manufacture final Generx product following FDA approval. We
expect that it will take approximately one year to manufacture Generx supplies for the clinical study at an
estimated cost of $5.0 million. In addition, once the final Generx study product is manufactured, Gene
Bio will be required to conduct a preclinical biodistribution study in preparation for the submission of the
Generx Biologics License Application (BLA) with the FDA.
(2) Comac Medical: We are planning to enter into an agreement with Comac Medical, which is located
in eastern Europe, to conduct our final FDA-cleared, Phase 3 clinical study. Comac Medical will be
conducting the study at up to 35 clinical sites, that will include approximately 30 sites in eastern Europe
and Turkey and approximately five sites in the U. S. Based on a recently completed geographic survey,
Comac believes that it is feasible enroll up to all 225 patients during a 12-month recruiting period following
the availability of Generx from FujiFilm Bio. Based on this current plan, we estimate that this clinical
study will cost up to $10.0 million. A copy of this plan, as prepared by Comac Medical, is included in this offering document.
lakes
7 months ago
I can't respond privately so will do it here. Absolutely, I would be interested in selling my shares to you. I am going to give them time to respond to the SEC complaint before selling. If it looks like Reinhard will let it die on the vine, as someone else suggested, then you can have all of my 800,000 shares for .10 a share. Subject to change, of course.