Financial Overview
Capital Requirements & Offering
$10 Million
A large (180 patients), extensively controlled, double disease Phase-1 clinical trial of our Exo-B© against Alzheimer’s and Long Covid.
$35 Million
Rapid, robust, simultaneous exploitation of our 5 additional exosome applications:
Spinal Cord Injuries/Transections
New Cartilage for Worn Joints
Acute Heart Attack
Repair of Ruptured Tendons
Erectile Dysfunction
Phase-1 clinical trials of all 5 applications ASAP -- using freshly submitted FDA data for the first Phase-1 clinical trial
$46 Million
Manufacture 114,000 patient regimens for Alzheimer’s disease and Long Covid dementias in year 1 – if Phase-1 clinical trial is successful.
Pipeline
The great versatility of our exosome nanoparticles is being explored and readied for additional Phase 1 trials in the following applications:
Spinal cord transections
Coronary heart disease
Tendon transections
New cartilage for osteoarthritic or traumatized joints
Erectile dysfunction
ALLOCATIONS
Four companies have been selected as CDO and CRO after numerous lengthy evaluations and eliminations.
RoosterBio, Inc for CDO ($500,000-$600,000)
Contenders for GMP CMO Phase-1 clinical trial medication production:
Fujifilm ($2,000,000)
AGI ($2,000,000)
Thermo Fisher ($2,000,000)
Yale, PPD, Charles River Lab ($35,000,000)
Thermo-Fisher’s PPD for CRO ($7,100,000)
Contenders for GMP CMO:
Fujifilm ($46,000,000)
AGI ($46,000,000)
Thermo Fisher ($46,000,000)
TIMELINE
21-23 Months
FOR SALE
Equity in the Company
*Patent pending & ™
Finances
RoosterBio, Inc. the company we plan to hire as our CDO for Pre-Ind FDA preparation, prepared this production cost estimate using 3 liter and 50 liter bioreactors for the first year of operation treating
19,000 – 114,000 patients:
Between $3.7-$6.0 million for 19,000
Between $22 million -$36 million for 114,000
Cost per patient regimen (pt reg):
19,000 pt reg at $3.7 million = $194.74 per pt reg
19,000 pt reg at $6.0 million = $315.79 per pt reg
x 6 runs of 50L:
114,000 pt reg at $22,200,000/114,000 = $194.74 per pt reg
x 6 runs of 50L:
114,000 pt reg at $36,000,000/114,000 = $315.79 per pt reg
Timeline 17-23 months
“For 100,000 LCS or AD patients in year 1, it would take 5-6 runs in a 50 L bioreactor to manufacture their meds, say 6 runs, for 114,000 pts. [19,000 x6].” The pt regimen cost doesn’t change, still varying from:
$194.74 -- $315.79/pt regimen
if 200 L or 2,000 L bioreactors are used, the cost would be somewhat lower.”
Crystal M. Cruz, M.S.
Bioprocessing Consultant
RoosterBio, Inc.
240-220-4248
No company has yet manufactured 100 million exosome pt regimens, but it can be done because the medications, being only miRNAs, mRNAs and small molecules, can be generated by multiple runs in 2,000 L bioreactors, bottled and shelved.
A huge advance in upscaling from lab preparations to commercial production!
Economies of Scale using the larger bioreactors of 500 L and even 2,000 L, could lower the exosome production cost.
Even adding 40% for distribution, the room for profit margin is generous, also considering that insurance companies will be expected to offer the medication.
But no company has produced 100 million patient regimens of exosomes because no FDA authorization has thus far been awarded for such related applications.
$10 million invested in the above system at the $315.79 cost, and 40% distribution, with 10x markup for 19,000 patients would yield revenue of $36,000,060 or 125% ROI – if the clinical trial succeeds and $6 million more is raised to pay medication production costs for a total initial investment of $16 million.
For 114,000 patients est. pretax profit would be $216,000,360, on the later investment of $46,000,000 for 370% profit, or ROI, again only if the clinical trial succeeds and another $36 million is raised for a total investment of $46 million.
LCS Single Disease Phase 1 Clinical Trial
PPD Estimate
LCS & AD Double Disease Phase 1 Clinical Trial
PPD Estimate
Pro Forma
