Confidential Joint Venture Materials
Capital-efficient launch model using qualified blood supply and contract-laboratory NK-cell processing.
Tijuana, Baja California, Mexico
Confidential — Investor Planning Draft
The Oncology Adjacent Support Institute is proposed as a physician-supervised, cash-pay cellular-therapy clinic in Tijuana serving primarily U.S. cancer patients seeking investigational adjunctive oncology support.
The business is deliberately designed notas a biotechnology manufacturing company. Instead, it uses an asset-light model:
Qualified donor blood source → Contract NK-cell processing laboratory → Release testing & cryopreservation → Tijuana clinic → Physician-supervised patient administration
This structure concentrates the Company's capital on patient acquisition, clinical operations, quality systems and the patient experience while outsourcing the technically intensive cell-processing function to qualified specialists.
The Company seeks $875,000 of initial capitalization. The target operating model is 10 new NK patients per month, divided among $30,000, $50,000 and $75,000 treatment tiers, together with a $50,000 annual physician-directed maintenance program for appropriate returning patients.
At target volume, the base new-patient business generates approximately $5.64 million of annual revenue. At a mature maintenance penetration of approximately 30%, total annualized revenue approaches $7.44 million.
Using deliberately conservative preliminary assumptions for blood sourcing, outsourced cell processing, quality/release testing, storage, clinical administration, product-loss reserve and a 4% Scientific Partner Protocol & Advisory allocation, the mature model produces approximately $3.23 million of projected EBITDA, or approximately 43% EBITDA margin, before corporate income taxes, interest and noncash items.
The thesis is straightforward:
Cancer patients increasingly seek options beyond their immediate conventional treatment pathway, particularly after completion of therapy, during stable disease, when concerned about recurrence, or when disease progresses despite treatment.
NK-cell science gives the business a credible scientific foundation without requiring the Company to claim that NK therapy is proven cancer treatment. The field is actively being developed, particularly around allogeneic approaches, while significant questions about persistence, efficacy and commercialization remain.
That distinction is central to the business.
The Company will notsell a cure.
It will sell a professionally operated, physician-supervised investigational oncology-support programbuilt around:
The opportunity is therefore to occupy the space between two extremes: expensive experimental cell-therapy development on one side and poorly documented “miracle clinic” offerings on the other.
Tijuana offers an unusually attractive location because the clinic can serve the enormous Southern California market without requiring patients to undertake international long-haul medical travel.
A patient can reach San Diego, cross into Tijuana, receive scheduled care and remain geographically close to the United States.
This creates several advantages:
Patient accessibility.Repeat treatment is practical.
Operating economics.Clinical operating costs should be substantially below comparable U.S. specialty-clinic costs.
Cash-pay model.The Company is not dependent upon U.S. insurance reimbursement.
Medical-tourism infrastructure.Tijuana already supports substantial cross-border medical activity.
Repeat treatment.Proximity makes multi-visit and annual maintenance programs commercially feasible.
The Company initially performs no NK manufacturing at the clinic.
The supply chain is:
Purchase appropriately qualified donor-derived blood/leukapheresis material in commercially reasonable units from legally authorized suppliers.
Contract with a qualified laboratory to isolate/expand/process NK cells according to the approved product specification.
Product undergoes required quality testing and receives appropriate batch documentation and Certificate of Analysis.
Released product is cryopreserved/stored and transported under validated conditions.
Patient eligibility and treatment plan are determined by licensed physicians.
The Tijuana clinic administers the released product under physician supervision.
Safety, tolerance and outcomes are tracked.
This separation reduces both capital requirements and operational complexity.
The Company will engage an established scientific partner to provide protocol and scientific advisory services.
The current financial model assumes:
for the Scientific Partner Protocol & Advisory allocation.
The agreement should define substantive services, potentially including:
The agreement should be reviewed by Mexican and U.S. counsel for professional fee-splitting, referral, healthcare and tax implications. It should notbe characterized as compensation for patient referrals.
The business model assumes three initial treatment tiers.
Weighted average initial patient revenue is:
$47,000 per patient.
The precise cellular dose, number of administrations and clinical schedule for each tier remain matters for the medical protocol rather than the financial plan.
Patients completing an initial program may, where medically appropriate, elect a physician-directed annual NK oncology-support maintenance program.
$50,000 per year
The commercial plan anticipates periodic administrations involving approximately 250 million viable NK cells per administration, but the frequency and dose must remain physician-directed rather than contractually guaranteed.
For financial planning, we assume:
30% maintenance conversion.
At 120 new patients annually:
120 × 30% = 36 maintenance enrollments
At $50,000:
36 × $50,000 = $1,800,000 annual maintenance revenue
The maintenance program is strategically important because it converts a purely transactional clinic into a partially recurring-revenue business.
The Company should purchase donor-derived source material in commercially sensible units rather than source blood independently from individual donors.
Preferred sources include appropriately qualified leukapheresis/leukopak or other clinically appropriate donor material.
Supplier qualification should establish:
The business model assumes approximately $2,500–$4,000 of source-material allocation per initial treatment patient, depending upon tier and realized manufacturing yield.
Actual supplier contracts replace this assumption before final investor closing.
The Company's most important strategic decision is not to build an NK processing laboratory during launch.
A dedicated cellular manufacturing laboratory would substantially increase:
Instead, the Company purchases a released cellular product/service packagefrom a qualified processing partner.
The CMO/laboratory relationship should address:
The financial plan assumes that each delivered product has an appropriate release package addressing matters such as:
A patient appointment never overrides a product-quality failure.
The basic clinic pathway begins with establishing the Mexican operating entity, securing the premises and responsible healthcare professionals, and completing the applicable health-establishment requirements.
COFEPRIS currently identifies COFEPRIS-05-036as the notice of operation/responsible sanitary officer for a health-services establishment. The current government procedure states that it can be submitted through DIGIPRiS and identifies the responsible sanitary professional as part of the establishment structure.
COFEPRIS also makes an important distinction: an Aviso de Funcionamientois not itself necessarily a sanitary authorization, even though certain establishments are required to file one.
Therefore the Company will not assume that COFEPRIS-05-036 authorizes administration of allogeneic NK cells.
Before patient launch, Mexican regulatory counsel must provide a written opinion addressing:
COFEPRIS's current forms separately include health-services licenses in addition to establishment notices, reinforcing the need to determine the correct pathway rather than treating the basic notice as dispositive.
Weeks 1–6
Form Mexican operating entity.
Establish U.S. parent ownership structure.
Retain Mexican health-regulatory counsel.
Obtain written preliminary regulatory classification.
Identify Mexican medical director/responsable sanitario.
Weeks 3–10
Qualify blood-source suppliers.
Obtain donor/source documentation.
Select outsourced NK processing laboratory.
Negotiate CMO quality agreement.
Obtain actual pricing.
Validate logistics and cryogenic chain of custody.
Weeks 4–14
Lease Tijuana premises.
Complete zoning/use review.
Build infusion rooms and clinical areas.
Install clinical equipment.
Complete local business/civil-protection requirements.
Complete applicable COFEPRIS/COEPRIS filings.
Weeks 8–16
Finalize SOPs.
Finalize patient consent.
Finalize product-release specifications.
Establish adverse-event system.
Implement electronic medical records.
Implement product/batch traceability.
Train clinical personnel.
Weeks 14–18
Obtain final Mexican regulatory opinion.
Confirm establishment authorization.
Confirm cellular-product administration pathway.
Confirm advertising compliance.
Conduct mock patient/product traceability run.
Medical Director + Quality + Counsel sign Launch Authorization.
Begin with limited patients.
Audit first cases.
Validate actual product cost and yield.
Refine workflow.
Scale toward 10 new patients/month.
Approximately 34% of the investment is retained as operating reserve, providing roughly three months of planned fixed operating expense.
These are preliminary planning assumptions pending actual supplier/CMO bids.
Target mix:
4 Tier I + 4 Tier II + 2 Tier III
4 × $30,000 = $120,000
4 × $50,000 = $200,000
2 × $75,000 = $150,000
Product/clinical COGS:
$162,900
Scientific Partner 4%:
$18,800
Gross contribution:
I would budget the steady-state clinic more conservatively than the original draft:
Annual fixed operating expenses:
Planning assumptions:
36 mature annual maintenance patients.
Price:
$50,000/year
Revenue:
Estimated product/clinical COGS:
$761,400
Scientific Partner at 4%:
$72,000
Maintenance contribution:
Contribution margin:
53.7%
Because the existing clinic fixed-cost base already supports much of the maintenance activity, a substantial portion of maintenance contribution should flow through to EBITDA, although additional clinical staffing may eventually be required.
This is the principal mature-state investment case.
We should not tell investors the business produces $3.2M EBITDA immediately.
A reasonable Year 1 ramp might be:
That produces approximately 75 new patients during Year 1, rather than 120.
At the $47,000 weighted average:
Year 1 initial-treatment revenue ≈ $3.525M.
Maintenance revenue should initially be modest because the patient cohort has not matured.
A reasonable planning case is:
*Illustrative planning case subject to actual product costs, maintenance enrollment timing and patient-acquisition costs.
That is a much more credible investor presentation than showing immediate steady-state economics.
The weighted contribution from a new patient is approximately:
$28,830 per patient
before fixed operating expense.
At approximately $100,000 monthly fixed costs:
$100,000 ÷ $28,830 ≈ 3.5 patients
Therefore the clinic reaches approximate operating break-even at:
before maintenance contribution.
That is one of the strongest features of the model.
The target of 10 patients/month therefore provides substantial cushion above estimated operating break-even.
The investor is not being asked to finance a $10–$30 million biologics manufacturing facility.
The investment purchases:
A clinic.
A regulatory pathway.
A qualified medical team.
A contracted cellular supply chain.
Initial product inventory/capacity.
A quality system.
Patient acquisition infrastructure.
Three months of operating runway.
And potentially reaches operating break-even at only approximately four new patients per monthunder the base assumptions.
At target volume, the $875,000 initial capitalization supports a business modeled to generate approximately:
$5.6M initial-treatment revenue
and approximately
$2.26M EBITDA
before mature maintenance revenue.
Once the maintenance base matures, the model potentially reaches:
on an initial capitalization of $875,000.
That is why the opportunity is financially interesting.
The moat is not merely “we have NK cells.”
Cells can eventually become commodities.
The defensible asset is the platform:
Scientific partner
-
Qualified supply chain
-
Processing relationship
-
Regulatory pathway
-
Physician network
-
Cross-border clinic
-
Patient acquisition
-
Clinical quality system
-
Longitudinal patient registry
The longer the Company operates successfully, the more valuable those combined assets become.
The business plan should disclose these plainly.
The commercial administration pathway must be confirmed by Mexican counsel. The basic establishment notice alone should not be represented as authorization for allogeneic NK therapy.
NK therapy remains investigational, and clinical benefit—particularly in solid tumors—is not established sufficiently to promise outcomes.
Batches may fail yield, viability, purity, sterility or other release requirements.
The model requires approximately four patients/month to reach estimated operating break-even and ten/month to achieve target economics.
Cancer-related marketing requires exceptional discipline.
Patients may have advanced disease and substantial baseline morbidity.
Current COGS figures are planning assumptions. Actual supplier and processing quotations may materially change margins.
Before accepting the final investment tranche, I would require management to obtain:
Those ten items turn the current business plan from a promising thesis into an investable operating plan.
Exhibit A — Regulatory Pathway Memorandum
Exhibit B — Model Mexican Regulatory Counsel Opinion
Exhibit C — Clinic Licensing Checklist
Exhibit D — Blood/Source Material Supplier Qualification SOP
Exhibit E — Laboratory Qualification & Quality Agreement SOP
Exhibit F — Chain of Identity / Chain of Custody SOP
Exhibit G — Product Receipt & Release SOP
Exhibit H — Patient Eligibility SOP
Exhibit I — Informed Consent
Exhibit J — Adverse Event & Emergency Transfer SOP
Exhibit K — Marketing Claims SOP
Exhibit L — Product Failure / Refund Policy
Exhibit M — Five-Year Financial Model
Exhibit N — Scientific Partner Agreement Term Sheet
Exhibit O — Patient Outcome Registry Framework