CMSV/ExoLip™ Nanoplatform:
AI-Enhanced Hybrid System for Targeted Regenerative Therapeutics
“The future of medicine won’t be defined by stronger drugs, but by smarter delivery.” Most therapeutic delivery systems fail not from insufficient potency, but from lack of precision—and BIOVANTIX™ is changing that. Our AI-driven CMSV™ / ExoLip™ nanotechnology delivers therapies to the right organ, at the right moment, with unmatched accuracy, turning therapeutic potential into precision reality. This precision-delivery engine fuels a diversified pipeline across oncology, neurodegeneration, cardiometabolic disease, immunology, rare disease, and more, positioning BIOVANTIX™ to redefine how medicine reaches disease and lead the next era of intelligent therapeutic delivery.
Series A: $25M
A Decisive Inflection Point in Biologic Delivery
CMSV/ExoLip™ Nanoplatform
The CMSV/ExoLip™ Nanoplatform is a fully integrated, AI-enhanced exosome–nanoparticle hybrid system. It is set to redefine targeted regenerative therapeutics by unifying cell-mimetic surface vesicle (CMSV) engineering with liposomal encapsulation and AI-driven pharmacokinetic optimization, delivering unprecedented precision, scalability, and cross-therapeutic versatility.
Strategic Financial Advantages
Leveraging Puerto Rico's Act 60 framework, BIOVANTIX™ achieves a 4% effective tax rate and 50% qualified R&D expenditure credit. This materially increases retained earnings and reinvestable capital. Clinical trial relocation efficiencies produce 35–45% cost savings versus U.S. mainland execution, establishing a capital efficiency multiplier unmatched in comparable biotech valuations.
Probabilistic Confidence Modeling
This comprehensive investor document integrates probabilistic confidence modeling across three sequential funding rounds, reflecting both near-term developmental momentum and long-term valuation scalability. Statistical modeling indicates a strong likelihood of achieving all major development targets within 24 months, supported by optimized regulatory sequencing, parallel R&D streams, and a high internal execution confidence interval exceeding ≥0.8.
Core Platform Technology: CMSV/ExoLip Hybrid Nanocarriers
Hybrid Nanocarriers: Precision Delivery
BIOVANTIX™ leverages bioengineered CMSV (cell membrane-derived submicron vesicles) and ExoLip (exosome-liposome hybrid) nanocarriers. This proprietary hybrid architecture combines the biocompatibility and cellular tropism of natural exosomes with the structural stability and loading capacity of synthetic liposomes. This creates an optimal delivery vehicle for RNA therapeutics, peptides, and small molecules.
AI-Powered Biofeedback Control
The platform’s key differentiator is its AI-powered biofeedback control system. This system integrates real-time physiological sensors to detect organ-specific markers suchs as inflammation status, oxidative stress levels, tissue oxygenation, and electrophysiological signals. This closed-loop approach ensures highly responsive and adaptive therapeutic action.
Adaptive Therapeutics: Dynamic Dosing
This intelligent system enables dynamic modulation of payload release kinetics, effectively creating a "smart therapeutic" that adjusts dosing in response to patient-specific physiological parameters. This precision minimizes side effects and maximizes treatment efficacy.
Rapid Translation Across Indications
The single technology foundation of BIOVANTIX™ enables rapid translation across multiple organ systems and disease states. This dramatically compresses preclinical-to-proof-of-concept timelines compared to traditional, indication-specific development approaches.
Platform Architecture: Scientific Foundation
The BIOVANTIX™ CMSV/ExoLip™ hybrid platform fundamentally advances therapeutic delivery, meticulously engineered to enhance payload delivery, immune compatibility, and tissue-specific uptake.
Exosome–Liposome Convergence
Achieves superior molecular stability and extended systemic half-life, projecting 2.3× therapeutic persistence over conventional Lipid Nanoparticles (LNPs).
Biomimetic Engineering
Cell-mimetic surface architecture enhances immune compatibility and reduces clearance rates for optimal therapeutic efficacy and safety.
AI-based Molecular Pattern Recognition
Advanced AI leverages molecular pattern recognition to optimize targeted therapeutic interactions and improve delivery efficiency.
Tissue-Specific Targeting
Proprietary surface modifications enable precise biodistribution and targeted delivery to critical neural, ophthalmic, and immune tissues.
Modular Manufacturing & Scalability
Modular architecture facilitates rapid adaptation across diverse therapeutic verticals, maintaining manufacturing consistency for robust scalability.
Controlled Release Mechanisms
Implement advanced stimuli-responsive release systems, enabling precise payload delivery triggered by physiological cues for optimized drug action and minimal off-target effects.
This innovative design extends applications across neurodegenerative, ophthalmic, autoimmune, and regenerative categories, validated by comprehensive preclinical data and rigorous third-party assessments.
ExoVantix AI™: Computational Acceleration
ExoVantix AI™ leverages advanced computational models to accelerate and de-risk therapeutic development. This sophisticated platform dynamically models complex biological interactions, offering predictive power and efficiency far beyond traditional methodologies.
Dynamic Pharmacokinetic Modeling
ExoVantix AI™ dynamically models biodistribution and therapeutic kinetics, refining dosing via predictive simulation. This de-risks IND-enabling studies and compresses development timelines. Proprietary algorithms accelerate optimization cycles by up to 70%, boosting capital efficiency.
Predictive Biodistribution
Machine learning models forecast tissue accumulation patterns with 89% concordance to in vivo validation, providing unparalleled insight into therapeutic distribution.
Adaptive Dosing Optimization
The platform facilitates real-time algorithm adjustment based on continuous pharmacokinetic feedback loops, ensuring optimal therapeutic delivery and patient safety.
Manufacturing Process Control
AI-guided quality parameters minimize batch-to-batch variability, ensuring consistent product integrity and efficacy throughout manufacturing.
Clinical Outcome Forecasting
Advanced probability modeling forecasts efficacy endpoints across diverse patient subpopulations, enabling informed decision-making and optimized trial design.
Accelerated Drug Discovery
Utilizes AI to rapidly identify novel therapeutic candidates and optimize their properties, significantly reducing the timeline and cost associated with traditional drug discovery pipelines. This enables faster progression from concept to clinical trials.
Strategic Advantage: Four Pillars of Differentiation
Scientific Edge
Exosome–liposome convergence dramatically improves molecular stability and extends systemic half-life, yielding a projected 2.3× therapeutic persistence compared to conventional lipid nanoparticles. This fundamental advantage translates directly to reduced dosing frequency, enhanced patient compliance, and expanded therapeutic windows, solidifying our competitive edge.
AI Reinforcement
Proprietary algorithms within Synexome AI™ accelerate optimization cycles by up to 70%. This enables rapid iteration across formulation parameters, biodistribution modeling, and efficacy prediction, materially reducing time-to-IND and significantly enhancing the probability of first-in-human success.
Regulatory Efficiency
Leveraging Puerto Rico's unique jurisdiction allows for hybrid FDA/CBER oversight coordination under U.S. law, paired with lower-cost infrastructure. This strategic positioning provides 30–40% faster site approval via the PR–FDA coordination office, maintaining full regulatory rigor while optimizing operational efficiency and timelines.
Manufacturing Continuity
Integration of cGMP micro-batch facilities in Puerto Rico ensures a seamless transition from pre-clinical to early clinical production. This established infrastructure eliminates critical technology transfer delays and maintains process consistency across all development stages, guaranteeing robust supply chain continuity.
Together, these pillars yield a quantitatively de-risked development pathway that enhances Series A and B investor ROI while improving long-term scalability through reproducible manufacturing and cross-therapeutic adaptability.
Multi-Indication Therapeutic Portfolio
BIOVANTIX™'s adaptive delivery platform addresses eight major therapeutic areas, each representing significant unmet medical needs and substantial commercial opportunities. The platform's versatility stems from its ability to encapsulate diverse payload types while maintaining tissue-specific targeting through surface functionalization and AI-guided release kinetics.
Cardiology
Payload/Mechanism: Cardioprotective exosomes, regenerative mRNA factors
Adaptive AI Feedback: EKG monitoring, troponin levels, hemodynamic parameters
Delivery Route: IV nanoparticle infusion
Pulmonology
Payload/Mechanism: Anti-inflammatory & regenerative exosomes for COPD, ARDS
Adaptive AI Feedback: Oxygen saturation (SpO₂), inflammatory cytokine profiling
Delivery Route: Inhalable aerosols or IV
Traumatic Brain Injury
Payload/Mechanism: Neuroprotective RNA, neurotrophic growth factors
Adaptive AI Feedback: Intracranial pressure (ICP), EEG, brain oxygenation sensors
Delivery Route: Intranasal or IV with CNS targeting
Macular Degeneration
Payload/Mechanism: VEGF modulators, neuroprotective peptides
Adaptive AI Feedback: Retinal imaging biomarkers, oxidative stress indicators
Delivery Route: Intravitreal injection
Stroke Recovery
Payload/Mechanism: Neurotrophic exosomes, RNA modulators
Adaptive AI Feedback: Cerebral perfusion imaging, motor function assessment
Delivery Route: IV infusion or targeted local delivery
Pain Management
Payload/Mechanism: Targeted opioid-free analgesic peptides
Adaptive AI Feedback: Pain scores, local tissue pH/temperature sensors
Delivery Route: Transdermal patch or local injection
Oncology
Payload/Mechanism: Immuno-stimulatory RNA, checkpoint inhibitor modulators
Adaptive AI Feedback: Tumor imaging, cytokine profiles, immune response
Delivery Route: IV or tumor-targeted injection
Autoimmune-Immunology
Payload/Mechanism: Regulatory RNA, anti-inflammatory vesicles
Adaptive AI Feedback: Cytokine storm sensors, systemic inflammation markers
Delivery Route: IV or tissue-specific delivery
Each indication leverages the same core CMSV/ExoLip platform with indication-specific payload formulations and AI feedback parameters, enabling parallel development streams and significant R&D cost efficiencies.
Versatile Delivery Modalities
IV Infusions
Systemic delivery for cardiology, stroke recovery, oncology, and immunology applications. Enables whole-body biodistribution with active targeting to diseased tissues through surface-functionalized nanocarriers.
Intranasal/CNS Delivery
Direct nose-to-brain transport for traumatic brain injury and neurodegenerative conditions. Bypasses blood-brain barrier through olfactory and trigeminal nerve pathways, achieving rapid CNS penetration.
Inhalable Aerosols
Pulmonary-targeted delivery for COPD, ARDS, and respiratory conditions. Engineered particle size distribution (1-5 μm) ensures deep lung deposition and sustained local therapeutic concentrations.
Intravitreal Injection
Retinal and macular degeneration therapy via direct intraocular administration. Extended release formulations reduce injection frequency compared to current anti-VEGF standards of care.
Transdermal/Local Injection
Site-specific delivery for pain management and localized immunomodulation. Minimizes systemic exposure while achieving high local concentrations at target tissues.
Sublingual Administration
Rapid systemic absorption through sublingual mucosa, bypassing first-pass metabolism. Ideal for emergency medicine or conditions requiring rapid onset of therapeutic action.
Route flexibility is a critical strategic advantage, enabling optimization of pharmacokinetics and patient compliance for each indication while maintaining the core platform technology foundation.
Hybrid CMSV/ExoLip™ Nanoplatform Family Trademarks™
ExoVantix™ "Where cell intelligence meets lipid precision."
ExoVantix™ defines BIOVANTIX's flagship hybrid nanoplatform — merging cell-mimetic surface vesicle (CMSV™) technology with liposomal encapsulation to achieve optimal biodistribution, payload protection, and cross-tissue compatibility. It represents the company's core engine for regenerative biologic delivery across both injectable and topical modalities.
RegenVantix™
"Dual-pathway regeneration, amplified by design."
RegenVantix™ fuses the regenerative potency of CMSV™ injectables with the sustained-release lipid environment of ExoLip™ systems. This hybrid formulation enables simultaneous deep-tissue and surface-level repair — accelerating clinical recovery in wound healing, orthopedic repair, and vascular regeneration.
NeuroVantix™
"Smart vesicles for intelligent neural repair."
NeuroVantix™ combines CMSV™ neuro-targeting capability with lipid-layer stabilization to cross biological barriers safely and efficiently. Tailored for stroke, TBI, and cognitive restoration, it unites precision nanodelivery and AI-guided biodistribution analytics within a single therapeutic platform.
CardioVantix™
"Hybrid therapeutics for a healing heart."
CardioVantix™ integrates CMSV™ regenerative vesicles and ExoLip™ lipid carriers optimized for cardiac microcirculation. The system supports targeted angiogenesis, inflammation control, and myocardial repair, establishing a new model for non-invasive cardiovascular regeneration.
PulmoVantix™
"A breath of precision in pulmonary regeneration."
PulmoVantix™ adapts BIOVANTIX's hybrid vesicle science for aerosolized and systemic lung delivery. The platform's lipid-coated CMSVs provide enhanced epithelial adhesion and controlled release, offering novel treatment pathways for fibrosis, ARDS, and post-viral lung injury.
HepaVantix™
"Restoring metabolic intelligence from cell to system."
HepaVantix™ applies dual-phase hybrid delivery to liver and metabolic repair, combining hepatocyte-targeted CMSVs with lipid-based modulation of inflammatory signaling. It is being developed as a next-generation therapy for NASH, fibrosis, and systemic metabolic dysfunction.
ImmunoVantix™
"Balancing immunity through hybrid nanotherapy."
ImmunoVantix™ unites immune-modulatory exosomes and lipid-anchored cytokine regulators into a precision hybrid for autoimmune and inflammatory diseases. The platform adapts dynamically to immune feedback via AI analytics, reinforcing BIOVANTIX's vision of programmable immunology.
OncoVantix™
"Stealth delivery for the era of intelligent oncology."
OncoVantix™ brings together the cloaking ability of CMSVs with ExoLip™ payload encapsulation for targeted tumor penetration. It enhances therapeutic precision while reducing systemic toxicity — a critical leap in the evolution of nanomedicine-guided cancer therapy.
DermaVantix™
"Hybrid skin regeneration engineered at the nanoscale."
DermaVantix™ translates the CMSV–ExoLip hybrid system into dermatologic applications, achieving multi-layer skin restoration. From scar remodeling to aesthetic rejuvenation, it exemplifies BIOVANTIX's ability to merge medical efficacy with commercial market opportunity.
ReparaVantix™
"Repair is no longer reactive — it's intelligent."
ReparaVantix™ serves as the cross-platform regenerative formulation adaptable to multiple indications. By combining injectable CMSVs with lipid-based depot release, it achieves both immediate cellular signaling and prolonged therapeutic effect, offering a unified model for sustained biologic repair.
Strategic Integration Insight
The Exo-CMSV Hybrid Family represents BIOVANTIX's transition from discrete delivery platforms to a unified nanotherapeutic ecosystem — where lipid, vesicle, and AI systems co-function as one adaptive machine.
For investors, these hybrid brands highlight the scalability of BIOVANTIX IP: each platform can be tuned to address distinct organ systems, indications, and commercialization pathways while retaining a shared manufacturing and regulatory framework.
Accelerated Clinical Development Strategy
Overlapping Multi-Indication Trial Design
BIOVANTIX™ employs a revolutionary clinical development approach that initiates multiple indication-specific trials in parallel. This strategy leverages shared platform safety data and AI-optimized protocols to compress traditional sequential development timelines.
The overlapping design allows safety learnings from early cohorts to inform protocol optimization in later-starting trials, while adaptive AI algorithms continuously refine dosing parameters across all active studies. This creates a network effect where each trial strengthens the scientific foundation for the entire platform.
Parallel Trial Initiation
Multiple indication-specific trials begin concurrently, maximizing efficiency.
Shared Safety Data & AI Protocols
Platform safety data and AI-optimized protocols are integrated across all studies, informing adaptive design.
Network Effect & De-risking
Each trial contributes to a stronger scientific foundation, accelerating proof-of-concept demonstration and de-risking the entire platform within 24-30 months.
Detailed Clinical Timeline
Key Strategic Advantage: Accelerated Timeline
This strategy compresses the timeline to multi-indication Phase 2 data to just 24-30 months, a significant improvement over the 5-7 years typically required for traditional sequential development. This acceleration creates multiple early value inflection points and rapidly de-risks the platform technology assumptions.
Platform Advantage
BIOVANTIX™'s modular delivery science platform—combining CMSV/ExoLip technology with AI-driven optimization—creates a compounding valuation model as it demonstrates successful therapeutic delivery across progressively challenging biological barriers. Starting with the blood-brain barrier as the most technically demanding proof point, each validated organ system unlocks incremental enterprise value while de-risking subsequent tissue targets.
Platform Valuation Growth Architecture
Barrier-by-Barrier Value Unlocking
Base Platform: $200M
Core AI-Driven Architecture
- Foundational CMSV/ExoLip technology
- Machine learning optimization
- Ready for tissue customization & clinical translation
Dermatology Validation: +$200M
Total: $400M
- Validated topical delivery for skin applications
- Overcomes skin barrier challenges
- Enables dermatology therapeutics & cosmetic applications
BBB Validation: +$500M
Total: $900M
- BBB delivery validated (preclinical/early clinical)
- Highest-risk, highest-reward milestone
- Enables CNS therapeutics & neurodegeneration
Ocular Validation: +$200M
Total: $1.1B
- Retinal/ocular targeting validated (measurable endpoints)
- Moderate technical risk
- Clinical pathways: ophthalmology, AMD, gene therapy
Cardiology Validation: +$300M
Total: $1.4B
- Cardiac delivery validated (e.g., gene therapy for heart failure)
- Addresses significant unmet needs in cardiovascular disease
- Large market opportunity for therapeutic intervention
Oncology Validation: +$300M
Total: $1.7B
- Targeted delivery to tumor sites demonstrated
- Enables precision oncology and reduced systemic toxicity
- Potential for novel chemotherapy, immunotherapy, and gene therapy combinations
Pulmonary Validation: +$150M
Total: $1.85B
- Lung targeting demonstrated (inhalation/vascular)
- Opportunities: pulmonary fibrosis, inhaled biologics, respiratory diseases
- Controlled delivery kinetics
Hepatic/Sys. Validation +$200M
Total: $2.05B+
- Validated hepatocyte transfection & systemic clearance
- Broad therapeutic reach: mRNA, gene therapy, metabolic disease
- Established regulatory pathways
Immunology Validation: +$200M
Total: $2.25B+
- Addresses immunological disorders
- Targets autoimmune diseases
- Enables immune system modulation
- Potential for vaccines & immunotherapies
Cumulative Value Creation Model
The stacked valuation architecture demonstrates how BIOVANTIX™ transforms from a $200M platform technology into a multi-billion dollar delivery infrastructure. Each biological barrier conquered serves as both proof of technical capability and gateway to new therapeutic verticals.
Key Inflection Point:: BBB validation represents a 3.5× valuation multiplier, establishing the platform's ability to solve the industry's hardest delivery challenge while simultaneously de-risking all subsequent tissue targets.
Technical Difficulty vs. Market Opportunity Matrix
BBB (CNS)
Difficulty: High
Market: CNS disorders, neurodegeneration ($60B+)
Validation: Prove penetration, efficacy, and safety across the toughest barrier.
Heart (Cardiac)
Difficulty: Moderate - High
Market: Heart failure, ischemia ($45B+)
Validation: Tissue-specific uptake data, cardioprotective delivery.
Eye (Ocular)
Difficulty: Moderate
Market: Ophthalmology, AMD, gene therapy ($20B+)
Validation: Localized delivery, visible, measurable clinical endpoints.
Lung (Pulmonary)
Difficulty: Moderate
Market: Pulmonary fibrosis, inhaled biologics ($15B+)
Validation: Controlled aerosolized or systemic targeting, precise dosing.
Liver (Hepatic)
Difficulty: Low-Moderate
Market: mRNA, gene therapy, metabolic diseases ($30B+)
Validation: Efficient hepatocyte transfection, favorable biodistribution and clearance.
Skin (Dermatological)
Difficulty: Low
Market: Dermatological disorders, wound healing, cosmetic applications ($60B+)
Validation: Localized absorption, topical/transdermal delivery efficacy, minimal systemic exposure.
Each barrier presents a distinct risk-reward profile. BIOVANTIX™ prioritizes BBB validation as ultimate technical proof, de-risking and accelerating progress across other targets. Our modular platform allows simultaneous development across multiple barriers once core tech is validated, creating parallel revenue streams and partnership opportunities.
Market Opportunity Quantification
The CMSV/ExoLip™ platform addresses a combined $230 B total addressable market across six target therapeutic areas, with opportunities for market expansion through superior delivery enabling previously undruggable targets. Our platform is poised to capture significant market share by addressing critical unmet needs in these high-value areas.
Neurodegenerative (BBB)
Current Market: $60 B+
- Unmet Needs: Effective CNS delivery, disease modification.
- Population: 50M+ patients globally (Alzheimer's, Parkinson's).
- Competitive Gap: Lack of targeted, non-invasive therapies.
Cardiology (Heart)
Current Market: $45 B+
- Unmet Needs: Regenerative therapies, precise drug delivery to damaged tissue.
- Population: 100M+ patients globally (heart failure, ischemia).
- Competitive Gap: Limited tissue-specific delivery.
Ophthalmology (Eye)
Current Market: $20 B+
- Unmet Needs: Long-acting, non-invasive treatments for chronic conditions.
- Population: 20M+ patients (AMD, diabetic retinopathy).
- Competitive Gap: Frequent injections, side effects of current therapies.
Pulmonary (Lung)
Current Market: $15 B+
- Unmet Needs: Targeted delivery for fibrosis, asthma, COPD.
- Population: 500M+ patients globally.
- Competitive Gap: Inefficient systemic delivery, localized side effects.
Hepatic (Liver)
Current Market: $30 B+
- Unmet Needs: Gene therapy for metabolic diseases, chronic liver conditions.
- Population: 50M+ patients (NASH, genetic disorders).
- Competitive Gap: High viral vector costs, immunogenicity.
Dermatology (Skin)
Current Market: $ 60 B+
- Unmet Needs: Localized, non-systemic treatments for chronic skin diseases.
- Population: Millions globally (psoriasis, eczema, wound healing).
- Competitive Gap: Limited topical penetration, systemic side effects.
The chart above quantifies the current addressable market in billions of dollars for each therapeutic area. Our platform's ability to overcome delivery challenges presents significant market penetration opportunities and strong revenue projection potential as we unlock previously undruggable targets. We project a combined market growth of over $250 B in these areas by 2030, driven by the increasing prevalence of these conditions and the critical need for advanced therapeutic solutions.
Capital Structure: Three-Round Strategy
Total capitalization: $250M, delivering a projected Series C pre-exit valuation in the $4–5B range. This structure balances aggressive development momentum with disciplined capital deployment, ensuring each funding round achieves demonstrable value inflection before subsequent dilution.
The sequential staging allows investors to de-risk progressively while maintaining substantial upside participation. Series A investors benefit from full platform validation before material clinical spend, while later-stage investors enter with substantially reduced technical and regulatory uncertainty. This phased approach mitigates binary risk inherent in early-stage biotech, providing clear valuation step-ups based on predefined scientific, clinical, and operational achievements.
Detailed Capital Deployment by Round:
1
Series A ($25M):
Focus on generating robust IND-enabling data for our lead small molecule candidates across neurology and ophthalmology. This includes advanced toxicology, pharmacokinetics/pharmacodynamics (PK/PD) studies, and efficacy in complex animal models. Funds will also establish a state-of-the-art GMP pilot manufacturing line in Puerto Rico, ensuring early supply chain control and cost efficiency. Critical regulatory affairs personnel will be hired to manage initial FDA and EMA interactions.
2
Series B ($75M):
Primarily allocated to human clinical trials. This encompasses patient recruitment, clinical site management, drug supply for Phase I/II, and comprehensive data analysis. A significant portion will also be invested in expanding our proprietary AI model's training dataset with real-world clinical data, enhancing its predictive accuracy for patient stratification and drug repurposing. Manufacturing will be scaled up to support mid-stage clinical demand, optimizing for cost per dose.
3
Series C ($150M):
Dedicated to the expansive and resource-intensive Phase III clinical program, including global trial sites, large patient cohorts, and long-term safety studies. A substantial investment will be made in pre-commercial activities, including building out sales and marketing infrastructure, securing reimbursement pathways, and establishing distribution networks. Strategic alliances for global market penetration will be finalized and funded.
Investor Protections and Governance:
Our capital structure incorporates standard investor protections including pro-rata rights, liquidation preferences (1x non-participating), and board representation commensurate with investment levels. A robust governance framework, including an independent board and a scientific advisory board comprising industry leaders, ensures strategic oversight and accountability. Quarterly financial and clinical progress reports will be provided, alongside annual audits by top-tier accounting firms, to maintain transparency and investor confidence.
Capital Efficiency via Puerto Rico Operations:
Leveraging our manufacturing and R&D facilities in Puerto Rico offers significant capital efficiency advantages, including preferential tax incentives (e.g., Act 60) and access to a skilled biopharmaceutical workforce. This strategic location enables cost-effective GMP production, contributing to a lower Cost of Goods Sold (COGS) and extending our cash runway compared to mainland U.S. operations. The local infrastructure also supports accelerated tech transfer and scale-up, critical for maintaining development timelines.
Bridge Funding & Alternative Financing:
While our three-round strategy provides a clear path, we remain agile for potential bridge financing or non-dilutive funding, such as strategic grants or partnerships, to accelerate specific programs or address unforeseen development challenges. Options for venture debt will be explored if advantageous for maintaining equity value and extending operational periods between rounds.
ROI Projections and Industry Benchmarks:
Our projected Series C pre-exit valuation of $4-5B represents a compelling 16-20x return on the total $250M capital invested, significantly outpacing biotech industry averages for similar stage companies. This aggressive projection is underpinned by: 1) our validated multi-indication platform, 2) efficient drug development timelines, and 3) large, underserved market opportunities in neurodegeneration and ophthalmology. Our internal models project peak sales exceeding $1B for our lead asset, with additional significant value from pipeline assets. Benchmarking against recent biotech IPOs and acquisitions at comparable clinical stages supports the feasibility of these ambitious valuations.
Competitive Advantages:
This capital structure, combined with our innovative platform, provides a distinct competitive advantage. It allows us to attract and retain top-tier talent, accelerate critical preclinical and clinical development without compromising scientific rigor, and establish early manufacturing independence. The sequential de-risking strategy positions us favorably against competitors relying on single-asset approaches, offering a more robust and diversified investment profile. Our Puerto Rico footprint further enhances operational cost-efficiency, creating a lean, high-output development engine.
Strategic Partnerships and Co-Development:
Beyond traditional financing, we are actively cultivating relationships with global pharmaceutical companies for potential strategic partnerships or co-development agreements, particularly for late-stage clinical development and commercialization in specific geographies. These collaborations could provide non-dilutive capital, access to broader commercial infrastructure, and validate our platform's potential, thereby enhancing overall investor returns and market reach.
Valuation Step-Up Progression
Our capital structure is strategically designed to drive substantial valuation step-ups at each funding round, rewarding investors for progressively de-risking the venture while unlocking significant upside potential.
The valuation trajectory reflects probability-adjusted milestone achievement with conservative assumptions, showcasing significant value inflection points at each stage.
Series A Returns
Investors achieve a 3–4× uplift upon IND filing completion, driven by successful preclinical development and regulatory milestones.
Series B PoC Validation
Investors capture a 5–7× step-up through Phase I/II proof-of-concept validation, reflecting de-risking from positive human clinical data.
Series C Pre-Exit Valuation
Investors participate in a 10–12× appreciation to pre-exit valuation, capitalizing on pivotal Phase III results and commercialization readiness.
Robust Return Projections
Full milestone achievement projects probability-adjusted IRR over 30% and cumulative ROI potential exceeding 18× across all investors.
Competitive Benchmarking
This risk-adjusted return profile compares favorably to biotech benchmarks, with substantial downside protection from our efficient Puerto Rico operations.
Exit Scenarios
Strategic acquisition, IPO, or licensing provides 15-25× total returns for early investors, with multiple pathways ensuring liquidity within 48 months.
Geographic & Cost Diversification Benefits
Our strategic presence in Puerto Rico delivers significant geographic and cost diversification advantages, leading to substantial capital efficiencies across all development phases. The detailed breakdown below highlights key areas of cost optimization compared to mainland US operations, ensuring enhanced investor returns through extended runway and reduced dilution.
Phase I Clinical Cost Savings
A significant reduction from $8.5 million on the mainland to $5.1 million in Puerto Rico, demonstrating a direct 40% capital efficiency improvement in early-stage trials. This critical saving allows for earlier pipeline advancement or additional exploratory research.
Phase II Clinical Cost Reduction
Cost efficiency continues into Phase II, with expenses lowered from $25 million to $15 million, translating to a 40% savings. This enables more robust trial designs or expanded patient cohorts without escalating capital expenditure.
GMP Manufacturing Advantages
Savings from $12 million (mainland) to $7.2 million (Puerto Rico) for GMP manufacturing represent a 40% cost benefit. Our integrated Puerto Rico facility ensures seamless process transfer and scale-up, minimizing batch consistency risks.
Regulatory Affairs Efficiency
Regulatory affairs costs are optimized from $3 million to $2.1 million, a 30% reduction. Enhanced communication channels with the Puerto Rico FDA coordination office contribute to a more streamlined and cost-effective approval pathway.
Personnel Cost Benefits
Personnel costs are reduced from $15 million to $9.75 million, yielding a 35% saving. Access to a skilled and dedicated workforce in Puerto Rico significantly lowers operational overheads without compromising talent quality.
Aggregate Savings & Capital Efficiency
These strategic advantages culminate in $26.85 million in aggregate savings across early development phases, translating to an impressive 42% capital efficiency improvement. This redefines the financial landscape for our biotech initiatives.
Extended Runway & Investor Benefits
The substantial savings directly translate to an extended financial runway and reduced investor dilution. This materially enhances investor returns by allowing for accelerated parallel program development or greater flexibility in strategic decision-making.
A sensitivity range of ± 15% on milestone completion costs still yields positive IRR in all Series A–C tiers under conservative assumptions — a rare resilience profile in early-stage biotech that reflects the fundamental capital efficiency of the Puerto Rico operational model.
Puerto Rico Act 60: Economic Foundation
4%
Corporate Tax Rate
Versus 21% mainland effective rate, yielding 17-point advantage on retained earnings
50%
R&D Tax Credit
Applied against qualified expenditures, materially reducing net development costs
75%
Property Tax Exemption
Reduces facility operational overhead and infrastructure investment burden
100%
Dividend Exemption
To shareholders, enhancing capital return flexibility and exit efficiency
These combined incentives create an effective reinvestment advantage of 60–70% versus mainland operations, significantly reducing Series A and B capital burn rates. The tax structure directly translates to extended runway, reduced dilution, and enhanced milestone achievement probability.
Critically, all benefits apply under full U.S. regulatory jurisdiction, maintaining FDA oversight standards while capturing jurisdictional economic advantages. This eliminates regulatory uncertainty common in offshore development strategies.
Clinical Trial Relocation: Operational Efficiency
40% Phase I/II Cost Savings
Achieved versus U.S. mainland execution, optimizing early-stage capital deployment.
35% Site Approval Acceleration
Driven by streamlined PR–FDA coordination, enhancing trial commencement timelines.
25% Per-Patient Cost Reduction
Resulting from superior labor and operational efficiencies within the Puerto Rico ecosystem.
Regulatory Continuity
Full FDA jurisdiction is maintained, complemented by enhanced local coordination office support for seamless oversight.
Expedited Patient Recruitment
Access to a diverse demographic within the U.S. regulatory framework significantly improves enrollment timelines.
Integrated Infrastructure
Proximity of GMP manufacturing to clinical sites reduces logistics complexity and mitigates timeline variability.
Leveraging Institutional Expertise
Benefit from established CRO partnerships and robust site networks specifically optimized for Puerto Rico operations.
Optimized Milestone Probability
The synergy of cost efficiency and operational acceleration yields a capital-adjusted milestone probability of success > 80%, factoring both economic and execution optimization. This substantially exceeds industry benchmarks for early-stage clinical programs.
Puerto Rico Competitive Advantages
Dramatic Cost Reduction
Clinical Trial Savings: 30-40% Lower Costs
- Site fees: $3,000-5,000 per patient vs. $8,000-12,000 mainland
- Investigator compensation: 35-45% reduction
- Infrastructure & overhead: 25-30% savings
Operational Efficiencies:
- Highly trained bilingual workforce at 40% lower salary costs
- Lab space rental: $18-25/sq ft vs. $45-75/sq ft (Boston/San Diego)
- Reduced regulatory consulting through local FDA expertise
Full FDA Equivalence
Zero Regulatory Compromise:
- Puerto Rico clinical data fully acceptable for U.S. NDA/BLA submissions
- GMP manufacturing facilities inspected under identical FDA standards
- No bridging studies or additional regulatory requirements
- Direct access to FDA reviewers through local office presence
Quality Infrastructure:
- CAP/CLIA-accredited clinical laboratories
- Academic medical centers with Phase 1-3 trial experience
- Established CRO presence (Integrium, Alliance Pharma)
Act 60 Tax Incentives
Corporate Benefits:
- 4% corporate tax rate (vs. 26-29% U.S. federal + state)
- Up to 50% R&D tax credits on qualifying expenditures
- 100% tax exemption on dividends and interest income
- Zero capital gains tax on PR assets
Individual Founder Benefits (Optional):
- 0% tax on capital gains and dividends for bona fide PR residents
- Maintains U.S. citizenship and passport
- No expatriation or GILTI complications
Biotech-Ready Ecosystem
Established Infrastructure:
- PRIDCO biotech parks with plug-and-play facilities
- University of Puerto Rico Medical Sciences Campus
- Ponce Health Sciences University research capabilities
- Manufacturing supply chain from pharma legacy (Amgen, Pfizer historical presence)
Talent Pipeline:
- 800+ MD/PhD graduates annually from accredited institutions
- Experienced clinical research coordinators and regulatory specialists
- Bilingual capabilities enabling Latin American expansion
Financial Impact Analysis: Mainland vs. Puerto Rico
Development Cost Comparison
Total Development Savings: $160M
Exit Taxation Comparison
Note: Assumes asset sale structure. Stock sale by founders as PR residents incurs 0% capital gains tax vs. 20-37% mainland rates
Total Puerto Rico Advantage: ≈$1.01 Billion
24-Month High-Probability Execution Window
All major development targets achievable within compressed timeline through optimized regulatory sequencing and parallel R&D streams
Statistical Confidence Framework
Our execution forecasting is driven by a sophisticated, multi-dimensional probability model. This framework assigns an internal confidence score to each scientific, regulatory, and operational milestone, leveraging AI-validated predictive modeling and historical analogs across comparable biologic platforms.
AI-Validated Predictive Modeling
A multi-dimensional probability model underlies all execution forecasting, assigning internal confidence scores derived from AI-validated predictive modeling and historical analogs across comparable biologic platforms.
Preclinical-to-IND Transition
Achieving > 0.85 confidence, supported by completed feasibility studies, third-party validation, and positive regulatory pre-IND meeting feedback.
Phase I Safety Endpoints
Exhibiting >0.82 confidence, based on robust preclinical toxicology margins, biodistribution validation, and precise dose-escalation modeling.
Phase II Efficacy Signals
Projected at 0.78 confidence, derived from mechanism-of-action validation, strong biomarker correlations, and adaptive trial design strategies.
High Statistical Confidence (≥ 0.80)
Integrated projections indicate high statistical confidence for achieving all core milestones within 24 months.
Controlled Variance (σ ≈ 0.12)
Moderate variance across therapeutic verticals reflects controlled diversification. The cumulative de-risking effect due to portfolio overlap enables investors to interpret progress as probabilistically compounded rather than binary.
Phase 1 Roadmap: Foundation Building
Months 0–12: Platform Validation & Regulatory Readiness
IND-Enabling Studies Completion
Finalization of ophthalmic and neuro indication packages with full GLP toxicology, biodistribution, and pharmacokinetic datasets
GMP Facility Establishment
Puerto Rico micro-batch manufacturing line operational with initial process validation runs and stability testing protocols
0
AI Optimization Iteration
BIOVANTIX™ AI™ pharmacokinetic refinement with first-in-human dosing predictions and biodistribution modeling validation
Regulatory Submission
Dual IND filings to FDA for lead ophthalmic and neurodegenerative indications with anticipated 30-day review clearance
Critical Milestones
- Pre-IND meeting completion (Month 3)
- GMP facility FDA inspection readiness (Month 8)
- IND submission (Month 10)
- First-in-human study initiation authorization (Month 12)
Resource Allocation
- CMC development: 40% of Phase 1 budget
- Regulatory affairs: 25%
- AI model refinement: 20%
- Clinical site preparation: 15%
Phase 2 Roadmap: Clinical Validation
Months 12–24: Proof-of-Concept Generation
Synexome AI™ & Biomarker Discovery
Integrating comprehensive clinical data into Synexome AI™ for advanced AI-driven data analysis, adaptive dosing optimization, and precise efficacy forecasting. This iteration also focuses on biomarker identification systems and validation protocols for early indicators of response.
Advanced Biomarker & Interim Analysis
Establishing advanced biomarker discovery and validation protocols to refine patient selection. Implementation of robust interim analysis protocols and predefined go/no-go decision criteria ensures agile clinical progression and efficient resource allocation.
Phase I/II Transition & Regulatory Milestones
Seamless transition to Phase II proof-of-concept, guided by biomarker-driven assessment and rigorous regulatory alignment. Achieved key regulatory milestone achievements, including positive FDA interactions on trial design and endpoints, ensuring a clear path forward.
Series B Acceleration
Series B capital accelerates manufacturing expansion and new indication initiation, leveraging our validated platform. Strategic partnership discussions are underway with potential collaborators to enhance global reach and development capabilities.
Accelerated Progression
FDA/PR framework enables 30–40% faster progression through early clinical stages, accelerating therapeutic confirmation. This accelerated timeline is supported by continuous regulatory engagement and adaptive trial methodologies.
Multi-site Coordination & Patient Monitoring
Initiating multi-site clinical trials to broaden patient access and data diversity. Advanced patient monitoring systems are deployed across all sites, ensuring real-time data capture and enhanced safety surveillance for robust clinical evidence generation.
Key Risk Mitigation & Collaboration
Parallel regulatory pathways (CDER + CBER) ensure continuous agency engagement, minimizing approval bottlenecks. Proactive partnership discussions with potential strategic collaborators are integral to de-risk development and prepare for commercialization.
Patient Engagement Strategy
Developing and implementing robust patient engagement programs to ensure high recruitment rates, patient retention, and collection of patient-reported outcomes for a comprehensive understanding of drug efficacy and safety in real-world settings.
Phase 3 Roadmap: Commercial Preparation
Months 24–48: Validation & Market Entry
Pivotal Trial Initiation
Launching large-scale Phase III trials across diverse populations to confirm long-term safety and efficacy, incorporating adaptive trial designs for efficiency and robust data generation.
Manufacturing Scale-Up & Readiness
Scaling up manufacturing capabilities to commercial volumes, optimizing processes for cost-efficiency, consistency, and global supply chain readiness. This includes detailed process validation and capacity planning.
GMP Facility Operations
Ensuring full compliance with Good Manufacturing Practices (GMP) across all production sites, including rigorous quality control, assurance protocols, and facility accreditation to meet global standards.
Regulatory Strategy & Submissions
Compiling and submitting comprehensive New Drug Applications (NDAs) or Biologics License Applications (BLAs) to major global regulatory authorities, including strategic pre-submission meetings and dossier preparation.
Regulatory Approval Process
Actively managing interactions with regulatory agencies throughout the review process, addressing queries, and ensuring timely responses to facilitate market authorization. This includes post-approval commitments.
Commercial Preparation & Partnerships
Establishing commercial infrastructure, building a high-performing commercial team, developing market access strategies, and securing key partnerships and licensing opportunities to ensure broad product availability.
Market Entry & Launch
Executing targeted market launch plans in key regions, engaging proactively with healthcare providers, payers, and patient advocacy groups for successful adoption and market penetration.
Post-Market Surveillance & Expansion
Implementing robust pharmacovigilance programs, real-world evidence generation, and health economics outcomes research, while continuously exploring lifecycle management for additional indications and formulations.
Operational Timeline Visualization
Months 0-6: Series A Deployment
IND preparation, facility establishment, and proactive regulatory engagement lay the groundwork for our initial phase.
Months 6-12: Platform Validation
Achieving IND submission and GMP qualification, alongside continuous AI model refinement, validates our foundational platform.
Months 12-18: Clinical Entry
Initiation of Phase I trials and robust safety data generation are pivotal, supported by a successful Series B raise.
Months 18-24: Patient Enrollment & Data Management
Implementing advanced systems for efficient patient enrollment and meticulous data collection, ensuring integrity and compliance.
Months 24-30: Proof-of-Concept
Focused Phase II enrollment yields crucial efficacy signals, concurrent with vital manufacturing scale-up efforts.
Months 30-36: Pivotal Preparation
Strategic Phase III design, targeted global expansion, and securing Series C capital accelerate our journey towards market entry.
Months 36-42: Regulatory Pathway Management
Proactive management of regulatory milestones, including ongoing interactions with health authorities and preparing comprehensive submission dossiers.
Months 42-48: Commercial Readiness
Culminating in NDA/BLA submission and licensing completion, this phase positions us optimally for market entry and exit strategies.
Risk Mitigation Strategy
Comprehensive risk analysis identifies three primary categories — regulatory timing, CMC scalability, and data readout variance — each addressed through systematic mitigation protocols.
Regulatory Timing Uncertainty
Risk: FDA review delays or additional data requests extending development timeline
Mitigation: Parallel regulatory pathways with CDER + CBER joint guidance ensure continuous agency engagement. Pre-IND meetings establish clear expectations and eliminate late-stage surprises. Puerto Rico FDA coordination office provides enhanced communication channels.
Residual Probability: < 15% of material schedule impact
CMC Scalability Challenges
Risk: Manufacturing process transfer difficulties or batch consistency issues during scale-up
Mitigation: AI-guided manufacturing process control minimizes batch-to-batch variability through real-time parameter optimization. Integrated Puerto Rico GMP facility eliminates technology transfer delays. Continuous process verification throughout scale-up phases.
Residual Probability: < 12% of requiring significant process modification
Clinical Data Readout Variance
Risk: Efficacy or safety endpoints not meeting statistical significance thresholds
Mitigation: Adaptive trial designs allow mid-course corrections based on emerging data. Portfolio diversification across multiple indications reduces binary outcome dependency. Biomarker-driven patient selection improves response probability. AI predictive modeling enables proactive protocol adjustments.
Residual Probability: < 20% per individual indication, < 8% across portfolio
A sensitivity range of ± 15% on milestone completion costs still yields positive IRR in all Series A–C tiers under conservative assumptions — a rare resilience profile in early-stage biotech that reflects the fundamental capital efficiency of the Puerto Rico operational model.
Exit Strategy: Three Pathways to Liquidity
Strategic Acquisition
Our primary pathway targets major pharmaceutical companies, seeking platform integration to enhance existing pipelines. With a projected timeline of 36–48 months post-Series C and a 3–5× Series C valuation multiple, the CMSV/ExoLip™ technology's cross-therapeutic capabilities justify premium acquisition multiples. Recent comparables for similar platform acquisitions range from $2.8B to $6.2B for pre-commercial assets.
Public Offering (IPO)
Positioning for a public offering with a target market capitalization of > $4B on NASDAQ or NYSE, this pathway anticipates a 42–54 month post-Series C timeline. The biotech sector's appetite for platform companies with diversified pipelines, coupled with our Puerto Rico operational efficiency, creates a compelling margin story for public markets, allowing for optimal market entry timing.
Licensing Roll-Up Model
Commencing ongoing from Month 24 forward, this model projects > $200M annually in royalties. Through indication-specific licensing to multiple pharmaceutical partners, we maximize total value extraction while retaining platform ownership. This non-exclusive approach offers strategic flexibility, enabling a "sell and develop" hybrid model that funds continued pipeline expansion.
High Likelihood of Liquidity
A probability-weighted expected value analysis indicates a 70% likelihood of a liquidity event within 48 months post-Series C, assuming full milestone adherence. This timeline compares favorably to biotech sector medians, reflecting a robust and accelerated path to investor returns.
Favorable Timeline Comparisons
Our projected liquidity timeline demonstrates superior performance against biotech sector medians. This efficiency is a direct outcome of our optimized operational model and strategic focus, ensuring accelerated value creation for stakeholders.
Downside Protection through Optionality
The strategic incorporation of multiple exit pathways provides substantial downside protection for investors. This rare resilience profile in early-stage biotech is a testament to the fundamental capital efficiency of our operational model, offering enhanced security and flexibility.
Investor Return Scenarios
Conservative Scenario
Even with a single indication approval and a modest acquisition multiple, our conservative scenario projects strong investor returns:
- Series A ROI: 12.5×
- Series B ROI: 6.2×
- Series C ROI: 2.8×
Base Case Scenario
Our base case, founded on dual indication approval and a strategic acquisition at 4× Series C, targets substantial returns:
- Series A ROI: 22.4×
- Series B ROI: 11.2×
- Series C ROI: 4.0×
Optimistic Scenario
A multi-indication portfolio leading to a premium acquisition or successful IPO, showing exceptional potential:
- Series A ROI: 35.8×
- Series B ROI: 17.9×
- Series C ROI: 5.5x
Exceeding Venture Benchmarks
All scenarios incorporate probability-adjusted milestone achievement rates and assume standard liquidation preference structures. Notably, the base case delivers a probability-adjusted IRR exceeding 30% across all investor cohorts. This is substantially above venture biotech benchmarks, which typically range from 18–22% for comparable risk profiles.
Capital Advantage & Downside Protection
Critically, even conservative scenarios yield attractive returns, underpinned by our Puerto Rico operational efficiency. This creates a fundamental capital advantage, offering a 60–70% reinvestment benefit compared to mainland operations. This provides a level of downside protection rarely available in early-stage biotech investments.
$4–5B
Projected Series C Pre-Exit Valuation Range
Based on probability-adjusted milestone achievement and comparable platform company transactions
Intellectual Property Landscape
BIOVANTIX™ has established a comprehensive IP portfolio providing freedom-to-operate and competitive exclusivity across core platform components and therapeutic applications.
Foundational Patents
3 filed U.S. patents covering CMSV/ExoLip™ hybrid architecture, with continuation applications and international filings in EU, Japan, China providing global protection through 2041
Manufacturing Process IP
2 filed patents on scalable exosome-liposome fusion methodology, trade secret protection on critical process parameters, know-how providing additional competitive barriers
AI Algorithm Protection
Trade secret strategy for ExoVantix AI™ predictive models, copyright protection on software implementation, continuous evolution creating moving target for competitors
Indication-Specific Applications
8 provisional applications covering therapeutic uses in neurodegenerative, ophthalmic, and autoimmune diseases, with additional filings planned based on clinical data generation
Freedom-to-Operate Analysis: Comprehensive third-party patent landscape review confirms no blocking patents identified. Strategic licensing agreements secured for enabling technologies where beneficial. Ongoing monitoring and defensive publication strategy maintains clearance.
Competitive Positioning Analysis
The biologic delivery landscape includes both established pharmaceutical companies and emerging platform biotechs. BIOVANTIX™ differentiates through unique technology integration, capital efficiency, and execution velocity.
Versus Pharma Incumbents
Large pharmaceutical companies possess distribution infrastructure but lack platform flexibility and development speed. BIOVANTIX™ offers superior adaptability and faster iteration cycles, with partnership opportunities for late-stage commercialization leveraging their strengths.
Versus Single-Modality Platforms
Pure exosome or pure liposome platforms lack the hybrid advantages of CMSV/ExoLip™ technology. Our dual-mechanism approach provides superior pharmacokinetics while maintaining manufacturing feasibility — a combination competitors cannot easily replicate.
Versus Academic Spinouts
University-originated technologies often struggle with manufacturing scale-up and regulatory execution. BIOVANTIX™ addresses these challenges proactively through Puerto Rico infrastructure integration and experienced management team, avoiding common academic-to-commercial translation failures.
The combination of these strengths positions BIOVANTIX™ to capture disproportionate value within the competitive landscape, with partnership optionality enhancing rather than threatening independent success.
Technological Differentiation
Leveraging unique hybrid CMSV/ExoLip™ technology for superior delivery.
Operational Efficiency
Strategic infrastructure and lean operations optimize resource utilization.
Execution Capability
Experienced management and proactive regulatory planning ensure rapid translation.
Investment Highlights: Summary
Differentiated Technology Platform
CMSV/ExoLip™ hybrid nanoplatform delivers 2.3× therapeutic persistence advantage with AI-enhanced optimization accelerating development by 70%
Capital Efficiency Leadership
Puerto Rico Act 60 benefits create 60–70% reinvestment advantage, extending runway 2.4× versus mainland operations while maintaining full FDA regulatory jurisdiction
Probability-Weighted De-Risking
Statistical confidence modeling shows > 0.8 probability of achieving all major milestones within 24 months, with portfolio diversification reducing binary outcome dependency
Attractive Return Profile
Base case scenario delivers > 30% probability-adjusted IRR across all investor cohorts, with Series A investors achieving potential 22× return at exit
Multiple Exit Pathways
Strategic acquisition, IPO, and licensing options provide 70% probability of liquidity within 48 months post-Series C, with flexibility to optimize exit timing and structure
Proven Leadership Team
Management combines deep scientific expertise, regulatory experience, and prior successful exits, with governance structure providing institutional investor protections
Investment Terms & Process
Series A Structure
- Raise Amount: $25M
- Security Type: Series A Common Stock (standard protective provisions)
Investor Rights & Governance
- Board Representation: 1 seat for investors ≥ $10M
- Information Rights: Quarterly financials, annual audits, monthly operational updates
- Major Investor Rights: Pro-rata participation, standard drag-along, ROFR on secondary sales
Current Status: BIOVANTIX™ is actively raising Series A with $2M in soft commitments from existing angel and seed investors. Lead investor position available for committed capital ≥ $10M with board seat and enhanced information rights.
Investor Confidence & Conclusion
The CMSV/ExoLip™ Nanoplatform unites clinical precision, statistical confidence, and jurisdictional efficiency into one coherent investment narrative. By embedding cost and probability optimization at every stage — from AI-driven formulation to Puerto Rico–enabled clinical execution — BIOVANTIX™ has structurally de-risked the path to commercialization.
Why Invest Now
- Inflection Point: Platform validation complete, IND-enabling studies in final stages, regulatory pathway clarified
- Capital Efficiency Window: Puerto Rico infrastructure operational, providing maximum efficiency advantage during capital-intensive clinical phases
- Competitive Timing: Market validation of delivery platforms creating acquisition appetite while competition remains fragmented
- Valuation Entry: Series A pricing reflects platform risk, not yet incorporating clinical validation premium
Distinctive Value Proposition
- Technology: Hybrid platform superiority validated through head-to-head preclinical comparisons
- Economics: 60–70% capital advantage creating resilience across downside scenarios
- Execution: Experienced team with track record of translating platform technologies to commercial success
- Portfolio: Multi-indication diversification reducing binary risk while maintaining focused execution
"BIOVANTIX™ represents the rare convergence of breakthrough science, operational excellence, and structural capital advantage. The CMSV/ExoLip™ platform addresses fundamental limitations in biologic delivery while the Puerto Rico model provides quantifiable economic benefits that materially enhance investor returns. This combination — technological differentiation plus capital efficiency — positions the company to achieve outsized success across multiple scenarios."
We invite life-science investors to engage in detailed due diligence and participate in this decisive opportunity to shape the next generation of targeted therapeutics while capturing exceptional risk-adjusted returns.
Executive Team
Leadership That Drives Innovation
Our executive leadership brings decades of combined experience across biotechnology, finance, and organizational development, driving innovation and growth in complex, highly regulated industries. Our CEO is the inventor of BIOVANTIX™'s proprietary CMSV delivery platform, positioning us at the forefront of regenerative medicine and longevity science.
We temporarily omit individual scientist names to protect IP timing, and we provide complete team disclosures to serious investors as part of the diligence process.
Christian Carnes is a biotechnology CEO and platform-innovation strategist with deep expertise in organizational leadership, capital strategy, and enterprise execution. His multidisciplinary background spans biologic development, investment finance, strategic governance, and high-performance culture design — enabling him to fuse scientific breakthrough with superior investor outcomes. Christian employs endgame-first strategy planning and competitive game-theory modeling to ensure BIOVANTIX™ advances along the highest-return, lowest-risk pathway to global adoption and premium-multiple exit opportunities.
As CEO of BIOVANTIX™, Christian leads the development and market expansion of the CMSV™ / ExoLip™ AI-enabled precision-delivery nanoplatform — engineered to overcome the primary failure mode of modern biologics: targeted organ-level delivery and activation. Under his direction, BIOVANTIX has architected a multi-asset, multi-exit pipeline spanning oncology, cardiometabolic disorders, neurodegeneration, immunology, rare disease, regenerative medicine, and infectious disease — each asset strategically designed to produce valuation inflection points attractive to top-tier pharmaceutical partners.
Christian is building a culture where technology, innovation, and execution excellence reinforce one another — accelerating timelines, reducing burn, and establishing operational readiness for strategic acquisition. By integrating AI-powered clinical efficiency, precision translational modeling, and partner-aligned development plans, he positions BIOVANTIX as a first-to-scale category leader in delivery-enabled medicine — and as a strategic imperative for future healthcare consolidators.
"BIOVANTIX is designing a future where therapies reach precisely where disease begins — unlocking outcomes biology has never before allowed. We are building not just a platform, but a new global standard for how medicine is delivered, measured, and valued — accelerating impact for patients and exponential returns for investors."
— Christian Carnes, Chief Executive Officer
- PhD Leadership & Organizational Behavior, Pepperdine
- MA Accounting, Rutgers
- MBA Finance and Economics, Pepperdine
- BS Management, Accounting and Finance, Pepperdine
Bill Aubin is a proven biopharma operations executive with more than 30 years of expertise transforming advanced biologics into globally scalable medical products. His leadership spans CMC development, GMP manufacturing, technology transfer, and end-to-end supply chain build-out for modalities ranging from monoclonal antibodies to complex nanomedicine platforms. He has directed the operational progression of over 20 biologics through clinical development, ensuring manufacturing readiness and regulatory continuity at every stage.
At BIOVANTIX™, Bill leads the industrial execution of the CMSV™ / ExoLip™ precision delivery platform, transitioning breakthrough discovery into pharma-grade production pathways. His strategy integrates manufacturability by design, enabling BIOVANTIX programs to meet the expectations of top Global Pharma partners from the earliest development phases. By building flexible, regionalized supply infrastructure, he ensures the company can rapidly scale manufacturing volume, maintain uninterrupted supply, and meet international regulatory requirements.
Bill's operational discipline enables BIOVANTIX to move faster, derisk milestone execution, and position the company as an immediately integrable acquisition asset — not a speculative pipeline project. His focus on technical scalability and cost efficiency protects investor capital while accelerating BIOVANTIX toward revenue-generating partnerships and global clinical expansion.
"Operational excellence is the bridge between great science and global impact. BIOVANTIX is building scalable systems that bring next-generation biologics to patients faster, safer, and with uncompromising quality."
— Bill Aubin, Chief Operating Officer
- BA Management, University of Florida
Jack Sunier is an accomplished biopharma financial strategist with deep expertise across investment banking, corporate development, royalty monetization, and valuation engineering. He has executed capital formation strategies, constructed blended monetization frameworks, and driven asset-level exit events in competitive, fast-moving global markets — particularly those undergoing delivery-technology transformation. His analytical approach includes probability-weighted valuation, exit scenario modeling, and capital allocation designed for maximum ROI.
At BIOVANTIX™, Jack architects financial strategy and investment governance for the CMSV™ / ExoLip™ portfolio. He develops and executes multi-path monetization opportunities, including milestone-linked out-licensing, regional commercialization rights, strategic divestitures, and IPO scalability. By mapping investor return dynamics to milestone pacing and peak buyer demand windows, he ensures BIOVANTIX™ advances along a track to repeatable premium liquidity events.
Jack's leadership elevates BIOVANTIX™ beyond a pure science company, positioning it as a financial outperformer in a consolidating delivery-technology market. His work ensures BIOVANTIX™'s innovations are consistently framed through a value-expansion lens: protecting investor equity, maximizing optionality, and keeping the company strategically exit-qualified at all points in the development cycle.
"BIOVANTIX™ is uniquely positioned to convert scientific breakthroughs into exponential economic value. We are advancing a platform where precision delivery drives superior returns — for patients, partners, and investors — as the future of medicine rapidly accelerates."
— Jack Sunier, Chief Investment Officer
- MA International Economics, NYU
- BA Economics, UCLA
Elena Verutina is a globally recognized biotech growth strategist with over two decades of executive leadership guiding the commercialization and monetization of next-generation biologic platforms. She has built global commercialization roadmaps, designed access strategies for emerging modalities, and negotiated strategic drug partnerships that have resulted in billions in potential enterprise value. Her career includes leading high-impact launches and market acceleration initiatives across the U.S., Europe, LATAM, and MENA, specializing in programs where delivery innovation and capital discipline drive competitive advantage.
At BIOVANTIX™, Elena oversees the corporate growth engine behind the company's AI-powered CMSV™ / ExoLip™ precision-delivery platform. She leads investor relations, capital formation, and global partnership development while managing competitive and regulatory alignment across eight major therapeutic markets. Her deal-making structure prioritizes valuation-rich inflection points through royalty-aligned out-licensing, co-development alliances, strategic asset sales, and IPO preparation, ensuring BIOVANTIX™ advances aggressively and efficiently — while minimizing dilution.
Elena's market intelligence, payer strategy expertise, and ability to sequence program advancement across regions enables BIOVANTIX™ to secure pricing power, commercial footholds, and acquisition visibility earlier than traditional clinical-stage biotechs. Her leadership ensures BIOVANTIX's™ delivery-first positioning becomes a commercial standard, enabling the company to expand its market footprint faster and more profitably than single-asset therapeutic competitors.
"We are engineering the future of biologics — delivery platforms that don't just treat disease, but reshape the expectations of science itself. BIOVANTIX™ transforms where therapies can go, how fast they reach patients, and the scale of value they create — forging entirely new markets where medical and financial outcomes advance together."
— Elena Verutina, Chief Growth Officer
- BA Business, Cornell
She is an accomplished scientific leader with advanced expertise in RNA-based drug delivery, nanotechnology engineering, and neurobiological therapeutic design. She previously served as CSO of a neurobiology-focused biotech venture, where she led the translation of novel biologic concepts into early-stage clinical strategies. Most recently, she worked within a leading nanotechnology company developing programmable RNA cargo systems designed to improve intracellular delivery efficiency and disease-specific activation—experience directly aligned with the evolution of BIOVANTIX™'s delivery advantages.
At BIOVANTIX™, she serves as Chief Scientific Officer, responsible for advancing the company's AI-powered CMSV™ / ExoLip™ precision-delivery platform into therapeutic leadership across eight major disease categories, including oncology, immunology, metabolic and cardiovascular disease, neurodegeneration, regenerative medicine, rare genetic disorders, and infectious disease. She leads platform strategy, preclinical development, payload optimization, and target selection, ensuring scientific roadmap decisions directly support licensing potential, clinical differentiation, and strategic exit pathways.
Her work integrates molecular engineering, tissue-specific delivery mechanisms, and efficient translational execution to derisk the multi-asset pipeline and rapidly generate pharma-attractive proof points. She collaborates closely with the CIO and CGO to prioritize programs with the highest technical feasibility, market urgency, and probability-weighted ROI—accelerating BIOVANTIX™ toward commercial visibility and premium acquisition fit.
"We are not just improving biologic delivery — we are redefining the rules of how precision medicine reaches its target. By unlocking the true power of modality-agnostic cargo deployment, BIOVANTIX™ is expanding what modern therapeutics can achieve for patients, partners, and the future of healthcare innovation."
— Chief Scientific Officer
- Ph.D., Cell and Molecular Biology/ Stem Cells
- MS, Biomedical Sciences
- BS, Biochemistry
She is a physician-scientist and translational clinical leader with deep expertise in RNA-based therapeutics, nanoparticle delivery platforms, and exosome-inspired biologics. Most recently, she contributed to advanced RNA delivery programs with a global nanotechnology innovator, optimizing tissue-specific cargo deployment for high-impact disease targets. Previously, as Chief Scientific Officer of a neurobiology-focused startup she co-founded, she successfully guided platform development and strategic positioning through a successful corporate acquisition by a major pharmaceutical company — demonstrating the rare ability to take cutting-edge science from concept to exit.
At BIOVANTIX™, she serves as Medical Director, responsible for the clinical translation and safety advancement of the company's AI-powered CMSV™ / ExoLip™ precision-delivery platform. She leads preclinical-to-clinical development, clinical strategy design, endpoint prioritization, patient selection insight, and regulatory alignment across eight major therapeutic arenas including oncology, immunology, metabolic disease, cardiovascular disease, neurodegenerative conditions, regenerative medicine, rare genetic disorders, and infectious disease. Her guidance ensures that BIOVANTIX™'s asset progression is tightly aligned with clinical differentiation, health-economic relevance, and partner-ready milestones that accelerate both scientific credibility and valuation lift.
She is particularly focused on proving tissue-targeting performance, establishing delivery-based medical superiority, and enabling rapid first-in-human readiness — generating the clinical evidence strategic acquirers require to justify premium deal structures. By working cross-functionally with R&D and operational leadership, she ensures every program advances with the medical and regulatory rigor needed to win in competitive global markets.
"BIOVANTIX™ is redefining clinical expectations for biologic delivery — proving that precision targeting is not just possible but scalable. We are enabling therapies to reach previously inaccessible disease drivers, unlocking outcomes that elevate both patient lives and investment value."
— Medical Director
Education & Clinical Foundation
- MD, Medical Genetics
- MS, Nanoscience
- BS, Biochemistry
He is a bioinformatics-driven cellular microbiologist and data-science leader specializing in RNA therapy modeling, nanoparticle delivery optimization, and predictive exosome-based targeting analytics. His expertise bridges molecular cell biology, advanced computational biology, and AI/ML workflow development, enabling rapid translation of delivery innovations into measurable clinical and economic advantages. His work focuses on solving the core challenge that determines success in modern biologics: whether a therapeutic reaches its intended target, in the right concentration, at the right moment.
At BIOVANTIX™, he leads platform intelligence and AI-enhanced discovery for the proprietary CMSV™ / ExoLip™ precision-delivery nanoplatform. He develops algorithms and simulation engines that quantify organ-selective delivery, predict payload durability, and evaluate mechanistic performance before in-human testing — dramatically reducing clinical failure risk and accelerating milestone achievement. His insights directly inform target selection, biomarker strategy, patient stratification, and evidence generation that strengthen strategic partnerships, regulatory confidence, and premium valuation inflection.
He plays a critical role in positioning BIOVANTIX as an AI-native biotech — where computational proof of success is established long before clinical data becomes available. By unifying biological significance with predictive analytics, he enables BIOVANTIX to deliver precision therapies with superior certainty, efficiency, and scalability, boosting the probability of high-multiple exit outcomes.
"BIOVANTIX™ is harnessing AI to decode the biological realities that determine whether a therapy succeeds or fails. By guiding delivery with data, we transform precision medicine into predictable medicine — elevating both patient outcomes and the economic value of every therapeutic we touch."
— Senior Director of Bioinformatics & AI-Driven Discovery
Education & Technical Expertise
- Ph.D., Cell & Microbiology (Bioinformatics focus)
- MBA, Finance (Bioinformatics minor)
- BS, Microbiology
Pallav Regmi is a technology and data-infrastructure leader specializing in AI-accelerated biologics development, secure research computing environments, and enterprise-grade system scalability. With a decade of experience architecting high-compliance cloud environments for biotech, he brings a sophisticated command of cybersecurity, operational resilience, and analytical performance — ensuring BIOVANTIX™'s breakthrough delivery science is powered by equally advanced technology.
As Chief Technology Officer at BIOVANTIX™, Pallav is responsible for building and managing the AI intelligence backbone behind the CMSV™ / ExoLip™ precision-delivery nanoplatform. He oversees secure data ecosystems designed for multi-omics integration, model-driven targeting predictions, and clinically aligned performance analytics, ensuring the company's advantages in molecular targeting and organ-specific biodistribution are computationally proven and partner-ready. His work ensures full compliance with HIPAA, GxP, and global security frameworks, enabling trusted collaboration with biopharma partners and scientific institutions worldwide.
Pallav leads a multidisciplinary technology organization developing TensorFlow- and Python-based AI engines, workflow automation tools, and high-fidelity delivery simulations that significantly reduce manual analytics, increase data integrity, and accelerate precision-therapy advancement. He has a proven record of turning technical architecture into operational excellence — reducing analytical timelines from months to days and establishing clean, auditable data pipelines essential for clinical and regulatory success.
His mission is to ensure BIOVANTIX™'s technology infrastructure is not just supportive — but a core differentiator that unlocks better science, faster development, and superior investor outcomes.
"AI is redefining how therapeutics achieve impact. At BIOVANTIX™, our technology ensures that delivery innovation is modeled, measured, and proven before it reaches the clinic — transforming precision medicine from possibility into predictable reality."
— Pallav Regmi, CTO
- BS, Computer Science, University of Wisconsin
CONTACT
Headquarters
600 West Broadway 7th Floor, San Diego, CA 92101
600 West Broadway 7th Floor, San Diego, CA 92101
Puerto Rico
53 Calle Las Palmeras, San Juan PR 00901
Phone (442) 290 8091
Email: info@biovantix.org
For investment inquiries, partnership opportunities, or additional information about our technology platform and development programs, please contact us directly. We welcome dialogue with investors, potential partners, and collaborators who share our vision for transforming regenerative medicine through the convergence of AI and molecular biology.
CONTACT
For investment inquiries, partnership opportunities, or additional information about our technology platform and development programs, please contact us directly. We welcome dialogue with investors, potential partners, and collaborators who share our vision for transforming regenerative medicine through the convergence of AI and molecular biology.
Headquarters
600 West Broadway 7th Floor, San Diego, CA 92101
600 West Broadway 7th Floor, San Diego, CA 92101
Puerto Rico
53 Calle Las Palmeras, San Juan PR 00901
Phone (442) 290 8091
Email: info@biovantix.org
BIOVANTIX™ Series A Legal Disclosures – SEC & FDA Compliance Statement I. SEC Compliance – Regulation D (Private Offering) This Series A raise by BIOVANTIX™ Biotechnology, Inc. is conducted pursuant to an exemption from registration under the Securities Act of 1933 via Regulation D, allowing private placement of securities to accredited investors.
- General Legal Basis If using Rule 506(b): No general solicitation or advertising is permitted. Investors must be accredited, and the issuer must file Form D electronically within 15 days after the first sale. If using Rule 506(c): General solicitation is permitted, but investor accreditation must be verified through reasonable steps (CPA letter, third-party verification, etc.).
- Core SEC Disclosures Private Offering / No Registration: This presentation is provided solely for informational purposes in connection with a potential private offering of securities of BIOVANTIX™ Biotechnology, Inc. ('the Company') pursuant to an exemption from registration under Regulation D of the Securities Act of 1933, as amended. These securities have not been registered with the U.S. Securities and Exchange Commission ('SEC') or any state securities authority. Not an Offer to Sell: This presentation does not constitute an offer to sell or a solicitation of an offer to buy any securities, and may not be relied upon in connection with any offer or sale in any jurisdiction where such offer or sale would be unlawful. Forward-Looking Statements: Certain statements contained herein are forward-looking and are based on current expectations, estimates, projections, and assumptions involving risks and uncertainties that could cause actual results to differ materially from those expressed or implied. BIOVANTIX™ undertakes no obligation to update these statements. Investment Risk: An investment in the Company’s securities involves a high degree of risk. Prospective investors should be prepared to lose all or a substantial portion of their investment. Accredited Investor Limitation: Participation in this offering is limited to investors who are accredited under Regulation D Rule 501(a). Verification of accredited status may be required prior to any acceptance of investment. No Public Market / Transfer Restrictions: There is no public market for the Company’s securities, and there can be no assurance that any such market will ever exist. Transfer or resale of these securities is restricted by applicable securities laws. Form D Filing Notice: The Company intends to file a Form D notice of exempt offering of securities with the SEC and relevant state regulators as required.
II. FDA and Biotech Regulatory Compliance As a pre-approval biotechnology company, BIOVANTIX™ must comply with FDA and FTC rules governing communications about investigational products and scientific claims. No FDA Approval: The Company’s investigational products and technologies have not been approved or cleared by the U.S. Food and Drug Administration (FDA) or any foreign regulatory agency. All research and development activities are currently in preclinical or early- stage evaluation. Research-Stage Status: All BIOVANTIX™ technologies and materials are intended For Research Use Only – Not for Human or Diagnostic Applications. No Medical Claims: Nothing contained in this presentation should be construed as a claim regarding the safety, efficacy, or potential regulatory approval of any BIOVANTIX™ product candidate. Forward-Looking Science: Any references to anticipated clinical trials, regulatory submissions, or product launches are forward-looking statements subject to significant uncertainty and dependent upon future scientific and regulatory outcomes. Export Control / ITAR / EAR: Certain materials, data, or technology may be subject to U.S. Export Administration Regulations (EAR) or other international controls. BIOVANTIX™ maintains compliance with all applicable export and biosafety regulations.
III. Legal Notice & Disclaimers Confidential – For Accredited Investors Only .This presentation is confidential and intended solely for discussion with potential accredited investors under Regulation D. The securities described herein have not been registered under the Securities Act of 1933 or any state securities laws. This material does not constitute an offer to sell or solicitation of an offer to buy any securities. Any such offer will be made only pursuant to definitive offering documents. The Company’s investigational technologies have not been approved or cleared by the FDA or any foreign regulatory authority. All scientific and technical statements herein are preliminary, subject to regulatory review, and provided For Research Use Only – Not for Human or Diagnostic Applications. Forward-looking statements involve significant risks and uncertainties; actual results may differ materially. Prospective investors should perform independent due diligence and consult with their own legal and financial advisers before making any investment decision.
