Objective Diagnostics for Parkinson’s Disease
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This pitch deck introduces AptaMark, our objective diagnostic solution for Parkinson's Disease.
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Objective Diagnostics for Parkinson’s Disease
- 1. Objective Diagnostics for Parkinson’s Disease ®
- 2. info@BrainBackups.com Our Name - Brain Backups High-Resolution Brain Imaging Platform Nondestructive, noninvasive, whole brain in vivo imaging at the connectome level Current methods for whole brain imaging ● Current methods of whole brain in vivo imaging do not provide adequate resolution. ● Methods providing adequate resolution have incomplete coverage, or require destructive slicing of the brain. First Target: An Early & Accurate Parkinson’s Disease Diagnostic
- 4. info@BrainBackups.com The Solution - AptaMark Accurate & Objective Dopamine D2R test AptaMark will be the first contrast agent with a single cell resolution, allowing neurodegeneration in the substantia nigra and other relevant areas can be tracked objectively. • First Objective Diagnostic for PD • Enables early detection • Tracks degradation directly at source • Differentiates amongst PD subtypes • Non destructive/non invasive • 1 micron resolution
- 5. info@BrainBackups.com ● 34 drugs in development ● Aging population ● $26B in US Healthcare Costs ● $3B in PD specific treatment “Large potential market for neurotechnology” - NeuroTech Business Report The Opportunity PD diagnosis and mid-treatment imaging demand will continue to grow.
- 6. info@BrainBackups.com Competitive Analysis Cost Accuracy Early Detection Objectivity Resolution Doctors Low ~76% Clinical No N/A Movement Software $100 Low Clinical Yes N/A CT $700 Moderate Clinical No 1mm MRI $1,200 ~85% Clinical No 1mm DaTscan $5,000 ~84% Clinical No 1mm AptaMark $2,800 Aim >90% Preclinical Yes 1µm
- 7. info@BrainBackups.com The Competitors New contrast agents are being developed every year. All lack the specificity of AptaMark and many rely on expensive small molecule chemistry & approvals process and often less precise methods. DaTscan is a SPECT iodine-123 contrast agent that images dopamine transporter and allows clinicians to distinguish essential tremor from PD. AptaMark permits imaging at 1 micron resolution, 100X better than MRI; offers specificity to subtypes of dopamine receptors; uses same GE imaging hardware provides better diagnosis.
- 8. info@BrainBackups.com Revenue Projections Assuming a 5% market share in Y4, we can reasonably expect close to $4M per year in initial diagnostic revenue. If AptaMark is used in treatment management, revenue growth becomes exponential. 40,000 out of 1.5M total patients tested twice a year will result in $100M of revenue. Market Share RevenueCost per Test As costs decrease with scale, EBITA will grow from 11% to more than 48% as quantity grows past 1000.
- 9. info@BrainBackups.com Potential Partnerships From MRI to aptamers, a lot of companies work with relevant technology. We are continuing an active outreach process to engage researchers and clinicians alike with our technology.
- 10. info@BrainBackups.com The Team Mihai Dinulescu Russell Hanson Jason Fuller Robert Cunningham Webster Heffern
- 11. info@BrainBackups.com ...to demonstrate Parkinson’s can be imaged at the source. ● $2.5M for further optimization & research deployment ● Potentially positive ROI from research revenue alone ● $30M+ for Phase I & Phase II toxicology trials ● Exit after proven safety & efficacy ● Clinical trials performed through partnerships What we are asking for...
- 12. info@BrainBackups.com 30,000 Validation and Optimization 1.2% 20,000 Scale up batches 0.8% 50,000 At scale batches 2% 400,000 Real estate: laboratory & office space 16% 250,000 Main laboratory equipment 10% 500,000 In vivo validation FDA 510K 20% 100,000 Licensing to established vendors 4% 1,100,000 Personnel and marketing 44% 50,000 To be budgeted and incidentals 2% Total: 2,500,000 100% Appendix: Financial I - $2.5M Series A Breakdown
- 13. info@BrainBackups.com Appendix: Financial II - Research Revenue Core product is a recurring cost consumable ● Initial product cost*: $1,300/test ● Scale product costA: $550/test ● Cost to consumer: $2,800/test ● Break-even point T: ~1,200 tests ● Assuming an MRI cost of ~$1,000, AptaMark is competitive with DaTscan for diagnostic and treatment management imaging ● Even with 80% production profit margin, AptaMark remains 100x more rentable than current destructive research methods A Cost estimates are for total cost of production, manufacturing, and overhead at appropriate stage * Assumes 200+ test batches T At scale cost, associated profit margin, and 2.5M Series A
- 15. info@BrainBackups.com Appendix: Financial III - Ancillary Markets Research Products ● Alzheimer’s ● Autism ● Huntington’s ● Schizophrenia ● Additional research ● Obsessive Compulsive Disorder ● Etc...
- 16. info@BrainBackups.com Appendix: Science I - About Aptamers Advantages of Using Aptamers ● Very small, very precise ~ 1 micron ● Chemically synthesized, no bioreactors ● Easy to ship, safe to handle ● Cross blood brain barrier ● Don’t trigger the neurons they bind to ● Safely cleared
- 17. info@BrainBackups.com Appendix: Science II - Technology Details Gold nanoparticle with attached D2-specific ligand Rat knee imaged at 3 microns (0.003mm voxel) Nanoparticle uniformity validation using dynamic light scattering
Editor's Notes
- Name and branding is good.
- http://www.caringfortheages.com/news/geriatric-medicine/single-article/how-to-avoid-the-most-common-diagnostic-pitfalls-for-parkinson-s/9887e4762644a0fac594c98b26445af7.html Clinical utility of dopamine transporter single photon emission CT (DaT-SPECT) with (123I) ioflupane in diagnosis of parkinsonian syndromes jnnp.bmj.com/content/early/2013/03/12/jnnp-2012-304436.full.pdf
- the only real - objective diagnostic is post-mortem
- how does it undercut current research cost what is current research cost say $1300 per treatment - millions for slicing ad imaging, never been done due to cost Monogenic disease, so diagnostic is already done and much cheaper For autism - check out C-Side therapeutics (contact CEO, Randy Carpenter) Gross macro level current diagnosis for Parkinson’s - we should look at getting a more granular look Market background for our MJ Fox proposal, same for Huntington’s Research Center 1/20 patients with Parkinson’s is misdiagnosed - real opportunity to improve management of patients Consequences for how early treatment Allison: For an investor pitch, this slide will probably be in the appendix. You should have what your product does in the solution slide. You can go into further detail in the appendix if someone asks, but more likely than not, investors do not want the niddy griddy of what you can do. You should be able to describe what you do and why you add value to your market in 1 slide. Find a way to be concise and clear for the investors.
- 76% conflicts with slide 2 in 40 years of research no diagnostic has gotten to 90% accurate Imaging Approaches to Parkinson Disease jnm.snmjournals.org/content/51/4/596.fulte
- Add a graphic for Avid - imaging area for disease Biologic Imaging Reagents: Technologies and Global Markets Report http://www10.giscafe.com/nbc/articles/view_article.php?articleid=735344&page_no=3 http://ir.navidea.com/phoenix.zhtml?c=68527&p=irol-newsArticle&id=1881352 Iodine-123 labeled NAV5001 is a patented, novel, small molecule radiopharmaceutical used with single photon emission computed tomography (SPECT) imaging to identify the status of specific regions in the brains of patients suspected of having Parkinson’s disease. The agent binds to the dopamine transporter (DAT) on the cell surface of dopaminergic neurons in the striatum and substantia nigra regions of the brain. Loss of these neurons is a widely recognized hallmark of Parkinson’s disease and other forms of Parkinsonism. Lantheus - isotope producer: already in the space, lower resolution Nanoprobes - nonspecific agent to provide brain imaging Nanosphere - maybe like nanoprobes Allison: If you can put this in a competitive landscape graph or a comparison chart. It is easier to read and see right off the bat how you are better than the competitors. 180,000 people imaged using DaTSCAN to date https://www.michaeljfox.org/files/Imaging%20FAQ%20Sheet%20for%20Patients.pdf The FDA has approved a new neuroimaging agent that offers nonspecialists the possibility of differentiating parkinsonism from essential tremor (ET). http://www3.gehealthcare.com/search?q=datscan%20&u=http://www3.gehealthcare.com/en#
- What are the kind of partners? Marketing? Exit? What’s your business model? What’s your product strategy? Existing relationships with end customers More efficient to go through them in the short term before building an inhouse sales team Fewer distributors: show a relationship or envisaged one and the way it would work
- Logos of Companies you worked at Titles - Maybe
- Value End with the ask Money to exclusively license all the ligands - $ up front Technology license
- Ask questions around the value proposition? How do we intend to position this? What will we actually ask a customer for? This is for clinical uncertainty Vs This is for unresponsive therapy Where do we carve out a niche initially and where can we expand to from a longer point standpoint with sequenced growth. IF we go into a hospital this is who we talk about: do we see physicians? Key opinion leaders? PD clinics or other focused dept? Pick your sweet spot? Are hospitals making money on DaTscan? Reimbursement amounts? Define the buying process, talk to some buyers in hospitals, opinion leaders in movement disorder clinics, follow the money and show where it comes in and where our leverage points are Scaling over time: where we’re going to be? EBITA there Allison: Do you have other revenue streams outside the “core product”? Can you put this in a graph or timeline or something?
- What is that partnership? To sell the drug? IP Status snapshot Patent panel of aptamers computational analysis piece around series C - IPO Capitalize Tranche make “profitablity line” a different color than Start/seed Change for DIAGNOSTIC Series A -
- Problem with Huntington’s - monogenic disease - price for gene sequencing is going through the floor Therapies currently don’t work very well. Nothing that is immediately available. Follow up with Daniel - therapies Tetrabenazene - no one knows exactly what target we should be identifying MRI in diagnosing MS - look further into usage GE launched MRI - PET machine 2 weeks ago - combined machine is interesting Imaging companies jump in after proof of concept is done MGH/GE/BB partnership potential for development & application VC arms of large pharma (Pfizer, etc) GE Antaries - GE Ventures arm - GE Healthcare group What do we offer a partner? What exactly is the business model we would propose to GE? Would it only work no GE machines? Analytics/Software - GE MRI API Deliverable framed as a quid pro quo for their API GE is the only one that has the resolution that we need to make this work Make two slides about why there is an opportunity for GE Look up UCB - does research in epilepsy, TBI, stroke Deal with Oxford on imaging UCB - aggressive program to identify imaging opportunities for potential drug development Merck - imaging Eli Lilly - bought Avid & doing research in Alzheimer’s Supernus - Company in UK doing research in Epilepsy Abbott - fair amount of imaging (PET) Janssen - GsK - neuroimaging work Janssen neuroscience innovation center in Cambridge - Jeff Nye head of initiative Market snapshot in its current form, number of patients, market share, revenues, overlays the impact of what our technology would be patient provider relationships, research relationships, partnerships, etc What this would look like tomorrow given what we can do? MGH head of neuroscience - Tom Brady A lot of facilities are losing medicare reimbursement for imaging Not that easy to read a paper and go recreate what was published Neurotechinsights.com Focus on Parkinson’s is on remission Allison: You could do the Market slide and market growth in 1 slide. Have the overarching market, then the target market first and then how the market can grow. The partnerships and other institutions that you are working with, I would put those in a different slide after the revenue. You have a bunch of institutes in the market slide, are those partnerships? Who are they? If they are partnerships, I would put them in a separate slide and place that slide after revenue. so you can say here is how we are going to make money, and then these partnerships will be how we execute the plan to make money.
- Is there some data we could show? What drove the hypothesis, how we’re going to test it? how does it undercut current research cost what is current research cost say $1300 per treatment - millions for slicing ad imaging, never been done due to cost Monogenic disease, so diagnostic is already done and much cheaper For autism - check out C-Side therapeutics (contact CEO, Randy Carpenter) Gross macro level current diagnosis for Parkinson’s - we should look at getting a more granular look Market background for our MJ Fox proposal, same for Huntington’s Research Center 1/20 patients with Parkinson’s is misdiagnosed - real opportunity to improve management of patients Consequences for how early treatment Allison: Is this part of your competitive comparison how your product is better because you use aptamers? Again, I would put this in the appendix in case an investor asks for further detail. Again though, investors typically want to know the high overview and understand but don’t need the details.
- Movie reconstruction from human brain activity https://www.youtube.com/watch?v=nsjDnYxJ0bo