EXECUTIVE SUMMARY
1. Introduction
We are a neurosciences biopharmaceutical company who has developed blood-brain barrier (BBB) technology. We are now using this technology to develop curative therapies for diseases of the central nervous system (CNS) such as Alzheimer’s and Parkinson’s. We are raising $3M to manufacture Parkinson’s drug candidate and get an IND Application approved by US FDA.
2. Our Team
i. Ram Bhatt, PhD, Founder and CEO, a veteran of the biotech industry who has worked with internationally known, top tier, companies.
ii. Wen-Hua Fan, PhD, MD, VP R&D, Cell Biologist, Molecular Biologist, and Geneticist.
iii. Ranya Alexander, PhD, MD, COO, VP of Clinical Trials, a physician trained in biochemistry, emergency medicine, and past assistant director of multiple urgent care facilities.
iv. Arvind Bhambri, DBA, Business Strategy Advisor, a professor at USC Marshall School of Business.
v. Howard Sampson, BA, CFO, a biotech renowned figure with decades’ experience in raising funds and M & A (merger and acquisitions).
vi. Arshan Amiri, JD, Corporate Attorney.
3. Problem Addressed
i. Currently there is no cure for Alzheimer’s (AD), Parkinson’s (PD), and many other CNS diseases. Current drugs only provide short-term symptomatic relief.
ii. Why there is no cure: Most drugs, particularly the proteins, antibodies, and DNA/RNA capable of modifying CNS diseases cannot cross the blood-brain barrier (BBB) to reach the brain or do so very poorly. BBB is a physical barrier that has hindered success in curing brain diseases for decades.
iii. The market for AD and PD is more than $15 billion. The global prevalence of combined AD and PD is more than 65 million individuals.
4. Our Solution
i. We have developed unique and novel antibody mimics derived from camelids that have shown superior brain permeability compared to the classical mouse derived monoclonal antibodies currently on the market that only showed marginal success for CNS diseases.
ii. The BBB permeability of our antibody mimics is 2-3 logs several degrees of magnitude higher than mouse antibodies in tested animal models of AD and PD.
iii. This technology is protected by seven issued US and European approved patents and has won three grant awards: Two from the Michael J. Fox Foundation and one from US Department of Health and Human Services.
iv. Our antibody mimics have demonstrated clearance of 66% of the amyloid plaque in the brain of transgenic animals with one weekly injection for 12 weeks. The classical mouse antibodies typically require 18 months + treatment to clear some plaque.
v. We believe a shorter treatment with our drugs will be adequate to clear harmful plaque in patients making the therapy with our drugs much less expensive than current traditional mouse monoclonal antibodies.
vi. Animals treated with our therapy have shown no detectable toxicity.
5. Business Model
i. Licensing or sale of drugs for a specific target including (but not limited to) PD and AD.
ii. Merger and acquisition after Phase-2A or 2B clinical trials.
iii. IPO will also be considered depending upon market conditions.
6. Competition
i. Big pharmaceutical companies are our competition.
ii. In 2023, the FDA approved Eli Lilly’s Donanemab and Biogen/Eisai’s Lecanemab even though these mouse monoclonal antibodies showed a very modest slowdown of cognition decline in some patients with early Alzheimer's disease.
iii. It is important to note that these FDA approved drugs are neither a cure nor reverse the symptoms or fully halt disease progression in patients. Additionally, these drugs have serious side effects including brain bleeds and inflammation.
7. Our Vision
i. We are certain that higher brain uptake of our antibody mimics will be revolutionary in providing curative therapies to AD and PD patients that do not exist so far.
ii. We will own the market because we expect physicians, clinics, and hospitals to prescribe our drugs to their patients because of superior therapeutic index, lower cost and shorter treatment time, and without toxic side effects.
iii. We plan to use all possible channels, such as social media, TV, News Papers, Radios, Pod Casts, and international symposiums to promote our drugs.
iv. Stability at room temperature and low-cost manufacturing will make our therapies available for worldwide shipment and use in low- and middle-income countries.
8. Traction
i. We have presented our technology in national and international neurosciences meetings, which made several big pharmaceutical companies contact us and invited us to contact them after we have conducted Phase-1 and 2A clinical trials in humans.
9. Funding Ask
i. We are asking for $3M to manufacture three lots (500 grams each) of our Parkinson’s drug, validate each lot, conduct comprehensive animal toxicity study, and meet FDA to get approval of IND application to conduct Phase-1 study in healthy individuals.
ii. Our estimated timeline is 9-10 months to accomplish this goal.
iii. It is important to note that we will raise additional funding for Phase-1 clinicals.
10. Projections
i. Approval of an IND application by the US FDA will be a major win for ICBII’s new technology.
ii. This winning will open the doors for us to conduct clinical trials Phase-1, 2A, and 2B clinical trials.
iii. We are confident that Phase-1 (Safety Study) will pass without any issues because we have not observed any toxicity of our Parkinson’s drug in animals.
11. Closing Remarks
i. The founder’s former employer, a top tier, internationally known pharmaceutical company, is waiting to see the Phase-1 and Phase-2A human clinical data for the initiation of discussion for a licensing deal.
ii. Approval of an IND application will facilitate the next step of beginning clinical trials.
iii. We are confident that we can secure three lots of manufactured PD drug candidate by CRO and have an IND application approved with $3M.
Contact: Ram Bhatt, PhD., CEO
Ready to Ask For Funding for your company?
Post a Funding Request