“In 30 plus years of working in business development and funding start-ups, SpinUp Campus is the most exciting concept I have seen. It has the potential to yield a great return on investment. The concept to partner with universities to bring groundbreaking science to the masses is revolutionary. SpinUp’s first launch is TrippBio, which has a drug candidate that could essentially cure COVID-19 in days. With the global attention on coronavirus, this has a high potential to be a lucrative investment and improve people's lives.”
TrippBio is a new biotechnology company focused on developing innovative applications of existing drugs to prevent and treat rogue viruses starting with the SARS-CoV-2 virus that causes COVID-19. Viruses like SARS-CoV-2 lack their own machinery, or ability to replicate independently, so they hijack the host cell machinery to travel into the cell to replicate and then spread throughout the body. TrippBio has discovered that an existing drug, referred to as TD213, can prevent the host cell from assembling SARS-CoV-2 and can dampen hyper-inflammation and severe respiratory symptoms. “Basically, TD213 has a dual mechanism that locks the doors to virus replication, and reduces the negatives consequences of infection,” explains Chief Science Officer, Ralph Tripp, Ph.D..
TrippBio is a SpinUp Campus company. SpinUp Campus connects trailblazing university scientists with public investors to bring life-changing innovations to market.
- TrippBio is developing a potential treatment for COVID-19, by repurposing an FDA-approved drug, referred to as TD213. TD213 could be used as a preventive or as a treatment for active COVID-19 infection.
- Research demonstrates that TD213 could prevent and lessen the severity of COVID-19 by decreasing viral replication. Laboratory studies shows that TD213 can decrease the viral load by 90%.
- TD213 will not compete with preventive vaccines. Effective treatments for active COVID-19 infection, as well as vaccines to potentially prevent future infections, are urgently needed.
- TD213 will not contribute to viral mutations, meaning it will not lose efficacy over time.
- In 2019, the global antivirals market was valued at $52 billion U.S. dollars and is forecasted to reach $75 billion U.S. dollars by 2027, an increase of 23%. Expectations are that the current pandemic will continue to drive up the antivirals market.
“Georgia Research Alliance Eminent Scholar Ralph Tripp has been a prolific researcher at University of Georgia since he arrived in 2004. His work on a vaccine for respiratory syncytial virus has the potential to bring hope to the 60,000 children who are hospitalized due to RSV each year. I’m encouraged that Dr. Tripp is now part of the search for a treatment for COVID-19 and I look forward to seeing his work progress.”
- With global confirmed cases of COVID-19 surpassing 27 million, and no sign of abatement in sight, the urgency to find effective treatments and vaccines to combat SARS-CoV-2 continues.
- Vaccines take a long time to develop and just when they are ready, the virus could mutate, rendering a vaccine ineffective.
"If COVID-19 acts like other coronaviruses, it [vaccine efficacy] likely isn’t going to be a long duration of immunity,” stated Dr. Anthony Fauci, M.D., Director of the National Institute of Allergy and Infectious Diseases, during an interview with JAMA Editor Howard Bauchner.
- On average, it takes close to one billion U.S. dollars and ten years to bring a new drug to market.
Even though timelines are accelerated due to the pandemic, the world cannot afford to waste any time, or opportunities, to identify safe, effective treatments that can be administered as soon as possible.
"While we're waiting for a vaccine, drugs currently being used to treat other illnesses can be investigated as treatments for COVID-19 - in other words repurposed," said Dr. Steve Alexander from the University of Nottingham.
- Johns Hopkins University of Medicine Coronavirus Resource Center
- "Dr. Fauci says there's a good chance coronavirus vaccine may not provide immunity for very long," CNBC June 2, 2020
- BioSpace.com March 4, 2020
- "Repurposing existing drugs for COVID-19 offers a more rapid alternative to vaccines," ScienceDaily May 7, 2020
- TrippBio is focused on developing innovative applications of existing drugs to prevent and treat rogue viruses, starting with SARS-CoV-2, virus that causes COVID-19.
- TrippBio works on therapeutic treatments for respiratory diseases that work with your body's natural defenses. This way, it doesn't matter if the virus mutates; the therapy still helps your body to fight the illness.
- By repurposing TD213, a drug with an excellent safety profile, TrippBio can pursue a rapid development path while proving efficacy against COVID-19.
- TD213 has documented pharmacokinetics (how the body processes the drug) and safety profiles in humans and dampens hyper-inflammation and severe respiratory (influenza) virus disease.
- By investing in TrippBio, you will be investing in your future while helping the world to combat COVID-19 and other infectious diseases.
TrippBio management anticipates having multiple revenue generation, financing and exit options for TD213, as well as other drugs currently under investigation. These options include, but are not limited to:
- TrippBio markets and sells a proprietary application of TD213.
- TrippBio licenses the intellectual property rights to an established pharmaceutical company.
- TrippBio lists on NASDAQ or NYSE.
- TrippBio offers the company for sale and is acquired.
Viruses are hijackers; small, parasitic terrorists that invade a living cell and take control. Once they have taken over the human cell, or host, they replicate and deploy their viral army throughout the body, at times causing severe illness or long-term complications, and even death.
The most common viruses affect the respiratory system, like influenza, pneumonia and coronaviruses. Respiratory virus infections may cause severe illness in infants, the elderly and those with lung or heart disorders and other illnesses.
Treating viruses is challenging, as these invaders, by their nature, are always mutating and evolving. While preventive vaccines are key to potentially controlling or slowing the viruses, defeating the enemy requires a multi-pronged effort. Antiviral treatments for active infection will be needed for years to come.
In 2019, the global antivirals market was valued at $52 billion U.S. dollars and is forecasted to reach $75 billion U.S. dollars by 2027, an increase of 23%. This valuation could extend even higher given the intense focus brought on by the COVID-19 global pandemic.
Scientists and researchers across the world are working tirelessly to develop effective treatments for COVID-19. Currently, extensive work in happening in the vaccine, prophylactic and therapeutic areas. Vaccines work with the body’s natural defenses to develop immunity to disease, and while vaccine development is being fast-tracked for COVID-19, a solution, where efficacy can be measured, is likely several years away. Then there is the issue of durability of protection, meaning how long the vaccine remains effective against this virus. According to Dr. Anthony Fauci, M.D. and Director of the National Institute of Allergy and Infectious Diseases, that’s the larger issue,
Antiviral drugs are specifically used to treat viral infections and primarily are focused on inhibiting viral replication. Currently, there are no FDA-approved medicines specifically for coronavirus, though multiple therapies and new drug development are being explored. At this time, only one marketed drug has shown a positive response to treating symptoms of COVID-19 and this is an intravenous product for use in hospitals.
"There's unlikely to be a single magic bullet - we will probably need several drugs in our armory, some that will need to be used in combination with others. The important thing is that these drugs are cheap to produce and easy to manufacture. That way, we can ensure access to affordable drugs across the globe, not just for wealthier nations," states Dr. Steve Alexander of the University of Nottingham.
But this area of research – into respiratory viruses overall, and more specifically coronaviruses – is not new for TrippBio. Chief Science Officer, Ralph Tripp, Ph.D., and his team at the University of Georgia have been focused on it for quite some time,
“For years, my lab has studied virus and host interactions across respiratory illnesses like influenza, RSV [respiratory syncytial virus] and SARS [severe acute respiratory syndrome] which is one of the human coronaviruses. Though viruses are different, they replicate in the same way, that is, by hijacking host cells. Once you understand how the virus interacts with the host, you can begin to see the road map for replication,” said Dr. Tripp.
“We’ve been doing work with TD213 and its impact on influenza and other viruses for the last five to six years. There was little interest in it because vaccines and treatments for flu were already available, despite their varying degrees of efficacy. Then, coronavirus hit,” stated Dr. Tripp.
The fact that TrippBio is focused on repurposing existing drugs means getting the treatment to those who need it will be faster than new drugs that require intense, long-term testing for safety in humans, even before efficacy trials begin.
"While we're waiting for a vaccine, drugs currently being used to treat other illnesses can be investigated as treatments for COVID-19 - in other words repurposed," said Dr. Steve Alexander from the University of Nottingham.
Previously, those known as major players in the biotechnology and research space, a.k.a. “big pharma” were predominantly leading the charge in drug therapy development. However, now, given the intense focus on COVID-19, all significant contributions from smaller research teams and university scientists have an opportunity to enter this market. As a result of the Title III JOBS Act and Regulation CF, companies like TrippBio, who are small in size, but large in potential, talent and commitment, have the opportunity to get to market. Only one thing is missing: you.
TrippBio is researching several drug therapies to combat respiratory viruses. With the advent of the COVID-19 pandemic, TrippBio’s primary focus is on TD213, the active ingredient in a currently approved and safe product used to treat another disease for over 40 years. Initial research focused on in vitro studies (outside of a living organism) using isolated cells in tissue culture. These cell lines allow studies directly on TD213’s mechanism of action on the virus. Results demonstrate that TD213 is highly effective in decreasing virus levels in vitro.
Even more promising, the results from a recently concluded in vivo study (within a living organism) using mammalian models demonstrate that TD213 could both prevent and lessen the severity of COVID-19 by decreasing the virus count. If similar results are seen in human trials, TD213 could not only reduce patient suffering, it could help control the spread of COVID-19.
AFTER 3 DAYS OF TREATMENT, THE VIRUS COUNT WAS DECREASED BY 90% COMPARED TO ANIMALS TREATED WITH PLACEBO.
With this news, TrippBio plans to quickly move into human clinical trials to determine the efficacy of the drug to treat COVID-19 patients. The drug development program and clinical trials will be conducted through a partnership with Florida Atlantic University and Linical, a world-class Contract Research Organization with deep experience in infectious disease clinical trials such as Ebola and SARS. Capital from this raise will be used to fund the trials.
The skills of TrippBio's operating team combine business acumen and entrepreneurial know-how with scientific and biotechnology brilliance. This is a group of dedicated and focused individuals, who together, are committed to bringing health-improving and life-saving treatments to the world.
Billy Meadow is a serial technology entrepreneur and has thrived for decades in commercializing and funding companies like TrippBio, based on the ideas of professors and research scientists. His latest company, SpinUp Campus, focuses on matching trailblazing university scientists with public investors to bring new drug treatments and medical innovations to market. He excels at business strategy and is seasoned in the art and science of start-up company success. Billy has a Bachelor of Science degree in business from Florida State University.
Phil Young has successfully managed the growth of public and private companies taking scientific innovations from discovery to commercialization. He has served as an executive officer and board member for biopharma companies for the past 20 years and has consistently created significant shareholder value while building integrated scientific and commercial operations. Phil has directed successful M&A transactions and was responsible for generating more the $900MM through acquisitions and equity financings, while managing business operations and transactions across the globe.
Richard Still has a strong background in finance, operations and corporate startups. He has most recently served as CFO of a $100 million dollar privately held company. His previous positions included COO of a multi-location environmental company, financial analyst for an investment banking firm and plant manager for a manufacturing company. Richard was also the founder and CEO of three different companies.
Richard has a Bachelor of Science degree in mechanical engineering from Duke University and an MBA from Columbia University School of Business.
Dr. Ralph Tripp’s main focus is on developing translational disease intervention strategies for emerging respiratory viruses. He has been a professor and Georgia Research Alliance Chair in vaccine and therapeutic development at the University of Georgia for 24 years. Dr. Tripp is a viral immunologist, having experience in molecular biology and biochemistry with a Ph.D. from Oregon State University. TrippBio was named after Dr. Tripp and his amazing work in the field of disease intervention.
Dr. Sancilio is a serial entrepreneur in the healthcare field and is currently a principle of Clearway Global, Inc., a pharmaceutical development advisory service. He is also president and serves on the board of directors of Alpha Cognition, Inc., a Canadian biotechnology company that is developing neurological products to treat Alzheimer’s and Lou Gehrig’s diseases. Dr. Sancilio received his Master of Science and Doctorate degrees from Rutgers, The State University of New Jersey. For over four decades, he has contributed to the development of over 1,000 drug products marketed worldwide, holds numerous patents and has written dozens of scientific publications. Dr. Sancilio served as a research professor and managing director of Translational Development & Commercialization at Florida Atlantic University and was an adjunct professor of chemistry at University of North Carolina.
Dr. David E. Martin has over 29 years of hands-on drug development experience across the spectrum of drug discovery, pre-clinical development, Phase I-IV clinical development, and regulatory affairs. He has been responsible for managing 30 discovery/early phase clinical programs in a variety of therapeutic areas including cardiovascular, inflammation, respiratory, and HIV. Dr. Martin has published more than 137 peer-reviewed, scientific publications and has 14 granted/provisional patents. Dr. Martin received his PharmD from the University of Southern California, as well as completed his Residency in Clinical Pharmacy there.
Dr. Kathy Blahunka has 27 years of pharmaceutical industry experience in a variety of roles within drug development including clinical development, regulatory, technology assessment, R&D technology enablement and medical affairs. She was on teams for two successful NDA submissions and approvals, is active with two incubator programs and the University of Illinois College of Pharmacy. She received her BS and Doctor of Pharmacy degrees from the University of Illinois Medical Center Campus.
Dr. Kevin Pegg has over 30 years of experience as an entrepreneur with seven startup biotechnology companies in both environmental and clinical diagnostics instrumentation, and in chemistry. He has a doctorate from Florida State University with studies on a molecular model for multiple chemical sensitivity, a master's in genetic toxicology, and a bachelor’s in marine sciences. Dr. Pegg also has spent over 15 years in academia as a professor of biotechnology and microbiology. He has received numerous grants, holds multiple U.S. and international patents, and is a registered U.S. patent agent specializing in biotechnology art.
Use of Proceeds
If the offering's maximum Reg CF allocation of $1,070,000 is raised:
|Use||Value||% of Proceeds|
|CRO - Initial Clinical Trial||$447,234||41.8%|
|Develop & Manufacture TD213||$30,000||2.8%|
|Marketing & Advertising||$80,000||7.5%|
|CRO - Ramp-Up Clinical Trial||$300,802||28.1%|
|Regulation A Legal Services||$39,534||3.7%|
|Regulation A Marketing & Advertising||$50,000||4.7%|
If the offering's maximum amount of $1,870,000 across Reg. CF and Reg. D is raised:
|Use||Value||% of Proceeds|
|CRO - Initial Clinical Trial||$447,234||23.9%|
|Develop & Manufacture TD213||$30,000||1.6%|
|Marketing & Advertising||$80,000||4.3%|
|CRO - Ramp-Up Clinical Trial||$300,802||16.1%|
|Regulation A Legal Services||$39,534||2.1%|
|Regulation A Marketing & Advertising||$50,000||2.7%|
|Additional Clinical Trials||$760,800||40.7%|
This is a side-by-side offering of Common Stock, under registration exemptions 4(a)(6) and 506(c), in TrippBio, Inc.. Up to $1,070,000 may be raised under the 4(a)(6) exemption. Netcapital will determine which exemption applies to your investment and notify you before you complete your investment.
The amount raised under the two exemptions must total at least $10,000 by January 29, 2021 at 11:59am ET. If the total doesn’t reach its target, then your money will be refunded. TrippBio, Inc. may issue additional securities to raise up to $1,870,000, the offering’s maximum.
If the side-by-side offering is successful at raising the maximum amount, then the company’s implied valuation after the offering (sometimes called its post-money valuation) will be:
These financial statements have been reviewed by an independent Certified Public Accountant.
The Offering Statement is a formal description of the company and this transaction. It’s filed with the SEC to comply with the requirements of exemptions 4(a)(6) and 506(c) of the Securities Act of 1933. Similar information is sometimes offered in a Private Placement Memorandum for 506(c) offerings.
We’re also required to share links to each of the SEC filings related to this side-by-side offering with investors.
Understand the Risks
Be sure to understand the risks of this type of investment. No regulatory body (not the SEC, not any state regulator) has passed upon the merits of or given its approval to the securities, the terms of the offering, or the accuracy or completeness of any offering materials or information posted herein. That’s typical for Regulation CF offerings like this one.
Neither Netcapital nor any of its directors, officers, employees, representatives, affiliates, or agents shall have any liability whatsoever arising from any error or incompleteness of fact or opinion in, or lack of care in the preparation or publication of, the materials and communication herein or the terms or valuation of any securities offering.
The information contained herein includes forward-looking statements. These statements relate to future events or to future financial performance, and involve known and unknown risks, uncertainties, and other factors, that may cause actual results to be materially different from any future results, levels of activity, performance, or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties, and other factors, which are, in some cases, beyond the company’s control and which could, and likely will, materially affect actual results, levels of activity, performance, or achievements. Any forward-looking statement reflects the current views with respect to future events and is subject to these and other risks, uncertainties, and assumptions relating to operations, results of operations, growth strategy, and liquidity. No obligation exists to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
- Aug 14, 2023#3: Check out the videos on our website...
#3: Check out the videos on our website (https://TrippBio.com) from Dr. Robert Redfield, the former Director of the Centers for Disease Control and Prevention (CDC) from 2018 to 2021 discussing the potential of our drug PanCytoVir.
#4: We have more details of this exciting news regarding TrippBio in the “Shareholder Update for Q2 2023”.
- Aug 14, 2023TrippBio Investors: We have 4 points we’d like...
TrippBio Investors: We have 4 points we’d like to share with you.
#1: Our Phase 2 study published on July 6th in the peer reviewed MDPI Viruses journal shows that we delivered better results than Pfizer’s $5+ billion-dollar drug Paxlovid. (https://doi.org/10.3390/v15071508). We have a potential “Blockbuster” drug that could save many lives from the COVID-19 virus (that continues to be a major health threat worldwide).
#2: We recently completed a pre-clinical study on PanCytoVir’s efficacy against Influenza in animal studies – along with a comparison of Tamiflu’s efficacy (Tamiflu is currently the primary therapeutic for Influenza, with over $1 billion in revenue). The results of the study showed that PanCytoVir is MORE EFFECTIVE at reducing viral lung titers and preventing weight loss than Tamiflu. We plan to launch a Phase 2 study shortly.
- Feb 16, 2023TrippBio Shareholder: Please see the attached...
TrippBio Shareholder: Please see the attached 2022 Shareholder Report.TrippBio Management Discussion and Analysis Shareholder Report 2022 r04.pdf
- Aug 31, 2022See the attached press releases announcing...
See the attached press releases announcing significant advances in our program. In July, we announced the start of our Clinical Trial with PanCytoVir - we are expecting topline data within the next few months. We also announced the filing of additional patent applications expanding the list of viruses that are sensitive to PanCytoVir. This application also includes claims for newly identified analogs of PanCytoVir. This new data allows us to expand our list of target indications to diseases such as influenza, RSV, measles, Dengue, and Zika. As we continue to explore the pan-virus activity of PanCytoVir, we anticipate this list of indications to grow. We have expanded our collaboration with the University of Georgia to include this new patent filing. This expanded agreement will allow us to continue to work with Dr. Ralph Tripp to advance therapeutic drug development against these serious respiratory viruses. We anticipate more exciting events in the coming weeks!TrippBio Press Releases.pdf
- Jul 19, 2022TrippBio Announces Initiation of the Phase 2...
TrippBio Announces Initiation of the Phase 2 Study to Evaluate PanCytoVir™ in Patients with Mild-to-Moderate COVID-19: First patient screened in study to define the antiviral effect of PanCytoVir™ in patients with mild-to-moderate COVID-19. JACKSONVILLE, FL, UNITED STATES, July 19, 2022 /EINPresswire.com/ – TrippBio, Inc. (TrippBio), a clinical development-stage biopharmaceutical company developing antiviral treatments announces that the first patient was screened in the Phase 2, dose-range finding study with PanCytoVir™ (formally known as TD-213) in patients with mild-to-moderate COVID-19. The study will enroll up to 75 non-hospitalized patients with symptomatic, mild-to-moderate COVID-19 infection. Patients will be randomly assigned to one of three treatment groups: 500 mg twice daily, 1000 mg twice daily, or matching-placebo twice daily and treated for 5 days. Topline results from this study are expected in 3Q22.2022-07-19 Press Release Initiation of Phase 2 Study.pdf
- Aug 27, 2021Dear TrippBio Investors, We wanted to provide...
Dear TrippBio Investors,
We wanted to provide a quick update on our progress this year. There have been two major material changes in the Company subsequent to December 31, 2020.
The first is that in March of 2021 the Company received a Notice of Allowance from the U.S. Patent and Trademark Office on its patent for using TD213 for treatment of coronavirus infections.
The second major change is that Phil Young resigned from the CEO position in March 2021 and David Martin (a current Board Member) was installed as the new CEO.
In addition, on 26 May 2021 we announced publication of data supporting the antiviral potency of TD-213 against SARS-CoV-2. The data is undergoing scientific peer-review for publication and is available in an online preprint server at:
We have posted press releases discussing these developments along with our 2020 Annual Report on our website (www.TrippBio.com). We encourage you to visit the website and review these documents and to familiarize yourself with our program.
We wish you the best and encourage everyone to get vaccinated and wear a mask.
Best regards, David David E. Martin, PharmD, MBA CEO TrippBio, Inc.
- Mar 10, 2021
- Jan 29, 2021Primary offering finalized, sellingsharesSold $4 for a total of $184,644shares at
- Dec 9, 2020
- Dec 8, 2020Greetings! Thank you to each of our 172...
Greetings! Thank you to each of our 172 investors (and growing!) who support our efforts to bring TD213 to market. Many of you have invested multiple times, signaling your belief in the need for effective therapeutics to fight COVID-19. Experts agree!
Recently, we were asked if there are limits on investment amounts. Under Reg CF rules, an investor’s limit is typically the lesser of 10% of income or net worth, which is self-reported during the investment process. Once the rules are changed early next year, it will be the greater of 10% of income or net worth.
Please spread the word!
- Nov 24, 2020Hello TrippBio Community! As we head into the...
Hello TrippBio Community! As we head into the Thanksgiving holiday in the U.S., let us take the opportunity to say how grateful we are for all of you. We are working hard to bring TD213 to market and each one of you is an integral part of our team. Thank you for spreading the word. Be safe and be well!
- Nov 19, 2020Greetings, TrippBio Community! As promised,...
Greetings, TrippBio Community! As promised, here’s the link to CEO Phil Young’s Q&A with Netcapital earlier this week. Please share with your friends and help us to get the word out. We’re making great strides towards bringing TD213 to market to fight COVID-19. We need your help to make it happen. Thank you for being part of our team!Watch now
- Nov 17, 2020Thank you, TrippBio community for joining our...
Thank you, TrippBio community for joining our Q&A on Tuesday! You had great questions and we were excited to share our progress with you. We’ll post a link for the webinar, for anyone who was unable to make the event. Let’s keep the momentum going!
- Nov 16, 2020There's still time to register for our live Q&A...
There’s still time to register for our live Q&A with Phil Young of TrippBio. Tuesday, Nov. 17 at 1PM EST. Please join us - we’d love to talk to you and share our progress on TrippBio and TD213. Can’t wait!Register now
- Nov 16, 2020Greetings TrippBio Community! Happy to share...
Greetings TrippBio Community! Happy to share some very good news. Interim data from an investigator-initiated study shows that TD213 cleared the SARS-CoV-2 virus by day 14 in 90% of patients tested. This beats the median data of 17.2 days recently published in a review of 77 studies of mild-moderate COVID-19 patients. We are making great progress! Check out the press release for more details. Thank you for your continued support - we can’t do it without you.
And don’t forget to join us on Tuesday, Nov. 17 for a live Q&A with Phil Young of TrippBio. We’ll repost the registration link.Read more about the study
- Nov 9, 2020Hello TrippBio friends! Please join us next...
Hello TrippBio friends! Please join us next Tuesday, November 17 at 1PM EST for a live Q&A session on Netcapital. President & CEO Phil Young will share updates and his vision for TrippBio. Get your questions ready!Register here
- Oct 22, 2020Hello Friends! Progress continues at TrippBio:...
Hello Friends! Progress continues at TrippBio: the last patient has been enrolled in the POC study to assess efficacy of TD213 against COVID-19. We look forward to sharing results soon. Check out the link below for more details & share with friends. We are grateful for your support!Read more
- Oct 12, 2020Hello TrippBio Community! Exciting things are...
Hello TrippBio Community! Exciting things are happening at TrippBio! First patient enrolled in our TD213 clinical study. Stay tuned for updates. Sincere thanks to 100+ investors who have helped raise $100K+ in less than a month. Please share with friends; let’s keep building this momentum together.
- Sep 28, 2020Hello from TrippBio! We’re excited to see so...
Hello from TrippBio! We’re excited to see so much interest in Dr. Tripp’s work and specifically in the potential for TD213. We recently received some excellent questions from a potential investor and wanted to share the questions and our responses. If you have questions, please post them in the Discussion area. Thanks again.
Question1: How many patients will be enrolled in the pilot study?
Response: The Pilot study and subsequent Ph II/III study are distinctly different. We plan to enroll 10-20 patients in this Pilot with mild to moderate active COVID-19 infection. This Pilot study is a Proof of Concept and we plan to use it to demonstrate that the animal and lab data is reproducible in humans.
Question2: What are the key inclusion and exclusion criteria for the pilot study population?
Response: The list of inclusion and exclusion criteria are too detailed to go into. It should suffice to say that our criteria will largely mirror other studies in the space and will be finalized once we have final FDA input.
Question 3: Is the additional Reg D funding sufficient to enroll the projected 600 patients in the full Phase 2 study? Over what timeframe?
Response: The Reg D is not designed to get the large PH II/III study funded. We intend to use the money to finalize the POC study and work on the regulatory approach, product development and other necessary development activities all geared toward an ultimate FDA approval.
Question 4: Are the inclusion and exclusion criteria the same as for the pilot study? Response: See response to question above.
Question 5: What are the clinical endpoints? Viral load only, or clinical signs and symptoms as well? Is there FDA guidance on endpoints needed for EUA?
Response: This type of information is generally not shared unless a large investor is under a non-disclosure agreement.
Question 6: Are there any preclinical data comparing TD213 to a SARS-CoV2 neutralizing antibody, and to combinations of the two (additive, synergy or interference)?
Response: As of this time, preclinical tests have not been conducted comparing TD213 to a SARS-CoV-2 neutralizing antibody or to the combinations described.
Question 7: Has the Company secured a supply chain for TD213? How many doses can be produced over what timeframe? Is a cold chain required for storage and distribution?
Response: This is proprietary information and not shared with the public.
- Sep 15, 2020Primary offering of $4shares at
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