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|1||Applied our expertise in RNA analysis to co-develop FDA authorized COVID-19 saliva test with SUNY.|
|2||Developed & commercialized world's first saliva based epigenetic test for autism spectrum disorder.|
|3||Sales from our new saliva COVID-19 tests have exceeded $6.5MM to date since September 2020.|
|4||We are working with NY State to test municipalities' wastewater for COVID-19.|
|5||Working with SUNY on pooled saliva surveillance of returning college students for COVID-19.|
|6||Development of Parkinson's disease, concussion, and Anorexia Nervosa, diagnostic tools in progress.|
|7||Our company is led by a former Chairman & CEO of Morgan Stanley Bank, Richard Uhlig.|
Quadrant Biosciences is a life science company working with universities across the US to develop and commercialize epigenetic diagnostic solutions for autism spectrum disorder, Parkinson’s disease, and mild traumatic brain injury (concussion). Working closely with medical researchers such as SUNY Upstate Medical University and Penn State College of Medicine, we have developed a novel, saliva-based diagnostic platform called Clarifi®.
In December 2019 we launched Clarifi ASD®, the world's first saliva test for autism spectrum disorder. The test, intended for children 18 months through six years of age, provides a probability of an autism diagnosis based on epigenetic markers in the saliva.
Then the COVID-19 pandemic happened.
Not long after we began to introduce Clarifi ASD to pediatric health care providers, the world was besieged by the COVID-19 pandemic. Our ability to access healthcare providers and share the scientific and practical utility Clarifi ASD provides to parents and physicians was greatly restricted by social distancing mandates and virus concerns which, in turn, limited our sales team’s ability to affect sales and increased commercial demand for Clarifi ASD. As a result, our sales of the Clarifi ASD test have been below expectations.
So, we adapted!
In response to the COVID pandemic, we immediately reduced our operating costs and, given our existing experience with RNA analysis - and the fact that COVID-19 is an RNA virus - we made the decision to pivot and work with our university partners to develop diagnostic tools for COVID-19. As a result, today we are involved in three significant, complementary COVID-19 projects to aid in the detection of COVID-19 in individuals and communities across the U.S.
Watch this brief overview video of our company projects:
Three Levels of Testing: A Comprehensive Approach to Assessing COVID-19
1. Individual Testing - Clarifi COVID-19 Test Kit
The development of an individual saliva test for COVID-19 was a natural extension of our earlier work with Clarifi ASD®, which used a similar saliva collection methodology. Working in partnership with SUNY Upstate Medical University, we developed the "Clarifi COVID-19 Test Kit by SUNY Upstate Medical and Quadrant Biosciences," a non-invasive and easy to administer swab that collects saliva which is then analyzed to determine the presence or absence of the SARS-CoV-2 virus. On September 22nd, we received Emergency Use Authorization (EUA) for the Clarifi COVID-19 Test Kit!
The Clarifi COVID-19 Test Kit contains the saliva collection swab and the reagents needed to run the analysis and is available for use by high-complexity clinical laboratories serving patients through physicians' offices, urgent care clinics, and hospitals.
2. Community/Municipal Screening: Wastewater Surveillance
This project, funded by New York State, involves our collaboration with SUNY ESF, Upstate Medical University, Syracuse University, and global civil engineering firm Arcadis, to collect and analyze wastewater from the county and municipal sewer systems for the presence of the COVID-19 virus. Our analysis of wastewater samples provides local health officials and policymakers with early indications and information regarding the presence and preponderance of COVID-19 infections in these communities.
“This can be a real game-changer in the detection and monitoring of COVID-19. Information from this testing will allow municipalities to estimate COVID-19 transmission in real time, provide instant feedback on social distancing and reopening phases, help predict hospitalizations and provide confidence for locations with zero transmission to resume normal activity.”
Richard Uhlig, Founder and CEO of Quadrant Biosciences
Because this allows for large regions to be effectively tested for the presence of the COVID-19 virus, it provides a cost-effective and efficient way to screen residents in towns, cities, states, and universities, even in the absence of individual testing.
3. Group/College Testing: Pooled Testing
Finally, in response to an overwhelming need to efficiently test university students prior to attending classes, we have partnered with the Upstate Medical University to conduct pooled testing services for over 450,000 students preparing to begin the fall semester at SUNY schools.
Each of these pooled tests for COVID-19 involves a single test of saliva samples collected from a group of 12 students. A negative test result means that all 12 students are presumed to be coronavirus-free. A positive test for the pool would mean every student in that group would need to be individually tested. Performing single tests of groups of students greatly reduces the cost of supplies, staffing, and time required to perform and interpret tests.
"SUNY Upstate Medical University's work with Quadrant Biosciences, a Start-Up New York company, has led to important breakthroughs in the development of saliva-based diagnostic solutions for neurological conditions such as autism spectrum disorder, Parkinson's disease and concussion injuries. The ability to transfer this innovative approach to assist colleges and universities with the unprecedented and complex work of preparing for the return of students to campuses across the state is an important part of New York's response to the COVID pandemic."
Dr Mantosh Dewan, Interim President, SUNY Upstate Medical University
*On September 22, 2020, The Clarifi COVID-19 Test Kit obtained Emergency User Authorization (EUA) by the Food and Drug Administration (FDA) to be used for the diagnosis fo SARS-CoV-2. The Clarifi COVID-19 test Letter of Authorization, along with the authorization Fact Sheet for Healthcare Providers, the authorized Fact Sheet for Patients and authorized labeling are available on the FDA website.
The Clarifi COVID-19 Test Kit has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories. Clarifi COVID-19 has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Despite the fact that we have the expertise, capability, and customer demand for these COVID-19 tests, the supplies needed to perform quantitative PCR are becoming increasingly difficult to obtain. This, and supply chain disruptions generally throughout the industry, could impair our ability to successfully commercialize one or all of these tests.
The Clarifi ASD® Test - A Game-Changer for Autism Diagnostics
We continue to maintain a focus on our core mission to develop epigenetic diagnostic tools, such as Clarifi ASD®, the world's first saliva test for autism spectrum disorder.
What is it?
Clarifi ASD is a saliva test that indicates the probability that a child has autism spectrum disorder.
Who is it for?
Clarifi ASD is being used primarily by pediatricians and family physicians with patients (18 months through 6 years of age) with a positive autism screening test or a clinical suspicion to aid in a formal diagnosis.
Why is it needed?
With 1 in 54 children being diagnosed with autism in the US according to the CDC, it is one of the most commonly diagnosed developmental disabilities in the country. Unfortunately, the current diagnostic process involves long wait times, largely the result of a small number of trained clinicians to administer behavioral tests. This, in turn, leads to delays in children receiving critical intervention services. If autism is identified and treatment is initiated early, the trajectory of a child's life can be positively changed.
How Clarifi ASD Can Make a Difference
For the first time, clinicians have an accurate biological tool to aid in the early diagnosis of autism. With this simple saliva test, Clarifi ASD can:
~ Help start services earlier when treatment is most effective
~ Provide specialists biological data to support their behavioral assessments
~ Facilitate cost savings through improving the diagnostic process
"What we’ve been able to do over the last 7 years, working together with a very dedicated team, is develop a test that utilizes saliva and can accurately distinguish whether a child has autism spectrum disorder or does not. This relies on a new type of molecular analysis that wasn't even possible until recently."
Frank Middleton, Ph.D. Associate Professor of Neuroscience and Physiology, Biochemistry and Molecular Biology, Pediatrics, and Psychiatry and Behavioral Sciences.
When was it launched?
Clarifi ASD was launched commercially in the US in 49 states (excluding New York), in December 2019.
Watch a short video about Clarifi ASD here:
Who we are
Quadrant Biosciences Inc was started in 2015 by Founder and CEO Rich Uhlig, and we have since grown to over 40 employees. Our team has a shared passion in being a part of positive changes in healthcare.
“As a company, we are committed to looking outside ourselves, and deploying our resources to assist other organizations and research efforts dedicated to improving the lives of people with autism and their families.”
Richard Uhlig, Founder and CEO, Quadrant Biosciences
Capital Raised to Date
As of January 2020, we have raised over $30 million in previous financing rounds from private investors who have recognized the value in how we intend to change the landscape of diagnostics in the future.
Research Grants Received To Date
We have received numerous grants to support our research efforts.*
(*The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.)
Quadrant Biosciences in the Media
Our company has been featured many times in national news and scientific media outlets regarding our research and technology accomplishments in the areas of autism, concussion, and Parkinson's disease.
Clarifi ASD is just the Beginning! Future products in the works.
One of the most exciting things that we’ve discovered is that our Clarifi epigenetic diagnostic platform has applications for many other health issues. Diagnostic solutions for early-stage Parkinson's disease, mTBI/concussion, anorexia, and schizophrenia are currently in development. Several peer-reviewed research papers have already been published on the application of this approach to these worldwide neurological health concerns.
We have numerous peer-reviewed publications supporting our science
To date, there have been 18 peer-reviewed papers published supporting our development of epigenetic biomarkers for autism, mild traumatic brain jury, Parkinson's disease, anorexia nervosa, and Pantothenate kinase-associated neurodegeneration disease (PKAN). These have been published in a variety of scientific journals including JAMA Pediatrics, Frontiers in Genetics, Journal of Neurotrauma, Journal of Oral Microbiology, Journal of Experimental Neuroscience, and Autism Research.
We are honored to partner with a number of outstanding research universities and organizations to help further the understanding of epigenetics.
International Research Partnerships
We also actively partnered with several international research organizations:
European Autism Interventions, A Multicentre Study for Developing New Medications (EU-AIMS) - first Europe-wide collaboration between organizations with the goal of identifying markers of autism that would help in earlier and more accurate diagnosis, prognosis, and the development with new therapies
Comprehensive Care Center for Disability (CAID) - centers in Santiago, San Juan, Higuey and Santo Domingo, the Dominican Republic dedicated to the evaluation, diagnosis and rehabilitation of children from zero to ten years with Autism Spectrum Disorder.
Our Clinical Advisory Board
Our clinical advisory board comprises some of the leading autism and epigenetic researchers and clinicians. It is our privilege to work alongside these luminaries in the field to help families and children with autism.
Want to learn more?
For more information about the company, download the investor deck and visit Quadrant Biosciences www.quadrantbiosciences.com; for more information about Clarifi ASD visit www.clarifiasd.com.
Quadrant Biosciences has financial statements ending December 31 2019. Our cash in hand is $2,800,000, as of July 2020. Over the three months prior, revenues averaged $568,000/month, cost of goods sold has averaged $425,000/month, and operational expenses have averaged $757,000/month.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and the related notes and other financial information included elsewhere in this offering. Some of the information contained in this discussion and analysis, including information regarding the strategy and plans for our business, includes forward-looking statements that involve risks and uncertainties. You should review the "Risk Factors" section for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.
We translate cutting edge research into practical diagnostic solutions for some of the most critical public health issues facing the world today. Specifically, we have been early pioneers in identifying and developing epigenetic biomarkers in saliva. We recently launched the first ever epigenetic saliva test for autism, and are actively involved in several Covid-19 testing projects. We are currently working on developing similar tests for Parkinson's disease, concussion, and Anorexia nervosa.
Our goal is to have the Clarifi epigenetic diagnostic tests become the standard of care, positively impacting millions of people across the globe. (We also want to be on the forefront of RNA analysis and continue to be in a position to positively contribute to the fight against RNA viruses such as Covid-19.)
Quadrant Biosciences Inc. was incorporated in the State of New York in March 2015.
Since then, we have:
Historical Results of Operations
Liquidity & Capital Resources
To-date, the company has been financed with $6,435,600 in debt and $26,591,359 in equity.
After the conclusion of this Offering, should we hit our minimum funding target, our projected runway is 8 months before we need to raise further capital.
We plan to use the proceeds as set forth in this Form C under "Use of Funds". We don’t have any other sources of capital in the immediate future.
We will likely require additional financing in excess of the proceeds from the Offering in order to perform operations over the lifetime of the Company. We plan to raise capital in 3 months. Except as otherwise described in this Form C, we do not have additional sources of capital other than the proceeds from the offering. Because of the complexities and uncertainties in establishing a new business strategy, it is not possible to adequately project whether the proceeds of this offering will be sufficient to enable us to implement our strategy. This complexity and uncertainty will be increased if less than the maximum amount of securities offered in this offering is sold. The Company intends to raise additional capital in the future from investors. Although capital may be available for early-stage companies, there is no guarantee that the Company will receive any investments from investors.
Runway & Short/Mid Term Expenses
Quadrant Biosciences Inc. cash in hand is $2,800,000, as of July 2020. Over the last three months, revenues have averaged $568,000/month, cost of goods sold has averaged $425,000/month, and operational expenses have averaged $757,000/month, for an average burn rate of $614,000 per month. Our intent is to be profitable in 3 months.
Our business is subject to a number of risks and uncertainties, including those highlighted in the section titled “Risk Factors” in our Reg CF Offering Document. These risks include, but are not limited to, the following:
Risks Related to the Company’s Business
We are an early stage revenue producing company and have incurred losses since our inception.
We expect to incur losses for the foreseeable future as we further expand our product offerings and may never achieve or maintain profitability.
The company has a limited operating history, which makes it hard to evaluate its ability to generate revenue through operations.
If the company loses certain senior management and key personnel or are unable to attract and retain skilled employees when needed, it may not be able to operate successfully.
The company may face substantial competition from a number of known and unknown competitors as well as the risk that one or more of them may obtain patents covering technology critical to the company’s businesses.
We rely on a limited number of suppliers or, in some cases, sole suppliers for some of our laboratory instruments and materials and may not be able to find replacements or immediately transition to alternative suppliers.
The company relies on certain major distributors, making it vulnerable to changes in the business and financial condition of, or demand for its services by, such distributors.
The technology upon which the company relies for its operations may malfunction; company methodologies may produce unanticipated consequences.
Our business and operations would suffer in the event of system failures.
The company and its subsidiaries are subject to cyberattacks, security risks and risks of security breaches.
We worked in concert with Admera Health, a licensed clinical laboratory located in South Plainfield, New Jersey, to design, develop and commercially run our epigenetic diagnostics. Any disruption in Admera Health’s operations could materially impact our ability to continue to offer and sell our epigenetic diagnostics tests, including but not limited to Clarifi ASD, which could significantly affect our business, financial condition, results of operations, and reputation.
If we are unable to support demand for our existing and our future products, including ensuring that we have adequate capacity to meet increased demand, or we are unable to successfully manage the evolution of our bioinformatics platform, our business could suffer.
The company has a convertible note that it is treating as debt.
New product development involves a lengthy and complex process, and we may be unable to successfully commercialize any other products we may develop on a timely basis, or at all, and the development and commercialization of additional products may negatively affect the commercialization of existing products.
Our existing collaborations are important to our business, and future licenses may also be important to us. If we are unable to maintain any of these collaborations, or if these arrangements are not successful, our business could be adversely affected.
We have no experience manufacturing our products at commercial scale, and if we decide to establish our own manufacturing facility, we cannot assure you that we can manufacture our products in compliance with regulations at a cost or in quantities necessary to make them commercially viable.
Even if any of our product candidates receives marketing clearance or approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.
Our future success depends on the efforts of a small management team. The loss of services of the members of the management team may have an adverse effect on the company. There can be no assurance that we will be successful in attracting and retaining other personnel we require to successfully grow our business.
Risks Related to Government Regulation
We offer products that are subject to regulation as medical devices by the FDA. If we fail to comply with any applicable FDA regulatory requirements, it may have a substantially negative impact on our business, financial condition or results of operation.
We plan to perform epigenetic diagnostic tests that could, at some point in the future, be regulated by the FDA as medical devices. If the FDA decides to actively regulate tests like those that we plan to offer, we may need to obtain FDA and/or other regulatory clearances or approvals, and comply with other regulatory requirements, which may delay, encumber or block us from commercializing these diagnostic tests.
If we fail to meet any applicable requirements of CLIA or state clinical laboratory licensure laws, that failure could prohibit and/or restrict the commercial sale of our epigenetic testing diagnostic technologies and otherwise cause us to incur significant expense.
We are subject to federal and state healthcare regulations and laws relating to anti-bribery and anti-corruption, and non-compliance with such laws could lead to significant penalties.
A violation of privacy, security or data protection laws could have a material adverse effect on the company and the value of the shares.
Government regulations and other legal requirements affecting our company are subject to change. Such change could have a material adverse effect on our business.
Our employees, independent contractors, principal investigators, contract research organizations, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could expose us to liability and hurt our reputation.
If we or our contract manufacturers or other third parties fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business.
We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic and international markets. We can face criminal liability and other serious consequences for violations, which can harm our business.
Risks Related to Investment in the Shares
Any valuation of the company at this stage is difficult to assess.
There is no minimum amount set as a condition to closing this offering.
Future fundraising may affect the rights of investors.
The securities are equity securities and are subordinate to existing and future indebtedness of the company.
The company may not be able to declare and pay dividends on the shares of Common Stock.
The amended and restated certificate of incorporation and the subscription agreement have forum selection provisions that requires disputes be resolved in specific forums, regardless of convenience or cost to you, the investor.
The holders of the majority of the outstanding shares of our capital stock may require other stockholders to participate in certain future events, including our sale or the sale of a significant amount of our assets.
Investors in this offering may be subject to transfer restrictions.
There is currently no public market for our Common Stock, and a public market for our Common Stock may never develop.
Risks Related to our Intellectual Property
Though we currently do not solely own any issued patents or pending patent applications, our goal is to either solely or jointly with our partners receive patent protection. We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and ultimately unsuccessful.
We rely on a licensing agreement with the Research Foundation for the State University of New York and the Pennsylvania State Research Foundation.
We may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property or claiming ownership of what we regard as our own intellectual property.
We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
We may not be successful in obtaining or maintaining necessary rights to our product candidates through acquisitions and in-licenses.
If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
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