Get the right cancer treatment.
The first time.
Personalized cancer treatment through measuring drug resistance ex vivo
Personalized cancer treatment through measuring drug resistance ex vivo
A patient that is diagnosed with cancer today will have a genetic screen on their tumor sample to determine their subtype of cancer. Based on the cancer subtype, they are given a first line of treatment. If that doesn't work, they are given a second line of treatment. If that doesn't work, they are given a third line of treatment. Why experiment with a patient's body; wasting time and risking their life?
Drugs fail because of drug resistance. Ourotech measures drug resistance on a patient's tumor sample outside of their body so we can determine the best cancer treatment the first time. Ourotech has created a hydrogel that can culture tumors outside of the human body and mimic the drug resistance of tumors inside the human body. We use IC50, the industry standard for measuring drug resistance, so we can determine the best treatment for a patient and eliminate the trial and error process.
Ourotech's first hydrogel, Genesis, is usable for breast, colon and brain (GBM) cancers.
Cancer treatment is trial and error. Ourotech helps doctors deliver the ideal treatment for a patient by testing all potential treatments on their cancer cell samples in our medical device.
Purchased securities are not currently tradeable. Expect to hold your investment until the company lists on a national exchange or is acquired.
Ourotech is offering securities under both Regulation D and Regulation CF through SI Securities, LLC ("SI Securities"). SI Securities is an affiliate of Slice Capital, Inc, a registered broker-dealer, and member FINRA/SIPC. SI Securities will receive cash compensation equal to 5% of the value of the securities sold. Investments made under both Regulation D and Regulation CF involve a high degree of risk and those investors who cannot afford to lose their entire investment should not invest. Furthermore, the contents of the Highlights, Term Sheet sections have been prepared by SI Securities and shall be deemed broker-dealer communications subject to FINRA Rule 2210 (the “Excluded Sections”). With the exception of the Excluded Sections noted above, this profile contains offering materials prepared solely by World's Best without the assistance of SI Securities, and not subject to FINRA Rule 2210 (the “Issuer Profile”). The Issuer Profile may contain forward-looking statements and information relating to, among other things, the company, its business plan and strategy, and its industry. Investors should review the risks and disclosures. The contents below are meant to be a summary of the information found in the company’s Form C. Before making an investment decision, investors should review the company’s Form C for a complete description of its business and offering information, a copy of which may be found both hereand below.
Total Global Market Size
> Immediately available market of $1.65B
> Partnerships with Stanford, Harvard Dana Farber Cancer Institute
> Pre clinical trials in progress with Dongsan Medical Center, Korea
> Patents: 1 Published, 1 Pending, 2 Provisional
> Graduate of Singularity University Accelerator
Total Amount Raised
> Raise Description: Seed
> Minimum Commitment: US $500/Investor
> Security Type: Crowd Note
> Valuation Cap: Us $6,000,000
> Offering Type: Side by Side Offering
Ourotech is taking the guesswork out of cancer treatment by using our medical device to simulate the human body and test all potential treatments. Our hydrogels keep patient tumor cells alive outside the body, allowing doctors to select and test potential treatments in an automated drug testing device. This allows doctors to individualize cancer treatments specifically for each patient, improving the chances of survival for cancer patients.
Duleek Ranatunga, Co-Founder & CEO
William Lin, Co-Founder & CTO
What are your competitive advantages?
Most cancer treatments today are combinations of drugs, but existing drug testing technology can't test multiple drugs on a single tumor sample due to drug accumulation from a a lack of circulation, metabolism and excretion. This leads treatments to appear more effective that they really are and a drug that works on a tumor sample outside the body doesn't work inside a patient. Ourotech's system simulated the major activities in the human body that control drug safety and efficacy, particularly blood/drug circulation, metabolsim and side effects on the liver and drug excretion in order to accurately predict what the best drug is on each complex and unique patient.
Can you elaborate on your customer acquisition strategy and how you plan to scale?
We are starting with sales to pharma companies while we run mice and early human trials in 2018. Clinical trials will occur in 2019 and the US and Europe will be the initial markets. We are currently using past pilot tests and partners to market to pharma and the relationships we form with pharma companies now will allow us to find distribution partners that can sell and spread our product quickly through North America and Europe.
What are exit expectations?
There are two possibilities. We can be acquired early when the device is approved for our first indication, breast cancer, in North America and Europe (2021/2022) for an expected acquisition of over $100M by a pharma company. If our other indications, particularly colon cancer, are far ahead in development, we will continue to develop the device for as many cancers as possible, and look to IPO around 2025 at $1B+.
The current funding round, which consists of crowdfunding and traditional investment will total $2M and will be used for the following.
- Mice Trials (Pre-clinical): Mice trials for breast cancer treatments (drug combinations)
- IP & Regulatory Filings: IP and regulatory filings, including an IDE (investigational device exemption) for US clinical trials for future FDA approval and a potential CE mark filing for European approval prior to US approval
- Human Trials (Clinical): Observational human studies
- Employees & Contractors: Includes all administrative, r&d, and sales (pharmaceutical sales) employee recruiting costs and salaries
Please see the financial information listed on the cover page of the Form C and attached to this profile in addition to the following information. Financial statements are attached to the Form C as Exhibit B.
Ourotech is a medical device company, specializing in personalized medicine using hydrogels and organ chips. Our initial targets are breast and colorectal cancer treatments. The Company is also focused on developing new hydrogels to tackle other cancers, including, but not limited to, lung, liver, and throat cancers. The Company is also dedicated to researching new methods of using its technology to further enhance the accuracy of test results using its system.
Liquidity & Capital Resources
The Offering proceeds are essential to our operations. We plan to use the proceeds as set forth above under "use of proceeds", which is an indispensable element of our business strategy.
Capital Expenditures and Other Obligations
The Company intends to invest in R&D equipment to research new hydrogels and new applications for its hydrogels with the goal of eventual regulatory approva, all in accordance with the use of funds outlined abovel.
Trends and Uncertainties
After reviewing the above discussion of the steps the Company intends to take, potential Purchasers should consider whether achievement of each step within the estimated time frame is realistic in their judgment. Potential Purchasers should also assess the consequences to the Company of any delays in taking these steps and whether the Company will need additional financing to accomplish them. The financial statements are an important part of the Form C and should be reviewed in their entirety. The financial statements of the Company are attached hereto as Exhibit B.
As discussed in "Dilution" below, the valuation will determine the amount by which the investor’s stake is diluted immediately upon investment. An early-stage company typically sells its shares (or grants options over its shares) to its founders and early employees at a very low cash cost, because they are, in effect, putting their "sweat equity" into the Company. When the Company seeks cash investments from outside investors, like you, the new investors typically pay a much larger sum for their shares than the founders or earlier investors, which means that the cash value of your stake is immediately diluted because each share of the same type is worth the same amount, and you paid more for your shares (or the notes convertible into shares) than earlier investors did for theirs.
There are several ways to value a company, and none of them is perfect and all of them involve a certain amount of guesswork. The same method can produce a different valuation if used by a different person.
Liquidation Value - The amount for which the assets of the Company can be sold, minus the liabilities owed, e.g., the assets of a bakery include the cake mixers, ingredients, baking tins, etc. The liabilities of a bakery include the cost of rent or mortgage on the bakery. However, this value does not reflect the potential value of a business, e.g. the value of the secret recipe. The value for most startups lies in their potential, as many early stage companies do not have many assets (they probably need to raise funds through a securities offering in order to purchase some equipment).
Book Value - This is based on analysis of the Company’s financial statements, usually looking at the Company’s balance sheet as prepared by its accountants. However, the balance sheet only looks at costs (i.e. what was paid for the asset), and does not consider whether the asset has increased in value over time. In addition, some intangible assets, such as patents, trademarks or trade names, are very valuable but are not usually represented at their market value on the balance sheet.
Earnings Approach - This is based on what the investor will pay (the present value) for what the investor expects to obtain in the future (the future return), taking into account inflation, the lost opportunity to participate in other investments, the risk of not receiving the return. However, predictions of the future are uncertain and valuation of future returns is a best guess.
Different methods of valuation produce a different answer as to what your investment is worth. Typically liquidation value and book value will produce a lower valuation than the earnings approach. However, the earnings approach is also most likely to be risky as it is based on many assumptions about the future, while the liquidation value and book value are much more conservative.
Future investors (including people seeking to acquire the Company) may value the Company differently. They may use a different valuation method, or different assumptions about the Company’s business and its market. Different valuations may mean that the value assigned to your investment changes. It frequently happens that when a large institutional investor such as a venture capitalist makes an investment in a company, it values the Company at a lower price than the initial investors did. If this happens, the value of the investment will go down.
The development and commercialization of our products and services require regulatory approval, clinical trials and may encounter competition. The primary risk in investing in an early health technology is the clinical outcome and regulatory approval. Medical device companies creating novel technology must test the devices on humans in clinical trial and regulatory approval is dependent on the results of these clinical trials. A successful clinical trial will significantly increase the value of the company and can lead to an exit, but a failed clinical trial costs significant money and can result in the failing of the company, if resources are not available for a new trial and new funding cannot be raised. If products gain regulatory approval, there will be competition for market share. While novel medical devices have relatively few competitors compared to most industries, the competition that can arise consist of mostly global companies. We face competition with respect to any products that we may seek to develop or commercialize in the future. Our competitors include major companies worldwide. Many of our competitors have significantly greater financial, technical and human resources than we have and superior expertise in research and development and marketing approved services and thus may be better equipped than us to develop and commercialize products and services. These competitors also compete with us in recruiting and retaining qualified personnel and acquiring technologies. Smaller or early stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. Accordingly, our competitors may commercialize products more rapidly or effectively than we are able to, which would adversely affect our competitive position, the likelihood that our services will achieve initial market acceptance and our ability to generate meaningful additional revenues from our products.
As a manufacturer of medical devices, our business depends on developing and maintaining close and productive relationships with our materials suppliers. We depend on our materials suppliers to sell us quality products at favorable prices. Many factors outside our control, including, without limitation, raw material shortages, inadequate manufacturing capacity, labor disputes, transportation disruptions or weather conditions, could adversely affect our suppliers' ability to deliver to us quality merchandise at favorable prices in a timely manner. Furthermore, financial or operational difficulties with a particular supplier could cause that supplier to increase the cost of the materials or decrease the quality of the materials we purchase from it. Supplier consolidation could also limit the number of options from which we may purchase products and could materially affect the prices we pay for these materials. We would suffer an adverse impact if our suppliers limit or cancel the return privileges that currently protect us from inventory obsolescence.
We plan to implement new lines of business or offer new products and services within existing lines of business. There are substantial risks and uncertainties associated with these efforts, particularly in instances where the markets are not fully developed. In developing and marketing new lines of business and/or new products and services, we may invest significant time and resources. Initial timetables for the introduction and development of new lines of business and/or new products or services may not be achieved and price and profitability targets may not prove feasible. We may not be successful in introducing new products and services in response to industry trends or developments in technology, or those new products may not achieve market acceptance. As a result, we could lose business, be forced to price products and services on less advantageous terms to retain or attract clients, or be subject to cost increases. As a result, our business, financial condition or results of operations may be adversely affected.
In general, demand for our products and services is correlated with general economic conditions. Declines in economic conditions in the U.S. or in other countries in which we operate may adversely impact our consolidated financial results. Because such declines in demand are difficult to predict, we or the industry may have increased excess capacity as a result. An increase in excess capacity may result in declines in prices for our products and services.
The Company’s success depends on the experience and skill of the board of directors, its executive officers and key employees. In particular, the Company is dependent on Duleeka Ranatunga, the CEO, and William Lin, the Head of R&D. The loss of Duleek Ranatunga or any member of the board of directors or executive officer could harm the Company’s business, financial condition, cash flow and results of operations. The loss of William Lin could harm the Company's progress regarding R&D and product development.
We have not prepared any audited financial statements. Therefore, you have no audited financial information regarding the Company’s capitalization or assets or liabilities on which to make your investment decision. If you feel the information provided is insufficient, you should not invest in the Company.
We are not subject to Sarbanes-Oxley regulations and lack the financial controls and safeguards required of public companies. We do not have the internal infrastructure necessary, and are not required, to complete an attestation about our financial controls that would be required under Section 404 of the Sarbanes-Oxley Act of 2002. There can be no assurance that there are no significant deficiencies or material weaknesses in the quality of our financial controls. We expect to incur additional expenses and diversion of management’s time if and when it becomes necessary to perform the system and process evaluation, testing and remediation required in order to comply with the management certification and auditor attestation requirements.
We may not timely identify or effectively respond to general trends or developments regarding healthcare and medical devices, which could negatively affect our ability to address our customers' needs. It is difficult to predict consistently and successfully the products and services our customers will demand. The success of our business depends in part on how accurately we predict demand, availability of merchandise, the related impact on the demand for existing products and the competitive environment through our businesses. Failure to timely identify or effectively respond to changing trends or developments in technology could negatively affect our relationship with our customers and the demand for our products and services.
Start-up investing is risky. Investing in startups is very risky, highly speculative, and should not be made by anyone who cannot afford to lose their entire investment. Unlike an investment in a mature business where there is a track record of revenue and income, the success of a startup or early-stage venture often relies on the development of a new product or service that may or may not find a market. Before investing, you should carefully consider the specific risks and disclosures related to both this offering type and the company which can be found in this company profile and the documents in the data room below.
Your shares are not easily transferable. You should not plan on being able to readily transfer and/or resell your security. Currently there is no market or liquidity for these shares and the company does not have any plans to list these shares on an exchange or other secondary market. At some point the company may choose to do so, but until then you should plan to hold your investment for a significant period of time before a “liquidation event” occurs. A “liquidation event” is when the company either lists their shares on an exchange, is acquired, or goes bankrupt.
The Company may not pay dividends for the foreseeable future. Unless otherwise specified in the offering documents and subject to state law, you are not entitled to receive any dividends on your interest in the Company. Accordingly, any potential investor who anticipates the need for current dividends or income from an investment should not purchase any of the securities offered on the Site.
Valuation and capitalization. Unlike listed companies that are valued publicly through market-driven stock prices, the valuation of private companies, especially startups, is difficult to assess and you may risk overpaying for your investment. In addition, there may be additional classes of equity with rights that are superior to the class of equity being sold.
You may only receive limited disclosure. While the company must disclose certain information, since the company is at an early-stage they may only be able to provide limited information about its business plan and operations because it does not have fully developed operations or a long history. The company may also only obligated to file information periodically regarding its business, including financial statements. A publicly listed company, in contrast, is required to file annual and quarterly reports and promptly disclose certain events — through continuing disclosure that you can use to evaluate the status of your investment.
Investment in personnel. An early-stage investment is also an investment in the entrepreneur or management of the company. Being able to execute on the business plan is often an important factor in whether the business is viable and successful. You should be aware that a portion of your investment may fund the compensation of the company’s employees, including its management. You should carefully review any disclosure regarding the company’s use of proceeds.
Possibility of fraud. In light of the relative ease with which early-stage companies can raise funds, it may be the case that certain opportunities turn out to be money-losing fraudulent schemes. As with other investments, there is no guarantee that investments will be immune from fraud.
Lack of professional guidance. Many successful companies partially attribute their early success to the guidance of professional early-stage investors (e.g., angel investors and venture capital firms). These investors often negotiate for seats on the company’s board of directors and play an important role through their resources, contacts and experience in assisting early-stage companies in executing on their business plans. An early-stage company may not have the benefit of such professional investors initially.