We are from Amgen, Genentech, MIT, Harvard, KTH and we're changing the way chronic inflammation is understood and treated, with solutions for patients with life-long, inflammation-mediated diseases.
Motivation, Driving Force and Unmet Medical Need:
My daughter developed something called Complex Regional Pain Syndrome (CRPS) following a delicate right-hand wrist surgery. She is right-handed. She remains in constant pain, often debilitatingly intense and has limited use of the right wrist. It is heart-breaking to see her in such pain and not be able to do much to help.
Complex regional pain syndrome, with a prevalence of about 1:2,000, is a chronic inflammation and pain condition experienced by humans. It is a severe post-traumatic pain disorder. CRPS is usually triggered by trauma to the distal regions of a limb and is further associated with limb-restricted edema; sensory, vasomotor, sudomotor, motor, and trophic abnormalities; and profound sensory central nervous system (CNS) reorganization.
While most patients with CRPS show an improvement within months, either with or without treatment, 20% of patients develop persistent pain, often lasting for years or even through their lifetime. This type of persistent pain is intrusive and results in among the lowest quality of life scores in medical conditions. There is no cure. Current treatments are either short-lived, ineffective or just plain unsuccessful. Since many patients cannot be successfully treated, the treatment of CRPS remains an important unresolved problem and a major unmet medical need.
At DNX, we had been working for a few years on mechanisms of more effectively blocking the activity of a master pro-inflammatory cytokine. This pro-inflammatory cytokine and its natural antagonist have evolved over a billion years to check and countercheck each other. When all is well in the human body, both molecules are in balance. In the event of trauma, some inflammation is good as it alerts the body’s natural defense mechanisms to swing into action. Unfortunately, in cases when the ‘check-countercheck’ mechanism is thrown off balance, for any number of reasons - as in the case of my daughter - there is nothing to stop the master pro-inflammatory cytokine from continuing its action, without an effective countercheck, resulting in “dysfunctional-,” “smoldering-,” or chronic inflammation.
The natural antagonist molecule has a very short half-life in the human body. Thus, when the balance is thrown off, the natural antagonist molecule is unable to mount a continuously elevated countercheck to the actions of the pro-inflammatory cytokine. Therefore, the natural antagonist must be injected daily and, in some cases, even possibly 2-3 times per day, depending upon the indication and severity of the condition. This is most inconvenient to patients.
DNX has developed a genetically modified, long-acting version of the natural antagonist, which has demonstrated in preclinical testing a dramatic improvement in efficacy (4x to 50x), greatly reduced dosing frequency (1 per week to 1 per two weeks to 1 per month versus daily or multiple daily) and without sacrificing safety.
Promising Treatment Option for CRPS:
Medical researchers at the Universities of Manchester, Sheffield and Liverpool in the UK and the Universities of Pecs and Budapest in Hungary, published a breakthrough paper in the July 26, 2019 edition of the Proceedings of the National Academy of Sciences (PNAS), in which they were successfully able to create an animal model of CRPS and subject it to treatment by the natural antagonist molecule. The team discovered that ‘blocking’ of the pro-inflammatory cytokine with the natural antagonist helped to both ‘prevent and reverse’ all of the changes in the animal model of CPRS. Their results indicate that persistent CRPS is often contributed to by autoantibodies and highlight, for the first time, the promise of a potential therapeutic use of the antagonist to ‘prevent or treat’ CRPS by blocking the actions of the pro-inflammatory cytokine!
The preliminary results of the PNAS study is extraordinarily encouraging to me personally and to the Team at DNX. The lead researcher from this study is planning a clinical trial at the University of Liverpool. My daughter hopes to be a participant in such a clinical trial.
From a successful funding round, DNX will aim to collaborate with the lead researcher from the study in advancing our proprietary molecule for testing in CRPS. A positive outcome may not only help my daughter and all the other patients who struggle with CRPS daily, but it additionally has the potential of treating several other rare diseases, especially those of pediatric origin that arise from dysfunctional inflammation.
The Link Between Dysfunctional Inflammation and Cancer:
There is a growing body of evidence from a multitude of proof-of-concept clinical trials that smoldering-, or dysfunctional inflammation drives normal cells and tissue to malignancy. Implicated at the heart of these early findings is the complex activities of the master pro-inflammatory cytokine. DNX believes it may even be possible to catch and stop cancers from developing early in the process by cutting-off chronic inflammation ‘at the pass.’ Now that, in our opinion, may well qualify as the “greatest thing since sliced bread!”
The Inflammation Spectrum:
It is said that the longer you can keep inflammation at bay, the longer you will live! The inflammation spectrum is linked to a host of disease indications – from rare, orphan indications to gout to several cancers to cardiovascular diseases. The DNX proprietary molecule has the potential to positively impact some of these diseases and change the life trajectory of patients.
We invite you to join us in our journey to providing essential solutions to some tough health problems.
DNX Biopharmaceuticals Announces Collaboration With Lung Cancer Initiative at Johnson & JohnsonFebruary, 2020
Traction & Validation by Big Pharma: DNX is an awardee and a portfolio company of Johnson & Johnson Innovation Labs. A major achievement!June, 2019
Unlike acute inflammation (for example, fever due to the flu), chronic inflammation is a slow, creeping condition caused by a misfiring of the immune system that keeps the body in a constant, long-term state of high alert.
Researchers have linked inflammation – to be specific, “low-grade” or “chronic” or “smoldering” – inflammation to nearly every critical disease of aging.
Researchers have suspected for years that health issues such as cancer, heart disease, dementia, diabetes and more, have at their heart one common trigger: low-grade inflammation.
In a recent, landmark study, cardiologists in Boston reported on a clinical trial with more than 10,000 patients in 39 countries that tested to see if an anti-inflammatory drug could lower rates of heart disease. They discovered it could. But they also found that the same drug reduced lung cancer mortality more than 77%, along with reports of gout and arthritis (conditions linked to inflammation) also falling.
According to a recent report in FiercePharma, the global market for orphan drugs is expected to reach $209 billion a year by 2022.
Across several cancers such as lung, breast, pancreatic, colon and melanoma to name a few, the total market sizes in the 2025 timeframe is expected to be well over $100 billion.
DNX believes that the potential for its lead drug(s) could well be in the $3-$5 billion in the rare diseases segment and in the $5-$7 billion in the inflammation-cancer segment.
Biologics drug development takes time and patience. If all goes well and more or less as per plan, it could take between 5-7 years to bring a drug to the market.
RISKS AND DISCLOSURES
THIS OFFERING IS SUBJECT TO RISK, INCLUDING, BUT NOT LIMITED TO, THE FOLLOWING:
Biotechnology start-ups at our stage are risky! Don't invest anything you can't afford to lose. Having said that, the DNX Team brings together a consolidated base of over 250 person-years of seasoned biotech experience in drug development, commercialization and biotech M&A.Our Team members have been successful in bring several biotech drugs into the market, and we have every intention of using our knowledge and experience in knocking it out of the ballpark!
An investment in DNX Biopharmaceuticals, Inc. common shares involves a high degree of risk including, but not necessarily limited to, the risks described below. These risk factors should be considered along with the forward-looking statements at the end of this Disclosure because these factors could cause our actual results or financial condition to differ materially from those projected in forward-looking statements. The following discussion is not an all-inclusive listing of risks, although we believe these are the more material risks that we face. If any of the following occur, our business, financial position, results of operations or cash flows could be negatively affected.
Risks Related to Our Financial Condition
We have relied on the issuance of equity and debt securities to fund our operations and will continue do so for the foreseeable future.Our ability to continue as a going concern will be in substantial doubt if we are unable to continue to periodically obtain such funding.
The development of biopharmaceuticals is an expensive and time-consuming undertaking. The Company faces substantial risks in under-estimating the costs and efforts associated with bringing drugs to the market. For example, for a startup biotech such as DNX, it can cost upwards of $120 million to complete a Phase 3 clinical trial.
We have historically funded our operations through the issuance of equity securities and debt financing and to a much lesser extent through revenue from our contracts and/or from collaborations, grants and awards. We will continue to be dependent upon such sources for the foreseeable future.The actual amount of funds we will need to operate is subject to many factors, some of which are beyond our control. These factors include, but are not limited to, the following:
Our ability to obtain additional funding when needed, changes to our operating plans, our existing and anticipated working capital needs, the acceleration or modification of our planned development activities or expenditures, increased expenses or other events may affect our need for additional capital in the future and may require us to seek additional funding sooner than anticipated. Additional funding may include milestone payments under existing collaborations, up-front fees or research funding through new out-licensing transactions, sales of debt or equity securities and/or securing additional credit facilities.
If we are unable to generate enough revenue or secure additional sources of funding and/or reduce our current rate of development spending or further reduce our expenses, we may be required to curtail operations significantly, which could prevent us from successfully executing our operating plan and could raise substantial doubt as to our ability to continue as a going concern in future periods. Even if we are able to secure the additional sources of funding, it may not be on terms that are favorable or satisfactory to us and may result in significant dilution to our stockholders. These events may result in an inability to maintain a level of liquidity necessary to continue operating our business and the loss of all or part of the investment of our stockholders in our common stock.
As a result of significant losses in recent years, our financial condition has been materially weakened.
We incurred significant losses in recent years, which has materially weakened our financial condition. We lost $1.0 million in 2010, $1.5 million in 2009 and $1.7 million in 2008, and we anticipate losses in 2011 and beyond.Our weakened financial condition increases our vulnerability to the impact of, among other things, unexpected events (such as terrorist attacks), downturns in the capital markets or the economy generally, a sudden loss of key personnel, significant increases in operating costs, significant increased competition and changes in the legal and regulatory environment.
If the value of our intangible assets is materially impaired, our financial condition, results of operations and stockholders’ equity could be materially adversely affected.
If we choose not to protect our proprietary rights or fail in our efforts to protect our proprietary rights, our competitors might gain access to our technology. Unauthorized parties might attempt to copy aspects of our products or to obtain and use information that we regard as proprietary. Others might independently develop similar or competing technologies or methods or design around our patents. In addition, the laws of many foreign countries do not protect our intellectual property rights to the same extent as the laws of the United States. As a result, our proprietary rights could be compromised, our competitors might offer products similar to ours and we might not be able to compete successfully.
We also cannot assure that:
We may be required to spend in the future, significant resources to monitor and protect our intellectual property rights. Any litigation, whether resolved in our favor, and whether initiated by us or by a third party, could result in significant and possibly material expense to us and divert the efforts of our management and technical personnel. In addition, while patents are territorial and a ruling on a certain given patent does not necessarily impact the validity or enforceability of a corresponding or related patent in a different country, an adverse ruling in one country might negatively impact our ability to enforce the corresponding or related patent in other countries. Finally, certain of our customer contracts may contain provisions that require us to defend and/or indemnify our customers for third party intellectual property infringement claims, which would increase the cost to us of an adverse ruling in such a claim. An adverse determination could also negatively impact our ability to license certain of our technologies and methods to others, and result in our competitors being allowed to sell products with, or add to their products, features and benefits contained in our products, thereby reducing our competitive advantages over these competing products.
Capital market conditions may reduce our ability to fund our operations.
Capital market conditions have fluctuated widely over the past five years.Market conditions dictate to a high degree the terms applied to our funding efforts. Difficult market conditions result in increased financing costs and decreased net return on our funding efforts, and can result in an inability to obtain funding in the short or even the long term.If we are unable to obtain equity or debt financing on terms that are favorable to us, it could have a material impact on our results of operations, ability to engage in business development and even our ability to continue as a going concern.
Any acquisitions we make may require the issuance of a significant amount of equity or debt securities and may not be scientifically or commercially successful.
As part of our business strategy, we may effect acquisitions to obtain additional businesses, product- and/or process technologies, capabilities and personnel. If we make one or more significant acquisitions in which the consideration includes securities, we may be required to issue a substantial amount of equity, debt, convertible or other securities. Such an issuance could dilute your investment in DNX common stock or increase our interest expense and other expenses.
Further, acquisitions involve a number of operational risks, such as:
Any one of these risks could prevent an acquisition from being scientifically or commercially successful, which could have a material impact on our results of operations not only with respect to the operations of the acquired company but with respect to DNX on a consolidated basis.
We are subject to the risks associated with doing business abroad, where business climates can be unprofitable, unpredictable or even hostile.
The Company has technical collaborations with overseas entities and may conduct operations in other foreign countries in the future, where it may face business climates that are unprofitable, unpredictable and/or hostile.Among the risks of doing business abroad are the following:
Additionally, “Rule of Law”, foreign ownership, patent regulation, business and tax laws, and medical regulation can vary substantially and change quickly, adversely affecting projects and enterprises planned in these countries. We may not be able to continue to operate in compliance with applicable customs, currency exchange control regulations, transfer pricing regulations or any other laws or regulations to which we may be subject.
We are subject to risks relating to currencies.
If we have a portion of our business in foreign countries, the Company faces risks inherent in foreign exchange. This may also cause the Company to face a more complicated procedure in foreign exchange payment to foreign creditors under the current account items and thus will affect the restrictions on borrowing through international commercial loans, creation of foreign security and borrowing through foreign loans under guarantees in foreign currencies. Any fluctuations in the exchange rate of USD could have an adverse effect on the operational and financial conditions of the Company.
Risks Related to Our Common Stock
We have a limited operating history and have incurred operating losses since our inception. We expect to continue to incur losses in the future.
We have a limited operating history. You should consider our prospects in light of the risks and difficulties frequently encountered by early stage companies. In addition, we have incurred operating losses since entering the biopharmaceuticals and biotech market and we expect to continue to incur operating losses for the foreseeable future. As we continue our research and development efforts, we will incur increasing losses. We may continue to incur substantial operating losses even if we begin to generate revenues from our drug candidates and/or income from any services that we may offer.
Our ability to achieve profitability depends on a number of factors, including our ability to complete the development efforts for our drugs on a timely basis and the ability to obtain regulatory approval for our drug candidates.
Convertible debentures and equity compensation may substantially depress the price of our common stock.
In the past, we have raised funds and compensated employees and consultants through the issuance of convertible debentures and common shares, and we will likely continue to do so for the foreseeable future.The conversion of debentures into common shares and issuances of common shares as compensation or for any other reason will dilute your ownership of DNX.
Our common stock may be considered a “penny stock.”
The SEC has adopted regulations which generally define “penny stock” to be an equity security that has a market price of less than $5.00 per share, subject to specific exemptions.The market price for our common stock has been well below $5.00 per share for several years, and so long as our stock trades for less than $5.00 per share, it will be considered a “penny stock” according to SEC rules.This designation requires any broker or dealer selling these securities to disclose certain information concerning the transaction, obtain a written agreement from the purchaser and determine that the purchaser is reasonably suitable to purchase the securities.These rules may restrict the ability of brokers or dealers to sell our common stock and may affect the ability of investors to sell their shares.
We do not intend to pay any cash dividends on our stock.
We do not anticipate paying any cash dividends on our stock in the foreseeable future. The payment of cash dividends depends on our future earnings, financial condition and other business and economic factors that our board of directors may consider relevant.
Risks Related To Product Development
We may not receive royalty or milestone revenue under our collaboration agreements for several years, or at all.
Much of our current revenue is non-recurring in nature and unpredictable as to timing and amount. Our out-license and collaboration agreements provide for royalties on sales of products generated by our clients. However, because our contracted drug development candidates are often at early stages of development, and drug development entails a high risk of failure, we do not expect to receive any royalty revenue for several years, if at all. For the same reasons, we may never realize much of the milestone revenue provided for in our out-license and collaboration agreements.
Our potential collaborators may choose not to commercialize a drug candidate at any time during development, which would also reduce or eliminate our potential return on investment for that drug.
Our potential collaborators may have substantial control and discretion over the timing and the continued development and marketing of the drug candidates we develop for them. Our collaborators may decide to postpone the release of a drug candidate, even indefinitely, which could negatively impact our revenues and liquidities.
We rely on a small number of collaborators, therefore the termination of a significant agreement or relationship could have a material impact on our results of operations.
We rely on a small number of clients and collaborators for a significant portion of our revenue. If one or more of our major clients or collaborators terminates, fails to renew or reduces the scope of its agreement with us our revenue may significantly decrease.
We rely on third parties to manufacture and analytically test our products. If these third parties do not successfully manufacture and test our clients’ products, our business will be harmed.
We have limited capacity to manufacture products for clinical or commercial purposes. We intend to continue, in whole or in part, to use third parties to manufacture and analytically test our products for use in clinical trials and for future sales. We may not be able to enter into future contract agreements with these third parties on terms acceptable to us, if at all.
Our collaborators depend upon our ability to develop and manufacture their products at appropriate scales and at a competitive cost, and in accordance with current Good Manufacturing Practices, or cGMP, and other regulatory requirements, including requirements from federal and state environmental and safety regulatory agencies. Prior to such approvals, we will need to conduct validation studies that the FDA must review and approve. Significant scale-up of manufacturing may result in unanticipated technical challenges and may require additional validation studies that the FDA must review and approve. Contract manufacturers often encounter difficulties in scaling up production, including problems involving raw material supplies, production yields, scaled-up product characteristics, quality control and assurance, shortage of qualified personnel, compliance with FDA and foreign regulations, production costs and development of advanced manufacturing techniques and process controls. Any of these difficulties, if they occur, and are not overcome to the satisfaction of the FDA or other regulatory agency, could lead to significant delays and possibly the termination of the development program for any of our clients’ drug candidates. These risks can potentially become more acute as we scale up for commercial quantities, if for example, a reliable source of raw material supplies becomes critical to the commercial scale operation.
Third-party manufacturers to us may not perform as agreed or may not remain in the contract manufacturing business for the time required by us to successfully complete our drug development program. In addition, our third-party contract manufacturers along with us will be subject to ongoing periodic and unannounced inspections by the FDA and corresponding foreign governmental agencies to ensure strict compliance with cGMP, as well as other governmental regulations and corresponding foreign standards. While we would periodically audit our own sub-contractors for adherence to regulatory requirements, we cannot assure you that unforeseen changes at these contractors may occur that change their regulatory standing. The same issues apply to contract analytical services which we use for testing of our clients’ products. We will not have direct control over them, other than by contract and periodic oversight, third-party manufacturers' compliance with these regulations and standards.
If we do not establish or maintain manufacturing and drug development arrangements with third parties, we may be unable to fully develop our drug products.
We do not as yet possess the production capacity to fully develop and manufacture our drug products on our own. From time to time, we may need to contract with third parties to:
We can provide no assurance that we will be able to successfully enter into agreements with such third parties on terms that are acceptable to us, or our collaborators, if at all. If we are unable to successfully contract with third parties for these services when needed, or if existing arrangements for these services are terminated, whether or not through our actions, or if such third parties do not fully perform under these arrangements, we may have to delay, scale back or end one or more of our clients’ drug development programs, which could result in loss of revenues. Furthermore, such failure could result in the termination of license rights to one or more of our product- and/or process technologies. If these manufacturing and development agreements take the form of a partnership or strategic alliance, such arrangements may provide our collaborators with significant discretion in determining the efforts and resources that they will apply to the development and commercialization of our clients’ products. Accordingly, to the extent that we rely on third parties to research, develop or commercialize our clients’ products, we are unable to control whether such products will be scientifically or commercially successful. Additionally, if these third parties fail to perform their obligations under our agreements with them or fail to perform their work in a satisfactory manner, in spite of our efforts to monitor and ensure the quality of such work, we may face delays in achieving the regulatory milestones required for commercialization of one or more of our drug candidates.
If, in the future, the market conditions for raising capital deteriorate, we may be forced to rely predominantly or entirely on our ability to contract with third parties to satisfy our needs for manufacturing and drug development. If we are unable to contract with such third parties, we may be forced to limit or suspend or terminate the development of some or all of our product candidates.
Our reliance on third parties, such as clinical research organizations, or CROs, may result in delays in completing, or a failure to complete, clinical trials if such CROs fail to perform under our agreements with them.
In the course of product development for our clients, we may engage CROs to conduct and manage clinical studies and to assist us in guiding our clients’ products through the FDA review and approval process. If the CROs fail to perform their obligations under our agreements with them or fail to perform clinical trials in a satisfactory manner, our clients may face significant delays in completing their clinical trials, as well as commercialization of one or more of their drug candidates. Furthermore, any loss or delay in obtaining contracts with such entities may also delay the completion of our own product development programs or for those of our collaborators.
If we are unable to identify and enter into agreements with business partners who possess adequate sales, marketing or distribution capabilities for their products, the products will not be commercialized effectively, which would reduce or eliminate our potential return on investment onthat client’s particular drug development program.
In the event that one or more of our business partners’ drug candidates are approved by the FDA, we will rely upon them to market, sell and distribute the drug in order to continue the manufacturing contract with us. Because we will rely upon business partners to market, sell and distribute products that we assist them in manufacturing, some or all of the revenues we receive will depend to some extent upon their efforts, and those efforts may be unsuccessful.
Pre-clinical testing and clinical development are long, expensive and uncertain processes. If our drug candidates do not receive the necessary regulatory approvals, we will be unable to produce our drug candidates.
Pre-clinical testing and clinical development are long, expensive and uncertain processes. Satisfaction of regulatory requirements typically depends on the nature, complexity and novelty of the product. It requires the expenditure of substantial resources. Data obtained from pre-clinical and clinical tests can be interpreted in different ways, which could delay, limit or prevent regulatory approval. The FDA, or regulatory authority of another country as applicable, may pose additional questions or request further clinical substantiation. It may take our collaborators many years to complete the testing of their drug candidates and failure can occur at any stage of this process. Negative or inconclusive results or medical events during a pre-clinical or clinical trial could cause them to delay or terminate the development efforts.
Clinical trials have a high risk of failure. A number of companies in the pharmaceutical industry, including biotechnology companies, have suffered significant setbacks in advanced clinical trials, even after achieving what appeared to be promising results in earlier trials. If our clients experience delays in the testing or approval process or if they need to perform more or larger clinical trials than originally planned, our financial results and the manufacturing prospects for our drug candidates may be materially impaired. Although we may engage, from time to time, clinical research organizations with experience in conducting regulatory trials for our collaborators, errors in the conduct, monitoring and/or auditing could potentially invalidate the results.
Even if FDA approval is obtained to market our drug products, if they fail to achieve market acceptance, we may never record meaningful revenues.
Even if our drug candidates are approved for sale, they may not be commercially successful in the marketplace. Market acceptance of their drug products will depend on a number of factors, including:
Because we expect sales of our collaborators, if approved, to generate substantially all of our revenues in the long-term, their failure to find market acceptance would harm our business and could require us to seek additional financing or other sources of revenue.
If our collaborators are unable to successfully complete their clinical trial programs, or if such clinical trials take longer to complete than is projected, our ability to execute our current business strategy will be adversely affected.
Whether or not and how quickly our collaborators complete clinical trials is dependent in part upon the rate at which they are able to engage clinical trial sites and, thereafter, the rate of enrollment of patients, and the rate at which they will collect, clean, lock and analyze the clinical trial database. Patient enrollment is a function of many factors, including the size of the patient population, the proximity of patients to clinical sites, the eligibility criteria for the study, the existence of competitive clinical trials, and whether existing or new drugs are approved for the indication we are studying. We are aware that other companies are currently conducting or planning clinical trials that seek to enroll patients with the same diseases that we are studying. Certain clinical trials are designed to continue until a pre-determined number of events have occurred in the patients enrolled. Trials such as this are subject to delays stemming from patient withdrawal and from lower than expected event rates. They may also incur additional costs if enrollment is increased in order to achieve the desired number of events. If our collaborators experience delays in identifying and contracting with sites and/or in patient enrollment in their clinical trial programs, we may incur additional costs and delays in our development and manufacturing programs. In addition, conducting multinational studies adds another level of complexity and risk. We are subject to events affecting countries outside the U.S. Negative or inconclusive results from the clinical trials, or unanticipated adverse medical events could cause our collaborators to repeat or terminate the clinical trials, thereby affecting our revenues.
Risks Related To Our Business and Industry – Competition
If our collaborators competitors develop and market products that are less expensive, more effective or safer than our development efforts are able to produce, our commercial opportunities may be reduced or eliminated.
Biopharmaceuticals development carries the inherent risk that more than one product can meet the requirements to treat or cure illnesses. Any one of our competitors may develop and market products that better meet the market demand for a product we are developing for our collaborators.There are numerous reasons why a competitor’s product would better meet market demand, such as being less expensive, more effective or safer. The inability to develop competitive products would have a material adverse effect on our results of operations.
If we lose our key personnel, or are unable to attract and retain additional personnel, our operations could be disrupted and our business could be harmed.
To successfully develop our business, we must be able to attract and retain highly skilled personnel. We may not be able to recruit and retain the highly skilled and experienced scientists and management we need to compete in the drug research and development and manufacturing industry. Our limited resources may hinder our efforts to attract and retain such highly skilled personnel. In addition, if we lose the services of our current personnel, in particular, Rajiv Datar, our Chief Executive Officer, our ability to continue to execute on our business plan could be materially impaired.
Risks Related To Our Business and Industry – Intellectual Property and Technology
Because our proprietary technology is licensed to us by a third party, termination of this license agreement could impact our revenues.
We have licensed the rights, patent or otherwise, from third parties, to develop and make our drug candidates. These license agreements require us to meet development milestones and impose development and commercialization due diligence requirements on us. In addition, under these agreements, we must pay royalties on sales of products resulting from such licensed technologies and pay the patent filing, prosecution and maintenance costs related to the licenses. If we do not meet our obligations in a timely manner or if we otherwise breach the terms of our license agreements, our licensors could terminate the agreements, and we would lose the rights to our drug candidates. From time to time, we may have disagreements with our licensors or collaborators, or they and/or we may have disagreements with the original inventors, regarding the terms of our agreements or ownership of proprietary rights, which could lead to delays in the research, development and commercialization of such drug candidates, could require or result in litigation or arbitration, which would be time-consuming and expensive, or could lead to the termination of a license, or force us to negotiate a revised or new license agreement on terms less favorable than the original.
Technology and other aspects of the biopharmaceuticals industry are rapidly changing, and our results of operations will be adversely affected if we are unable to quickly identify and adapt to those changes.
The Company is principally engaged in the rapidly growing and developing field of Life Sciences and Biotechnology. New and improved process- and manufacturing technologies and drugs are constantly being discovered and developed. There is no guarantee that the Company will be able to keep abreast of the latest development and stay ahead of its competition. In the event that the Company fails to do so, its competitiveness and profitability may be adversely affected.
The intellectual property that we own or have licensed relating to our product candidates is limited, which could adversely affect our ability to compete in the market and adversely affect the value of our product candidates.
The patent rights that we own or have licensed relating to our product candidates are limited in ways that may affect our ability to exclude third parties from competing against us if we obtain regulatory approval to market these product candidates.
Litigation or third-party claims could require us to spend substantial time and money defending such claims and adversely affect our ability to develop and commercialize our clients’ products.
We may be forced to initiate litigation to enforce our contractual and intellectual property rights, or we may be sued by third parties asserting claims based on contract, tort or intellectual property infringement. In addition, third parties may have or may obtain patents in the future and claim that our drug products or technologies infringe their patents. If we are required to defend against suits brought by third parties, or if we sue third parties to protect our rights, we may be required to pay substantial litigation costs, and our management's attention may be diverted from operating our business. In addition, any legal action against our licensors or us that seeks damages or an injunction of our commercial activities relating to our drug products or technologies could subject us to monetary liability and require our licensors or us to obtain a license to continue to use our drug products or technologies. We cannot predict whether our licensors or we would prevail in any of these types of actions or that any required license would be made available on commercially acceptable terms, if at all.
Risks Related To Our Business and Industry – Government Regulation and Legal Liability
The biopharmaceuticals and biotech industry is heavily regulated and controls we have in place may not be effective to ensure compliance with all applicable laws and regulations.
The Company intends to develop and to sell products that are heavily regulated and there cannot be any assurances that problems will not arise with regards to the safety and deemed viability of any of its bio-technical products.The development, testing, manufacturing, pricing, marketing, sales, and reimbursement of our clients’ products, together with our general operations, are subject to extensive regulation by federal, state and other authorities within the U.S. and numerous entities outside of the U.S. We also have significantly fewer employees thanother companies that have a similar services offering, and we rely heavily on third parties to conduct many important functions. While we believe that our corporate compliance program is sufficient to ensure compliance with applicable regulations, we cannot assure you that we are or will be in compliance with all potentially applicable regulations. Government regulations are very extensive in this industry and new or amended regulations that may alter our practice and procedures requirements could be overlooked resulting in increased liability risks. If we fail to comply with any of these regulations we could be subject to a range of regulatory actions, which could include the suspension or termination of our clients’ clinical trials, the failure to approve a client’s product candidate, restrictions on our products or manufacturing processes, withdrawal of products from the market, significant fines, or other sanctions or litigation.
The status of reimbursement from third-party payors for newly approved health care drugs is uncertain and failure to obtain adequate reimbursement could limit our ability to generate revenue.
Our collaborators’ ability to commercialize pharmaceutical products may depend, in part, on the extent to which reimbursement for the products will be available from:
Significant uncertainty exists as to the reimbursement status of newly approved health care products. Third-party payors, including Medicare, are challenging the prices charged for medical products and services. Government and other third-party payors increasingly are attempting to contain health care costs by limiting both coverage and the level of reimbursement for new drugs and by refusing, in some cases, to provide coverage for uses of approved products for disease indications for which the FDA has not granted labeling approval. Third-party insurance coverage may not be available to patients for our clients’ products. If government and other third-party payors do not provide adequate coverage and reimbursement levels for our clients’ products, their market acceptance may be reduced.
Health care reform measures could adversely affect our business.
The business prospects and financial condition of pharmaceutical and biotechnology companies are affected by the efforts of governmental and third-party payors to contain or reduce the costs of health care. In the U.S. and in foreign jurisdictions there have been, and we expect that there will continue to be, a number of legislative and regulatory proposals aimed at changing the health care system, such as proposals relating to the pricing of healthcare products and services in the U.S. or internationally, the reimportation of drugs into the U.S. from other countries (where they are then sold at a lower price), and the amount of reimbursement available from governmental agencies or other third party payors. In the U.S., health care reform legislation titled the Patient Protection and Affordable Care Act and the Reconciliation Act was signed into law on March 23, 2010. This comprehensive legislation will affect the terms of public and private health insurance and have a substantial impact on the pharmaceutical industry. For example, the new law will impose an annual fee on manufacturers of branded prescription pharmaceuticals that will impact our clients’ products. Regulations to implement this and other provisions related to the research, marketing and sale of such prescription pharmaceutical products could result in a decrease in our stock price or limit our ability to raise capital or to obtain strategic partnerships or licenses. Government-financed comparative efficacy research could also result in new practice guidelines, labeling or reimbursement policies that discourages use of our products.
On September 27, 2007, the Food and Drug Administration Amendments Act of 2007 was enacted, giving the FDA enhanced post-market authority, including the authority to require post-marketing studies and clinical trials, labeling changes based on new safety information, and compliance with risk evaluations and mitigation strategies approved by the FDA. The FDA's exercise of this authority may result in delays or increased costs during the period of product development, clinical trials and regulatory review and approval, which may also increase costs related to complying with new post-approval regulatory requirements, and increase potential FDA restrictions on the sale or distribution of approved products.
We face product liability risks and may not be able to obtain adequate insurance.
The use of drug candidates manufactured by us for ourselves or our collaborators in their clinical trials, and the future sale of any approved drug candidates and new technologies, exposes us to product liability claims and related claims. Although we are not aware of any historical or anticipated product liability claims against us, if we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to cease manufacturing of our clients’ drug candidates or limit commercialization of any approved products.
We intend to expand our insurance coverage to include the commercial sale of any approved products if marketing approval is obtained; however, insurance coverage is becoming increasingly expensive. We may not be able to maintain insurance coverage at a reasonable cost. We also may not be able to obtain additional insurance coverage that will be adequate to cover product liability risks that may arise. Regardless of merit or eventual outcome, product liability claims may result in:
●decreased demand for a product;
●injury to our reputation;
●our inability to continue to develop a drug candidate;
●withdrawal of clinical trial volunteers; and
●loss of revenues.
Consequently, a product liability claim or product recall may result in losses that could be material.
If the Company is not successful in completing the development and commercialization of its technology, expanding its business then the purchaser of the Company’s Common Stock could lose all or substantially all of their investment.
NO REPRESENTATIONS OR WARRANTIES OF ANY KIND WITH RESPECT TO THE ECONOMIC RETURN OR THE TAX TREATMENT, WHICH MAY ACCRUE TO THE SUBSCRIBERS BY REASON OF A PURCHASE OF THE OFFERING, ARE MADE OR INTENDED AND NONE SHOULD BE INFERRED.
Inadequacy of Funds
Gross offering proceeds of a maximum of $30,000,000 may be realized. Management believes that such proceeds will capitalize and sustain the Company sufficiently to allow for the implementation of the Company’s business plan; however, this cannot be assured. If only a fraction of this Offering is sold, or if certain assumptions contained in management’s business plans prove to be incorrect, the Company may have inadequate funds to develop its business fully.
Risks of Borrowing
Although the Company does not intend to incur any additional debt from the investment commitments provided in this Offering and to the contrary intends to gradually extinguish any existing debt, should the Company fail to eliminate its existing debt or need to obtain secure bank debt in the future, possible risks could arise. If the Company incurs additional indebtedness, a portion of the Company’s cash-flow will have to be dedicated to the payment of principal and interest on such new indebtedness. Typical loan agreements also might contain restrictive covenants, which may impair the Company’s operating flexibility. Such loan agreements would also provide for default under certain circumstances, such as failure to meet certain financial covenants. A default under a loan agreement could result in the loan becoming immediately due and payable and, if unpaid, a judgment in favor of such lender which would be senior to the rights of members of the Company. A judgment creditor would have the right to foreclose on any of the Company’s assets resulting in a material adverse effect on the Company’s business, operating results or financial condition.
Unanticipated Obstacles to Execution of the Business Plan
The Company’s business plans may change significantly. Many of the Company’s potential business endeavors are capital intensive and are subject to statutory or regulatory requirements. Management believes that the Company’s chosen activities and strategies are achievable in light of current economic and legal conditions with the skills, background, and knowledge of the Company’s principals and advisors. Management reserves the right to make significant modifications to the Company’s stated strategies depending on future events.
Management Discretion as to Use of Proceeds
The net proceeds from this Offering will be used for the purposes described under “Use of Proceeds.” The Company reserves the right to use the funds obtained from this Offering for other similar purposes not presently contemplated which it deems to be in the best interests of the Company and its shareholders in order to address changed circumstances or opportunities. Because of the foregoing, the success of the Company will be substantially dependent upon the discretion and judgment of the Company’s management with respect to application and allocation of the net proceeds of this Offering. Investors for the Shares offered hereby will be entrusting their funds to the Company’s management, upon whose judgment and discretion the investors must depend.
Minimum Amount of Capital to be Raised
There is no minimum amount of Securities that need to be sold in this Offering for it to become effective (other than the 1,000 minimum number of Shares or even lots of 1,000 shares to be purchased by any investor) or for the Company to access the investment funds. All investor funds will be transferred from the transfer agent’s investment holding escrow account to the Company immediately upon the Company’s request after stock issuance or at regular intervals (e.g., weekly). The Company cannot assure you that subscriptions for the entire Offering will be obtained. The Company has the right to terminate this Offering at any time, regardless of the number of Shares that have sold. The Company’s ability to meet financial obligations, cash needs, and to achieve objectives, could be adversely affected if the entire offering of Shares is not fully subscribed.
Control by Management
As of November 21, 2019, our key executive officers owned approximately 88% of our outstanding common stock. Upon completion of this Offering, if all of the Shares are sold, our executive officers will own approximately 67% of our outstanding common stock and thus will have the ability to elect our directors. Shareholders will have not have the ability to control the Company’s operations.
The Company’s Continuity as a Going Concern Depends Upon Financing
If the Company does not raise sufficient working capital and continues to experience pre-operating losses, there will most likely be substantial doubt as to its ability to continue as a going concern. Because the Company has generated no revenue, all expenditures during the development stage have been recorded as pre-operating losses. Revenue operations have not commenced because the Company has not raised the necessary capital.
Broker-Dealer Sales of Shares
The Shares are not included for trading on any exchange, and there can be no assurances that the Company will ultimately be registered on any exchange. It is the requirement by all U.S. exchanges and certain quotation systems that a company be a reporting company with the Securities and Exchange Commission to be eligible for listing or quotation by market makers. The Company is not and will not be a reporting company with the SEC in connection with this Offering.
The NASDAQ Stock Market, Inc. has recently enacted certain changes to the entry and maintenance criteria for listing eligibility on the NASDAQ Capital Market. The entry standards require at least $4 million in net tangible assets or $750,000 net income in two of the last three years. The proposed entry standards would also require a public float of at least 1 million shares, $5 million value of public float, a minimum bid price of $2.00 per share, at least three market makers, and at least 300 shareholders. The maintenance standards (as opposed to entry standards) require at least $2 million in net tangible assets or $500,000 in net income in two of the last three years, a public float of at least 500,000 shares, a $1 million market value of public float, a minimum bid price of $1.00 per share, at least two market makers, and at least 300 shareholders.
No assurance can be given that the Shares or any of the common stock of the Company will ever qualify for inclusion on the NASDAQ System or any other trading market. As a result, the common stock (including the Shares) are covered by a Securities and Exchange Commission rule that imposes additional sales practice requirements on broker-dealers who sell such securities to persons other than established customers and qualified investors. For transactions covered by the rule, the broker-dealer must make a special suitability determination for the purchaser and receive the purchaser’s written agreement to the transaction prior to the sale. Consequently, the rule may affect the ability of broker-dealers to sell the Company’s securities and will affect the ability of members to sell their Shares in the secondary market.
No application is currently being prepared for the Company’s securities to be admitted to the Official Listing and trading on any regulated market. No application is being prepared to include the Company’s securities to trading on an “Over-the-Counter” or “Open Market”, though the Company intends to apply for OTC-QB listing within twelve months of the close of this Offering. There can be no assurance that a liquid market for the Shares will develop or, if it does develop, that it will continue. If a market does develop, it may not be liquid. Therefore, investors may not be able to sell their Shares easily or at prices that will provide them with yield comparable to similar investments that have a developed secondary market. Illiquidity may have a severely adverse effect on the market value of the Shares and investors wishing to sell the Shares might therefore suffer losses.
Certain Factors Related to Our Common Stock
The Company’s common stock may be considered a “penny stock,” and a shareholder may have difficulty selling shares in the secondary trading market.
The Company’s common stock may be subject to certain rules and regulations relating to “penny stock” (generally defined as any equity security that has a price less than $5.00 per share, subject to certain exemptions). Broker-dealers who sell penny stocks are subject to certain “sales practice requirements” for sales in certain nonexempt transactions (i.e., sales to persons other than established customers and institutional “qualified investors”), including requiring delivery of a risk disclosure document relating to the penny stock market and monthly statements disclosing recent price information for the penny stocks held in the account, and certain other restrictions. For as long as the Company’s common stock is subject to the rules on penny stocks, the market liquidity for such securities could be significantly limited. This lack of liquidity may also make it more difficult for the Company to raise capital in the future through sales of equity in the public or private markets.
The price of the Company’s common stock may be volatile, and a shareholder’s investment in the Company’s common stock could suffer a decline in value.
There could be significant volatility in the volume and market price of the Company’s common stock, and this volatility may continue in the future. The Company’s common stock may be quoted on the OTCQB, OTCQX, OTC Pink, the Bermuda BSX Exchange, the London Stock Exchange’s AIM Market, the Canadian TSX Venture Exchange or TMX Exchange, the Irish Stock Exchange, the Frankfurt Stock Exchange and/or the Berlin Stock Exchange, where each has a greater chance for market volatility for securities that trade on these markets as opposed to a national exchange or quotation system. This volatility may be caused by a variety of factors, including the lack of readily available quotations, the absence of consistent administrative supervision of “bid” and “ask” quotations and generally lower trading volume. In addition, factors such as quarterly variations in our operating results, changes in financial estimates by securities analysts or our failure to meet our or their projected financial and operating results, litigation involving us, general trends relating to liposuction and bariatric surgery, the medical device and technology industry, actions by governmental agencies, national economic and stock market considerations as well as other events and circumstances beyond our control could have a significant impact on the future market price of our common stock and the relative volatility of such market price.
Compliance with Securities Laws
The Shares are being offered for sale in reliance upon certain exemptions from the registration requirements of the Securities Act, applicable Florida and New York Securities Laws, and other applicable state securities laws. If the sale of Shares were to fail to qualify for these exemptions, purchasers may seek rescission of their purchases of the Shares. If a number of purchasers were to obtain rescission, we would face significant financial demands, which could adversely affect the Company as a whole, as well as any non-rescinding purchasers.
The price of the Shares has been arbitrarily established by our current management, considering such matters as the state of the Company’s business development, intellectual property, and the general condition of the industry in which it operates. The Offering price bears little relationship to the assets or net worth of the Company, or any other objective criteria.
Lack of Firm Underwriter
The Shares are being offered on a “best efforts” basis by the management of the Company and any FINRA-registered broker dealer who subsequently may choose to assist in sale of the Offering. Accordingly, there is no assurance that the management of the Company or any FINRA-registered broker-dealer that may be engaged in the future will sell the maximum number of Shares offered in the Offering, or any lesser amount.
Projections: Forward Looking Information
Management has prepared projections regarding anticipated financial performance. The Company’s projections are hypothetical and based upon a presumed financial performance of the Company, the addition of a sophisticated and well-funded marketing plan, and other factors influencing the business. The projections are based on management’s best estimate of the probable results of operations of the Company and the investments made by management, based on present circumstances, and have not been reviewed by independent accountants and/or auditing counsel. These projections are based on several assumptions, set forth therein, which management believes are reasonable. Some assumptions, upon which the projections are based, however, invariably will not materialize due the inevitable occurrence of unanticipated events and circumstances beyond management’s control. Therefore, actual results of operations will vary from the projections, and such variances may be material. Assumptions regarding future changes in sales and revenues are necessarily speculative in nature. In addition, projections do not and cannot take into account such factors as general economic conditions, unforeseen regulatory changes, the entry into a market of additional competitors, the terms and conditions of future capitalization, and other risks inherent to the Company’s business. While management believes that the projections accurately reflect possible future