Patented technology that makes fighting disease simpler, faster and cheaper.

Biopact Cellular Transport

Now Accepting Investors

**Limited availability

Offering Type

Regulation CF

Price per share

$1.55

Valuation

$30 million

Minimum

$465

OFFERING TYPE: Regulation CF

PRICE PER SHARE: $1.55

VALUATION: $30 million

MINIMUM INVESTMENT: $465

This Stunning Medical Breakthrough Could Radically Change How Diseases Are Fought in the 21st Century.
Biopact CT's intracellular delivery technology transports cutting-edge gene-editing technologies into the cell more safely, effectively, and affordably than anything on the market today...
Dozens of patents protect the underlying technology, making this one of the most potentially lucrative med-tech investments you could make in your lifetime.

INVESTMENT HIGHLIGHTS:

     INVESTMENT HIGHLIGHTS:

Founded by former Dow Chemical VP, who was responsible for generating over $30 billion worth of value for Dow and built its largest profit generator.
Pioneering a patented intracellular technology that reduces the cost of new cancer-fighting therapies like CAR-T by up to 50% — cutting prices by hundreds of thousands of dollars and enabling more patients to access these highly promising (and potentially life-saving) treatments.
Has the potential to dramatically decrease the development time of next generation cellular therapies, getting them into the hands of patients faster.
Major market opportunity. This technology has the potential to be instrumental in helping cell-based therapies fight many diseases including cancer, diabetes, osteoporosis, and more.
Biopact CT’s technological breakthrough could open the doors to today’s most promising cellular medicines for millions of individuals who otherwise couldn’t afford advanced life-saving treatments.
This is your rare opportunity to get in on a potentially revolutionary medical advancement.

investor presentation

     investor presentation

biopact and the next-generation of medicine:

     biopact and the next-generation of medicine:

Chemotherapy. Radiation. Even Antibiotics…
Today’s most powerful medicines are indiscriminately destructive, damaging both healthy and diseased tissues. What’s worse, side effects often cause even more suffering… all the while compromising an already taxed immune system (with no guarantee of success).
But thanks to new advancements, these forms of treatment could soon be a thing of the past.
The Next Generation Of Medicine Is Here
And it fights disease at the cellular level
New Technologies Have Unlocked The Ability To Genetically Engineer Our Own Cells To Potentially Do Everything From Destroying Tumors To Repairing Tissues.
New technologies have unlocked the ability to genetically engineer our own cells to potentially do everything from destroying tumors to repairing tissues.

Two of the most notable advancements include:
Two of the most notable advancements include:
1) CRISPR and TALEN: these genetic editing tools allow researchers to easily modify gene function. They are the world’s most powerful tools for editing genomes and will play a key role in engineering cells to treat disease.
2) CAR-T Therapy: the greatest advancement in the fight against cancer in over a generation, CAR-T involves genetically altering a patient’s own T-cells (a type of immune system cell) so they can seek out and attack specific cancer cells.
CRISPR May Be The Most Consequential Discovery In Biomedicine This Century
“There are about 6,000 or more diseases that are caused by faulty genes. The hope is that we will be able to address most if not all of them.”
– CBS News 60 Minutes

     a major problem for the industry:

a major problem for the industry:

Next-Generation Technologies Like CRISPR, TALEN and CAR-T Hold Tremendous Promise…
But for cell therapy technologies to work, they need an effective delivery mechanism to transport specialized molecular cargo across fragile cell membranes — and this is a MAJOR problem.
Current intracellular delivery tools include using custom-made viruses, harsh detergents, strong zaps of electricity, and liposomes – all of which are known to damage the cell. In fact, some even cause such severe toxicity… they kill it.
Viral delivery methods also cause mutations.
Mutations happen when the virus delivers its genetic payload into the wrong DNA sequence. Side effects from viral-delivered genetic mutations are severe and can result in cell death.
CRISPR’s Breakthrough Problem
If the CRISPR gene editing system is to live up to its disease-curing potential, researchers must devise a plan to deliver it into the body.
In fewer than five years, a gene-editing technology known as CRISPR has revolutionized research. Now, many are wondering if it can do the same for medicine. Several companies are hoping to commercialize CRISPR-based therapies that could potentially offer a permanent fix for a vast array of genetic diseases. But there’s a catch: Getting CRISPR into the body, across cell membranes, and into human DNA is no simple feat.

     biopact's breakthrough:

biopact's breakthrough:

Biopact’s Technology Can Transport Molecules Into The Cell More Safely And More Effectively Than Any Other Delivery Mechanism.
Biopact has developed a breakthrough intracellular delivery vehicle called MGMR. MGMR can transport next-generation cellular medicines more safely, and effectively than anything available today. Its unique composition is a major reason why this is possible.
MGMR has an ultra high surface-to-volume ratio that enables it to carry molecules other delivery methods cannot, including gene-editing materials, drugs, and enzymes.
Biopact has developed a breakthrough intracellular delivery vehicle called MGMR. MGMR can transport next-generation cellular medicines more safely, and effectively than anything available today. Its unique composition is a major reason why this is possible.
MGMR has an ultra high surface-to-volume ratio that enables it to carry molecules other delivery methods cannot, including gene-editing materials, drugs, and enzymes.
Learn more about how MGMR works and it’s potential impact the Cancer market here.
MGMR is a universal transport system. Unlike other delivery vehicles, it is not cargo- or treatment-specific. It can effectively deliver a variety of treatments to different cell types.
MGMR Is The Ultimate “Molecular Shuttle” For Delivering Next- Generation Technologies Like TALEN And CRISPR Into The Cell.
Its nanoscale size and unique architecture allow it to serve as an ideal “molecular shuttle” for carrying specialized molecules like drugs, DNA, and enzymes across cells’ outer protective membrane. It can even transport proteins which are known to be very sensitive, easily diminished, and do not efficiently cross membranes.
(click to enlarge)
MGMR also does NOT cause damage or toxicity to the cell like other delivery methods (i.e. viruses and electricity). It migrates into the cell via a natural transport process called endocytosis and releases its medicine payload using diffusion.
Its nanoscale size and unique architecture allow it to serve as an ideal “molecular shuttle” for carrying specialized molecules like drugs, DNA, and enzymes across cells’ outer protective membrane. It can even transport proteins which are known to be very sensitive, easily diminished, and do not efficiently cross membranes.
MGMR also does NOT cause damage or toxicity to the cell like other delivery methods (i.e. viruses and electricity). It migrates into the cell via a natural transport process called endocytosis and releases its medicine payload using diffusion.
(click to enlarge)
Learn more about how MGMR works and it’s potential impact the Cancer market here.
MGMR IS PROTECTED BY OVER 70 PATENTS:
There is nothing like MGMR on the planet. In fact, the technology is protected by 77 patents worldwide.

    cellular medicine treatments are too expensive

cellular medicine treatments are
too expensive

Cell Therapy Treatments For Devastating Diseases Like Cancer Have High Success Rates.
But these life-saving cellular therapies are often too expensive and out of reach for many people who desperately need them…
Treatment costs:
KYMRIAH
CAR-T therapy for cancer.
Price: $425,000
LUXTURNA
Cell therapy for a form of inherited vision loss. Price: $475,000
YESCARTA
CAR-T therapy for cancer. Price: $373,000
ZOLGENSMA
Cell therapy treatment for spinal muscular atrophy. Price: $2.1 million
Why Are Treatments So Costly?
  1. The initial development and testing of the underlying drug can cost hundreds of millions of dollars.
  2. The production process and quality control of the end-product is time-consuming and highly expensive.
  3. Each treatment is personalized and labor-intensive. It takes a team of doctors and a specialized lab several weeks to prepare and grow enough modified cells to transfer back into a patient for the therapy to be effective.
Gene Therapy Gets FDA Approval – And a $2 Million Price Tag
The US Food and Drug Administration approved a treatment, Zolgensma, for a genetic disease called muscular atrophy that causes infants’ muscles to waste away, potentially killing them before age 2. And then came the price tag: $2.125 million for a one-time treatment.
-Michael Nedelman, CNN

     biopact can dramatically reduce the cost
     and
development time of next-generation
     treatments

biopact can dramatically reduce the cost and development time of next-generation treatments

As a viral-free technology for intracellular delivery, MGMR could decrease treatment costs by up to 50%. It will also greatly reduce the time it takes to produce a treatment, enabling the patient to receive it faster. Here’s how…
MGMR Increases Cell Yield Manyfold
MGMR stimulates cell growth which results in significantly higher cell production, reducing manufacturing and production costs.
MGMR Increases Cell Yield Manyfold
MGMR stimulates cell growth which results in significantly higher cell production, reducing manufacturing and production costs.
Higher Quality Output
MGMR’s end-product is more consistent and has a near 100% cell survival rate (other methods are often below 50%). This reduces costs and increases production speed.
MGMR Is Universal
MGMR is a universal intracellular transport mechanism in that it can be loaded with a variety of different molecule types to help fight a variety of different diseases. As a result, the costly and time-intensive process of creating a new virus for each treatment is eliminated.
Easy To Scale
MGMR has a patented production process making it easy to produce and scale.
Add it up and the bottom line is: MGMR can get treatment to the patient CHEAPER and FASTER.

     biopact has another major advantage...

biopact has another major advantage...

Because Biopact Has Invented A Better Intracellular Delivery Mechanism, Other Drug Companies Can Use It To Transport Their Cell Engineering Technologies Into The Cell.
Biopact’s doesn’t need to spend hundreds of millions on drug research and undergo years-long trials. It simply provides a better vehicle to get the drug into the cell.
Think of it like “FedEx” for cellular delivery. FedEx doesn’t create the packages – it’s a more effective way of getting them to their destination safely and reliably.
Biopact plans to license its technology to other drug companies and will also provide MGMR to custom specifications to biopharmaceutical clients.
THE BENEFITS OF MGMR ARE UNDENIABLE.
Biopact’s groundreaking technology can carry more types of molecules and deliver them into the cell more safely, effectively, and cheaper than other mechanisms.

     there is major investment potential here

there is major investment potential here

Biopact’s MGMR Technology Can Be Used To Help Engineer Cellular Therapies For The Fight Against Disease Worldwide.
Because MGMR is not drug or disease specific, it can be used universally across the entire medical spectrum, with cancer being a top priority.
Cancer treatment represents one of the largest markets on the planet. Combined with other diseases treatable at the cellular level, Biopact’s potential market is worth hundreds of billions…

     management team

management team

Biopact’s Management Team Knows How To Deliver Shareholder Value.
Kurt Swogger
CEO + Founder
35-year veteran and former VP of Research & Development of The Dow Chemical Company. While at Dow, Kurt was directly responsible for creating products that delivered over $30 billion worth of value. He was also key in building the company’s largest profit-generating business.
Served on the board of directors for Univation, a joint venture between Dow and Exxon.
Has been honored with many distinguished awards such as the US Medal of Technology, the Corporate Innovators Award, and the American Chemical Society’s Chemical Leadership Award.
Randy Kinsel
President
Serial entrepreneur who has founded and developed several successful companies including a behavioral health agency he founded in 2002 and grew to over 100 employees with thousands of clients.
Milos Marinkovic
Director of Technology
Received doctorate degree in biomedical engineering from University of Texas San Antonio.
His work has resulted in multiple patents and publications as well as two NIH-funded grants.
Tena Jamieson
Chief Operation Officer
25 years of business management, logistics, human resources veteran.
Specializes in operations optimization for established organizations and positioning start-up companies to grow.

     5 key reasons to consider investing

5 key reasons to consider investing

Biopact CT is opening its doors to a limited number of ground- floor investors in anticipation of rapid growth in cellular medicine and demand for its cell-delivery technology.
Here Are Five Key Reasons To Consider Investing:
1) Biopact’s MGMR technology could revolutionize the next-generation of cellular medicines.
2) MGMR is one of the world’s first truly-universal intracellular delivery vehicles.
It can be loaded with gene-editing CRISPR molecules, cancer-fighting CAR-T treatments, different types of drugs, proteins and other medicinal payloads, and then delivery them safely inside the cell. As a result, MGMR is not “disease-specific” but rather can help combat many different diseases at the cellular level.
1) Biopact’s MGMR technology could revolutionize the next-generation of cellular medicines.
2) MGMR is one of the world’s first truly-universal intracellular delivery vehicles.
It can be loaded with gene-editing CRISPR molecules, cancer-fighting CAR-T treatments, different types of drugs, proteins and other medicinal payloads, and then delivery them safely inside the cell. As a result, MGMR is not “disease-specific” but rather can help combat many different diseases at the cellular level.
3) The technology is protected by 77 patents worldwide, ensuring others cannot encroach on the advantages of MGMR.
4) MGMR is far superior to other delivery mechanisms on the market today:
It doesn’t damage the cell membrane or cause toxicity like other methods.
It reduces costs of cell therapies like CAR-T by up to 50%.
And it increases the speed at which innovative cellular therapies may be developed, helping get treatments to the patient faster.
5) This is a very rare opportunity to get in on a potentially revolutionary medical advancement.

     company milestones

company milestones

  • Drug Delivery Partnerships Technology Innovation Award

  • First Use of MGMR to Delivery Proteins to Cells

  • First In Vivo Drug Delivery Study in Lymphoma Model

  • First MGMR Patent

  • First Biopharmaceutical Collaboration

  • First Discussions with CAR-T Developers

  • First Scientific Publication

    how to invest:

how to invest:

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     investment documents, risks & disclosures

investment documents, risks & disclosures

Subscription Agreement

Financials

Form C

Amendments

An investment in the Company involves a high degree of risk. You should carefully consider the risks described above and those below before deciding to purchase any securities in this offering. If any of these risks actually occurs, our business, financial condition or results of operations may suffer. As a result, you could lose part or all of your investment.
Read more
Risks Related to the Company
We have a limited operating history upon which you can evaluate our performance, and accordingly, our prospects must be considered in light of the risks that any new company encounters.
Risks Related to the Company We have a limited operating history upon which you can evaluate our performance, and accordingly, our prospects must be considered in light of the risks that any new company encounters.We were incorporated under the laws of the State of Nevada on August 28, 2019. We have limited operations and no operating revenue to date.  We are in the development stage, and our future operations are subject to all of the risks inherent in the establishment of a new business enterprise.  The likelihood of the success of our company must be considered in light of the problems, expenses, difficulties, complications and delays frequently encountered in connection with the development of an entity in the business of providing intracellular transport systems for use in delivering gene-editing chemistry, proteins, genetic materials and pharmaceutically active agents to the surface or interior of human or other cells. There can be no assurance that we will be able to generate revenues, that future revenues will be significant, that any sales will be profitable or that we will have sufficient funds available to complete our marketing and development programs or to market any new products which we may develop. We currently have operating losses, have no substantive source of operating revenue, are unable to self-finance operations, have limited resources, and there can be no assurance that we will be able to develop such revenue sources or that our operations will become profitable, even if we are able to commercialize our products and build brand awareness.
In order for the Company to compete and grow, it must attract, recruit, retain and develop the necessary personnel who have the needed experience.
Recruiting and retaining highly qualified personnel is critical to our success. These demands may require us to hire additional personnel and will require our existing management personnel to develop additional expertise. We face intense competition for personnel. The failure to attract and retain personnel or to develop such expertise could delay or halt the development and commercialization of our product candidates. If we experience difficulties in hiring and retaining personnel in key positions, we could suffer from delays in product development, loss of customers and sales and diversion of management resources, which could adversely affect operating results. Our consultants and advisors may be employed by third parties and may have commitments under consulting or advisory contracts with third parties that may limit their availability to us.
Quality management plays an essential role in determining and meeting customer requirements, preventing defects, improving the Company’s products and services and maintaining the integrity of the data that supports the safety and efficacy of our products.
Our future success depends on our ability to maintain and continuously improve our quality management program. An inability to address a quality or safety issue in an effective and timely manner may also cause negative publicity, a loss of customer confidence in us or our current or future products, which may result in the loss of sales and difficulty in successfully launching new products. In addition, a successful claim brought against us in excess of available insurance or not covered by indemnification agreements, or any claim that results in significant adverse publicity against us, could have an adverse effect on our business and our reputation.
We may 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.
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 Kurt Swogger, who is the President and CEO, and Randy Kinsel, who is the Secretary and Treasurer of the Company. The loss of Kurt Swogger and Randy Kinsel 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.
If we or our licensors are unable to obtain and maintain patent protection for our technology and products, or if the scope of the patent protection obtained is not sufficiently broad, competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully commercialize our technology and products may be impaired.
Our success depends in large part on our (or our licensor’s) ability to obtain and maintain patent and other intellectual property protection in the United States and other countries with respect to our proprietary technology and products. Our licensors’ seek to protect our proprietary position by filing patent applications in the United States and abroad related to their novel technologies and drug candidates.
The patent prosecution process is expensive and time-consuming, and our licensors may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost, in a timely manner, or in all jurisdictions. It is also possible that our licensors will fail to identify patentable aspects of our or their research and development output before it is too late to obtain patent protection. Moreover we do not have the right to control the preparation, filing and prosecution of patent applications, or to maintain the patents, covering technology that we license from third party licensors. We may also require the cooperation of our licensors in order to enforce the licensed patent rights, and such cooperation may not be provided. Therefore, these patents and applications may not be prosecuted and enforced in a manner consistent with the best interests of our business.
The patent position of biotechnology companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation. In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the United States and our licensors may fail to seek or obtain patent protection in all major markets. For example, European patent law restricts the patentability of methods of treatment of the human body more than United States law does. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Therefore, we cannot know with certainty whether our licensors were the first to make the inventions claimed in their owned patents or pending patent applications, or that our licensors were the first to file for patent protection of such inventions. As a result, the issuance, scope, validity, enforceability and commercial value of our or our licensors’ patent rights are highly uncertain. Our and our licensors’ pending and future patent applications may not result in patents being issued which protect our and our licensors’ technology or products, in whole or in part, or which effectively prevent others from commercializing competitive technologies and products. Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of our licensors’ patents or narrow the scope of our patent protection.
Recent patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents. On September 16, 2011, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, was signed into law. The Leahy-Smith Act includes a number of significant changes to United States patent law. These include provisions that affect the way patent applications are prosecuted and may also affect patent litigation. The U.S. Patent and Trademark Office, or U.S. PTO, recently developed new regulations and procedures to govern administration of the Leahy-Smith Act, and many of the substantive changes to patent law associated with the Leahy-Smith Act, and in particular, the first to file provisions, only became effective on March 16, 2013. Accordingly, it is not clear what, if any, impact the Leahy-Smith Act will have on the operation of our business. However, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business and financial condition.
The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our owned and licensed patents may be challenged in the courts or patent offices in the United States and abroad. Such challenges may result in loss of exclusivity or freedom to operate or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our technology and products. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.
We may become involved in lawsuits to protect or enforce our or our licensors’ patents or other intellectual property, which could be expensive, time- consuming and ultimately unsuccessful.
Competitors may infringe issued patents or other intellectual property that is licensed to us. To counter infringement or unauthorized use, we or our licensors may be required to file infringement claims, which can be expensive and time-consuming. Any claims we or our licensors assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we or our licensors infringe their intellectual property. In addition, in a patent infringement proceeding, a court may decide that a patent of our licensor is invalid or unenforceable, in whole or in part, construe the patent’s claims narrowly or refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. An adverse result in any litigation proceeding could put one or more of our licensed patents at risk of being invalidated or interpreted narrowly, which could adversely affect us and our collaborators.
If we fail to comply with our obligations in our intellectual property licenses with third parties, we could lose rights that are important to our business.
We are party to a key license agreement that imposes, and we may enter into additional licensing and funding arrangements with third parties that may impose, diligence, development and commercialization timelines, milestone payment, royalty, insurance and other obligations on us. Under our existing licensing agreement, we are obligated to pay royalties of revenues to the extent they are covered by the agreement. If we fail to comply with our obligations under current or future license agreements, our counterparties may have the right to terminate these agreements, in which event we might not be able to develop, manufacture or market any product that is covered by these agreements or may face other penalties under the agreements. Such an occurrence could materially adversely affect the value of drug candidates being developed using rights licensed to us under any such agreement. Termination of these agreements or reduction or elimination of our rights under these agreements may result in our having to negotiate new or reinstated agreements with less favorable terms, or cause us to lose our rights under these agreements, including our rights to important intellectual property or technology.
If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
In addition to seeking patents for some of our licensed technology, we also rely on trade secrets, including unpatented know- how, technology and other proprietary information, to maintain our competitive position. We seek to protect these trade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as our employees, corporate collaborators, outside scientific collaborators, contract manufacturers, consultants, advisors and other third parties. We also seek to enter into confidentiality and invention or patent assignment agreements with our employees and consultants. Despite these efforts, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches. Our trade secrets may also be obtained by third parties by other means, such as breaches of our physical or computer security systems. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent them, or those to whom they communicate it, from using that technology or information to compete with us. If any of our trade secrets were to be disclosed to or independently developed by a competitor, our competitive position would be harmed.
We are subject to income taxes as well as non-income based taxes, such as payroll, sales, use, value-added, net worth, property and goods and services taxes, in the U.S.
Significant judgment is required in determining our provision for income taxes and other tax liabilities. In the ordinary course of our business, there are many transactions and calculations where the ultimate tax determination is uncertain. Although we believe that our tax estimates are reasonable: (i) there is no assurance that the final determination of tax audits or tax disputes will not be different from what is reflected in our income tax provisions, expense amounts for non-income based taxes and accruals and (ii) any material differences could have an adverse effect on our financial position and results of operations in the period or periods for which determination is made.
Successful development of our products is uncertain.
The products that we expect to develop are based on processes and methodologies that are not currently widely employed. Our development of current and future products are subject to the risks of failure and delay inherent in the development of new products and products based on new technologies, including delays in product development, testing, or manufacturing; unplanned expenditures in product development, testing, or manufacturing, a failure to receive regulatory approvals, the inability to manufacture on our own, or through any others, products on a commercial scale, or failure to achieve market acceptance, and the emergence of superior or equivalent products.
Because of these risks, our research and development efforts may not result in any commercially viable products. If a significant portion of these development efforts are not successfully completed, required regulatory approvals are not obtained, or any approved products are not commercially successfully, our business, financial condition, and results of operations may be materially harmed.
Political, economic and regulatory influences are subjecting the healthcare industry to potential fundamental changes that could substantially affect our results of operations.
Government and private sector initiatives to limit the growth of healthcare costs, including price regulation, competitive pricing, coverage and payment policies, comparative effectiveness of therapies, technology assessments and alternative payment models, are continuing in countries where we do business, including the U.S. These changes are causing the marketplace to put increased emphasis on the delivery of more cost-effective treatments. As a U.S. headquartered Company with most of our future sales being expected to come from the U.S., this healthcare reform legislation will materially impact us. Certain provisions of the legislation will not be effective for a number of years and it is unclear what the full impact of the legislation will be. Provisions of this legislation, including Medicare provisions aimed at improving quality and decreasing costs, comparative effectiveness research, an independent payment advisory board, and pilot programs to evaluate alternative payment methodologies, could meaningfully change the way healthcare is developed and delivered, and may adversely affect our business and results of operations. Further, we cannot predict what healthcare programs and regulations will be ultimately implemented at the federal or state level, or the effect of any future legislation or regulation in the U.S. or internationally. However, any changes that lower reimbursements for our products, reduce medical procedure volumes or increase cost containment pressures on us or other participants in the healthcare industry could adversely affect our business and results of operations.
Products that we manufacture, source, distribute or market are required to comply with regulatory requirements.
To lawfully operate our businesses, we are required to hold permits, licenses and other regulatory approvals from, and to comply with operating and security standards of, governmental bodies. Failure to maintain or renew necessary permits, licenses or approvals, or noncompliance or concerns over noncompliance may result in suspension of our ability to distribute, import or manufacture products or criminal and civil sanctions and could have an adverse effect on our results of operations and financial condition.
Although we are not required to register MGMR with U.S. Food and Drug Administration (“FDA”) since it is a tool used to make the active compound our future third party licenses will be subject to substantial regulation by the FDA and other regulatory authorities globally.
Since MGMR will only be used to modify cells outside the body, we are not required to register MGMR with the FDA as it is a tool to make the active compound. However, our future licensees who are the formulators of CAR-T will have to register use of MR with the FDA. Accordingly, the use of our product by third party licensees will be subject to substantial regulation by the FDA.
Any new licensee product must undergo lengthy and rigorous testing and other extensive, costly and time-consuming procedures mandated by FDA and foreign regulatory authorities. Changes to current products may be subject to vigorous review, including additional 510(k) and other regulatory submissions, and approvals are not certain. Our licensees’ facilities must be approved and licensed prior to production and remain subject to inspection from time to time thereafter. Failure to comply with the requirements of FDA or other regulatory authorities, including a failed inspection or a failure in our licensees’ adverse event reporting system, could result in adverse inspection reports, warning letters, product recalls or seizures, monetary sanctions, injunctions to halt the manufacture and distribution of licensee products, civil or criminal sanctions, refusal of a government to grant approvals or licenses, restrictions on operations or withdrawal of existing approvals and licenses. Any of these actions could cause our licensees to lose the confidence of their customers in the licensees’ products, which could adversely affect our sales and results of operations as our sales and results of operations are dependent upon royalty revenue from our clients.
The commercial success of our products will depend in part upon the level of reimbursement our licensees receive from third parties for the cost of their products to users.
The commercial success of any licensee product will depend, in part, on the extent to which reimbursement for the costs of licensee products and related treatments will be available from third-party payors such as government health administration authorities, private health insurers, managed care programs, and other organizations. Adequate third-party insurance coverage may not be available for our licensees to establish and maintain price levels that are sufficient for them to continue their business or for realization of an appropriate return on investment in product development. The result of this occurring would be to reduce our royalty revenues from our licensee customers which could have a material adverse effect on our business, financial condition and prospects.
If our future licensees are not able to obtain, or if there are delays in obtaining, required regulatory approvals, our licensees will not be able to commercialize their drug candidates or will not be able to do so as soon as anticipated, and our ability to generate royalty revenue from our licensees will be materially impaired.
Our licensees’ products and the activities associated with their development and commercialization, including their design, testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale and distribution, are subject to comprehensive regulation by the FDA and other regulatory agencies in the United States and by the EMA and similar regulatory authorities outside the United States. Failure to obtain marketing approval for our licensees’ products will prevent them from commercializing their products. We have not yet licensed our products to any licensee. Therefore, none of our future licensees have received approval to market any of their products which contain our transport mechanism from regulatory authorities in any jurisdiction. Securing marketing approval requires the submission of extensive preclinical and clinical data and supporting information to regulatory authorities for each therapeutic indication to establish the drug candidate’s safety and efficacy. Securing marketing approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities by, the regulatory authorities. Our future licensees’ products may not be effective, may be only moderately effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude their obtaining marketing approval or prevent or limit commercial use. For example, new cancer drugs frequently are indicated only for patient populations that have not responded to an existing therapy or have relapsed. If our future licensee’s products with a cancer indication receives marketing approval, the accompanying label may limit the approved use of our drug in this way, which could limit sales of the product and thereby have a negative effect on the level of royalties that we receive for licensing our technology to our future licensees and also negatively impact our results of operations and financial condition.
The process of obtaining marketing approvals, both in the United States and abroad, is expensive and may take many years. If additional clinical trials are required for certain jurisdictions, these trials can vary substantially based upon a variety of factors, including the type, complexity and novelty of the products involved, and may ultimately be unsuccessful. Changes in marketing approval policies during the development period, changes in or the enactment of additional statutes or regulations, or changes in the regulatory review process for each submitted product application, may cause delays in the review and approval of an application. Regulatory authorities have substantial discretion in the approval process and may refuse to accept a marketing application as deficient or may decide that our data is insufficient for approval and require additional preclinical, clinical or other studies. In addition, varying interpretations of the data obtained from preclinical and clinical testing could delay, limit or prevent marketing approval of a drug candidate. Any marketing approval our future licensees ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the approved product not commercially viable.
The FDA and other regulatory authorities are monitoring whether nanotechnology-based therapeutics pose any specific health and human safety risks. In June 2014, the FDA issued guidance providing that it will address issues such as safety, effectiveness, public heath impact, and regulatory status of nanotechnology products on a case-by-case basis using the FDA’s existing review processes. It is possible that the FDA or other regulatory authorities could issue additional guidance or regulations in the future regarding nanotechnology-based therapeutics that could adversely affect our future licensees’ drug candidates.
If our future licensees experience delays in obtaining approval or if they fail to obtain approval of their drug candidates, the commercial prospects for their drug candidates may be harmed and their ability to generate revenues will be materially impaired, which would result in a material impairment in our ability to generate royalty revenue from them.
We face significant competition from other biotechnology companies.
Our MGMR product faces unique groupings of competitive technologies depending on the application. Not all competitive technologies are relevant in each application and market. Depending on the application, competitors technologies are associated with a unique set of advantages and disadvantages which vary in magnitude relative to MGMR. We face potential competition from many different sources, including major pharmaceutical, specialty pharmaceutical and biotechnology companies, academic institutions and governmental agencies and public and private research institutions. We also face competition from other nanomedicine platforms developing targeted therapies, including platforms focused on albumin nanoparticles, liposomes and polymeric nanoparticles.
Many of our competitors may have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do. Mergers and acquisitions in the pharmaceutical, biotechnology and diagnostic industries may result in even more resources being concentrated among a smaller number of our competitors. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.
Our manufacturing activity is subject to certain risks.
We may manufacture the products sold to our customers in a location to be obtained in the future. As a result, we may be dependent upon the uninterrupted and efficient operation of our manufacturing facility and our distribution facilities throughout the country. Our manufacturing facilities and distribution facilities may be subject to the risk of catastrophic loss due to, among other things, earthquake, fire, flood, terrorism or other natural or man-made disasters, as well as occurrence of significant equipment failures. If any of these facilities were to experience a catastrophic loss, it would be expected to disrupt our operations and could result in personal injury or property damage, damage relationships with our customers or result in large expenses to repair or replace the facilities or systems, as well as result in other liabilities and adverse impacts.
We may contract with third-party manufacturers to produce our products in the future in accordance with our specifications and standards. These contract manufacturers are subject to the same risks as our manufacturing facility as noted above. While we plan to implement stringent quality control procedures to verify that our contract manufacturers comply with our specifications and standards, we will not have full control over their manufacturing activities. Any difficulties, delays and defects in our products resulting from the activities of our contract manufacturers may have an adverse effect on our business and results of operations.
We are dependent on our collaborative agreements for the development of products and business development, which exposes us to the risk of reliance on the viability of third parties.
In conducting our research and development activities, we will in the future rely on collaborative agreements with third parties such as manufacturers, contract research organizations, commercial partners, universities, governmental agencies and not-for-profit organizations for both strategic and financial resources. The loss of, or failure to perform by us or our partners under, any applicable agreements or arrangements, or our failure to secure additional agreements for other products in development, would substantially disrupt or delay our research and development and commercialization activities. Any such loss would likely increase our expenses and materially harm our business, financial condition and results of operation.
Reliance on third-party relationships and outsourcing arrangements could adversely affect our business.
We utilize third parties, including suppliers, alliances with other pharmaceutical and biotechnology companies, and third-party service providers, for selected aspects of product development, the manufacture and commercialization of certain products, support for information technology systems, and certain financial transactional processes. Outsourcing these functions involves the risk that the third parties may not perform to our standards or legal requirements, may not produce reliable results, may not perform in a timely manner, may not maintain the confidentiality of our proprietary information, or may fail to perform at all. Failure of these third parties to meet their contractual, regulatory, confidentiality, or other obligations to us could have a material adverse effect on our business.
The forecasts of market growth included in our business plan and investor presentations may prove to be inaccurate, and even if the markets in which we compete achieve the forecasted growth, we cannot assure you our business will grow at similar rates, if at all.
Growth forecasts are subject to significant uncertainty and are based on assumptions and estimates that may not prove to be accurate. The forecasts in our business plan and investor presentations may prove to be inaccurate. Even if these markets experience the forecasted growth described in our business plan, we may not grow our business at similar rates, or at all. Our growth is subject to many factors, including our success in implementing our business strategy, which is subject to many risks and uncertainties. Accordingly, the forecasts of market growth included in our business plan should not be taken as indicative of our future growth.
We will need additional financing to execute our business plan, which we may not be able to secure on acceptable terms, or at all.
We will require additional financing in the near and long term to fully execute our business plan. Our success depends on our ability to raise such additional financing on reasonable terms and on a timely basis. Conditions in the economy and the financial markets may make it more difficult for us to obtain necessary additional capital or financing on acceptable terms, or at all. If we cannot secure sufficient additional financing, we may be forced to forego strategic opportunities or delay, scale back or eliminate further development of our goals and objectives, operations and investments or employ internal cost savings measures.
We plan to obtain insurance that may not provide adequate levels of coverage against claims.
We plan to obtain insurance customary for businesses of our size and type. However, there are types of losses we may incur that cannot be insured against or that we believe are not economically reasonable to insure. Such losses could have a material adverse effect on our business and results of operations.
Risks Related to the Company’s Securities and this Offering
Affiliates of our company, including officers, directors and existing stockholder of our company, may invest in this offering and their funds will be counted toward our achieving the minimum amount.
There is no restriction on our affiliates, including our officers, directors and existing stockholders, investing in the offering. As a result, it is possible that if we have raised some funds, but not reached the minimum amount, affiliates can contribute the balance so that there will be a closing. The minimum amount is typically intended to be a protection for investors and gives investors confidence that other investors, along with them, are sufficiently interested in the offering and our company and its prospects to make an investment of at least the minimum amount. By permitting affiliates to invest in the offering and make up any shortfall between what non-affiliate investors have invested and the minimum amount, this protection is largely eliminated. Investors should be aware that no funds other than their own and those of affiliates investing along with them, may be invested in this offering.
We intend to use some of the proceeds from the offering for unspecified working capital.
This means that we have ultimate discretion to use this portion of the proceeds as we see fit and have chosen not to set forth any specific uses for you to evaluate. The net proceeds from this offering will be used for the purposes, which our management deems to be in our best interests in order to address changed circumstances or opportunities. As a result of the foregoing, our success will be substantially dependent upon our discretion and judgment with respect to application and allocation of the net proceeds of this offering. We may choose to use the proceeds in a manner that you do not agree with and you will have no recourse. A use of proceeds that does not further our business and goals could harm our company and its operations and ultimately cause you to lose all or a portion of your investment.
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.
The securities being sold in this offering will not be freely tradable until one year from the initial purchase date. Although our securities may be tradable under federal securities law, state securities regulations may apply, and each investor should consult with his or her attorney.
You should be aware of the long-term nature of this investment. There is not now and likely will not be a public market for our securities. Because our securities have not been registered under the Securities Act or under the securities laws of any state or non-United States jurisdiction, our securities have transfer restrictions and cannot be resold in the United States except pursuant to Rule 501 of Regulation CF. It is not currently contemplated that registration under the Securities Act or other securities laws will be effected. Limitations on the transfer of the securities may also adversely affect the price that you might be able to obtain for our securities in a private sale. Investors should be aware of the long-term nature of their investment in the Company. Each investor in this offering will be required to represent that it is purchasing the securities for its own account, for investment purposes and not with a view to resale or distribution thereof.
Neither the offering nor the securities have been registered under federal or state securities laws, leading to an absence of certain regulation applicable to us.
No governmental agency has reviewed or passed upon this offering, our company or any Securities of our company. We also have relied on exemptions from securities registration requirements under applicable state securities laws. Investors, therefore, will not receive any of the benefits that such registration would otherwise provide. Prospective investors must therefore assess the adequacy of disclosure and the fairness of the terms of this offering on their own or in conjunction with their personal advisors.
No Guarantee of Return on Investment
There is no assurance that an investor will realize a return on its investment or that it will not lose its entire investment. For this reason, each investor should read the Form C and all Exhibits carefully and should consult with its own attorney and business advisor prior to making any investment decision.
A majority of our company is owned by a small number of owners.
Prior to the offering our officers, directors and those of our stockholders who own ten percent or more of our securities collectively own directly or indirectly 100% of our company. Subject to any fiduciary duties owed to our other owners or investors under Delaware law in the case of our officers and directors, these stockholders may be able to exercise significant influence over matters requiring owner approval, including the election of directors or managers and approval of significant company transactions, and will have significant control over our management and policies. These control persons may have interests that are different from yours. For example, they may support proposals and actions with which you may disagree. The concentration of ownership could delay or prevent a change in control of our company or otherwise discourage a potential acquirer from attempting to obtain control of the Company, which in turn could reduce the price potential investors are willing to pay for our company. In addition, this owner could use his voting influence to maintain the Company’s existing management, delay or prevent changes in control of our company, or support or reject other management and board proposals that are subject to owner approval.
We have the right to extend the offering deadline.
We may extend the offering deadline beyond what is currently stated herein. This means that your investment may continue to be held in escrow while we attempt to raise the minimum amount even after the offering deadline stated in this offering statement is reached. Your investment will not be accruing interest during this time and will simply be held until such time as the new offering deadline is reached without our company receiving the minimum amount, at which time committed funds will become immediately available for withdrawal from the investor’s brokerage account maintained with the Intermediary without interest or deduction, or until we receive the minimum amount, at which time it will be released to us to be used as set forth herein. Upon or shortly after release of such funds to us, the securities will be issued and distributed to you.
Your ownership of the shares will be subject to dilution.
If we conduct subsequent offerings of securities, issue shares pursuant to a compensation or distribution reinvestment plan or otherwise issues additional shares, investors who purchase securities in this offering who do not participate in those other stock issuances will experience dilution in their percentage ownership of our company’s outstanding shares. Furthermore, shareholders may experience a dilution in the value of their underlying shares depending on the terms and pricing of any future share issuances (including the underlying shares being sold in this offering) and the value of the our assets at the time of issuance.
Management has discretion over proceeds of this offering.
We expect to use the net proceeds of this offering, over time, for general marketing and advertising, leasing costs, debt repayment and general working capital. However, we have no current specific plans for the net proceeds of this offering other than as outlined in the use of proceeds section of this offering statement. As a result, our management will have the discretion to allocate the net proceeds to uses that investors may not deem desirable. There can be no assurance that the net proceeds can or will be invested to yield a significant return.
The securities will be equity interests in our company and will not constitute indebtedness.
The securities will rank junior to all existing and future indebtedness and other non-equity claims on our company with respect to assets available to satisfy claims on the Company, including in a liquidation of our company. Additionally, unlike indebtedness, for which principal and interest would customarily be payable on specified due dates, there will be no specified payments of dividends with respect to the securities and dividends are payable only if, when and as authorized and declared by us and depend on, among other matters, our historical and projected results of operations, liquidity, cash flows, capital levels, financial condition, debt service requirements and other cash needs, financing covenants, applicable state law, federal and state regulatory prohibitions and other restrictions and any other factors our board of directors deems relevant at the time. In addition, there is no limit on the amount of debt or other obligations we may incur in the future. Accordingly, we may incur substantial amounts of additional debt and other obligations that will rank senior to the securities, which are the most junior securities of our company.
There can be no assurance that we will ever provide liquidity to investors through either a sale of our company or a registration of the securities.
There can be no assurance that any form of merger, combination, or sale of our company will take place, or that any merger, combination, or sale would provide liquidity for investors. Furthermore, we may be unable to register the securities for resale by investors for legal, commercial, regulatory, market-related or other reasons. In the event that we are unable to effect a registration, investors could be unable to sell their securities unless an exemption from registration is available.
The offering price in this offering may not represent the value of our securities.
The price of the securities being sold in this offering has been determined based on a number of factors and does not necessarily bear any relationship to our book value, assets, operating results or any other established criteria of value. Prices for our securities may not be indicative of the fair market value of our securities now or in the future.
Read less
Next-Generation Technologies Like CRISPR, TALEN and CAR-T Hold Tremendous Promise…
But for cell therapy technologies to work, they need an effective delivery mechanism to transport specialized molecular cargo across fragile cell membranes — and this is a MAJOR problem.
Protective membranes shield cells from foreign materials and contaminants. Getting past the membrane safely and delivering the molecules needed to trigger the desired changes inside the cell (such as genetic engineering) is a HUGE hurdle.

     communication forum

communication forum

Showing 16 comments
  • Jerry Mlack
    Jerry Mlack

    Kurt, If one wishes to add to their present commitment, would they use the same Investor ID to add to that particular account? Or would one just sign up again? Best Regards, Jerome

    • Kurt Swogger

      Hello Jerry,
      Thank you for your question. To make an additional investment, you should login into your account using your email and password. Click on the “invest now” button and complete the forms again.

      This insures that each subscription agreement and transaction id is crystalized upon completion.

      Hope this help.
      Regards,
      Kurt

  • Virginia Mlack Mooney
    Virginia Mlack Mooney

    Hello Kurt,
    Clarification needed:
    In the Q&A section, there are two dates listed as being the “Last day of Offering”:
    First date: February 27th states June 1, 2020
    Second date: March 3, 2020 states June 30, 2020.
    Please advise as to which date is correct.

    Also, if one has already invested, am I correct in that one has up to the last day of offering to do so?
    Thank you in advance.
    Ginny

    • Kurt Swogger

      Dear Virginia,

      Excellent catch! The correct date is June 30, 2020 and you can invest up to and on that date. We made an error in my response to Leonardo and I apologize for that.
      Rest regards, Kurt

  • Guenadi Jilevski
    Guenadi Jilevski

    Do you need FDA approval and if so when do you plan to apply? Do you have any projections?

    • Kurt Swogger

      Dear Guenadi,

      Thank you for the question. MGMR is a microscopic nanosize tool used during the process of making products such as CAR-T. MGMR does not enter the body, so consequently, it does not require FDA approval. The final product such as CAR-T does need FDA approval, but the drug company has to obtain that registration. MGMR only has to meet the specifications set by BioPact CT and the drug maker. BioPact CT will target companies that have or will have product registrations to more quickly ramp up sales and milestone payments.

  • William McGuire
    William McGuire

    Kurt, BioPact CT is fully owned by BioPact Ventures, LLC, correct? I don’t see anything in the financials about Molecular Rebar Design, LLC. Please explain the relationship.

    • Kurt Swogger

      Hi William, thank you for the question. BioPact CT was fully owned by BioPact Ventures prior to this offering. Molecular Rebar Design, LLC owns about 50% of BioPact Ventures, LLC and licensed the rights to use MGMR in the medical field to BioPact Ventures which in turn licensed the rights to BioPact CT for the use in outside the body cellular transport.

  • Sheldon Cohn
    Sheldon Cohn

    what is the minimum investment?

    • Kurt Swogger

      Hi Sheldon, thanks for the question. The minimum investment is $455 which is 300 shares.

  • Sean Mendez
    Sean Mendez

    Is there a investment window when does it close?

    • Kurt Swogger

      Hi Sean, thank you for the question.
      The last date of the offering at this time is June 30, 2020.

  • Leonardo Lee
    Leonardo Lee

    Hi. I’m very interested in investing but I have a few questions:
    -How do you make money? Selling software, subscriptions, special equipment, by procedure, etc?
    -Can you give me your revenue projections for the next 5 years? If you are not allowed to disclose it then can you please share your revenue goals for that period of time?
    -What’s your fundraising goal and how much has been raised so far?
    -When does this offering close?
    Thanks.

    • Kurt Swogger

      Leonardo, thanks for the question. BpCT will make money on licenses which have milestone payments, royalties and product sales. Each license is likely to be a bit different and later licenses will have higher payments on milestones. Our 5 year sales forecast is $19 million with an 80% margin. The offering closes June 1, 2020.
      Best regards, Kurt

  • Michael Perkovich
    Michael Perkovich

    Are you licensing this technology from someone and if so how long do you have the rights?

    Hiw much have you raised so far this CF round?

    • Kurt Swogger

      Michael, thanks for the question. BioPact CT licensed the technology from Molecular Rebar Design,LLC which owns a significant equity interest in this new company. There are several patents that cover this effort; a key patent expires in 2037 or about 17 years. This is the first day of the offer so you could be the first investor! We appreciate your interest. Regards, Kurt

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