KEY HIGHLIGHTS

cassderma Rx was founded in 2020 to begin the process of bringing to market an innovative discovery in a curative wound healing topical product that has resulted from the decade-long work of Dr. Daniel Rastein. As an educator and noted industry leader in healthcare and biomedical research, Dr. Rastein has been involved in designing the regulatory standards of numerous drugs and biomedical devices for cutting-edge manufacturing, research, medical, aerospace, and agriculture companies.

The cassderma Rx Wound Healing Hydrogel is a first-of-its-kind patented solution for dealing with persistent chronic wound repair. The product and the company have several distinguishing differentiators including:

• The formulation utilizes a naturally occurring hormone for treatment of the wound with a nutrient-rich cell culture medium providing nutrition to the wound site.
• The combination of the hormone with a nutrient-rich cell culture medium, has been shown to be effective on a variety of chronic wounds, including deep burns, persistent sores, and diabetic ulcers.
• The company is ready to begin its POC animal wound model study followed by its non-clinical toxicity study in order to prepare for its IND approval.
• The awarding of the IND will result in a significant increase in the the valuation of the company with a 4x multiplier should a purchase exit option be taken.
• The company is headed by a carefully selected Executive Management Team who have the requisite skills across all clinical, toxicology, pharmacology, CMC, regulatory, and marketing fields to successfully bring a product of this type to a lead position in the pharmaceutical wound treatment marketplace.

INVESTMENT OVERVIEW

By packaging this startup equity investment within a proven revenue-generating program at PFD Management Opportunity Fund 3001, LLC (PFDMOF3001).

The investor receives:

• 5% annually on invested capital, distributed on a quarterly basis.
• 165% of invested capital back at the end of year 5 ($1.00 gets $1.65 at term)

The internal rate of return is 18% annually

• 5% annually for 5 years is 25%
• 165% at term is an additional 13% annually for 18% IRR

The investor has little else to be concerned with should the exit of this project take longer to exit, or the projected valuation varier from initial projections.

• Upon exit of this portfolio company, the fund will distribute the net proceeds to fund members proportional to their ownership in the fund.

Projected additional equity return:

• The targeted additional return is estimated for a 70% one-time distribution.

 PRESENTATION

The cassderma Rx Wound Healing Hydrogel provides a new class of wound treatment that has the potential to bring faster healing to patients who suffer from a variety of wounds including diabetic ulcers, pressure ulcers, burns, and surgical wounds. For some patients who have not responded to current treatments, the cassderma Rx Wound Healing Hydrogel may offer an effective cure to healing long-term persistent wounds.

TAKE A LOOK AT THIS PRESENTATION TO SEE HOW AND WHY THE CASSDERMA RX WOUND HEALING HYDROGEL WILL MAKE AN IMPACT IN PROVIDING A BETTER OPTION FOR WOUND CARE.

PAIN POINT

Wound Care Is A Global Pandemic

The National Council for Biotechnology Information, the World Health Organization, and the National Institutes of Health describe the need for wound care as a “worldwide pandemic” affecting 6.5 million patients in the US alone costing over $25 billion annually and rapidly growing due to increase in healthcare costs, aging population and the sharp rise in obesity and diabetes

• 1000 patients in hospitals die each week from pressure ulcers.

• 84% of amputations for diabetes patients are attributed to open wounds.

• A 2000 study showed that 40 million inpatient surgical procedures and 31.5 million outpatient surgeries were performed in the US. All of these patients required some level of wound care post-operatively.

WOUND (noun) /wo͞ond/: a break in the continuity of the skin, caused by a traumatic injury such as burn, cut, or scrape, exposure to excessively hot or cold temperatures, chemical damage due to acid or alkaline burns or damage by radiation.

TREATMENT: application of various antibiotics and bandages or alternatively, the wound is closed by surgical procedures of suturing the wound’s edges, by grafting cultured skin, or by split skin grafts

PURPOSE: avoid complications such as infection and inflammation and promote the growth of granulation tissue that may or may not follow promptly, depending on adequate blood supply bringing into the wound the nutrients that the cells need for growth.

COMPLICATIONS: wounds can become infected, the blood supply can be insufficient for tissue growth, or contamination overcomes the antiseptics. In these cases, the healing process fails, and the wound becomes chronic. This is the case in most hospitals with pressure ulcers, unsanitary conditions, or underlying conditions, such as diabetes, venous insufficiency, or compromised immune system.

Nothing exists in the world to make wounds heal faster on their own than our body’s own healing power.

cassderma Rx is utilizing that power for the first time to bring a powerful solution for Chronic Wound Repair.

ELEVATOR PITCH

• Wound care is becoming a growing pandemic around the globe.
• With the aging population, increase in diabetes, obesity, and invasive surgical operations, the need for better wound treatment is critical for those whose wounds are persistent or do not respond well to traditional treatments.
• cassderma Rx has created a patented prescription topical gel that has been shown to provide relief and healing to patients with persistent wound care needs.
• The formulation utilizes a serum-free, nutrient-rich cell culture media supplement, along with a naturally occurring hormone that supplies the cells in the wound with the nutrients and the cell-growth stimulation required for the regeneration of tissues to treat recalcitrant chronic wounds.
• cassderma Rx is working to complete its formulation to begin its initial pre-clinical toxicity trials to show its proof-of-concept.
• The pre-clinical trials will gain the data needed to proceed with securing the regulatory approvals needed by the FDA for its IND designation.

ADDRESSING THE MARKET

The market for both procedures and materials needed for treating wound care represents a $20B a year sector affecting more than 20 million people in the U.S. alone. Material cost for items such as dressings, sutures, antibiotics, salves, and other topical and oral items is a major part of that market sector.  For patients with persistent wound care needs, the cost for basic dressing supplies can reach $1,300.00 annually alone 1

Wound management has made rapid advances over the last 25 years with the increase in the understanding of the biology of chronic non-healing wounds. There are many product solutions in the wound care topical ointment and gel category. All of these fall into either an antiseptic or antimicrobials framework. Treatment selection depends on the practitioner’s skilled assessment of the wound and his knowledge of how to provide the optimum wound healing environment through the use of modern interactive dressings.

The cassderma Rx Wound Healing Hydrogel is uniquely positioned as it is the first product of its kind in the topical wound care category that has an ability not to just clean and protect against infection while the body heals itself, but rather to actually accelerate the body’s own regeneration process by providing wound-site delivery of nutrients along with a naturally occurring cell-growth hormone. Though effective for all types of wound care, cassderma Rx‘s primary focus is on providing a solution for physicians who need a solution for treating those patients whose wounds are persistent and recalcitrant. In this sector of the market, there are a limited number of effective topical options that are utilized currently, but none of these promote actual cell growth of the connective tissues in order to effect a cure.

As the cassderma Rx Wound Healing Hydrogel product is targeted for treating a chronic wound, it is a prescription topical gel formulation and will require a physician’s prescription for use. Because of this, the product will have a higher price point which will be covered by insurance reimbursement. Targeting this market sector, even with minimal share achievement, will mean a substantial revenue stream for the producing company.

As the market has shown, effective topical cure products have garnered significant value in their acquisition. Examples of this include Eli Lilly’s purchase of Dermira ‘s eczema cream for $1.3 billion, and Nestlé’s Skin Health Division’s purchase of Galderma, a dermatological skin-care product developer, for $10.5 billion in 2019.

The management of cassderma Rx even at its early stage of development has been approached by large players in this space interested in the product’s differentiators and potential.

1. https://www.woundsource.com/blog/purchasing-wound-care-supplies-potential-patient-hurdles#:~:text=Steps%20for%20Helping%20Patients%20Acquire%20Wound%20Care%20Supplies&text=Most%20wounds%20do%20not%20heal,annually%20for%20basic%20dressing%20supplies.

SCALABLE BUSINESS MODEL

As cassderma Rx’s Wound Healing Hydrogel presents a potential market disruptor in its market sector, it has several advantages to scalable growth as well as some challenges. cassderma Rx’s strategy for growth is positioned for two potential outcomes. One is to pursue its FDA regulatory process for an Investigational New Drug (IND) number. Achieving this will result in a significantly higher valuation for the company, which is anticipated to be at least a 4x multiplier. This new valuation would be able to position the company for a purchase exit from a key player in the industry. The second option is to continue its path to an NDA at which point it will be able to move forward with its own commercialization strategy. Should even a 1% market share be realized in the first year of commercialization, this could represent $100M in sales.

With either end goal, cassderma Rx is moving forward to finalizing the needed requirements for FDA approval. This strategy involves:

1. 1. Development of the Product Formulation and the Chemistry Manufacturing, and Control (CMC) requirements including:
      1. Selection of components (excipients) that provide for a stable topical gel formulation.
   2. Optimizing maximum levels of hormone and cell culture medium within the gel formulation without compromise to target product viscosity that is important in maintaining product residence within the wound site.
   3. Scale-up and refinement to GLP drug manufacture requirements for preclinical efficacy and toxicology studies to include:
   4. A 14-Day Hypersensitivity Study in Guinea Pigs
   5. A 3-Day Ocular Safety Study in Rabbits
   6. A 3-Month Dermal Toxicity Study in Mini-pigs

Projected delivery is six months notwithstanding risk issues such as legal, bandwidth, further pandemic barriers

1. An FDA Pre-IND Meeting to include:
2. Advisement on data to support an IND application.
3. Discussion on First in Human (FIH) clinical study.

After IND submission, cassderma Rx will determine its decision to pursue a purchase exit or continue onto the next phase of product development.

COMPETITIVE LANDSCAPE

Although there are many competitors in the topical ointment and gel wound care market sector, none of these are able to make a claim or show an ability to provide an effective method of promoting cell growth to enhance and accelerate the healing of wounds. cassderma Rx feels its unique formulation sets it in a category of its own and is well placed to be a disruptive product that will be able to dominate its market position.

HISTORY OF EXCELLENCE

The members of the cassderma Rx Executive Management have extensive backgrounds in each of their respected fields. Their expertise and abilities are highly sought after by top global companies and have contributed significantly to their respective successes.

RISK FACTORS

The following is not an exhaustive list of risk factors that may impact the PFDMOF3001 and or this particular portfolio company’s ability to fulfill its goals and/or negatively impact stakeholder value.

In evaluating the PFDMOF3001, the Company itself, and the portfolio company described within these pages and its business, one should carefully consider the following risk factors.