Welcome to ReGen Factor’s latest quarterly update. Since our last update in May 2022, we have made significant strides towards achieving our goals. This update follows our H1 2024 and H2 2024 updates to keep our stakeholders informed about our progress and future plans.
Dear Shareholders,
We are delighted to provide you with an update on our strategic initiatives and recent progress as we advance our innovative solutions in skin biology. Your continued support is invaluable, and we are excited to share our latest developments.
Strategic Focus: Diabetic Ulcers and Diabetic Eye Complications
After careful consideration and extensive research, our expert FDA Consultant, Dr. Mukesh Kumar, has recommended that we prioritize FDA applications for treating diabetic ulcers and diabetic eye complications (specifically diabetic retinopathy) using our recombinant human basic Fibroblast Growth Factor (rh bFGF). Here’s why:
Significant Unmet Medical Needs
• Diabetic Ulcers: The market for advanced wound care, including treatments for diabetic ulcers, was valued at approximately USD 10.2 billion in the US in 2023. The Australian market adds significantly to this figure. With the increasing prevalence of diabetes and chronic wounds, there is a substantial demand for effective treatment options.
• Diabetic Eye Complications: The US market for diabetic retinopathy was valued at USD 8.9 billion in 2023, projected to grow significantly as the incidence of diabetes rises. The global market size is expected to reach approximately USD 14.51 billion by 2031, reflecting the urgent need for innovative therapeutic solutions.
Therapeutic Potential of rh bFGF
Our rh bFGF has demonstrated promising regenerative and angiogenic properties, essential for healing chronic wounds and promoting retinal health. These properties make it an ideal candidate for addressing both diabetic ulcers and diabetic eye complications.
Strategic Benefits of Parallel Trials
• Cost Efficiency: Conducting parallel clinical trials allows us to share resources, streamline regulatory processes, and reduce overall costs.
• Accelerated Timelines: Parallel trials can expedite data collection and regulatory submissions, potentially leading to faster market entry.
• Robust Data: The comprehensive data from these trials will strengthen our FDA submissions and support subsequent applications for other indications.
Clinical Background
Diabetic ulcers are a significant complication of diabetes, often leading to severe morbidity and mortality. Current treatments are limited in efficacy, and there is a critical need for more effective therapies. Basic fibroblast growth factor (bFGF) has shown promising results in promoting wound healing by stimulating fibroblast proliferation, collagen synthesis, and angiogenesis. Recent studies have demonstrated the efficacy of rh-bFGF in various wound healing models, including diabetic ulcers.
Regulatory Background
Several wound healing agents, such as Integra Omnigraft, Dermagraft, and Apligraf, have been approved by the FDA for the treatment of diabetic ulcers. These products provide scaffolds for cellular growth, bioengineered skin substitutes, and bilayered living cell-based therapies, respectively. Rh-bFGF, approved in Japan for wound healing, presents a novel mechanism of action by directly promoting cellular regeneration and tissue repair. A comparison of rh-bFGF with these approved agents is detailed in the table below.
Comparison Table: rh-bFGF vs. Approved Agents
| Product Name | Mechanism of Action | FDA Approval Status | Comparison with rh-bFGF |
| Integra Omnigraft | Scaffold for cellular growth | Approved for diabetic ulcers | Provides structural support, less direct cellular stimulation compared to rh-bFGF |
| Dermagraft | Bioengineered skin substitute | Approved for diabetic ulcers | Similar cellular stimulation, different source and composition |
| Apligraf | Bilayered living cellbased product | Approved for diabetic ulcers | Mimics human skin, less direct cellular regeneration stimulation |
| ReGen Factor rhbFGF Cream | Direct fibroblast growth stimulation | Seeking FDA approval | Directly promotes cellular regeneration and tissue repair |
Commitment to Androgenetic Alopecia
We understand that our initial focus was on seeking FDA approval for treating androgenetic alopecia in men and women. We have seen numerous anecdotal successes with this treatment and remain committed to pursuing this application. However, based on Dr. Kumar’s recommendation, starting with diabetic ulcers and diabetic eye complications will be more beneficial at this point. This strategic shift will not deter us from our original plan but rather strengthen our position by addressing larger unmet medical needs first.
Future Focus on Acne Vulgaris
Once we have achieved significant milestones in our FDA applications for diabetic ulcers and diabetic eye complications, we plan to focus on securing FDA approval for treating acne vulgaris. This condition affects a large portion of the population, and our preliminary data and anecdotal successes suggest that rh bFGF could offer a highly effective treatment option.
Strategic Progress and Future Plans
• Pre-IND Meeting and IND Submission: We have made significant strides in preparing for the pre-IND meeting and subsequent IND submission. These steps are critical in our journey towards obtaining FDA approval and bringing our innovative treatments to market.
• Phase 1 Clinical Trials: We are gearing up for Phase 1 clinical trials, focusing on demonstrating the safety and dosage efficacy of rh bFGF. These trials will provide essential data to support our future clinical phases.
• Phase 2 and Phase 3 Clinical Trials: Following successful Phase 1 trials, we will proceed with Phase 2 and Phase 3 trials to evaluate the efficacy and long-term safety of rh bFGF in treating diabetic ulcers and diabetic eye complications. These trials will be pivotal in substantiating our FDA applications and ensuring regulatory compliance.
Cost Savings with AI Integration
| Stage | Savings (%) |
| Pre-IND Meeting | 30%-50% |
| IND Submission | 30%-50% |
| Phase 1 Clinical Trials | 30%-50% |
| Phase 2 Clinical Trials | 30%-50% |
| Phase 3 Clinical Trials | 30%-50% |
| FDA Approval and Commercialization | 30%-50% |
| Stage | Savings (%) |
| Total | 30%-50% |
Distribution and Sales Growth
• Poland: Well Concept has been appointed as our exclusive distributor, leveraging their extensive network to introduce PepFactor Scalp across Poland.
• Dubai and UAE: Remak Medical, managed by Dr. Khalid Remaly, is now our exclusive distributor for the UAE, promising significant sales growth in the region.
New Product Innovations
• PepFactor Shampoo Bar: An eco-friendly product designed to rejuvenate hair with natural ingredients fortified with PepFactor technology.
• HA 30ml Vials for Home Use: Offering unparalleled hydration and rejuvenation, these vials bring the transformative benefits of PepFactor technology to home users.
• PepFactor Skin Maximiser Mist: A groundbreaking topical application delivering targeted nourishment and hydration.
New Products in Development
• PepFactor Exosomes for Skin and Scalp
New Areas of Research
• Anti-Aging
AI Integration for Cost and Time Efficiency
Integrating AI into our processes has resulted in substantial cost savings and expedited timelines across various stages of our FDA approval process. This integration underscores our commitment to innovation and efficiency.
Marketing and Website Overhaul
Our ongoing website overhaul aims to enhance transparency and foster meaningful engagement with our investors. This digital portal will serve as a dynamic information hub, providing timely updates, insights, and announcements.
Delay in ASX Listing
We had a delay in proceeding with an ASX listing due to capital markets and capital being difficult to raise during the latest interest rate hikes, high inflation rate, and worries about the economy and possible more interest rate hikes. However, our goal remains to list as soon as market opportunities are right to ensure a successful listing in the optimal environment, maximizing shareholder value.
Conclusion
We are grateful for your unwavering support and belief in our vision. Your continued backing enables us to innovate and progress towards our goals. Thank you for being an integral part of our journey.
Warm regards,
Stephen Blignaut Founder and CEO ReGen Factor Pty Ltd
Media Contact: Claire Ironside – Media Consultant ReGen Factor
Phone: +61 2 8916 6220
Email: [email protected]
Website: www.regenfactor.com.au
