Prioritizing FDA applications for diabetic ulcers and diabetic retinopathy using their recombinant human basic Fibroblast Growth Factor (rh bFGF). This shift addresses substantial unmet medical needs, potentially accelerating regulatory timelines and market entry.
Introduction
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:
1. Significant Unmet Medical Needs:
o Diabetic Ulcers: The market for advanced wound care, which includes 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.
o 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.
2. Therapeutic Potential of rh bFGF:
o 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.
3. Strategic Benefits of Parallel Trials:
o Cost Efficiency: Conducting parallel clinical trials allows us to share resources, streamline regulatory processes, and reduce overall costs.
o Accelerated Timelines: Parallel trials can expedite data collection and regulatory submissions, potentially leading to faster market entry.
o 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 cellbased 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 rh-bFGF 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
*Table 1: Projected Cost Savings by Introducing AI (with a range of 30% to 50%)
| Stage | Traditional Cost (USD) | *AI-Assisted Cost (USD) | *Savings (USD) (30%- 50%) |
| Pre-IND Meeting | 110,000 | 75,000 | 35,000 – 37,500 |
| IND Submission | 300,000 | 200,000 | 60,000 – 120,000 |
| Phase 1 Clinical Trials | 5,000,000 | 4,000,000 | 1,000,000 – 1,500,000 |
| Phase 2 Clinical Trials | 15,000,000 | 10,000,000 | 3,000,000 – 5,000,000 |
| Phase 3 Clinical Trials | 40,000,000 | 30,000,000 | 9,000,000 – 12,000,000 |
| FDA Approval and Commercialization | 12,000,000 | 10,500,000 | 1,100,000 – 2,000,000 |
| Total | 72,410,000 | 54,775,000 | 14,195,000 – 34,853,000 |
Time Savings with AI Integration
*Table 2: Time Savings by Introducing AI (with a range of 30% to 50%)
| Stage | Traditional Timeline (months) | *AI-Assisted Timeline (months) | *Savings (months) (30%- 50%) |
| Pre-IND Meeting | 12 | 6 | 4 – 7 |
| IND Submission | 24 | 12 | 7.2 – 12 |
| Phase 1 Clinical Trials | 36 | 18 | 10.8 – 18 |
| Phase 2 Clinical Trials | 48 | 24 | 14.4 – 24 |
| Phase 3 Clinical Trials | 72 | 36 | 21.6 – 36 |
| FDA Approval and Commercialization | 24 | 12 | 7.2 – 12 |
| Total | 216 | 108 | 65.2 – 109 |
Capital Raise Process and Valuation
Table 3: Capital Raise Process, Capital Requirements, and Valuation
| Stage | Capital Requirement (USD) | Use of Funds | *Projected Valuation Increase (USD) | *Reasoning for Valuation Increase |
| Pre-IND Meeting | 500,000 | Preparation and submission of Pre-IND documents | 18.75 million – 25 million | Early regulatory engagement, high potential of treatment |
| IND Submission | 1,500,000 | IND application submission, additional preclinical studies | 37.5 million – 75 million | Progress towards clinical trials, enhanced data quality |
| Phase 1 Clinical Trials | 5,000,000 | Initial human trials, safety and dosage assessment | 56.25 million – 150 million | Successful safety data, demonstration of human safety |
| Phase 2 Clinical Trials | 15,000,000 | Larger efficacy trials, expanded patient recruitment | 112.5 million – 450 million | Stronger efficacy data, larger patient sample |
| Phase 3 Clinical Trials | 40,000,000 | Extensive trials, multi-center operations | 337.5 million – 2.25 billion | Substantial clinical efficacy and safety data, nearing FDA approval |
| FDA Approval and Commercialization | 12,000,000 | Final submission, marketing preparations, production scaling | 1.687 billion – 22.5 billion | FDA approval, market entry, high commercial potential |
AI in Marketing
ReGen Factor will also greatly benefit from AI in marketing. Here are some examples:
• Customer Data Analysis: AI allows us to quickly analyze vast amounts of customer data to predict their needs and preferences, thereby improving customer experience [2].
• Targeted Marketing Campaigns: With AI, we can segment our offerings to different categories, such as spas, allowing for more detailed and targeted marketing campaigns specific to each segment’s needs [4].
• Marketing Automation: AI tools can automate various marketing tasks, such as email campaigns, social media management, and telemarketing, significantly enhancing our marketing efforts [3].
Your Role and Our Gratitude
Your unwavering support propels us forward as we strive to deliver groundbreaking solutions that improve lives. We are confident that our strategic focus on addressing critical healthcare challenges will yield significant benefits for both patients and shareholders.
Conclusion
We are excited about the future and the potential impact of our innovations on healthcare. Thank you for your continued trust and investment in ReGen Factor. Together, we stand poised to achieve remarkable milestones and drive sustained growth.
Warm regards,
Stephen Blignaut CEO ReGen Factor Pty Ltd 0430 960 262
References
1. FDA – Artificial Intelligence and Machine Learning in Software as
2. Persado – AI in Marketing: Benefits, Use Cases, and Examples
3. LinkedIn – The Impact of Generative AI on Writing and Reviewing
4. Online MBS – The power of AI: A digital marketer’s friend, foe or future?
5. Divi Engine – What is AI in Marketing: Benefits, Use Cases, and Examples
6. FDA – Artificial Intelligence and Machine Learning (AI/ML)
*Legal Disclaimer Disclaimer
The information contained in this shareholder update is for general informational purposes only. The information is provided by ReGen Factor Pty Ltd (“the Company”). While we endeavor to keep the information up to date and correct, we make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability, or availability with respect to the information, products, services, or related graphics contained in this document for any purpose. Any reliance you place on such information is, therefore, strictly at your own risk.
No Financial Advice
The content of this shareholder update does not constitute financial advice. The Company, its officers, and employees are not licensed financial advisers and are not authorized to provide financial advice. Nothing in this document should be construed as financial, investment, or other professional advice. We recommend that you seek independent financial advice from a qualified and licensed financial adviser before making any financial decisions.
Indemnity
To the fullest extent permitted by law, the Company and its officers, employees, agents, and affiliates shall not be liable for any loss or damage, including, without limitation, indirect or consequential loss or damage, or any loss or damage whatsoever arising from reliance on the information provided in this shareholder update. By reading this document, you agree to indemnify and hold harmless the Company, its officers, employees, agents, and affiliates from and against all claims, liabilities, damages, losses, and expenses arising out of or in connection with your use of the information contained herein.
Governing Law
This disclaimer is governed by the laws of New South Wales, Australia. Any disputes arising out of or in connection with this disclaimer shall be subject to the exclusive jurisdiction of the courts of New South Wales.
