We are delighted to provide you with an update on the strategic initiatives and recent
progress as ReGen Factor advances innovative solutions in skin biology.

Read the update below:

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.

Strategic Focus: Diabetic Ulcers and Diabetic Eye Complications

After careful consideration and extensive research, the Company has taken the decision to
prioritize treatment of diabetic ulcers and diabetic eye complications (specifically diabetic
retinopathy) as the first application to seek US FDA approval 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 11.06 billion in 2023 and is projected to grow significantly, reaching around USD 20.21 billion by 2035, with a compound annual growth rate (CAGR) of about 5.15% during the forecast period. With the increasing prevalence of diabetes and chronic wounds, there is a substantial demand for effective treatment options¹.

o Diabetic Eye Complications: The global market for diabetic retinopathy was valued at approximately USD 8.76 billion in 2023 and is projected to grow to around USD 15.33 billion by 2032, exhibiting a compound annual growth rate (CAGR) of 6.41% during the forecast period².

2. Therapeutic Potential of rh bFGF:

o Our rh bFGF growth factor 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 may allow us to share resources, streamline regulatory processes, and reduce overall costs.

o Accelerated Timelines: Parallel trials may expedite data collection and regulatory submissions, potentially leading to faster market entry.

o Robust Data: The comprehensive data from these trials may 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 is already approved in Japan for wound healing, and 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.

Commitment to Androgenetic Alopecia

The change in focus to pursuing FDA approval for the treatment of diabetic ulcers and diabetic eye complications do not deter us from our initial plan to seek FDA approval for treating androgenetic alopecia (pattern baldness) in men and women. Our work in this field over a number of years has delivered positive outcomes and we remain committed to pursuing this application as part of the Company’s longer-term plans to pursue regulatory approval for a range of treatment applications using its growth factor technology. The Company has determined that pursuing FDA approval for the treatment of diabetic ulcers and diabetic eye complications as a first clinical indication is a preferred option at this point. It will allow us to target a larger unmet market need and may potentially have a shorter timeframe to approval (subject to positive trial results).

Future Focus on Acne Vulgaris

We also plan to focus on securing FDA approval for treating acne vulgaris (acne). This condition affects a large portion of the population, and our preliminary data and anecdotal successes suggest that rh bFGF may offer a highly effective treatment option.

Strategic Progress and Future Plans

o Pre-IND Meeting and IND Submission: We have made significant strides in preparing for the pre-IND meeting and subsequent IND submission for the diabetic ulcer and diabetic eye complications indications. These steps are critical in our journey towards obtaining FDA approval and bringing our innovative treatments to market.

o 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.

o 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. We are confident that our strategic focus on addressing critical healthcare challenges will yield significant benefits for both patients and shareholders in the future.

Conclusion

Thank you for your support of 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. Zion Market Research. (2023). "Diabetic Retinopathy Market Size, Share, Trend, Outlook,
Forecast 2024-2032." Retrieved from Zion Market Research.
2. Skyquest. (2024). "Diabetic Retinopathy Market Size, Share, Growth Analysis, By Type,
Management - Industry Forecast 2024-2031." Retrieved from Skyquest.
3. Straits Research. (2024). "Diabetic Retinopathy Market Size, Trends and Growth Analysis
2032." Retrieved from Straits Research.
4. Grand View Research. (2023). "Diabetic Retinopathy Market Size And Share Report, 2030."
Retrieved from Grand View Research.
5. Market Data Forecast. (2023). "Diabetic Retinopathy Market Size, Share | 2024 to 2029."
Retrieved from Market Data Forecast.
6. U.S. Food and Drug Administration. (2016). FDA approves Integra Omnigraft Dermal
Regeneration Matrix to treat diabetic foot ulcers. Retrieved from FDA.gov.
7. U.S. Food and Drug Administration. (2019). Premarket Approval (PMA) - Dermagraft.
Retrieved from Accessdata.fda.gov.
8. U.S. Food and Drug Administration. (1998). Apligraf - Summary of Safety and Effectiveness
Data. Retrieved from FDA.gov.

Footnotes

1. Zion Market Research. (2023). "Diabetic Retinopathy Market Size, Share, Trend,
Outlook, Forecast 2024-2032." Retrieved from Zion Market Research. ↩
2. Skyquest. (2024). "Diabetic Retinopathy Market Size, Share, Growth Analysis, By
Type, Management - Industry Forecast 2024-2031." Retrieved from Skyquest. ↩
3. Straits Research. (2024). "Diabetic Retinopathy Market Size, Trends and Growth
Analysis 2032." Retrieved from Straits Research. ↩
4. Grand View Research. (2023). "Diabetic Retinopathy Market Size And Share Report,
2030." Retrieved from Grand View Research. ↩
5. Market Data Forecast. (2023). "Diabetic Retinopathy Market Size, Share | 2024 to
2029." Retrieved from Market Data Forecast. ↩
6. U.S. Food and Drug Administration. (2016). FDA approves Integra Omnigraft Dermal
Regeneration Matrix to treat diabetic foot ulcers. Retrieved from FDA.gov. ↩

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.

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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.