Welcome to ReGen Factor’s latest quarterly update.
Since our last update in May, your
company has been working hard to progress our goals of FDA approval for PepFactor
and, corporately to pursue the ASX listing of the Company.
To support these goals, we have implemented a number of significant changes,
designed to best position the business to achieve these objectives.
New FDA consultant engagement
ReGen Factor is in the process of engaging new FDA consultants, Brij Strategic
Consultations, LLC (trading as FDAMap), to manage the FDA application process for
PepFactor Scalp to treat androgenetic alopecia (hair loss), our lead application for
PepFactor. FDAMap has decades of experience specialising in FDA applications for new
drugs.
FDAMap will work with regulators, government agencies, and other relevant
stakeholders to build ReGen Factor’s platform for regulatory submissions, clinical trials,
and quality assurance along the FDA approval pathway. FDAMap has reviewed our
current research and clinical data and has indicated their favourable view of our FDA
approval application. Clinical trial planning is scheduled to commence later this year.
New advisory board appointment
We are delighted to announce the appointment of Associate Professor Veysel Kayser of
the School of Pharmacy at the University of Sydney to the advisory board of ReGen
Factor. A. Prof Veysel has vast relevant experience and he is a key appointment for
ReGen Factor. He received his PhD from the University of Leeds (UK) and then
performed post-doctoral research at the Max-Planck Institute (Germany) and at MIT
(US). Before joining the University of Sydney, he was a senior scientist at MIT.
Apart from his extensive work with vaccines, including working with flu and Covid
vaccines, A. Prof Veysel has extensive expertise in growth factors. This includes work
on the development of biologics including therapeutic monoclonal antibodies (mAbs)
and antibody-based products, biosimilars and next-generation biologics (biobetters),
plus formulation of biologics, protein folding and aggregation, and molecular
engineering of biopharmaceutical products. He also has extensive experience working
with regulatory bodies such as the TGA and FDA.
We are looking forward to his experience driving ReGen Factor towards our research
and regulatory goals. Welcome to the team, A. Prof Veysel.
PepFactor sales and distribution update
Appointment of new distributor – Poland
We are pleased to announce the appointment of Well Concept as our exclusive
PepFactor distributor in Poland. Well Concept is managed by Aleks and Weronika
Slupek, who is the lead trichologist in Poland and has authored several books on
trichology and is a leading hair restoration expert. Well Concept boasts an extensive
network in Poland, and they plan to introduce the benefits of PepFactor Scalp to their
network and build a sales and distribution footprint for PepFactor in Poland and
surrounding countries.
Appointment of new distributor Dubai and UAE excluding Kuwait
Remak Medical, managed by Dr Khalid Remaly has been appointed as our exclusive
distributor for the UAE region, based in Dubai. Since its inception in 2003, Remak
Medical has established a successful track record in introducing, building, and
developing profitable brands in the fields of biotechnology products and medical
devices. We are excited to work with Remak and anticipate a high volume of sales
throughout the region in the coming months and years.
New websites
We have appointed MTB Strategies to develop new websites for both ReGen Factor
and PepFactor. The ReGen Factor website will be aimed toward the investor market
and will serve as a point of reference for all industry and company news as well as
answering the most commonly asked questions investors have of our company.
The PepFactor website will be aimed to serve the B2C and B2B markets for PepFactor,
and will include a practitioner portal for wholesale purchasers where marketing
material, consultation forms, usage instructions, and order placement will be accessible
within one place. At-home purchasing will also be possible within the site.
PepFactor 21-Day Challenge – launching soon
ReGen Factor is planning to launch an innovative new marketing strategy for
PepFactor and device sales within the skin care industry. A new skincare bundle
available to clinicians combines PepFactor Hyaluronic acid with our skin analysis
machine and multimodal skin treatment device to provide accurate reports on clients’
skin pre and post-PepFactor treatment over a 21-day period.
Initial trials have been conducted and have shown a skin age reversal of up to 10 years
when combining PepFactor treatments with PepFactor Hyaluronic acid use over the
21-day period. The marketing materials for this campaign are being produced and the
campaign is planned to be launched in this month, with a large marketing focus on Skin age results were obtained using PepFactor’s skin analysis device on one subject. Scans were completed on day one and a PepFactor Hyaluronic Acid treatment was performed and daily administration of PepFactor Hyaluronic Acid serum was completed for twenty-one days. Scans were retested on day twenty-one with a skin age reduction of 10 years.
USA, Australia and UK markets initially. We are anticipating a high uptake within the
skincare industry for both individuals and salons alike.
New Lead Manager Appointed
ReGen Factor has appointed KS Capital as our new lead manager for our capital raising
requirements, including our proposed Initial Public Offer (IPO) and ASX listing. ReGen
Factor and KS Capital plan to commence a pre-IPO capital raise in H2 calendar 2022,
with the funds raised designed to support our FDA application, PepFactor trials and
research projects with Sydney University. Beyond this, we aim to initiate ASX listing
plans in early 2023.
KS Capital will replace Barclay Pearce, who provided invaluable early capital support to
ReGen Factor, and we would like to thank Barclay Pearce Capital for their support of the
business.
We thank you for your continued support as we work to bring PepFactor through the
FDA approval process, to see it achieve its ultimate goal of securing FDA approval for
the treatment of hair loss.
Yours sincerely
Stephen Blignaut
Founder and CEO
ReGen Factor Pty Ltd
