09:49:14 EDT Thu 18 Apr 2024
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or Name
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RepliCel Life Sciences Inc (2)
Symbol RP
Shares Issued 21,442,584
Close 2018-01-24 C$ 0.56
Market Cap C$ 12,007,847
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RepliCel Life plans RCS-01 clinical trial in 2018

2018-01-25 07:55 ET - Shareholders Letter

Mr. Lee Buckler reports

REPLICEL CEO PROVIDES 2018 SHAREHOLDER UPDATE

RepliCel Life Sciences Inc. has provide an update to shareholders from its president and chief executive officer, R. Lee Buckler.

Dear shareholders,

I am very pleased to be providing this 2018 update. The company had a very successful 2017, which has only paved the way for a successful year as we enter into 2018. We are ramping up for expansion of all our programs and are actively focused on additional partnership discussions to drive the company toward maturation. These are exciting times and we look forward to sharing more news as RepliCel continues to gain momentum taking its place as a biotech industry leader.

Looking back over the past 24 months, 2016 was about restructuring and refinancing the company, 2017 was about delivering promised clinical and injector milestones, and now 2018 is about expansion.

With the rebuilding that the company has accomplished in the past 24 months, RepliCel has now set the stage to execute across multiple fronts over the next 24 months. Armed with clinical data, functioning device prototypes, a new partner committed to financing our programs in Greater China, and significant capital to execute our programs elsewhere through 2019, we have now positioned RepliCel to deliver on its next phase across several platforms at a faster pace.

We have continuing research programs at the University of British Columbia in Vancouver, the Shiseido-financed clinical research in Japan and our dermal injector development taking place in Europe. Expanding from there, we are laying plans for development programs with lead experts in North America and Europe, phase 2 clinical trials in Europe, new clinical trials in Hong Kong and mainland China, regulatory clarity with the United States Food and Drug Administration, and exploring other deals currently under discussion.

In 2018, shareholders should expect to see:

  • The launch of a European multicentre, phase 2 clinical trial measuring the impact of RCS-01 injections on aging skin;
  • Completion of commercial-grade prototypes for the RCI-02 dermal injector;
  • Filing of a CE-mark application for our dermal injector seeking the regulatory marketing approval needed to commercially launch the device in Europe and Hong Kong;
  • Preparations for launching the device in Hong Kong by licensing partner, YOFOTO (China) Health Industry Co. Ltd.;
  • Data from the clinical research being financed by Shiseido in Japan measuring the benefit of RCH-01 injections in men and women suffering from hair loss due to androgenic alopecia;
  • Data from the research program at UBC identifying different genetic marker expression profiles of various cell populations in the hair follicle with an aim of potentially improving cell selection, manufacturing and clinical outcomes;
  • The launch of tendon repair (RCT-01) and skin rejuvenation (RCS-01) clinical trial activity in Hong Kong and/or mainland China, financed by YOFOTO;
  • The launch of planned product development projects with various partners intended to add significant value to our programs;
  • A meeting with the FDA reviewing one or more of our programs;
  • Business development activity which may well lead to the execution of other commercial partnerships.

Unlike previous years, not only are we are financed to move through these milestones, we have new, significant non-dilutive financing commitments for much of this expansion, subject to successful closing of the deal with YOFOTO.

The pending investment from and partnership with YOFOTO, announced earlier this month, brings to RepliCel a new major shareholder committed not only to finance the programs licensed for Greater China but also to the overall success of the company. The dilutive investment upfront will be used to finance our programs outside of Asia. This will be counterbalanced with YOFOTO's financing of our programs in Greater China which will bring significant value to the company as they generate clinical data and commercialize products. RepliCel shareholders can also look forward to the company receiving further non-dilutive milestone and royalty payments as part of the YOFOTO partnership.

With the YOFOTO partnership including the dermal injector, we now have a commercial partner able to launch the device commercially in Hong Kong once we have obtained CE-mark approval. This means we now have commercial partnerships in place not only with the potential for near-term commercial launch of RCH-01 in Japan but also a near-term launch of the injector of the device in Hong Kong.

As I outlined in our September press release, we have leveraged our progress in 2017 into a very exciting pipeline of ongoing partnership discussions. While we have now announced the YOFOTO partnership focused on product development and commercialization in Greater China, we have other deals we are in a position to consider in the months ahead. These potential partnerships offer unique opportunities to position and capitalize the company on its path to increasing maturity.

About RepliCel Life Sciences Inc.

RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness and chronic tendon degeneration. These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function. The company's product pipeline comprises RCT-01 for tendon repair, RCS-01 for skin rejuvenation and RCH-01 for hair restoration. RCH-01 is currently being co-developed with, and under exclusive license by, Shiseido for certain Asian countries.

We seek Safe Harbor.

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