Building leadership in topical therapies for chronic inflammatory conditions
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PAD™ Technology - releasing the full potential
Building leadership in topical therapies for chronic inflammatory
conditions
© mc2 therapeutics 1
Highlights – MC2 is ready to leverage its favorable position in topicals
Mature private
Privately held emerging pharma company focused on topicals and inflammatory conditions
company
Late stage
Launch in psoriasis 2020/21 (US and EU) + other Ph3/2 assets and strong news flow
pipeline
PAD™ enables a
PAD™ Technology – an innovative solution enabling an array of new topical therapies
paradigm shift
Significant market
Market dynamics provide a unique opportunity for MC2 to build leadership in topicals
opportunity
© mc2 therapeutics 2
MC2 is addressing attractive opportunities in the topical dermatology industry
Leading topicals can be
significantly upgraded
❖ Penetration
New potent molecules
The innovative
❖ Stability
are difficult to formulate ❖ Tolerability
solution
❖ New patents
Annual patient cost
Payers need new tools
to defend topicals Biologics $20 - 60,000
Topicals ~ $2,000
Patients are longing for
convenience in daily Greasy!
routines
Current leading formulations Not doable in daily routines –
are ointments, liquid oils very low compliance
© mc2 therapeutics 3
Our business focus areas are synergistic and enhances brand value of PAD™ Tech
Rx data enhances attention
on BioMee and Tech License
Rx
PAD™
PAD™ Tech License brings
credibility to Rx and BioMee
Tech
BioMee is a novel range of PAD™
PAD™ Tech BioMee based consumer healthcare products
Non-Rx designed for dry and sensitive skin
License
Enables pre-launch promotion of
PAD™ based Rx vehicles and
interactions with patients and
physicians
© mc2 therapeutics 4
Experienced leadership team with a history of commercialization success
Executive Previous Experience Executive Previous Experience
Business Development
Jesper J. Lange, LLM Attorney - Partner - M&A Ann Kristin Led, Exec. VP Director
President & CEO Finance & Strategy
Senior Medical Scientist Various managerial Head of Business Research Analyst
Johan Selmer, MD positions Frédéric Gomez, Msc Development
Chief Medical Officer Business Development
Research Manager Department Manager
Morten Præstegaard, PhD (BioImage spin-off) Samia Kappe, Exec. VP Chief Executive Officer
Chief Operating Officer Sales & Marketing EU
Commercial Strategy Marketing and Sales
Christopher Billis Dermatology
Chief Commercial Officer
© mc2 therapeutics 5
Support by experienced board of directors and strong investors
Board of Directors
Name Experience
Mads Clausen Led the establishment of MC2 Therapeutics and serves as Chairman of the Board
Chairman and Owner
Paul L Berns Appointed as President and Chief Executive Officer of Anacor Pharmaceuticals Inc. in 2014, prior to the
Director company’s acquisition by Pfizer in June 2016
Anders D. Hove, M.D. Served most recently as a managing general partner at Venrock Associates (“Venrock”), a venture capital
Director firm, which he joined in 2004 focusing on private and public biotech investments
Mette Vagner Johannesen Held executive roles in finance, strategy, HR, administration and general management
Director
Jesper J. Lange, LL.M. Co-founder of MC2 Therapeutics and joined the company from his position as partner in a major Danish
Director law firm
Investors / Owners
Name Commentary
Mads Clausen Grandson of Danish industrialist and founder of Danfoss A/S
Johan Schrøder family Former owner of Radiometer A/S
© mc2 therapeutics 6
PAD™ Technology
- introducing a paradigm shift in topicals
© mc2 therapeutics 7
Optimal topical therapies for chronic conditions must meet four criteria
Actives Formulation Compliance Hydration
Safe and potent Optimal delivery Want to use in Helps barrier
to target tissue daily routines repair and itch
Releasing full clinical potential in real life
© mc2 therapeutics 8
PAD™ Technology is challenging status quo – introducing a new standard of topicals
Trial efficacy
All-in-one
• Releasing full efficacy potential
• High convenience in daily routines
Paradigm
• Moisturizing the skin
shift
High
PAD™
Non-aqueous aqueous
e.g. greasy formulations
ointment or
liquid oil
Aqueous
e.g. cream,
Low lotion
Comfortable – absorbs quickly, easy
to apply and moisturizes skin
Low High (preferred by patients in daily routines)
© mc2 therapeutics 9
PAD ™ structure – a new tool for effective relief and high convenience
Conventional cream PAD™ Technology
oil drop structure oil drop structure
Water
Excess ✓ 10-30 fold less
Surfactants
Oil Oil
Fragile shell ✓ Thick & robust
Shell structure
PAD™ Benefits
✓ Optimizes efficacy by improved delivery of actives (no API clustering)
Low surfactants
✓ No stinging – high tolerability
Robust shell ✓ Enables stabile water-based formulations of potent but unstable molecules
Contains water ✓ Very pleasant in daily routines - non-greasy, moisturizing, easy to spread
© mc2 therapeutics 10The high impact of PAD™ is demonstrated in several projects
Psoriasis US Ph3: MC2-01 is significantly better than leading NDA ready Atopic dermatitis: PAD™ Tacrolimus outperforms Protopic® in Preclinical
brand Taclonex® TS – same % actives allergic contact dermatitis pig model
50
% PGA Treatment Success
MC2-01 Cream
40
Taclonex ****
MC2-01 Vehicle ****
30
****
20
10
0
0 2 4 6 8
Weeks
Dry Eye: PAD™Cciclosporin – high efficacy in severe keratitis Phase 2 Atopic dermatitis: PAD™ crisaborole 2% has better delivery to dermis
Preclinical
(dry eye) patients than Eucrisa® (minipig biopsies)
80% p=0.023 6000
2-grade corneal staining
70% Dermis
5000
ng/g crisaborole
60% p=0.003
p=0.020
responders
50% 4000
40% 3000
30%
2000
20%
10% 1000
0% 0
Month 1 Month 3 Month 6
0.03% CsA Vehicle Lubricant
© mc2 therapeutics 11
n = 25 per group, non-imputed dataPAD™ formulations are even more pleasant than conventional creams – paradigm shift
Conclusion on cosmetic acceptance comparing PAD™ Vehicle to conventional creams:
”Overall the PAD™ Vehicle was considered to be the main formulation having highest patient acceptance”
Formulation preference* Quotations from physicians
35
USA ”This is closer to
Preferred by % respondents
30 Germany cosmetics than
conventional drugs
Japan ”It feels elegant on the
25 (Japan)”
skin – it’s easily
spreadable and does not “The advantage over the others is
20
leave much residue (USA)” that it spreads well and vanish
15 quickly – you can put on clothes
quickly; you do not have to wait or
10 wonder whether you can put on a
white shirt because greasy spots
5 may appear (Germany)”
0
Cream A Cream B PAD™ Vehicle
*N=70 Physicians (USA 30, EU 20 and Japan 20)
Study performed by third party
© mc2 therapeutics 12MC2 Rx Pipeline
MC2-01 Psoriasis
MC2-03 Dry Eye
MC2-11 Atopic Dermatitis
MC2-22 Atopic Dermatitis
MC2-25 Uremic Pruritus
© mc2 therapeutics 13Rx pipeline: Mature and targeting major chronic inflammatory conditions
Program Active Ingredient Indication MC2 Rights Pre-Clinical Phase 2 Phase 3 Filing Launch
Worldwide US US Q3-2019 US H2-2020
MC2-01 Calcipotriene/BDP Psoriasis 1
2038 EU EU H1-2020
,
EU 2021
Worldwide EU 2024
MC2-03 Ciclosporin Dry Eye Start 2020
2032 US TBD
Worldwide
MC2-11 Tacrolimus AD/Inv. Psoriasis H1 2020 2024
2037
Worldwide
MC2-22 Crisaborole AD and Psoriasis 2037 2020 TBD
FTO 2027-30
Worldwide
MC2-25 Undisclosed Uremic Pruritus 2020 2024
2038
© mc2 therapeutics 14BioMee™ (PAD™ Non-Rx pipeline)
MC2-02 Anti-itch
MC2-10 Sanitizer
MC2-18 Barrier protection
MC2-21 Dry Skin
MC2-26 Sunscreen
© mc2 therapeutics 15PAD™ offers a unique vehicle branding opportunity – “New pearl in dermatology” © mc2 therapeutics 16
BioMee™ Health: Unique non-Rx products that also supports Rx launch activities
Program Type MC2 Rights Health claim Clinical data Launch
Cosmetic / Med. Worldwide Severe dry skin: Designed for severe dry skin
MC2-21 H2-2019 H2-2019
Device 2024 associated with filaggrin deficiency
Cosmetic / Med. Worldwide
MC2-02 Anti-itch: Designed for aged itchy and dry skin TBD 2020
Device 2038
Sanitizer: World’s first cream based sanitizer
Cosmetic / Worldwide
MC2-10 Designed as a truly moisturizing sanitizer meeting H2-2019 US H2-2019
antiseptic 2026
hospital standards
Barrier Protectant: Designed to protect skin against
Cosmetic / Med. Worldwide
MC2-18 occupational toxins and harsh skin conditions thereby Q1-2020 H2-2019
Device 2024
preventing contact dermatitis
Worldwide
MC2-26 Sunscreen Sunscreen: Designed for sensitive skin – SPF 50 TBD 2020
2024
© mc2 therapeutics 17BioMee: The new brand of innovative non-Rx therapies for dry and sensitive skin
Unmet need Market
10-20% of the global population suffers from dry, itchy and The OTC and consumer care markets are very large and
sensitive skin for various reasons growing and is to a large extent driven by marketing muscles
BioMee is the brandname of a new range of innovative patented BioMee™ Health product line is an excellent tool to promote the
PAD™ enhanced creams (non-Rx) designed for various types of new PAD™ creams to physicians and patients ahead of Rx
dry and sensitive skin launches and offer differentiated therapies
Life companions for consumers and professionals BioMee™ Beauty has the potential to evolve into a valuable
consumer brand
Data MC2-02 Cream improved severe dry skin in filaggrin Next milestone
deficient patient and reduced use of steroids
Q419’: Data from clinical trial of Dry Skin in moderate to severe
dry skin patients
Q419’: Launch of new products covering Dry Skin, Barrier,
Sanitizer and Itchy Dry Skin
August 21st, 2018 Nov 14th 2018
© mc2 therapeutics 18We make topical products that patients want to use
By using PAD™ vehicles to release
the full potential of active ingredients
We make topical products
that patients WANT TO USE
Pleasant, effective drugs,
medical devices & cosmetics
in elegant dispensers
Network oriented business model
© mc2 therapeutics 19
integrating contributors and partnersRelease your full
potential
© mc2 therapeutics 20You can also read
