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 successfully positioned for growth
Mature private
Privately held emerging pharma company focused on topicals and inflammatory conditions
company
Late stage
PDUFA July 2020 on Wynzora™ (psoriasis), MAA EU 2020 + Ph3 and Ph2 ready assets
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 topical therapies
Leading topicals can be
significantly upgraded
❖ Penetration
New potent molecules
The innovative
❖ Stability
are difficult to formulate ❖ Tolerability
solution
❖ New patents
Costs of systemics are Annual patient cost
growing rapidly – need Biologics >$30,000
for new topicals Topicals ~ $2,000
Need to improve
treatment experience Upgrade!
and compliance
Leading topicals are greasy Non-greasy PAD™ creams
Vaseline-like formulations convenient in daily routines
© mc2 therapeutics 3
Rx pipeline: Mature and targeting major chronic inflammatory conditions
Program Active Ingredient Indication MC2 Rights Pre-Clinical Phase 2 Phase 3 Filing Launch
Worldwide US PDUFA July 20’ US H2-2020
MC2-01 Calcipotriene/BDP Psoriasis 1
2038 EU EU H1-2020
,
EU 2021
Worldwide
MC2-03 Ciclosporin Dry Eye 2020 TBD
2032
Worldwide
MC2-11 Tacrolimus AD/Inv. Psoriasis 2020 TBD
2037
Worldwide
MC2-22 Crisaborole AD and Psoriasis 2037 2020 TBD
FTO 2027-30
Worldwide
MC2-25 Undisclosed Uremic Pruritus 2020 TBD
2038
© mc2 therapeutics 4
Our business focus areas are synergistic and enhances brand value of PAD™ Tech
Rx data enhances attention on
BioMee™ and Tech License
Rx
PAD™ Tech License brings
credibility to Rx and BioMee™ BioMee™ is a novel range of PAD™
PAD™ Tech BioMee™ based consumer healthcare products
Non-Rx designed for dry and sensitive skin
License
Enables promotion of PAD™ creams
as a new vehicle for Rx and
interactions with patients and
physicians
© mc2 therapeutics 5
Experienced leadership team
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 Commercial Strategy Marketing and Sales
Morten Præstegaard, PhD (BioImage spin-off) Christopher Billis Dermatology
Chief Operating Officer Chief Commercial Officer
© mc2 therapeutics 6
Support by experienced board of directors and strong owners
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
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 7
PAD™ Technology
- introducing a paradigm shift in topicals
© mc2 therapeutics 8
Optimal topical therapies for chronic conditions must meet three criteria
Actives Formulation Compliance
Safe and potent Optimal delivery Want to use in
to target tissue daily routines
Releasing full clinical potential in real life
© mc2 therapeutics 9
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 10PAD ™ structure – a new tool for effective relief of symptoms and high convenience
Conventional cream PAD™ Technology
oil drop structure oil drop structure Scanning electron
microscopy image of
Water PAD™ droplet
Excess ✓ 10-20 fold less
Emulsifiers
Oil Oil
Fragile ✓ Thick & robust
Shell structure
1 µm
PAD™ Benefits
✓ Optimizes efficacy by improved delivery of actives (no API clustering)
Less emulsifiers
✓ No stinging – high tolerability
Robust shell ✓ Enables stable water-based formulations of potent but unstable molecules
Contains water ✓ Very pleasant in daily routines - non-greasy, moisturizing, easy to spread
© mc2 therapeutics 11Ph3 data on Wynzora™ Cream for plaque psoriasis -
Head-to-head trial against branded Taclonex® Topical Suspension
(0.005% w/w calcipotriene + 0.064% w/w betamethasone dipropionate cream)
© mc2 therapeutics 12Rationale: Improve the best topical therapy for psoriasis (fixed-dose CAL/BDP)
Calcipotriene (CAL) Betamethasone diproponate (BDP)
Dual synergy
Higher efficacy than each of the monads – synergistic dual MoA of CAL and BDP
Favorable safety profile - CAL and BDP mitigate each others potential adverse effects1
PAD™ Tech is the only way to make an
aqueous formulation – PAD™ cream
✓ Optimal delivery of actives to target tissue
✓ Non-greasy and moisturizing
© mc2 therapeutics 13 1. Norsgaard et al. Arch Dermatol Res (2014) 306:719–729Ph3 trial to evaluate efficacy and safety of Wynzora™ Cream compared to Taclonex® TS
Screening 8 week treatment period – 1x daily Follow-up
Baseline Week 8
Wynzora™ Cream (n~342)
Adults
mild to
R Wynzora™ vehicle (n~115) 2 week follow-up
moderate
psoriasis
Taclonex Topical Suspension (n~337)
© mc2 therapeutics 14Wynzora™ demonstrates significantly higher treatment success than Taclonex® TS
Primary efficacy variable: PGA Treatment Success
50
Wynzora™ Cream
Taclonex Topical Suspension ****
40
% PGA Treatment Success
Vehicle Cream ****
30 ****
20
(*) p = 0.05
10 Wynzora™ vs Taclonex TS
(*)
**** p < 0.0001
Wynzora™ vs Taclonex TS
0
0 2 4 6 8
Weeks
© mc2 therapeutics 15Wynzora™ Cream demonstrates significantly better reduction in mPASI than Taclonex® TS
Secondary efficacy variable: Percentage Change in mPASI from Baseline
80
Wynzora™ Cream
70
% Change in mPASI from Baseline
Taclonex Topical Suspension ****
****
60 Vehicle Cream
****
50
40
30 ***
*** p < 0.001
20
(Wynzora™ vs Taclonex TS)
10 **** p < 0.0001
(Wynzora™ vs Taclonex TS)
0
0 2 4 6 8
Weeks
© mc2 therapeutics 16Wynzora™ Cream is more convenient to use than Taclonex® Topical Suspension
Secondary PRO: Patients treatment convenience scale
Patient Treatment Convenience Scale 50
Wynzora™ Cream
Vehicle Cream
45
****
****
****
40
35
**** p < 0.0001
Wynzora™ vs Taclonex TS
30
0 2 4 6 8
Weeks
© mc2 therapeutics 17Wynzora™ Cream shows significant and clinically meaningful reduction of itch
Proportion of subjects with ≥4-point improvement of itch on 11-point NRS scale
80
% ≥4-point improvement of NRS Itch Wynzora™ Cream
70 **
Vehicle Cream
**
60
50
40
30
20
** p < 0.01
10
Wynzora™ vs Taclonex TS
0
0 2 4 6 8
Weeks
© mc2 therapeutics 18Wynzora™ Cream has significant PASI 75 treatment success
Other efficacy variable: PASI 75 Treatment Success
50
Wynzora™ Cream
**
Taclonex Topical Suspension
40
Vehicle Cream
**
% PASI 75
30
**
20
10
** p < 0.01
Wynzora™ vs Taclonex TS
0
0 2 4 6 8
Weeks
© mc2 therapeutics 19No adverse reaction >1% observed for Wynzora™ Cream in US phase 3
Very few adverse
No SAEs Mild adverse events
reactions
No SAEs with relationship to Very few adverse reactions The majority of adverse
study medication was related to Wynzora™ Cream events were mild and
observed in the US phase 3 substantiates attractive occurred at a frequency
trial (MC2-01-C2) safety profile similar to vehicle
All adverse reactions
observed in US phase 3 trial
had a frequency < 1%
© mc2 therapeutics 20BioMee™ (PAD™ Non-Rx pipeline)
MC2-02 Anti-itch
MC2-10 Sanitizer
MC2-18 Barrier
MC2-21 Dry Skin
MC2-26 Sunscreen
© mc2 therapeutics 21BioMee™ is an unprecedented valuable tool to promote PAD™ Cream and Rx vehicles
BioMee™ Creams are designed for sensitive skin
Promote PAD™ Cream as new
vehicle for topical drugs
• Emulsifiers are required in oil-in-water formulations like
creams and lotions
• Too much emulsifier may cause or enable skin irritation
especially on sensitive skin
• BioMee™ Creams have multifold less emulsifierBioMee™ - unique PAD™ based skincare product line for dry and sensitive skin
Program Type MC2 Rights Health claim Clinical data Launch
Cosmetic / Med. Worldwide Dry skin: Designed for chronic dry skin associated with
MC2-21 H2-2019 H1-2020
Device 2024 filaggrin deficiency
Cosmetic / Med. Worldwide
MC2-02 Anti-itch: Designed for itchy skin H1-2020 H1-2020
Device 2038
Cosmetic / Worldwide Sanitizer: World’s first cream-based sanitizer
MC2-10 H2-2019 H1-2020
antiseptic 2026 Moisturizing and meeting hospital standards
Barrier: Designed to protect skin against toxins and
Cosmetic / Med. Worldwide
MC2-18 harsh skin conditions thereby preventing contact Q1-2020 H1-2020
Device 2024
dermatitis
Worldwide
MC2-26 Sunscreen Sunscreen: Designed for sensitive skin – SPF 50 TBD 2021
2024
© mc2 therapeutics 23We 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 24
integrating contributors and partnersRelease your full
potential
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