Building leadership in topical therapies for chronic inflammatory conditions

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Building leadership in topical therapies for chronic inflammatory conditions
PAD™ Technology - releasing the full potential

                         Building leadership in topical therapies for chronic inflammatory
                         conditions

© mc2 therapeutics  1
Building leadership in topical therapies for chronic inflammatory conditions
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
Building leadership in topical therapies for chronic inflammatory conditions
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
Building leadership in topical therapies for chronic inflammatory conditions
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
Building leadership in topical therapies for chronic inflammatory conditions
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
Building leadership in topical therapies for chronic inflammatory conditions
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
Building leadership in topical therapies for chronic inflammatory conditions
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
Building leadership in topical therapies for chronic inflammatory conditions
PAD™ Technology
                  - introducing a paradigm shift in topicals

© mc2 therapeutics  8
Building leadership in topical therapies for chronic inflammatory conditions
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
Building leadership in topical therapies for chronic inflammatory conditions
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  10
PAD ™ 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  11
Ph3 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  12
Rationale: 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) 306:719–729
Ph3 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  14
Wynzora™ 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  15
Wynzora™ 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  16
Wynzora™ 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  17
Wynzora™ 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  18
Wynzora™ 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  19
No 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  20
BioMee™ (PAD™ Non-Rx pipeline)
                  MC2-02 Anti-itch
                  MC2-10 Sanitizer
                  MC2-18 Barrier
                  MC2-21 Dry Skin
                  MC2-26 Sunscreen

© mc2 therapeutics  21
BioMee™ 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 emulsifier
BioMee™ - 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  23
We 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 partners
Release your full
            potential

© mc2 therapeutics  25
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