Building leadership in topicals for Immunology and Inflammation (I&I) - Q3 2021 Global company presentation

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Building leadership in topicals for Immunology and Inflammation (I&I) - Q3 2021 Global company presentation
Building leadership in topicals for Immunology and Inflammation (I&I)

                       Global company presentation

                                Q3 2021
Building leadership in topicals for Immunology and Inflammation (I&I) - Q3 2021 Global company presentation
MC2 is positioned for significant growth and leadership in topical therapies for I&I

Commercial-stage company       Wynzora® Cream for plaque psoriasis is on track for US and EU launch in 2021

Strong pipeline                First or best-in-class drugs also for indications with no approved therapies

Transformative technology      PAD™ Technology enables a new standard of topical therapies

Strong leadership and owners   Successful strategy execution - from concept through approval to global launch

Unique branding opportunity    PAD™ based biomee™ skin care line provides an unprecedented stakeholder engagement

 2   | © MC2 Therapeutics
Building leadership in topicals for Immunology and Inflammation (I&I) - Q3 2021 Global company presentation
Our strategy is fully developed to accelerate growth and build leadership

                                                                                                                      3

                                                                           2                                    Long term
                                                                        Ongoing                               Build Leadership

                                 1                         Commercialize/Roll Out and Growth

                             Existing                                                             Gain significant market share of topicals
                Leverage existing favorable position                                                                in I&I
                                                           Launch of Wynzora® in US and EU +
                                                                                                   Own first or best-in-class therapies in
                                                                     partner RoW
                                                                                                           attractive indications
           Mature infrastructure and expertise in       Continue development of attractive high
          formulation, R&D and commercialization                                                      Position MC2 Therapeutics as
                                                                    value pipeline
                                                                                                   a Thought Leader in topicals for I&I
           Wynzora® and novel biomee™ skin care           Engage in strategic new opportunities
             Strong pipeline and PAD™ Technology              to further accelerate growth

                               Strategy executed by experienced management supported by strong and engaged owners

 3   | © MC2 Therapeutics
Building leadership in topicals for Immunology and Inflammation (I&I) - Q3 2021 Global company presentation
PAD™ Technology
– a paradigm shift in topicals
Building leadership in topicals for Immunology and Inflammation (I&I) - Q3 2021 Global company presentation
Unmet need for topical drugs combining the three essentials in a single product

                                                            The three essentials of topical treatment
                               Many patients are dissatisfied with currently available drugs due to lack of one or more of the three essentials

                              High                                           High tolerability                                         Adherence
                             efficacy                                           and safety                                             to therapy

     Optimal delivery of actives to target                             Application site safety and                             Pleasant, easy and fast
        tissue releasing full potential                                   limited adverse events                               to use in daily routines
      Some topicals are compromised                                     High efficacy often comes                        Treatment options based on greasy
      due to poor drug delivery or lack                              at the price of a less favourable                    formulations are time-consuming
             of molecule potency                                               safety profile                                resulting in discontinuation

                                              Releasing full clinical potential of therapy in real-world setting
 5    | © MC2 Therapeutics
Building leadership in topicals for Immunology and Inflammation (I&I) - Q3 2021 Global company presentation
MC2 has developed the most powerful vehicle for topicals

               releasing the full potential
Building leadership in topicals for Immunology and Inflammation (I&I) - Q3 2021 Global company presentation
PAD™ Technology – a quantum leap in formulation of topical therapies

           1                                                                                                                              2
                             Stability and solubility                                                Delivery and efficacy
                             Robust oil drop structure protects                                      Optimized delivery of active
                             molecules from degradation and                                          ingredients into target tissue -
                             enables a new formulation space                                         releasing the full potential
                             allowing for a new array of topicals

                                                                               Oil
           3                                                                                                                              4
                             Safety and tolerability                                                 Convenience and adherence
                             Several-fold less emulsifiers                                           Unique pleasant feel and fast
                             compared to conventional                                                absorption into the skin –
                             creams and lotions supporting a                Surfactants
                                                                                                     designed to improve usage into
                             very favorable tolerability profile                                     daily routines

                            PAD™ Technology is our cornerstone in our topical therapies which addresses a clear unmet need for patients

 7   | © MC2 Therapeutics
Pipeline: Leveraging years of research into the
pathology of poorly understood diseases:
➢   First or best-in-class topicals
➢   New treatment paradigms in I&I
Pursuing first or best-in-class topical therapies and new treatment paradigms

                                          Dry eye incl. in
                                         Sjögren patients                                      Uremic pruritus                                     Lichen sclerosus        Vitiligo         Atopic dermatitis

                                                                                                          4-5%2                                                Un-
                                                  4-5%1                                                                                                                    0.5-2%4                 >8%5
        Patient                                                                                                                                              known3
       population
      (US and EU,
        millions)
                                               ~35M                                                 ~35M                                            Orphan?              4-15M                  ~55M

                                        Currently no                                          Currently no                                        Currently no           Currently no     Need to manage rising
                                     approved drug for                                      approved drug –                                     approved drug –        approved drug –      costs of systemics
                                   Sjögren Syndrome dry                                    significant unmet                                   significant unmet      significant unmet   through a significantly
                                      eye. Significant                                   need. Breakthrough in                                need. Breakthrough             need            improved topical
     Unmet needs
                                        unmet need                                           understanding                                      understanding of                                 therapy
                                                                                         pathology - patented                                 pathology - patented

1. Sjögren’s foundation
2.Hill NR et al Global Prevalence of Chronic Kidney Disease - A Systematic Review and Meta-Analysis. PLoS One. 2016 Jul 6;11(7):e0158765
3. Melnick et al. Lichen sclerosus among women in the United States, International Journal of Women's Dermatology, Volume 6, Issue 4, 2020, Pages 260-262,
4. Bergqvist C, Ezzedine K: Vitiligo: A Review. Dermatology 2020;236:571-592.
5. aafa.org

 9   | © MC2 Therapeutics
Strong pipeline focusing on first or best-in-class topicals for major I&I conditions
  Program                  Active Ingredient      Indication        MC2 Rights     Pre-Clinical   Phase 2        Phase 3   Filing   Launch Est.

                                                                                                                 US                  Launched
  Wynzora®                  Calcipotriene                           Worldwide
                                               Plaque Psoriasis
   Cream                        + BDP                                 2039
                                                                                                            EU                       Q4 2021

                                                                    Worldwide
  MC2-03                     Ciclosporin       Sjögren Dry Eye                                                   Q1 2022               TBD
                                                                      2036

                             Repurposed                             Worldwide
  MC2-25                                       Uremic Pruritus                                    Q1 2022                              TBD
                           Known Molecule                             2038

                             Repurposed                             Worldwide
  MC2-27                                       Lichen Sclerosus                                   Q1 2022                              TBD
                           Known Molecule                             2040

                                                                    Worldwide
  MC2-11                     Tacrolimus         Vitiligo and AD                                                                        TBD
                                                                      2037

                                                                    Worldwide
  MC2-22                     Crisaborole       Atopic Dermatitis                                                                       TBD
                                                                   2038, FTO 27’

 10 | © MC2 Therapeutics
MC2-03: Targeting first approved treatment of Sjögren Syndrome dry eye

 Introduction to Sjogren Syndrome dry eye1                                                                                                      MC2-03 value proposition
                                How Sjögren’s syndrome can affect the body
                                                                                                                                                ▪ Addressing a clear unmet need for a therapy that effectively and
                     Brain fog                                                   Dry eyes                                                         tolerably provides relief of symptoms

                       Fatigue                                                   Dry mouth
                                                                                                                                                ▪ Targeting first approved treatment based on a well-known molecule and
           Swollen glands                                                                                                                         PAD™ Technology
                                                                                 Dental problems
            Chronic cough
                                                                                                                                                ▪ Potential for expansion into general dry eye and ocular rosacea*
                                                                                 Vaginal dryness
               Pain in joints
                                                                                                                                                ▪ Regulatory scientific advice provides the basis for starting Ph3 trial
         Nerve problems                                                          Dry and itchy skin                                               within next 12 months

     • Dry eyes can lead to ocular surface discomfort e.g. feeling of                                                                                             It is estimated that 3-5M Sjögren patients
       dryness, burning, a sandy/gritty sensation, tearing, or itchiness                                                                                         are suffering from dry eyes in EU and the US
     • Moderate to severe dry eye in Sjögren patients is very common - it
       significantly reduces the patient’s quality of life
     • Root cause is until now poorly understood and currently no
       treatments are approved for Sjögren Syndrome dry eye

 1.sjogrens.org/understanding-sjogrens
 *Topical cyclosporin A as a steroid-sparing agent for ocular rosacea: Acta Ophthalmologica 2017 Mar;95(2):e158-e159. doi: 10.1111/aos.13137.

 11 | © MC2 Therapeutics
MC2 has uniquely developed a ground-breaking
   understanding of urea related diseases:

          MC2-25 Uremic Pruritus
          MC2-27 Lichen Sclerosus
MC2-25: Targeting most effective treatment of Uremic Pruritus and skin dryness

 Introduction to Uremic Pruritus (UP)                                                                                                    MC2-25 value proposition
                                          Most commonly affected areas                                                                   ▪ There is a need for therapy that effectively and safely provides relief of
             Symptoms                                                                               Complications                          both the itchiness and dryness of the skin
       Daily bouts of itching                                                                      Skin infections
      that tend to worsen at                                                                         (scratching)                        ▪ MC2 is developing a topical non-steroidal first-in-class drug candidate
               night                                                                                   Papules                             based on a repurposed known molecule and PAD™ Technology
        Very dry/scaly skin                                                                      Chronic, lichenified
                                                                                                 dermatitis / eczema                     ▪ Regulatory scientific advice provides the basis for starting Ph2 trial early
                                                                                                                                           2022

 ▪ Uremic pruritus¹ is a frequent and compromising symptom in patients                                                                           ~4-5% of the population in US and EU (>35 M) are diagnosed
   with advanced (CKD 3-4) or end-stage (CKD 5) renal disease                                                                                    with CKD 3-5 and suffer from Uremic Pruritus
 ▪ More than 40% of patients with CKD 3-5 suffer from chronic pruritus, very
   dry skin and daily bouts of itching reducing the patient’s quality of life
   through deprivation of sleep
 ▪ Root cause is until now poorly understood and currently no treatments
   are approved

 1.     Also known as chronic kidney disease-associated pruritus, Kidney International, https://dermnetnz.org/topics/uraemic-pruritus/

 13 | © MC2 Therapeutics
MC2-27: Targeting first approved treatment of Lichen Sclerosus
               Introduction to Lichen Sclerosus (LS)                                                                                            MC2-27 value proposition
                                                       Most commonly affected areas                                                             ▪ There is a need for therapy that effectively and safely provides relief of
                   Symptoms                                                                                         Complications                 both the itchiness and dryness of the skin
                Patchy white skin                                                                                   Painful sexual
                    Redness                                                                                           function                  ▪ MC2 is developing a topical non-steroidal first-in-class drug candidate
                     Itching                                                                                      Urinary retention               based on a repurposed known molecule and PAD™ Technology
                Discomfort/pain                                                                                     Constipation
                  Bleeding and                                                                                  Increased risk of skin          ▪ Regulatory scientific advice provides the basis for starting Ph2 trial early
                    blistering                                                                                         cancer¹                    2022

               ▪ Lichen sclerosus is a chronic, inflammatory, cutaneous disorder that                                                                   The prevalence of lichen sclerosus in US and EU is poorly
                 can lead to impaired sexual function, and malignancy1                                                                                  understood1
               ▪ It can affect any area of the body for males and females, however, more
                 often appears in female genital epithelium for postmenopausal
                 women1
               ▪ Causes of lichen sclerosus are until now unknown1

1 Melnick et al. Lichen sclerosus among women in the US International Journal of Women’s Dermatology, Volume 6, Issue 4, 2020, Pages 260-262,

                14 | © MC2 Therapeutics
MC2 commercial products launching in 2021:
▪ Wynzora® Cream topical drug for plaque psoriasis
▪ Biomee™ skin care for dry, itchy and sensitive skin
Wynzora® Cream for plaque psoriasis
                          Based on head-to-head Ph3 trials

                          (0.005% w/w calcipotriene + 0.064% w/w betamethasone dipropionate cream)

                          Please see more at Wynzora.com

16 | © MC2 Therapeutics
Our PAD™ Technology innovation has enabled the development of Wynzora® Cream

                              Calcipotriene (CAL)                                                Betamethasone diproponate (BDP)

Stability                Requires pH>8                                                     Stability    Requires Ph 4-6

MoA                      Vitamin D analogue.                                               MoA          Potent corticosteroid
                         Inhibition of cell proliferation,                                              Typical anti-inflammatory, antipruritic,
                         stimulation of cell differentiation and                                        vasoconstrictive and immunosuppressive
                         regulation of inflammation                                                     properties of corticosteroids

                                                                                       Water
Dual efficacy of CAL and BDP equivalent to super                                                 PAD™ Technology uniquely enables:
potent steroids while offering a more favorable
safety profile                                                                                   1. A stable aqueous (fast absorbing) formulation
                                                                                 Oil                of CAL/BDP optimizing patient adherence in
▪     BDP counteracts potential skin irritation of CAL                                              daily routines
▪     CAL mitigates potential skin atrophogenic
                                                                                                 2. Powerful delivery of actives to target tissue
      effect of BDP1
                                                                   Surfactants                      providing high efficacy

1. Norsgaard et al. Arch Dermatol Res (2014) 306:719–729

    17 | © MC2 Therapeutics
Wynzora® Cream is an excellent example our PAD™ Technology
                                                             Key product features enabled by PAD™ Technology

                               ✓ Stability                                                                                                                   ✓ Efficacy

                           Uniquely enabled a cream formulation                                                        Significant better efficacy in Ph3
                            of calcipotriene and betamethasone                                                         head-to-head trials1 using same
                                   fixed-dose combination                                                                 actives and concentration

                                  Favorable safety profile: Only one                                                     Better patient preference than
                                  application site adverse reaction in                                                      comparator in Ph3 trials
                                  USPI: 1% application site irritation2

                                 ✓ Safety                                                                                                                 ✓ Adherence
                           1   In USPI Wynzora® Cream has 14.6% points better PGA treatment success compared to Taclonex® TS

                           2In   USPI additional adverse reactions are listed: Upper Respiratory Infection: Wynzora (7%), Vehicle (5%); Headache: Wynzora (2%), Vehicle (0%);

 18 | © MC2 Therapeutics
MC2 has successfully initiated a global roll-out of Wynzora® Cream

 19 | © MC2 Therapeutics
The biomee™ universe is an unprecedented branding opportunity

                   Innovative skin care line
                for dry, sensitive and itchy skin

                           Launch 2021

 20 | © MC2 Therapeutics
High execution leadership through diversity and strong owners
Executive Management                                                                 Board of Directors and Owners¹

                 Jesper J. Lange           Ann Kristin Led
                 President & CEO           Exec. VP, Finance & Strategy

                                                                             Mads Clausen                Jesper J. Lange   Mette V. Johannesen
                                                                          Chairman and Owner                Director             Director

                 Johan Selmer              Frédéric Gomez
                 Chief Medical Officer     Business Development

                                                                                              Anders D. Hove
                                                                                         Director, Founder of Acorn
                                                                                                 Bioventure

                 Morten Præstegaard        Christopher Billis
                 Chief Operating Officer   Chief Commercial Officer
                                                                           Clausen Family                                   Schrøder Family
                                                                                                                            Former owner of:

  21 | © MC2 Therapeutics
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