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)
Global company presentation
Q3 2021
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
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
PAD™ Technology – a paradigm shift in topicals
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
MC2 has developed the most powerful vehicle for topicals
releasing the full potential
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 TherapeuticsPipeline: 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 TherapeuticsStrong 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 TherapeuticsMC2-03: 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 TherapeuticsMC2 has uniquely developed a ground-breaking
understanding of urea related diseases:
MC2-25 Uremic Pruritus
MC2-27 Lichen SclerosusMC2-25: 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 TherapeuticsMC2-27: 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 TherapeuticsMC2 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 TherapeuticsOur 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 TherapeuticsWynzora® 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 TherapeuticsMC2 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 TherapeuticsHigh 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:
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