Primary endpoint (negative culture and/or clear nail growth) met with 83.3% response rate 

Secondary endpoints met at Week 52 after 9-months off treatment

Blueberry Therapeutics Limited (“Blueberry” or “the Company”), a pharmaceutical company focused on developing innovative, topical nanomedicines to treat dermatological conditions, announces that BB2603, a novel topical terbinafine antifungal product, has met the primary endpoint in the Phase 2b trial (BBTAF202) in patients with onychomycosis, showing superiority over placebo (vehicle) with a high level of statistical significance.

BBTAF202 was a European trial conducted in 111 subjects with mild to moderate distal subungual onychomycosis (DSO) of the toenail, recruited from sites in Germany, Poland and the Czech Republic. This trial assessed the efficacy, safety and pharmacokinetics of 3 months twice-daily treatment of BB2603-10 versus vehicle, along with 2 lower formulation strengths of BB2603-3 and BB2603-1. A 3‑month treatment duration is considerably shorter than for other topical agents used for onychomycosis (~11 months).

The primary objective was an assessment of early clinical and/or mycological activity of BB2603-10 versus vehicle at Week 16, 1 month after end of treatment. Significantly more subjects treated with BB2603-10 (83.3%) had a response of negative dermatophyte culture and/or clear nail growth at Week 16 compared with those who received vehicle (51.8%, p=0.004). This treatment difference was driven by an early effect of BB2603-10 on negative culture (80.6% vs 40.5%, p<0.001). Growth of clear nail was observed in many subjects as early as Week 4. Clear nail and improvement in the appearance of fungally-infected toenail addresses an important aesthetic need of patients.

We’d like to extend a warm welcome to our new Laboratory Technician, Megan Dawson. Megan joins us with a Masters in Medical Microbiology from the University of Manchester, and after gaining lots of relevant skills in an associate practitioner role at Alder Hey Children’s Hospital. In her spare time, Megan’s interests include attending festivals and gigs, and reading (she is a huge Harry Potter fan). Welcome to Blueberry, Megan!

Alderley Park, 04 July 2023 – Blueberry Therapeutics is pleased to announce the completion of our European Phase 2b trial of BB2603 (BBTAF202). This trial is assessing the efficacy and safety of different doses of BB2603, a new topical anti-fungal spray formulation, in subjects with fungal nail infection (onychomycosis). The last subject entered has attended their last visit for the final Week 52 endpoint. We now turn our attention to preparing for the trial results. We would like to express our gratitude to all sites and participants for their continued involvement through this year-long trial period.

Alderley Park, 17 February 2023 – Blueberry Therapeutics is pleased to announce further progress on our Phase 2b European trial of BB2603 (BBTAF202). We previously announced the completion of recruitment, and we now provide an update that the final subject in this trial has passed through the Week 16 primary endpoint assessment time point.

This trial is assessing the efficacy and safety of different doses of BB2603, a new topical anti-fungal spray formulation, in subjects with fungal nail infection (onychomycosis). These subjects will continue through to the end of this 1-year trial, when the trial will readout and we will assess final efficacy and safety. We would like to express our gratitude to all participants for their continued involvement.

For more information about Blueberry Therapeutics please contact:

Dr Emma Leigh, Director of Communications

info@blueberrytherapeutics.com

Alderley Park, 22 November 2022 – Blueberry Therapeutics are pleased to announce that their novel cream formulation for the treatment of atopic dermatitis (BB1511) has been nominated for clinical development.

This nomination decision was unanimous following review of pharmaceutical development and pre-clinical data, which demonstrated the required drug attributes to progress towards regulatory advice and then clinical trials. The nomination of BB1511 followed on from the development of BB0107, which although did not quite meet our high standards for nomination, provided valuable insight to allow us to adapt the formulation development for BB1511.

BB1511 is a light cream formulation designed to support skin barrier function whilst reducing the inflammation associated with atopic dermatitis, which we hope will help many patients in managing their disease more effectively.

BB1511 adds to our expanding drug portfolio in the clinical phase (alongside BB2603 for onychomycosis and BB1202 for tinea pedis).

For more information about Blueberry Therapeutics please contact:

Dr Emma Leigh, Director of Communications

info@blueberrytherapeutics.com

About Blueberry Therapeutics

Blueberry Therapeutics is a pharmaceutical company focused on the discovery, development and commercialisation of high value medicines for the treatment of common dermatological conditions that will positively impact on treatment outcomes and improve patient quality of life.

Blueberry applies innovative technologies to improve the delivery of existing drugs through the skin and nail. This enables better efficacy, safety and patient compliance while reducing drug dosage and cost of goods. The Company has a de-risked portfolio of best-in-class [advanced stage] clinical and preclinical assets addressing high value and poorly served indications in dermatology, including onychomycosis (fungal nail infection), tinea pedis (athletes’ foot) and atopic […]

Blueberry extends a warm welcome to Sinead Sunner, who joins our preclinical team as an Analytical Scientist. Since graduating with an MSc with Honours in Medicinal and Biological Chemistry from the University of Nottingham, Sinead has worked at LCG in Cambridge and Alderley Analytical here at Alderley Park. Sinead describes herself as having a passion for physical and medicinal chemistry! In her free time, she grows her own chilli plants and plays women’s football.

Welcome to Blueberry Sinead!

Alderley Park, 29 July 2022 – Blueberry Therapeutics are pleased to announce that recruitment into our Phase 2b European trial of BB2603 for fungal nail infection is now complete.

This trial (BBTAF202) assesses the efficacy and safety of different doses of BB2603, a new topical anti-fungal formulation, in patients with fungal nail infection (onychomycosis). Data from the primary endpoint (an early response assessment at 16 weeks) are expected in Q1 2023, with final results to follow for the 52-week endpoints.

For more information about Blueberry Therapeutics please contact:

Dr Emma Leigh, Director of Communications

info@blueberrytherapeutics.com

About Blueberry Therapeutics

Blueberry Therapeutics is a pharmaceutical company focused on the discovery, development and commercialisation of high value medicines for the treatment of common dermatological conditions that will positively impact on treatment outcomes and improve patient quality of life.

Blueberry applies innovative technologies to improve the delivery of existing drugs through the skin and nail. This enables better efficacy, safety and patient compliance while reducing drug dosage and cost of goods. The Company has a de-risked portfolio of best-in-class [advanced stage] clinical and preclinical assets addressing high value and poorly served indications in dermatology, including onychomycosis (fungal nail infection), tinea pedis (athletes’ foot) and atopic dermatitis (eczema).

Alderley Park, 24 May 2022 – Blueberry Therapeutics are pleased to report significant progress in our Phase 2b European trial of BB2603 in onychomycosis (BBTAF202).

The COVID-19 pandemic led to operational challenges in all 3 participating countries (Germany, Poland and Czech Republic) – including a trial pause to ensure patient and site staff safety. Blueberry has worked creatively to implement strategies to boost patient numbers and minimise delays, including protocol changes and roll-out of a multi-media advertising campaign to increase awareness of clinical research in this area. These have required multiple regulatory submissions to notify or obtain approval from Ethics Committees and Competent Authorities. We are delighted to share that the final approval in this jigsaw has been received and recruitment is expected to complete in July 2022. The primary endpoint is expected 1Q23.

For more information about Blueberry Therapeutics please contact:

Dr Emma Leigh, Director of Communications

info@blueberrytherapeutics.com

About Blueberry Therapeutics

Blueberry Therapeutics is a pharmaceutical company focused on the discovery, development and commercialisation of high value medicines for the treatment of common dermatological conditions that will positively impact on treatment outcomes and improve patient quality of life.

Blueberry applies innovative technologies to improve the delivery of existing drugs through the skin and nail. This enables better efficacy, safety and patient compliance while reducing drug dosage and cost of goods. The Company has a de-risked portfolio of best-in-class [advanced stage] clinical and preclinical assets addressing high value and poorly served indications in dermatology, including onychomycosis (fungal nail infection), tinea pedis (athletes’ foot) and atopic dermatitis (eczema).

• Phase 2 trial with BB2603 in onychomycosis: continues, with initial readout expected in Q1 2023

• Phase 3 trial with BB1202 for tinea pedis: ready to enter late-stage clinical development with Blueberry seeking advice from regulatory agency to finalise trial design

• Phase 1 trial with BB0107 for atopic dermatitis: expected to move into the clinical phase in the second half of 2022

Alderley Edge, 24 March 2022 – Blueberry Therapeutics Limited (“Blueberry” or “the Company”), a pharmaceutical company focused on developing innovative, topical medicines to treat dermatological conditions, today provides an update on its research and development activities. The Company is progressing a de-risked portfolio of best-in-class assets addressing high value markets, including onychomycosis (fungal nail infection), tinea pedis (athlete’s foot) and atopic dermatitis (eczema).

Blueberry has applied innovative formulation technologies to improve the delivery of existing drugs through the skin and nail. These enhanced formulations support better efficacy, safety and compliance, representing significant improvements over existing prescribed and over-the-counter treatments, with the potential to reduce dose and cost of goods.

Dr John Ridden, CEO of Blueberry Therapeutics, commented:

 “Over the past year, we have made significant clinical progress with our lead programmes, BB2603 for onychomycosis and BB1202 for the treatment of tinea pedis, with further important milestones expected this year. We anticipate that recruitment into our ongoing Phase 2 study with BB2603 will be complete by July 2022 with the primary endpoint data anticipated in Q1 2023.

 “For BB1202, in tinea pedis, we are currently designing a Phase 3 clinical programme to support registration, with the aim of initiating a Clinical Trial Application in […]

From the 19-25th April, Blueberry employees took on a challenge to collectively reach a target distance of 200 km in one week to raise money for the charity In2Science. Our active bunch answered this call by walking, running, swimming, cycling, rowing and kayaking and went above and beyond our target to reach a final distance of 546 km! In doing so we have raised £1,412 in sponsorship for In2Science, who improve access and remove barriers to STEM careers to young people from low income and disadvantaged backgrounds. Blueberry will top up this fundraise to donate a total of £2,000 for this great cause!

Blueberry will also join the mentorship program run by In2Science later this year, to mentor Year 12 students in the North West – a program which has already had great success in other parts of the UK where 83% of students who have taken part have progressed to University. We’re proud to contribute to this great cause and help the next generation of scientists, engineers and mathematicians.

Blueberry Therapeutics Limited would like to announce that it has completed a £3.6m extension to the previously successful Series B Fundraising of £10.8m. This investment is from a Japanese investor, Medical Incubator Japan (MIJ) and a private syndicate of US Board Certified Dermatologists led by Dr Omar Ibrahimi of Stamford, CT. Blueberry Therapeutics is a dermatology-focused drug discovery and development company focused on developing innovative nanomedicines for difficult to treat diseases of the skin and nail, with a lead candidate in Phase II development.

The fundraise is partly in response to the COVID-19 pandemic, which has affected clinical trials globally, but primarily because of a series of pre-clinical successes during 2020, which have broadened the company’s drug portfolio. Blueberry Therapeutics will use the Series B extension proceeds to continue its development programme for BB2603 for the treatment of onychomycosis, and additional funding will be used to advance other programmes, including in tinea pedis, where there are encouraging efficacy and safety data, and a potentially efficient route to market.

BB2603 is Blueberry Therapeutics lead development drug candidate; after completing a Phase I/II study in 2018, this is now in Phase II clinical development. Using nanotechnology, BB2603 is designed to greatly enhance delivery of terbinafine to target fungal infection under the nail and within the upper layers of the skin. In onychomycosis, BB2603 aims to achieve equivalent efficacy and treatment duration but at a dose which is several thousand-fold lower than approved for oral terbinafine, thereby avoiding the systemic side effects and patient monitoring requirements of oral administration. The additional funding supports completion of […]

Blueberry expansion at Alderley Park. The Blueberry team are delighted to be moving into a larger, more spacious office area on the Alderley Park site, with views over the Cheshire plains. The move will bring the whole team together into one office, and provides space for further expansion, with integrated meeting rooms and a board room.

Blueberry’s CSO, Dr David Cook has been invited to present at the Alderley Park Science Seminar series with his talk “Understanding what makes a good drug discovery project: can we ever really predict success?” on Tuesday 21st July 2020 12.00-13.00.

The seminar will be virtual and you can find out more, and register for the event here: https://www.alderleypark.co.uk/events/2020/7/21/alderley-park-science-seminar-series-with-dr-david-cook

We are delighted to be featured on this month’s Disruption Hub article “Businesses Rise to the Covid-19 Challenge”. You can read the full article on our efforts here: https://disruptionhub.com/businesses-rise-to-the-covid-19-challenge