Interim Report January – June 2022, Dicot AB

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Press release: Uppsala, August 25, 2022. A summary of the Interim report January – June 2022, for Dicot AB (publ) is now available on the company website www.dicot.se.

Second quarter 2022

  • Net sales amounts to KSEK 6 (33)
  • Earnings for the period amounts to KSEK -8,733 (-5,583).
  • Earnings per share SEK -0.08 (-0.09)

 

January – June 2022

  • Net sales amounts to KSEK 34 (69)
  • Earnings for the period amounts to KSEK -18,079 (-14,051).
  • Earnings per share SEK -0.18 (-0.26)

 

Significant events during the Second Quarter

April

  • Elin Trampe becomes CEO on April 1 while former CEO Göran Beijer remains in the company as a part-time consultant.
  • Dicot announces that it is prioritizing the development of an oral drug candidate for clinical phase 1 studies, after evaluating two formulation options. Starting first studies in humans is therefore revised to mid-2023.
  • Dr. Charlotta Gauffin is hired as the new Chief Scientific Officer starting July 11.

May

  • At the Annual General Meeting, Eva Sjökvist Saers, Mikael von Euler-Chelpin, Per-Göran Gillberg and Lena Söderström are re-elected. Fredrik Buch and Michael Zell are elected as new members of the board. Two incentive programs were decided on – one for board members and one for employees and other key stakeholders.
  • A research collaboration with Uppsala University and the W. Szafer Institute of Botany at the Polish Academy of Sciences is initiated, to investigate a new technology for making starting material for the drug substance production.

June

  • A patent application is being prepared to protect new production methods and various chemical compounds in the manufacturing of the drug substance in LIB-01. The patent application is intended to be submitted after the summer and should provide 20 years of market exclusivity.
  • June 1 to 15 is the exercise period for warrants in series TO 3, where 34,202,814 warrants are exercised, which corresponds to approximately 90% subscription and adds Dicot around SEK 10 million before issue costs.
  • Dicot announces that it has demonstrated good results in new efficiency studies with the newly developed oral formulation. LIB-01 had a statistically proven effect on all studied parameters in the test in animals measured seven days after the last dose.

 

Significant events after the end of the period

  • No significant events after the end of the period.

 

Statement from the CEO

 

We want to drastically change the way of treating erectile dysfunc­tions. Our goal is clear: to launch a brand-new long-lasting drug and become the first choice of treatment for affected men and couples. During this past quarter, we have taken several important steps in realizing this objective. We have also actively participated in the de­bate about the stigma associated with erectile dysfunctions.
 

IN APRIL WE WERE PLEASED to announce that we now have an oral formulation to proceed with, a result of intensive development work. Previously, Dicot used a sub­cutaneous formulation, that is, administration by syringe under the skin. A drug that can be ingested as a tablet or capsule is significantly easier for future users, which is an important factor in the pursuit of making LIB-01 the first choice.

 

WE ARE WORKING ON MULTIPLE FRONTS to ensure that Dicot and LIB-01 have the best prerequisites to succeed and reach a global market. A strong patent port­folio is a natural and important part of this work. In June, we started preparing a new patent application concerning new production methods and various chemical compounds during the manufacture of the pharmaceutical substance. With additio­nal patents, we can secure market exclusivity until at least 2042.

 

THE MARKET FOR POTENCY DRUGS is growing rapidly, but the need is proba­bly significantly greater than the sales statistics indicate. According to RFSU, the Swedish Association for Sexuality Education, only a quarter of all affected men seek help. The stigma and the culture of silence that prevails in regard to erectile problems is a strong contributing factor. During the spring, a welcomed debate about this culture of silence has spread in Swedish media and Dicot has participated actively, something we intend to continue doing.

 

AFTER JUNE’S EXERCISE OF WARRANTS, which was subscribed to approxima­tely 90%, our finances were strengthened by SEK 9 million. This is a satisfactory outcome given the difficult situation on the capital markets during the spring. We are now evaluating several ways to capitalize the company in the future to ensure long-term financing.

 

WE ARE BROADENING OUR EXPERTISE to prepare for upcoming phases in the development of Dicot. The composition of the Board is an important factor in this. We are therefore very pleased to welcome Fredrik Buch and Michael Zell, who were elected as new members of the Board during the annual meeting in May. Both strengthen us with solid business and market knowledge. The Board’s confidence in LIB-01’s potential is substantial. This became particularly clear in June when we could announce that the Board’s and management’s combined shareholding increa­sed by over 700,000 shares.

 

OUR DRUG CANDIDATE HAS BEEN CALLED a potential ”block buster” and ”game changer”. The positive reviews from external stakeholders and the positive study results with the oral formulation give us extra energy and confidence to continue the work of drastically improving the treatment of erectile dysfunctions and giving affected men and couples an increased quality of life.

 

For further information, please contact:

Elin Trampe, CEO

Tel: +46 739 80 14 08

Email: elin.trampe@dicot.se

 

Björn Petersson, CFO

Tel: +46 76 109 0000

E-mail: bjorn.petersson@dicot.se

 

About Dicot AB

Dicot is developing the drug candidate LIB-01, which will be a potency agent to better treat erectile dysfunction and premature ejaculation. The ambition is to create a drug with significantly longer effect and far fewer side effects, compared to those on the market. Today, at least 500 million men suffer from these sexual dysfunctions and the market is valued at SEK 50 billion. Research and development are conducted under own auspices up to phase 2 studies. Thereafter, Dicot's intention is to form strategic alliances, or alternatively carry out a trade sale, with larger, established pharmaceutical companies to be able to introduce LIB-01 on the world market.

Dicot is listed on Spotlight Stock Market and has approximately 3,300 shareholders. For more information, please visit www.dicot.se.