Interim Report January - June 2022, Dicot AB

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: [email protected]

Björn Petersson, CFO
Tel: +46 76 109 0000
E-mail: [email protected]

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.

Ny studie: LIB-01 antas vara nästa generations potensläkemedel

Uppsala, 15 november 2022. Dicots senaste studie av verkningsmekanismen hos LIB-01, dvs hur läkemedlet fungerar i kroppen för att nå önskad effekt, visar att den skiljer sig från dagens potensläkemedel. Detta innebär att LIB-01 kan antas representera en ny generation av potensläkemedel.


New study: LIB-01 assumed to be the next generation of potency drugs

Uppsala, November 15, 2022. Dicot's latest study of the mechanism of action of LIB-01, i.e., how the drug affects the body to achieve the desired effect, shows that it differentiates from today's potency drugs. This means that LIB-01 can be assumed to represent a new generation of potency drugs.


Lyckat första myndighetsmöte för LIB-01

Uppsala, 14 november 2022. Dicot meddelar idag att det första formella myndighetsmötet för LIB-01 inför en ansökan om start av kliniska studier har genomförts. Detta var det första av två planerade vetenskapliga rådgivningsmöten med Läkemedelsverket, i syfte att förankra det underlag som ska ingå i en klinisk prövningsansökan.


Successful first regulatory meeting for LIB-01

Uppsala, November 14, 2022. Dicot announces today that the first regulatory meeting for LIB-01 prior to an application to start clinical trials has been conducted. This was the first of two planned scientific advisory meetings with the Swedish Medical Products Agency, with the purpose of anchoring the scientific background documentation for a clinical trial application.


Valberedningen för Dicot AB utsedd

Pressmeddelande: Uppsala, 3 november 2022. Enligt det beslut om valberedningen som fattades vid årsstämman i Dicot AB den 24 maj 2022 ska valberedningen inför årsstämman den 23 maj 2023 bestå av tre ledamöter representerande de tre största aktieägarna per den sista september 2022.


The Nomination committee for Dicot AB appointed

Press release: Uppsala, November 3, 2022. According to decision at the Annual General Meeting of Dicot AB on May 24, 2022, the Nomination committee for the Annual General Meeting on May 23, 2023, shall consist of three members representing the three largest shareholders as of the end of September 2022.


Rättelse: Dicot AB Delårsrapport januari - september 2022

Pressmeddelande: Uppsala, 1 november 2022. Rättelsen avser att informera om att tidigare pressmeddelande gällande Dicot ABs (publ) delårsrapport för januari - september 2022 ej skulle ha varit markerad med MAR-etikett. 


Correction: Interim Report January-September 2022, Dicot AB

Press release: Uppsala, November 1, 2022. The correction is to inform that the previous press release regarding Dicot AB's (publ) interim report for January - September 2022 should not have been marked with the MAR label.


Dicot AB Delårsrapport januari - september 2022

Pressmeddelande: Uppsala, 1 november 2022. Dicot ABs (publ) delårsrapport för januari - september 2022 finns nu tillgänglig på bolagets hemsida www.dicot.se.


Interim Report January-September 2022, Dicot AB

Press release: Uppsala, November 1, 2022. A summary of the Interim report January - September 2022, for Dicot AB (publ) is now available on the company website www.dicot.se.


Dicot AB (publ) tidigarelägger publicering av finansiell rapport för Q3 2022

Publicering av Dicots rapport för tredje kvartalet kommer tidigareläggas till den 1 november 2022. Tidigare meddelat datum för publicering var den 15 november 2022 


Dicot AB (publ) brings forward publication of financial report for Q3 2022

Publication of Dicot's report for the third quarter will be brought forward to November 1, 2022. Previously announced date for publication was November 15, 2022.


Dicot sänker kostnader genom flytt av tillverkningssteg

Uppsala, 25 oktober 2022. Dicot flyttar delar av tillverkningen av sin läkemedelssubstans för att sänka kostnader och minska transporter. Det är extraktionsprocessen som flyttas till Sydafrika där startmaterialet redan hanteras och där bolaget har etablerade samarbetspartners.


Dicot reduces costs by moving manufacturing step

Uppsala, October 25, 2022. Dicot is moving parts of the manufacturing of its drug substance to lower costs and reduce transportations. It is the extraction process that is being moved to South Africa where the starting material is already handled and where the company has established collaboration partners.


Dicot har skickat in ny patentansökan

Nyhet: Uppsala, 17 oktober 2022. Dicot AB meddelar idag att bolaget har skickat in en ny patentansökan till Patent- och registreringsverket. Detta följer den IP-plan som tidigare kommunicerats av bolaget. Nya patent ger 20 års marknadsexklusivitet från det att en ansökan skickas in.


Dicot has submitted a new patent application

News: Uppsala, October 17, 2022. Dicot AB announces today that the company has submitted a new patent application to the Patent and Registration Office. This is according to the IP plan previously communicated by the company. New patents provide 20 years of market exclusivity from the time an application is submitted.


Dicot rapporterar goda resultat från prekliniska toxikologistudier

Dicot rapporterar att de prekliniska toxikologistudierna som nu genomförs, hittills visar att läkemedelskandidaten LIB-01 har en god säkerhetsprofil.


Dicot reports good results from preclinical toxicology studies

Dicot reports that the preclinical toxicology studies that are now being conducted, so far show that the drug candidate LIB-01 has a good safety profile.


EU-kommissionen har valt ut Dicot att tävla i Innovation Radar Prize

Uppsala, 7 september 2022. EU-kommissionen har utifrån tusentals små och medelstora europeiska företag valt ut Dicot som ett av bolagen att bjuda in till tävlingen Innovation Radar Prize 2022.


The European Commission has selected Dicot to compete in the Innovation Radar Prize

Uppsala, September 7, 2022. The European Commission has selected Dicot from thousands of small and medium-sized European companies as one of the companies to participate in the Innovation Radar Prize 2022.


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