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.
Third quarter 2022
- Net sales amounts to KSEK 54 (0)
- Earnings for the period amounts to KSEK -5,073 (-4,716).
- Earnings per share SEK -0.04 (-0.07)
January - September 2022
- Net sales amounts to KSEK 89 (30)
- Earnings for the period amounts to KSEK -23,152 (-18,767).
- Earnings per share SEK -0.20 (-0.32)
Significant events during the Third Quarter
July
- On July 1, payment was received from the warrants of series TO 3 that were subscribed for during June. Dicot received a net contribution of SEK 9.0 million.
- In July, Charlotta Gauffin assumed the role of Chief Scientific Officer (CSO) with the task of managing the development of the company's potency drug. Gauffin has over 20 years of experience in drug development, of which more than 15 years in clinical development.
August
- During the third quarter, evaluation and procurement of the CRO service for Dicot's phase 1 clinical trials began, i.e., the first human studies which are planned to start in mid-2023.
Significant events after the end of the period
- On October 11, good results from the preclinical toxicology program with the drug candidate LIB-01 were reported. LIB-01 has so far shown to be well tolerated with a good safety profile, and no signs of side effects have been seen in the animal studies.
- On October 17, Dicot announced that a new patent application has been submitted in accordance with the company´s IP-plan. It includes both new production methods and intermediates (various chemical compounds) during the manufacture of the drug substance.
- Late October, Dicot announced that parts of the manufacturing of the drug candidate are being moved to South Africa where the starting material is already being handled. It will lead to improved logistics, shorter lead times and reduced costs.
Statement from the CEO
During the third quarter, the development work has continued according to defined time frames, and we are getting closer and closer to the start of the phase 1 clinical trials. Procurement of a CRO for conducting clinical studies has also begun this eventful quarter. We recently reported on good results from toxicology studies, an important part of the authorities' assessment prior to the start of clinical studies in humans. We have also visited our partners in South Africa, which provided the opportunity for in-depth dialogues to further develop our collaborations.
MYSELF AND DICOT'S CSO, Charlotta Gauffin, have recently returned from a very valuable trip to South Africa where we met with our partners. The active substance in LIB-01 is a semi-synthetically produced molecule with starting material comes from nature. It is seeds that undergo an extraction process followed by a number of synthesis steps. Everything starts in South Africa where our main partner Parceval with its experience and network coordinates all activities connected to the raw material.
IT IS CLEAR that there is a great dedication from our partners. Meetings and site visits in South Africa have given us many insights to take forward to facilitate collaborations and for Dicot to make well-grounded decisions. As a result of good collaboration, we now take the step to move the extraction process from Sweden to South Africa. By moving this part of the manufacturing, unnecessary transportation is avoided, it facilitates the coordination of activities and, not least, reduces our costs.
THE DRUG DEVELOPMENT HAS CONTINUED at full speed during the quarter. We are on schedule to start clinical trials mid next year and now the procurement of a CRO to perform our clinical trials has begun. We have sent out application documents to leading research organizations that we consider to be innovative and modern and have been met with great international interest in working with our candidate. In addition to that, our toxicology program is also in full swing, and we have recently reported results showing that LIB-01 has a good safety profile and that no side effects have been identified so far.
DURING THE MONTH OF JULY, we had the privilege of presenting the results of our preclinical effect studies at the European Association of Urology, a scientific forum that we previously announced had selected our submitted abstract for presentation during its 2022-year congress.
THE CAPITAL INJECTION IN JULY from the warrant program in the second quarter has enabled us to follow our set schedule and expenditure framework for both preclinical work and business development. At the same time, we are now working on securing funding for the upcoming phase 1 clinical trials.
EVERY IMPORTANT INNOVATION requires strong IP protection and we have now submitted the new patent application that we announced before the summer we were working on. A new patent means market exclusivity until at least 2042 on a global market, which greatly increases the long-term value of LIB-01.
THE THIRD QUARTER of the year has been eventful, and it is with great pleasure that I see the commitment and drive of the Dicot team and our partners.
For further information, please contact:
Elin Trampe, CEO
Tel: +46 739 80 14 08
elin.trampe@dicot.se
Björn Petersson, CFO
Tel: +46 76 109 00 00
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.
Uppsala, March 28, 2023. Dicot has now conducted the last of two planned regulatory meetings prior to an application to start clinical trials. The purpose was to anchor the scientific background documentation to be included in a clinical trial application and covered central parts of Dicot's study design to which the Swedish Medical Product Agency was positive.
Press release: Uppsala, Sweden, March 8, 2023. Dicot has entered into a consultancy agreement with medical doctor Harin Padma-Nathan, a world leading medical expert in male sexual dysfunctions. Dr Padma-Nathan was involved in the development of the drugs for erectile dysfunction currently on the market, e.g., as Lead Principal Investigator during the development of Viagra and Cialis. His Viagra paper in The New England Journal of Medicine is the most cited paper in the field of urology.
Press release: Uppsala, February 27, 2023. Dicot AB (publ) hereby publishes its year-end report for the period January - December 2022 and for the fourth quarter. The year-end report is available as an attached document and on the company's website www.dicot.se. Below is a summary of the report.
Fourth quarter 2022
- Net sales amounts to KSEK 0 (0)
- Earnings after financial items amounts to KSEK -8,604 (-8,408)
- Earnings per share amounts to SEK -0.06 (-0.10)
January - December 2022
- Net sales amounts to KSEK 0 (0)
- Earnings after financial items amounts to KSEK -31,756 (-27,175)
- Earnings per share amounts to SEK -0.26 (-0.42)
Press release: Uppsala, February 20, 2023. Dicot announces that the GMP manufacturing of the study drug for the planned phase 1 studies has begun. This is completely in line with the company's time schedule for start of clinical studies. The manufacture refers to both study drugs with active substance and placebo.
Uppsala, February 17, 2023. Today the pharmaceutical company Dicot presented the latest study of the mechanism of action of LIB-01 at the European Society for Sexual Medicine's annual congress in Rotterdam. The study shows that the mechanism of action differs from today's most common potency drugs, PDE5 inhibitors, and that LIB-01 may thus represent a completely new generation of potency drugs.
Uppsala, January 23, 2023. The pharmaceutical company Dicot AB that develops LIB-01 to become a new potency drug, today announces that it is moving forward with a new patent application. The patent application covers the new oral formulation for LIB-01 that was developed in 2022 and which will be used in the phase 1 clinical studies. This follows the IP strategy earlier communicated by the company.
Press release: Uppsala, January 19, 2023. The pharmaceutical company Dicot has contracted Thermo Fisher Scientific, the world leader in serving science, to perform GMP manufacturing of the drug candidate LIB-01 for the upcoming clinical trials.
Uppsala, January 4, 2023. The pharmaceutical company Dicot announces the contracting of reputable Clinical Trial Consultants AB (CTC) for conducting clinical phase 1 studies intended to start in mid-2023. The studies will take place at the contracted company's research clinic in Uppsala.
Uppsala, December 8, 2022. The pharmaceutical company Dicot announces that results from the latest study of the mechanism of action of LIB-01 have been selected to be presented at the European Society for Sexual Medicine's annual congress in February 2023.
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.