NefIgArd Phase 3-study initiated according to plan
“This quarter, the company went into execution mode with regards to the preparations related to our clinical Phase 3 study NefIgArd. We were excited to get going after receiving the necessary funds in July. We have been submitting requests for approval to ethic committees, negotiated contracts with clinics and continued to tie up the hundreds of ends required in order to initiate such a large, global study. With 19 countries and 149 sites, we believe that this is one of largest clinical studies to be managed out of Sweden today.
Based on progress to date, we believe that we are on track to dose our first patient in 2H 2018 as planned.”
Renée Aguiar-Lucander, CEO
Summary of Q3 July 1 – September 30, 2018
- Net sales for the period amounted to SEK – (-) million.
- Net income (loss) for the period was SEK -31.4 (-18.4) million.
- Earnings and diluted earnings per share totaled SEK -0.91 (-1.21).
- At September 30, 2018, cash and cash equivalents amounted to SEK 685.9 (22.0) million.
Significant events during the period July 1 – September 30, 2018, in summary
- The liquidity from the rights issue of 650 MSEK, before deduction of issue costs, in connection with the listing was received in early July.
- In July, the over-allotment option issued in connection with the listing was utilized, which resulted in the company receiving an additional SEK 88.7 million, before deduction of issue costs.
|Amounts in SEK 000s||2018||2017||2018||2017||2017|
|Expenses relating to research and development||-24,055||-7,773||-65,088||-24,529||-51,686|
|Expenses relating to research and development/operating expenses, %||77%||44%||74%||56%||61%|
|Operating profit (loss)||-31,273||-17,474||-87,737||-43,97||-84,509|
|Earnings per share before and after dilution, SEK1||(0.91)||(1.21)||(2.90)||(3.21)||(5.81)|
|Total registered shares at the end of period||35,202,347||16,531,500||35,202,347||16,531,500||16,673,000|
|Equity at the end of the period||659,568||12,067||659,568||12,067||33,176|
|Equity ratio at the end of the period %||96%||44%||96%||44%||53%|
|Cash and cash equivalents at the end of the period||685,871||21,952||685,871||21,952||57,352|
Investor presentation November 1, 15:00 CET
Audio cast with teleconference, Q3, 2018, November 1, 2018, 15:00 (Europe/Stockholm)
Teleconference: Dial-in number UK: +442030089809 SE: +46856642697 US: +18557532237
- Year-end report for the period 1 January – 31 December 2018 – February 7, 2019
- Interim report for the period 1 January – 31 March 2019 – May 8, 2019
- Annual General Meeting 2019 – May 8, 2019
- Interim report for the period 1 January – 30 June 2019 – August 15, 2019
- Interim report for the period 1 January – 30 September 2019 – November 7, 2019
- Year-end report for the period 1 January – 31 December 2019 – February 14, 2020
For further information, please contact:
Renée Aguiar-Lucander, CEO at Calliditas
Telephone: +46 722 52 10 06
Mikael Widell, Head of Communications at Calliditas
Telephone: +46 703 11 99 60
This is information that Calliditas Therapeutics AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 07:00 CET on November 1, 2018.
About Calliditas Therapeutics
Calliditas Therapeutics is a specialty pharmaceutical company based in Stockholm, Sweden, focused on developing high quality pharmaceutical products for patients with a significant unmet medical need in niche indications, in which the Company can partially or completely participate in the commercialization efforts. The Company is focused on the development and commercialization of the product candidate Nefecon, a unique formulation optimized to combine a time lag effect with a concentrated release of the active substance budesonide, within a designated target area. This patented, locally acting formulation is intended for treatment of patients with the inflammatory renal disease IgA nephropathy. Calliditas Therapeutics aims to take Nefecon through a global Phase 3 study to commercialization. Visit www.calliditas.com for further information.