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| Drug | Stage | Catalyst Date |
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Nefecon (NefIgArd)
IgA nephropathy
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Drug Pipeline
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Setanaxib
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Phase 2/3 trial to be initiated 2H 2021.
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Latest News
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STOCKHOLM and BAD VILBEL, Germany, July 21, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALT), (Nasdaq Stockholm: CALTX) ("Calliditas") and STADA Arzneimittel AG ("STADA") announced today that they have entered into a license agreement to register and commercialize a novel specialty drug candidate for the treatment of the chronic autoimmune kidney disease Immunoglobulin A Nephropathy (IgAN) in the European Economic Area (EEA) member states, Switzerland and the UK.
Under the terms of the agreement, Calliditas is entitled receive an initial upfront payment of 20M EUR ($24m) upon signing and up to an additional 77.5M EUR ($91m) in future payments linked to pre-defined regulatory and commercialization milestones. STADA is also obligated pay tiered royalties on net sales expressed as a percentage between the low twenties and the low thirties.
The partnership relates to a novel oral formulation, developed under the project name 'Nefecon', of a potent and well-known active substance – budesonide – designed to target down regulation of IgA1 with a view to be disease modifying. If approved, this value-added specialty medicine, which received an EU orphan-drug designation in 2016, would be the first treatment authorized in the European Union for IgAN, a rare autoimmune disease. IgAN, also known as Berger´s disease, is a serious progressive autoimmune disease in which up to 50% of patients end up at risk of developing end stage renal disease and thus requiring dialysis or a kidney transplant. Prevalence in Europe is estimated at 4 in 10,000, translating into approximately 200,000 patients.
"We are excited to be entering into this partnership with STADA to bring this IgAN therapy to market in Europe, where there is a significant unmet medical need for this patient population. We look forward to working in close collaboration with STADA to pursue marketing authorization with the goal of bringing the first ever EU-approved medication in IgAN to patients as soon as possible, utilizing STADA's extensive marketing and sales platform throughout Europe," said Renée Aguiar-Lucander, CEO of Calliditas.
"This partnership, which leverages Calliditas' drug-delivery expertise and clinical data in this under-served patient population, further validates STADA's position as a go-to-partner for specialty pharmaceuticals, as well as for generics and consumer health products," commented STADA CEO Peter Goldschmidt. "This value-added novel formulation for a large orphan indication will complement STADA's offerings in nephrology, where we have built strong expertise over more than a decade through our epoetin zeta biosimilar and where we continue to place a clear strategic focus on seeking further opportunities to bring new options to patients."
The novel formulation is designed to deliver the drug to the Peyer's patch region of the lower small intestine, where the disease originates as per the predominant pathogenesis models. The formulation uses a unique two-step technology, which allows for the substance to pass through the stomach and intestine without being absorbed, and to be released in a pulse like fashion only when it reaches the ileum in the lower small intestine. In addition to its potent local effect, another advantage of using this active substance is that it has very low bioavailability, with around 90% being inactivated in the liver before it reaches the systemic circulation. This means that a high concentration can be applied locally where needed, whilst limiting systemic exposure.
On May 28, 2021, Calliditas announced that the company had, under the drug-development candidate name Nefecon, submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for a novel oral formulation of budesonide targeting down regulation of IgA1 for the treatment of primary IgAN. The company also filed an application for accelerated approval in the US on March 15, 2021 and was granted priority review in April 2021. The commercial brand name for this therapy in Europe will be determined and disclosed at a later date.
Calliditas´ oral formulation has been granted Accelerated Assessment procedure by the Committee for Human Medicinal Products (CHMP) within the European Medicines Agency, which is intended to expedite access to drugs that the CHMP considers to be of major therapeutic interest from the point of view of public health and in particular from the viewpoint of therapeutic innovation. Accelerated assessment reduces the maximum timeframe for review of the MAA to 150 days (excluding clock-stops).
IgAN is designated as an orphan disease in both the US and Europe. In Europe, an orphan disease is defined as a disease or condition affecting no more than five in 10,000 European citizens with no satisfactory method of diagnosis, prevention or treatment. Orphan incentives consist of ten years of market exclusivity from the grant date of marketing approval in the EU, protocol assistance and scientific advice, fee reductions on EMA procedural activities and eligibility for EU grants.
If approved, the product could be available to patients in Europe in the first half of 2022 and would become the first therapy specifically designed and approved for the treatment of IgAN, and which has the potential to be disease modifying.
Torreya acted as exclusive financial advisor to Calliditas on the transaction.
For further information, please contact:
Marie Galay, IR Manager, Calliditas
Tel.: +44 79 55 12 98 45, email: [email protected]
STADA Arzneimittel AG
Stadastrasse 2–18
61118 Bad Vilbel - Germany
Phone: +49 (0) 6101 603-165
Fax: +49 (0) 6101 603-215For Media Relations, email: [email protected]
Or visit us on the Internet at www.stada.com/pressFor Investor & Creditor Relations, email: [email protected]
Or visit us on the Internet at www.stada.com/investor-relationsThe information in the press release is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was sent for publication, through the agency of the Calliditas contact person set out above, on July 21, 2021 at 8:45 a.m. CET.
About STADA Arzneimittel AG
STADA Arzneimittel AG is headquartered in Bad Vilbel, Germany. The company focuses on a three-pillar strategy consisting of generics, specialty pharma and non-prescription consumer healthcare products. Worldwide, STADA Arzneimittel AG sells its products in approximately 120 countries. In financial year 2020, STADA achieved group sales of EUR 3,010.3 million and adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) of EUR 713.3 million. As of December 31, 2020, STADA employed 12,301 people worldwide.
About Calliditas
Calliditas Therapeutics is a biopharma company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas' lead product candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of adults with the autoimmune renal disease primary IgA nephropathy (IgAN), for which there is a high unmet medical need and there are no approved treatments. Calliditas has recently read out topline data from Part A of its global Phase 3 study in IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is also planning to start clinical trials with NOX inhibitors in primary biliary cholangitis and head and neck cancer. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding Calliditas' strategy, business plans, regulatory submissions and focus, as well as Calliditas's partnership with STADA, the parties' plans with respect to registration and commercialization of the specialty therapy, the terms of the collaboration and the intended benefits therefrom, the regulatory pathway and interactions for Nefecon, including timing of review and assessment of the candidate, and the intended benefits of regulatory designations such as Accelerated Assessment and orphan disease. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, any related to Calliditas' business, operations, the conduct of Calliditas's partnership with STADA, the potential for regulatory acceptance for and the success and timeline of its regulatory marketing application for Nefecon, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other biopharmaceutical companies, and other risks identified in the section entitled "Risk Factors" in Calliditas' reports filed with the Securities and Exchange Commission. Calliditas cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Calliditas disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Calliditas' views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.
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Calliditas EU Partner ENG
View original content:https://www.prnewswire.com/news-releases/calliditas-therapeutics-and-stada-partner-to-register-and-commercialize-specialty-therapy-for-iga-nephropathy-in-europe-301338303.htmlSOURCE Calliditas Therapeutics
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STOCKHOLM, July 15, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the company has signed a loan agreement of up to the Euro equivalent of $75 million with Kreos Capital. Proceeds from the loan will be utilized for the launch of Calliditas' lead product candidate Nefecon, if approved, as well as to support clinical development efforts and for general corporate purposes.
The loan facility is divided into three tranches of $25 million each. Drawdown of the first $25 million tranche can be made until 31 December 2021 and will be available after the satisfaction of customary closing conditions. Drawdown of the second tranche of $25 million can be made until 30 June 2022 and will be available subject to accelerated approval of Nefecon by the U.S Food and Drug Administration (FDA). Drawdown of the third and final $25 million tranche can be made until 31 December 2022 and will be available subject to certain revenue milestones and coverage metrics.
"Signing this loan facility broadens our financing options and gives us access, on a non-dilutive basis, to significant additional capital, which bolsters our ability to invest in our commercial capabilities in the US both on a pre- and post-approval basis, subject to FDA approval later in the year, as well as in to our development activities with NOX inhibitors," said CEO Renée Aguiar-Lucander.
"This is an important time for Calliditas as the company progresses through the approval process and prepares to commercialise Nefecon. We are very pleased to support the company in bringing their innovative new medicines to patients with IgA nephropathy," commented Aris Constantinides, General Partner at Kreos.
The loan is denominated in Euro and the loan agreement provides for interest only payments through December 2024, should certain milestones be achieved. The loan is due in December 2025, but is prepayable in full, including the final payment and certain fees, at any time at the option of Calliditas. The senior, secured loan initially bears an interest at a rate of 9.00%, which may be reduced to 7.95% upon reaching certain milestones. The loan is secured by Calliditas' owned intellectual property in the US. Calliditas will pay a customary fee to Kreos for the establishment of the loan and the loan agreement does not contain any financial covenants.
Carnegie and Lazard acted as advisors to Calliditas in this transaction.
For further information, please contact:
Marie Galay, IR Manager, Calliditas
Tel.: +44 79 55 12 98 45, email: [email protected]
The information in the press release is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was sent for publication, through the agency of the contact persons set out above, on July 15, 2021 at 8:20 a.m. CET.
About Calliditas
Calliditas Therapeutics is a biopharma company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas' lead product candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of adults with the autoimmune renal disease primary IgA nephropathy (IgAN), for which there is a high unmet medical need and there are no approved treatments. Calliditas has recently read out topline data from Part A of its global Phase 3 study in IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is also planning to start clinical trials with NOX inhibitors in primary biliary cholangitis and head and neck cancer. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.
About Kreos Capital:
Kreos Capital is the leading growth debt provider in Europe and Israel, backing high-growth companies through every stage of their life cycle. Kreos targets investments in all areas of the Technology and Healthcare sectors and, to date, has committed in excess of €3.1 billion in more than 630 portfolio company transactions, across 17 countries. With over $1.5 billion in current funds under management Kreos can invest between $2 million and $100 million per transaction in both public and private companies across stages.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding Calliditas' strategy, business plans, regulatory submissions and focus as well as our plans with respect to the loan facility and the terms thereof. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, any related to Calliditas' business, operations, the potential for FDA acceptance for and the success and timeline of its regulatory marketing application for Nefecon, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other biopharmaceutical companies, and other risks identified in the section entitled "Risk Factors" in Calliditas' reports filed with the Securities and Exchange Commission. Calliditas cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Calliditas disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Calliditas' views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.
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Calliditas secures loan facility
View original content:https://www.prnewswire.com/news-releases/calliditas-secures-75-million-term-loan-facility-301334423.htmlSOURCE Calliditas Therapeutics
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STOCKHOLM, May 28, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the company submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for Nefecon, a novel oral formulation targeting down regulation of IgA1 for the treatment of primary IgA Nephropathy (IgAN).
The submission is based on positive data from Part A of the NefIgArd pivotal Phase 3 study, a randomized, double-blind, placebo-controlled, international multicenter study designed to evaluate the efficacy and safety of Nefecon compared to placebo in 200 adult patients with IgAN. The study achieved its primary endpoint of proteinuria reduction compared to placebo, and also showed a renal protective effect by way of stabilization of eGFR at 9 months.
The submission also includes clinical data from the Phase 2 NEFIGAN trial, which met the same primary and secondary endpoint as the NefIgArd study. The NefIgArd trial also showed that Nefecon was generally well-tolerated, with a safety profile in keeping with the Phase 2b results. Calliditas is the only company which has achieved positive data in randomized, double-blind, placebo-controlled Phase 2b and Phase 3 clinical trials in IgAN.
"This is another important step forward in our endeavors to bring the first approved medication to patients suffering from IgAN. We look forward to engaging with the agency with the target of achieving an approval in Q1 next year," said CEO Renée Aguiar-Lucander
As previously reported, the MAA for Nefecon has been granted Accelerated Assessment procedure by EMA's Committee for Human Medicinal Products (CHMP), which is intended to expedite access to drugs that the CHMP considers to be of major therapeutic interest from the point of view of public health and in particular from the viewpoint of therapeutic innovation. Accelerated assessment reduces the maximum timeframe for review of the MAA to 150 days (excluding clock-stops).
If approved, Nefecon could be available to patients in Europe in H1 2022 and would become the first therapy specifically designed and approved for the treatment of IgAN, and which has the potential to be disease modifying.
For further information, please contact:
Marie Galay, IR Manager, Calliditas
Tel.: +44 79 55 12 98 45, email: [email protected]The information in the press release is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was sent for publication, through the agency of the contact persons set out above, on May 28, 2021 at 2:40 p.m. CET.
About Calliditas
Calliditas Therapeutics is a biopharma company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas' lead product candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of adults with the autoimmune renal disease primary IgA nephropathy (IgAN), for which there is a high unmet medical need and there are no approved treatments. Calliditas has recently read out topline data from Part A of its global Phase 3 study in IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is also planning to start clinical trials with NOX inhibitors in primary biliary cholangitis and head and neck cancer. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.
About the NefIgArd Study
The global Phase 3 clinical trial NefIgArd, which investigated the effect of Nefecon versus placebo in patients with primary IgA nephropathy (IgAN), consists of two parts.
Part A, which was designed to provide the basis for regulatory submissions and approvals, evaluates data on the efficacy and safety of Nefecon. The first patient in the NefIgArd trial was randomized by Calliditas in November 2018, and in December 2019, Calliditas announced the full recruitment of Part A, across approximately 146 sites in 19 countries. Calliditas read out topline data for Part A in November 2020.
The trial met its primary objective of demonstrating a statistically significant reduction in urine protein creatinine ratio, UPCR or proteinuria, after 9 months of treatment with 16 mg of Nefecon compared to placebo, with significant continued improvement at 12 months. The primary endpoint analysis showed a 31% mean reduction in the 16 mg arm versus baseline, with placebo showing a 5% mean reduction versus baseline, resulting in a 27% mean reduction at 9 months (p=0.0005) of the 16 mg arm versus placebo. The trial also met the key secondary endpoint, showing a statistically significant difference in estimated glomerular filtration rate or eGFR after 9 months of treatment with Nefecon compared to placebo. The key secondary endpoint, eGFR, showed a treatment benefit of 7% versus placebo at 9 months, reflecting stabilization in the treatment arm and a 7% decline of eGFR in the placebo arm (p=0.0029). This reflected an absolute decline of 4.04 ml/min/1.73m2 in the placebo group over 9 months compared to a 0.17 ml/min/1.73m2 decline in the treatment group. Nefecon was also generally well-tolerated, and the safety profile was in keeping with the Phase 2b results and consistent with the known safety profile of budesonide.
Part B of the NefIgArd study is designed to be a confirmatory post-market observational trial to confirm long-term renal protection and assess the difference in kidney function between treated and placebo patients as measured by eGFR over a two-year period from the start of dosing of each patient. The 360-patient population of the complete Phase 3 trial includes another 160 patients enrolled in addition to the 200 patients from Part A. The trial was fully recruited in January 2021, and aims to read out data in early 2023, after all patients have completed 2 years in the trial.
About Nefecon
Nefecon is a patented oral formulation of a potent and well-known active substance – budesonide – for targeted release. The formulation is designed to deliver the drug to the Peyer's patch region of the lower small intestine, where the disease originates, as per the predominant pathogenesis models. Nefecon is derived from the TARGIT technology, which allows for the substance to pass through the stomach and intestine without being absorbed, and to be released in a pulse like fashion only when it reaches the lower small intestine.
The combination of dose and optimized release profile is required to be effective in patients with IgAN, as shown in a large Phase 2b trial, completed by Calliditas. In addition to its potent local effect, another advantage of using this active substance is that it has very low bioavailability, i.e. around 90% of it is inactivated in the liver before it reaches the systemic circulation. This means that a high concentration can be applied locally where needed but with only very limited systemic exposure and side effects.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding Calliditas' strategy, business plans, regulatory submissions and focus. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, any related to Calliditas' business, operations, the potential for FDA acceptance for and the success and timeline of its regulatory marketing application for Nefecon, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other biopharmaceutical companies, and other risks identified in the section entitled "Risk Factors" in Calliditas' reports filed with the Securities and Exchange Commission. Calliditas cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Calliditas disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Calliditas' views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.
conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Calliditas' views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.
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The following files are available for download:
EMA Submission ENG
View original content:http://www.prnewswire.com/news-releases/calliditas-announces-submission-of-marketing-authorisation-application-for-nefecon-to-the-european-medicines-agency-301301707.htmlSOURCE Calliditas Therapeutics
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STOCKHOLM, May 28, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") today announced that management will present at the Jefferies Virtual Healthcare Conference on Tuesday, June 1, 2021 at 2:30 pm CET/8:30 am ET. Calliditas will also host 1x1 meetings during the conference. Details for the presentation are as follows:
Jefferies Virtual Healthcare Conference
Date: Tuesday, June 1, 2021
Time: 2:30 pm CET / 8:30 am ETRegistration Link: https://wsw.com/webcast/jeff174/register.aspx?conf=jeff174&page=calt&mmid=3325730&refer=meetmax&firstname=&lastname=
The webcast will be archived for a period of 30 days following the conclusion of the event.
For further information, please contact:
Marie Galay, IR Manager, Calliditas
Tel.: +44 79 55 12 98 45
email: [email protected]The information was sent for publication, through the agency of the contact persons set out above, on May 28, 2021 at 12:00 p.m. CET.
About Calliditas
Calliditas Therapeutics is a biopharma company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas' lead product candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas successfully reported top line data of its global Phase 3 study in IgAN in November of 2020 and, if approved, aims to commercialize Nefecon in the United States on its own and partner elsewhere. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.
This information was brought to you by Cision http://news.cision.com
The following files are available for download:
Jefferies Conference Press Release - En
View original content:http://www.prnewswire.com/news-releases/calliditas-therapeutics-to-present-at-jefferies-virtual-healthcare-conference-301301624.htmlSOURCE Calliditas Therapeutics
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STOCKHOLM, May 27, 2021 /PRNewswire/ -- The following resolutions were passed at Calliditas Therapeutics AB (publ) ("Calliditas") annual general meeting held today, on May 27, 2021.
Adoption of income statement and balance sheet for the financial year 2020 and discharge from liability
The annual general meeting resolved to adopt the income statement and the consolidated income statement for the financial year 2020 as well as the balance sheet and consolidated balance sheet as of 31 December 2020. The members of the board of directors and the managing director were discharged from liability for the financial year 2020.
Allocation of profit or loss
The annual general meeting resolved, in accordance with the board of directors' proposal, that no dividend shall be paid for 2020 and that the results of the company shall be carried forward.
Election of board members, auditors, fees to the board of directors and auditors
The annual general meeting resolved, in accordance with the nomination committee's proposal, that the number of members of the board of directors shall be five without deputies and that the number of auditors shall be one without deputies.
In accordance with the nomination committee's proposal, Elmar Schnee, Hilde Furberg, Lennart Hansson, Diane Parks and Molly Henderson were re-elected as members of the board of directors for the period until the end of the next annual general meeting. Elmar Schnee was re-elected as the chairman of the board of directors. The audit firm Ernst & Young AB was re-elected auditor of the company for the period until the end of the next annual general meeting, and it was noted that the authorised public accountant Anna Svanberg will continue as auditor in charge.
The annual general meeting further resolved, in accordance with the nomination committee's proposal and for the time period until the end of the next annual general meeting, that the directors' fees shall be paid with SEK 850,000 to the chairman of the board of directors and with SEK 300,000 to each of the other members, with SEK 150,000 to the chairman of the audit committee and with 75,000 SEK to the other members of the audit committee as well as with SEK 50,000 to the chairman of the remuneration committee and SEK 25,000 to the other members of the remuneration committee. In addition to the above remuneration, it was determined that board members residing in the United States shall receive an additional amount of SEK 140,000 and that board members residing in Europe, but outside the Nordics, shall receive an additional amount of SEK 50,000. The annual general meeting further resolved, in accordance with the nomination committee's proposal, that the remuneration to the auditor shall be paid in accordance with approved statement of costs.
Nomination committee for the next annual general meeting
The annual general meeting resolved, in accordance with the nomination committee's proposal, on principles for appointing the nomination committee. In short, the nomination committee should be composed of the chairman of the board of directors together with one representative of each of the three largest shareholders, based on ownership in the company as of the expiry of the third quarter of the financial year.
Remuneration report
The annual general meeting approved the board of directors' proposal regarding remuneration report.
Long-term performance-based incentive program for members of the board of directors
The annual general meeting resolved, in accordance with the nomination committee's proposal, to adopt a new long-term performance-based incentive program for members of the board of directors, including a resolution to issue not more than 32,000 warrants to ensure delivery of shares to participants under the program. The incentive program entails that the members of the board of directors will be granted share awards, free of charge, that can entitle to shares in Calliditas, subject to the fulfilment of certain performance conditions.
Long-term incentive program for the management and key personnel
The annual general meeting resolved, in accordance with the board of directors' proposal, to adopt a new long-term incentive program for the company's management and key personnel, including a resolution to issue not more than 1,500,000 warrants to ensure delivery of shares to participants under the program. The incentive program entails that the participants will be granted options which after three years will entitle the holder to the acquisition of shares in the company at a pre-determined exercise price corresponding to 115 per cent of the volume-weighted average price of Calliditas' share during the ten trading days preceding the granting date.
Authorisation to issue new shares
The annual general meeting resolved, in accordance with the board of directors' proposal, to authorise the board of directors, at one or several occasions and for the period up until the next annual general meeting, to increase the company's share capital by issuing new shares. Such share issue resolution may be carried out with or without deviation from the shareholders' preferential rights and with or without provisions for contribution in kind, set-off or other conditions. The authorisation may only be utilised to the extent that it corresponds to a dilution of not more than 20 per cent of the total number of shares outstanding at the time of the general meeting's resolution on the proposed authorisation.
Amendment to the articles of association
The annual general meeting resolved, in accordance with the board of directors' proposal, to amend the articles of association as a result of statutory amendments as well as to introduce a new section whereby the board is enabled to collect powers of attorney and to resolve that the shareholders shall be entitled to exercise their voting rights by post prior to a general meeting.
For further information, please contact:
Mikael Widell, Head of Communications
Email: [email protected]
Telephone: +46 703-11 99 60
The information was submitted for publication, through the agency of the contact person set out above, at 6.30 pm CEST on May 27, 2021.
About Calliditas
Calliditas Therapeutics is a biopharma company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas' lead product candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of adults with the autoimmune renal disease primary IgA nephropathy (IgAN), for which there is a high unmet medical need and there are no approved treatments. Calliditas has recently read out topline data from Part A of its global Phase 3 study in IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is also planning to start clinical trials with NOX inhibitors in primary biliary cholangitis and head and neck cancer. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.
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AGM_2021_-_Bulletin from the annual general meeting (Eng)
View original content:http://www.prnewswire.com/news-releases/bulletin-from-the-annual-general-meeting-of-calliditas-therapeutics-ab-publ-301301118.htmlSOURCE Calliditas Therapeutics