Karolinska Development: Q1 2019 Interim Report – January-March
May 21 2019 - 2:00AM
Karolinska Development: Q1 2019 Interim Report – January-March
STOCKHOLM – 21 May 2019. Karolinska
Development AB (Nasdaq Stockholm: KDEV) today publishes its Interim
Report for the period January – March 2019. The full report is
available on the Company's website.
“We are working to solve Karolinska
Development's convertible loan and negotiations are in progress
with the largest holder of the convertible loan, but we have not
yet reached a solution. The company also works with alternative
solutions together with financial institutions. The objective is to
be able to present a proposal to the Annual General Meeting.
Several of the portfolio companies reported
progress in their clinical development projects during the first
quarter of the year. Umecrine Cognition’s GR3027 showed a good
safety profile, favourable pharmacokinetics, and indications of
efficacy in a Phase II study, while Forendo presented positive
results from a Phase I study of FOR6219. After the quarter end,
Dilafor secured financing for the continued development of
tafoxiparin and OssDsign submitted a request for listing on the
NASDAQ First North Exchange. Aprea Therapeutics also announced
positive results from a study of APR-246 in combination with immune
checkpoint blockade, and the candidate drug received both Orphan
Drug and Fast Status Designations from the FDA. The results of
Modus Therapeutics’ Phase II study of sevuparin, however, were not
what we had hoped for, with no clinically meaningful effect
observed from the treatment”, says Viktor Drvota, CEO, Karolinska
Development.
Significant events during the first quarter
- Negotiations on the solution of the convertible loan are
ongoing. There is still no solution, but the management and the
board continue to work intensively with various possible solutions
to solve the financial situation. The objective is to be able to
present a proposal to the Annual General Meeting.
- Modus Therapeutics announced that patient enrollment for the
Phase II study of sevuparin in patients with sickle cell disease
(SCD) has been completed (January 2019).
- Umecrine Cognition presented the results of its Phase IIa study
of the GR3027 candidate drug in patients with idiopathic
hypersomnia. The primary study objectives were met in regard to
safety and pharmacokinetics. The study also showed preliminary
evidence of clinical efficacy in a subset of patients. Umecrine
Cognition will analyze the data further before a decision to
potentially move forward with the development of GR3027 in
idiopathic hypersomnia or other sleep disorders. In parallel,
Umecrine Cognition will continue the clinical development of GR3027
for hepatic encephalopathy (January 2019).
- OssDsign announced the closing of a private placement of SEK 64
million. Swedish private investors and the French investment
company Alto Invest took part in the private placement. (February
2019).
- Modus Therapeutics announced that they had successfully dosed
the first cohort of patients in their Phase I study of
subcutaneously administered sevuparin. The study is examining
pharmacokinetics, safety, and tolerability in healthy subjects
(February 2019).
- Aprea Therapeutics announced that investment funds managed by
Janus Henderson Investors have joined the Series C financing of the
company as a new investor, raising the total amount of the
financing from EUR 50 million to EUR 55 million (February
2019).
- Forendo Pharma presented positive results from a Phase Ia study
with the drug candidate FOR 6219 for the treatment of
endometriosis. The results found FOR 6219 to be safe and well
tolerated, with good pharmacokinetics at the doses tested (March
2019).
- Promimic announced a new partnership with the US company, Onkos
Surgical® to commercialize Promimic’s proprietary Hydroxyapatite
Surface Technologies in Limb Salvage Surgery (March 2019).
- Aprea Therapeutics appointed Dr. Eyal C. Attar as Senior Vice
President and Chief Medical Officer. Dr. Attar joins Aprea from
Agios Pharmaceuticals, where he was Senior Medical Director and IDH
Hematology Medical Lead (March 2019).
Significant post-period events
- Aprea Therapeutics presented promising results from studies of
APR-246 in combination with immuno-oncology agents. The results
showed that APR-246 can improve the effects of immuno-oncology
treatments (April 2019).
- Aprea Therapeutics announced that APR-246 had been granted
Orphan Drug Designation and Fast Track Designation by the FDA, for
treatment of patients with MDS (April 2019).
- Dilafor announced completion of a capital raising and plans to
start a new Phase 2b study of tafoxiparin to soften the cervix
prior to labor induction. The transaction will increase the value
of Karolinska Development’s holding in Dilafor and gives a positive
effect on earnings by approximately SEK 16.8 million (April
2019).
- The Annual Report contained an update from The Board of
Directors in Karolinska Development regarding the company's
financial situation and actions taken to strengthen the company’s
financials. The annual report also contains an emphasis of matter
paragraph from the Auditor regarding going concern (April
2019).
- OssDsign announced application for listing on Nasdaq First
North and published a prospectus in connection with a share issue
of SEK 151,3 million (May 2019).
- The results of the Phase II study of sevuparin by our portfolio
company, Modus Therapeutics, did not show any meaningful clinical
effect in conjunction with acute Vaso Occlusive Crisis (VOC) in
patients with sickle cell disease (SCD). Modus is now considering
alternative options for the further development of sevuparin (May
2019).
Financial update
First quarter
- The net profit/loss for the first quarter was SEK -18.6 million
(SEK 14.9 million in the first quarter of 2018). Earnings per share
totalled SEK -0.3 (SEK -0.3 in the first quarter of
2018).
- The result of the Change in fair value of shares in portfolio
companies amounted to SEK -0.01 million (SEK -4.8 during the first
quarter of 2018).
- The total fair value of the portfolio was SEK 970.0 million at
the end of March 2019, corresponding to an increase of SEK 17.7
million from SEK 952.3 million at the end of the previous quarter.
The net portfolio fair value at that time was SEK 636.0 million,
corresponding to an increase of SEK 17.1 million from SEK 618.9
million at the end of the previous quarter.
- Net sales totalled SEK 0.9 million during the first quarter of
2019 (SEK 0.7 million during the first quarter of 2018).
- Karolinska Development invested a total of SEK 17.1 million in
portfolio companies during the first quarter. First quarter
investments in portfolio companies by Karolinska Development and
other specialised life sciences investors totalled SEK 121.4
million.
- Cash and cash equivalents decreased by SEK 24.0 million during
the first quarter, totalling SEK 61.8 million on 31 March
2019.
- The Parent Company’s equity on 31 March 2019 was SEK 277.4
million.
The Q1 2019 Interim Report for Karolinska Development AB for the
period January-March 2019 is available as a PDF at
www.karolinskadevelopment.com.
For further information, please contact:
Viktor Drvota, CEO, Karolinska Development ABPhone: +46 73 982
52 02, e-mail: viktor.drvota@karolinskadevelopment.com
Fredrik Järrsten, CFO, Karolinska Development
AB Phone: +46 70 496 46 28, e-mail:
fredrik.jarrsten@karolinskadevelopment.com
TO THE EDITORS
About Karolinska Development
AB
Karolinska Development AB (Nasdaq Stockholm:
KDEV) is a Nordic life sciences investment company. The company
focuses on identifying breakthrough medical innovations in the
Nordic region that are developed by entrepreneurs and leadership
teams. The Company invests in the creation and growth of companies
that advance these assets into commercial products that are
designed to make a difference to patients' lives while providing an
attractive return on investment to shareholders.
Karolinska Development has access to world-class
medical innovations at the Karolinska Institutet and other leading
universities and research institutes in the Nordic region. The
Company aims to build companies around scientists who are leaders
in their fields, supported by experienced management teams and
advisers, and co-funded by specialist international investors, to
provide the greatest chance of success.
Karolinska Development has established a
portfolio of ten companies targeting opportunities in innovative
treatment for life-threatening or serious debilitating
diseases.
The Company is led by an entrepreneurial team of
investment professionals with a proven track record as company
builders and with access to a strong global network.
For more information, please visit
www.karolinskadevelopment.com
This information is information that Karolinska Development AB
(publ) (Nasdaq Stockholm: KDEV) is obliged to make public pursuant
to the EU Market Abuse Regulation. The information was submitted
for publication, through the agency of Viktor Drvota, at 08:00 am
CET on 21 May 2019.