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Egetis Therapeutics

Quarterly Report Apr 22, 2020

3152_10-q_2020-04-22_16f1d834-9a1c-49f5-ad60-8333fa2e8775.pdf

Quarterly Report

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Interim report January-March 2020

January-March

  • Quarterly net sales MSEK 11,7 (54.9)
  • Quarterly result MSEK till -42,8 (22,9)
  • Cash and cash equivalents MSEK 221,1 (258,0)
  • Cash flow from operating activities MSEK -37.2 (27.0)
  • Result per share SEK -0.8 (0.5)

PledOx®

  • US Food and Drug and Administration (FDA) and French regulatory authority (ANSM) issued a clinical hold in the US and France, respectively, of the phase III POLAR studies
  • PledPharma places dosing of patients in the POLAR program on hold

Aladote®

• PledPharma has following interactions with the FDA and the European Medicines Agency (EMA) finalised the development program for Aladote. The development program consists of one pivotal Phase II/III study which is expected to be sufficient for a marketing authorisation application in both US and EU.

Significant events after the reporting period

• PledPharma to close the POLAR phase 3 program with a data cut-off targeted for the third quarter 2020. Data generated will enable a thorough evaluation of safety and efficacy to determine the future of PledOx

2020 2019 2019
Jan-Mar Jan-Mar Jan-Dec
Net revenues, KSEK 11,712 54,902 82,562
Result after tax, KSEK -42,818 22,890 -61,422
Cash flow, KSEK -37,172 27,000 24,079
Cash, KSEK 221,141 258,036 255,101
Equity ratio % 86% 91% 91%
Result per share, SEK -0.8 0.5 -1.2
Result per share after dilution, SEK -0.8 0.5 -1.2
Average number of employees 9 10 9

PledPharma in brief – therapies for disabling and life-threatening diseases

PledPharma is an innovative, unique and integrated pharmaceutical drug development company, focusing on improving treatments for diseases with substantial unmet medical need.

The company's project PledOx® is a first in class drug candidate and is being developed to prevent nerve damage associated with chemotherapy. The phase III program was recently stopped with a data cut-off targeted for the third quarter 2020.

The drug candidate Aladote® is a first in class drug candidate and is being developed to reduce the risk of acute liver injury associated with paracetamol poisoning. A proof of principle study has been successfully completed, and the design of the next study is being finalised. Aladote® has been granted Orphan Drug Designation in the US. Ambition to initiate one pivotal study phase II/III study with Aladote for marketing authorization application in both US and EU.

PledPharma (STO: PLED) is listed on the Nasdaq Stockholm main market. For more information, see http://www.pledpharma.com/

Comments from the CEO

PledOx POLAR program

In the first quarter of this year, PledPharma experienced a major setback with the pivotal clinical POLAR program for the lead candidate PledOx®, developed to provide patients that are treated adjuvantly or for metastatic colorectal cancer prevention against the nerve damage that can occur in conjunction with chemotherapy treatment. In January, the US FDA issued a clinical hold in the US on the POLAR program due to a less than a handful of observed CNSrelated adverse events.

In early March, the French regulatory authority ANSM expressed the same concern as the FDA on less than a handful of observed CNS adverse events and requested that recruitment and dosing of patients should stop in France. PledPharma maintains its position that these CNSrelated events are not related to PledOx; a position which is also supported by the independent Drug Safety Monitoring Board (DSMB) and an additional independent external evaluation of these cases.

POLAR program data cut-off in Q3 2020

In April, we took the decision to close the POLAR program, with a data cut-off targeted for the third quarter 2020 and a thorough evaluation of the safety and efficacy will follow to determine the future of PledOx. The decision was taken after a recommendation from DSMB to stop the studies due to severe allergic reactions in eight patients, which have been observed after repeated dosing. Allergic hypersensitivity reactions are not uncommon in relation to platinum-based chemotherapy. However, the DSMB recommendation implies that there is an increased risk in subjects treated with PledOx. We are currently working to better understand why these allergic hypersensitivity reactions occur withcoadministration of oxaliplatin and why they occur after repeated dosing.

The current status of the POLAR program is as follows:

A total of 590 patients out of the planned 700 patients have been randomized. In terms of dosing, 420 patients have completed more than 6 cycles of treatment with study drug and about 250 more than 9 cycles. We expect that these patients randomized to PledOx have received sufficient treatment to evaluate prevention of neuropathy.

Our assessment is that the totality of data generated will enable a thorough efficacy and safety evaluation and an assessment of the benefit/risk of PledOx. This evaluation will determine if further activities to find a path forward for PledOx to treat nerve damage associated with chemotherapy are motivated.

The safety of patients in our clinical studies is our most important responsibility. We will now concentrate on collecting the remaining data in the challenging COVID-19 environment and how we can best use the data from the POLAR studies to potentially support future clinical trials, as we believe nerve damage associated with chemotherapy remains an unmet medical need.

Continued development of Aladote

Our focus on this important asset Aladote and the forthcoming regulatory interactions and clinical study remain unchanged as Aladote represents an important opportunity to address the high unmet medical need following paracetamol intoxication. A Phase I/IIa Proof-of-Principle study has been successfully completed, and a pivotal phase II/III study with a single administration is under planning. It is reassuring that no severe allergic-hypersensitivity reactions have been reported after single administrationin the clinical trials with calmangafodipir.

In order to continue the development of our clinical portfolio, we are well financed with approximately 221 million SEK in cash and cash equivalents reported at the end of the first quarter 2020.

The Covid-19 pandemic will most likely have far-reaching financial and structural consequences, not the least within the life science sector, where many clinical trials are now forced to be put on hold due to the acute situation at hospitals and potential study centres. Despite these uncertain and unsettling times, our focus on Aladote and the forthcoming regulatory interactions and clinical study remains firm. I look forward to relaying news to you around the planned study, as well as the data from the POLAR program.

Nicklas Westerholm, CEO PledPharma AB, Stockholm

Project updates

Pledox®

Events during the quarter

FDA issued a clinical hold in the US of the phase III POLAR program on the 23rd of January for PledOx. PledPharma decided on the 1st of March to place the dosing of patients in the POLAR program on hold. The decision follows interactions with the French regulatory authority, ANSM.

Significant events after the reporting period

PledPharma decided to close and read-out the POLAR phase 3 program with a data cut-off targeted for the third quarter 2020. Data generated will enable a thorough evaluation of the safety and efficacy to determine the future of PledOx. The decision was taken after a recommendation from the independent Drug Safety Monitoring Board (DSMB) to stop the studies due to severe allergic reactions in eight patients.

About PledOx®

PledOx is a "first in class" drug candidate developed to provide patients that are treated adjuvantly or for metastatic colorectal cancer prevention against the nerve damage that can occur in conjunction with chemotherapy treatment. The results from a completed Phase IIb trial (PLIANT), where patients with metastatic colorectal cancer were treated with the chemotherapy combination FOLFOX and PledOx, indicate that the patients who received PledOx had a lower risk than the placebo group to suffer from nerve damage during the chemotherapy. PledOx showed 38% effect (odds ratio=0.62; p=0.16) on investigator reported sensory nerve damage, the primary endpoint, compared with the placebo group. This was not statistically significant, but a difference of this magnitude is considered clinically relevant. After completion of chemotherapy, PledOx showed 77% effect (odds ratio=0.23; exploratory analysis: p=0.014) on patientreported moderate and severe neuropathy compared to the

placebo group. This is considered valuable for the success of the POLAR studies, where patient-reported symptoms after completion of treatment will be the primary efficacy parameter. No apparent negative effect on the efficacy of the cancer treatment was observed. The global phase III program for PledOx consists of two double blinded randomized placebo-controlled trials, POLAR-M and POLAR-A. POLAR-M includes 420 patients undergoing chemotherapy treatment for metastatic colorectal cancer and is being conducted in Asia, Europe and the US. The study compares PledOx at doses of 2 µmol/kg and 5 µmol/kg with placebo. POLAR-A includes 280 patients undergoing adjuvant chemotherapy treatment for colorectal cancer and is being conducted in Asia and Europe. The study compares PledOx at a dose of 5 µmol/kg with placebo. The phase III program was recently stopped with a data cut-off targeted for the third quarter 2020.

Aladote®

Events during the quarter

Following regulatory interactions with the FDA and the EMA, the company has finalized the development program for Aladote. The development program consists of one pivotal phase II/III study which is expected to be sufficient for a marketing authorization application in both US and EU.

About Aladote®

.

Aladote is a "first-in-class" drug candidate with the potential to reduce the risk of acute liver injury caused by paracetamol overdose. Aladote has shown good efficacy in relevant preclinical models, even in the time-window when N-acetylcysteine (NAC) treatment is no longer effective. A proof of principle study in patients with paracetamol poisoning has been successfully completed. The study results established the safety and tolerability of the combination of Aladote and NAC. Further, the results indicate that Aladote may reduce liver injury in this patient population. This is based on the measurement of the predefined exploratory biomarkers, Keratin-18 (K18) and microRNA-122 (miR-122) in patients treated with Aladote and NAC compared to NAC alone. Following regulatory interactions with the FDA and the EMA, the company has finalized the development program for Aladote. The

Continued interactions are ongoing with the regulatory agencies to finalize specific study details.

Significant events after the reporting period There are no events to report.

development program consists of one pivotal phase II/III study which is expected to be sufficient for a marketing authorization application in both US and EU. Aladote has been granted Orphan Drug Designation in the US.

Paracetamol is the most used drug in the world for the treatment of fever and pain, but also one of the most overdosed drugs – intentional or unintentional. Paracetamol overdose is also one of the most common method in intentional suicide attempts. When excessive amounts of paracetamol are broken down in the liver, the harmful metabolite NAPQI is formed, which can cause acute liver failure. The current standard of care for paracetamol poisoning (NAC) is effective if the patient seeks medical care within 8 hours of ingestion. However, NAC is substantially less effective if started more than 8 hours after overdose.

Aladote is effective ىپ Effective up to ~8h after overdose
after the critical
eight-hour threshold
where NAC treatment
Acetylcysteine (NAC)
Can be given even after 8h
Aladote®
Intensive care
Liver transplant
Death
is less effective. Overdose Time

Financial Information

First quarter, January - March 2020

Revenue, and results

Revenues

Revenue amounted to KSEK 11,712 (54,902) during the quarter and was primarily due to forwarding of expenses related to the Asian part of the POLAR program. In the corresponding period last year a milestone payment from Solasia Pharma K.K., JPY 600M (c. SEK 49M), was received.

Expenses

Operating expenses amounted to KSEK 58,588 (34,748) for the quarter. Of these, project costs amounted to KSEK 49,932 (26,239) for the quarter. The increase is due to the global POLAR program with PledOx®. Project costs related to PledPharma amounted to KSEK 38,215 (19,966).

Employee costs amounted to KSEK 5,708 (5,539) for the quarter. Other external costs amounted to KSEK 2,099 (2,724) for the quarter. Depreciation amounted to KSEK 54 (48) for the quarter and is due to IFRS 16.

Results

Operating result amounted to KSEK -46,876 (20,154) for the quarter. Financial and related items amounted to KSEK 4,057 (2,736). Results are related to revaluation of company's FX-accounts at the end of the quarter. Results after financial items amounted to KSEK -42,818 (22,890) for the quarter. No income tax was reported for the periods. Result per share before and after dilution amounted to SEK -0.8 (0.5) for the quarter.

Financial position

Cash

Cash at March 31, 2020 amounted to KSEK 221,141 (258,036).

Cash flow

Cash flow from operating activities amounted to KSEK -37,119 (26,855) for the quarter. Cash flow amounted to KSEK -37,172 (27,000) for the quarter.

Equity and equity ratio

At March 31, 2020 equity amounted to KSEK 202,057 (242,452). Shareholders' equity per share amounted to SEK 3.8 (5.0), at the end of the period. The company's equity ratio was 86 (91) %.

Debts and receivables

Long-term liabilities amounted to KSEK 29 (117) and are due to IFRS16. Current liabilities amounted to KSEK 32,018 (23,482). Accounts receivables amounted to KSEK 1,001 (5,441). Non-current assets amounted to KSEK 193 (283) and are due to IFRS16.

Investments, tangible and intangible assets

During the period, investments in tangible and intangible fixed assets corresponded to KSEK 0 (0).

Share

The number of shares at March 31, 2020 were 53,533,321. PledPharma´s shares are listed on Nasdaq Stockholm's main market since October 31, 2019.

Warrant program

The 2018 Annual General Meeting resolved on a warrants program for employees of PledPharma of 779,500 warrants, each warrant entitles the holder to subscribe for one (1) new share in the company at a subscription price of SEK 26 per share. As of March 31, 2019, 395,000 warrants were subscribed for by employees, of which the CFO and the CMO subscribed for the maximum allowed allocation of 100,000 each. 1,526,500 warrants had been subscribed for by employees and board members of PledPharma from the previous warrants program, of which the CEO holds 500,000 warrants.

At full utilization of all warrants, the company's shares will be increased by 2,306,000 to 55,839,321.

Employees

Number of employees as of March 31, 2020 were 9 (10) persons, 3 women and 6 men.

Parent company

The parent company's revenues for the quarter amounted to KSEK 11,712 (54,902). Operating expenses for the quarter amounted to KSEK -58,588 (-34,754).

The parent company's result amounted to KSEK -42,817 (22,885) for the quarter.

Consolidated statement of comprehensive income

KSEK 2020 2019 2019
Jan-Mar Jan-Mar Jan-Dec
Revenue
Sales 11,712 54,902 82,562
Other operating income - - -
11,712 54,902 82,562
Operating expenses
Project costs -49,932 -26,239 -112,240
Other external costs -2,099 -2,724 -13,334
Employee costs -5,708 -5,539 -23,386
Depreciation and impairment -54 -48 -210
Other operating expenses -795 -197 -74
Operating results -46,876 20,154 -66,681
Financial items
Interest income and similar items 4,059 2,737 5,266
Interest expense and similar items -1 -1 -7
Results after financial net -42,818 22,890 -61,422
Tax - - -
Results after tax -42,818 22,890 -61,422
Statement of comprehensive income
Other comprehensive income - - -
Comprehensive income for the period -42,818 22,890 -61,422
Net earnings and comprehensive income is
entirely attributable to parent company
shareholders
Share Data
Number of shares at the end of period 53,533,321 48,666,656 53,533,321
Average number of shares during period 53,533,321 48,666,656 51,626,655
Result per share before dilution (SEK) -0.8 0.5 -1.2
Result per share after dilution (SEK) -0.8 0.5 -1.2
Equity per share (SEK) 3.8 5.0 4.7
Equity per share after dilution (SEK) 3.8 5.0 4.7

Consolidated statement of financial position

KSEK 3/31/2020 3/31/2019 12/31/2019
ASSETS
Non-current assets
Tangible non-current assets 193 283 123
Total non-current assets 193 283 123
Current assets
Accounts receivables 1,001 5,441 5,200
Other receivables 2,563 586 1,704
Prepaid expenses and accrued income 9,207 1,703 7,945
12,771 7,730 14,849
Cash and bank balance 221,141 258,036 255,101
Total current assets 233,912 265,767 269,950
Total assets 234,104 266,050 270,073
KSEK 3/31/2020 3/31/2019 12/31/2019
Equity
Share capital 2,818 2,561 2,818
Other capital contributions 705,278 618,600 705,278
Accumulated loss including net loss -506,038 -378,709 -463,220
Total equity 202,057 242,452 244,876
Long-term liabilities 29 117 117
Current liabilities
Accounts payable 13,264 16,835 11,207
Other liabilities 980 1,557 1,328
Accrued expenses and deferred income 17,774 5,090 12,546
Total current liabilities 32,018 23,482 25,081
Total equity and liabilities 234,104 266,050 270,073

Consolidated statement of cash flows

KSEK 2020 2019 2019
Jan-Mar Jan-Mar Jan-Dec
OPERATING ACTIVITIES
Result after financial net -42,818 22,890 -61,422
Adjustments for non-cash items* -3,158 -1,112 -937
Cash flow from operating activities before changes -45,977 21,778 -62,358
in working capital
Changes in short term receivables 2,078 4,431 49
Changes in accounts payable 2,057 1,661 -3,967
Changes in other liabilities 4,723 -1,015 3,636
Cash flow from operating activities -37,119 26,855 -62,641
INVESTING ACTIVITIES
Cash flow from investing activities - - -
FINANCING ACTIVITIES
New share/Warrants issue - 200 91,258
Cost new share issue - - -4,323
Repayment of lease liability -54 -55 -216
Cash flow from financing activities -54 145 86,720
Cash flow for the period -37,172 27,000 24,079
Balance at beginning of period 255,101 229,876 229,876
Change in cash -37,172 27,000 24,079
Exchange rate difference in cash 3,212 1,160 1,146
CASH BALANCE AT THE END OF THE PERIOD 221,141 258,036 255,101

*predominantly revaluation of bank accounts in foreign currency

Consolidated statement of changes in equity

KSEK Share capital Other capital Accumulated loss Total equity
contributions incl. net result for
the period
Opening balance 20200101 2,818 705,278 -463,220 244,876
Comprehensive income for period - - -42,818 -42,818
Closing balance 20200331 2,818 705,278 -506,038 202,057
Opening balance 20190101 2,561 618,598 -401,798 219,362
Incentive program - 200 - 200
Comprehensive income for period - - 22,890 22,890
Closing balance 20190331 2,561 618,798 -378,908 242,452
Opening balance 20190101 2,561 618,598 -401,798 219,362
Transactions with shareholders - - - -
New share issue 256 91,002 - 91,258
Cost new share issue - -4,323 - -4,323
Comprehensive income for period - - -61,422 -61,422
Closing balance 20191231 2,818 705,278 -463,220 244,876

Consolidated key ratios

The key ratios below are useful to those who read the financial statements and a complement to other performance targets in evaluating strategic investment implementation and the Group's ability to achieve financial goals and commitments.

KSEK 2020 2019 2019
Jan-Mar Jan-Mar Jan-Dec
Equity 202,057 242,452 244,876
Equity ratio % 86% 91% 91%
Return on equity % neg. neg. neg.
Number of shares at the end of the period 53,533,321 48,666,656 53,533,321
Number of shares at the end of the period after
dilution
53,533,321 48,666,656 53,533,321
Average number of shares under the period 53,533,321 48,666,656 51,626,655
Average number of shares under the period after 53,533,321 48,666,656 51,626,655
dilution
Share Data
Result per share -0.8 0.5 -1.2
Result per share after dilution -0.8 0.5 -1.2
Cash flow from operating activities -0.7 0.6 -1.2
Equity per share 3.8 5.0 4.7
Equity per share after dilution 3.8 5.0 4.7
Dividend - - -
Average number of employees 9 10 9

*Effect from dilution is not considered when result is negative.

Key ratios definitions

Ratios that have been calculated according to IFRS

Earnings per share Net income divided by average number of shares before dilution

Number of shares at end of period The number of outstanding shares before dilution at the end of the period

Number of shares after dilution The number of issued shares after dilution effect of potential shares at end of period

Average number of shares during the period Average number of outstanding shares before dilution for the period

Average number of shares during the period after dilution Average number of issued shares after dilution effect of potential shares

Ratios that have not been calculated in accordance with IFRS

Equity ratio, % The company defines the ratio as follows; The period's closing equity divided by the period's closing balance sheet. The company uses the alternate ratio Equity as it shows the proportion of total assets represented by shareholders' equity and has been included to allow investors to assess the company's capital structure.

Return on equity, % The company defines the ratio as follows; Net income divided by shareholders' equity. The company uses the alternate key figure Return on equity, % because the company believes that the key ratio gives investors a better understanding of the return generated on the total capital that the shareholders have invested in the Company.

Cash flow from operations per share The company defines the ratio as follows; Cash flow from operating activities divided by the number of shares outstanding at the end of the period. The company uses the alternate key figure Cash flow from operations per share because the Company believes that the key ratio gives investors a better understanding of the company's cash flow in relation to its number of shares adjusted for changes in the number of shares outstanding during the period.

Equity per share The company defines the ratio as follows; Equity divided by number of shares outstanding at the end of the period. The company uses the alternate key ratio equity per share because the Company believes that the key ratio gives investors a better understanding of the historical return per share adjusted for changes in the number of shares outstanding during the period.

Number of employees (average) The average number of employees at the end of each period

Parent company - income statement

KSEK 2020 2019 2019
Jan-Mar Jan-Mar Jan-Dec
Revenue
Sales 11,712 54,902 82,562
Other operating income - - -
11,712 54,902 82,562
Operating expenses
Project costs -49,932 -26,239 -112,240
Other external costs -2,152 -2,778 -13,553
Employee costs -5,708 -5,539 -23,386
Other operating expenses -795 -197 -74
Operating results -46,876 20,148 -66,690
Financial items
Interest income and similar items 4,059 2,737 5,266
Interest expense and similar items 0 - -2
Results after financial net -42,817 22,885 -61,427
Tax - - -
Results after tax -42,817 22,885 -61,427

Parent company - balance sheet

KSEK 3/31/2020 3/31/2019 12/31/2019
ASSETS
Non-current assets
Financial non-current assets 50 50 50
Total non-current assets 50 50 50
Current assets
Receivables from group companies - 2,686 -
Accounts receivables 1,001 5,441 5,200
Other receivables 2,563 586 1,704
Prepaid expenses and accrued income 9,207 1,703 7,945
12,771 10,417 14,849
Cash and bank balance 220,841 255,101 254,800
Total current assets 233,612 265,517 269,649
Total assets 233,662 265,567 269,699
KSEK 3/31/2020 3/31/2019 12/31/2019
Equity
Restricted Equity
Share capital 2,818 2,561 2,818
Non-restricted equity
Share premium reserve 705,027 618,599 705,026
Retained earnings -463,226 -401,799 -401,798
Net profit for the year -42,817 22,885 -61,427
Total equity 201,802 242,247 244,619
Current liabilities
Accounts payable 13,264 16,835 11,207
Other liabilities 823 1,396 1,328
Accrued expenses and deferred income 17,774 5,090 12,546
Total current liabilities 31,861 23,321 25,081
Total equity and liabilities 233,662 265,567 269,699

Notes

Note 1 - Accounting principles

PledPharma applies International Financial Reporting Standards (IFRS) as adopted by the EU. This report is prepared in accordance with IAS 34 Interim Financial Reporting and the Annual Accounts Act. Applied accounting principles and calculation methods are the same as in the latest annual report for 2019. All the numbers in this interim report are, if nothing else is stated, stated in thousands.

As of April 1, 2019, the group has categorized and identified two independent segments of development for calmangafodipir, PledOx and Aladote. These two segments are independent R&D projects for which the CEO allocates company's resources.

Parent company

The parent company PledPharma AB (Publ) prepares financial reports in accordance with the Swedish Financial Reporting Board's recommendation RFR 2 Accounting for Legal Entities and the Swedish Annual Accounts Act. All leases are reported operationally in the Parent Company.

IFRS16

IFRS 16 has replaced IAS 17 Lease Agreement, with new accounting requirements for lessee. All leases, except short-term and low value leasing contracts, is reported as an asset with right of use and as a corresponding liability in the leaseholder's balance sheet. The standard means that most operating leases will be reported according to IFRS 16. Hence, costs consist of interest expense and depreciation and are reported accordingly. Leasing contracts of low value is accounted as operating leases and reported in the income statement. Group's leasing portfolio consists of five agreements which includes operating leases of office space, office equipment and a car. At the entry into 2020 one of the group's rental agreements had a duration of less than 12 months and two contracts related to office equipment were regarded to be of low value. These agreements fall into the exception of short term leasing contracts and low value leasing contracts.

Operating risks

All business operations involve risk. Risks may be company specific or due to events in the external environment and may affect a certain industry or market. The group is, among others, exposed to the following operational and financial risks. Operational risks: Pharmaceutical development, Manufacturing, Regulatory and Intellectual property. Financial risks: Foreign currency, Need of working capital, General market risk, Credit and Interest rate risks. A more detailed description of Group's risk exposure is included in PledPharma's 2019 Annual Report. There are no major changes in the Group's risk exposure in 2020 compared with previous year.

Note 2 – Additional information

Other information in accordance with IAS 34.16A are found on pages before the income statement and statement of comprehensive income. Information on earnings, cash flow and financial position, see page 5. For events after the period, see page 1.

Note 3 – Financial assets and liabilities

KSEK Hold to
collect
Financial
debts
Total
Amortised
cost
Amortised
cost
Group March 31, 2020
Accounts receivable 1,001 - 1,001
Cash 221,141 - 221,141
Total financial assets 222,142 - 222,142
Long-term liabilities - 29 29
Accounts payable - 13,264 13,264
Other liabilities - 158 158
Total financial liabilities - 13,452 13,452
Group March 31, 2019
Accounts receivable 5,441 - 5,441
Cash 258,036 - 258,036
Total financial assets 263,477 - 263,477
Accounts payable - 16,835 16,835
Other liabilities - 162 162
Total financial liabilities - 16,997 16,997

Note 4 – Related party transactions

There are none transactions to be reported with related parties.

Note 5 – Segments

As of June 1, 2019, the group has categorized and identified two independent areas of development for calmangafodipir. The chief operating decision maker in the company allocates company resources between these two projects. 2019 PledOx revenues reported are attributed to milestone payments and forward expenses for the Asian part of the POLAR studies. 2020 PledOx revenues reported are attributed to forward expenses for the Asian part of the POLAR studies. Table below depicts revenues and costs attributed to PledOx and Aladote.

2020 2019
Jan-Mar Jan-Mar
KSEK PledOx Aladote Common Sum KSEK PledOx Aladote Common Sum
Revenues 11,712 - - 11,712 Revenues 54,902 - - 54,902
Project costs -49,051 -881 - -49,932 Project costs -24,558 -1,544 -137 -26,239
Other -10 - -8,646 -8,656 Other 0 - -8,508 -8,508
Operating results -37,349 -881 -8,646 -46,876 Operating results 30,344 -1,544 -8,645 20,154
Net financial items 4,057 Net financial items 2,736
Pretax profit -42,818 Pretax profit 22,890
2019
Jan-Dec
KSEK PledOx Aladote Common Sum
Revenues 82,539 - 22 82,562
Project costs -106,148 -6,091 - -112,240
Other -75 - -36,928 -37,003
Operating results -23,684 -6,091 -36,906 -66,681
Net financial items 5,259
Pretax profit -61,422

Note 6 – Changes in financial liabilities in the financing activities

Group's financial liabilities in the financial items consists of current leasing liabilities of KSEK 157 and long-term liabilities of KSEK 29. Opening leasing liability for the year 2020 was KSEK 244. Amortization for the period was KSEK 54 and closing balance leasing liability was KSEK 186. All items are related to IFRS16.

Other information

Next reports Half-year report Jan – Jun 2020, August 20, 2020 Interim report Jan – Sep 2020, November 4, 2020

This report, and further information is available on the website, www.pledpharma.se This report has not been reviewed by the company's auditor. This is a translation of the Swedish interim report.

Annual General Meeting 2020

Annual general meeting will be held April 23, 2020. Time: 16:00 CET, Venue: Erik Penser Bank, Apelbergsgatan 27, Stockholm.

For further information, please contact: Nicklas Westerholm, CEO Yilmaz Mahshid, CFO Phone:+46 (0)73-354 20 62 Phone:+46 (0)72-231 68 00 E-mail: [email protected] E-mail: [email protected]

This information is such information as PledPharma AB (publ) is obliged to disclose in accordance with EU market abuse regulation and the Securities Markets Act. The information was submitted, through the above contact persons, for publication on April 22, 2020 at 8.00 am (CET).

PledPharma AB (publ) Grev Turegatan 11c, 114 46 Stockholm Org.nr. 556706-6724 Phone: +46(0)8-679 72 10 www.pledpharma.se

Analysts who follow PledPharma Pareto Securities, Dan Akschuti and Johan Unnérus Redeye, Klas Palin. Carnegie, Ulrik Trattner.

Certification

This report provides a true and fair overview of the company's business activities, financial position, and results of operations, and describes significant risks and uncertainties to which the company is exposed.

Stockholm, April 22, 2020

Chairman of the board Board member

Håkan Åström Marie Ekström Trägårdh

Board member Board member

Sten Nilsson Gunilla Osswald

Board member CEO

Elisabeth Svanberg Nicklas Westerholm

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