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Cantargia

Quarterly Report Feb 24, 2022

3022_10-k_2022-02-24_70fad1fd-0aa6-4ac9-8871-15ef87f83bca.pdf

Quarterly Report

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FULL YEAR REPORT

January - December 2021

A successful year validated by new partnership

FULL YEAR REPORT

  • Net sales: SEK 0 M (0)
  • January December 2021 • Operating loss: SEK -105.8 M (-56.5)
    • Loss after tax: SEK -104.2 M (-56.5)
    • Loss per share: before and after dilution, SEK -1.04 (-0.60)

FOURTH QUARTER JANUARY - DECEMBER

  • Net sales: SEK 0 M (0)
  • Operating loss: SEK -370.3 M (-173.9)
  • Loss after tax: SEK -366.5 M (-173.1)
  • Loss per share: before and after dilution, SEK -3.66 (-1.94)
  • Equity/assets ratio: 89 (96) per cent
  • Cash and cash equivalents: SEK 247.3 M (693.4)
  • Short-term investments: SEK 312.1 M (210.0)

Significant events in the fourth quarter

  • Updated encouraging survival data were reported from the CANFOUR trial with nadunolimab and chemotherapy in pancreatic cancer (PDAC)
  • Nadunolimab was granted orphan drug status for treatment of PDAC by the European Medicines Agency (EMA)
  • The first patient was treated in the CESTAFOUR trial
  • Two scientific articles on nadunolimab were published in peer-reviewed journals
  • Positive results were reported for CAN10 in a preclinical model for systemic sclerosis as well as progress in the manufacturing process development
  • Oppositions were filed against one of Cantargia's European patents providing broad protection for IL1RAPtargeting antibody

Significant events after the end of the period

  • Clinical development of nadunolimab in PDAC was advanced by including nadunolimab in Pancreatic Cancer Action Network's (PanCAN) phase II/III clinical trial Precision Promise℠
  • The first patient with non-squamous non-small cell lung cancer (NSCLC) was treated in a new arm in CANFOUR, and the first triple negative breast cancer patient in the TRIFOUR trial
  • Positive safety data were reported from the CIRIFOUR trial with nadunolimab combined with pembrolizumab
  • New encouraging non-GLP toxicology results were reported for CAN10 and start of the clinical phase I trial scheduled for early 2023
  • A third party appealed the previous decision by the European Patent Office (EPO) to reject the opposition of one of Cantargia's patents for treatment of solid tumors

Comments on significant events

Updated interim results were reported for the first cohort of PDAC patients treated with nadunolimab and chemotherapy in CANFOUR. Results continue to show improved efficacy than expected from chemotherapy only, as median survival is 12.7 months and median immune progression-free survival is 7.2 months. The safety profile is in line with the previous update, with higher occurrence of neutropenia and febrile neutropenia than expected for chemotherapy only. No cases of severe neuropathy, a frequent side effect of the chemotherapy used, have been observed.

Cantargia announced that clinical development of nadunolimab in PDAC would advance in PanCAN's clinical phase II/III trial, Precision Promise℠. In this pivotal trial, patients will be randomized to receive nadunolimab with chemotherapy, or standard of care chemotherapy alone. Up to 175 patients will be enrolled to the nadunolimab arm. The plan is to submit a pre-IND application to the US Food and Drug Administration in Q2 2022 for including nadunolimab in the trial. Results are expected in 2027 or earlier. In line with the FDA previously granting orphan drug status in the US to nadunolimab for treatment of PDAC, this status was also granted by the EMA in Europe. The clinical development of nadunolimab in NSCLC was advanced by treatment of the first non-squamous NSCLC patient in combination with platinum-based chemotherapy in a new arm in CANFOUR.

From CIRIFOUR, updated interim data were reported, showing a favorable safety profile for combination therapy of nadunolimab with pembrolizumab. Additionally, the first patients started treatment in the CESTAFOUR and TRIFOUR trials. Two scientific articles were also published in peer-reviewed journals, one focusing on safety data from the phase I part of CANFOUR, and the other on functional and structural analyses of interaction between nadunolimab and IL1RAP.

For CAN10, positive results were reported in a systemic sclerosis model where CAN10 counteracted disease development. Progress in manufacturing process development for CAN10 was also reported as well as encouraging results from non-GLP toxicology and pharmacokinetic studies with both intravenous and subcutaneous formulation. However, global shortage in raw materials for production of clinicalgrade CAN10 and limited availability of models for GLP toxicology studies, caused by the COVID pandemic, affected timelines and start of the first clinical study for CAN10 was adjusted to early 2023.

Oppositions were filed by competitors against one of Cantargia's European patents for anti-IL1RAP antibodies with similar properties as nadunolimab. A third party appeal was also filed against the decision by the EPO to reject a previous opposition of another European Cantargia patent for treatment of solid tumors.

CHIEF EXECUTIVE'S REVIEW

A successful year validated by new partnership

Another very eventful quarter has passed, ending a 2021 marked by exciting new results for Cantargia, in a climate that has generally been challenging for the global biotech sector. It is therefore encouraging that, as a company, we are able to maintain a strong cash position and generate good results, and have clear plan for how to continue creating value in our projects.

Our results have drawn international attention, as evidenced by the collaboration recently initiated with the PanCAN network. This partnership grants us the possibility to conduct a pivotal trial with nadunolimab to treat patients with metastatic pancreatic cancer, together with leading hospitals in the United States. PanCAN is currently conducting a study called Precision Promise℠ with the goal of developing new and effective treatments for pancreatic cancer. The study was designed in collaboration with the US Food and Drug Administration (FDA) and it is in this major venture that nadunolimab will be included. We are very proud to have been selected despite strong competition. This is largely owing to our results, which show a median survival of 12.7 months in pancreatic cancer patients treated with nadunolimab and chemotherapy. These results are perceived as very promising and PanCAN have therefore agreed to finance part of the study, and we will also gain access to leading experts in the field to ensure that the study is carried out in the best possible way. The first milestone is to update the Precision Promise℠ protocol to include a treatment arm with nadunolimab and to discuss this with regulatory authorities, which will be done during the second quarter. During this

quarter we also expect to be able to present new results from our clinical studies in pancreatic cancer and lung cancer. In addition to our focus on nadunolimab in pancreatic cancer and lung cancer, new activities were started in 2021, which build on the positive results we have obtained thus far and aim to broaden the development to include other cancers and new combination strategies. As these studies involve new combination therapies, the first part has been designed to study safety at different dose levels of nadunolimab. Additional patients can then be included with the aim of documenting safety and efficacy in a larger patient population. Due to the ongoing pandemic, patient recruitment is a challenge, but our assessment is that the first safety parts will be completed in the summer and autumn of 2022. We will then also be able to make an initial assessment of which combinations are the most promising.

Our second project, CAN10, is also advancing. The pandemic has had an impact on CAN10, with adjustments in timelines for production of clinical-grade material and GLP toxicology studies. This is due to the great need for vaccines, which has put tremendous pressure on global capacity for development of new pharmaceuticals. As a consequence, the first clinical study for CAN10 is now expected for start early 2023. In parallel, preclinical studies are making progress and we will be presenting new results for treatment of a model of systemic sclerosis with CAN10 in the first quarter.

During the autumn and the beginning of this year, there has also been some activity related to parts of our patent portfolio. Cantargia not only has patents covering our products, but also broader protection for IL1RAP as a molecular target. The strong results we have shown have provoked competition, and various competitors are doing their best to restrain us. Despite several oppositions in Europe, these attempts have not been successful, and the fact that the patents have been carefully examined in the course of these proceedings further strengthens our position.

Cantargia continued to make progress during 2021, and I am convinced that 2022 will be very interesting with many milestones in both the first and second half of the year.

Göran Forsberg CEO, Cantargia AB

ABOUT CANTARGIA

Cantargia is a Swedish biotech firm, operating in the borderland between immunotherapy and targeted treatments, developing targeted antibody-based therapy for lifethreatening diseases. Owing to the significant research advances made in recent years, both immunotherapy and targeted treatments have been added as new cancer treatment options, in addition to surgery, radiation therapy and chemotherapy. Intense research is being conducted in this field and it is likely that many new treatment options will become available in the coming years.

Cantargia's research and development were born out of an important discovery at Lund University, where research on leukemic stem cells showed that the IL1RAP molecule is present on the cell surface of immature cancer cells. Continued research showed that this molecule is also present on cancer cells from a large number of tumor types. Modern drug development is aimed at identifying unique targets against which pharmaceutical substances can be aimed, and in this research IL1RAP has proved to be a highly interesting target. Cantargia's treatment against IL1RAP is unique and has a double mechanism of action: killing cancer cells directly while also suppressing tumor inflammation, one of the key hallmarks of tumor progression.

For nadunolimab (CAN04), Cantargia has initially focused on non-small cell lung cancer and pancreatic cancer. Lung cancer is the form of cancer that causes the largest number of deaths and non-small cell lung cancer is the most common form of the disease. Pancreatic cancer is very difficult to treat, and few effective treatments are available on the market. The development activities were recently broadened to include

triple negative breast cancer, biliary tract cancer, colon cancer, as well as other tumor types.

Targeted antibody treatments increase the likelihood of achieving an effective treatment with fewer side effects. Cantargia's objective for nadunolimab is to develop a new drug which, individually or in combination with other drugs, can become an important part of future cancer therapy.

In a parallel, Cantargia is developing additional antibodies targeting IL1RAP outside the field of cancer. In the CAN10 project, the initial focus is on two serious autoimmune/ inflammatory diseases: systemic sclerosis and myocarditis. The goal is to initiate clinical studies for CAN10 early 2023.

Vision

Cantargia's vision is to become an important part of tomorrow's more effective cancer treatment by developing a new generation of targeted immunotherapies against IL1RAP. Our ambition is to be able to broaden the use of the technology to several disease areas with significant medical needs, such as autoimmune/inflammatory diseases.

Business model and strategy

Cantargia's business model and scientific strategy are based on partnerships, and Cantargia has established agreements with a number of different companies, hospitals and academic groups. Currently, around 50 international and local players are involved in research and development related to Cantargia's nadunolimab project. We are now building partnerships in a similar way for our new project, CAN10. The strategy is based on driving the development of our candidate drugs by in-house capacity.

Project Disease Type of
treatment
Discovery
phase
Preclinical
phase
Clinical
phase l
Clinical
phase II
Clinical
phase III
Commercial
phase
PDAC 1st line Gemcitabine/nab-paclitaxel
FOLFIRINOX
1st line Cisplatin/gemcitabine
nscic 2nd/3rd line Docetaxel
CANO4
Nadunolimab
Non-squamous
NSCLC
1st/2nd line Carboplatin/pemetrexed
1st line Pembro/carboplatin/pemetrexed
TNBC 1st/2nd line Carboplatin/gemcitabine
Billiary tract cancer 1st line Cisplatin/gemcitabine
Colon cancer 3rd line FOLFOX
Solid tumors ICI combo Pembro
CAN10 Myocarditis;
Systemic sclerosis
CANxx New opportunities within
IL1RAP platform

Cantargia's project portfolio

Our clinical studies

In Cantargia's first clinical study, CANFOUR, nadunolimab is studied for treatment of non-small cell lung cancer and pancreatic cancer. CANFOUR is a phase I/IIa study consisting of two parts. While the first part primarily evaluated safety and dosage of monotherapy, the second part, phase IIa, focuses on combination therapy with the standard treatments for non-small cell lung cancer and pancreatic cancer. The phase I results were very encouraging and indicated good safety, as well as effects on key biomarkers.

Moreover, positive interim results from the phase IIa part show clear signals on the efficacy of combination therapy as stronger effects are observed in both lung cancer and pancreatic cancer patients compared to what would be expected from chemotherapy alone. Patients with non-small cell lung cancer showed a response of 48 per cent, resulting in a median progression-free survival of 7.2 months, an improvement over historical control data. An even higher response is achieved in patients with the non-squamous subtype of non-small cell lung cancer. In patients with pancreatic cancer, durable responses or pseudoprogression are observed, resulting in a median progression-free survival of 7.2 months and a median overall survival of over 12.7 months.

For pancreatic cancer, patient recruitment to an extension cohort of CANFOUR has recently been completed. The results from these patients will provide a more robust picture of the relationship between dose, efficacy and safety and will be presented in the first half of 2022. In CANFOUR, additional patients with non-squamous non-small cell lung cancer are being recruited. This is a first step in a focused strategy for late-stage clinical development and these patients are being

prioritized as they are most likely to benefit from treatment with nadunolimab and chemotherapy.

In a further clinical study, CIRIFOUR, nadunolimab is being studied in combination with the immunotherapy pembrolizumab (Keytruda®), where the main purpose is to assess safety. Studies of biomarkers and efficacy are also being conducted. For CIRIFOUR, patient recruitment was completed in 2021 for the initial treatment arm, which included patients with non-small cell lung cancer, head and neck cancer and malignant melanoma, with patients no longer responding to immunotherapy. Interim safety data show that the combination is well-tolerated and efficacy data will be reported in the second quarter of 2022. CIRIFOUR was expanded to include an additional combination therapy arm where nadunolimab is assessed in combination with immunotherapy and platinum-based chemotherapy in patients with non-squamous non-small cell lung cancer. Recruitment of these patients is expected to start during the first quarter of 2022.

In 2021, further studies were initiated with the aim to broaden the clinical programme for nadunolimab to include additional forms of cancer and combination therapies. One such study is the phase Ib study CAPAFOUR where nadunolimab is evaluated in combination with the FOLFIRINOX chemotherapy regimen in pancreatic cancer. The phase I/II study CESTAFOUR and phase Ib/II study TRIFOUR were also started. In CESTAFOUR, nadunolimab is evaluated in three different forms of cancer: non-small cell lung cancer, biliary tract cancer and colon cancer in combination with standard of care chemotherapies. In TRIFOUR, the focus is on triple negative breast cancer, where nadunolimab is also evaluated in combination with chemotherapy.

Study Disease Combination therapy Estimated
enrollment
Status NCT number
CANFOUR NSCLC Cisplatin/gemcitabine 33 Recruitment completed
Non-squamous NSCLC Carboplatin/pemetrexed 40 Recruiting NCT03267316
PDAC Gemcitabine/nab-paclitaxel 76 Recruitment completed
NSCLC, bladder cancer,
HNSCC, melanoma
Pembro 15 Recruitment completed NCT04452214
CIRIFOUR Non-squamous NSCLC Pembro/carboplatin/
pemetrexed
24 Recruitment start in
Q1 '22
CAPAFOUR PDAC FOLFIRINOX 30 Recruiting NCT04990037
NSCLC Docetaxel 55 NCT05116891
CESTAFOUR Biliary tract cancer Cisplatin/gemcitabine 55 Recruiting
Colon cancer FOLFOX 55
TRIFOUR TNBC Carboplatin/gemcitabine 113 Recruiting NCT05181462
Precision Promise5M PDAC Gemcitabine/nab-paclitaxel 175 Pre-IND submission in
Q2 '22
NCT04229004

Ongoing clinical studies for nadunolimab

N CLC non small cell lung cancer P AC pancreatic cancer N CC head and neck cancer N C triple negative breast cancer Pembro pembroli umab

CANTARGIA OPERATES IN A GROWING MARKET

Cancer is one of the most common causes of death in the world, accounting for around 20 per cent of deaths in the West. Globally, more than 19 million people are diagnosed with cancer each year and nearly 10 million lose their lives to cancer-related diseases. Despite significant advances in treatment and diagnosis, there is a great need for new treatment methods.

To maximize the effectiveness of the treatment, it is necessary to take into account the type, location and spread of the tumor, as well as the patient's general condition and other diseases. Owing to the advances made in cancer treatment, it is now standard practice to combine different cancer treatments as far as possible to achieve the best possible treatment results. Cantargia has initially focused on non-small cell lung cancer and pancreatic cancer, but is also conducting studies in bladder cancer, head and neck cancer and malignant melanoma. These are IL1RAP-expressing cancers and immunotherapy is today one of the standard treatments for these diseases.

The lung cancer market

In 2020, around 2.2 million new cases of lung cancer were diagnosed globally while more than 1.7 million people died as a result of lung cancer.1 Around 85 per cent of all lung cancers are non-small cell lung cancer. In the United States, the number of people being diagnosed with lung cancer has declined by around 31 per cent over the past 14 years2 , while the number of people being diagnosed with the disease in countries like China and India as well as in European countries like Hungary, Denmark and Serbia is increasing.

Number of new cancer cases in the US per 100,000 inhabitants Source: SEER Cancer Statistics Review

Sales of drugs for non-small cell lung cancer totalled USD 19 billion in 2019 and are projected to increase to USD 33 billion by 2029.3 Sales are driven mainly by increasing use of various antibody-based immunotherapies. Another important factor driving the growth of the global market is the increasing incidence of lung cancer in many countries, mentioned above.

The pancreatic cancer market

Worldwide, around 495,000 new cases of pancreatic cancer were diagnosed in 2020. In the same year, 466,000 people died from the disease.1 In the US, the number of people being diagnosed with the disease has increased by nearly 11 per cent over the past 14 years. Being hard to diagnose, the disease is difficult to treat, as it is often well advanced by the time it is discovered.

The global market for pancreatic cancer treatment is expected to be worth USD 5.8 billion by 2029. In 2020, the market was worth around USD 2.5 billion.4 The market is expected to grow by 11 per cent annually from 2020 to 2029. The main factor contributing to the growth of this market is the growing number of cancer cases, which in turn is driven by an aging population and the increasing incidence of diabetes, both of which are risk factors for developing this disease. Another factor why the market is expected to grow is improved diagnostics, which increases the chance of discovering pancreatic cancer at an earlier stage and thus enabling treatment. The number of people being diagnosed with pancreatic cancer is expected to grow by 55 per cent by 2030. This year, pancreatic cancer is expected to be the third most common cause of cancer-related deaths in the US.5

The head and neck cancer market

Head and neck cancer is a group of cancer indications that affect the lips, salivary gland, pharynx, nasal cavity, larynx and thyroid gland. The number of new annual cases of head and neck cancer in the 7MM countries is forecast to rise from 164,000 in 2020 to around 175,000 in 2025.6 The global pharmaceutical market for head and neck cancer treatment was estimated at USD 1.3 billion in 2019 and is forecast to be worth USD 1.5 billion by 2025.7 This represents an annual growth rate of 4 per cent from 2020 to 2025.

The bladder cancer market

Bladder cancer is the sixth most common form of cancer in men and the seventeenth most common form of cancer in women. The number of newly diagnosed yearly cases of bladder cancer is expected to increase from 225,000 in 2018 to 275,000 in 2028.8 The bladder cancer market is forecast to grow by 18.5 per cent annually from 2018 to 2028.8 The market was estimated at USD 732 million in 2018 and is forecast to grow to USD 3,990 million by 2028.8

The market for systemic sclerosis and myocarditis

Systemic sclerosis is a chronic autoimmune disease that is characterized mainly by inflammation and fibrosis of the skin and subcutaneous tissue as well as blood vessels and internal organs such as the lungs, heart and kidneys. The estimated annual incidence of the disease in North America is approximately 4.5 cases per 100,000 inhabitants and the corresponding figure in Europe is 1.8.9 The estimated incidence of myocarditis is around 1.7 million and the disease accounts for around 46,400 deaths annually worldwide.10

Immunotherapy

In 2011, the first immunotherapeutic drug was approved by the US Food and Drug Administration (FDA). Since then, the FDA has approved a number of new therapies. Of these, the four that have achieved the highest sales are Yervoy® (Bristol-Myers Squibb), Opdivo® (Bristol-Myers Squibb), Keytruda® (Merck & Co) and Tecentriq® (Roche). In 2017, these four therapies generated sales of around USD 10.4 billion, and sales grew to USD 22 billion in 2019.11 In the first quarter of 2020, sales had increased by nearly 30 per cent compared with the same period in 2019. Lung cancer and malignant melanoma are two types of cancers that can be treated with these therapies.

1 Globocan 2020, https://gco.iarc.fr/today/data/factsheets/cancers/13-Pancreas-fact-sheet.pdf

2 https://www.lungcancer.org/find_information/publications/163-lung_cancer_101/268-types_and_staging

3 Non-Small Cell Lung Cancer:Global Drug Forecast and Market Analysis to 2029

4 Market Research.com Pancreatic Cancer Therapeutics Market Research Report by Product (Chemotherapy and Targeted Therapy), by Type (Endocrine Pancreatic

Cancer and Exocrine Pancreatic cancer) - Global Forecast to 2025 - Cumulative Impact of COVID-19

5 American Cancer Society, Cancer Facts & Figures 2020, 2020

6 GlobalData, OpportunityAnalyzer: Head and Neck Squamous Cell Carcinoma, March 2018

7 Markets and Research.biz Global Head and Neck Cancer Drugs/Therapeutics Market 2020 by Company, Regions, Type and Application, Forecast to 2025 8 GlobalData, Opportunity Analyzer: Bladder Cancer, April 2020

9 Best Pract Res Clin Rheumatol. 2018 Apr;32(2):223-240, Clin Epidemiol. 2019 Apr 18;11:257-2 och Ann Rheum Dis. 2014 Oct;73(10):1788-92 10 Lancet. 2018;392:1736-88

11 ales data for the drugs have been obtained from the companies' year-end reports

FINANCIAL INFORMATION

Revenue

he company's revenue was EK 0.0 M (0.0) in the fourth quarter and for the full year 2021 to SEK 0.0 M (0.0).

Operating expenses/operating loss

Research and development costs totalled SEK 101.8 M (52.9) in the fourth quarter and SEK 352.7 M (158.4) for the full year 2021. The change compared to the previous year is primarily related to Cantargia's main project, CAN04, and the expansion of the clinical programme with the CIRIFOUR, CAPAFOUR, CESTAFOUR, and TRIFOUR studies. Investments in production development (CMC) and preclinical studies for CAN10 also increased.

Administrative expenses amounted to SEK 3.2 M (3.4) in the fourth quarter and SEK 15.3 M (14.9) for the full year.

Other operating expenses, which mainly comprise foreign exchange differences on trade payables, were SEK 0.7 M (0.1) in the fourth quarter and SEK 2.2 M (0.6) for the full year. Other operating expenses are mainly related to changes in the value of the Swedish krona against EUR.

The operating loss was SEK -105.8 M (-56.5) in the fourth quarter and SEK -370.3 M (-173.9) for the full year.

Net financial income/expense

Net financial income/expense consists substantially of foreign exchange differences on the company's currency accounts and interest earned on short-term investments in fixed-rate accounts and fixed income funds. Net financial income was SEK 1.6 M (0.0) for the fourth quarter and SEK 3.8 M (0.9) for the full year 2021.

Earnings

Cantargia's loss before tax, which is the same as the loss for the period, was SEK -104.2 M (-56.5) in the fourth quarter and SEK -366.5 M (-173.1) for the full year.

Cash flow and investments

Cash flow from operating activities was SEK -89.9 M (-44.7) in the fourth quarter and SEK -346.4 M (-156.4) for the full year. As part of cash flow from operating activities, changes in working capital were SEK -7.8 M (6.8) in the fourth quarter and SEK 14.4 M (6.5) in the full year 2021.

Cash flow from investing activities was SEK -0.2 M (-75.1) in the fourth quarter and SEK -102.4 M (-109.0) in the full year. Cash flow from investing activities refers essentially to the reallocation of other short-term investments in fixed-rate accounts and fixed income funds.

Cash flow from financing activities was SEK 0.0 M (531.2) in the fourth quarter and SEK 0.0 M (918.5) in the full year. The outcome for the previous year is related to directed share issues completed in that year.

The total change in cash and cash equivalents was SEK -90.0 M (411.5) for the fourth quarter and SEK -448.9 M (653.1) for the full year.

Financial position

he company's cash and cash equivalents, which consist of cash and demand deposits with banks and other credit institutions, were SEK 247.3 M (693.4) at the balance sheet date. In addition to cash and cash equivalents, the company had short-term investments with banks and in fixed income funds of SEK 312.1 M (210.0). Total available funds, bank deposits and short-term investments amounted to SEK 559.4 M (903.4).

Cantargia's equity/assets ratio at 31 December 2021 was 89 (96) per cent and equity was SEK 532.7 M (891.9).

At the end of the period, total assets amounted to SEK 600.2 M (925.5).

SHAREHOLDER INFORMATION

Share information

As of 25 eptember 2018, Cantargia's shares have been listed on the main list of Nasdaq Stockholm, under the stock symbol

"CAN A". On 31 December 2021, the number of shares was 100,192,737 (100,192,737).

Share price performance in 2021

Ownership distribution, 31 December 2021

Number of Capital/Votes
Owner shares (%)
Swedbank Robur Fonder 9 626 665 9,6%
Fjärde AP-fonden 8 846 347 8,8%
Alecta Pensionsförsäkring, Ömsesidigt 7 259 577 7,2%
Six Sis AG 6 997 319 7,0%
Första AP-fonden 6 324 244 6,3%
Försäkringsaktiebolaget, Avanza Pension 5 312 781 5,3%
SEB AB, Luxemburg Branch 3 492 124 3,5%
Unionen 2 000 000 2,0%
Andra AP-fonden 1 321 268 1,3%
KUDU VP AB 1 243 216 1,2%
Other 47 769 196 47,7%
Total 100 192 737 100,0%

Ownership distribution by size class, 31 December 2021

Number of Number of Capital/Votes Market Cap
Holding shareholders shares (%) (kSEK)
1 - 500 6 948 1 024 482 1,0% 18 912
501 - 1 000 1 553 1 250 505 1,2% 23 084
1 001 - 5 000 2 440 5 900 480 5,9% 108 923
5 001 - 10 000 563 4 170 239 4,2% 76 983
10 001 - 15 000 226 2 864 621 2,9% 52 881
15 001 - 20 000 128 2 288 571 2,3% 42 247
20 001 - 333 82 693 839 82,5% 1 526 528
Total 12 191 100 192 737 100,0% 1 849 558

OTHER INFORMATION

Employees

The average number of employees during the period January to December 2021 was 22 (15), of whom 13 (9) were women. Cantargia operates to a large extent through external partners.

Financial calendar

  • Annual report 2021, April 2022
  • Interim report January-March, 23 May 2022
  • Interim report April-June, 18 August 2022
  • Interim report July-September, 10 November 2022
  • Year-end report 2022, 23 February 2023

Proposed appropriation of earnings

The Board of Directors propose in accordance with established dividend policy that no dividend be paid for the financial year 1 January 2021 – 31 December 2021.

Annual General Meeting 2022

The Annual General Meeting of Cantargia will be held at Ideon Gateway, Scheelevägen 27 in Lund on 23 May, 2022, at 4 p.m.

Review by auditors

The interim report has not been reviewed by Cantargia's auditors.

Contact

Göran Forsberg, CEO of Cantargia AB Telephone: +46 (0)46-275 62 60 E-mail: [email protected]

Interim reports and the annual report are available at www.cantargia.com.

Lund, 24 February 2022

Göran Forsberg CEO

STATEMENT OF COMPREHENSIVE INCOME

2021 2020 2021 2020
SEK thousand
Note
Oct-Dec Oct-Dec Jan-Dec Jan-Dec
Operating income
Net sales - - - -
Other operating income - - - -
Operating expenses
6
Research and development costs
5
-101 800 -52 932 -352 709 -158 396
Administrative costs -3 230 -3 450 -15 309 -14 919
Other operating expenses -721 -75 -2 249 -630
-105 751 -56 457 -370 267 -173 945
Operating loss -105 751 -56 457 -370 267 -173 945
Financial income and expense
Interest income and similar items 1 572 -31 3 766 860
Interest expense and similar items -3 0 -3 -1
1 569 -31 3 763 859
Loss before taxes -104 182 -56 488 -366 504 -173 085
Loss for the period *) -104 182 -56 488 -366 504 -173 085
Earnings per share before and after dilution (SEK) based -1,04 -0,60 -3,66 -1,94
on average number of shares

*) No items are reported in other comprehensive income, meaning total comprehensive income is consistent with the loss for the period.

STATEMENT OF FINANCIAL POSITION

SEK thousand Note 31-12-2021 31-12-2020
ASSETS
Fixed assets
Intangible assets
Patent 6 459 7 360
6 459 7 360
Tangible assets
Machinery and equipment 3 097 5 262
3 097 5 262
Total fixed assets 9 556 12 622
Current assets
Other receivables 4 588 2 673
Prepaid expenses and accrued income 26 713 6 846
31 301 9 519
Short-term investments
Other short-term investments 312 064 210 019
312 064 210 019
Cash and bank balances
Cash and bank balances 247 322 693 354
247 322 693 354
Total current assets 590 688 912 892
TOTAL ASSETS 600 244 925 514
EQUITY AND LIABILITIES
Equity
Restricted equity
Share capital 8 015 8 015
8 015 8 015
Non-restricted equity
Share premium account 1 404 595 1 404 595
Retained earnings -513 362 -347 590
Loss for the period -366 504 -173 085
524 729 883 919
Total equity 532 745 891 935
Long-term liabilities
Provision for social security contributions, incentive program 8 892 3 111
892 3 111
Short-term liabilities
Trade payables 34 512 10 678
Tax liabilities 570 349
Other liabilities 1 105 859
Accrued expenses and deferred income 30 420 18 583
66 607 30 469
TOTAL EQUITY AND LIABILITIES 600 244 925 514

Cantargia AB (publ) | 556791-6019 | FULL YEAR REPORT January – December 2021 PAGE 12

STATEMENT OF CHANGES IN EQUITY

SEK thousand Restricted equity Non-restricted equity Total
Paid not
registered Retained earnings
share Share premium incl Loss for the
1 January 2021 - 31 December 2021 Note Share capital capital account period Total equity
Opening balance 1 January 2021 8 015 - 1 404 595 -520 676 891 935
Loss for the period - - - -366 504 -366 504
Transactions with shareholders
Employee stock option program
8
- - - 7 314 7 314
8 015 - 1 404 595 7 314 7 314
Closing balance 31 December 2021 8 015 - 1 404 595 -879 866 532 745
1 January 2020 - 31 December 2020
Opening balance 1 January 2020 5 824 - 488 272 -351 823 142 273
Loss for the period - - - -173 085 -173 085
Transactions with shareholders
Issue of new shares for the year 2 184 - 971 575 - 973 759
Capital acquisition cost - - -56 214 - -56 214
Warrant program, TO 2017/2020
8
7 - 962 - 969
Employee stock option program
8
- - - 4 233 4 233
2 191 - 916 323 4 233 922 747
Closing balance 31 December 2020 8 015 - 1 404 595 -520 676 891 935

STATEMENT OF CASH FLOW

2021 2020 2021 2020
SEK thousand
Note
Oct - Dec Oct - Dec Jan-Dec Jan-Dec
Operating activities
Operating loss -105 751 -56 457 -370 267 -173 945
Adjustments for non-cash items
7
2 680 4 919 8 541 10 592
Interest received etc. 8 9 7 3 927 501
Interest paid etc. -3 0 -3 -1
Cash flow from operating activities
before changes in working capital -102 985 -51 465 -360 802 -162 853
Changes in working capital
Change in receivables 8 442 4 839 -21 782 -219
Change in trade payables 13 480 3 339 23 834 -1 943
Changes in other current liabilities -8 811 -1 419 12 304 8 627
13 112 6 760 14 357 6 466
Cash flow from operating activities -89 873 -44 705 -346 445 -156 387
Investing activities
Acquisition of intangible assets - - - -8 111
Acquisition of tangible assets -123 -57 -383 -890
Increase in other short-term investments -46 -75 000 -177 046 -225 000
Decrease in other short-term investments - - 75 000 125 000
-169 -75 057 -102 429 -109 002
Financing activities
Issue of new shares for the year - 564 234 - 973 759
Capital acquisition cost - -33 017 - -56 214
Warrant program, TO 2017/2020 - - - 969
- 531 217 - 918 514
Change in cash and cash equivalents -90 043 411 455 -448 873 653 126
Cash and cash equivalents at beginning of period 335 882 282 004 693 354 39 870
Exchange rate difference in cash equivalents 1 483 -104 2 839 359
Cash and cash equivalents at end of period *) 247 322 693 354 247 322 693 354

*) The company's cash and cash equivalents consist of cash and disposable balances with banks and other credit institutions.

KEY FIGURES

2021 2020 2021 2020
SEK thousand Oct-Dec Oct-Dec Jan-Dec Jan-Dec
Net sales - - - -
Operating loss -105 751 -56 457 -370 267 -173 945
Loss for the period -104 182 -56 488 -366 504 -173 085
Average number of shares 100 192 737 94 125 705 100 192 737 89 380 405
Earnings per share before and after dilution (SEK) based -1,04 -0,60 -3,66 -1,94
on average number of shares
Change in cash and cash equivalents -90 043 411 455 -448 873 653 126
Cash and cash equivalents 247 322 693 354 247 322 693 354
Short-term investments 312 064 210 019 312 064 210 019
Total available funds 559 387 903 373 559 387 903 373
Equity end of period 532 745 891 935 532 745 891 935
Equity/assets ratio, % 89% 96% 89% 96%
Average number of employees 2 6 1 8 2 2 1 5
Number of employees at end of period 2 6 1 8 2 6 1 8
R&D costs as a percentage of operating expenses 96% 94% 95% 91%

Key performance indicators, definitions

Operating profit/loss, SEK thousand Net sales less total operating expenses. Earnings per share, SEK Profit/loss for the period divided by average number of shares for the period. Total available funds, SEK thousand Cash and cash equivalents plus Short term investments. Equity/assets ratio, % Equity divided by total capital. R&D costs as a percentage of operating expenses, % Research and development costs divided by operating expenses.

NOTES

Note 1 General information

his interim report refers to Cantargia A (publ) ("Cantargia"), corporate I number 556791-6019. Cantargia has no subsidiaries.

Cantargia is a wedish public limited company with registered office in Lund, weden. he company's address is Ideon Gateway, Scheelevägen 27, SE-223 63 Lund.

The full year report for 2021 was approved for publication on the 24 th of February 2022 in accordance with a resolution of the Board of Directors on the 23 rd of February.

Note 2 Accounting policies

This year-end report has been prepared in accordance with the Swedish Annual Accounts Act, Recommendation RFR 2 Financial Reporting for Legal Entities of the Swedish Financial Reporting Board and IAS 34 Interim Financial Reporting. The accounting policies applied in preparing this year-end report are consistent with those used in preparing the annual report for 2020.

The year-end report has been prepared using the cost method. No IFRS or IFRIC interpretations that have not yet become effective are expected to have a material impact on the company. Cantargia applies the alternative performance measures issued by the European Securities and Markets Authority (ESMA).

Note 3 Information on risks and uncertainties

Operational risks

Research and drug development up to approved registration is subject to considerable risk and is a capital-intensive process. The majority of all initiated projects will never reach market registration due to the technological risk such as the risk for insufficiency efficacy, intolerable side effects or manufacturing problems. If competing pharmaceuticals capture market share or reach the market faster, or if competing research projects achieve better product profile, the future value of the product portfolio may be lower than expected. The operations may also be impacted negatively by regulatory decisions, such as approvals and price changes. External factors such as COVID-19 may also impact the company negatively by hampering the company's possibilities to conduct clinical trials, get necessary regulatory approvals or conduct sales related activities. A more detailed description of the company's risk exposure and risk management can be found in the section "Risks and risk management" in the irectors' report on page 40 in the Annual Report for 2020.

Financial risk management

Cantargia's financial policy governing the management of financial risks has been designed by the board of directors and represents the framework of guidelines and rules in the form of risk mandated and limits for financial activities. The company is primarily affected by foreign exchange risk since the main part of the development costs are paid in EUR and U . In accordance with Cantargia's financial policy, the company exchanges cash into USD and EUR based on entered agreements in order to manage the currency exposure. For more information about the company's financial risk management see note 3 on page 55 in the Annual Report for 2020.

Note 4 Critical judgements and estimates

The preparation of financial statements and application of accounting policies are often based on judgements, estimates and assumptions made by management which are deemed reasonable at the time when they are made. The estimates and assumptions applied are based on historical experience and other factors which are deemed reasonable under current circumstances. The results of these are then used to determine carrying amounts of assets and liabilities that are not readily apparent from other sources. Actual outcomes may differ from these estimates and assessments.

Estimates and assumptions are reviewed regularly. Any changes are recognised in the period in which the change is made if the change affects only that period, or in the period in which the change is made and future periods if the change affects both the current and future periods.

The critical judgements and estimates that are of the greatest importance for Cantargia are described in Note 4 on page 57 in the Annual Report for 2020.

Note 5 Related party transactions

In 2021, Cantargia has signed a new research agreement with Lund University, where Gunilla Westergren-Thorsson, Professor of Lung Biology, is engaged in research. Under the agreement, Gunilla Westergren-Thorsson, who is a related party of an insider at Cantargia, will conduct a project aimed at expanding knowledge about IL1RAP as part of her employment at Lund University. Under the agreement, Cantargia has the right to use and, if applicable, take over all research results from the projects free of charge. During the period January to December 2021, the company incurred a cost of SEK 650 thousand (500) under the agreement.

The Board considers that the above agreement has been concluded on commercial terms.

Note 6 Costs by nature of expense

On a "by nature" basis, the sum of expenses by function is distributed as follows.

2021 2020 2021 2020
SEK thousand Oct-Dec Oct-Dec Jan-Dec Jan-Dec
Project costs -88 050 -40 220 -304 229 -121 897
Other external expenses -4 966 -3 574 -22 378 -15 985
Personnel expenses -11 145 -11 733 -37 966 -32 185
Other operating expenses -721 -75 -2 249 -630
Depreciation -869 -855 -3 446 -3 248
-105 751 -56 457 -370 267 -173 945

Note 7 Adjustments for non-cash items

2021 2020 2021 2020
SEK thousand Oct-Dec Oct-Dec Jan-Dec Jan-Dec
Depreciation -870 -854 -3 446 -3 248
Employee stock option program -1 811 -4 065 -5 095 -7 344
-2 680 -4 919 -8 541 -10 592

Note 8 Share-based incentive programs

Employee stock option program

The purpose of share-based incentive programs is to promote the company's long-term goals and to create opportunities for the company to retain competent personnel.

Cantargia currently has two active programs that covers the company's management, other employees, and consultants. These programs are the employee stock option program 2021/2024 approved at the Annual General Meeting 2021 and the employee stock option program 2020/2023 approved at the Annual General Meeting 2020.

For further information about these programs, see Note 19 in the Annual Report for 2020 and minutes from the Annual General Meeting 2021, available at the company´s website, www.cantargia.com.

Below is a summary of the total number of shares that granted options may entitle to as of December 31, 2021. Full exercise of granted options as of December 31, 2021, corresponding to a total of 3,170,333 shares, would result in a dilution of shareholders by 3.1 percent. If decided, but not allotted options, a further total of 1,666,000 are fully exercised, it would result in a total dilution of shareholders of 4.7 percent.

Changes in existing incentive programs during 2021 (number of shares)
Granted instruments
Employee stock option program 2021/2024 1 334 000
Employee stock option program 2020/2023 147 000
Exercised instruments -
Lapsed instruments
Employee stock option program 2021/2024 -24 000
Employee stock option program 2020/2023 -26 667
Total change 1 430 333
Number of shares granted instruments may entitle to December 31, 2021
Employee stock option program 2021/2024 1 310 000
Employee stock option program 2020/2023 1 860 333
Number of shares granted instruments may entitle to 3 170 333

SUBMISSION OF INTERIM REPORT

This is information that Cantargia AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication through the Chief Executive Officer on 24 February 2022, at 8:30 a.m.

Cantargia AB (publ) Ideon Gateway Scheelevägen 27 SE-223 63 Lund Telephone: +46(0)46 2756260 www.cantargia.com

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