Interim / Quarterly Report • Aug 23, 2017
Interim / Quarterly Report
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"During Q2 we announced that we are establishing our American office in Boston. The head office for the US includes our own reference laboratory that complements our earlier collaboration with Knight Diagnostic Laboratories and gives us delivery capacity in both the east and west of the United States."
"Another highlight for Immunovia during the quarter was the excellent results from the study of differentiation of Rheumatoid Arthritis (RA), Sjögren's Syndrome and Systemic Vasculitis. These results complement the ones from the earlier differential study that we presented for SLE in Q1. They further confirm that our IMMrayTM platform is generally applicable for many unsolved clinical problems within both cancer and autoimmunity while specifically strengthening our possibilities in the autoimmunity field."
"During the quarter we announced that, together with Knight Cancer Institute at OHSU, we received a research grant from PanCAN, a patient advocacy group, to support a retroactive analysis of American patients who developed pancreatic cancer after being diagnosed with diabetes."
Mats Grahn, CEO of Immunovia AB
| Key indicators SEK thousand unless otherwise stated |
1 April-30 June 2017 |
1 April-30 June 2016 |
1 Jan-30 June 2017 |
1 Jan-30 June 2016 |
Full year 2016 |
|---|---|---|---|---|---|
| Net sales | 68 | 66 | 95 | 66 | 177 |
| Operating earnings | -10,645 | -2,967 | -18,515 | -5,403 | -14,978 |
| Earnings before tax | -10,554 | -2,892 | -18,325 | -5,298 | -14,723 |
| Net earnings | -10,554 | -2,892 | -18,325 | -5,298 | -14,723 |
| Earnings per share before dilution (SEK/share) | -0.63 | -0.20 | -1.09 | -0.37 | -0.98 |
| 30 June 2017 | 30 June 2016 | 31 Dec 2016 | |||
| Equity ratio, % | 96 | 93 | 96 | 93 | 98 |
| No. of shares at the end of the period | 16,804,059 | 14,291,216 | 16,804,059 | 14,291,216 | 16,804,059 |
| Average number of shares before and after dilution | 16,804,059 | 14,291,216 | 16,804,059 | 14,291,216 | 16 804 059 |
This financial statement has been produced in accordance with IFRS for the Immunovia Group, which comprises Immunovia AB and the wholly-owned subsidiary Immunovia Inc.
Immunovia is focused on fundamentally transforming diagnosis of complex forms of cancer and autoimmune diseases. The antibody-based platform, iMMrayTM, is the result of 15 years of research at CREATE Health – the Center for Translational Cancer Research at Lund University, Sweden. IMMrayTM is a technology platform for the development of diagnostic tests and the company's primary test. IMMrayTM PanCan-d is the first test in the world for early diagnosis of pancreatic cancer.
We are staying focused on bringing our patented test for pancreatic cancer to the market. The main activities that will take us to the commercial phase are the prospective studies and certifications, accreditations and scaling up of production, both of the product itself and of laboratory capacity. During Q2 we announced that we are establishing our American office in Boston. The main office includes its own reference laboratory that will complement our earlier collaboration with Knight Diagnostic Laboratories and give us delivery capacity in both east and west of the United States. Having our own laboratory with highly qualified staff also safeguards quality and service, which is very important, especially in the initial commercialisation phase.
Another highlight for Immunovia during the quarter was the excellent results from the study of differentiation of Rheumatoid Arthritis (RA), Sjögren's Syndrome and Systemic Vasculitis. These results complement the ones from the earlier differential study that we presented for SLE in Q1. They further confirm that our IMMrayTM platform is generally applicable for many unsolved clinical problems within both cancer and autoimmunity while specifically strengthening our possibilities in the autoimmunity field.
"Another highlight for Immunovia during the quarter was the excellent results from the study of differentiation of Rheumatoid Arthritis (RA), Sjögren's Syndrome and Systemic Vasculitis.
These results complement the ones from the earlier differential study that we presented for SLE in Q1."
In December 2016 we announced the start of a prospective study on hereditary risk groups, 'PANFAM-1'. The purpose of this study is to monitor over three years one thousand individuals with a genetic predisposition for pancreatic cancer. In the study, IMMrayTM PanCan-d testing will be added to the existing high-risk surveillance in familiar pancreatic cancer programs in the US and Europe. During Q2, in addition to the commitment from the existing cancer centre participants, we have worked intensively to involve more cancer centers in the study, both in the US and the EU. We will continue to involve key partners during the remainder of the year, for both analytical and marketing purposes. A very important milestone will be an interim reading at the half way stage of the study, something we greatly look forward to.
One of the highest risk groups for pancreatic cancer that has gained a lot of attention in recent time are new onset Type II diabetes patients diagnosed after 50 years of age.
During the quarter we announced that, together with Knight Cancer Institute at OHSU, we received a research grant from PanCAN, a patient advocacy group, to support a retroactive analysis of American patients who developed pancreatic cancer after being diagnosed with diabetes. This provides access to unique samples from a very large diabetes biobank. During Q2 we also started a study with a similar biobank from the Skåne region which is designed to give us vital info that will help establish IMMrayTM PanCan-d as standard for diabetes risk groups. These studies are designed to complement existing data by showing that we have the capability to specifically distinguish between diabetes patients with or without cancer.
Meanwhile, through our collaboration with NCI and the healthcare systems that are members of the consortium, we are continuing the work of identifying and starting up the studies that are needed within this highly-interesting risk group. We are holding direct discussions about planning the studies with some of the most important of these members. We are also performing similar initiatives in Europe in order to set up prospective studies among diabetes risk groups as quickly as possible and eventually receive reimbursement and national guideline status.
During the quarter we started work on our market access scheme for diabetes risk groups. The first marketing activities are being established. The aim is cultivate awareness among key decision makers and interest groups about how pancreatic cancer is linked to diabetes and how our test can improve the chances of survival.
As previously reported, our Key Opinion Leaders have pointed to the opportunity for using IMMrayTM PanCan-d in another area, solving the delay that occurs from the time a patient seeks medical help for vague symptoms that could be the early stages of pancreatic cancer to the time when the cancer is diagnosed. Often, it is a question of something other than pancreatic cancer. However, for a patient with a developing cancer it has been shown that it takes on average 18 visits to a doctor over 6-9 months before pancreatic cancer is diagnosed. This delay can mean that a treatable situation becomes one that is no longer treatable.
During the quarter we have been working intensively with experts in this area in order to understand the market potential in greater detail and then define the steps needed to reach this market. We have not previously included this potential in our total summary of the market opportunities for the pancreatic cancer test. As we announced in July, one of the world's leading experts in this field, Professor Stephen Pereira at University College London, has begun working with Immunovia as a clinical adviser. We now intend to start prospective studies in this field as we believe that there are good opportunities for early market penetration regarding this risk group. Our assessment is that the market potential may exceed one million tests per year in Europe and the United States at full penetration.
We are working intensively to industrialize IMMrayTM PanCan-d and start sales, which is our most important milestone. This includes development and all preparation for ISO 13485 certification and other related accreditations required for starting sales in the US and Europe. The preparation
for the market introduction and the CE marking has included developing strategies for scaling up the production of the antibody microarray while maintaining the same robustness and reproducibility as in the retrospective validation studies.
Industrialization, software verification, validation according to ISO 13485:2016 and upscaling of production are being performed in parallel. We have also carried out work to rationalize laboratory methods in order to reduce the time required for a commercial sample, which is an important parameter both for customer acceptance and the product cost for the company. The increased workload has been addressed with greater resources but it affects the timetable for the certifications and accreditations, which are linked and dependent on the scaling up of production, in such a way that we will be able to conclude it in the second half of 2018.
In Q1 we reported the results of an important study that proved our ability to use IMMrayTM to differentiate between SLE and other common autoimmune diseases. The study's excellent results, showing that SLE could be differentiated with accuracy of 96% against a mix of healthy, rheumatoid arthritis, Sjögren's syndrome and Vasculitis patient samples, gives us a very strong reason to invest further in the autoimmune area. During Q2, analysis was completed for RA, Sjögren's syndrome and Vasculitis, whereby very good accuracy was achieved in distinguishing these conditions in a mix of them: 89% for RA, 95% for Vasculitis and 83% for Sjögren's. This provides very strong data as we continue the process of establishing our product.
A number of important activities will be carried out in parallel during the remainder of the year:
We look forward to providing regular updates about progress within autoimmunity during 2017.
In March we strengthened our management team with the appointment of Henrik Winther as business development manager for Immunovia. Henrik was previously Vice President and General manager for Agilent/Dakos Companion Diagnostics Division, a world-leading organization for diagnostics projects supplied to pharmaceutical companies that required diagnostics for their products and projects. Significant interest is now being shown in the IMMray technology and this reinforcement of our management team will significantly increase Immunovia's capacity to handle and prioritize various external collaborations, to make them more concrete and advantageous for Immunovia.
Thank you for your continuing support of Immunovia!
Mats Grahn CEO, Immunovia AB
Net sales for Q2 2017 were SEK 68 thousand (66 k). For the first six months of 2017 net sales were SEK 95 thousand (66 k). Net sales principally comprise royalties.
In Q2 2017, investment in the form of capitalisation of development costs amounted to SEK 5,553 thousand (6,695 k). Where capitalised development costs are financed through approved and paid grants, the reported amounts are reduced by a comparable amount. In the first six months of 2017 no grants for development costs were received. In the corresponding period in 2016, grants amounting to SEK 800 thousand were received.
The net loss for Q2 2017 was SEK 10,554 thousand (-2,892 k). The loss for the first six months of 2017 was SEK 18,325 thousand (-5,298 k). The net loss for the first six months of 2017 was mainly due to higher costs, which in turn were due to an expanded organization and increased market activity. Other external costs and personnel costs increased by a total of SEK 6,261 thousand compared with the previous year to reach SEK 25,537 thousand in the first six months of 2017.
Research and development follows established plans. The total cost of research and development the first six months of 2017 was SEK 13,236 thousand (11,884 k), which corresponds to 45% (68) of the Group's total operating costs. The decrease in the proportion of R&D activity was mainly due to the increase in activities and costs for marketing and production.
Cash flow for Q2 2017 from operating activities amounted to SEK -9,833 thousand (-3,662 k) and total cash flow for the first six months of 2017 amounted to SEK -30,768 thousand (-16,039 k). Cash and cash equivalents as at 30 June 2017 were SEK 228,326 thousand (59,728 k).
Shareholders' equity at the end of the period was SEK 258,779 thousand (78,697 k) and the equity ratio was 96% (93).
Management believes that there is sufficient working capital to meet working capital needs, given the current business and development plan, for approximately 2 years going forward.
In Q1 2017, intangible assets were acquired for SEK 6,176 thousand (5,536 k), consisting of capitalized development expenditure for SEK 5,174 thousand (5,189 k) and patents for SEK 1,002 thousand (347 k).
In Q2 2017, intangible assets were acquired for SEK 6,156 thousand (7,848 k), consisting of capitalized development expenditure for SEK 5,322 thousand (6,695 k) and patents for SEK 834 thousand (1,153 k).
Investments were made in Q2 2017 in tangible assets in the form of inventories amounting to SEK 2,520 thousand. For the corresponding period last year the total was SEK 70 thousand.
In the first six months of 2017, intangible assets were acquired for SEK 12,332 thousand (13,384 k), consisting of capitalized development expenditure for SEK 10,496 thousand (11,884 k) and patents for SEK 1,836 thousand (1,500 k).
The number of employees in the Group during the period averaged 28 (12) and at the end of the period the number of full-time positions was 30, divided across 30 individuals.
During the quarter the Japanese Patent Office awarded Immunovia a patent for its biomarker signature for the diagnosis of pancreatic cancer. Japanese Patent No. JP 611501 is the first patent awarded to Immunovia in Japan covering its proprietary IMMray™ PanCan-d test.
Announcement of timetable for listing on Nasdaq Stockholm's main market The Board of Directors of Immunovia announced during Q2 the timetable for the application for listing of the company's shares on Nasdaq Stockholm's main market.
The company's preparations of internal processes to meet the requirements on the main market are expected to be completed in September. After that, Nasdaq's process is expected to be initiated and Immunovia anticipates that listing on the main market will begin by the end of the year.
Immunovia announced the results of the analysis of the three other autoimmune diseases included in the previously reported retrospective autoimmune disease study performed at Lund University. The study included 315 blood samples and covered main autoimmune indications such as Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA), Sjögren's Syndrome and Systemic Vasculitis.
In this third data set, the IMMray™ biomarker signature was able to differentiate RA from SLE, Sjögren Syndrome and Systemic Vasculitis with 89% accuracy. The IMMray™ signatures also detected RA with an accuracy of 98% from the healthy controls. When differentiated from Sjögren's Syndrome, and Systemic Vasculitis, the RA accuracy was 83% and 95%, respectively.
Finally, Sjögren's Syndrome and Systemic Vasculitis could also be differentiated with high accuracies from the three other autoimmune diseases, at 85% and 94%, respectively.
Immunovia establishes headquarter for US operations in Boston including accredited reference laboratory
Immunovia has chosen Boston, Massachusetts, as the location for the headquarters of its American office. An agreement was signed to ensure that facilities at the premises will meet the company's requirements. The American business will operate a reference laboratory for the Eastern US states as well as facilitating commercialization, covering marketing, sales and customer support.
This grant will be used to investigate the possibility to screen the high risk group of new-onset diabetics (NoD, patients over the age of 50 with new diabetes diagnosis and with no prior medical or family history of the disease) for early diagnosis of pancreatic cancer. The risk of developing pancreatic cancer among these patients is reported to be nearly eight times greater than that of the general population over the three years following diagnosis. The project will start July 1, 2017 and will continue until June 30, 2019.
Professor Stephen Pereira from University College London, one of the globally leading experts in the diagnosis of early symptoms of pancreatic cancer, has been appointed to Immunovia's Scientific Advisory Board.
Professor Pereira has been involved in the setting up of multidisciplinary diagnostic centers in London. He is currently Professor of Hepatology & Gastroenterology at University College London, and an honorary consultant in pancreaticobiliary medicine at UCL Hospitals and The Royal Free Hospital.
Immunovia's shares have been listed on Nasdaq First North, Stockholm (ticker: IMMNOV) since 1 December 2015.
First North is Nasdaq's European growth market and has a less extensive regulatory framework than the main market. Each company on First North has a Certified Adviser to ensure that companies meet requirements and regulations. Shares on First North and the main Nasdaq market are traded in the same trading system.
At the end of the period the total number of shares was 16,804,059. On 30 June 2016 there were 14,291,216 shares. The nominal value of each share is SEK 0.05.
Immunovia has three outstanding warrants schemes covering 688,000 warrants entitling to subscription of 688,000 shares. All outstanding options have an exercise price less than the market price on the balance sheet date. There will be no dilution as long as the Group's earnings are negative. For more information about he warrants, see page 8.
The largest shareholders as of 30 June 2017.
| Share capital | ||
|---|---|---|
| Name | No. of shares | and votes |
| Carl Borrebaeck | 1,709,900 | 10.18% |
| Vincent Saldell | 1,000,000 | 5.95% |
| Sara Andersson Ek | 888,950 | 5.29% |
| Christer Wingren | 888,950 | 5.29% |
| Per Mats Ohlin | 888,950 | 5.29% |
| Försäkringsbolaget Avanza Pension | 711,949 | 4.24% |
| Handelsbanken Svenska Småbolag | 650,000 | 3.87% |
| Michael Löfman | 411,000 | 2.45% |
| Ålandsbanken ABP, Bank of Åland Ltd | 354,496 | 2.11% |
| Nordnet Pensionsförsäkring | 312,269 | 1.86% |
| Ten largest | 7,816,464 | 46.52% |
| Others | 8,987,595 | 53.48% |
| Total | 16,804,059 | 100.00% |
Immunovia's business operations and market are subject to a number of risks that are wholly or partly outside the company's control and that affect or may in future affect Immunovia's business operations, financial position and earnings. The following risk factors are described in no special order and with no claim to be comprehensive:
The Group operates both nationally and internationally, which involves exposure to fluctuations in various currencies, especially USD and EUR. Currency risk arises from future commercial transactions and recognized assets and liabilities. The extent of the company's business currently means that the net exposure in foreign currencies is limited. The company therefore does not have a currency hedging policy.
Interest rate risk is the risk that the value of financial instruments will fluctuate because of changes in market interest rates. The Group currently only has interest-bearing financial assets in the form of bank deposits.
Credit risk is the risk that one party to a transaction with a financial instrument fails to meet its obligation. The maximum exposure to credit risk on financial assets as of 30 June 2017 amounted to SEK 231,160 thousand (60,522 k).
Prudent liquidity risk management implies maintaining sufficient cash or agreed credit options to close market positions. Based on the existing business plan, there is enough liquidity for around two years.
Nasdaq First North is an alternative market, operated by the different exchanges within NASDAQ. Companies whose shares are traded on First North are not obliged to follow the same rules as companies whose shares are traded on a regulated market, but are subject instead to a more limited regulatory framework adapted for small growth companies. An investment in a company whose shares are traded on First North may therefore be more risky than an investment in a company whose shares are traded on a regulated market. All companies whose shares are traded on First North have a Certified Advisor who ensures that the company complies with First North's rules for disclosure of information to the market and investors.
In some cases figures have been rounded off, which means tables and calculations will not always appear to be correctly totalled.
| Page | |
|---|---|
| Consolidated income statement in summary | 9 |
| Consolidated statement of comprehensive income in summary | 9 |
| Consolidated statement of financial position in summary | 10 |
| Consolidated statement of change in equity | 11 |
| Consolidated cash flow statement in summary | 12 |
| Key indicators for the Group | 12 |
| Parent company, income statement in summary | 14 |
| Parent company, statement of comprehensive income in summary | 14 |
| Parent company, statement of financial position in summary | 15 |
| Parent company, cash flow statement in summary | 15 |
Wildeco Ekonomisk Information AB is the company's Certified Adviser on Nasdaq First North.
Contakt information: Immunovia AB (publ) Medicon Village Scheelevägen 2 223 81 Lund SWEDEN
Tel: Tel: +46 46-2756 000 [email protected] www.immunovia.com
For further information, please contact: Mats Grahn, CEO, Immunovia AB E-mail: [email protected]
Immunovia's annual report is available on the company's website: www.immunovia.com
23 August 2017, 16.00 (CET) SE: +46 856 642 690 CH: +41 225675548 DE: +49 692 222 290 46 DK: +45 354 455 75 UK: +44 203 008 98 08 US: +18 558 315 945
10 November 2017 Q3 2017 interim report 15 February 2018 2017 Financial statement
The Group complies with the Swedish annual accounts act and applies International Financial Reporting Standards (IFRS) as adopted by the EU along with RFR 1 Complementary accounting rules for groups in the preparation of financial statements. The parent company complies with the Swedish annual accounts act and applies RFR 2 Accounting for legal entities in the preparation of financial statements. The accounting principles that have been applied are in agreement with those presented in the company's 2016 annual report.
This interim report has been prepared in accordance with IAS 34 Interim Financial Reporting. New and amended standards adopted from 2017 have not had any significant impact on the Group's financial position.
No transactions have occurred with related parties in addition to salaries and other remuneration to company managers, and fees to Board members, as decided at the annual general meeting.
The Group currently has no financial instruments measured at fair value. Instead all financial assets and liabilities are measured at amortized cost. There is not expected to be any significant differences between the fair value and the carrying value of the financial assets and liabilities. The carrying amount of financial assets on the closing day amounted to SEK 231,160 (60,522) thousand.
The Annual General Meeting held on 25 April 2017 resolved to offer a warrants scheme (series 2017/2020) to employees and key persons in the company. The warrants (61,000) can be used to subscribe for newly issued shares of the Company during the period from registration of the decision until 15 October 2020. Each warrant entitles the holder to subscribe for one share at a subscription price of SEK 205.00 per share. Full utilization would increase the company's share capital by SEK 3,050.
The Annual General Meeting held on 30 May 2016 resolved to offer a warrants scheme (series 2016/2019) to employees and key persons in the company. The warrants (137,000) can be used to subscribe for newly issued shares of the Company during the period from registration of the decision until 15 October 2019. Each warrant entitles the holder to subscribe for one share at a subscription price of SEK 82.90 per share. Full utilization would increase the company's share capital by SEK 6,850.
The Annual General Meeting held on 1 June 2015 resolved to offer a warrants scheme (series 2015/2018) to employees and key persons in the company. The warrants (47,000) can be used to subscribe for newly issued shares of the Company during the period from registration of the decision until 15 October 2018. Each warrant entitles the holder to subscribe for one share at a subscription price of SEK 13.50 per share. Full utilization would increase the company's share capital by SEK 2,350.
The board meeting held on 10 September 2014 utilised the mandate issued by the Annual General Meeting held on 2 May 2014 to issue warrants (series 2014/2017) to employees and key persons in the company. The warrants (504,000) can be used to subscribe for new shares in the Company during the period from registration of the decision until 15 October 2017. Each warrant entitles the holder to subscribe for one share at a subscription price of SEK 9.50 per share. Full utilization would increase the company's share capital by SEK 25,200.
All the warrants schemes are subject to customary recalculation terms in connection with share issues, etc.
| SEK thousand | 1 Apr-30 Jun 2017 |
1 Apr-30 Jun 2016 |
1 Jan-30 Jun 2017 |
1 Jan-30 Jun 2016 |
Full year 2016 |
|---|---|---|---|---|---|
| Operating income, etc. | |||||
| Net sales | 68 | 66 | 95 | 66 | 177 |
| Capitalized work for own account | 5,553 | 6,695 | 11,080 | 11,884 | 24,293 |
| Other income | 8 | 0 | 24 | 7 | 33 |
| Total | 5,629 | 6,761 | 11,199 | 11,957 | 24,503 |
| Operating costs | |||||
| Other external costs | -8,253 | -6,519 | -15,513 | -11,029 | -24,115 |
| Personnel costs | -7,646 | -3,119 | -13,572 | -6,154 | -14,815 |
| Depreciation and amortization of tangible and intangible | |||||
| assets | -267 | -92 | -507 | -175 | -549 |
| Other operating expenses | -108 | 2 | -122 | -3 | -2 |
| Total operating expenses | -16,274 | -9,728 | -29,714 | -17,360 | -39,481 |
| Operating profit/loss | -10,645 | -2,967 | -18,515 | -5,403 | -14,978 |
| Financial items | |||||
| Interest income | 92 | 76 | 191 | 106 | 256 |
| Interest costs | -1 | -1 | -1 | -1 | -1 |
| Total financial items | 91 | 75 | 190 | 105 | 255 |
| Profit/loss after financial items | -10,554 | -2,892 | -18,325 | -5,298 | -14,723 |
| Tax on income | 0 | 0 | 0 | 0 | 0 |
| Profit/loss for the period | -10,554 | -2,892 | -18,325 | -5,298 | -14,723 |
| Earnings per share before and after dilution (SEK) | -0.63 | -0.20 | -1.09 | -0.37 | -0.98 |
| Average number of shares before and after dilution | 16,804,059 | 14,291,216 | 16,804,059 | 14,291,216 | 14,985,688 |
| No. of shares at the end of the period | 16,804,059 | 14,291,216 | 16,804,059 | 14,291,216 | 16,804,059 |
| SEK thousand | 1 Apr-30 Jun 2017 |
1 Apr-30 Jun 2016 |
1 Jan-30 Jun 2017 |
1 Jan-30 Jun 2016 |
Full year 2016 |
|---|---|---|---|---|---|
| Profit/loss for the year | -10,554 | -2,892 | -18,325 | -5,298 | -14,723 |
| Items that may be later reclassified in the income statement | 0 | 0 | 0 | 0 | 0 |
| Exchange rate differences for foreign net investment | 0 | 0 | 0 | 0 | 0 |
| Other comprehensive income for the year | 0 | 0 | 0 | 0 | 0 |
| Comprehensive income for the period | -10,554 | -2,892 | -18,325 | -5,298 | -14,723 |
| SEK thousand | 30 Jun 2017 | 30 Jun 2016 | 31 Dec 2016 |
|---|---|---|---|
| ASSETS | |||
| Fixed assets | |||
| Intangible fixed assets | 31,720 | 22,615 | 19,483 |
| Tangible fixed assets | 5,142 | 948 | 3,002 |
| Financial fixed assets | 0 | 0 | 0 |
| Total fixed assets | 36,862 | 23,563 | 22,485 |
| Current assets | |||
| Current receivables | 3,359 | 1,029 | 1,830 |
| Cash and cash equivalents | 228,326 | 59,728 | 259,094 |
| Total current assets | 231,685 | 60,757 | 260,924 |
| TOTAL ASSETS | 268,547 | 84,320 | 283,409 |
| EQUITY AND LIABILITIES | |||
| Shareholders' equity | |||
| Share capital | 840 | 715 | 840 |
| Other contributed capital | 309,273 | 101,566 | 308,800 |
| Retained earnings including total comprehensive income | -51,334 | -23,584 | -33,009 |
| Total shareholders' equity | 258,779 | 78,697 | 276,631 |
| Current liabilities | |||
| Other liabilities | 9,768 | 5,623 | 6,778 |
| Total current liabilities | 9,768 | 5,623 | 6,778 |
| TOTAL EQUITY AND LIABILITIES | 268,547 | 84,320 | 283,409 |
| SEK thousand | Share capital | Other contributed equity |
Retained earnings including total comprehensive income |
Total shareholders' equity |
|---|---|---|---|---|
| Equity, 1 January 2016 | 715 | 101,372 | -18,286 | 83,801 |
| Comprehensive income for the period | -5,298 | -5,298 | ||
| Received subscription warrant premiums | 194 | 194 | ||
| Equity, 30 June 2016 | 715 | 101,566 | -23,584 | 78,697 |
| Comprehensive income for the period | -9,425 | -9,425 | ||
| Received subscription warrant premiums | 127 | 127 | ||
| New share issue | 125 | 218,492 | 218,617 | |
| Costs of share issue | -11,385 | -11,385 | ||
| Equity, 31 December 2016 | 840 | 308,800 | -33,009 | 276,631 |
| Comprehensive income for the period | -18,325 | -18,325 | ||
| Received subscription warrant premiums | 473 | 473 | ||
| Equity, 30 June 2017 | 840 | 309,273 | -51,334 | 258,779 |
| SEK thousand | 1 Apr-30 Jun 2017 |
1 Apr-30 Jun 2016 |
1 Jan-30 Jun 2017 |
1 Jan-30 Jun 2016 |
Full year 2016 |
|---|---|---|---|---|---|
| Operating activities | |||||
| Operating profit/loss | -10,645 | -2,967 | -18,515 | -5,403 | -14,978 |
| Adjustment for items not included in cash flow | 267 | 92 | 507 | 175 | 548 |
| Received interest | 92 | 76 | 191 | 106 | 256 |
| Paid interest | -1 | -1 | -1 | -1 | -1 |
| Paid tax | 0 | 0 | 0 | 0 | 0 |
| Cash flow from operating activities before changes in operating capital |
-10,287 | -2,800 | -17,818 | -5,123 | -14,175 |
| Cash flow from changes in operating capital | |||||
| Change in operating receivables | -1,733 | -230 | -1,527 | 158 | -645 |
| Change in operating liabilities | 2,187 | 1,986 | 2,987 | 1,732 | 2,951 |
| Cash flow from operating activities | -9,833 | -1,044 | -16,358 | -3,233 | -11,869 |
| Investment activities | |||||
| Investment in intangible assets | -6,156 | -7,848 | -12,332 | -13,384 | -28,028 |
| Investment in tangible assets | -2,520 | -70 | -2,552 | -415 | -2,781 |
| Cash flow from investing activities | -8,676 | -7,918 | -14,884 | -13,799 | -30,809 |
| Financing activities | |||||
| National and European grants for development costs | 0 | 800 | 0 | 800 | 18,451 |
| New share issue | 0 | 0 | 0 | 0 | 207,233 |
| Received subscription warrant premiums | 474 | 194 | 474 | 194 | 321 |
| Cash flow from financing activities | 474 | 994 | 474 | 994 | 226,005 |
| Cash flow for the period | -18,035 | -7,968 | -30,768 | -16,039 | 183,327 |
| Cash and cash equivalents at beginning of period | 246,361 | 67,696 | 259,094 | 75,767 | 75,767 |
| Cash and cash equivalents at end of period | 228,326 | 59,728 | 228,326 | 59,728 | 259,094 |
| SEK thousand unless otherwise stated | 1 Jan-30 Jun 2017 |
1 Jan-30 Jun 2016 |
Full year 2016 |
|---|---|---|---|
| Operating profit/loss (SEK thousand) | -18,515 | -5,403 | -14,978 |
| Profit/loss for the year (SEK thousand) | -18,325 | -5,298 | -14,723 |
| Earnings per share before and after dilution (SEK) | -1.09 | -0.37 | -0.98 |
| R&D costs (SEK thousand) | -13,236 | -11,884 | -24,293 |
| R&D costs as percentage of operating costs (%) | 45 | 68 | 62 |
| Cash and cash equivalents at end of period (SEK thousand) | 228,326 | 59,728 | 259,094 |
| Cash flow from operating activities (SEK thousand) | -16,357 | -3,233 | -11,869 |
| Cash flow for the period (SEK thousand) | -30,768 | -16,039 | 183,327 |
| Equity (SEK thousand) | 258,779 | 78,697 | 276,631 |
| Equity per share (SEK) | 15.40 | 5.51 | 16.46 |
| Equity ratio (%) | 96 | 93 | 98 |
| Average no. of employees | 28 | 12 | 16 |
| Average no. of employees in R&D | 16 | 9 | 11 |
| Key indicator | Definition | Reason for using key indicator not defined in accordance with IFRS |
|---|---|---|
| Net sales | Revenues for goods and services sold in the main activity during the current period. |
|
| Operating profit | Profit before financial items and tax. | Operating income provides a picture of the results that the company's regular operations have generated. |
| Earnings per share before and after dilution |
Profit attributable to parent company shareholders divided by the weighted aver age number of shares during the period before and after dilution. |
|
| Average number of shares before and after dilution |
Average number of shares outstanding during the period before and after dilution. As the Group's performance is negative, there is no dilution although the issue price is lower than the market price. |
|
| R & D costs | The Company's direct costs for research and development. Refers to the costs of person nel, materials and external services. |
The company's main activity is research and development. Management believes that its R & D costs is an important parameter to follow as an indicator of the level of activity of the company. |
| R & D expenses as a percentage of operating expenses |
R & D expenses divided by operating expenses, which include other external costs, personnel costs and depreciation. |
Management believes that the company's R & D expenses in relation to total costs is an impor tant parameter to follow as an indicator of how much of the total costs is used for the compa ny's main business. |
| Cash and cash equivalents | Cash and bank balances. | |
| Cash flow from operating activities | Cash flow before cash flows from investing and financing activities. |
|
| Cash flow | Net change in cash and cash equivalents excluding the impact of unrealized gains and losses. |
|
| Equity per share | Equity divided by number of shares at period end. |
Management monitors this number to monitor how much value is equity per share. |
| Equity ratio | Equity as a percentage of total assets. | Management monitors this ratio as an indicator of the financial stability of the company. |
| Average number of employees | The average number of employees is calcu lated as the sum of hours worked during the period divided by the normal working hours for the period. |
|
| Average number of employees in R & D | The average number of employees in the company's research and development departments. |
| SEK thousand | 1 Jan-30 Jun 2017 |
1 Jan-30 Jun 2016 |
Full year 2016 |
|---|---|---|---|
| Operating income, etc. | |||
| Net sales | 95 | 66 | 177 |
| Capitalized work for own account | 11,080 | 11,884 | 24,293 |
| Other income | 24 | 7 | 33 |
| Total | 11,199 | 11,957 | 24,503 |
| Operating costs | |||
| Other external costs | -17,595 | -11,029 | -24,115 |
| Personnel costs | -11,490 | -6,154 | -14,815 |
| Depreciation and amortization of tangible and intangible assets | -507 | -175 | -549 |
| Other operating expenses | -122 | -3 | -2 |
| Total operating expenses | -29,714 | -17,360 | -39,481 |
| Operating profit/loss | -18,515 | -5,403 | -14,978 |
| Financial items | |||
| Interest income | 191 | 106 | 256 |
| Interest costs | -1 | -1 | -1 |
| Total financial items | 190 | 105 | 255 |
| Profit/loss after financial items | -18,325 | -5,298 | -14,723 |
| Tax on income | 0 | 0 | 0 |
| Profit/loss for the period | -18,325 | -5,298 | -14,723 |
| Earnings per share before and after dilution (SEK) | -1.09 | -0.35 | -0.98 |
| Average number of shares before and after dilution | 16,804,059 | 14,925,216 | 14,985,688 |
| No. of shares at the end of the period | 16,804,059 | 14,291,216 | 16,804,059 |
| SEK thousand | 1 Jan-30 Jun | 1 Jan-30 Jun | Full year |
|---|---|---|---|
| 2017 | 2016 | 2016 | |
| Profit/loss for the period | -18,325 | -5,298 | -14,723 |
| Other comprehensive income | 0 | 0 | 0 |
| Comprehensive income for the period | -18,325 | -5,298 | -14,723 |
| Parent company, statement of financial position in summary | |||
|---|---|---|---|
| ------------------------------------------------------------ | -- | -- | -- |
| SEK thousand | 30 Jun 2017 | 30 Jun 2016 | 31 Dec 2016 |
|---|---|---|---|
| ASSETS | |||
| Fixed assets | |||
| Intangible fixed assets | 31,720 | 22,615 | 19,483 |
| Tangible fixed assets | 5,142 | 948 | 3,002 |
| Financial fixed assets | 0 | 0 | 0 |
| Total fixed assets | 36,862 | 23,563 | 22,485 |
| Current assets | |||
| Current receivables | 3,781 | 1,029 | 1,831 |
| Cash and cash equivalents | 227,903 | 59,728 | 259,093 |
| Total current assets | 231,684 | 60,757 | 260,924 |
| TOTAL ASSETS | 268,546 | 84,320 | 283,409 |
| EQUITY AND LIABILITIES | |||
| Shareholders' equity | |||
| Restricted equity | |||
| Share capital | 840 | 715 | 840 |
| Reserve for development expenses | 35,373 | 7,267 | 24,293 |
| 36,213 | 7,982 | 25,133 | |
| Unrestricted equity | |||
| Premium fund | 474 | 194 | 207,107 |
| Retained earnings including total comprehensive income | 222,092 | 70,521 | 44,391 |
| 222,566 | 70,715 | 251,498 | |
| Total shareholders' equity | 258,779 | 78,697 | 276,631 |
| Current liabilities | |||
| Other liabilities | 9,767 | 5,623 | 6,778 |
| Total current liabilities | 9,767 | 5,623 | 6,778 |
| TOTAL EQUITY AND LIABILITIES | 268,546 | 84,320 | 283,409 |
| SEK thousand | 1 Jan-30 Jun 2017 |
1 Jan-30 Jun 2016 |
Full year 2016 |
|---|---|---|---|
| Cash flow from operating activities | -16,780 | -3,233 | -11,870 |
| Cash flow from investment activities | -14,884 | -13,799 | -30,809 |
| Cash flow from financing activities | 474 | 994 | 226,005 |
| Cash flow for the period | -31,190 | -16,039 | 183,326 |
| Cash and cash equivalents at beginning of period | 259,093 | 75,767 | 75,767 |
| Cash and cash equivalents at end of period | 227,903 | 59,728 | 259,093 |
This interim report has not been audited by the company's auditor.
The Board of Directors and the Group CEO certify that this interim report provides a fair overview of the arent Company's and the Group's operations, their financial position and result, and describes material risks and uncertainties that the Parent Company and other companies in the Group are facing.
Lund, 23 August 2017.
Carl Borrebaeck Hans Johansson
Chairman Board member
Åsa Hedin Ann-Christin Malmborg Hager Board member Board member
Mats Grahn Ann-Christine Sundell CEO Board member
Actionable information – In this context this means information that is sufficiently reliable and specific to form the basis for clinical decisions.
Antibodies – Antibodies, or immunoglobulins, are a type of protein used by the body's immune system to detect and identify foreign substances such as viruses, bacteria or parasites.
Antigen – A foreign body substance that elicits a reaction of the immune system in contact with the organism. The substance may be a chemical substance, a protein or a carbohydrate.
Autoimmunity – Autoimmunity is the immune system's harmful attack on the body's own tissue, which can take the form of disease or rejection of organs during transplantation.
Benign – If a tumour is benign it means that the tumour is not dangerous and will not spread.
Bioinformatics – Bioinformatics is an interdisciplinary field in which algorithms are developed for the analysis of biological (especially molecular biology) data.
Biomarker – A biomarker can be defined as a biological response to a change caused by disease or foreign substance. Biomarkers can be used as early warning signs of biological changes in an organism.
Companion Diagnostics – Diagnostics tools aimed at identifying which groups of patients will respond well to a particular treatment and thus ruling out ineffective treatments.
Discovery Study – Research carried out in order to verify a special hypothesis.
Histology – Histology is the study of biological tissue.
Invasive – Invasive means to penetrate or attack. Invasive medical examinations refer to examinations that include any form of penetration through a hole in the body or surgical operation.
Malignant – Malignant tumours tend to worsen and become mortal. They are termed cancer, and thus differ from benign tumours.
Metastasis – A metastasis is a tumour that has spread to other organs.
Microarray – A microarray is a molecular biology test format for simultaneously measuring the relative concentrations of proteins.
Out-of-pocket customers – Patients or organizations that pay for drugs without reimbursement from insurance companies or government agencies.
Palliative care – Palliative care is administered when the patient's disease is beyond the ability to cure. The purpose of palliative care is to provide support to patients and families using both psychological and medical practices.
Prospective study – A study in which a group of individuals are studied and followed over a period of time (often long) to see how a disease develops. A prospective study is used to study the link between different risk factors and a specific disease. Individuals with or without risk factors are monitored over time. At the end of the study a comparison is made of the proportion of individuals who have developed the disease in both groups.
Proteomics – Proteomics is a branch of biology and includes surveys of large amounts of data about proteins.
Reproducibility – Within the field of statistics, reproducibility is described as the correlation between results from repeated measurements performed by different observers with different instruments of the same type, which measurements are performed in order to reject any measurement error due to materials and personnel.
Retrospective study – A study in which you look back at something that has already occurred, i.e. historical data is used. A retrospective study begins with the answer, i.e. you already know which individuals will develop the disease.
Screening – Screening refers to medical examinations to identify a disease. It is normally carried out before the patient has exhibited obvious symptoms.
Sensitivity – Sensitivity is a statistical measure of the reliability of a binary diagnostic test and the probability that a generated positive result is correct.
Serum – A serum is a transparent yellowish liquid obtained by allowing the blood to clot, and then removing the blood cells and the coagulation proteins. Serum contains proteins, including antibodies.
SLE (Systemic Lupus Erythematosus) – SLE is an autoimmune inflammatory disease which means that the immune system attacks the body. The symptoms come and go in cycles, sometimes the patient is sick and sometimes has no sickness at all. Usually it is the joints, skin, blood and kidneys which become inflamed, but also the nervous system, lungs and heart can be affected. The disease is currently difficult to diagnose and is often confused with other autoimmune diseases.
Specificity – Specificity is a statistical measure of the reliability of a binary diagnostic test and the probability that the generated negative result is de facto negative.
Vinnova – Vinnova is a Swedish government agency under the Ministry of Industry which aims to promote sustainable growth by improving conditions for innovation and by funding needs-driven research.
Immunovia is a Swedish molecular diagnostic company entering a commercialisation phase with a strong financial position. The company develops and commercialises diagnostic tools for complex forms of cancer and autoimmune diseases.
Immunovia AB was founded in 2007 by researchers from the Department of Immunotechnology at Lund University and CREATE Health, the Center for Translational Cancer Research in Lund, Sweden. The purpose was to establish a base from which to make scientific discoveries and gain patents within the fields of human antibodies, biomarkers and antibody arrays, covering the stages from research to clinical application.
Immunovia's core technology platform, IMMray™, is based on microarray analysis of biomarker antibodies. IMMray™ PanCan-d is the company's primary diagnostic tool, capable of diagnosing with a high level of sensitivity and specificity. This enables diagnosis of patients with pancreatic cancer before symptoms are noted (stages I and II), which is not currently possible with existing methods. Immunovia is now performing clinical validation studies to prepare for the commercialization of IMMray™ PanCan-d, which could become the first bloodbased test for early diagnosis of pancreatic cancer.
The antibody-based technology platform, IMMray™, is the result of 15 years of research at CREATE Health, Lund University. It is used to decode mechanisms behind the body's immune system, the first system in the body that reacts to disease. The platform can also be used for the development of diagnostic tests for lupus (SLE), prostate cancer and breast cancer.
Each year about 338,000 patients fall ill with pancreatic cancer. This form of cancer has one of the worst survival forecasts and only about 5% of diagnosed patients live more than five years, making it one of the deadliest cancers in the world. It is estimated that early detection would increase the five-year survival rate by 59%. The initial addressable market for Immunovia consists of two high-risk pancreatic cancer groups. The market in the US and Europe for diagnosis of these groups is estimated to be worth over SEK 30 billion per year.
Immunovia's goal is to provide diagnostic tests that will enable earlier, more efficient and more accurate diagnosis of patients who run the risk of developing cancer or autoimmune disease. The aim is to make Immunovia's tests the first choice of specialist doctors and general practitioners across the world in the screening of specially high-risk groups or when there is a suspicion of the aforementioned diseases.
As the first company, Immunovia's strategy is to decipher the wealth of information in blood and translate it into clinically useful tools to diagnose complex diseases earlier and more accurately than previously possible. The focus is on unsolved problems in early diagnosis, monitoring of the course of a disease and the patient's response to treatment. These are areas where there are extensive clinical benefits for patients and the healthcare system, current solutions are lacking or insufficient, and where IMMray™ has significant competitive advantages.
Initially, the key focus for Immunovia is to bring IMMray™ PanCan-d to the market. Because early detection of pancreatic cancer constitutes a major clinical problem, Immunovia considers there to be good prospects for being the first to establish a strong position on the market.
Immunovia has its head office in Lund, Sweden. Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm First North. The Certified Advisor is Wildeco. For more information, visit www.immunovia.com
Scheelevägen 2 Medicon Village 223 81 Lund SWEDEN
Tel: 00 46 46-2756 000 [email protected] www.immunovia.com
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