Interim Report 2018-01-01 – 2018-03-31
The Management Board and Chief Executive Officer of Oncology Venture Sweden AB hereby submit a report for the accounting year 2017. “Oncology Venture Sweden AB” refers to Oncology Venture Sweden AB with corporate identification number 559016-3290. “The Company” or “Oncology Venture” refers to the group, that is Oncology Venture Sweden AB and its subsidiary company Oncology Venture ApS (100% owned by Oncology Venture), 2X Oncology (92% by Oncology Venture) and OV-SPV2 ApS (40% owned by Oncology Venture).
Summary of communique on financial report
First quarter (2018-01-01 – 2018-03-31)
- The Group’s net turnover increased to 298 (0) KSEK.
- The Group’s result after tax decreased to -14 363 TSEK (-11 626) KSEK.
- The Group’s cash and bank assets decreased to 40 145 TSEK (19 512) KSEK.
- The Group’s result per share decreased to -1,11 SEK (-1,15) SEK.
- Its solidity increased to 68,5 (87,8) %.
The Group’s result per share: The result for the period divided by the average number of shares. Total number of shares as of
31 December 2017 increased to 13,832,716. Average number of shares for the period is 12 882 002.
Amount within brackets: Comparable period in the previous year.
Solidity: Equity divided by total capital.
Important events during the first quarter of 2018
- On March 27, Claus Frisenberg Pedersen, CCO and CFO in Oncology Venture, bought 3 700 shares in Oncology Venture at a price of 18,36 SEK per share and 6 300 shares in MPI at a price of 10,816 SEK per share.
- On March 22, Oncology Venture announces that positive study results for the diagnostic tool DRP® in lung cancer patients treated with cisplatin has been published in the scientific journal PLOS ONE under the title "Molecular Prediction of adjuvant cisplatin efficacy in Non-small cell lung cancer - validation in two independent cohorts."
- On 9 March, Oncology Venture and Medical Prognosis Institute A/S (“MPI”) jointly announces that their respective Boards of Directors have agreed on a joint merger plan to accomplish a merger of the companies. Combining these two highly complementary businesses will result in a leading integrated oncology biotechnology company with a promising anticancer drug pipeline resting on a proprietary patient screening technology to predict drug response.
- On 5 February 2018 Oncology Venture appoints Claus Frisenberg Pedersen as new Chief Financial Officer (CFO). Claus Frisenberg Pedersen succeeds Nikolaj Buhl Jensen, who is moving on to a position as Senior Consultant in the management company Buhl Oncology (Buhl Krone Holding APS).
- Oncology Venture advises on 31 January 2018 the results of the other interim assessment of the phase-2 part of an ongoing phase 1/2 trial of LiPlaCis® - a targeted liposomal formulation of cisplatin - in difficult-to-treat patients with metastatic breast cancer. Clinical benefit has now been demonstrated in seven out of ten assessable patients who have been treated with LiPlaCis®, while conventional treatment with cisplatin in trials carried out previously resulted in a clinical response of only ten per cent in this patient category.
- On 31 January, Oncology Venture advises that the Company’s representative subscription of approx. MSEK 44.7 to finance planned clinical trials with existing drugs candidates and build up a financial buffer has been over-subscribed. The representative subscription was for approx. MSEK 59.6, equivalent to a subscription level of around 133 per cent. Through the representative subscription, 2,745,143 shares were newly issued and Oncology Venture made approx. MSEK 44.7 before subscription costs.
- On 15 January 2018, Oncology Venture publishes the initial conclusions from a DRP® trial relating to a phase 3 TKI product from Big Pharma. In the study of biopsy data from renal cancer - where the DRP® results were compared with the results from clinical trials - a consistent result could be seen. On this basis, the Company’s objective is now to further develop the drug and its DRP® commercially.
- The subscription period for Oncology Venture’s new share issue was initiated on 11 January 2018.
- On 8 January 2018, Oncology Venture advises that the Company’s CFO Nikolaj Buhl Jensen has used 100,000 options of the 2015/2018 series, which means that 107,000 new shares are issued at a rate of 6.88 SEK per share.
On 4 January 2018, Oncology Venture publishes a prospectus on the occasion of the company’s representative subscription which was initiated on 11 January 2018.
- An extraordinary annual general meeting is held in Oncology Venture on 4 January 2018. A communiqué from the extraordinary annual general meeting is available at the Company’s and AktieTorget’s (www.aktietorget.se) respective websites.
Important events after the end of the period
- On May 1, the prospectus was published regarding the planned fusion of Oncology Venture and MPI.
- On April 30, Oncology Venture publishes notice to the Annual General Meeting. The Annual General Meeting will be held in Malmö on May 30.
- On April 30, the fusion plan between Oncology Venture and MPI is published.
- On April 9, Oncology Venture announces that the Company has entered an agreement with Novartis Pharma AG (Basel, Switzerland), for the exclusive global rights to develop and commercialize dovitinib (TKI258), a small molecule, multi- tyrosine kinase inhibitor (TKI).
Other events after the end of the period
- On May 4, Oncology Venture announces that the investment research company Edison has taken up coverage of the Oncology Venture share.
|Below, you will find the pipeline of Oncology Venture. The company’s aim is performing focused phase 2 studies and when positive results can be presented, to out-license, to further co-develop with a partner, or to sell the products.|
|Drug Candidate||Indication||Activity||Activity Initiated||Ownership|
|TKI||Kidney Cancer||DRP analysis of biopsies from phase 3 Tyrosinkinase inhibitor from Novartis
Planning material for meeting with FDA
|the initial conclusion from a study of the DRP of a phase 3 TKI product from Big Pharma showed a consistent result. Several parameters were evaluated in this blinded study and though some were not statistically significant, others were, and a consistent signal was seen of the TKI DRP's ability to foresee clinical benefit in the phase 3 TKI trial in renal cancer patients. Ongoing||The TKI is planned to be developed by SPV company OV-SPV2 ApS, whereof 40 % is owned by Oncology Venture, 10 % by MPI and 50 % by external investors. It was recently announced Oncology Venture may acquire another 35 % of the OV-SPV2 shares before June 1, 2018.Oncology Venture announced in January 2018 that the board have decided to execute the license for the TKI product.|
|Oral PARP inhibitor – 2X-121||Metastatic Breast Cancer
|EISAI Phase 2 PARP inhibitor (E7449)Planning material for meeting with FDA||In-licensed. The company is now planning a defined phase 2 study, aimed to be financed with liquid assets from a planned rights issue. The study is expected to begin during 2018, and to be finished approximately 12 months later. After this, the company will be able to communicate the future of 2X-121. Ongoing||2X-121 is developed by SPV company 2X Oncology Inc., whereof 92 % is owned by Oncology Venture and 8 % by external investors until a possible capital raise.|
|LiPlaCis®||Breast Cancer||Screening patients ( > 1300 patients)||Ongoing||Oncology Venture has signed an exclusive global license agreement with Liplasome Pharma, and possible future sales revenue will be divided as follows: Oncology Venture 45%, MPI 10% and Liplasome Pharma 45%. The company has also signed a development agreement with Cadila Pharmaceutical Ltd. Provided Cadila delivers according to this agreement, Oncology Venture’s part of any future LiPlaCis® income will be 29,25 %.|
|Phase 2 study*Planning material for meeting with FDA||Started Q3 2016. Inclusion of first 12 patients in the phase 2 part finished Q3 2017. New permit for up to 20 patients: ongoing. Last patient is expected to be included Q1 2018 and results are estimated to Q3-Q4 2018, depending on required length of patient treatment. Interim results announced in January 2018Ongoing|
|Breast Cancer||Randomized phase 2 study||To be initiated 2018. Inclusion of first patient Q2 2018, and last patient during Q4 2019. The study is estimated to include about 80 patients which is sufficient to achieve statistical proof at a doubling of progression-free survival. The study has received EUROSTARS funding in co-operation with our partner Smerud.|
|Skin, Head & Neck, Esophagus and Prostate Cancer,Cadila sponsored||Phase 2 studies||To be initiated by Cadila. The Indian authorities are very keen on its population not being used for pharmaceutical studies and has even stricter rules regarding for example stability studies than the rules in Europe and the US, which is the reason that the study takes longer time.|
|Breast Cancer, Cadila sponsored||Pivotal/phase 3 study||To be initiated by Cadila|
|TOP2 inhibitor – 2X-111||Glioblastoma
Metastatic Breast Cancer
|Liposomal doxorubicin-Glutathion phase 2||In-licensed to 2X Oncology Inc. The company is planning a defined phase 2 study which is estimated to begin during 2018, and to be finished approximately 12 months later. By then, the company will be able to communicate the future of 2X-111.||2X-111 is developed by SPV company 2X Oncology Inc., whereof 92 % is owned by Oncology Venture and 8 % by external investors until a possible capital raise.|
|Irofulven||Metastatic Prostate Cancer||Screening patients||Ongoing||Oncology Venture has acquired 75% of the rights to Irofulven from Lantern Pharma Inc. Lantern will receive 25 % of possible milestone payments, a number that may increase to 40% if Lantern makes use of their purchase option of 2 million USD when eight patients have been treated in the planned phase 2 study. Should Lantern use their option, Oncology Venture will own 60% and Lantern 40% of the rights for Irofulven.|
|Study is approved by the Danish authorities. Preparing for initiation of phase 2 at Danish sites||Ongoing|
|Phase 2 study*||15 patients in phase 2 study. Last patient expected to be included during Q1 2019.|
|APO010||Immuno-oncology drugFirst indication Multiple Myeloma (Bone Marrow Cancer)||Screening patients (approx. 150 patients)||Ongoing||Oncology Venture has acquired the rights for APO010 from Onxeo. At a possible market launch, Oncology Venture will receive >90 % of the sales profit.|
|Clinical phase 1/2 study||Phase 1 dose escalation part ongoing. Total phase 1 and 2 circa 30 patients, depending on how many patients are to be included in the phase 1 dose escalation part. If about 30 patients are included, the last patient is estimated to be included during Q1 2019.|
|Regarding Special Purpose Vehicles (SPV)||Seed investment of 3,5 million USD||Secured in December 2016|
|Series A financing||Ongoing|
Peter Buhl Jensen comments
In the first quarter of 2018 we have announced several good news regarding the development of our drug candidates and also conducted a rights issue and announce our fusion plan with MPI.
In january we conducted a succesfull rights issue of approximately SEK 44,7 million, in order to increase the pace in our development in a focused way by conducting our planned clinical studies. I want to thank all you that participated in the rights issue and also take the time to welcome all of our new shareholders.
In the end of the quarter, we announced a plan to merge Oncology Venture and MPI. The merger will be valuable with the establishment of a collected ownership of the DRP – we will create a cross-over industry between software and Pharma, a valuable advantage in negotiations with drug owners, potential biotech and pharma partners and future acquirers of our drug candidates. The future of oncology drug development is increasingly integrating drugs and their companion diagnostics – we will be on the forefront of this development. I believe that by creating a ‘One Stop Shop’ the unified focus and savings will enable us to do more – faster. I also believe that the business model which includes both the DRP® technology as well as anticancer drug development differentiates us from other companies and positions us as an attractive partner for drug developers. Our business model is to develop and sell products with the DRP to the Pharma industry. As previously communicated, these is a large interest for our products, and the DRP technology in particular, among the mid-size Pharma industry, which are our likely first deal partners.
In the end of January, we presented positive interim results from a Phase 1/2 study in hard to treat metastatic breast cancer patients. With great pleasure, we can establish that the interim results from the Phase 2 part of the study meets our high expectations. In a hard to treat metastatic breast cancer population like this, with a mean of seven prior treatments, it is remarkable that in the top third most susceptible patients as identified by the DRP® companion diagnostic kit, all had clinical benefit of LiPlaCis®. It not only demonstrates the benefit of LiPlaCis®, but also that DRP® can find the responding patients for a prospective clinical study. In March, we also announced that positive study results for the diagnostic tool DRP® in lung cancer patients treated with cisplatin has been published in the scientific journal PlosOne. The positive results from the collaboration with Danish Rigshospitalet is an important addition to the previously conducted prospective, retrospective and blinded studies of the diagnostic tool DRP®. Cisplatin is one of the most important chemotherapeutics which is widely used around the world – and yet there is until now no biomarker in clinic to tell whether a patient is likely to benefit from the treatment or not. This adds further support to our LiPlaCis program.
In April, we announced that we have entered into an agreement with Novartis Pharma AG for the exclusive global rights to develop and commercialize dovitinib (TKI258), a small molecule, multi- tyrosine kinase inhibitor (TKI), which we previously have negotiated with Novarits.
Dovitinib has demonstrated clinically relevant efficacy in renal cancer and breast cancer and good efficacy in several other solid tumors. Over the coming 6-8 months, we look very much forward to analyse the enormous amount of data. By using our Drug Response Predictor (DRP®) biomarker for dovitinib to select likely responder patients - and the recent success with a combination of a TKI and a PD-1 inhibitor (Keytruda®) in renal cancer - we will raise the chances of success for dovitinib in further clinical development. We are for instance looking into the possibilities of submitting a fast application for market approval of dovitinib in renal cancer where the drug substance has shown equal efficacy as the existing compound on the market. The coming analysis of the comprehensive data will support our strategy for dovitinib, which makes up a substantial part of the potential in our pipeline of selected drugs which, together with our Drug Response Predictor, gives a new hope for new and effectuve treatment options for cancer patients.
Peter Buhl Jensen – CEO, Oncology Venture Sweden AB
About Oncology Venture
Many anti-cancer drugs are only beneficial to a minor part of a patient group, and there is currently no way of identifying which patient will respond to a certain treatment. This is forcing oncologists to treat many patients blindly, and if the number of patients responding to a certain drug is too low, the drug candidate will most likely not be used even if it may in fact be well suited for some patients. The same problem occurs in medical studies of drug candidates. Insufficient efficacy has become the most common reason for clinical failures within drug development. A great part of these failures cannot be attributed to the drug as such, but are instead a consequence of difficulties performing clinical studies in an adequate way, i.e. with a satisfactory well-defined patient group. The operating subsidiary Oncology Venture ApS has a license from Medical Prognosis Institute A/S (“MPI”) to use the Drug Response Prediction (DRP®) technology. Oncology Venture and MPI has agreed on a fusion plan in order to conduct a merger of the companies. The combination of these highly complementary companies will result in a leading integrated oncology biotech company with a promising portfolio of drug candidates for treatment of cancer, based on a proprietary patient screening technology to predict the treatment effect of drugs. The new company will be a One-Stop-Shop with a business model including both the DRP® technology and the development of anti-cancer drugs. The company is expected to create substantial value for its shareholders through synergies which is a result of co-ordination of the two original companies’ operations, and through expansion of the combined company’s potential business opportunities, compared with those which MPI and OV could meet on their own.
Business Model in Short
Oncology Venture’s business is built on optimizing the use of anti-cancer drugs that have shown efficacy but stalled in clinical development, either due to insufficient response rate, or due to difficulties in raising enough capital to drive the business forward. The company works with a model that betters the odds compared to traditional drug development. Instead of treating all patients suffering from a specific type of cancer, the patients are first screened, and only those likely to respond to treatment with the specific drug will then be treated. With a more well-defined patient group, the use of the drug is optimized, and risks and costs are reduced. At the same time, both treatment and development become more efficient. Oncology Venture shall in-licence (or buy) drug candidates that have been stopped in clinical development, and thereafter perform new clinical studies based on extended knowledge of which patients are likely to respond to a specific drug candidate. OV has recently reached a new level by being able to in-license high quality Big Pharma products referring to the company’s success criteria: efficacy, favourable side effect profile, positive manufacturing process - preferably existing products – all regulatory documents in place, and good business potential. Oncology Venture’s ambition is to in-license effective drug candidates where the company’s DRP technology can be used for reaching success as far as high precision, and to perform focused phase 2 studies on a well-defined population based on relevant bio markers. It is also part of Oncology Venture’s business model to create SPVs, i.e. privately owned spin-out companies, thereby becoming the owner of several projects and exporting technology to other countries. This way, more capital can be raised from different types of investors including venture capital, business angels and private family businesses around the world without intention to invest in listed companies (more scoring opportunities in attracting capital). 4 million USD has already been raised for 2X Oncology and OV-SPV2. Oncology Venture in-licenses the products which are placed in the SPV’s if these can raise sufficient funding to run the clinical development. After performed clinical studies, Oncology Venture will out-license (or sell) drug candidates with a high response rate connected to a DRP test. A deal in this phase typically includes incomes at the time of out-licensing (up-front), plus milestone and royalty incomes. Oncology Venture has also been able to attract public financing for several projects, and intend to remain proactive within this field.
Company Structure and Shareholding
Oncology Venture Sweden AB owns 100 % of the subsidiary Oncology Venture ApS. All operations take place within the subsidiary, and the only operative procedure of Oncology Venture Sweden AB is owning the subsidiary Oncology Venture ApS. Beyond this, Oncology Venture ApS owns 92 % of American subsidiary 2X Oncology, and 40 % of spin-out company OV-SPV2 ApS with an option until June 1, 2018 to increase ownership to 75% for 3,5 million USD. Prolongation is under discussion. Further on, the SPVs will be owned by Oncology Venture ApS together with new investors - a split between the parts will be negotiated and determined.
Oncology Venture’s Drug Candidates
APO010 – an Immuno Oncology product
Oncology Venture holds the exclusive global rights for drug candidate APO010, which is currently in its phase 1 dose escalation part of clinical phase 1/2 development. In March 2017, the Danish Medicines Agency approved Oncology Venture’s focused study of APO010 in Multiple Myeloma, meaning a previously manufactured stock of APO010 could be used in the study. APO010 is a FAS-receptor immuno-oncology product that kills cancer cells through the same mechanism as the T cells of the human body. Four Danish haematology clinics are open in the study, recruiting patients. So far, over 70 patients have approved to have their tumors DRP scanned for sensitivity to APO010. The study began with the first patient being included in May, 2017. The company holds all rights for this candidate, rights transferred from TopoTarget A/S (later Onxeo) during 2012. The APO010 project has received a EUROSTARS grant of 13.5 million SEK. Oncology Venture has acquired the DRP®
for APO010 from MPI, meaning OV holds all rights to the APO010-DRP in the foreseeable future.
Irofulven - a transcription-coupled repair-specific antitumor agent’
Irofulven has previously undergone phase 2 and 3 studies and shown a 10% response rate (RR) in patients suffering from Prostate Cancer, 13% RR in Ovarian Cancer patients, and 7% RR in Liver Cancer. However, these levels are insufficient for obtaining authority approval. With the help of Professor Knudsen’s DRP® for the product, the company aims to find patients who are likely to respond to Irofulven treatment, and include these patients in a focused phase 2 study to increase the response rate. After Q2 2017, it was announced that Irofulven had successfully been manufactured and bottled in injection bottles for clinical studies. Oncology Venture submitted the clinical trial application to the authorities in October for initiating the studies in Denmark and Sweden, where the company has screened >70 Prostate Cancer patients. Oncology Venture is negotiating with potential partners in China for development of Irofulven in Liver Cancer.
LiPlaCis – a liposomal formulation of cisplatin
LiPlaCis® is a liposomal formulation of the active substance cisplatin, first and foremost aiming to treat Breast Cancer patients. In the phase 1/2 study of LiPlaCis®, a phase 1 dose escalation phase among patients with advanced tumors has been performed. The phase 1 part is finished, and the first goal of including 12-15 patients in the phase 2 part was reached during the third quarter of 2017. Furthermore, the number of patients was increased to up to 20 for further investigation of the cut-off of the DRP®. The company has been allowed to increase the cut-off of 20% with highest DRP score to include 2/3 of the patients with highest DRP score which increases the possibility to identify the relevant cut-off level and to expand the study from 12 to up to 20 patients. After this, the company plans to initiate an international, randomised phase 2 multicentre study in Europe. Preparations for this are ongoing. The first DRP positive Breast Cancer patient has shown partial remission (i.e. > 30% reduction of the tumor) after treatment with LiPlaCis®. Data from the ongoing phase 1/2 study show how the tumor response to LiPlaCis® can be predicted with Oncology Venture’s Drug Response Predictor (DRP®) regardless of tumor type, including Breast Cancer. In January 2018, Oncology Venture announced the results of the second interim evaluation from the Phase 2 part of an ongoing Phase 1/2-study of LiPlaCis – a targeted liposomal formulation of cisplatin – in difficult-to-treat patients with metastatic breast cancer. Clinical effect has now been shown in 7 out of 10 evaluable patients treated with LiPlaCis®, while conventional treatment with cisplatin in earlier conducted studies has resulted in a clinical response of only ten percent in this patient category. Beyond this, the Danish Medicines Agency and The Ethics Committee gave their permission to include Metastatic Breast Cancer patients in the phase 2 study of LiPlaCis® already after the patient’s second line of treatment. The possibility of partaking in the phase 2 study of LiPlaCis can now be offered to the patients earlier in their treatment process. This gives more patients a potential new treatment, and enables an expansion of the LiPlaCis indication. The LiPlaCis® programme has achieved a higher value through a permission for treating patients with symptoms from liver metastases and patients with low thrombocyte count - patients excluded from many other drug treatments.
Oncology Venture has signed a development agreement with Cadila Pharmaceuticals Ltd regarding joint development of LiPlaCis® in combination with its DRP®. According to the agreement, Cadila Pharmaceuticals has the possibility to acquire a 35 % ownership of the drug’s value, given they can prove clinical data of FDA/EMA quality from 320 patients within a certain time frame. The aim is to evaluate the effect of LiPlaCis® in several different indications in focused phase 2 studies, and to perform a randomized phase 3 study as a base for and important part of the data package for market approval by the FDA, EMA and CDSCO (Central Drugs Standard Control Organisation of India). Cadila will be using chilled product and stability studies for this product version. The Indian authorities are very particular their population must not be used as ”guinea pigs of the world”, and have even stricter rules for stability studies than those of Europe and the US. This is the reason why the study takes longer. The phase 2 studies are expected to begin within Head and Neck, Prostate, Skin and Esophagus Cancer. The company is also looking forward to the start of the Cadila phase 3 study in Metastatic Breast Cancer. Cadila Pharmaceuticals Ltd. will invest in the form of research and development activities regarding 320 cancer patients, and DRP screening of over 1400 patients. Oncology Venture has acquired the DRP for LiPlaCis® from MPI, meaning OV holds all future rights for LiPlaCis®-DRPTM for the foreseeable future.
Special Purpose Vehicles
Previously called 2B3-101, 2X-111 is a liposomal formulation of doxorubin, using so called G technology to enable the drug of passing the blood-brain barrier to better the treatment of brain metastases and primary brain tumors. 2X-111 has shown clinical activity in a phase 2 study with patients suffering from Metastatic Breast Cancer, and in patients with Glioblastoma (primary Brain Cancer). These are both hard-to-treat cancers with great medical needs. 2X-111 will be combined with its Drug Response Predictor (DRP®) as companion diagnostics in DRP focused phase 2 studies for patients with high likelihood of responding to the treatment.
2X-121 – a PARP inhibitor
Oncology Venture has signed an agreement with Big Pharma Company EISAI about global rights to its PARP inhibitor E7449 (now called 2X-121). Oncology Venture have announced that it has identified the responding patients. In a blinded study, Professor Knudsen’s DRP® analysis showed how DRP from 13 patients could accurately predict respons and overall survival with a p value of 0.07, meaning there is a 7% risk of the result being a random outcome. The company has pills in stock for the projects, facilitating for a quick start. Also in this case, DRP® has been evaluated as a potential game changer for Big Pharma company EISAI’s high quality PARP inhibitor. Should Oncology Venture’s DRP® achieve positive results, the combination of the drug and its companion diagnostics has great market potential.
During 2017, Oncology Venture has formed an additional oncology therapeutic spin-out OV-SPV2 for the development of a specific drug against cancer, utilizing DRP®. OV-SPV2 intends to test and potentially develop an oral tyrosine kinase inhibitor from Novartis Pharma AG, currently holding the worldwide rights to this anticancer drug. Analysis setup from previous phase 3 studies of the TKI product is ongoing. The company is currently working together with FDA and EMA regulatory experts in evaluating the possibility to discuss a potential fast approval from the regulatory authorities. The drug has previously shown very competitive and interesting data in both Liver and Kidney Cancer. The drug candidate has been tested in phase 2 and phase 3 studies, and biopsies and results are available from these trials.
Oncology Venture has conducted a fast DRP® test to assess whether the DRP® tool can identify respondents from the clinical trials. In the study of biopsy data from renal cancer patients – where DRP® results were compared with results from clinical studies – a consistent result was identified. Based on this, the Company’s goal is to continue the drug and its DRP® to commercial success. Several parameters was evaluated in this blinded study and though some was not statistically significant, others were, and a consistent signal was identified regarding the TKI DRP’s ability to predict clinical benefit in the Phase 3 TKI study of renal cancer patients. Oncology Venture has decided to execute the license option for the TKI, the conditions of which has been previously negotiated.
Development in Numbers during the First Quarter of 2018
Net revenue for the first quarter amounted to 298 (0) KSEK.
The company’s result after taxes for the first quarter 2018 amounted to -14 363 (-11 626) KSEK, and was mainly influenced by operating costs, amounting to 14 511 KSEK. These mainly consisted of production costs of approximately SEK 1 million, approximately SEK 5 million in preparing and running clinical trials and approximately SEK 1 million in sales and marketing activities.
Cash and Bank
Per March 31, 2018, the cash and bank of Oncology Venture was 40 145 (19 512) KSEK. Besides this, Oncology Venture holds short-term receivables of 12 798 (10 495) KSEK, consisting of receivables, other prepaid costs and a tax receivable since the Danish Government reimburses 22% of all expenses referred to research and development
The shares of Oncology Venture Sweden AB were listed on AktieTorget on July 22, 2015. The short name/ticker is OV, and the ISIN code is SE0007157409. AktieTorget is a secondary name of ATS Finans AB, which is a securities company under supervision of the Swedish Financial Supervisory Authority (Finansinspektionen). AktieTorget runs a trading platform (MTF), which is a non-regulated market. Per March 31, 2018, the number of shares was 13 832 716. Each share equals the same rights to the company’s assets and result.
List of Share Holders Owning Over 5% per 2018-03-31
|Name||Share of Votes and Capital (%)|
|Sass & Larsen ApS||15,03|
|Buhl Krone Holding ApS*||9,28|
|Medical Prognosis Institute A/S**||8,45|
* 80 % owned by Peter Buhl Jensen (CEO of Oncology Venture Sweden AB). The other 20 % owned by Ulla Hald Buhl, board member of Oncology Venture Sweden AB, and married to Peter Buhl Jensen.
** 10,49 % owned by Peter Buhl Jensen (CEO of Oncology Venture Sweden AB) and spouse.
At an Extraordinary General Meeting on June 28, 2015, a decision was made to introduce three stock option programs for The Company’s employees and board members. The option programs contain a total of 325 000 warrants.
Warrant Program 1
This program consists of 170 000 warrants, and is directed to key employees who worked with the Initial Public Offering of Oncology Venture Sweden AB. The warrants were received free of charge, and can be subscribed to during a period that expires on August 22, 2018. Each warrant entitles subscription to 1.07 new share in Oncology Venture Sweden AB at a rate of 6.88 SEK per share. The warrants have a lock-up period of one year, which is transferred to stock shares if the warrants are used during the first year.
Warrant Program 2
Consists of 125 000 warrants received free of charge, and is directed to employees of the company, among these board member Ulla Hald Buhl, Nils Brünner, and board member Steen Knudsen, who all received 10 000 warrants each. One third of the warrants can be subscribed to at a rate of 7.58 SEK per share between August 1, 2016 and August 22, 2018. Another third can be subscribed to at a rate of 8.34 SEK per share between August 1, 2017 and August 22, 2018. The remaining third of the warrants can be subscribed to at a rate of 9.16 SEK per share during August 1 to August 22, 2018. Each warrant entitles subscription to 1.07 new share in the company. Should a warrant holder leave his or her employment before the end of the first subscription period, all warrants will return to the company. If an employee leaves after the end of the first subscription period, two thirds of his/her warrants will return to the company. If leaving after the second subscription period, one third of the employee’s warrants will return to the company.
Warrant Program 3
Consists of 30 000 warrants and is directed to Duncan Moore and Sanjeevi Carani, board members of Oncology Venture. Each warrant entitles subscription to 1.07 new share in Oncology Venture Sweden AB at a rate of 13.96 SEK per share. The warrants can be subscribed to August 1-22, 2018. Moore and Carani are offered warrants at a price of 1.15 SEK per warrant.
Warrants as consideration for exclusive license from MPI
As consideration for the extended exclusive license, MPI has received a total of 302 243 warrants, entitling the signing of stock shares in Oncology Venture Sweden AB. The warrants entitle signing of one share per warrant at a subscription price of 10 SEK per share. The warrants can be exercised until December 31, 2019. At full exercise of the warrants, the total dilution will be approximately 2.8 % (based on the 10 877 007 shares currently outstanding in Oncology Venture, but excluding those shares that would be added when/if current outstanding warrants in Oncology Venture Sweden AB are exercised). Per the date of this document, MPI has exercised 100 000 of above mentioned warrants. Through exercising the warrants, approximately 1 000 000 SEK was added to the Company. After this exercise, MPI holds 202 243 warrants.
Risks and Uncertainties Related to Company Operations
In short, the risks and uncertainties applicable to Oncology Venture’s company operations relate to drug development, competition, technology development, patents, authority requirements, capital needs, currencies and interest rates. During the current period, no major changes in risks or uncertainty factors have occurred. For a more detailed presentation of risks and uncertainties, we kindly refer you to a previous Prospectus published in March 2017.
In accordance with AktieTorget’s regulations, the report has not been reviewed by The Company’s auditor.
Principles for Interim Report
The interim report has been made in accordance with Swedish jurisdiction for annual accounts, and following general advice of the Swedish National Board of Accounting 2012:01, Annual Accounts and Consolidated Accounts (”K3”and in accordance with ”BFNAR 2007:1 Voluntary Interim Reporting”). For further information on accounting principles, we refer to the Annual Accounts of Oncology Venture for 2017.
|Q2 report, 2018||August 31, 2018|
|Q3 report, 2018||November 30 2018|
|Q4 report, 2018||February 28, 2019|
The Board and CEO hereby certify that the interim report gives an accurate overview of The Company’s operations.
Hoersholm, May 31, 2018
Oncology Venture Sweden AB
The Board and CEO
For further information regarding Oncology Venture, kindly contact:
Ulla Hald Buhl, COO, Manager of IR & Communications Peter Buhl Jensen, CEO
Phone: +45 21 70 10 49 Phone: +45 21 60 89 22