Decision on rights issue subject to approval at Extraordinary General Meeting
On September 22, 2016, the Board of Oncology Venture Sweden AB ("Oncology Venture") decided to – subject to approval at Extraordinary General Meeting – conduct a rights issue of up to 774 984 shares at an issue price of 29.00 SEK per share. Fully subscribed rights issue provides Oncology Venture approximately 22,5 million SEK before issuing costs. Beforehand, the company has agreed on subscription commitments amounting to approximately 12,1 million SEK, which equals about 54 % of the rights issue’s total volume. Notice of Extraordinary General Meeting will be published shortly. In view of the planned rights issue, the publication of Oncology Ventures interim report three is brought forward. New date for publication is the 19 October, 2016.
Goals and prioritized activities
At the time of going public in July 2015, it was stated the over-all goal amongst others was to in-license 5 drugs and with these drugs perform 5 focused Phase 2 studies in a three-year period. In addition, the goal is within a three-year period to generate at least two drug candidates for out-licensing (or sale).
The Company’s activities on the earlier in-licensed drug candidates APO010, Irofulven and LiPlaCis® is running according to plans. The Company has capital from the emission from the time of the listing in 2015 to run focused clinical phase 2 trials for APO010 and Irofulven. The LiPlaCis-program has moved from the dose escalation part to an extension phase of the proof-of-concept-study. Through the capital raise at the time of the rights issue during spring 2016 it is possible to keep a high pace of development of LiPlaCis®.
Planned rights issue
Oncology Venture is focused on development of anticancer drugs in combination with its Drug Response Predictor – DRP – and has now the possibility to increase the pace of the company and as a consequence of this seeks capital. To raise capital, the Company plans to do a rights issue of approximately 22,5 million SEK with a relatively low rebate. The raised capital will primarily be used to finance the in-licensing and the development of a fourth anticancer drug candidate an oral tyrosine kinase inhibitor, manufacturing of LiPlaCis for the clinical studies in accordance with the Cadila Pharmaceuticals Ltd. (”Cadila”) agreement and to secure the rights for three highly interesting products for development in women’s cancers for 2X Oncology Inc. – an US spinout (Special Purpose Vehicle) from Oncology Venture.
Development deal with Cadila Pharmaceuticals Ltd.
In accordance with the agreement Cadila Pharmaceuticals will finance and conduct studies with a total of 310 cancer patients including those who have the highest likelihood of success with the LiPlaCis® treatment. The drug development is planned as follows:
- Screening by the use of the LiPlaCis-DRP™ of 1 250 metastatic breast cancer patients to identify 250 patients with high likelihood to respond to LiPlaCis treatment and perform a randomized phase 3 trial in these 250 patients comparing standard therapy with LiPlaCis®.
- Through Cadilas strong network and Cadials CRO run four (4) clinical Phase 2 trials in 20 patients (out of 100 screened) with Head & Neck cancer, 20 prostate cancer patients (out of 100 screened), and 10 skin cancer patients and 10 esophagus cancer patients – the two latter indications are in a high frequency sensitive to cisplatin – of which LiPlaCis ® is an improved formulation – why the patients will not be screened.
Cadila has commercialization rights in India, Russia, Africa and South East Asia (ASEAN countries only), Oncology Venture has the commercialization rights to America, Europe and China and RoW. Oncology Venture will be responsible for the manufacturing and pay for manufacturing of the product. Estimated costs for product in 2017-2018 is 0,6 MUSD. In the consortium of owners now including Cadila Pharmaceuticals, LiPlasome, MPI and Oncology Venture - Oncology Venture owns 29% of the total value of the LiPlaCis project after Phase 3. When developed parties may choose to market themselves in their own territories or out license or sell to a third party.
An oral Tyrosine Kinase Inhibitor-project
A fourth OV product – an oral Tyrosine Kinase Inhibitor (TKI)– has been identified and terms are under negotiation with a non-disclosed Big Pharma company who owns all rights to the drug. The product has been tested in Phase 2 and Phase 3 studies and biopsies are available. Oncology Venture has the possibility to run a quick proof-of-concept DRP test on the biopsies to see if Oncology Venture can identify responders from the clinical trials why this – according to the board – is a de-risked and unique investment case. The test can be run in two months.
Oncology Venture has the opportunity to acquire rights to DRP-test the biopsies for 500,000 USD and the Company has an investor who intends to invest in the rights from the drug owner, a Big Pharma Company. If this proof of concept testing falls out positively it is likely that the drug will be spun out in a Special Purpose Vehicle (SPV), in which Oncology Ventures investors and institutional investors will be offered to invest.
Special Purpose Vehicle (SPV) – gives the opportunity to increase the product pipeline
The Company has incorporated an oncology product spin-out, 2X Oncology Inc. for Womens Cancers i USA. The company focusses on precision medicine for cancer indications specific for women with the aim to develop promising cancer drugs in clinical phase by the use of the DRP-tool. The initial therapeutic focus will be directed towards unmet medical needs in breast and ovarian cancer. Oncology Venture has identified three products for which the company planes to secure rights for 2X Oncology Inc. The plan is to test the products in proof-of-concept-studies in Scandinavia with the help of the Drug Response Prediction tool and thereafter move the most promising candidate to a randomized possibly pivotal Phase 2-study in the US.
Summary of the Offer
- Subscription Period: October 27, 2016 – November 10, 2016.
- Record Date and Preferential: Last day of trading in Oncology Ventures stock shares including the right to receive subscription rights is 19 October, 2016 and the first day of trading excluding the right to receive subscription rights is 20 October 2016. The record date is October 21, 2016.
Each currently held stock share qualifies for one (1) subscription right. Possession of twelve (12) subscription rights entitle to subscription of one (1) new share.
- Issue price: 29,00 SEK per stock share.
- Volume of Issuance: Oncology Venture is hereby conducting a rights issue of 22 474 536.00 SEK, comprising a maximum of 774 984 shares. The rights issue is also open to the public.
- Subscription commitments: Oncology Venture has received subscription commitments of approximately 12,1 million SEK, which equals around 54 % of total volume of issuance.
- Number of shares before the rights issue: 9 299 810 shares.
- Valuation (pre-money): Approximately 269,7 million SEK.
- Trading in subscription rights: Trading in subscription rights will be done at AktieTorget during the time period October 27, 2016 - November 8, 2016.
- Trading in BTA: Trading in BTAs (paid subscription share) will take place on AktieTorget from 27 October 2016 until Bolagsverket (the Swedish Company Authority) has registered the new rights issue. This registration is expected to take place in early December 2016.
Full terms and conditions, information on subscription commitment as well as the memorandum and the folder will be published on the companys (www.oncologyventure.com) Sedermera Fondkommissions (www.sedermera.se) and AktieTorgets (www.aktietorget.se) respective websites no later than when the subscription period of the offering begins.
New date for publishing of interim report three, 2016
In view of the planned rights issue, Oncology Venture has decided to bring forward the publication of the interim report three, 2016. The previously announced date was 17 November 2016. New date for publication is the 19 October, 2016.
Sedermera Fondkommission is the financial advisor to Oncology Venture in connection with the planned rights issue.
For further information, please contact
|Ulla Hald Buhl , COO and Chief IR & CommunicationsMobile: +45 2170 firstname.lastname@example.org||Or||Peter Buhl Jensen , CEOMobile: +45 21 60 89 email@example.com|
This information is information that Oncology Venture Sweden AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on September 22nd 2016.
About Oncology Venture Sweden AB
Oncology Venture Sweden AB is engaged in the research and development of anti-cancer drugs via its wholly owned Danish subsidiary Oncology Venture ApS. Oncology Venture has a license to use Drug Response Prediction – DRP™ – in order to significantly increase the probability of success in clinical trials. DRP™ has proven its ability to provide a statistically significant prediction of clinical outcomes from drug treatment in cancer patients in 29 of the 37 clinical studies that were examined. The Company uses a model that alters the odds in comparison with traditional pharmaceutical development. Instead of treating all patients with a particular type of cancer, patients’ tumors genes are screened first and only those who are most likely to respond to the treatment will be treated. Via a more well-defined patient group, the risk and costs are reduced while the development process becomes more efficient.
The current product portfolio: LiPlaCis for Breast Cancer, Irofulven developed from a fungus for prostate cancer and APO010 – an immuno-oncology product for Multiple Myeloma.