On August 30, 2019 Oncology Venture A/S (OV:ST) ("Oncology Venture") reported the Interim Report for the period January – June 2019 (Press release, Oncology Venture, AUG 30, 2019, View Source [SID1234539147]). The report is available as an attached document and on the company’s website (www.oncologyventure.com).
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Comment from CEO Peter Buhl Jensen
"We have a rich pipeline of seven mature drug candidates, and data that show us which projects are closest to the next value inflection points. Our priorities now are to continue planning the pivotal study of LiPlaCis to compile the marketing application for dovitinib and its DRP and to prepare a pivotal study that can be the base for marketing authorization of ixabepilone".
Summary of the Half Year Report
Consolidated group revenue amounted to 0.5 MDKK (1.6 MDKK).
Consolidated group loss before depreciation amounted to -28.1 MDKK (-6.4 MDKK).
Consolidated group loss before net financials amounted to -28.6 MDKK (-6.4 MDKK).
Consolidated net result amounted to -36.9 MDKK (3.6 MDKK).
Consolidated earnings per share (EPS) amounted to -0.65 DKK (0.15 DKK).
2019 numbers reflect the merged entity and 2018 numbers (in brackets) reflect Medical Prognosis Institute A/S only.
Highlights during Q2 2019
On June 24, Oncology Venture announced that the European Patent Office will grant Oncology Venture a patent on LiPlaCis DRP, which covers 205 genes and predicts the response in individual patients based on a pre-treatment biopsy.
On June 13, Oncology Venture acquired an additional 8% ownership in the dovitinib project from Sass & Larsen ApS at a purchase price of DKK 5.4 million. Following the transaction, Oncology Venture’s ownership amounts to 63%. Further, Oncology Venture has negotiated an option to acquire Sass & Larsen’s remaining ownership in dovitinib at a price of DKK 0.7 million per percent of the ownership. The current deal replaces a previous deal which allowed Oncology Venture to obtain 85% ownership. There is currently no time limit to this option.
On June 4, it was announced that an e-abstract has been published in Journal of Clinical Oncology – an ASCO (Free ASCO Whitepaper) Journal –, describing that DRP (Drug Response Prediction) is able to predict which breast cancer patients will be high likelihood responders to neoadjuvant (before surgery) treatment with doxorubicin.
On June 3, Oncology Venture announced that the US FDA had provided its initial response to the IND application and proposed pivotal Phase 3 study of LiPlaCis in the US. The FDA has requested some additional testing of LiPlaCis related to the product characterization. Oncology Venture expects to have these additional tests completed in good time before initiation of the study. The study design will be adapted to accommodate FDA’s recommendation for the pivotal study.
On May 16, Oncology Venture confirmed that its rights issue had been successfully executed, raising a gross amount of approximately DKK 56 million. None of the commitments from guarantors were utilized. The capital increase is a result of DKK 48.7 million paid in cash and DKK 7.7 as a debt conversion. In the event that the investor warrants allocated to the new shares issued are exercised in full during the 12-month exercise period, the company expects to receive additional net proceeds from the offering of approximately DKK 105 million.
On May 5, it was announced that members of Oncology Venture’s management team had decided to participate in the rights issue.
On April 30, Oncology Venture provided news on DRP based analyses of biopsies from clinical trials with dovitinib. In addition to renal, endometrial and GIST tumors, Oncology Venture has now also shown in two new indications – liver cancer and breast cancer – that DRP can predict the responding patients. Moreover, it was announced that the first patient has been dosed with 2X-121 (PARPi) at the Dana Farber Cancer Institute, Boston, US for the treatment of advanced ovarian cancer. Also, Oncology Venture disclosed that it had submitted an Investigational New Drug Application for LiPlaCis and its DRP to the FDA, with the intention to start a pivotal study in metastatic breast cancer.
On April 10, a supplement to the rights issue prospectus from April 5, 2019 was published. The reason for the supplement was that the company had obtained additional subscription undertakings from investors, raising the total undertaking to (DKK 56 million), and that the exercise periods for the Investor Warrants had been extended. Finally, a correction had been made in the terms for the Investor Warrants with regards to the exercise price.
On April 5, the Board of Directors of Oncology Venture decided to conduct a rights issue of shares supported by an authorization granted at the Annual General Meeting on April 4, 2019. The rights issue comprised of up to 25,155,639 offer units, each consisting of one new share at a subscription price of SEK 4/DKK 2.87 and one warrant at an exercise price of SEK 7.50.
On April 4, the Company announced that it has obtained an exclusive option to in-license the European rights to IXEMPRA (ixabepilone) from the pharmaceutical company R-Pharm U.S., LLC. In July 2015, R-PHARM U.S., LLC acquired global rights to IXEMPRA from Bristol-Myers Squibb (BMS). The drug is approved in the USA for the treatment of breast cancer. Oncology Venture will evaluate ixabepilone together with its drug specific DRP companion diagnostic in order to accomplish a market approval in Europe.
On April 3, it was announced that Oncology Venture intends to submit a new drug application to the FDA for marketing approval of dovitinib based on existing Novartis data in renal cancer. Also, the development of a new combination biomarker – PD1 – PD-L1/Dovitinib DRP has been completed. This gives a strong competitive edge in the immuno-oncology field. Oncology Venture has appointed US based Destum Partners to support its out-licensing activities.
Highlights after the period
On August 15 Oncology Venture informed that the US Food & Drug administration (FDA) had approved an IDE (Investigational Device Exemption) application for use of the company’s drug response predictor LiPlaCis DRP in a planned pivotal Phase 3 study. And in parallel, the FDA is evaluating Oncology Venture’s IND (Investigational New Drug) application for the drug substance LiPlaCis, which is primarily being developed as a potential new treatment of metastatic breast cancer in heavily pre-treated patients.
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