SIGNIFICANT EVENTS DURING THE SECOND QUARTER
- In April, Oasmia appointed Dr Reinhard Koenig as Chief Scientific Officer.
- In April, Oasmia presented Cantrixil final Phase I data at the 2021 AACR Annual Meeting.
- In April, a Phase 1b trial of Oasmia’s Docetaxel Micellar in advanced prostate cancer was granted ethical committee approval by Swissmedic.
- In May, Andrea Buscaglia was appointed as a new Board member by the Annual General Meeting.
- In June, following the ethical approval in April, the first Patient was enrolled in the Swiss Group for Clinical Cancer Research (SAKK) Investigator-Initiated Phase 1b trial of Docetaxel Micellar in advanced prostate cancer.
- In June, in addition to commercialization rights previously transferred for the rest of Europe, Oasmia also transferred the Nordic commercialization rights for Apealea® to Inceptua Group.
- In June, Cantrixil positive Phase I trial data were published in the open access oncology journal Cancers.
SECOND QUARTER: APRIL 1, 2021 – JUNE 30, 2021
- Consolidated net sales amounted to TSEK 4,596 (254)
- Operating profit/loss was TSEK -56,165 (-78,296)
- Net profit/loss after tax amounted to TSEK -57,677 (-80,090)
- Earnings per share was SEK –0.12 (-0.18)
THE PERIOD: JANUARY 1, 2021 – JUNE 30, 2021
- Consolidated net sales amounted to TSEK 4,633 (201,474)
- Operating profit/loss was TSEK –97,007 (50,311)
- Net profit/loss after tax amounted to TSEK –98,889 (44,615)
- Earnings per share was SEK –0.22 (0.10)
Oasmia continued to make progress during the second quarter. In particular, we made strides in progressing our development candidates, announcing a number of important milestones in key programs. All our development candidates target hard-to-treat or late-stage cancers where patients usually have limited treatment options and very poor prognoses.
Final data from a Phase I trial of Cantrixil, the ovarian cancer program we in-licensed from Kazia Therapeutics earlier in the year, was presented in an oral presentation at the prestigious American Association of Cancer Research (AACR) Annual Meeting in April. We also announced publication of this data in the peer-reviewed journal Cancers and it generated substantial interest among oncologists. What is highly interesting from a scientific perspective is the fact that Cantrixil may induce death in ovarian cancer stem cells and sensitize cancer cells to standard chemotherapy, prolonging survival in advanced ovarian cancer patients. There is a lot of work going on to prepare for the initiation of the Phase II trial in the second half of next year. Activities include establishing a clinical advisory board and initiating interactions with the FDA/EMA and of course securing drug supply and validating our Phase 2 trial design.
Also in Q2, the first patient was dosed in an open label, multicenter, single stage Phase 1b clinical trial of Docetaxel micellar in advanced prostate cancer. Docetaxel micellar is a solvent-free formulation of docetaxel, developed to avoid the need for the solubility enhancers in solvent-based docetaxel and mandatory high-dose steroid premedication, while still providing an effective treatment option. The trial is being conducted at major hospitals in Switzerland by the non-profit organization Swiss Group for Clinical Cancer Research (SAKK) which has been conducting clinical trials in oncology since 1965. Prostate cancer is a significant and increasingly prevalent health problem worldwide and is the leading cause of male cancer deaths so there remains a critical need for new therapeutics.
We made great progress in the second quarter on simplifying and focusing our activities. We entered into an agreement to transfer the rights for the commercialization of Apealea® (paclitaxel micellar) in the Nordics and Baltics to Inceptua Group. Inceptua already has exclusive rights for the commercialization of Apealea® in the rest of Europe, following an agreement signed with Oasmia’s global strategic partner, Elevar Therapeutics, Inc. in 2020. Apealea® is our most advanced product and is approved by the European regulatory authorities for use in combination with carboplatin for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. Inceptua is in the process of transferring all licenses and marketing approvals for Apealea in major European markets including Germany and the UK which will delay the full commercialization process across Europe and receipt of royalties. Elevar and Oasmia are confident Inceptua has the network, expertise and commitment to maximize the commercial value of Apealea in Europe. In the US, Elevar is reporting progress in the preparation of the PK study and the Phase 3 clinical trial for Apealea®.
Our main objective is to build our oncology pipeline through mergers, acquisitions, or in-licensing. I’m pleased to report we’re evaluating a number of opportunities and we look forward to updating you on any progress.
In addition to building a strong clinical product pipeline in cancer, we are committed to enhancing our proprietary drug delivery technology platform, XR-17™, which has already been applied in the creation of Apealea® and Docetaxel micellar and has potential in many therapeutic areas. We provided an update on R&D progress during the quarter. XR-18 is in an evaluation process as an enhancement to the XR-17 platform, while XR-19 may feature additional functionalities, specifically encapsulation of multiple APIs to enable combination therapy.
I am a firm believer that a quality team is critical to success. I’m pleased to report that we continued to build the capabilities of the Board and Management in Q2. Dr. Reinhard Koenig has accepted a position as Chief Scientific Officer as of April, bringing expertise in successful product development and commercialization in a number of fields, including oncology. Andrea Buscaglia was elected as new member of the Board of Directors at the Annual General Meeting on 27 May 2021. He brings over 30 years of financial experience in the biopharmaceutical, MedTech, investment banking and accounting sectors.
Working responsibly and ethically is central to the way we do business here at Oasmia and will become more important as we grow. Based on external expertise, we conducted an in-depth internal materiality assessment during Q2 on ESG (environment, social and governance) considerations relevant to us and over the course of the next few months we will decide which kind of key performance indicators and targets in this area we will continue working on and report progress implementing these by year end. Another key aspect of our ethical activities is the fact that we have appointed an external Data Protection Officer (DPO) to fully comply with GDPR regulations.
To increase our visibility and expand our sphere of influence with key stakeholders ever further, and also gain expertise, Oasmia has recently joined the European Federation of Pharmaceutical Industries and Associations (EFPIA). EFPIA is dedicated to working with members to ensure faster and more equitable access to medicines across Europe and create the policy environment in which the European industry can be a world leader in medical innovation.
After a lot of necessary changes since I joined last March I am confident that Oasmia is now well positioned with the vision of becoming one of the leading cancer biopharma company with an innovative oncology pipeline focused on late-stage, hard-to-treat cancers.
I’d like to close by thanking all of my colleagues and board members for their continued dedication and great work and to you, our shareholders, for your support.
Dr. Francois Martelet, M.D., CEO of Oasmia
The report is available on the company’s website: https://www.vivesto.com/en/financial-reports-and-presentations/
For more information:
Oasmia Pharmaceutical AB
Francois Martelet, Chief Executive Officer
Phone: +46 18-50 54 40
Fredrik Järrsten, Chief Financial Officer
Phone: +46 18-50 54 40
Consilium Strategic Communications
Jonathan Birt, Chris Welsh, Ashley Tapp
Phone: +44 (0)20 3709 5700
About Oasmia Pharmaceutical AB
Oasmia is a specialty pharmaceutical company focused on the development of new therapeutic options for patients suffering from hard-to-treat cancers. It has a growing pipeline of clinical-stage assets targeting late-stage cancers. Oasmia’s most advanced program is Apealea® (paclitaxel micellar), which is being made available to ovarian cancer patients through a partnership with Elevar Therapeutics, Inc. Other development programs include Cantrixil, in clinical development for late-stage ovarian cancer, and docetaxel micellar, in development for advanced prostate cancer. Oasmia’s proprietary drug delivery platform XR-17™ is designed to improve drug solubility, efficacy and safety. Oasmia’s shares are traded on Nasdaq Stockholm (OASM). To find out more about Oasmia please visit www.vivesto.com.