SIGNIFICANT EVENTS DURING THE FIRST QUARTER

  • In January, Oasmia appointed Dr. Heidi B. Ramstad as Chief Medical Officer.
  • In March Fredrik Järrsten took up the position as Chief Financial Officer. Robert Maiorana, who has been acting CFO since December 2020, will continue as Head of Accounting for the company.
  • In March, Oasmia signed an agreement with Kazia Therapeutics, an Australian oncology-focused biotechnology company, to acquire exclusive global development and commercialization rights for Cantrixil, a product candidate in development intended for the treatment of ovarian cancer.
  • In March Oasmia entered into a collaboration agreement with Karolinska Institutet in Stockholm. The collaboration will generate new information for the potential development of new therapeutic APIs in various cancer indications.
  • In March, an arbitral tribunal in Stockholm upheld Oasmia’s right to record assignment of its patents and patent applications in its own name, which enables a faster re-registration process.

SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD

  • 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 April, Andrea Buscaglia was proposed as a new Board member by the Nomination Committee.

FIRST QUARTER: JANUARY 1, 2021 – MARCH 31, 2020

  • Consolidated net sales amounted to TSEK 37 (201,220)
  • Operating profit/loss was TSEK –40,843 (128,607)
  • Net profit/loss after tax amounted to TSEK –41,209 (124,706)
  • Earnings per share was SEK –0.09 (0.36)

CEO REVIEW – WELL POSITIONED FOR FUTURE GROWTH

Oasmia achieved several key goals in the first quarter, making further important progress in implementing the strategic transformation initiated when I joined last year.

A critical goal for Oasmia is to significantly expand our pipeline of development-stage oncology assets through M&A and in-licensing opportunities that we believe will fit with our strategic goals. This ambitious ’string of pearls strategy’ will capitalize on our proven oncology development and regulatory skills and expertise. We have a solid cash position to execute on the current strategy as laid out, with the possibility to reevaluate the financing need when these opportunities occur and with the progress of our development projects.

The acquisition of global development and commercialization rights for Cantrixil from Kazia Therapeutics in March was an exciting development for Oasmia and represented the first stage in this pipeline expansion – the first “pearl” added to our portfolio. The acquisition brings to us a promising clinical program in late-stage ovarian cancer, an area we know exceedingly well. In April, we presented final Phase I results for Cantrixil at the prestigious American Association of Cancer Research (AACR) 2021 Annual Meeting. These highly promising results underscore our optimism about this program. Cantrixil is believed to target a wide spectrum of cancer cells, including chemotherapy-resistant tumor-initiating cells that are thought to be responsible for disease relapse. In addition to its promise as stand-alone therapy, Cantrixil has the potential to complement Oasmia’s lead product for ovarian cancer, Apealea®, through treatment protocols to be developed.

Since acquiring the rights to Cantrixil, we have been working to establish an advisory board of experts to provide input on the clinical development plan and have initiated discussions with regulators at the EMA and FDA. We have also made progress towards securing drug supply for forthcoming clinical trials.

Apealea® (paclitaxel micellar), a non-Cremophor based formulation of paclitaxel, is Oasmia’s most advanced development program, approved in Europe and in development elsewhere for advanced ovarian cancer. Since it was out licensed to Elevar Therapeutics last year, we’ve been working closely with Elevar and its partners to support development and commercialization activities. Post period , in April, Elevar received notification from the FDA authorizing a pharmaco-kinetic study in the US. In parallel, preparations are being made for an additional clinical study.  Both studies are intended to support an NDA application in the US.

We’re also pleased to report that Docetaxel micellar, a solvent-free formulation of docetaxel to avoid the need for solubility enhancers and mandatory high-dose steroid premedication, has been granted ethical committee approval in Switzerland, paving the way for the Swiss Group for Clinical Cancer Research (SAKK) to initiate a Phase Ib trial in advanced prostate cancer.

Our technology platforms remain an important part of our business and complement our development and regulatory expertise. During the period we signed a collaboration agreement with the world renowned Karolinska Institutet here in Stockholm. The goal is to generate additional data to help us gain a deeper understanding of the potential of our proprietary XR-17 platform technology, with a focus on niche cancer indications. Over the longer term this will help us generate new pipeline candidates.

A vital part of our transformation is building a leadership team with the experience to drive our future growth. I’m pleased to say that with Fredrik Järrsten joining as CFO, and Heidi B. Ramstad and Reinhard Koenig’s appointments as CMO and CSO, we have completed our leadership team. This greatly strengthens our ability to execute our strategy and thrive as a business in the future.

Business transformations take time to achieve, but in 12 months we have put in place the right leadership team supported by a stronger Board with new expertise to take us to the next level of success. We have clearly defined and started executing on our strategy to become a leading cancer biopharma company with an emerging oncology pipeline. Thank you for your continued support during this period as we transition to an exciting future.

Dr. Francois Martelet, M.D., CEO of Oasmia

The report is available on the company’s website: https://www.oasmia.com/en/financial-reports-and-presentations/

For more information:

Oasmia Pharmaceutical AB
Francois Martelet, Chief Executive Officer
Phone: +46 18-50 54 40
E-mail: IR@oasmia.com

Fredrik Järrsten, Chief Financial Officer
Phone: +46 18-50 54 40
E-mail: IR@oasmia.com

Consilium Strategic Communications

Jonathan Birt, Chris Welsh, Ashley Tapp
Phone: +44 (0)20 3709 5700
E-mail: oasmia@consilium-comms.com

About Oasmia Pharmaceutical AB

Oasmia is a specialty pharma company dedicated to improving the lives of patients by enhancing the intravenous delivery of established and novel drugs in significant diseases, including cancer. Product development is based on the Company’s proprietary drug delivery technology platform XR-17™ which can be applied to medicines used in many therapeutic areas, to develop water soluble formulations of drugs that currently require chemical solubilizers for dissolution. The first product approved using this technology is Apealea® (paclitaxel micellar).  Apealea has received market authorization in the European Union and several other territories for the treatment of first relapse in platinum-sensitive ovarian cancer, in combination with carboplatin. The Company is making Apealea accessible to patients through its partnership with Elevar Therapeutics, together with its existing commercial operations in the Nordic region. Oasmia’s shares are traded on the Nasdaq Stockholm stock exchange (ticker: OASM). To find out more about Oasmia please visit www.oasmia.com.