On June 18, 2020 Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, reported initiation of the first clinical trial site for PTX-35 (Press release, Heat Biologics, JUN 18, 2020, View Source [SID1234561210]). Anthony Tolcher, M.D., FRCPC, a medical oncologist and co-founder of NEXT Oncology, has been appointed the lead investigator for the Phase 1 clinical trial.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

PTX-35 is a novel, potential first-in-class antibody T-cell co-stimulator targeting TNFRSF25 (death receptor 3), a receptor that is preferentially expressed by antigen-experienced T cells. TNFRSF25 agonism leads to activation of antigen-experienced memory CD8+ T cells, which are instrumental for tumor destruction. Preclinical studies have demonstrated that PTX-35, in combination with antigen-driven immunotherapies, resulted in enhanced anti-tumor properties, including potent proliferation of antigen-specific T cells, production of effector cytokines and augmented effector immune function. A favorable safety profile was demonstrated in preclinical studies, with no deleterious cytokine release in mice, non-human primates or in vitro human immune cells.

Rahul Jasuja, PhD, CEO of Pelican Therapeutics, commented, "We are pleased to welcome Dr. Anthony Tolcher as the lead investigator for our PTX-35 Phase 1 trial. He is a distinguished medical oncologist with over 25 years of early drug development and clinical trial expertise and a principal investigator for 20 Phase 1 clinical studies of new agents that subsequently were FDA approved for the treatment of cancer, including Merck’s pembrolizumab (Keytruda). Dr. Tolcher has over 100 peer-reviewed publications in top scientific journals, and a proven track record of advancing multiple innovative oncology products through Phase 1. We believe NEXT Oncology under the leadership of Dr. Tolcher is an ideal site for our study and look forward to enrolling our first patient shortly."

Dr. Tolcher said, "PTX-35 is a promising product candidate that exquisitely targets TNFRSF25. This is a first-in-class antibody that targets an important pathway to activate antigen-experienced memory CD8+ T cells. I believe PTX-35 may provide additional treatment options for patients when current therapy does not work in controlling their cancers. Immunotherapy is the most exciting and a rapidly growing area of oncology and we are just beginning to see the potential for expanding new avenues and targets in harnessing the immune system for the treatment of cancer."

A $15.2 million grant has been awarded by Cancer Prevention and Research Institute of Texas (CPRIT) to support the pre-clinical development, manufacturing and Phase 1 clinical development for PTX-35.

About NEXT Oncology

NEXT Oncology is dedicated to the advancement of Phase 1 cancer research through clinical trials of anticancer agents with the goal of providing innovative developments in cancer treatment. Dr. Anthony Tolcher is a medical oncologist and co-founder of NEXT Oncology. He is dedicated to the advancement of new anticancer agents for patients whose current cancer therapy is no longer working to benefit them. Many of the initial Phase 1 studies of new agents that Dr. Tolcher was involved in were subsequently approved by FDA, including pembrolizumab (Keytruda), copanlisib (Aliqopa), trastuzumab emtansine (Kadcyla), regorafenib (Stivarga), liposomal vincristine (Marqibo), cabazitaxel (Jevtana), carfilzomib (Kyprolis), gefitinib (Iressa), erlotinib (Tarceva) and eribulin (Halaven). He is a reviewer for the Journal of Clinical Oncology, Clinical Cancer Research and Annals of Oncology, and chaired the Developmental Therapeutics Review Committee for the American Society for Clinical Oncology Annual Scientific Program. Dr. Tolcher has over 100 peer-reviewed publications in scientific journals.

On June 18, 2020 GlaxoSmithKline plc ("GSK"), acting through its subsidiary GSK Finance (No.3) plc ("the issuer") reported that the issuer has priced $280,336,000 of its senior notes due 2023 ("the notes") exchangeable into ordinary shares of Theravance Biopharma, Inc. ("Theravance Biopharma") currently held by GSK and its affiliates (Press release, GlaxoSmithKline, JUN 18, 2020, View Source [SID1234561209]). The notes will be guaranteed by GSK and will be exchangeable at the option of noteholders on any business day on or after 1 September 2020.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The notes will mature on 22 June 2023, will not bear interest and will be offered at an issue price 108.5% of their principal amount. The initial exchange rate is 34.4044 shares of Theravance Biopharma ordinary shares per $1,000 principal amount of notes, which is equivalent to an initial exchange price of approximately $29.0660 per share representing a premium of 35% over the volume weighted average price of Theravance Biopharma’s ordinary shares from 9:30 a.m. to 4:00 p.m., New York City time on 17 June 2020. In the aggregate, the notes will be exchangeable into substantially all of the 9,644,807 ordinary shares of Theravance Biopharma currently held by GSK and its affiliates. Upon exchange of the notes, the issuer expects to deliver ordinary shares of Theravance Biopharma but may at its option under certain circumstances, deliver cash or a combination of Theravance Biopharma shares and cash.

The offering is expected to close on 22 June 2020, subject to the satisfaction of customary closing conditions. Theravance Biopharma has agreed to file a shelf registration statement with the U.S. Securities and Exchange Commission (the "SEC") following the completion of the offering to register resales of its ordinary shares deliverable upon exchange of the notes.

GSK expects to use the net proceeds of the offering for general corporate purposes. Theravance Biopharma will not receive any proceeds from the offering.

The offering of the notes has not been registered under the U.S. Securities Act of 1933, as amended (the "Securities Act"), or any state securities laws and, unless so registered, may not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws. The notes will be offered by means of an offering memorandum solely to persons reasonably believed to be "qualified institutional buyers" (as that term is defined in Rule 144A under the Securities Act) that are also "qualified purchasers" (within the meaning of Section 2(a)(51) of the U.S. Investment Company Act of 1940, as amended). This press release does not constitute an offer to sell or the solicitation of an offer to buy the notes nor shall there be any sale of notes in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state.

This communication is only being distributed to and is only directed at (i) persons who are outside the United Kingdom (the "UK") or (ii) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order") or (iii) high net worth companies, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as "relevant persons"). The notes are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such notes will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on this document or any of its contents.

PROHIBITION OF SALES TO EEA AND UK RETAIL INVESTORS

The notes are not intended to be offered, sold or otherwise made available to and should not be offered, sold or otherwise made available to any retail investor in the European Economic Area ("EEA") or in the UK. For these purposes, a retail investor means a person who is one (or more) of: (i) a retail client as defined in point (11) of Article 4(1) of Directive 2014/65/EU (as amended, "MiFID II"); or (ii) a customer within the meaning of Directive (EU) 2016/97 (as amended, the "Insurance Distribution Directive"), where that customer would not qualify as a professional client as defined in point (10) of Article 4(1) of MiFID II. Consequently, no key information document required by Regulation (EU) No 1286/2014 (as amended, the "PRIIPs Regulation") for offering or selling the notes or otherwise making them available to retail investors in the EEA or in the UK has been prepared and therefore offering or selling the notes or otherwise making them available to any retail investor in the EEA or in the UK may be unlawful under the PRIIPs Regulation.

On June 18, 2020 Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM: HCM) reported that the U.S. Food and Drug Administration ("FDA") has granted Fast Track Designation for the development of fruquintinib, for the treatment of patients with metastatic colorectal cancer ("mCRC") who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor (VEGF) biological therapy, and, if RAS wild-type, an anti-epidermal growth factor receptor (EGFR) therapy (Press release, Hutchison China MediTech, JUN 18, 2020, https://www.chi-med.com/chi-med-announces-fruquintinib-granted-u-s-fda-fast-track-designation-for-mcrc/ [SID1234561208]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Chi-Med is initiating a Phase III registration study, known as the FRESCO-2 study, in refractory mCRC in the U.S., Europe and Japan (clinicaltrials.gov identifier: NCT04322539). FRESCO-2 is expected to start enrolling patients in mid-2020. The U.S. FDA acknowledged that the totality of the fruquintinib clinical data, including the FRESCO-2 study, if positive; the prior positive Phase III FRESCO study demonstrating improvement in overall survival that led to fruquintinib approval for mCRC in China in 2018; and additional completed and ongoing supporting studies in mCRC; could support a New Drug Application ("NDA") for the treatment of patients with mCRC in the third-line setting. The adequacy of the data to support a specific indication will be assessed during the review of a New Drug Application.

About Fast Track Designation
The FDA Fast Track Designation is one of several approaches utilized by the U.S. FDA to expedite development and review of potential medicines for serious conditions and that fulfill unmet medical needs. A potential new medicine may fill an unmet medical need by being the first therapy to address a specific serious condition, offer clinically significant advantages over available therapies, act via a different mechanism of action than available therapies, or have a benefit in patients who are unresponsive to or intolerant of available therapies. Programs that receive Fast Track Designation are entitled to more frequent interactions with the U.S. FDA on drug development plan, as well as eligibility for accelerated approval, priority review, and rolling review.1

About Colorectal Cancer ("CRC") in the U.S.
CRC is the third most common cancer worldwide, causing more than 880,000 deaths in 2018.2 In the U.S., CRC is the fourth most common cause of new cancer cases, but the second leading cause of cancer deaths.3 It is estimated that in 2020, 147,950 people will be diagnosed with CRC and 53,200 people will die from CRC in the U.S.4

About Fruquintinib
Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptor ("VEGFR") 1/2/3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may also be highly suitable for combinations with other anti-cancer therapies.

Chi-Med retains all rights to fruquintinib outside of China and is partnered with Eli Lilly and Company ("Lilly") in China.

About Fruquintinib in mCRC
Fruquintinib was approved for marketing by the China National Medical Products Administration ("NMPA") in September 2018 and commercially launched by Lilly in late November 2018 under the brand name Elunate. Elunate is for the treatment of patients with mCRC that have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received anti-VEGF therapy and/or anti-EGFR therapy (RAS wild type). Results of the FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients with mCRC in China, were published in The Journal of the American Medical Association, JAMA, in June 2018 (clinicaltrials.gov identifier: NCT02314819).

In December 2017, Chi-Med initiated a multi-center, open-label, Phase Ib clinical study to evaluate the safety, tolerability and pharmacokinetics of fruquintinib in U.S. patients with advanced solid tumors (clinicaltrials.gov identifier: NCT03251378). The study progressed into proof-of-concept trials in 2019, including patients with mCRC and metastatic breast cancer. In February 2020, an End of Phase II (EOP2) meeting was held with the U.S. FDA, and regulatory interactions with the European Medicines Agency (EMA) and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) are also underway.

Other Fruquintinib Development
Gastric Cancer in China: In October 2017, Chi-Med initiated the FRUTIGA study, a randomized, double-blind, Phase III trial evaluating the efficacy and safety of fruquintinib combined with paclitaxel for second-line treatment of advanced gastric or GEJ adenocarcinoma. The trial is designed to enroll patients who did not respond to first-line standard chemotherapy. Subjects will receive either fruquintinib combined with paclitaxel or placebo combined with paclitaxel. Patients will be randomized at a 1:1 ratio and stratified according to factors such as stomach vs. GEJ tumor type and performance status. The primary efficacy endpoint is overall survival. Secondary efficacy endpoints include progression-free survival (as defined by RECIST 1.1), objective response rate, disease control rate, duration of response, and quality-of-life score (EORTC QLQ-C30, version 3.0). Biomarkers related to the antitumor activity of fruquintinib will also be explored. Additional details about this study can be found at clinicaltrials.gov, using identifier NCT03223376. In June 2020, Chi-Med completed a planned interim data review. Based on the preset criteria, the Independent Data Monitoring Committee (IDMC) recommended that the trial continue.

Immunotherapy combinations: Chi-Med has entered into three collaboration agreements to evaluate the safety, tolerability and efficacy of fruquintinib in combination with programmed death-1 (PD-1) monoclonal antibodies, including with tislelizumab (BGB-A317), Tyvyt (sintilimab, IBI308) and geptanolimab (GB226, genolimzumab).

On June 18, 2020 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that the Phase III IMpassion031 study met its primary endpoint, regardless of PD-L1 status, as initial treatment for people with early triple-negative breast cancer (Press release, Chugai, JUN 18, 2020, View Source [SID1234561207]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

IMpassion031 study is evaluating Tecentriq in combination with chemotherapy (Abraxane, albumin-bound paclitaxel; nab-paclitaxel; followed by doxorubicin and cyclophosphamide) in comparison to placebo plus chemotherapy. The study met its primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in pathologic complete response (pCR) for the treatment of people with early triple-negative breast cancer (TNBC), regardless of PD-L1 expression. The IMpassion031 study is the second positive phase III study demonstrating the benefit of Tecentriq in TNBC, and the first Tecentriq study to demonstrate benefit in early TNBC.

Safety for the Tecentriq combination appeared consistent with the known safety profiles of the individual medicines and no new safety signals were identified. Results of the IMpassion031 study will be presented at an upcoming medical meeting and will be discussed with global health authorities including the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).

"Tecentriq is the first approved immune checkpoint inhibitor in the breast cancer field. We are pleased that Tecentriq showed positive results in the treatment of the early TNBC," said Dr. Osamu Okuda, Chugai’s President and COO. "TNBC is an aggressive and rapidly progressing disease with limited treatment options, and there are high unmet medical needs. We will be working together with Roche to provide patients with this new treatment option as early as possible."

About the IMpassion031 study
The IMpassion031 study is a Phase III, multicenter, randomized, double-blind study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (Abraxane, albumin-bound paclitaxel; nab-paclitaxel; followed by doxorubicin and cyclophosphamide) in comparison to placebo plus chemotherapy, in people with previously untreated, early TNBC. The study enrolled 333 people who were randomized in a 1:1 ratio to receive Tecentriq or placebo plus chemotherapy in the neoadjuvant (before surgery) setting. The primary endpoint is pCR using the American Joint Committee on Cancer (AJCC) staging system in the ITT population and in the PD-L1-positive population.

About Triple-Negative Breast Cancer (TNBC)
In Japan, 92,200 women (2019 predicted value) are estimated to be afflicted with breast cancer each year. 15,100 women in Japan (2019 predicted value) die as a result of the disease.1) Triple-negative breast cancer accounts for 15% of all breast cancer cases and, is more common in women under the age of 50, compared with other forms of breast cancer.2-4) Triple-negative breast cancer is defined by the lack of expression of hormone receptors (estrogen and progesterone receptors) and the overexpression of human epidermal growth factor receptor 2 (HER2). In general, triple-negative breast cancer has a high tumor-proliferative capacity and shorter overall survival, compared with other forms of breast cancer.3, 5)

Trademarks used or mentioned in this release are protected by law.

Sources

Project Cancer Statistics, 2019. Cancer Information Service, National Cancer Center, Japan. [Internet; cited June, 2020] Available from: View Source
Yao H et al. Triple-negative breast cancer: is there a treatment on the horizon? Oncotarget. 2017;8(1):1913–1924.
BreastCancer.org. What is Triple-Negative Breast Cancer? [Internet; June, 2020] Available from: View Source
Cancer Treatment Centers of America. Triple negative breast cancer risk factors. [Internet; cited June, 2020]
View Source
Pal SK et al. Triple negative breast cancer: unmet medical needs. Breast Cancer Res Treat. 2011;125(3):627-636.

On June 18, 2020Oasmia Pharmaceutical AB (publ). reported that Year-end report for the financial year May 1, 2019 – April 30, 2020 (Press release, Oasmia, JUN 18, 2020, View Source [SID1234561206]).

Oasmia and Elevar signed a global strategic partnership for the commercialization of Apealea with an upfront payment of USD 20 million, milestone payments with a potential of up to USD 678 million and double digit royalties. Oasmia received the upfront payment of USD 20 million.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Board of Directors appointed Dr. Francois Martelet as the new CEO. He took up his position on March 9 and replaced Dr. Sven Rohmann, who has been acting CEO during a crucial turnaround period. Dr. Rohmann remains as a Board member.
In early February, Oasmia launched its product, Apealea 60 mg, in Sweden, Denmark and Finland. The first batch of the drug was shipped to distributors in these countries.
The outbreak of Covid19 and its effects on society accelerated during the quarter. Due to the situation with the Covid19 virus, the company experiences a negative impact on its business due to the lack of access to health care providers and oncologists.
Oasmia’s Nomination Committee suggested changes to the Board of Directors to focus on members with pharmaceutical industry experience. The Company sent out a notice of an Extraordinary General Meeting on May 14 to decide on these changes.
EVENTS AFTER THE BALANCE SHEET DATE
Oasmia announced outcome of strategic review to deliver long-term, profitable growth as a specialty pharma company.
The company held an Extraordinary General Meeting on May 14, at the offices of the company in Uppsala. The Extraordinary General Meeting resolved, in accordance with the Nomination Committee’s proposal, about the following changes in the Board of Directors up to the next Annual General Meeting. Existing board member Anders Härfstrand became the new Chairman of the Board and Birgit Stattin Norinder became new member of the Board. Jörgen Olsson, former Chairman of the Board, and Gunilla Öhman, former Board member, left the Board.
On June 1, Oasmia announced that it had entered into a comprehensive settlement agreement with the plaintiffs in a Class Action filed against the Company in the United States in 2019.
On June 8, Oasmia announced that it had signed Phase 1b Trial Agreement with SAKK, The Swiss Group for Clinical Cancer Research for Evaluation of Docetaxel Micellar in advanced prostate cancer patients.
FOURTH QUARTER February 1, 2020 – April 30, 2020
Consolidated net sales amounted to TSEK 201,265 (266)
Operating income was TSEK 110,531 (-75,192)
Net income after tax amounted to TSEK 106,480 (-79,538)
Earnings per share was SEK 0.24 (-0.31)2
FINANCIAL YEAR May 1, 2019 – April 30, 2020
Consolidated net sales amounted to TSEK 201,843 (1,980)
Operating loss was TSEK -30,667 (-150,818)
Net loss after tax amounted to TSEK -11,114 (-201,881)
Loss per share was SEK -0.03 (-0.80)2
CEO’S COMMENTS
A new vision for growth

Since joining Oasmia in March 2020, I have been impressed by the quality and potential of our technology and capabilities, and the untapped potential of the development pipeline. During the first few months of 2020, Oasmia has signed a transformative global strategic partnership for our lead product Apealea, started to launch Apealea in the Nordics and set out a clear plan to accelerate growth both organically and through acquisitions, as well as significantly control our costs.

Apealea, our water-soluble, intravenously injectable formulation of paclitaxel, has continued to make progress since its approval in the European Union for the treatment of advanced ovarian cancer. Apealea was developed using our proprietary XR-17 platform technology, which facilitates the solubility of paclitaxel, improving safety, reducing infusion time for patients and almost eliminating the need for corticotherapy ahead or after treatment. Apealea’s approval and launch has demonstrated Oasmia’s ability to develop and deliver new products to market that meet unmet medical needs and enhance drug safety.
In early February, Apealea became commercially available in the Nordic region, a first step towards a pan-European launch. The launch in the Nordic countries has been significantly limited due to the Covid19 pandemic.

In March, we announced a global strategic partnership with Elevar Therapeutics, the US subsidiary of the multinational South Korean company HLB Co., LTD, to commercialize Apealea, in return for an upfront payment of $20 million, potential milestone payments of up to $678 million and double-digit royalties on future sales. This transformative agreement is a significant endorsement of the potential of the XR-17 platform in oncology and gives us a solid foundation for further significant progress.

Oasmia is now ideally placed to move into the next phase of growth. Following an extensive review assessing all aspects of the business initiated shortly after my appointment as CEO, we set out the strategic vision to broaden our focus and establish Oasmia as a leading specialty pharmaceutical company based in Sweden. To fulfil this goal, we have announced plans to maximize Oasmia’s resources, realise the full potential of the XR-17 platform technology and optimise the Company’s path towards long-term, profitable growth. We have identified a number of areas of strategic focus.

Firstly, we will continue to explore additional opportunities to apply Oasmia’s proprietary XR-17 solubility-enhancing technology platform in oncology, as well as in other therapeutic areas. This may include the out-licensing of non-core applications.

Secondly, we will continue to drive the development of our pipeline of XR-17-based products, including docetaxel micellar in prostate cancer and in collaboration with the well-known swiss research group SAKK, and we will assess the feasibility of the combination cancer therapy XR-19. We will leverage the experience of the Company’s GMP manufacturing facilities for R&D purposes.

Finally, we will look to expand Oasmia’s pipeline through acquisitions and/or in-licensing deals, with a focus on specialty pharmaceutical assets that will move the company towards positive cash flow.

In parallel, we are undertaking a comprehensive cost control program designed to maximise resources and enable us to invest in areas which can deliver the greatest return. We aim to achieve annualised cost savings of more than SEK 100 million, a ~50% reduction in the cash burn rate to below SEK 10 million a month. With Elevar assuming a greater role in the manufacturing of Apealea following the commercial agreement, Oasmia will be able to focus more on R&D manufacturing, which will significantly improve our operating efficiency.

At the same time we are working to strengthen the skills and capabilities of the management team and will aim to bring in highly talented and experienced managers from the pharmaceutical/biotechnology world.

The outlook is very promising. Oasmia is in a strong cash position, has a product approved in Europe with global potential and near-term value drivers in the pipeline. With our flexibility and proven expertise in product development and commercialization, we are also well placed for M&A, Business Development and partnering opportunities. We look forward to the initiation of a Phase I study investigating our product candidate docetaxel micellar, a solvent-free formulation of docetaxel (Taxotere) which is extensively used in the treatment of breast cancer, head and neck cancer, stomach cancer, prostate cancer and non-small-cell lung cancer. We hope to see Phase 1 results for docetaxel micellar in advanced prostate cancer within the next 12-18 months.

We continue to focus our efforts on developing compounds and/or products for unmet medical needs of patients suffering from cancer.

I would like to thank our shareholders and employees for their continued support. I am proud to be leading Oasmia at this important time in its development and I am confident we are well positioned to begin the next stage of innovation, growth and value generation to benefit both patients and shareholders.
Dr. Francois Martelet, M.D., CEO of Oasmia