On December 9, 2020 Oasmia reported that Interim report1 for the period May 1, 2020 – October 31, 2020(Press release, Oasmia, DEC 9, 2020, View Source [SID1234572492])

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SIGNIFICANT EVENTS DURING THE SECOND QUARTER
In August Oasmia appointed Peter Selin as Chief Business Officer.
Oasmia’s CFO Michael af Winklerfelt resigned from his role in August and Fredrik Järrsten was appointed as Chief Financial Officer in September.
In September Oasmia’s Nomination Committee revised its proposal for the AGM regarding Board of Directors and Sven Rohmann notified that he is no longer available for re-election.
In September Oasmia brought an action against the company’s former Board of Directors as a direct result of findings from an investigation into the former Board of Directors’ responsibilities by the auditing firm Deloitte.
In October Oasmia’s partner Elevar Therapeutics signed an agreement with Taiba Middle East FZ LLC for commercialization of Apealea in the Middle East and North Africa Region.
In October the disciplinary committee of Nasdaq Stockholm ordered Oasmia to pay a fine due to the former Board of Directors, in connection with the EGM in March 2019, in several respects violating generally accepted behavior in the securities market.
Oasmia announced in October that the company has continued to secure IP rights, including the approval of XMeNa patent in India and soon in Australia as well as approved Apealea trademark registrations in Switzerland, Israel, South Africa, Malaysia and Indonesia.
SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD
In November Robert Maiorana joined Oasmia as acting CFO, with effect from December 1, 2020 until Fredrik Järrsten commenced in the role. Thereafter, Robert will work as Finance Manager and support Fredrik.
On 3rd December Oasmia shared an update from its partner Elevar Therapeutics on the development plan for Apealea (paclitaxel micellar) in ovarian cancer.
SECOND QUARTER[2]: AUGUST 1, 2020 – OCTOBER 31, 2020
Consolidated net sales amounted to TSEK 154 (252)
Operating profit/loss was TSEK -53,693 (-47,436)[3]
Net profit/loss after tax amounted to TSEK –53,538 (-18,309)[3]
Earnings per share was SEK -0.12 (-0.06)[3],[4]
THE PERIOD2: MAY 1, 2020 – OCTOBER 31, 2020
Consolidated net sales amounted to TSEK 362 (433)
Operating profit/loss was TSEK -102,914 (-83 201)[3]
Net profit/loss after tax amounted to TSEK –106,643 (-58,093)[3]
Earnings per share was SEK -0.24 (-0.18)[3,4]
CEO’S COMMENTS
The last quarter at Oasmia has seen us focusing on building on the solid foundations we have laid so far this year following the implementation of recommendations highlighted by the strategic review initiated following my appointment as CEO in March. Since then, we have focused our activities on R&D and lab testing in line with our new strategy and reduced our rate of cash burn as the consequence of the rightsizing of our Company. Throughout the period we have continued to make progress on delivering our vision of creating a sustainable specialty pharma company.

In early December Elevar Therapeutics, our global strategic partner shared an update on the development plan for Apealea (paclitaxel micellar) in ovarian cancer. Following interactions with the FDA Elevar has decided to complete two new studies with Apealea which will be initiated in the first half of 2021 before filing the new drug application (NDA). These studies of Apealea may potentially help to secure a successful registration in the U.S. and provide new data to support a strong product label.

Over the period we have also been working with Elevar to support their partnering efforts for Apealea in key global territories. In October, Elevar announced an agreement with Taiba Middle East FZ LLC for the commercialization of Apealea in the Middle East and North Africa region. This is the first regional partnership deal for Apealea and Elevar is in late stage discussions with a number of potential partners for other regions around the world. Most recently, Elevar and Tanner Pharma Group announced the launch of a global Named Patient program to provide access to Apealea in areas outside of the United States and Middle East North Africa (MENA) where Apealea is not yet commercially available.

As previously communicated Oasmia retains marketing rights for Apealea in the Nordic countries and has made the product commercially available earlier this year. The COVID-19 pandemic continues to significantly impact the ability of our medical scientific liaisons to meet oncologists in the Nordics. However, we are pleased to report that as of November we have started to record initial sales in Finland. In Sweden a positive interest for Apealea has been shown in a few centres in a highly competitive oncology ward environment that is mostly closed to any face-to-face interactions with the Industry. In Denmark, against a negative outcome from the health technology assessment submission we are working on alternatives to generate clinical data.

A central pillar of our new strategy is to explore licensing and partnering opportunities for our existing assets. To drive this process forward in a timely manner I have appointed consultancy firms that will aid us in finding and selecting partners for our Animal Health division as well as the wider XR-17 platform.

To maximise the value of our platform we have hired a strategic firm to assist Oasmia and facilitate analysis, selection and engagement with potential partners related to licensing/M&A. A four-step project has therefore been initiated with developing a positioning analysis of the XR-17 platform against competing alternatives based on identification and validation of perceived industry needs among potential licensees.

I have also appointed an international investment bank focusing on healthcare with animal health experts to provide us strategic advisory services related to our Animal Health portfolio.

Our pipeline of development programmes continues to progress well. Docetaxel micellar is poised to enter on time in clinical development for advanced prostate cancer with the renowned Swiss Group for Clinical Cancer Research (SAKK). We are also working on adding a novel product candidate in pre-clinical development, using our XR-17 technology. I hope to be able to disclose further details soon provided a positive outcome.

Protecting intellectual property is critical at any innovative company in our sector, and during the period we worked to bolster our already strong position in this area. In October we announced that our XMeNa patent was approved in India and will soon to be approved in Australia. The XMeNa patent protects an improved method for producing our technology platform XR-17, which is a unique carrier system for anticancer drugs. We have also secured new trademark registrations for Apealea in Switzerland, Israel, South Africa, Malaysia and Indonesia during the year.

A key objective for Oasmia is to ensure that we have the right people in place to execute our plans and deliver success. We have made several senior level executive appointments over the last few months including the appointment of two senior scientists to our technical operations team. We believe that investing in this crucial area of the business will enable us to further develop and potentially upgrade our XR-17 platform.

In September we announced that Peter Selin would be joining us as Chief Business Officer and he is now on board since the start of November. His expertise in business development and strategy in the life sciences sector will be invaluable to Oasmia as we continue to pursue growth by seeking M&A and licensing opportunities that complement our technology and business model. Another key addition to the team, announced in October, was the appointment of Fredrik Järrsten as Chief Financial Officer. He has over 25 years of experience across the financial, medical technology and life sciences sectors in the Nordic region and internationally. I know that Fredrik will be an incredible asset to Oasmia when he joins us early next year.

With this experienced new senior team in place I look forward to the remainder of 2020 and beyond with confidence and optimism. Oasmia is in great shape to deliver our strategic objectives as a business and I look forward to keeping you up to date on our progress.

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

The report is available on the company’s website: View Source

Conference call
The company will hold a conference call and an online presentation on December 9, 2020 at 10.00 am CET. The call will be hosted by CEO Francois Martelet, CEO and Acting CFO Robert Maiorana. The presentation will be in English.
The conference call will be broadcast live on the web via the link:
View Source

On December 9, 2020 Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported the pricing of an underwritten public offering of 25,652,174 shares of its common stock at a public offering price of $5.75 per share for total gross proceeds of approximately $147.5 million (the "Offering") (Press release, Curis, DEC 9, 2020, View Source [SID1234572518]). Curis has granted the underwriters a 30-day option to purchase up to an additional 3,847,826 shares of common stock on the same terms and conditions. The Offering is expected to close on or about December 11, 2020, subject to customary closing conditions.

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Cantor Fitzgerald & Co. and JonesTrading Institutional Services LLC are acting as joint book-runners for the Offering. H.C. Wainwright & Co., LLC and Laidlaw & Company (UK) Ltd. are acting as co-lead managers for the Offering.

Curis intends to use the net proceeds from the Offering, together with its existing cash and cash equivalents, to continue development of CA-4948, in collaboration with Aurigene, and CI-8893, in collaboration with ImmuNext, and for general working capital and capital expenditures.

The securities in the Offering are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-224627) that was filed with the United States Securities and Exchange Commission ("SEC") on May 3, 2018, and declared effective by the SEC on May 17, 2018 and an additional registration statement on Form S-3 (File No. 333-224627) filed pursuant to Rule 462(b) which became automatically effective on December 9, 2020. A final prospectus supplement and accompanying prospectus relating to the Offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus, when available, may also be obtained by contacting Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022 or by email at [email protected].

The securities described above have not been qualified under any state blue sky laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On December 9, 2020 Agendia, Inc., a world leader in precision oncology for breast cancer, reported that data from FLEX, the large-scale, prospective, observational breast cancer study, has been selected for presentation in six posters during the 2020 San Antonio Breast Cancer Symposium (SABCS 2020) (Press release, Agendia, DEC 9, 2020, View Source [SID1234572536]). The posters, being presented at different sessions throughout SABCS 2020, focus on underrepresented or underserved populations or types of breast cancer.

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"FLEX could be one of the most valuable, impactful, flexible, and inclusive studies in breast cancer research to date," said Laura Lee, M.D., Surgical Oncology Specialist at Desert Comprehensive Breast Center at Desert Regional Medical Center, and first author of the FLEX update poster. "These data reveal that tumor heterogeneity goes beyond ethnicities and underscores the importance of gene expression analysis as a tool for bringing those differences to light. We are enrolling patients representing all of the clinical and genomic subtypes from a broad spectrum of community and academic sites. As researchers, we are excited by the opportunity to access this real-world data set where we can ask meaningful clinical questions and then see what the data tell us."

Highlights from the FLEX data are as follows:

[OT12-01] The FLEX real-world data platform explores new gene expression profiles and investigator-initiated protocols in early stage breast cancer outlines updates from the FLEX study, a registry intended to enable the discovery of novel genomic profiles to improve precision in the management of breast cancer. With purposefully-wide inclusion criteria, the registry aims to enable researchers to investigate the differences and trends between breast cancer subgroups and allow focus on smaller, more diverse patient populations, which have traditionally been challenging to recruit in sufficient numbers for clinical trials.
[PS7-69] Molecular profiles and clinical-pathologic features of Asian early-stage breast cancer patients assesses the clinical, pathological and molecular profiles from self-reported Asian breast cancer patients (AS), in comparison with age-matched Caucasian (CA) and African American patients (AA), to evaluate the influence of Asian ancestry on differential gene expression in breast tumors. The analysis revealed different gene set enrichment patterns in tumors of AS compared with CA and AA, which may contribute to differential clinical outcomes and highlights the importance of including patients of Asian ancestry in genomic breast cancer research. Additionally, the poster found more differentially-expressed genes in MammaPrint High Risk tumors between AS and AA patients than between AS and CA patients, reinforcing the need for additional research to evaluate the influence of ancestry on differential gene expression in breast tumors.
[PS14-11] Differential gene expression analysis and clinical utility of MammaPrint and BluePrint in male breast cancer patients compares the under-researched population of male breast cancer patients (MaBC) to that of female breast cancer patients (FBC) to determine whether significant molecular biological differences exist between the two groups. Utilizing the MammaPrint and BluePrint assays, the analysis suggests that distinct biological pathways between the two groups indicate an upregulation of estrogen response and MTORC1 signaling in MaBC compared to FBC, and warrants further investigation to assess clinical outcomes.
[PS7-68] Racial disparities within Basal-type breast cancer: clinical and molecular features of African American (AA) and Caucasian (CA) obese patients investigates differential gene expression between two ethnic groups with clinically-matched comorbidities, in this case diabetes and obesity, who have been diagnosed with Basal-type breast cancer. The goal is to determine the influence metabolic factors or patient ancestry may have on outcomes as these data mature. Currently, the analysis suggests that there are further disparities in AA and CA patients beyond those attributable to clinical and social factors, which may help identify novel treatment approaches in the future.
[PS18-03] Differential gene expression in Luminal-Type invasive lobular carcinoma and invasive ductal carcinoma by MammaPrint risk stratification assesses differential gene expression between invasive lobular carcinomas (ILC) and invasive ductal carcinomas (IDC) in a large, age-matched patient subset using MammaPrint and BluePrint to stratify those populations. The analysis suggests that when evaluated by MammaPrint, about one-third of ILCs were classified as MammaPrint High Risk, displaying heterogeneity in High Risk tumors and MammaPrint’s ability to predict unfavorable survival outcomes for patients with this type of tumor. The study results underscore the ability of FLEX to enroll smaller patient populations on a larger scale, enabling further investigation and the opportunity to provide targets for treatment optimization for those patients.
[PS18-05] Using BluePrint to elucidate the molecular heterogeneity of triple negative breast cancers assesses triple negative breast cancers (TNBC) to understand the relationship between gene expression signatures provided by BluePrint and immunohistochemistry-defined TNBC. The analysis suggests that BluePrint enables further stratification of TNBC tumors, moving this type of cancer into different subgroups and shedding new light on TNBC tumor heterogeneity that may one day impact treatment planning.
"TNBC has long been a difficult diagnosis for both patients and physicians because of its aggressive nature. Very often, there is no time and no room for trial and error in the treatment decision-making process so there is a lot of pressure to get things right," said Virginia Kaklamani, M.D., Co-director of SABCS, leader of the Breast Cancer Program at UT Health San Antonio MD Anderson Cancer Center, Professor of Medicine in the Division of Hematology/Oncology at UT Health San Antonio, and first author on the poster focusing on TNBC tumors. "By leveraging BluePrint for the evaluation and stratification of TNBC tumors, we hope to be able to tease out the differences in this challenging type of cancer – which can sometimes include more than one activated genomic pathway – to determine where and when to hit it hardest for the benefit of our patients."

These data are part of a large suite of 13 posters, spotlight sessions and an oral presentation on MammaPrint and BluePrint that were accepted to SABCS 2020, and underscore Agendia’s mission to help guide the diagnosis and personalized treatment of breast cancer for all patients throughout their treatment journey.

On December 9, 2020 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of fully human antibody therapeutics, reported the presentation of the latest interim data from its ongoing phase Ib combination trial of olinvacimab and pembrolizumab for metastatic triple-negative breast cancer (mTNBC) patients (Press release, PharmAbcine, DEC 9, 2020, View Source [SID1234572553]). The results were presented at the SABCS (San Antonio Breast Cancer Symposium) 2020, currently taking place virtually.

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As of the data cut-off date of September 2020, all 11 mTNBC patients were recruited and received at least one dose of treatment. No DLT (Dose Limiting Toxicity) was observed. Three patients were receiving treatment at the data cut-off date. 4 patients (36%) had partial response (PR) as best overall response, and 5 patients (45%) had clinical benefit (PR+SD≥24weeks). In the high-dose cohort, 3 patients (50%) showed PR and 4 patients (67%) received clinical benefit. 1 patient in PR showed complete response in the target lesion but was included in PR because a tumor was found in a non-target lesion.

The number of PR and SD remains the same from our previous interim results whose cut-off date was June 2020. The same 3 patients who were receiving treatment as of the previous cut-off date continued to receive treatment as of September 2020. As such, PFS (Progression Free Survival) and OS (Overall Survival) are likely to improve for the final results. Adverse events were similar to those shown in the previous interim results.

mTNBC is a highly malignant type of cancer that shows a high recurrence rate within the first five years after the diagnosis. mTNBC accounts for 10-20% of all breast cancers and shows a 5-year survival rate of approximately 11%. Unlike some other breast cancers, mTNBC does not express estrogen or progesterone receptors or human epidermal growth factor receptor 2 (HER2), and it does not respond to existing cancer drugs designed to target these markers. mTNBC is very difficult to treat, and there are very few FDA approved treatment options for these patients.

"The early activity signals for olinvacimab in combination with pembrolizumab for mTNBC patients are highly encouraging. We believe these findings provide an encouraging safety profile and evidence of clinical activity of the combo therapy," said Dr. Jin-San Yoo, CEO of PharmAbcine. "We are particularly thrilled by the efficacy data from the high-dose cohort, heightening our expectation for its continued clinical development or future planned clinical studies."

About San Antonio Breast Cancer Symposium

San Antonio Breast Cancer Symposium (SABCS) is the world’s largest breast cancer conference held annually. Nearly 10,000 researchers and medical experts participate event every year. The core mission of this event is to provide the latest research data in breast oncology to all participants around the globe. For the safety and security of all members in the COVID-19 global pandemic, the SABCS executive committee has decided to hold this year’s event virtually.

On December 9, 2020 Quirem Medical, a Terumo company, reported that it is awarded top 3 innovative medical device in the 2019 Belgian Galenus prize with the innovative Holmium-166 SIRT diagnostic scout dose product QuiremScout (Press release, Quirem Medical, DEC 9, 2020, View Source [SID1234573385]).

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The Galenus prize recognizes and rewards outstanding achievements that improve the global human condition through the development of innovative therapies1. It was created in France in 1970 by a pharmacist named Roland Mehl with the aim to advance pharmaceutical research. Recently, the Prix Galien award is also granted to innovative medical devices.2

The role of QuiremScout microspheres is to evaluate the expected safety and efficacy of the Selective Internal Radiation Therapy (SIRT). QuiremScout microspheres are based on the same Holmium-166 microspheres as the therapeutic treatment (QuiremSpheres). QuiremScout microspheres are intended to evaluate lung-shunt3 and extrahepatic deposition3 as part of the SIRT work-up. Moreover, they are intended for evaluation of the intrahepatic distribution3 during the work-up, which can be used to plan the SIRT treatment.4

Currently, 99mTc-MAA is most often used during the pre-treatment work-up of the SIRT treatment algorithm3.

However, QuiremScout has recently proven to be more accurate in terms of intrahepatic targeting5 and lung shunt assessment6 compared to 99mTc-MAA during the work-up. The usage of QuiremScout microspheres may allow physicians to improve their SIRT treatment planning.3

Recent clinical results continue to support the validation of QuiremScout microspheres in patient selection and planning as part of the Holmium Platform, such as the latest publication in the Lancet Oncology Journal from UMC Utrecht for the non-randomized HEPAR PLuS study7, which included Neuroendocrine tumor (NET) patients with liver metastasis after systemic radiation therapy with 177Lu-Dotatate.

The Holmium platform consists of three integrated products (QuiremScout, QuiremSpheres & Q-suite), which equips physicians with the necessary tools to optimize SIRT outcomes through more individualized treatment.

"QuiremScout is part of the Holmium platform that enables physicians to perform Selective intra-arterial radiation therapy. This technology uniquely allows a fine patient selection and individualized treatment for better outcomes. At Terumo, we are proud of this important recognition by the community.", said Laurent Domas, Vice President Global Interventional Oncology & Therapy Development, Terumo Interventional Systems.