Aurinia Pharmaceuticals to Present at Two Upcoming Virtual Healthcare Conferences

On January 8, 2021 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (the "Company") reported that members of the management team will participate in two upcoming virtual investor conferences and participate in a panel discussion hosted by Dr. Scott Gottlieb, former FDA Commissioner (Press release, Aurinia Pharmaceuticals, JAN 8, 2021, View Source [SID1234573692]):

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H.C. Wainwright Virtual BioConnect 2021 Conference. On-demand fireside chat available beginning Monday, January 11, 2021 at 6:00 a.m. EST;
Scott Gottlieb, M.D. Hosts a Panel Discussion on Clinical Trials with Neil Solomons, M.D., Chief Medical Officer of Aurinia, during the H.C. Wainwright BioConnect 2021 Conference on Monday, January 11, 2021 at 12:00 p.m. EST; and
J.P Morgan 39th Annual Healthcare Conference. Fireside chat to be hosted on Thursday, January 14, 2021 at 4:30 p.m. EST.
In order to listen to the audio webcast, interested parties can register and access the live webcast under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available for 30 days on Aurinia’s website.

Greenwich LifeSciences to Participate in Multiple Virtual Investor Conferences During 2021 JP Morgan Healthcare Week

On January 8, 2021 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported that Snehal Patel, CEO of Greenwich LifeSciences, will participate in three virtual investor conferences during the week of January 11, 2021 (Press release, Greenwich LifeSciences, JAN 8, 2021, View Source [SID1234573691]).

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H.C. Wainwright BioConnect Conference:

The Company will be participating in the H.C. Wainwright BioConnect Conference with a virtual presentation that will be available on demand beginning at 6:00 am EST on January 11, 2021 and can be viewed here.

The virtual presentation will also be available on the Company’s website here.

Biotech Showcase 2021 Digital:

The Company will be participating in the Biotech Showcase partnering event with an on-demand presentation available to conference participants.

BIO Partnering at JPM:

The Company will be participating in the BIO partnering event at the 2021 JP Morgan Healthcare Conference.

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

Consortium of industrial and academic partners led by Elthera receives Eurostars grant

On January 8, 2021 Elthera AG, iCellate Medical AB, Targos GmbH and Prof. Dr. Susanne Sebens at the Institute of Experimental Cancer Research (IET) at the University of Kiel reported that they have received a non-dilutive grant with a total budget of 2.7 M € from the EUREKA Eurostars programme (Press release, Elthera, JAN 8, 2021, View Source [SID1234573690]). The grant will allow the consortium to finalize the preclinical development of Elthera’s proprietary anti-L1CAM antibody and to develop novel L1CAM-based solid and liquid biopsy methods for patient selection and treatment monitoring in clinical trials. The consortium partners bring together a unique set of complementary cutting-edge technologies and a track record in the development of novel diagnostics and therapeutics. Elthera AG (Schlieren, Switzerland) will develop its anti-L1CAM therapy to an IND ready stage and will deliver a translational pharmacology package, which will facilitate entry into clinical trials. The consortium partners iCellate (Solna, Sweden) and Targos GmbH (Kassel, Germany), will develop L1CAM-specific liquid (blood-based) and solid (tumor-based) biopsy methods, respectively. The group of Prof. Dr. Susanne Sebens at the IET (Kiel, Germany) will provide access to primary samples from cancer patients and will evaluate the potential of the anti-L1CAM therapy to be combined with established chemo- and immunotherapies.

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Anne Schmidt, CEO of Elthera, commented: "We are very happy that we could attract such outstanding industry and academic experts for this exciting project. The combination of research excellence in the field of L1CAM biology, innovative diagnostic technologies, and access to primary patient samples will build the foundation for the successful translation of our anti-L1CAM therapy into clinical testing."

Christer Ericsson, CSO of iCellate, said: "Immunotherapies against cancer, such as the anti L1-CAM therapy for pancreatic and ovarian cancer developed by Elthera, have the potential to cure the disease by eradicating the cancer cells. We are pleased to have been given the opportunity to develop the blood-sample based companion diagnostic test that will guide the therapy so that only those patients who will benefit are treated."

Thomas Henkel, CEO of Targos commented: "It is exciting to be involved in the early phase of development towards a predictive biomarker or companion diagnostic for anti-L1CAM therapy. Targos can contribute its experience in clinical validation of tissue biomarkers and within the consortium we will compare it to the blood-sample based approach on a scientific evidence basis."

Prof. Susanne Sebens, Director of IET, said: "We are very excited to be part of this innovative project at the interface of industry and science. With this project we ideally continue our longstanding translational research activities in the field of L1CAM biology."

Biodesix Anticipates Strong Preliminary Fourth Quarter 2020 Revenue (unaudited)

On January 8, 2021 Biodesix, Inc. a leading data-driven diagnostic solutions company with a focus in lung disease, reported that the company expects to report record fourth quarter 2020 preliminary unaudited revenue in a range of $25 million to $27 million (Press release, Biodesix, JAN 8, 2021, View Source [SID1234573689]). The strength in the fourth quarter 2020 was a result of growth in the company’s COVID-19 testing services, lung diagnostic testing, and biopharma services. The financial results included in this release pertaining to all interim periods are unaudited and the financial results as of and for the three-month period ended December 31, 2020 are preliminary unaudited information and subject to final review and adjustments.

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Fourth Quarter 2020 and Recent Highlights

Generated record revenue of $25 million to $27 million for the three months ended December 31, 2020.
Completed initial public offering (IPO) that raised net proceeds of approximately $63 million after deducting offering costs, underwriting discounts and commissions, providing significant cash resources to fund the Company’s growth strategy and for working capital and general corporate purposes.
Initiated biomarker study to affirm Nodify XL2 test’s importance in clinical decision making (ALTITUDE). The first-in-class biomarker study is aligned with the recommendations from the official 2018 American Thoracic Society (ATS) policy statement on the early detection of lung cancer. Dr. Gerard A. Silvestri of Medical University of South Carolina named Principal Investigator.
Announced results of study showing the company’s proprietary blood collection device (BCD) collects, separates, and transports blood at ambient temperature to simplify specimen collection and transport while maintaining accuracy of diagnostic test results.
Partnered with Purdue University to support return to school COVID-19 testing for off campus students.
"We are pleased to see the growth in our lung diagnostic testing during the quarter even as healthcare practitioners and facilities were focused treating patients during the most recent surge of COVID-19 cases across the country," stated Scott Hutton, Chief Executive Officer. "With our diverse suite of commercially available lung cancer nodule management and tumor profiling tests, as well as the broad array of assays that we perform on behalf of our biopharmaceutical partners, we are very well positioned to continue to drive growth in our base business in 2021."

"The growth in our COVID-19 revenue reflects the value of our COVID-19 tests and our service capabilities to help a variety of customers across the country. While the country grapples with the uncertainty of the progression of the pandemic, we are pleased to offer the highly-accurate and rapid results that our customers require," Mr. Hutton concluded.

Revenue

We preliminarily estimate our revenues for the three months ended December 31, 2020 to be approximately $25 million to $27 million as compared to $9.2 million for the three months ended September 30, 2020, an increase of 172% to 193%, and as compared to $8.3 million for the three months ended December 31, 2019, an increase of 201% to 225%. Diagnostic test revenue and services revenue comprised an estimated 93% to 94% and 7% to 6% of estimated total revenues, respectively, for the three months ending December 31, 2020 as compared to 93% and 7%, respectively, for the three months ending September 30, 2020. Lung diagnostic testing revenue comprised approximately $3.5 million to $4.0 million for the three months ending December 31, 2020, as compared to $3.0 million for the three months ending September 30, 2020, an increase of 17% to 33%, and compared to $4.6 million for the three months ending December 31, 2019, a decrease of 13% to 24%, as health care practitioners, including pulmonologists, were diverted to pandemic-related care in 2020. COVID-19 testing services revenue comprised approximately $20 million to $21 million for the three months ending December 31, 2020, as compared to $5.5 million for the three months ending September 30, 2020, an increase of 264% to 282%.

Liquidity

The Company continues to maintain a strong liquidity position, primarily as a result of our IPO generating net cash proceeds of approximately $63 million, with cash and cash equivalents of approximately $62 million as of December 31, 2020, which reflects a required pre-payment of approximately $7 million for three years of premiums for the company’s directors and officers (D&O) liability insurance coverage. We expect our current cash position to provide sufficient liquidity to meet our growth expectations, including our ability to meet our financial obligations for at least the next twelve months.

Can-Fite Announces Publication of Namodenoson Liver Cancer Study in Peer
Reviewed Journal—Cancers

On January 8, 2021 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported a scientific paper titled, "Namodenoson in Advanced Hepatocellular Carcinoma and Child–Pugh B Cirrhosis: Randomized Placebo-Controlled Clinical Trial" was published in the peer reviewed journal Cancers (Press release, Can-Fite BioPharma, JAN 8, 2021, View Source [SID1234573688]).

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The paper highlights and analyzes results from Can-Fite’s Phase II study, a randomized placebo-controlled trial to investigate Namodenoson as a 2nd-line treatment for advanced hepatocellular carcinoma (HCC) and moderate hepatic dysfunction, as defined by Child–Pugh B (CPB) scores of 7–9. Even though the trial did not meet its primary endpoint, in patients with a CPB score of 7, Namodenoson was associated with a significant improvement in 12-month overall survival and 2 patients are still under treatment for more than 3.5 years.

A pivotal Phase III study of Namodenoson as a 2nd or 3rd line treatment in HCC CPB7 patients has been designed, and both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have agreed with the protocol. Upon successful results, the trial may lead to concurrent marketing approval in the U.S. and Europe. Namodenoson has been granted Orphan Drug Status by both the FDA and EMA, in addition to Fast Track Status by the FDA. Namodenoson continues to be administered to HCC patients under a compassionate use program in Israel.

"With the publication of this study, we believe we are advancing the body of scientific data needed to bring a treatment to HCC patients with Child-Pugh B7. This subset of patients with advanced disease and borderline liver function have few, if any treatment options. Nearly all other liver cancer studies exclude these patients due to poor prognosis. As detailed in our published paper, Namodenoson significantly prolonged 12-month survival in HCC CPB7 patients in our Phase II study. We are hopeful that if our planned pivotal study produces similar results, Can-Fite will be able to offer a much needed therapy to this population of advanced liver cancer patients," stated Can-Fite CEO Dr. Pnina Fishman.

Liver cancer is one of the leading causes of cancer deaths globally, with an estimated 854,000 new cases and 810,000 deaths annually. DelveInsight estimates the HCC drug market will reach $3.8 billion in 2027 in the G8 countries.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.