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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]).

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.

Jounce Therapeutics to Present at Upcoming Investor Conferences in January

On January 8, 2021 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that Jounce management will present at two upcoming investor conferences (Press release, Jounce Therapeutics, JAN 8, 2021, View Source [SID1234573687]):

H.C. Wainwright BioConnect 2021 Conference: A webcast presentation will be available on demand during the conference, starting Monday, January 11, 2021 at 6:00 a.m. ET.
39th Annual J.P. Morgan Healthcare Conference: A live webcast will take place on Thursday, January 14, 2021 at 8:20 a.m. ET.
A webcast of each presentation will be available by visiting "Events and Presentations" in the Investors and Media section of Jounce’s website at www.jouncetx.com. The webcasts will be archived for 30 days following the presentations.

Endeavor Biomedicines Launches With $62 Million Series A Financing And Mission To Reverse The Course Of Devastating Pulmonary Disease

On January 7, 2021 Endeavor BioMedicines, a biotechnology company developing new treatments targeting the underlying causes of pulmonary fibrosis, reported it has raised $62 million in a Series A financing (Press release, Endeavor BioMedicines, JAN 7, 2021, View Source [SID1234606755]). The round was led by Omega Funds, Longitude Capital and Endeavor’s management. Proceeds from the financing will be used to advance taladegib, an inhibitor of the Hedgehog pathway, into two Phase 2 clinical studies for the treatment of idiopathic pulmonary fibrosis (IPF) in 2021.

"IPF is a devastating condition with an estimated mean survival of 2-5 years from time of diagnosis, and currently there are no available therapies that stop the progression of fibrosis or treat the underlying causes of the disease," said John Hood, Ph.D., co-founder, CEO and chairman of Endeavor. "Emerging preclinical and clinical evidence shows the Hedgehog signaling pathway, which is implicated in chronic wound healing, plays a critical role in IPF disease pathology. With taladegib’s impressive potency and safety profile, there is the potential to introduce an entirely new class of medicine that may be able to stop or reverse the course of this deadly disease."

Studied in 176 subjects to date, taladegib has been shown to safely and effectively inhibit the Hedgehog pathway. Endeavor intends to initiate a Phase 2 study of taladegib as a monotherapy in patients with IPF in the second quarter of 2021. Pending results from the monotherapy study, Endeavor anticipates initiating a second Phase 2 study in combination with standard of care by 2022.

"In developing a best-in-class Hedgehog inhibitor therapy and applying it in an emerging area of science, Endeavor has the potential to completely change the trajectory of IPF," said Bernard Davitian, partner at Omega Funds. "This is a testament to Endeavor’s persistence in translating promising scientific insights into real medicines that can benefit patients with significant unmet medical needs. Omega is proud to support Endeavor’s world-class team in this mission."

To meet this immense demand in the IPF patient community, Endeavor BioMedicines was co-founded by Dr. Hood, who previously founded and served as CEO of Impact Biomedicines until its acquisition by Celgene in 2018. Miguel de los Rios, Ph.D., Endeavor BioMedicine’s co-founder and chief scientific officer, previously served as CEO of Rift Biotherapeutics and brings more than 15 years of management experience in R&D leadership, business development and business strategy. Endeavor’s board of directors includes Dr. Hood, Mr. Davitian and Sandip Agarwala of Longitude Capital.

"Endeavor is built on the solid foundation required for a biotech company to thrive: stellar management with a successful track record, data-driven scientific rationale for targeting the Hedgehog pathway in IPF and a devastating disease in need of innovative options," said Sandip Agarwala, managing director of Longitude Capital. "John has assembled an incredible team driven by the noble mission to transform the IPF disease area, which has been overlooked for far too long."

TARGETING AN OVERLOOKED PATHWAY AT THE CRUX OF IPF PROGRESSION
Taladegib is a small-molecule inhibitor of the Hedgehog signaling pathway. Hedgehog inhibitors have been approved for the treatment of cancers such as basal cell carcinoma and acute myelogenous leukemia, but they have yet to be applied toward pulmonary diseases.

The Hedgehog signaling pathway is a key modulator for disease progression in IPF. Myofibroblasts – the repair cells activated by the Hedgehog pathway – become dysregulated, relentlessly remodeling lung tissue, forming fibrotic scars and contracting the lung. This tissue remodeling disorder impairs lung function in IPF patients by making the lung inelastic, smaller and with compromised tissue structure. Selectively inhibiting this pathway in lung tissue causes the myofibroblasts responsible for the disorder to become inactivated and undergo apoptosis, thereby eliminating the key cellular driver of IPF and potentially stopping or reversing the disease.

AN OPPORTUNITY TO REVERSE ONE OF THE MOST DEVASTATING PULMONARY DISEASES
There are approximately 132,000 people affected with IPF in the United States alone. IPF is characterized by fibrosis in the lungs, and this scar tissue accumulates until it reaches deadly levels. As one of the most aggressive interstitial pulmonary diseases, patients with IPF face a severely depleted quality of life. Current treatments help to slow progression, but there are none available that treat the underlying mechanisms of disease progression.

Cyteir Therapeutics to Present at the 39th Annual J.P. Morgan Healthcare Conference

On January 7, 2021 Cyteir Therapeutics, a leader in the discovery and development of next-generation synthetic lethal therapies to treat cancer, reported that Markus Renschler, M.D., Cyteir’s president and chief executive officer, will present a scientific and business update at the 39th Annual J.P. Morgan Healthcare Conference on Monday, January 11, 2021 at 5:30 p.m. Eastern Time (Press release, Cyteir Therapeutics, JAN 7, 2021, View Source [SID1234577662]). A Q&A breakout session will immediately follow the presentation at 5:45 p.m. Eastern Time.