Can-Fite Reports Third Quarter 2020 Financial Results & Provides Clinical Update

On November 30, 2020 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 financial results for the nine months ended September 30, 2020 (Press release, Can-Fite BioPharma, NOV 30, 2020, View Source [SID1234571950]).

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Clinical Developments and Corporate Highlights for the Third Quarter and Recent Weeks Include:

Positive Interim Analysis in Phase III Comfort Trial of Piclidenoson in the Treatment of Psoriasis – The Independent Data Monitoring Committee (IDMC) for Can-Fite’s Phase III trial of Piclidenoson in the treatment of moderate-to-severe plaque psoriasis recommended the Company continue the study with the original sample size and drop one dose group based on the positive data from its interim analysis. While the interim data continue to be blinded to Can-Fite, the Company considers the IDMC’s recommendations highly encouraging. As the optimal dose has been identified, Can-Fite believes the study can be concluded earlier than originally planned. The majority of costs associated with the Phase III Comfort study have been previously paid. Piclidenoson is out-licensed for the indication of psoriasis in nine countries through agreements that include milestone payments and royalties on revenues upon regulatory approval.

Data from the Interim Analysis of the Acrobat Rheumatoid Arthritis Study – The IDMC recommended not to continue this study. The Company conducted a detailed analysis which showed that although Piclidenoson efficacy was significantly superior to placebo, the study missed the primary endpoint which was non-inferiority vs. the comparator methotrexate. The Company decided to stop this Phase III study and to focus on the developments that showed promising data including psoriasis, NASH and liver cancer.

Phase II COVID-19 IND Application for Piclidenoson Approved by FDA – The U.S. Food and Drug Administration (FDA) issued a "safe to proceed" notice for Can-Fite’s Investigational New Drug (IND) application for a Phase II study of Piclidenoson in the treatment COVID-19. The 28-day study will enroll 40 patients hospitalized with "moderate" COVID-19 per U.S. National Institutes of Health Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. The randomized, double blind study will evaluate patients who will receive Piclidenoson in addition to standard supportive care, as compared to patients who receive standard supportive care with placebo. The Company expects to commence patient enrollment in Q4 2020.

Namodenoson Abstract of Phase II Data Selected as ‘Best of The Liver Meeting’ in the NASH Category of the American Association of Liver Diseases (AASLD) – Dr. Rifaat Safadi, Principal Investigator of Can-Fite’s Phase II study of Namodenoson in the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH) delivered a late-breaking oral presentation at the prestigious American Association for the Study of Liver Diseases (AASLD) conference, The Liver Meeting Digital Experience 2020. Presenting to the world’s leading scientists and health care professionals committed to preventing and curing liver diseases, Dr. Safadi concluded that "Namodenoson’s very impressive study data may result in a promising drug for the treatment of NAFLD/NASH due to the combination of good efficacy and favorable safety." Can-Fite’s presentation was selected as ‘Best of The Liver Meeting’ in the NAFLD/NASH category. This selection is a singular honor and indicates the high level with which the AASLD review committee regards Can-Fite’s research.

Patent Protecting Namodenoson in Treatment of NASH Approved in Europe – A patent titled "An A3 Adenosine Receptor For Use In Treating Ectopic Fat Acculturation" was issued to Can-Fite by the European Patent Office. The patent’s claims include use of the A3 adenosine receptor (A3AR), the target of Can-Fite’s platform technology, in reducing ectopic fat accumulation particularly in fatty liver as manifested in NAFLD and NASH.

Completed Development of Assay to Identify Clinically Active Cannabis Derived Compounds – Can-Fite completed the development of a biological cell-based in vitro assay which can identify clinically active cannabis derived compounds that bind to and activate A3AR, the target of Can-Fite’s platform technology. In addition to using this assay in the development of its own cannabis derived compound-based therapeutics, Can-Fite plans to market the assay on a ‘fee for service’ basis to researchers and other cannabis companies worldwide.

"We are very pleased with the results of the IDMC’s interim analysis and recommendation for our Phase III psoriasis study. Piclidenoson has a clear value proposition in the psoriasis market we believe, based on its demonstrated safety and efficacy to date, and the benefit of being an oral drug among a growing number of injectable biologics. Oral drugs are cost effective and more convenient for the patient. Both of these factors are preferred by psoriasis patients based on a 2018 study published in an industry journal," stated Can-Fite CEO Dr. Pnina Fishman. "This quarter we anticipate enrolling the first COVID-19 patient in our U.S. FDA Phase II study. Piclidenoson’s anti-inflammatory and anti-viral properties make it a promising candidate in the fight against this pandemic. We are also very encouraged by the level of interest in Namodenoson in the treatment of NAFLD/NASH from the scientific and business communities."

Financial Results

Revenues for the nine months ended September 30, 2020 were $0.61 million compared with $1.84 million for the same period of 2019. The decrease in revenues was mainly due to the recognition of a lower portion of advance payments received under distribution agreements from Gebro, Chong Kun Dung Pharmaceuticals, and Cipher Pharmaceuticals.

Research and development expenses for the nine months ended September 30, 2020 were $9.05 million compared with $7.01 million for the same period of 2019. Research and development expenses for the nine months ended September 30, 2020 comprised primarily of expenses associated with the Phase II studies for Namodenoson in the treatment of NASH and HCC, as well as expenses for ongoing Phase III studies of Piclidenoson in the treatment of rheumatoid arthritis and psoriasis. The increase is primarily due to increased costs associated with the accelerating rate of absorption of patients for the Phase III clinical trial of Piclidenoson for the treatment of rheumatoid arthritis and for psoriasis during this period.

General and administrative expenses were $2.14 million for the nine months ended September 30, 2020 compared to $2.22 million for the same period in 2019. The decrease is primarily due to a decrease in professional services and travel expenses which was partly offset by an increase in salaries and related benefits and insurance expenses.

Financial expenses, net for the nine months ended September 30, 2020 was $0.22 million compared to $0.44 million for the same period in 2019. The decrease in financial expenses, net is mainly due to fair value revaluation of the investment in Wize Pharma Inc’s shares which is classified under short term investment.

Can-Fite’s net loss for the nine months ended September 30, 2020 was $10.81 million compared with a net loss of $7.84 million for the same period in 2019. As of September 30, 2020, Can-Fite had cash and cash equivalents of $10.22 million as compared to $2.69 million at December 31, 2019. The increase in cash during the nine months ended September 30, 2020 is due to an aggregate of $17.68 million net proceeds received through a warrant exercise transaction in January 2020, a public offering in February 2020, partial exercises in March, April and May 2020 of warrants issued in the February 2020 public offering, and a registered direct offering in June and July 2020 which was offset by net cash used in operating activity of $10.16 million.

The Company’s consolidated financial results for the nine months ended September 30, 2020 are presented in accordance with US GAAP Reporting Standards.

Conference Call

Management will host a conference call today, November 30, 2020 at 9:15 a.m. ET. Investors in the U.S. are invited to dial 877-423-9813. International investors may dial 201-689-8573. The conference ID is 13713545. Investors may also participate via webcast: View Source

A replay of the webcast will be archived on Can-Fite’s website for a period of time. 

IGM Biosciences to Host Conference Call and Webcast to Review IGM-2323 Data Presented at the 62nd Annual ASH Meeting

On November 30, 2020 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported that the Company will host a conference call and live audio webcast on Saturday, December 5, 2020, at 2:00 p.m. ET (Press release, IGM Biosciences, NOV 30, 2020, https://igmbio.com/2020/11/30/igm-biosciences-to-host-conference-call-and-webcast-to-review-igm-2323-data-presented-at-the-62nd-annual-ash-meeting/ [SID1234571949]). The event will take place following a poster presentation featuring the first clinical data from the Company’s Phase 1 trial evaluating IGM-2323 at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.

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The conference call may be accessed by dialing (866) 649-1996 (domestic) or (409) 217-8769 (international) and referring to conference ID 1141638. A live webcast of the presentation will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

Fate Therapeutics to Host Virtual Event at the 2020 ASH Annual Meeting

On November 30, 2020 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that management will host a virtual event entitled "The Power of hnCD16" on Friday, December 4, 2020 at 4:30 PM EDT (Press release, Fate Therapeutics, NOV 30, 2020, View Source [SID1234571948]).

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The event will highlight the unique therapeutic features and functionality of the Company’s proprietary high-affinity, non-cleavable CD16 (hnCD16) Fc receptor, a core component incorporated in its iPSC-derived NK cell product candidates. The Company’s hnCD16 Fc receptor is designed to maximize antibody-dependent cellular cytotoxicity, a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells.

The live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event. The event is not an official program of the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.

About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Company’s platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 300 issued patents and 150 pending patent applications.

CureVac Announces Financial Results and Business Updates for the Third Quarter and First Nine Months of 2020

On November 30, 2020 CureVac N.V. (Nasdaq: CVAC), a clinical-stage biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), reported business updates and financial results for the third quarter and first nine months of 2020 (Press release, CureVac, NOV 30, 2020, View Source [SID1234571947]).

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"The first nine months of 2020 have been a transformative time for us at CureVac and also for the world around us," said Franz-Werner Haas, Chief Executive Officer of CureVac. "From the very start of the year, we made it a priority to address COVID-19. Over the first nine months of 2020, we have remained focused on the development of our mRNA-based vaccine candidate to help stop the spread of this severe disease. Our team’s tremendous efforts were reflected in the positive Phase 1 interim data in early November as well as positive stability data, which indicates that our vaccine remains stable for at least three months at refrigerator temperature, and up to 24 hours at room temperature. These advancements, combined with our recent Advanced Purchase Agreement with the European Commission to supply 225 million doses of CVnCoV and an option for an additional 180 million doses, are highly promising for the anticipated large-scale vaccination efforts."

"The achievement of our financial milestones to date in 2020 has put us in a favorable financial position," said Pierre Kemula, Chief Financial Officer of CureVac. "Proceeds of our successful IPO, additional investments and a grant from the German government allow us to expand the business, advance the clinical development of our COVID-19 vaccine candidate, CVnCoV, and support the ramp up of our manufacturing capacity in the coming months. For the remainder of 2020 and moving into 2021, we are focused on supporting CVnCoV commercialization and developing our unique technology platform across our clinical pipeline."

Selected Business Updates for the Third Quarter and First Nine Months of 2020

Prophylactic Vaccines

CVnCoV – Covid-19 Vaccine Candidate

Phase 1 In June 2020, CureVac entered into a clinical Phase 1 dose escalation trial at clinical sites in Germany and Belgium to assess safety, reactogenicity and immunogenicity of CVnCoV. On November 10, 2020, the company reported detailed interim data based on more than 250 study participants tested in the dose range of 2µg to 12µg.

The interim data showed that CVnCoV was generally well tolerated and induced strong binding and virus-neutralizing antibody responses across all tested doses. First indication of T cell activation was detected, and full T cell analysis will follow before the end of 2020. The quality of the immune response was found to be comparable to recovered COVID-19 patients, mimicking the immune response after natural COVID-19 infection. The data support advancement of the 12µg dose into a pivotal Phase 2b/3 trial. Detailed data can be accessed through a manuscript available on the medRxiv pre-print server.

Phase 2a In September 2020, CureVac entered into a clinical Phase 2a study in Peru and Panama to further expand the clinical database of CVnCoV in a geographical environment with a high incidence of COVID-19 infection. The study includes individuals between 18 and 60 years old, but focuses on adults older than 60 years to further confirm safety and evaluate reactogenicity in this age group. The study will enroll approximately 690 individuals and includes testing at the 12µg dose.

Phase 2b/3 Contingent on regulatory approval, CureVac plans to initiate a pivotal Phase 2b/3 study of more than 35,000 individuals shortly. The Phase 2b component will assess safety, reactogenicity and immunogenicity in study participants stratified according to age (>18 and >60 years old), initially at clinical testing sites in Europe and South America. The Phase 3 component will further assess safety and efficacy. If CureVac gains authorization to initiate the pivotal trial, an interim analysis could be carried out within the first quarter of 2021.

Stability Study On November 12, 2020, CureVac announced initial data from its ongoing CVnCoV stability study. The data shows that CVnCoV remained stable and within defined analytical specifications for at least three months when stored at a standard refrigerator temperature of +5°C (+41°F), and for up to 24 hours at room temperature as a ready-to-use vaccine.

The stability profile has the potential to be compatible with existing standard cold chain logistics. This will support large-scale vaccination efforts by enabling decentralized storage and positively impacting immunization cost and waste. The stability study is ongoing with the goal to further evaluate the potential for a longer commercial product shelf-life.

Commercialization of COVID-19 vaccine candidate, CVnCoV

On November 17, 2020, the European Commission announced the approval of a contract for the initial purchase of 225 million doses of CureVac’s COVID-19 vaccine candidate, CVnCoV, including the option to request an additional 180 million doses on behalf of the European Union member states. CureVac is the fifth company to finalize an agreement with the European Commission. The doses will be supplied once CVnCoV has proven to be safe and effective against COVID-19. CureVac will receive an upfront payment to support the advanced clinical development of CVnCoV and the current expansion of its manufacturing network, as well as market launch and supply preparations.

Manufacturing of COVID-19 vaccine candidate, CVnCoV

CureVac currently operates three Good Manufacturing Practice (GMP) certified suites. Capacity of the third GMP suite is currently dedicated to the COVID-19 vaccine candidate, CVnCoV, to supply the ongoing Phase 1 and Phase 2a clinical trials, the planned pivotal Phase 2b/3 trial, as well as potential early commercialization activities. A fourth GMP facility is currently in development to handle all manufacturing steps from starting material to formulation, operating at industry scale to support future commercial launches.

On July 6, 2020, CureVac announced the closing of a €75 million loan agreement with the European Investment Bank to support the company’s efforts to expand existing GMP-certified production capabilities and accelerate the completion of the fourth production site.

On November 17, 2020, CureVac announced that it is building an integrated European vaccine manufacturing network with highly experienced Contract Development and Manufacturing Organization (CDMO) partners for each major manufacturing step. This strategy further strengthens the clinical development of CVnCoV, the preparations for a potential launch and rapid market supply. Based on the selection of a 12µg dose to move into advanced clinical trials, the manufacturing network will significantly increase the existing capacity to provide up to 300 million doses of CVnCoV in 2021 and up to 600 million doses in 2022.

GlaxoSmithKline Collaboration Agreement

In July 2020, CureVac entered into a Collaboration and License Agreement with GSK, one of the industry’s leading vaccine experts. Within the scope of the agreement, the companies will combine their respective mRNA expertise to collaborate on development opportunities across a range of infectious disease pathogens, selected with the potential to best leverage the advantages of this platform technology, while addressing significant unmet medical need and economic burden.

The strategic technology collaboration encompasses mRNA-based vaccines and monoclonal antibodies targeting infectious disease pathogens. Under the terms of the deal, GSK made an equity investment in CureVac of €150m and an upfront cash payment of €120m. CureVac is eligible to receive development and regulatory milestone payments, commercial milestone payments and tiered royalties on product sales.

Oncology

CV8102 – Cancer immuno-modulator in solid tumors

Phase 1 On November 9 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) conference, CureVac presented updated data from the ongoing Phase 1 dose-escalation study of its lead oncology product candidate. The study assesses tolerability as well as activity of CV8102 in the dose range of 25 to 900µg as a single agent, and in combination with systemic anti-PD-1 antibodies for the intra-tumoral treatment of four types of solid tumors: cutaneous melanoma, adenoid cystic carcinoma, squamous cell carcinoma of skin and squamous cell carcinoma of head and neck. CV8102 showed an acceptable tolerability with adverse events mainly accumulating around mild to moderate fever, fatigue, chills and headache.

Following a first data presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in April 2020, the data presented at SITC (Free SITC Whitepaper) (Cut-off was October 5, 2020) featured 29 patients treated with CV8102 as a single agent and 21 patients treated with CV8102 in combination with anti-PD-1 antibodies. The formerly observed objective tumor responses in two melanoma patients, and two additional patients with a stable disease, including shrinkage of non-injected lesions in the single agent cohort, were extended by a new partial response observed in a patient with cutaneous squamous cell carcinoma pre-treated with anti-PD-1. This observation expanded activity from melanoma into a second indication. Additionally, the first RECIST response in the PD-1 combination cohort was observed in a PD-1 refractory melanoma patient with regression of non-injected lesions in the lung and liver. CureVac plans to initiate an expansion cohort in early 2021.

Financial Update for the Third Quarter and First Nine Months of 2020

Cash Position

Cash increased from €30.7 million as of December 31, 2019 to €892.4 million as of September 30, 2020, mainly due to the €559.3 million raised in the 2020 Private Investment in July 2020, along with €192.9 million in proceeds, net of underwriting discounts and commission, from CureVac’s initial public offering (IPO) on the Nasdaq in August 2020, €100 million from the August 2020 concurrent private placement to Dietmar Hopp and the €120 million non-refundable upfront payment received from GSK.

Revenues

Revenue was €5.2 million and €42.8 million for the three and nine months ended September 30, 2020, respectively, representing an increase of €4.1 million and €32.2 million, or 371% and 304%, from €1.1 million and €10.6 million for the same periods in 2019, respectively.

These increases were primarily driven by the following events: in July 2020, GlaxoSmithKline plc (GSK) and CureVac signed a strategic collaboration agreement for the research, development, manufacturing and commercialization of mRNA-based vaccines and monoclonal antibodies targeting infectious disease pathogens. In addition to an equity investment of €150 million, made as part of the 2020 Private Investment, GSK made a non-refundable upfront payment of €120 million, which has been deferred and recognized as a contract liability. For the three months ending September 30, 2020, €3.7 million was released from contract liabilities and recognized as revenues. In June 2020, CureVac and Eli Lilly terminated the License and Collaboration Agreement dated November 29, 2017, as well as the Early Clinical Supply Agreement dated July 5, 2018 and related Quality Agreement dated June 29, 2018. As a result, on the termination date, €33.1 million in contract liabilities from an upfront payment was recognized as revenue as no further associated performance obligations remained.

Operating result

Operating loss was €36.8 million and €63.2 million for the three and nine months ended September 30, 2020, respectively, representing an increase of €17.6 million and a decrease of €1.2 million, or an increase of 92% and a decrease of 2%, from -€19.2 million and -€64.4 million for the same periods in 2019, respectively. The decreased operating loss was mainly driven by recognition of the €33.1 million in contract liabilities upon termination of the Eli Lilly collaboration, offset by higher research and development costs, primarily due to high costs for CVnCoV R&D activities, including research material manufacturing expenses, which began in 2020. This decrease was partially offset by a decrease in cost of sales during both of these periods in 2020 as compared to 2019 due to lower set-up activities and lower product manufacturing for our collaboration partners. The increase of the other operating income was driven by higher cost reimbursements received from CEPI.

Financial Result

Financial result was €0.1 million and -€9.4 million for the three and nine months ended September 30, 2020, respectively, representing no change compared to the first three months in the same period of 2019 and a decrease of €9.6 million from €0.2 million for the nine months ended in September 2019, respectively. Financial result for the nine months ended September 30, 2020, contains mainly interest for the convertible loans, which were fully repaid, including interest, in August 2020, partially offset by foreign exchange gains.

Net loss

Net loss was €36.8 million and €71.0 million for three and nine months ended September 30, 2020, or a loss of €0.24 and €0.61 per share (on a basic and diluted basis), respectively, compared to a net loss of €18.4 million and €63.9 million, or loss of €0.19 and €0.66 per share (on a basic and diluted basis), in the same respective periods of 2019.

Conference Call and Webcast

CureVac will host an analyst and investor webcast and conference call on Monday, November 30, 2020, at 4:00 p.m. CET / 10:00 a.m. EST). The live conference call dial-in details and webcast link can be accessed via the Investor Relations section of the CureVac homepage at View Source Corresponding presentation slides will be posted shortly before the start of the webcast. A replay will be made available at this website after the event.

TG Therapeutics to Participate in the 3rd Annual Evercore ISI HealthCONx Conference

On November 30, 2020 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, will participate in a fireside chat during the 3rd Annual Evercore ISI HealthCONx Conference (Press release, TG Therapeutics, NOV 30, 2020, https://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-participate-3rd-annual-evercore-isi-healthconx [SID1234571946]). The fireside chat is scheduled to take place on Tuesday, December 1, 2020 at 10:05 AM ET.

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A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source