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Ipsen Delivered Sales Growth and Margin Expansion in 2020 – Focused on Executing New Strategy and Delivering Financial Objectives in 2021

On February 10, 2021 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, reported its financial results for the full year 2020 (Press release, Ipsen, FEB 10, 2021, View Source;Focused-on-Executing-New-Strategy-and-Delivering-Financial-Objectives-in-2021 [SID1234574875]).

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Solid full year 2020 financial results in a COVID-19 environment
Group sales of €2.592 million, growing by 3.0%1 at constant currency or 0.6% as reported, driven by Specialty Care sales growth of 5.9%1, reflecting a resilient oncology portfolio, while Consumer Healthcare sales were down 21.3%1 mostly due to the impact of COVID-19.
Core Operating margin at 32.0% of the sales, up 1.6 points. IFRS Operating margin at 20.1% of the sales, up 21.4 points.
Core consolidated net profit of €610.5 million, with fully diluted Core EPS growing by 8.4% to reach €7.31. IFRS Consolidated net profit showing a gain of €548.9 million, with IFRS net earnings per share of €6.57.
Sound financial structure, with a closing Net Debt of €525.3 million and a Net Debt to EBITDA ratio of 0.6x. Strong Free Cash Flow at €646.4 million, up 38%, mainly driven by higher Operating Cash Flow.
Advancing solid pipeline in H2 2020
Cabometyx (cabozantinib) in combination with nivolumab for 1L renal cell carcinoma (RCC) filing with EMA based on successful Phase 3 CheckMate -9ER;
Onivyde (irinotecan liposome injection) received Fast Track designation from the FDA for 2L Small Cell Lung Cancer (SCLC);
Palovarotene on track for NDA and MAA submissions for fibrodysplasia ossificans progressiva (FOP).
Proposed dividend of €1.00 per share2 for the 2020 financial year, consistent with the prior year.
2021 guidance3 of Group sales growth greater than 4.0% at constant currency and Core Operating margin greater than 30.0% of the sales.
Executing on new strategy presented in December 2020: Focus. Together. For patients and society.
David Loew, Chief Executive Officer of Ipsen, stated: "I am truly proud of Ipsen’s performance in 2020. We met our financial objectives, delivering steady top-line growth, significant core operating margin expansion and strong cash flow generation to fund our external innovation strategy. The fact these achievements took place against the backdrop of the pandemic is remarkable and speaks to the dedication and patient-centricity of our highly motivated employees. We made encouraging pipeline progress, especially in Oncology. In December we announced our new strategy which will drive long-term value for all our stakeholders: Focus. Together. For patients & society. While the world continues to face uncertain business conditions in 2021, I am confident that Ipsen will build on its strong foundations and execute on its strategy to deliver another successful year."

New Strategy

Ipsen is executing on the four key pillars of its new strategy presented in December 2020:

The Group is focused on maximizing the value of its current Specialty Care product portfolio through commercial excellence and geographic expansion. It aims to maximize its core brands and capture the full potential of its innovative oncology products. A strategic review of the Consumer Healthcare business is proceeding.
Ipsen’s priority is to build a sustainable pipeline to drive long-term growth. Recent initiatives have prioritized the pipeline on the highest potential opportunities and progressed the transformation of the R&D organization. Ipsen is strengthening its external innovation efforts by targeting differentiated medicines in its three core therapeutics areas of Oncology, Rare Disease and Neuroscience, with a broader disease and modality scope than previously defined, and across all stages of clinical development.
The company is committed to generating efficiencies through a focused and agile operating model. Leveraging smart spending, streamlined operations, manufacturing efficiencies and optimizing digitalization, the Group will be able to reinvest in R&D and external innovation to fuel future growth.
Patients and society are at the core of Ipsen’s mission, starting with fully engaged employees and a culture of accountability to perform and compete in the long term. Ipsen is highly committed to its corporate social responsibility (CSR) initiatives which are centered around employees, community and the environment, as reflected throughout the organization and in the inclusion of responsibility metrics in management compensation.

2021 Financial guidance

The Group has set the following financial targets for the current year, assuming a progressive recovery from COVID-19 by H2 2021:

Group sales growth year-on-year greater than 4.0% at constant currency1, with an expected negative 3.0% impact of currency based on the level of exchange rates at the end of January 2021;
Core Operating margin greater than 30.0% of the sales, excluding any potential impact of incremental investments from external innovation.
This guidance assumes a phased launch of lanreotide generic in Europe by mid-2021 and a limited impact in case of a potential launch of octreotide or lanreotide generics in the U.S.
Group sales reached €2,591.6 million, up 3.0%1 year-on-year.

Specialty Care sales reached €2,381.1 million, up 5.9%1, driven by the continued strong growth of Somatuline (lanreotide) and Cabometyx. Somatuline growth of 13.1%1 was driven by continued positive momentum in North America with a double-digit growth (17.0%1) and solid performance throughout Europe despite the availability of the octreotide generic. Dysport (botulinum toxin type A) down by 3.4%1, was impacted in most geographies by the closure of treatment centers resulting from COVID-19 despite a faster recovery in the aesthetics market. Decapeptyl (triptorelin) sales reflected good volume growth across Major European countries offset by lower volumes in China.

Consumer Healthcare sales reached €210.6 million, down 21.3%1, mainly due to a decline in Smecta (diosmectite) sales impacted by COVID-19, the implementation of hospital central procurement in China and lower performance in France.

Core Operating Income reached €829.3 million in 2020, compared to €782.6 million in 2019, a growth of 6.0%, driven by sales growth, Group-wide efficiencies and costs savings with less travel, medical and marketing expenses due to COVID-19 partially offset by continued investment in R&D to advance key programs in Oncology, Rare Disease and Neuroscience.

Core Operating margin reached 32.0% of the sales, up 1.6 points compared to 2019.

Core consolidated net profit was €610.5 million in 2020, an increase of 8.4% versus €563.4 million in 2019, driven by higher Core Operating Income.

Fully diluted Core EPS (earnings per share) grew by 8.4% to reach €7.31, compared to €6.74 in 2019.

IFRS Fully diluted EPS was a net profit per share amounting to €6.57 versus a net loss of €0.61 in 2019.

Free Cash Flow reached €646.4 million, up by €178.7 million, mainly driven by higher Operating Cash Flow thanks to a lower level of capital expenditures and working capital partly offset by higher cash out from restructuring costs, financial result and current income tax.

Closing net debt reached €525.3 million at the end of 2020, as compared to closing net debt in 2019 of €1,115.6 million.

Conference call

Ipsen will hold a conference call Thursday, 11 February 2021 at 2:30 p.m. (Paris time, GMT+1). Participants should dial in to the call approximately five to ten minutes prior to its start. No reservation is required to participate in the conference call.

Advanced Chemotherapy Technologies, Inc. Announces $2.5M Series A Investment by Spectrum Financial

On February 10, 2021 Advanced Chemotherapy Technologies, Inc., a clinical-stage drug delivery company, reported that it has closed a Series A investment of $2.5 million with Spectrum Financial (Press release, Advanced Chemotherapy Technologies, FEB 10, 2021, View Source [SID1234574874]). This investment is in addition to the previously announced Series A investment of $5.5 million lead by Khosla Venture. The capital will be used to fund initial clinical development of the company’s ACT-IOP-003 local chemotherapy system for the treatment of locally advanced non-resectable and borderline resectable pancreatic cancer.

For pancreatic cancer, the ACT-IOP-003 system will be used to deliver the chemotherapy drug, gemcitabine, through the dense tumor microenvironment, directly to the tumor, while also minimizing the systemic toxicity commonly associated with chemotherapy treatments for pancreatic cancer. This approach offers three major advantages over traditional systemic chemotherapy: (1) Superior delivery of chemotherapy to the tumor cells, greatly increasing the amount of drug to treat the tumor, (2) Tumor shrinkage that can enable surgical resection, the only curative treatment for pancreatic cancer, and (3) Greatly decreased systemic toxicity so that the patient can remain in treatment.

This novel implantable drug delivery system uses a mild electrical current (iontophoresis) and can deliver a wide range of drugs directly to the local tumor. The system was developed in the laboratories of Jen Jen Yeh, MD, and Joseph M. DeSimone, PhD, at the University of North Carolina (UNC) at Chapel Hill. In preclinical studies, 100% of pancreatic cancer tumors treated with the device using gemcitabine shrunk by an average of 40%, while tumors treated with intraveneously delivered gemcitabine grew an average of 240%.

"We are excited to invest behind ACT to help bring their first product to market. ACT-IOP-003 is disruptive technology that will change the cancer treatment landscape and lead to breakthroughs for patients," said Bryan Martin, Chief Investment Officer of Spectrum Financial. "We believe that the Advanced Chemotherapy Technology team has developed a truly innovative technology that holds promise to significantly improve outcomes for pancreatic cancer patients."

"We are thrilled to bring on additional investors of the quality of Spectrum Financial. Closing additional Series A funding, during these uncertain times, further validates Advanced Chemotherapy Technologies disruptive approach to local drug delivery for treating solid tumors. This funding accelerates our ability to start clinical trials for our lead product in pancreatic tumors, one of the deadlist of all cancers," said Tony Voiers, CEO of Advanced Chemotherapy Technologies.

IPA Announces Closing of Over-Allotment Option Associated with the Recently Completed Bought Deal Offering of Common Shares

On February 10, 2021 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (NASDAQ: IPA / TSX VENTURE: IPA) a leader in full-service, therapeutic antibody discovery and development, reported that the over-allotment option (the "Option") granted in connection with its previously announced bought deal offering of 1,616,293 common shares (the "Common Shares") in the capital of the Company (the "Offering"), has been fully exercised. H.C. Wainwright & Co. has purchased additional 242,443 shares of the Company (the "Additional Shares") at the public offering price of $13.45 per Additional Share for additional aggregate gross proceeds to the Company of approximately $3.3 million, less underwriting discounts and commissions (Press release, ImmunoPrecise Antibodies, FEB 10, 2021, View Source [SID1234574873]).

H.C. Wainwright & Co. acted as sole book-running manager for the Offering.

The Company intends to use the net proceeds from the Offering and the issuance and sale of the Additional Shares for (i) pursuing the Company’s objective of expanding its operations into Good Laboratory Practice and Good Manufacturing Practice-certified; (ii) the development and commercialization of Talem Therapeutics, LLC’s, a wholly owned subsidiary of the Company, internal and partnered therapeutic discovery programs; (iii) investments in employees, partnerships, cloud computing, data curation and analysis to enable further work toward the development of custom algorithms, cloud computing, large-scale sequence data analysis, and expanded access to next-generation sequencing technologies; (iv) the development of its PolyTopeTM approach to the development of innovative therapeutics and vaccines against the COVID-19; and (v) general corporate and working capital purposes.

In connection with the Offering, the Company filed with the securities regulatory authorities in each of the provinces of Canada (except Quebec), a short form base shelf prospectus dated December 11, 2020. The short form base shelf prospectus was filed on Form F-10 with the U.S. Securities and Exchange Commission ("SEC"). The Company also filed a preliminary prospectus supplement to the short form base shelf prospectus with the securities regulatory authority in the Province of British Columbia as well as with the SEC as part of a registration statement on Form F-10 under the U.S.-Canada multijurisdictional disclosure system ("MJDS"). The Common Shares were only offered and sold in the United States either directly or through duly registered U.S. broker dealers. No Common Shares were offered or sold to Canadian purchasers.

The Offering was made in the United States only by means of the registration statement, including the base shelf prospectus and applicable prospectus supplement. Such documents contain important information about the Offering. A short form base shelf prospectus and accompanying preliminary prospectus supplement have been filed with the SEC and are available for free on the SEC’s website at www.sec.gov and on the SEDAR website at www.sedar.com. Copies of the short form base shelf prospectus and accompanying final prospectus supplement have been filed with the SEC and are available for free on the SEC’s website at www.sec.gov and on the SEDAR website at www.sedar.com. Electronic copies of the final prospectus supplement and registration statement may also be obtained from H.C. Wainwright & Co., LLC, 430 Park Avenue 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing [email protected].

No securities regulatory authority has either approved or disapproved the contents of this news release. This news release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any province, state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such province, state or jurisdiction.

Kite Announces New ZUMA-1 Cohort Analysis Evaluating Prophylactic Corticosteroid Use With Yescarta® in Patients With Relapsed or Refractory Large B-cell lymphoma

On February 10, 2021 Kite, a Gilead Company (Nasdaq: GILD), reported findings from a new analysis of the ZUMA-1 trial of Yescarta (axicabtagene ciloleucel) in adult patients with relapsed or refractory large B-cell lymphoma (LBCL) (Press release, Kite Pharma, FEB 10, 2021, https://www.businesswire.com/news/home/20210210005173/en/Kite-Announces-New-ZUMA-1-Cohort-Analysis-Evaluating-Prophylactic-Corticosteroid-Use-With-Yescarta%C2%AE-in-Patients-With-Relapsed-or-Refractory-Large-B-cell-lymphoma [SID1234574872]). Results were presented today in an oral session at the Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy (ASTCT) and Center for International Blood & Marrow Transplant Research (CIBMTR) (Abstract #70).

In a new ZUMA-1 safety management cohort (Cohort 6), the primary objective was to assess the impact of prophylactic use of corticosteroids and earlier treatment with corticosteroids and/or tocilizumab on the incidence and severity of cytokine release syndrome (CRS) and neurologic events. Patients with relapsed or refractory LBCL received dexamethasone 10 mg orally on the day of Yescarta infusion and each of the two following days. Corticosteroids and tocilizumab were started earlier, at lower grades of CRS and neurologic events, in Cohort 6 than in the ZUMA-1 pivotal cohorts (Cohorts 1 and 2). All 40 patients enrolled in Cohort 6 received at least one dose of corticosteroids.

In the Cohort 6 primary analysis, no Grade ≥3 CRS occurred. Grade ≥3 neurologic events occurred in 13 percent of patients and no patients experienced Grade 5 neurologic events at the time of data cut-off. Median time to onset of any grade CRS was five days and any grade neurologic events was six days. Sixty-eight percent of patients had no CRS or neurologic events within 72 hours of Yescarta infusion. Ninety-five percent of patients in Cohort 6 responded to Yescarta, including 80 percent of patients who achieved a complete response; 63 percent of patients were in an ongoing response at the time of the data cut-off (median study follow-up of 8.9 months). The median duration of response has not yet been reached.

A post-hoc propensity score-matching analysis was performed by selecting closely matched subgroups from Cohort 6 and pivotal cohorts based on pre-specified prognostic factors for patients with LBCL. This analysis provided a more robust comparison of the safety, efficacy and pharmacokinetic/pharmacodynamic profiles of Cohort 6 with pivotal cohorts. In this propensity score-matched subset, incidence of Grade ≥3 CRS was lower in Cohort 6 (0 percent) than in matched patients from the pivotal cohorts (13 percent) and median time to CRS onset was delayed (5 days versus 2 days). Severity and onset of neurologic events were generally similar between cohorts after propensity score-matching. The propensity score-matching analysis suggested that response rates in Cohort 6 were comparable to those observed in the pivotal cohorts.

"While previous analyses demonstrated a decrease in severity of CRS and neurologic events with earlier steroid intervention, this study suggests that prophylactic corticosteroids may also provide a benefit without compromising efficacy," said Olalekan O. Oluwole, MBBS, MPH, ZUMA-1 Cohort 6 lead investigator and Associate Professor of Medicine, Vanderbilt University Medical Center. "With two-thirds of patients experiencing no CRS or neurologic events up to three days after Yescarta and a five day time to onset of CRS, it is highly encouraging that use of prophylactic steroids may play a significant role in reducing the severe side effects of CAR T."

"As we work to bring the benefits of Yescarta to more patients, these results provide important insights into the use of Yescarta in LBCL, and for safety management protocols for trials with our CAR T-cell therapies," said Frank Neumann, MD, PhD, Kite’s Global Head of Clinical Development.

Yescarta was the first CAR T-cell therapy to be approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, and high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. The Yescarta U.S. Prescribing Information has a BOXED WARNING for the risks of CRS and neurologic toxicities, and Yescarta is approved with a risk evaluation and mitigation strategy (REMS) due to these risks; see below for Important Safety Information.

Prophylactic use of corticosteroids has not been approved by any regulatory agency in conjunction with Yescarta therapy. The safety and efficacy of this prophylactic adverse event management protocol requires further clinical investigation.

U.S. Important Safety Information for Yescarta

BOXED WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITIES

Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving Yescarta. Do not administer Yescarta to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving Yescarta, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with Yescarta. Provide supportive care and/or corticosteroids as needed.
Yescarta is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta and Tecartus REMS Program.
CYTOKINE RELEASE SYNDROME (CRS) occurred in 94% of patients, with 13% ≥ Grade 3. Among patients who died after receiving Yescarta, 4 had ongoing CRS at death. The median time to onset was 2 days (range: 1-12 days) and median duration was 7 days (range: 2-58 days). Key manifestations include fever (78%), hypotension (41%), tachycardia (28%), hypoxia (22%), and chills (20%). Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome. Ensure that 2 doses of tocilizumab are available prior to Yescarta infusion. Following infusion, monitor patients for signs and symptoms of CRS at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab or tocilizumab and corticosteroids as indicated.

NEUROLOGIC TOXICITIES occurred in 87% of patients, 98% of which occurred within the first 8 weeks with a median time to onset of 4 days (range: 1-43 days) and a median duration of 17 days. Grade ≥3 occurred in 31% of patients. The most common neurologic toxicities included encephalopathy (57%), headache (44%), tremor (31%), dizziness (21%), aphasia (18%), delirium (17%), insomnia (9%), and anxiety (9%). Prolonged encephalopathy lasting up to 173 days was noted. Serious events including leukoencephalopathy and seizures, as well as fatal and serious cases of cerebral edema have occurred. Following Yescarta infusion, monitor patients for signs and symptoms of neurologic toxicities at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter, and treat promptly.

REMS: Because of the risk of CRS and neurologic toxicities, Yescarta is available only through a restricted program called the Yescarta and Tecartus REMS Program which requires that: Healthcare facilities that dispense and administer Yescarta must be enrolled and comply with the REMS requirements and must have on-site, immediate access to a minimum of 2 doses of tocilizumab for each patient for infusion within 2 hours after Yescarta infusion, if needed for treatment of CRS. Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer Yescarta are trained about the management of CRS and neurologic toxicities. Further information is available at www.YescartaTecartusREMS.com or 1-844-454-KITE (5483).

HYPERSENSITIVITY REACTIONS: Allergic reactions, including serious hypersensitivity reactions or anaphylaxis, may occur with the infusion of Yescarta.

SERIOUS INFECTIONS: Severe or life-threatening infections occurred. Infections (all grades) occurred in 38% of patients. Grade ≥3 infections occurred in 23% of patients; those due to an unspecified pathogen occurred in 16% of patients, bacterial infections in 9%, and viral infections in 4%. Yescarta should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after infusion and treat appropriately. Administer prophylactic anti-microbials according to local guidelines. Febrile neutropenia was observed in 36% of patients and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum antibiotics, fluids, and other supportive care as medically indicated. In immunosuppressed patients, including those who have received Yescarta, life-threatening and fatal opportunistic infections including disseminated fungal infections (e.g., candida sepsis and aspergillus infections) and viral reactivation (e.g., human herpes virus-6 [HHV-6] encephalitis and JC virus progressive multifocal leukoencephalopathy [PML]) have been reported. The possibility of HHV-6 encephalitis and PML should be considered in immunosuppressed patients with neurologic events and appropriate diagnostic evaluations should be performed. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing.

PROLONGED CYTOPENIAS: Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and Yescarta infusion. Grade ≥3 cytopenias not resolved by Day 30 following Yescarta infusion occurred in 28% of patients and included thrombocytopenia (18%), neutropenia (15%), and anemia (3%). Monitor blood counts after infusion.

HYPOGAMMAGLOBULINEMIA and B-cell aplasia can occur. Hypogammaglobulinemia occurred in 15% of patients. Monitor immunoglobulin levels after treatment and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement. The safety of immunization with live viral vaccines during or following Yescarta treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during Yescarta treatment, and until immune recovery following treatment.

SECONDARY MALIGNANCIES may develop. Monitor life-long for secondary malignancies. In the event that one occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following Yescarta infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.

ADVERSE REACTIONS: The most common (incidence ≥20%) include CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections-pathogen unspecified, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias.

Kezar Life Sciences to Present at BIO CEO & Investor Digital Conference

On February 10, 2021 Kezar Life Sciences, Inc. (Nasdaq:KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, reported its Chief Executive Officer, John Fowler, will present a corporate overview at the BIO CEO & Investor Digital Conference, being held from February 16 – 18, 2021 (Press release, Kezar Life Sciences, FEB 10, 2021, View Source [SID1234574871]). Kezar’s Chief Scientific Officer, Chris Kirk, Ph.D., will participate in a panel discussion, "Progress in Drugging the Undruggable Cancer Targets" at the conference.

The presentation will be available on demand on Tuesday, February 16, 2021 and may be accessed at the "Events & Presentations" section of the Company’s website at View Source Kezar Life Sciences will maintain an archived replay of the webcast on its website for 90 days after the conference.