On February 25, 2021 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, and Pierre Fabre, a leading French pharmaceutical company, reported that they have agreed to extend the terms of the 2019 license agreement which grants Pierre Fabre exclusive rights to develop and commercialize NERLYNX (neratinib) within Europe, Turkey, Middle East and Africa (Press release, Puma Biotechnology, FEB 25, 2021, View Source [SID1234575691]). The amended agreement extends Pierre Fabre’s commercial rights for NERLYNX to Greater China, which includes mainland China, Taiwan, Hong Kong and Macau.

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Under the terms of the amendment, Puma will receive an upfront payment of $50 million, as well as additional regulatory and sales-based milestone payments that could add up to an additional $240 million. These milestones will be based solely on regulatory and sales achievements in Greater China. In addition, Puma will receive significant double-digit tiered royalties on the sales of NERLYNX in Greater China.

Concomitantly, Puma and CANbridge Pharmaceuticals, Inc., a biopharmaceutical company focused on developing drug candidates in China and North Asia, have mutually agreed to terminate the license agreement to commercialize NERLYNX (neratinib) in Greater China. Puma has agreed to pay CANbridge a one-time termination fee of $20 million to return all rights to neratinib in Greater China back to Puma. Additionally, Puma has agreed to dismiss the arbitration demand it filed on July 28, 2020 against CANbridge related to the parties’ 2018 license agreement, and as part of the settlement, CANbridge has agreed to dismiss its counterclaims against Puma. Such settlement is limited to claims that arose in arbitration, or could have been raised in arbitration, as well as claims arising under the to be terminated license agreement.

Alan H. Auerbach, Chief Executive Officer and President of Puma, said, "We are pleased to extend our collaboration with Pierre Fabre into the Greater China region. Pierre Fabre is well equipped with existing infrastructure to make NERLYNX a success in mainland China and Pierre Fabre plans to make NERLYNX available to breast cancer patients in mainland China in the second quarter of this year."

"We are excited about the opportunity to provide NERLYNX to Chinese patients with early stage HER2-positive breast cancer," said Jean-Luc Lowinsky, Chief Executive Officer, Pierre Fabre Pharmaceuticals. "Our oncology team based in Shanghai is fully committed to start the commercialization of NERLYNX, which perfectly complements our existing NAVELBINE chemotherapy in breast and lung cancers."

Neratinib is approved in the United States for both the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy and for adult patients with advanced or metastatic HER2-positive breast cancer in combination with capecitabine in patients who have received two or more prior anti-HER2 based regimens and is marketed in the United States as NERLYNX (neratinib) tablets.

About HER2-Positive Breast Cancer

Up to 20% of patients with breast cancer tumors over-express the HER2 protein (HER2-positive disease) and in the ExteNET study, 57% of patients were found to have tumors that were hormone-receptor positive. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer recurring, up to 25% of patients treated with trastuzumab experience recurrence within 10 years, the majority of which are metastatic recurrences.

On February 25, 2021 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company") a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported its financial results and business highlights for the fourth quarter and full year ended December 31, 2020 (Press release, Cyclacel, FEB 25, 2021, View Source [SID1234575777]).

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The Company’s net loss applicable to common shareholders for the three months and year ended December 31, 2020 was $6.6 million and $12.4 million, respectively. As of December 31, 2020, cash and cash equivalents totaled $33.4 million. Additional proceeds of $4.3 million were received from the exercise of warrants after December 31, 2020. Based on current spending, the proforma cash on hand of $37.7 million provides the Company with sufficient resources to fund planned operations including research and development through early 2023.

"During 2020 we have reported on fadraciclib’s oral bioavailability and evidence of durable anticancer activity," said Spiro Rombotis, President and Chief Executive Officer. "Independent evidence supporting the rationale for dual inhibition of CDK2 and CDK9 cancer pathways, the targets of fadraciclib, were published in peer-reviewed communications. Meanwhile our team, led by Dr. Mark Kirschbaum, our newly appointed CMO, has prepared a streamlined clinical development strategy to evaluate oral fadraciclib in multi-cohort, Phase 1b/2, registration-directed, studies for both solid and liquid cancers. A similar trial design will be applied to the development of CYC140, our selective PLK1 inhibitor, supported by extensive preclinical data demonstrating CYC140’s antimitotic mechanism and broad therapeutic potential in both solid and liquid cancers. We look forward to providing further details of our clinical development plans and our progress with fadraciclib and CYC140 to drive shareholder value."

Key 2020 Highlights

Corporate

Appointed Mark Kirschbaum, M.D. as Senior Vice President and Chief Medical Officer. Dr. Kirschbaum is a highly experienced hematologist/oncologist with over 30 years of experience in molecular medicine, new drug development, clinical trial design and patient care. Most recently, Dr. Kirschbaum served as Vice President, Hematology/Oncology at ArQule Inc.

Appointed two new Directors to strengthen and broaden our Board’s skill base:

Brian Schwartz, M.D. has wide-ranging experience as a drug development expert in the biopharmaceutical industry primarily in oncology, hematology, and rare diseases. Brian was formerly Senior Vice President, Head of Research & Development and Chief Medical Officer of ArQule Inc., which was acquired by Merck & Co. in 2020 for $2.7 billion. Dr. Schwartz is a member of the Company’s Science & Technology Committee.

Karin L. Walker brings over 30 years of extensive finance experience in biopharmaceuticals, including public biotechnology and technology companies. Ms. Walker currently serves as the Chief Accounting Officer of Prothena Corporation plc. Ms. Walker has been appointed as Chair of the Audit Committee.

Raised approximately $25 million in net cash in two equity financings, including a strategic investment by Acorn Bioventures of $6.9 million, net. An additional $8.8 million of proceeds have been received through warrant exercises ($4.3 million of which after year end).
Clinical studies

Reported data from a Phase 1 study of fadraciclib as a single agent at the Plenary Session of the 32nd EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Symposium:
Radiographically confirmed partial response (PR) after a month and a half on i.v. fadraciclib in a patient with MCL1-amplified endometrial cancer, who failed seven lines of prior therapy and is continuing treatment for more than 18 months with 96% reduction in target tumor lesions.
High bioequivalence observed in five patients treated with oral fadraciclib.
Enrolled 19 patients with relapsed or refractory AML/MDS and CLL receiving i.v. fadraciclib in combination with venetoclax with evidence of antileukemic activity.
Enrolled seven patients evaluating i.v. CYC140 in patients with advanced leukemias.
Enrolled 12 patients with relapsed or refractory AML/MDS in a Phase 1/2 study evaluating an oral regimen of sapacitabine in combination with venetoclax.
Announced a peer-reviewed publication describing the discovery of fadraciclib in PLOS ONE. Authored by scientists from Cyclacel and The Institute of Cancer Research, London, the publication shows that targeting of CDK2 and CDK9 holds broad therapeutic potential.
More information on our clinical trials can be found here.

Key Business Objectives for 2021

First patient dosed with oral fadraciclib in Phase 1b/2 advanced solid tumor and leukemia studies
First patient dosed with oral CYC140 in Phase 1/2 advanced solid tumor and leukemia studies
Manufacture clinical supplies of oral fadraciclib and oral CYC140 for registration-enabling studies
Data on safety and antileukemic activity from the i.v. fadraciclib-venetoclax Phase 1 study in relapsed/refractory AML and CLL
Data from the sapacitabine-venetoclax Phase 1/2 study in relapsed/refractory AML or MDS
Initial data from the i.v. CYC140 Phase 1 First-in-Human study in patients with advanced leukemias
Data from the Phase 1b/2 IST of sapacitabine-olaparib combination in patients with BRCA mutant metastatic breast cancer when reported by the investigators.
Financial Highlights

As of December 31, 2020, cash and cash equivalents totaled $33.4 million, compared to $11.9 million as of December 31, 2019. The increase of $21.5 million was primarily due to $29.5 million of net cash provided by financing activities, offset by net cash used in operating activities of $7.9 million and $0.1 million of net cash used in investing activities.

Research and development expenses were $1.4 million and $4.8 million for the three months and year ended December 31, 2020 as compared to $1.4 million and $4.7 million for the same periods in 2019. Research and development expenses relating to the transcriptional regulation, CDK inhibitor program with fadraciclib increased by $0.5 million from $3.1 million for the year ended December 31, 2019 to $3.6 million for the year ended December 31, 2020, as the clinical evaluation of fadraciclib progressed. Research and development expenses relating to CYC140 decreased by $0.1 million from $0.7 million for the year ended December 31, 2019 to $0.6 million for the year ended December 31, 2020, primarily as a result of a reduction in expenditures associated with drug supply manufacturing which were not required in 2020. Research and development expenses relating to other research and development decreased by $0.1 million from $0.4 million for the year ended December 31, 2019 to $0.3 million for the year ended December 31, 2020, due to a reduction in consultancy costs.

General and administrative expenses for the three months and year ended December 31, 2020 were $1.7 million and $5.9 million respectively, compared to $1.4 million and $5.0 million for the same periods of the previous year.

Total other income, net for the three months and year ended December 31, 2020 were $14,000 expense and $1.0 million income, compared to $41,000 and $0.6 million income for the same periods of the previous year. The increase of $0.4 million for the year ended December 31, 2020 is primarily related to income received under an Asset Purchase Agreement with ThermoFisher Scientific.

United Kingdom research & development tax credits were $0.4 million and $1.2 million for the three months and year ended December 31, 2020 as compared to $0.4 million and $1.3 million for the same periods in 2019.

Net loss for the three months and year ended December 31, 2020 were $2.8 million and $8.4 million compared to $2.3 million and $7.8 million for the same periods in 2019.

The Company raised net proceeds of approximately $29.7 million during 2020, from agreements to sell securities and warrant conversions. An additional $4.3 million in proceeds from warrant conversions was received after year end.

The Company estimates that proforma cash resources, including proceeds of recent warrant exercises after December 31, 2020, of $37.7 million, will fund currently planned programs through early 2023.

On February 25, 2021 Break Through Cancer (www.breakthroughcancer.org) reported its formal launch as a public foundation designed to find new solutions to the most intractable challenges in cancer (Press release, Break Through Cancer, FEB 25, 2021, View Source [SID1234575797]). The foundation is being launched with an extraordinary challenge pledge of $250 million from Mr. and Mrs. William H. Goodwin, Jr. and their family, and the estate of William Hunter Goodwin, III. This represents one of the largest gifts ever in support of cancer research. Led by Dr. Tyler Jacks, Founding Director of the Koch Institute for Integrative Cancer Research at the Massachusetts Institute of Technology, the David H. Koch Professor of Biology and Co-director of the Ludwig Center for Molecular Oncology, Break Through Cancer will fund and support collaborative research teams drawn from several of the country’s top cancer centers.

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Multidisciplinary research teams will be selected from across five participating institutions: Dana-Farber Cancer Institute, the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, The University of Texas MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, and the Koch Institute for Integrative Cancer Research at MIT.

Break Through Cancer will focus on historically highly challenging cancer types, including pancreatic cancer, ovarian cancer, glioblastoma, and acute myelogenous leukemia (AML), for its initial programs, aided by the guidance of a scientific advisory board of cancer experts from outside the participating institutions. Teams will receive substantial funding to bring new approaches and new thinking as rapidly as possible to the clinical challenges of cancer.

"Break Through Cancer’s model builds on the outstanding efforts of the broader cancer research community and presents the potential for major advances in our shared fight against these intractable cancers," said Dr. Jacks, President of Break Through Cancer. "Our tagline, "collaborating for cures," captures our collective goal to empower many of the brightest, most dedicated minds in cancer research and to maximize the capabilities of these highly respected institutions. In the future, we look forward to partnering with the broader philanthropic, biotech, and pharmaceutical communities to expand the impact of Break Through Cancer further still."

The organization is supported by a board that includes leaders from each of the participating institutions, with William G. Nelson, V, MD, PhD, the Marion I. Knott Professor of Oncology and Director of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, serving as Chairman.

"We owe a debt of gratitude to the Goodwin family and the late Hunter Goodwin, whose vision and generosity made this powerful collaboration possible," said Dr. Nelson, Break Through Cancer’s Chairman. "Their contributions have been key both financially and conceptually, as we worked together to create a research model that will provide a compelling advantage in the search for cures. We are fortunate to have such strong commitments from all of the parties involved."

"We realize there are no guarantees, yet we believe this effort to fight cancer, particularly with collaborative research, has a realistic probability of success," said Bill Goodwin. "We want to help people have better lives. And we sincerely hope that by being public with our support, we will inspire others to support this incredible effort."

On February 25, 2021 BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) reported financial results for the fourth quarter and full year ended December 31, 2020, and provided a corporate update (Press release, BioCryst Pharmaceuticals, FEB 25, 2021, View Source [SID1234575594]).

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"With two approvals for ORLADEYO, our launch in the U.S., proof of concept data for BCX9930 in complement-mediated diseases, a successful phase 1 trial of BCX9250 for FOP and the addition of more than $425 million through our May and December financings, 2020 was a transformational year for BioCryst," said Jon Stonehouse, president and chief executive officer of BioCryst.

"Using our strong balance sheet as a foundation, we expect to continue this transformation in 2021 with ORLADEYO generating revenue in the U.S., Japan and Europe, and the opportunity to significantly advance the 9930 program as an oral monotherapy for both PNH, and renal complement-mediated diseases," Stonehouse added.

Program Updates and Key Milestones

ORLADEYO (berotralstat): Oral, Once-daily Treatment for Prevention of Hereditary Angioedema (HAE) Attacks

BioCryst launched ORLADEYO in the United States following U.S. Food and Drug Administration (FDA) approval on December 3, 2020, and product shipments began on December 16, 2020.

On January 22, 2021, the company announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan had granted marketing and manufacturing approval for oral, once-daily ORLADEYO 150 mg for prophylactic treatment of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.

ORLADEYO is the first and only prophylactic HAE medication approved in Japan and will be commercialized in Japan by BioCryst’s partner, Torii Pharmaceutical Co., Ltd. OrphanPacific, Inc. is BioCryst’s representative partner in Japan and holds the marketing authorization.

Torii will launch ORLADEYO in Japan following the successful completion of BioCryst’s pricing negotiations with the Japanese National Health Insurance System (NHI).

BioCryst is eligible to receive an additional milestone payment of $15 million from Torii upon receipt of a reimbursement price from the NHI in excess of the threshold specified in the agreement with Torii. In addition, BioCryst will receive tiered royalties ranging from 20 percent to potentially 40 percent of Japanese net sales.
In Europe, the Committee for Medicinal Products for Human Use (CHMP) is scheduled to review the ORLADEYO marketing authorization application this week. The company expects approval from the European Commission (EC) approximately 60 days following a positive opinion from the CHMP.

On October 30, 2020, the company announced that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) had granted ORLADEYO a positive scientific opinion through the Early Access to Medicines Scheme (EAMS). Under the EAMS, HAE patients in the UK aged 12 years and older can gain access to ORLADEYO for the routine prevention of recurrent attacks of HAE before the drug is granted marketing authorization by the EC.

In the fourth quarter of 2020, the company presented data in several manuscripts and abstracts.

On October 22, 2020, the company announced that data from the first 24 weeks of the Phase 3 APeX-2 trial of ORLADEYO in 121 HAE patients ages 12 years or older had been published online by the Journal of Allergy and Clinical Immunology.

On November 13, 2020, the company presented data in several abstracts at the 2020 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology across HAE patients, caregivers and treating physicians showing many patients experience a significant treatment burden associated with current prophylactic HAE therapies.

On November 30, 2020, the company announced that the journal Allergy had published data from the APeX-J trial, a randomized, placebo-controlled trial conducted in Japan evaluating ORLADEYO for the prophylactic treatment of HAE.
Complement Oral Factor D Inhibitor Program – BCX9930

The company has completed the enrollment of its ongoing dose ranging trial in treatment-naïve (no prior treatment with C5 inhibitors) paroxysmal nocturnal hemoglobinuria (PNH) patients, and PNH patients with an inadequate response to C5 inhibitors. The company plans to present data from the 16 enrolled PNH patients (10 treatment naïve and six inadequate C5 responders) at its upcoming R&D day on March 22.

In previously reported data from treatment-naïve (no prior treatment with C5 inhibitors) PNH patients receiving doses of oral BCX9930 through 400 mg bid, oral BCX9930 drove rapid and dose-dependent reductions in key biomarkers, including LDH, and increasing hemoglobin levels in all PNH patients in the trial. Increases in hemoglobin levels were maintained without transfusions. BCX9930 has been safe and well tolerated at all doses in the trial. No drug-related serious adverse events have been reported.
Additional Updates

On December 7, 2020, the company announced transactions totaling $325 million in funding for BioCryst, with $250 million available at closing, to support the launch of ORLADEYO in HAE and the development of BCX9930. Royalty Pharma provided BioCryst with an upfront cash payment of $125 million and will receive royalties on direct annual net sales of ORLADEYO up to $550 million, and a tiered percentage of sublicense revenue for ORLADEYO in certain territories. In addition, Royalty Pharma will receive a 1.0% royalty on global net sales of BCX9930, if approved. A fund managed by Athyrium Capital Management provided BioCryst with a $200 million credit facility, of which BioCryst drew $125 million at closing. The additional capital will be available in two tranches at BioCryst’s option, upon reaching defined revenue milestones. The credit facility bears interest at LIBOR + 8.25% (with a LIBOR floor of 1.75%) and is interest-only for the entire five-year term, with all outstanding principal due at maturity.

On December 21, 2020, the company announced that in a Phase 1 clinical trial with BCX9250, an oral activin receptor-like kinase-2 (ALK-2) inhibitor discovered and developed by BioCryst for the treatment of fibrodysplasia ossificans progressiva, BCX9250 was safe and well tolerated at all doses studied, with linear and dose-proportional exposure supporting once-daily dosing.

On February 3, 2021, the company announced that the FDA had approved a supplemental new drug application for RAPIVAB (peramivir injection) expanding the patient population of RAPIVAB for the treatment of acute uncomplicated influenza to include patients six months and older who have been symptomatic for no more than two days. Prior to this approval, RAPIVAB had been indicated for patients two years and older.
Fourth Quarter 2020 Financial Results

For the three months ended December 31, 2020, total revenues were $4.0 million, compared to $39.7 million in the fourth quarter of 2019. In the fourth quarter of 2019, we recognized revenue of $20.1 related to a one-time upfront milestone per the Torii agreement. Additionally, in that period we recognized $13.9 million of RAPIVAB product sales under our U.S. Department of Health and Human Services (HHS) contract, while in the fourth quarter 2020 we had no RAPIVAB product sales under our HHS contract. ORLADEYO revenues in the fourth quarter of 2020 were $0.1 million.

Research and development (R&D) expenses for the fourth quarter of 2020 increased to $35.4 million from $26.8 million in the fourth quarter of 2019, primarily due to increased investment in our Factor D and galidesivir programs, partially offset by a ramp down of clinical investment related to ORLADEYO, which launched commercially in the U.S. during December 2020.

Selling, general and administrative (SG&A) expenses for the fourth quarter of 2020 increased to $21.0 million, compared to $10.5 million in the fourth quarter of 2019. The increase was primarily due to increased investment in commercial activities to support the U.S. launch of ORLADEYO.

Interest expense was $5.6 million in the fourth quarter of 2020, compared to $3.1 million in the fourth quarter of 2019. This increase was due to service on the royalty and debt financings which were completed in December 2020. As part of those financings, there was also a loss on debt extinguishing related to the closing of our secured credit facility with MidCap Financial.

Net loss for the fourth quarter of 2020 was $60.5 million, or $0.34 per share, compared to a net loss of $2.6 million, or $0.02 per share, for the fourth quarter of 2019.

Cash, cash equivalents, restricted cash and investments totaled $302.6 million at December 31, 2020, and reflect an increase from $137.8 million at December 31, 2019. Cash, cash equivalents, restricted cash and investments include $250 million in cash received through transactions with Royalty Pharma and Athyrium Capital Management in December 2020. Operating cash use for the fourth quarter of 2020 was $49.9 million, and for the full year of 2020 was $147.9 million.

Full Year 2020 Financial Results

For the full year ended December 31, 2020, total revenues were $17.8 million, compared to $48.8 million in the full year ended December 31, 2019. In the fourth quarter of 2019 we recognized revenue of $20.1 related to a one-time upfront milestone per the Torii agreement, with the remaining amount of $1.9 million recognized in 2020. Additionally, in the fourth quarter of 2019 we recognized $13.9 million of RAPIVAB product sales under our HHS contract, while in the fourth quarter 2020 we had no RAPIVAB product sales under our HHS contract.

R&D expenses in full year 2020 increased to $123.0 million from $107.1 million in full year 2019, primarily due to increased investment in our Factor D and galidesivir programs, and an increase in other research, preclinical and development activities, partially offset by a ramp down of clinical investment related to ORLADEYO, which launched commercially in the U.S. during December 2020.

SG&A expenses in full year 2020 increased to $67.9 million, compared to $37.1 million in full year 2019. The increase was primarily due to increased investment in commercial activities to support the U.S. launch of ORLADEYO.

Interest and other income was $9.4 million in full year 2020, compared to $1.9 million in full year 2019. The increase was primarily due to the settlement of arbitration proceedings related to our Seqirus dispute in the first quarter of 2020.

Interest expense was $14.5 million in full year 2020, compared to $11.9 million in full year 2019. This was due to service on the royalty and debt financings which were completed in December 2020. As part of those financings, there was also a loss on debt extinguishing related to the closing of our secured credit facility with MidCap Financial.

Net loss for full year 2020 was $182.8 million, or $1.09 per share, compared to a net loss of $108.9 million, or $0.94 per share, for full year 2019.

Financial Outlook for 2021

In the launch period for ORLADEYO, the company is not providing specific revenue or operating expense guidance. Based on our expectations for revenue, operating expenses, and our option to access an additional $75 million from our existing credit facility, we believe our current cash runway takes us into 2023.

Conference Call and Webcast

BioCryst management will host a conference call and webcast at 8:30 a.m. ET today to discuss the financial results and provide a corporate update. The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 6779206. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 6779206.

On February 25, 2021 Redx Pharma (AIM:REDX), the drug discovery and development Company focused on oncology and fibrosis, reported that Lisa Anson, Chief Executive Officer, will give an update on progress made by the Company, at the Cowen 41st Annual Health Care Conference on Thursday 4 March, 2021 at 16:10 GMT / 11:10 EST (Press release, Redx Pharma, FEB 25, 2021, View Source [SID1234575632]).

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