On October 29, 2020 Cerus Corporation (Nasdaq: CERS) reported financial results for the third quarter ended September 30, 2020 (Press release, Cerus, OCT 29, 2020, View Source [SID1234569360]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Recent developments and highlights include:

Q3 2020 Total Revenue of $29.2 million – driven by significant year-over-year platelet kit sales growth in the U.S. as well as plasma and platelet kit sales from the EMEA region. Total revenue was composed of (in millions, except %):
New technology add-on payment (NTAP) application submitted to the Centers for Medicare and Medicaid Services for pathogen-reduced cryoprecipitated fibrinogen complex (PR-Cryo)
First two modules (Clinical data package and Safety and Quality data package) submitted for CE Mark for INTERCEPT red blood cells
Entered into a five-year contract with the U.S. Food and Drug Administration (FDA) for the development of next generation compounds to optimize pathogen reduction treatment of whole blood to reduce the risk of transfusion transmitted infections
Presented 17 abstracts at the AABB 2020 Virtual Meeting highlighting the clinical and operational benefits of the INTERCEPT Blood System for platelets
Narrowing full year product revenue guidance to a range of $89 million to $91 million given the adverse effects of the COVID-19 pandemic on the U.S. and EMEA blood supply
Cash, cash equivalents, and short-term investments of $135.1 million at September 30, 2020
"We are pleased to report another record quarter with U.S. platelet kit sales fueling top line growth as blood centers and hospitals continue to embrace the INTERCEPT Blood System to comply with the FDA guidance on bacterial safety," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. "While COVID-19 has successfully underscored the global importance of pathogen reduction for pandemic preparedness, the potential for additional disruptions to the blood supply this fall and winter leads us to narrow our 2020 guidance range due to recent sharp rises in new COVID cases in certain regions, including Europe. We remain confident in our longer term growth opportunities, especially in the U.S. and with an anticipated continued increase in INTERCEPT adoption even beyond the March 2021 FDA compliance deadline."

Revenue
Product revenue during the third quarter of 2020 was $23.6 million, compared to $18.0 million during the same period in 2019, an increase of 31%. Revenue growth in the quarter benefited from robust year-over-year platelet kit sales in the U.S., in addition to strong plasma kit demand in our EMEA region. Year-to-date product revenue totaled $63.7 million, an increase of 19% compared to the same period in 2019.

Government contract revenue from the Company’s Biomedical Advanced Research and Development Authority (BARDA) agreement was $5.6 million during the third quarter of 2020, compared to $4.8 million during the same period in 2019, as a result of increasing INTERCEPT red blood cell clinical and development activities. Year-to-date government contract revenue totaled $16.9 million, compared to $13.6 million during the first three quarters of 2019. The total potential value of the current BARDA agreement is $214 million with $61 million recognized as revenue to date. The Company has not yet recognized any revenue to date from the recently awarded whole-blood pathogen reduction FDA contract.

BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. The development of the INTERCEPT red blood cell program has been funded partially with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600009C.

Gross Margins
Gross margins on product revenue during the third quarter of 2020 were 54% compared to 58% in the prior year period. Gross margins during the quarter were negatively impacted by an $870,000 non-routine period charge tied to certain inventoried components that failed to meet the Company’s quality standards. This non-routine period charge negatively impacted Q3 2020 gross margins by 3.7 percentage points. Gross margins during the first nine months of 2020 were 55% and consistent with those reported in the same period the prior year.

Operating Expenses
Total operating expenses for the third quarter of 2020 were $32.2 million and essentially flat compared with the same period during the prior year. Year to date, operating expenses totaled $95.7 million compared to $93.0 million for the first nine months of 2019.

Selling, general, and administrative (SG&A) expenses for the third quarter of 2020 totaled $16.3 million, compared to $16.1 million for the third quarter of 2019. Year-to-date SG&A expenses totaled $48.3 million compared to $49.0 million for the first nine months of 2019.

Research and development (R&D) expenses for the third quarter of 2020 were $15.9 million, compared to $16.1 million for the third quarter of 2019. Year-to-date R&D expenses totaled $47.3 million compared to $43.9 million for the first nine months of 2019 with the increase primarily tied to costs related to the red blood cell program as well as increased costs tied to product enhancements and expanded label claims for INTERCEPT-treated platelets.

Net Loss
Net loss for the third quarter of 2020 was $14.1 million, or $0.08 per diluted share, compared to a net loss of $18.0 million, or $0.13 per diluted share, for the third quarter of 2019. Year-to-date net loss was $45.5 million, or $0.28 per diluted share, compared to $54.3 million, or $0.39 per diluted share, in the first nine months of 2019.

Cash, Cash Equivalents and Investments
At September 30, 2020, the Company had cash, cash equivalents and short-term investments of $135.1 million, compared to $85.7 million at December 31, 2019.

At September 30, 2020, the Company had approximately $39.5 million in outstanding term loan debt, compared to $39.4 million in outstanding term loan debt at December 31, 2019.

2020 Product Revenue Guidance
The Company is narrowing its previously stated product revenue guidance range. The Company expects 2020 product revenue to be in the range of $89 million to $91 million, compared to our previous guidance range of $89 million to $93 million.

QUARTERLY CONFERENCE CALL

The Company will host a conference call and webcast at 4:30 P.M. EDT this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To listen to the live webcast and view the presentation slides, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on the Company’s website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 7249794. The replay will be available approximately three hours after the call through November 12, 2020.

On October 29, 2020 Seagen Inc. (Nasdaq:SGEN) reported financial results for the third quarter and nine months ended September 30, 2020 (Press release, Seagen, OCT 29, 2020, View Source [SID1234569359]). The Company also highlighted ADCETRIS (brentuximab vedotin), PADCEV (enfortumab vedotin-ejfv) and TUKYSA (tucatinib) commercial and development accomplishments, as well as progress with its lead pipeline programs to treat cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our third quarter and year-to-date strong financial performance was driven by product sales across our diverse portfolio of three marketed products as well as the positive financial impact of our recent collaborations with Merck on ladiratuzumab vedotin and TUKYSA," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seagen. "We plan to report clinical and preclinical data across our programs at several medical meetings during the remainder of 2020. In addition, we are pursuing multiple regulatory submissions, including our TUKYSA MAA that is under review by the EMA, a planned tisotumab vedotin BLA in the U.S. and global marketing applications for PADCEV. With our significant financial resources, robust drug development pipeline, expanding footprint in Europe and strategic oncology collaborations, we are well-positioned to continue building Seagen to address the unmet medical needs of cancer patients around the globe."

COMMERCIAL PRODUCTS HIGHLIGHTS

ADCETRIS

Presenting Data in Multiple Abstracts at ASH (Free ASH Whitepaper): ADCETRIS will be featured in multiple abstracts at the 62nd Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper), which will be a virtual event taking place December 5-8, 2020. Data will include five-year follow-up results from the ECHELON-1 trial in frontline stage III and IV Hodgkin lymphoma and the ECHELON-2 trial in frontline CD30-expressing peripheral T-cell lymphomas.
PADCEV

Announced Positive Topline Results from EV-301 Phase 3 Trial: In September 2020, Seagen and Astellas announced that PADCEV alone improved overall survival compared to chemotherapy in patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor. The trial was stopped early due to efficacy at the planned interim analysis. Data from EV-301 will be submitted for presentation at an upcoming scientific congress. In addition, the results will be submitted to the U.S. Food and Drug Administration (FDA) as the confirmatory trial following PADCEV’s accelerated approval in 2019, and EV-301 is also intended to support global registrations.
Announced Positive Topline Results from Second Cohort in EV-201 Phase 2 Pivotal Trial: In October 2020, Seagen and Astellas reported durable objective responses in patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor, have not received a platinum-containing chemotherapy and are ineligible for cisplatin. Data from this second cohort of the EV-201 trial will be submitted for presentation at an upcoming scientific congress and may support a supplemental Biologics License Application (BLA) to extend use of PADCEV in the U.S.
Entered Into Additional Clinical Trial Collaboration with Merck: In October 2020, Seagen, Astellas and Merck entered into a clinical trial collaboration and supply agreement under which PADCEV and KEYTRUDA will be evaluated in a planned phase 3 trial to be conducted by Merck in cisplatin-eligible muscle invasive bladder cancer to complement the ongoing study in cis-ineligible patients in the same setting.
TUKYSA

Received Approval in Fifth Country Under the FDA’s Project Orbis Initiative: In August 2020, Seagen announced TUKYSA’s approval in Australia for patients with metastatic HER2-positive breast cancer, including patients with brain metastases. Australia joined the U.S., Switzerland, Canada and Singapore in approving TUKYSA under Project Orbis, an initiative of the FDA Oncology Center of Excellence. In April 2020, TUKYSA became the first new medicine approved in the U.S. under Project Orbis. A TUKYSA marketing authorization application (MAA) is currently under review by the European Medicines Agency (EMA).
Entered into Exclusive License and Co-Development Agreement with Merck for TUKYSA: In September 2020, Seagen granted Merck an exclusive license to commercialize TUKYSA in Asia, the Middle East and Latin America and other regions outside of the U.S., Canada and Europe. The collaboration is intended to accelerate global availability of TUKYSA. Seagen received an upfront payment of $125 million and is eligible for progress-dependent milestones of up to $65 million as well as tiered royalties on sales of TUKYSA in Merck’s territory.
Expanded Clinical Development Program in HER2-Positive Cancers: Seagen initiated multiple trials to broadly evaluate TUKYSA in combination with other agents, including in gastrointestinal and other solid tumors.
PIPELINE HIGHLIGHTS

Entered into a Global Co-Development and Co-Commercialization Agreement with Merck for Seagen’s Ladiratuzumab Vedotin (LV): In September 2020, Seagen and Merck entered into an agreement under which the companies will jointly develop and equally share future costs and profits worldwide for LV, Seagen’s investigational antibody-drug conjugate (ADC). Merck made an upfront payment to Seagen of $600 million. In October 2020, following expiration of the waiting period under the Hart-Scott-Rodino Act, Merck made a $1.0 billion equity investment in 5.0 million shares of Seagen at $200 per share. In addition, Seagen is eligible for progress-dependent milestone payments of up to $2.6 billion.
Presented Results from Tisotumab Vedotin (TV) Pivotal Trial at ESMO (Free ESMO Whitepaper): In September 2020, Seagen and Genmab presented positive results at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 from the phase 2 single-arm clinical trial known as innovaTV 204. The trial is evaluating TV for the treatment of patients who have relapsed or progressed on or after prior treatment for recurrent or metastatic cervical cancer. The companies plan to submit a BLA to the FDA, which could support accelerated approval in the U.S.
Presenting Multiple Preclinical Abstracts at SITC (Free SITC Whitepaper): Several Seagen programs will be featured in presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting 2020, taking place virtually November 9-14, 2020. Abstracts encompass preclinical findings on the ADCs ADCETRIS, TV and LV, as well as the Company’s novel empowered antibody programs SEA-TGT and SEA-CD40.
For additional information on Seagen’s pipeline, visit www.seagen.com/science/pipeline.

OTHER CORPORATE HIGHLIGHTS

Received Milestone Payments Under ADC Collaboration with GlaxoSmithKline (GSK): In August 2020, Seagen achieved two milestones totaling $26 million under its ADC collaboration with GSK, triggered by FDA and EMA approval of BlenrepTM (belantamab mafodotin) for multiple myeloma.
Announced Seagen R&D Day to be Held on November 16: The R&D day will highlight the broad clinical development of Seagen’s marketed products as well as provide an overview of its deep pipeline of innovative cancer therapies.
THIRD QUARTER AND NINE-MONTHS 2020 FINANCIAL RESULTS

Revenues: Total revenues for the third quarter and nine months ended September 30, 2020 increased to $1.1 billion and $1.6 billion, respectively, compared to $213.3 million and $626.9 million for the same periods in 2019. Growth over 2019 was driven by the addition of PADCEV and TUKYSA to the Company’s commercial portfolio and impact of the Company’s recent collaborations with Merck. Revenues are composed of the following three components:
Royalty Revenues: Royalty revenues for the third quarter and year-to-date in 2020 were $35.9 million and $87.5 million, respectively, compared to $27.3 million and $66.2 million for the same periods in 2019. Royalty revenues are primarily driven by sales of ADCETRIS outside the U.S. and Canada by Takeda. To a lesser extent, royalty revenues include sales of Polivy (polatuzumab vedotin) by Roche, which is an ADC that uses Seagen technology.
Collaboration and License Agreement Revenues: Amounts earned under the Company’s product, development and technology collaborations were $758.3 million and $780.3 million in the third quarter and year-to-date in 2020, respectively, compared to $18.4 million and $99.1 million for the same periods in 2019. The 2020 periods included $725 million in upfront license revenue related to the Merck collaborations for LV and TUKYSA that were entered into in September 2020. In addition, during the third quarter of 2020 Seagen received $26 million in total milestone payments from GSK, triggered by FDA and EMA approvals of Blenrep.
Research and Development (R&D) Expenses: R&D expenses for the third quarter and year-to-date in 2020 were $217.7 million and $610.9 million, respectively, compared to $196.1 million and $518.3 million for the same periods in 2019. The increases in 2020 primarily reflect continued investment in the Company’s pipeline.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the third quarter and year-to-date in 2020 were $127.6 million and $375.5 million, respectively, compared to $96.1 million and $258.7 million for the same periods in 2019. The increases were primarily attributed to increased field sales personnel in the U.S. for Seagen’s recently commercialized products, PADCEV and TUKYSA, as well as higher infrastructure costs to support the Company’s continued growth and international expansion.

Cost of Sales: Cost of sales for the third quarter and year-to-date in 2020 were $78.3 million and $156.0 million, respectively, compared to $10.8 million and $32.0 million for the same periods in 2019. The increases in 2020 were primarily due to the gross profit share with Astellas based on PADCEV sales, which were $29.1 million and $72.6 million in the third quarter and year-to-date, respectively. Cost of sales also increased in 2020 due a payment owed to a third-party technology licensor related to the TUKYSA license agreement with Merck, amortization of acquired in-process technology costs that began with the approval of TUKYSA in April 2020, and third party royalties owed for ADCETRIS, PADCEV and TUKYSA net product sales.

Non-cash, share-based compensation cost for the first nine months of 2020 was $107.5 million, compared to $79.7 million for the same period in 2019.

Net Income (Loss): Net income for the third quarter of 2020 was $636.2 million, or $3.50 per diluted share, compared to net loss of $91.9 million, or $0.55 per diluted share, for the third quarter of 2019. Net income for the nine months ended September 30, 2020 was $446.6 million, or $2.47 per diluted share, compared to net loss of $184.5 million, or $1.13 per diluted share, for the same period in 2019. Net income for the periods in 2020 is the result of the upfront license payments received from Merck. This includes an income tax provision of $3.2 million in the third quarter of 2020. Seagen utilized federal net operating loss carryforwards as allowed, however the Company incurred income taxes in some states that did not have deferred tax assets available.

Cash and Investments: As of September 30, 2020, Seagen had $1.7 billion in cash and investments. The $1.0 billion equity investment by Merck, which closed in October 2020, will be reflected in the Company’s December 31, 2020 cash and investments.

2020 FINANCIAL OUTLOOK

Seagen’s 2020 financial guidance is shown below, which includes the impact of the Company’s collaborations with Merck.
Conference Call Details

Seagen management will host a conference call and webcast with supporting slides to discuss its third quarter 2020 and year-to-date financial results and provide an update on business activities. The event will be held today at 1:30 p.m. Pacific Time (PT); 4:30 p.m. Eastern Time (ET). The live event and supporting slides will be simultaneously webcast and available for replay from the Seagen website at www.seagen.com, under the Investors section. Investors may also participate in the conference call by calling 844-763-8274 (domestic) or 412-717-9224 (international). The conference ID is 10148256. A webcast replay will be archived on the Company’s website www.seagen.com, under the Investors section.

On October 29, 2020 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary artificial intelligence ("A.I.") platform, RADR , to transform oncology drug discovery and development, reported financial results for the third quarter ended September 30, 2020 (Press release, Lantern Pharma, OCT 29, 2020, View Source [SID1234569358]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Panna Sharma, CEO and President of Lantern Pharma, stated, "We have been extremely focused on advancing our portfolio of compounds, increasing the functionality, capabilities and data powering our A.I. platform, while also strengthening our team with cancer biologists, data scientists and drug development professionals who share our passion to transform oncology drug development."

Lantern has three drug compounds in development where genomics and data-driven methods have been used to refine and accelerate the development process: LP-100 in a Phase 2 trial for the treatment of metastatic, hormone-refractory prostate cancer (MHRPC), which is partnered with a European biotech; LP-300 which is preparing to enter into a Phase 2 trial for non-small cell lung cancer (NSCLC) as a combination therapy; and LP-184 which is in preclinical development for genomically defined cancers, including prostate, pancreatic and glioblastoma multiforme (GBM).

Mr. Sharma also commented, "Our proprietary RADR platform recently surpassed one billion data points – which is roughly four times the amount of data since our June IPO. The data is comprised largely of genomic, transcriptomic and drug sensitivity datapoints that have been thoughtfully curated from both our own studies and from relevant published studies and cancer data sets. RADR was essential in helping determine that GBM, a particularly deadly form of brain cancer, should be a key focus in our portfolio development. Additionally, RADR has significantly accelerated the process of developing an initial signature that could be used to identify GBM patients, potentially resulting in a new more effective treatment and in uncovering sub-types of GBM in which our compound can be most effective. Our growing A.I. platform will be pivotal in uncovering potential new therapeutic opportunities and also in developing insights into the creation of combination-therapy programs."

During the third quarter, Lantern also announced drug development and research collaborations with two leading academic and translational research cancer centers, Fox Chase Cancer Center in Philadelphia and Georgetown University in Washington D.C. These collaborations are focused on advancing LP-184 in specific, genomically defined sub-types of pancreatic and prostate cancer. The focus of both collaborations is to provide critical insights for the design of our upcoming clinical testing for LP-184. The data and results from these collaborative studies will provide data that will advance the development of biomarker signatures and aid in defining the patient groups most likely to benefit from our therapies.

Corporate and Scientific Highlights

●RADR surpassed one billion curated data points which will help further enhance our ability to better understand the mechanisms of action behind drugs and drug classes being used as anti-cancer agents and help determine signatures that correlate to drug response. The milestone was reached ahead of schedule and enables new capabilities such as the ability to identify and suggest combination therapy programs and the ability to compare and contrast signatures generated by a variety of machine learning algorithms.

●The Company launched the next phase of a collaboration with Georgetown University for LP-184, a next-generation, targeted DNA-damaging agent. The first stage of the joint research activities began in the fourth quarter of 2019 and generated compelling evidence of activity of LP-184 in solid tumors that overexpress PTGR1. LP-184 anti-tumor activity can be linked to the over-expression of PTGR1 and will be further validated in the ongoing collaboration in specific sub-types of prostate cancer. The research is also expected to help guide the development of a signature that correlates to increased response among certain sub-types of metastatic and metastatic, hormone-refractory prostate cancer.

●The Company initiated a collaboration and research agreement with Fox Chase Cancer Center for the further development of Lantern’s LP-184 in pancreatic cancer. This collaboration advances the targeted use of LP-184 in genetically defined sub-types of pancreatic cancer with the development of biologically relevant and robust gene signatures to be used in upcoming clinical testing. If successful, LP-184 could provide, in the future, pancreatic cancer patients a personalized therapy option that has the potential to improve survival.

●LP-300 development was advanced in preparation for a Phase 2 clinical trial in non-small cell lung cancer (NSCLC) among never-smokers during 2021. The Company entered into discussions with key opinion leaders in NSCLC to refine the patient selection and treatment regimen decision criteria that are expected to guide discussions with the FDA. In addition, the Company began selection of clinical trial sites and potential investigators for the ongoing development of LP-300 as a potential first-in-class combination therapy for never smoking (or non-smoking) NSCLC patients with histologically defined adenocarcinoma. Lantern also established a manufacturing network and process for GMP production in preparation for its Phase 2 clinical trial of LP-300.

●The Company conducted in vitro validation studies demonstrating the ability of LP-184 to penetrate the Blood Brain Barrier (BBB) while preserving neuronal cell viability. A critical property of any drug for GBM is its ability to penetrate the blood brain barrier without causing damage to the nerve cells and tissue. These studies validated the in-silico generated results (from Q1, 2020) that demonstrated that LP-184 would have a BBB permeability equivalent to temozolomide and other drugs being used for GBM patients. LP-184 demonstrated significant permeability to BBB, in-line with existing standard of care agents and in the expected range of nanomolar potency. The Company will be providing additional details on this data, the biomarker signature, and the IND-enabling studies involved in the clinical trial process during Q4 2020.

Third Quarter Financial Highlights

●Cash Position: Cash and cash equivalents were $20.8 million as of September 30, 2020, compared to $1.2 million as of December 31, 2019. The increase was primarily due to proceeds from the IPO in June 2020.

●R&D Expenses: Research and development expenses were $600,769 for the quarter ended September 30, 2020, compared to $228,401 for the quarter ended September 30, 2019. The increase was primarily attributable to increases in drug candidate research studies and manufacturing related expenses and expansion of the Company’s research team.

●G&A Expenses: General and administrative expenses were $1,100,719 for the quarter ended September 30, 2020, compared to $441,251 for the quarter ended September 30, 2019. This increase was primarily due to an increase in expenses associated with transitioning to and becoming a public company.

●Net Loss: Net losses were $1,701,488 for the quarter ended September 30, 2020, or $0.27 per share, compared to a net loss of $669,652 for the quarter ended September 30, 2019.

Mr. Sharma continued, "We are changing the pace, risk and cost of oncology drug discovery and development. The high failure rate and protracted development process lead to development costs in oncology that are not sustainable for our health-care system or for patients globally. A.I. and large scale machine-learning enabled systems that can leverage real-world oncology data and biomarker driven approaches offer the tremendous potential of a more sustainable route and one that can lead in the transformation of oncology drug development to benefit patients and advance medicine."

Conference Call

Lantern Pharma will host a conference call and webcast today, Thursday, October 29 at 4:00 p.m. ET.

Conference Call & Webcast Details

●Toll-free Domestic & Canada: 866.342.8588 – conference ID 55977

●International: 203-518-9865 – conference ID 55977

●US and Canada callers one touch dial: +1.866.342.8588,,55977#

●Live (audio-only) webcast and related presentation materials will be accessible via a weblink at View Source

Web participants should register 15 minutes prior to the start of the call. The webcast will be archived on the Lantern Pharma website for 30 days.

Replay Details

A replay of the conference call will be available for replay until 11:59 pm ET November 29, 2020.

●Replay Number: 1-800-925-9932 – passcode 55977.

On October 29, 2020 CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, reported that it will report its financial results for the third quarter ended September 30, 2020, after the market close on Thursday, November 5, and will host a corporate update conference call at 4:30pm EST (Press release, CorMedix, OCT 29, 2020, View Source [SID1234569355]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On October 29, 2020 GlaxoSmithKline (GSK) plc reported the European Commission has approved Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, as first-line monotherapy maintenance treatment for adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response following platinum-based chemotherapy (Press release, GlaxoSmithKline, OCT 29, 2020, View Source [SID1234569352]). This approval makes Zejula the only PARP inhibitor approved in the European Union for use as a monotherapy for patients with advanced ovarian cancer, regardless of their biomarker status.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: "Over 65,000 women in Europe are diagnosed with ovarian cancer each year.[i] This approval of Zejula means that many more women will have the option to receive this innovative medicine earlier, potentially extending the time they may spend without their devastating cancer progressing."

In April 2020, the US Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for Zejula in the United States for the same indication, which is supported by data from the pivotal phase 3 PRIMA study (ENGOT-OV26/GOG-3012) that demonstrated a clinically meaningful progression-free survival benefit of Zejula in the first-line maintenance setting. The PRIMA study enrolled patients with newly diagnosed advanced ovarian cancer who responded to first-line treatment with platinum-based chemotherapy, a population with high unmet needs and limited treatment options.

Dr Antonio Gonzalez-Martin, Co-Director, Department of Medical Oncology, Clinica Universidad de Navarra, Spain, and Primary Investigator for PRIMA, said: "Until now, only women with BRCA-mutant (BRCAm) ovarian cancer, representing just 20% of patients with advanced ovarian cancer, were eligible to be treated with a PARP inhibitor as monotherapy in the first-line maintenance setting.[ii] Expanding the potential use of Zejula, regardless of biomarker status, is an important step forward in treating this challenging cancer."

The primary endpoint in the PRIMA study was progression free survival analysed sequentially, first in the homologous recombination deficient (HRd) population, then in the overall population. The PRIMA study significantly improved PFS for patients treated with Zejula, regardless of biomarker status. In the HRd population, Zejula resulted in a 57% reduction in the risk of disease progression or death vs. placebo (HR 0.43; 95% CI, 0.31 to 0.59; p<0.0001) and a 38% reduction in the risk of disease progression or death vs. placebo in the overall population (HR 0.62; 95% CI, 0.50 to 0.76; p<0.001). In addition, there was a 60% reduction in risk of progression in those with BRCA mutation tumours (HR 0.40; 95% CI, 0.27 to 0.62; p<0.001).

Zejula’s safety profile, as demonstrated by the PRIMA results, was consistent with the previously observed clinical safety profile. At initiation of the PRIMA study, patients received a fixed starting dose of 300 mg of Zejula once-daily. The study was later amended to incorporate an individualised starting dose of either 200 mg or 300 mg of Zejula once-daily based on the patient’s baseline weight and/or platelet count. Lower rates of grade 3 and 4 haematologic treatment-emergent adverse events were observed with an individualised starting dose, compared to the overall population, including thrombocytopenia (21% compared to 39%), anaemia (23% compared to 31%) and neutropenia (15% compared to 21%).

Based on these results, the Zejula EU prescribing information has been updated to include the individualised starting dose once-daily based on the patient’s baseline weight and/or platelet count.

Clara MacKay, Chief Executive Officer, World Ovarian Cancer Coalition, said: "Having a new first-line maintenance option for patients with platinum-responsive advanced ovarian cancer in Europe — regardless of BRCA mutation status — speaks to the important role of PARP inhibitors in the fight against ovarian cancer. We are especially delighted that today’s approval means that more women in Europe who are diagnosed with ovarian cancer will have this new treatment option. We appreciate the commitment and scientific leadership required to develop innovative new therapies that address unmet needs in women’s cancer."

About Ovarian Cancer

In Europe, ovarian cancer is the sixth deadliest cancer among women[iii] and more than 65,000 women are diagnosed each year.i Despite high response rates to platinum-based chemotherapy in the first-line, approximately 85% of women with advanced ovarian cancer will see their disease return.[iv] With each recurrence, the time a woman may spend without her cancer progressing gets shorter.

About Zejula (niraparib)

Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in multiple pivotal trials. GSK is building a robust niraparib clinical development programme by assessing activity across multiple tumour types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development programme for niraparib includes several combination studies.

GSK in Oncology

GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody drug conjugates and cell therapy, either alone or in combination.

Important Information for ZEJULA

Zejula approved indication:

Zejula is indicated as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.

Important Safety Information

Contraindications: Hypersensitivity to niraparib or to any of the excipients and breast-feeding.

Warnings and precautions: Test complete blood counts (CBC) weekly for the first month of treatment, followed by monthly monitoring for the next 10 months of treatment and periodically after this time. This is recommended to monitor for clinically significant changes in any haematologic parameter during treatment. If a patient develops severe persistent haematologic toxicity (thrombocytopenia, anaemia and neutropenia including pancytopenia) that does not resolve within 28 days following interruption, Zejula should be discontinued. Patients with lower body weight or lower baseline platelet count may be at increased risk of Grade 3+ thrombocytopenia. Due to the risk of thrombocytopenia, anticoagulants and medicinal products known to reduce the thrombocyte count should be used with caution. If MDS and/or AML are confirmed while being prescribed Zejula, treatment should be discontinued, and the patient treated appropriately. Hypertension, including hypertensive crisis, has been reported with the use of Zejula. Pre‑existing hypertension should be adequately controlled before starting Zejula treatment. Zejula should be discontinued in case of hypertensive crisis or if medically significant hypertension cannot be adequately controlled with antihypertensive therapy. There have been reports of Posterior Reversible Encephalopathy Syndrome (PRES) in patients receiving Zejula. In case of PRES, it is recommended to discontinue treatment. Patients with galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption should not take this medicine. Tartrazine may cause allergic reactions. Paediatric safety and efficacy has not yet been established.

Undesirable effects: The most common serious adverse reactions were thrombocytopenia and anaemia.

Very common (≥1/10): anaemia, thrombocytopenia, nausea, fatigue, constipation, vomiting, headache, insomnia, platelet count decreased, neutropenia, abdominal pain, decreased appetite, diarrhoea, dyspnoea, hypertension, asthenia, dizziness, neutrophil count decreased, cough, arthralgia, back pain, white blood cell count decreased, and hot flush.

Common (≥1/1000 to <1/10): bronchitis, conjunctivitis, leukopenia, hypersensitivity, hypokalemia, anxiety, depression, dysgeusia, tachycardia, hypertension, epistaxis, dry mouth, abdominal distension, mucosal inflammation (including mucositis), stomatitis, photosensitivity, rash, myalgia, oedema peripheral, fatigue, asthenia, Gamma-glutamyl transferase increased, AST increased, blood creatinine increased, ALT increased, blood alkaline phosphatase increased and weight decreased.