On February 20, 2020 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products reported results from the monotherapy and combination arms of the Company’s ongoing Phase 1/2 study investigating ADXS-503 in patients with non-small cell lung cancer (NSCLC) at the IASLC 2020 Targeted Therapies of Lung Cancer Meeting in Santa Monica, California (Press release, Advaxis, FEB 20, 2020, View Source [SID1234554557]). The trial is evaluating ADXS-503, part of the Company’s ADXS-HOT cancer-type specific immunotherapy program which leverages Advaxis’ proprietary Lm technology platform to target hotspot mutations that commonly occur in specific cancer types as well as other proprietary, tumor-associated antigens, alone and in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy.

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Key findings presented by Jennifer Carlisle, M.D., Assistant Professor Department of Hematology and Medical Oncology, Winship Cancer Institute of Emory University and study investigator, titled, "A Phase 1/2 Study of ADXS-503 Alone and in Combination with Pembrolizumab in Subjects with Metastatic Squamous or Non-Squamous Non-Small Cell Lung Cancer" include:

●Nine patients have been dosed to date; seven in the monotherapy arm and two in the combination arm, with a total of seven evaluable patients
●50% (3 of 6) of evaluable patients from the monotherapy arm, from Part A, showed stable disease
●The first evaluable patient from the combination arm, Part B, who previously progressed on pembrolizumab, showed stable disease with a 25% reduction in a site lesion
●Stable disease was observed in a heavily pretreated patient population with patients failing up to six prior lines of therapy and most patients progressing on prior immunotherapy treatments
●ADXS-503 monotherapy and in combination with pembrolizumab appeared safe and tolerable in this heavily pretreated population of patients with no dose limiting toxicities observed
●Treatment-related adverse events were mostly Grade 1-2, with no additive toxicity observed with combination therapy

"The presented preliminary data on safety, tolerability and disease stabilization with ADXS-503 in patients with advanced NSCLC provides an important clinical proof-of-concept to the Company’s first off-the shelf, hotspot neoantigen construct tested thus far," said Dr. Andres Gutierrez, Chief Medical Officer of Advaxis. "These data are important given the highly refractory patient population with most evaluated patients progressing on prior immunotherapies and, while early, we are particularly interested in documenting additional potential signals of synergy with KEYTRUDA. We look forward to reporting additional clinical and immunogenicity data later this year in addition to starting Part C of the study which will evaluate ADXS-503 in combination with pembrolizumab as a first-line treatment for NSCLC patients."

The Phase 1/2 clinical trial of ADXS-503 will seek to establish the recommended dose, safety, tolerability and clinical activity of ADXS-503 administered alone and in combination with a checkpoint inhibitor in approximately 50 patients with NSCLC, in at least five sites across the U.S. The two dose levels with monotherapy in Part A, (1 X108 and 5 X108 CFU) have been completed and Part B in combination with a checkpoint inhibitor is currently open to enrollment.

About ADXS-HOT

ADXS-HOT is a program that leverages the Company’s proprietary Lm technology to target hotspot mutations that commonly occur in specific cancer types. ADXS-HOT drug candidates are designed to target acquired shared or "public" mutations in tumor driver genes along with other proprietary cancer-testes and oncofetal tumor-associated antigens that also commonly occur in specific cancer types. ADXS-HOT drug candidates are an off-the-shelf treatment, designed to potentially treat all patients with a specific cancer type, without the need for pretreatment biomarker testing, DNA sequencing or diagnostic testing.

On February 20, 2020 Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, reported financial results for the three and twelve months ended December 31, 2019 (Press release, Odonate Therapeutics, FEB 20, 2020, View Source [SID1234554575]).

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As of December 31, 2019, Odonate had $180.5 million in cash, compared to $139.1 million as of December 31, 2018. This increase in cash resulted primarily from the receipt of $135.1 million of net proceeds from Odonate’s June 2019 underwritten public offering, less net cash used in operating activities of $96.6 million. Odonate’s net loss for the three and twelve months ended December 31, 2019 was $27.9 million and $111.8 million, or $0.91 and $4.05 per share, respectively, compared to $28.8 million and $89.0 million, or $1.17 and $3.64 per share, respectively, for the same periods in 2018.

"We are pleased to have recently announced the completion of enrollment in CONTESSA, Odonate’s Phase 3 study investigating tesetaxel as a potential treatment for patients with metastatic breast cancer," said Kevin Tang, Chief Executive Officer of Odonate. "We expect to report top-line results from CONTESSA in the third quarter of 2020."

About Tesetaxel

Tesetaxel is an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Tesetaxel has several pharmacologic properties that make it unique among taxanes, including: oral administration with a low pill burden; a long (~8-day) terminal plasma half-life in humans, enabling the maintenance of adequate drug levels with relatively infrequent dosing; no history of hypersensitivity (allergic) reactions; and significant activity against chemotherapy-resistant tumors. In patients with metastatic breast cancer, tesetaxel was shown to have significant, single-agent antitumor activity in two multicenter, Phase 2 studies. Tesetaxel currently is the subject of three studies in breast cancer, including a multinational, multicenter, randomized, Phase 3 study in patients with metastatic breast cancer, known as CONTESSA.

About CONTESSA

CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). CONTESSA is comparing tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally for 14 days of each 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m2/day dosed orally for 14 days of each 21-day cycle) in approximately 600 patients randomized 1:1 with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. Patients with central nervous system (CNS) metastases are eligible. The primary endpoint is progression-free survival (PFS) as assessed by an Independent Radiologic Review Committee (IRC). The secondary efficacy endpoints are overall survival (OS), objective response rate (ORR) as assessed by the IRC and disease control rate (DCR) as assessed by the IRC.

About CONTESSA 2

CONTESSA 2 is a multinational, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). CONTESSA 2 is investigating tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally for 14 days of each 21-day cycle) in approximately 125 patients with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC not previously treated with a taxane. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. Patients with central nervous system (CNS) metastases are eligible. The primary endpoint is objective response rate (ORR) as assessed by an Independent Radiologic Review Committee (IRC). The secondary efficacy endpoints are duration of response (DoR) as assessed by the IRC, progression-free survival (PFS) as assessed by the IRC, disease control rate (DCR) as assessed by the IRC and overall survival (OS).

About CONTESSA TRIO

CONTESSA TRIO is a multi-cohort, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). In Cohort 1, approximately 90 patients (with potential expansion to up to 150 patients) with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior chemotherapy for advanced disease will be randomized 1:1:1 to receive tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus either: (1) nivolumab at 360 mg by intravenous infusion on the first day of each 21-day cycle; (2) pembrolizumab at 200 mg by intravenous infusion on the first day of each 21-day cycle; or (3) atezolizumab at 1,200 mg by intravenous infusion on the first day of each 21-day cycle. Nivolumab and pembrolizumab (PD-1 inhibitors) and atezolizumab (a PD-L1 inhibitor) are immuno-oncology (IO) agents approved for the treatment of multiple types of cancer. One of these agents, atezolizumab, in combination with the intravenously delivered taxane, nab-paclitaxel, was recently approved by the U.S. Food and Drug Administration (FDA) as a first-line treatment for patients with metastatic TNBC. The dual primary endpoints for Cohort 1 are objective response rate (ORR) and progression-free survival (PFS). Secondary endpoints include duration of response (DoR) and overall survival (OS). Efficacy results for each of the three PD-(L)1 inhibitor combinations will be assessed for correlation with the results of each of the three approved PD-L1 diagnostic assays. In Cohort 2, approximately 40 elderly patients (with potential expansion to up to 60 patients) with human epidermal growth factor receptor 2 (HER2) negative MBC will receive tesetaxel monotherapy dosed orally at 27 mg/m2 on the first day of each 21-day cycle. The primary endpoint for Cohort 2 is ORR. Secondary endpoints include PFS, DoR and OS. Patients with central nervous system (CNS) metastases are eligible for both cohorts.

On February 20, 2020 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer and wet age-related macular degeneration through our license to Santen Pharmaceutical Co. Ltd., and utilizing our product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported that it will report its fourth quarter and full year 2019 financial and operating results after the close of U.S. financial markets on Thursday, February 27, 2020 (Press release, Tracon Pharmaceuticals, FEB 20, 2020, View Source [SID1234554615]). In addition, management will host a conference call to provide an update on corporate activities and discuss the quarterly and full year financial results.

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Conference call and webcast:
Date: February 27, 2020
Time: 4:30 pm Eastern Time (1:30 pm Pacific Time)
Dial-in: (855) 779-9066 (Domestic) or (631) 485-4859 (International)
Passcode: 3228345
Via web: www.traconpharma.com; "Events and Presentations" section within the "Investors" section
A replay of the webcast will be available for 60 days on the website.

On February 20, 2020 Cerus Corporation (Nasdaq: CERS) reported complete financial results for the fourth quarter and year ended December 31, 2019 (Press release, Cerus, FEB 20, 2020, View Source [SID1234554558]).

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Recent developments and highlights include:

Total fourth quarter revenue of $26.5 million.
Record fourth quarter product revenue of $20.9 million, a 27% increase compared to the prior year quarter.
Government contract revenue of $5.6 million.
Continued increase in worldwide demand for INTERCEPT kits during the fourth quarter with the calculated number of treatable platelet doses up 23% during the quarter compared to the same period in 2018.
Provided 2020 annual product revenue guidance of $89 million to $93 million, representing an approximately 20% to 25% increase over 2019 reported product revenue.
Strengthened balance sheet with an upsized public offering of common stock in January 2020 raising gross proceeds of $63.3 million.
Received CE mark approval for pathogen-reduced 5-day thawed plasma.
Entered collaboration with the National Trauma Institute to supply INTERCEPT plasma for the PROpOLIs clinical study, a U.S. Department of Defense funded clinical trial evaluating use of INTERCEPT plasma in traumatic burn resuscitation in 94 patients at 5 U.S. sites.
"We exited 2019 on a high note with record quarterly product revenue and anticipate the momentum that we experienced this past year will continue into 2020," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. "We are looking forward to another successful year, as we expect many U.S. blood centers and hospitals to opt for INTERCEPT platelets as a strategy to comply with the final FDA guidance document on platelet safety. These institutions are on the clock and have just 13 more months to become compliant with the FDA Guidance."

The FDA guidance document on bacterial risk control strategies for platelets calls for all blood centers and hospitals to be compliant with new safety requirements by March 31, 2021.

"In addition to our commercial objectives goals for the year, we are looking forward to important regulatory milestones throughout 2020, led by our expected PMA-supplement submission for pathogen-reduced cryoprecipitate in the first half of the year," continued Greenman.

Revenue

Product revenue during the fourth quarter of 2019 was $20.9 million, compared to $16.5 million during the same period in 2018. Product revenue growth in the quarter benefited from strong continued demand for INTERCEPT platelet kits in the U.S. and platelet and plasma kit demand in EMEA, which were partially offset by the conversion to the double dose platelet kits in France and a 2% negative impact of foreign currency exchange rates. For the full year, product revenue totaled $74.6 million, an increase of 23% compared to the same period in 2018.

As a result of increased INTERCEPT red blood cell clinical and development activities, government contract revenue from the Company’s Biomedical Advanced Research and Development Authority (BARDA) agreement was $5.6 million during the fourth quarter of 2019, compared to $3.7 million during the same period in 2018. Full year 2019 government contract revenue totaled $19.1 million compared to $15.1 million in the same period the year prior. The total potential value of the current BARDA agreement is $201 million, with $44 million cumulatively recognized as government contract revenue to date.

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 in whole or in part 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 fourth quarter of 2019 were 56%, compared to 49% for the fourth quarter of 2018. The increase in gross margin was tied to economies of scale realized for our cost of goods sold, favorable platelet product mix, namely the French conversion to double dose platelet kits and additional manufacturing efficiencies. Gross margins on product revenue for the full year 2019 were 55% compared to 48% reported in the same period the year prior.

Operating Expenses

Total operating expenses for the fourth quarter of 2019 were $33.6 million compared to $27.3 million for the same period the prior year. Full year 2019 operating expenses totaled $126.6 million compared to $99.4 million for the full-year 2018.

Selling, general, and administrative (SG&A) expenses for the fourth quarter of 2019 totaled $17.2 million, compared to $14.8 million for the fourth quarter of 2018. The year-over-year increase in SG&A expenses was tied to increased non-cash stock compensation, higher investments in our supply chain capabilities and focused investments on preparatory activities for our anticipated pathogen-reduced cryoprecipitate launch. Full-year 2019 SG&A expenses totaled $66.2 million compared to $56.8 million for the full-year 2018.

Research and development (R&D) expenses for the fourth quarter of 2019 were $16.4 million, compared to $12.4 million for the fourth quarter of 2018. The year-over-year increase in R&D expenses was due in part to product enhancements and initiatives for expanded label claims, development activities to support our planned PMA supplement for pathogen-reduced cryoprecipitate, as well as activities related to the development of our INTERCEPT red blood cell system. Full-year 2019 R&D expenses totaled $60.4 million compared to $42.6 million for the full-year 2018.

Net Loss

Net loss for the fourth quarter of 2019 was $16.9 million, or $0.12 per diluted share, compared to a net loss of $16.2 million, or $0.12 per diluted share, for the fourth quarter of 2018. Full-year 2019 net loss was $71.2 million or $0.51 per diluted share compared to $57.6 million, or $0.44 per diluted share for the same period in 2018.

Cash, Cash Equivalents and Investments

At December 31, 2019, the Company had cash, cash equivalents and short-term investments of $85.7 million, compared to $117.6 million at December 31, 2018.

At December 31, 2019, the Company had approximately $39.4 million in outstanding term loan debt and $5.0 million of borrowings under its revolving loan credit agreement, compared to $29.9 million in outstanding term loan debt at December 31, 2018.

In January 2020, the Company completed an underwritten public offering of its common stock for gross proceeds of $63.3 million, before deducting offering expenses payable by the Company.

2020 Product Revenue Guidance

The Company expects 2020 product revenue to be in the range of $89 million to $93 million. The guidance range represents approximately 20% to 25% growth compared to 2019 reported product revenue.

QUARTERLY CONFERENCE CALL

The Company will host a conference call at 4:30 P.M. ET 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, 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 9268122. The replay will be available approximately three hours after the call through March 5, 2020.

On February 20, 2020 Physicians’ Education Resource (PER), a leading resource for continuing medical education (CME), reported that it will conduct six CME-accredited satellite symposia during the 37th Annual Miami Breast Cancer Conference at the Fontainebleau in Miami Beach, Florida, March 5-8 (Press release, Physicians’ Education Resource, FEB 20, 2020, View Source [SID1234554576]).

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"Our all-inclusive breast cancer conference is one of our biggest and most influential programs of the year," said Phil Talamo, president of PER. "This year we excited more than ever offering additional CME educational opportunities such as invaluable expert insights from world-renowned thought leaders, engaging symposia sessions and legendary medical crossfires. Join us in March, you won’t want to miss the 37th Annual Miami Breast Cancer Conference."

The PER satellite symposia are as follows:

Coffee Talk: Initiating Early Recognition and Intervention in a Rare Lymphoma Associated With Breast Implants, which will be held Thursday, March 5, from 9:15 to 10:45 a.m., in the meeting room Fontaine. The program will be chaired by Lloyd B. Gayle, M.D., FACS, chief of plastic surgery and vice chair of surgery, Maimonides Medical Center in Brooklyn, New York; and clinical associate professor of surgery, Weill Medical College of Cornell University in New York. To register, click here.
Managing Postoperative Pain: The Clinical Impact of Opioid-Sparing Strategies on Patients with Breast Cancer, which will be held Thursday, March 5, from 7 to 8:30 p.m., in the meeting room Fontaine. The program will be chaired by Patrick I. Borgen, M.D., chair of the department of surgery and director, breast cancer program, Maimonides Medical Center in Brooklyn, New York. To register, click here.
Coffee Talk: Perspectives on PARP, HER2/3, PI3K, and Emerging Oncogenic Targets in Breast Cancer Care, which will be held Friday, March 6, from 7 to 8:30 a.m., in the meeting room Fontaine. The program will be chaired by Mark E. Robson, M.D., chief, breast medicine service, and attending physician, breast medicine and clinical genetics services, Memorial Sloan Kettering Cancer Center; and professor of medicine, Weill Cornell Medical College in New York. To register, click here.
Leveraging Immunogenicity to Optimize Patient Outcomes in Triple Negative Breast Cancer: Current and Emerging Evidence, which will be held Friday, March 6, from 6:30 to 8:00 p.m., in the meeting room Fontaine. The program will be chaired by Joyce O’Shaughnessy, M.D., the Celebrating Women Chair in Breast Cancer Research, Texas Oncology-Baylor Charles A. Sammons Cancer Center; and chair, breast cancer research program, The US Oncology Network in Dallas, Texas. To register, click here.
Medical Crossfire: Real World Scenarios and Applications for Biosimilars in HER2-Positive Breast Cancer: Key Concepts for Clinical Decision-Making, which will be held Saturday, March 7, from 7 to 8:30 a.m., in the meeting room Fontaine. The program will be chaired by Hope S. Rugo, M.D., FASCO, professor of medicine, department of medicine (hematology/oncology), and director, breast oncology clinical trials program, University of California San Francisco Helen Diller Family Comprehensive Cancer Center in California. To register, click here.
How We Do it: Personalizing Treatment for Patients With HER2-Positive Breast Cancer, which will be held Sunday, March 8, from 7 to 8:30 a.m., in the meeting room Fontaine. The program will be chaired by Debu Tripathy, M.D., professor and chair, department of breast medical oncology, The University of Texas MD Anderson Cancer Center in Houston. To register, click here.
Each satellite is accredited by the Accreditation Council for Continuing Medical Education for 1.5 AMA PRA Category 1 Credits for physicians.