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Agendia to Present New Data at SABCS 2019 Demonstrating How Comprehensive Genomic Profiling Benefits Early-Stage Breast Cancer Patients

On November 19, 2019 Agendia, Inc., a world leader in precision oncology for breast cancer, reported that five abstracts featuring data and updates from its ongoing clinical research evaluating the MammaPrint and BluePrint genomic tests have been accepted for presentation at the 2019 San Antonio Breast Cancer Symposium (SABCS) taking place December 10-14, 2019, in San Antonio, Texas (Press release, Agendia, NOV 19, 2019, View Source [SID1234551500]).

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Data selected for presentation offer new insights into the unique clinical characteristics, tumor biology, risk of recurrence risk and treatment responses among specific populations of women with early-stage breast cancer. These include data from a study evaluating the clinical risk of recurrence among premenopausal women ≤50 years of age with breast cancer.

Two additional presentations will feature the first datasets from Agendia’s ongoing multicenter, prospective, observational trial for patients with Stage I, II, and III breast cancer (FLEX). Researchers will share data from FLEX analyses evaluating the predisposing clinical and molecular features associated with breast cancer tumor biology in African American women, and an initial clinical review of the molecular profiles and clinical-pathological features of early-stage breast cancer in Chinese patients.

"These data offer important insights into unique patient characteristics and associated clinical risk that will better equip clinicians to provide personalized treatment plans for their patients with breast cancer," says William Audeh, MD, MS, chief medical officer at Agendia. "Agendia remains committed to advancing the scientific and medical community’s understanding of the biologic drivers of breast cancer among specific populations of women, especially those who have historically been under represented in clinical studies, and we are excited to share new data that may benefit these patients and their health care professionals. Given the comprehensive gene set interrogated by MammaPrint + BluePrint, we are uniquely positioned to deliver valuable clinical insights that may improve patient outcomes."

Following are details of the five Agendia abstracts that have been accepted for poster presentations at 2019 SABCS:

Title: Racial disparities in breast cancer: Identifying predisposing clinical and molecular features associated with African American patients (Presentation P2-10-08)
Authors: Nunes R., et al.
Session: Epidemiology, Risk, and Prevention: Ethnic/Racial Aspects
Date/Time: Thursday, December 12 at 7:00 – 9:00 am
Location: Poster Session 2, Hall 1

Title: Different MammaPrint and BluePrint molecular profiles and clinical-pathological features of early stage breast cancer in Chinese patients in the United States and Hong Kong (Presentation P2-10-15)
Authors: Kwong A., et al.
Session: Epidemiology, Risk, and Prevention: Ethnic/Racial Aspects
Date/Time: Thursday, December 12 at 7:00 – 9:00 am
Location: Poster Session 2, Hall 1

Title: Treatment recommendations in ER+ patients ≤ 50 years: Comparison of the 21-gene assay and 70-gene signature in the PROMIS study (Presentation P2-14-11)
Authors: Tsai M., et al.
Session: Treatment: Adjuvant Therapy – Adjuvant Chemotherapy
Date/Time: Thursday, December 12 at 7:00 – 9:00 am
Location: Poster Session 2, Hall 1

Title: Cyclin E overexpression is associated with high risk 70 gene signature, and may indicate intrinsic resistance to CDK4/6 inhibitors (Presentation P4-10-24)
Authors: Mittempergher L., et al
Session: Prognostic and Predictive Factors: Biomarkers Predicting Treatment Sensitivity and Resistance
Date/Time: Friday, December 13 at 7:00 – 9:00 a.m.
Location: Poster Session 4, Hall 1

Title: The FLEX real world data platform explores new gene expression profiles and investigator-initiated protocols in early stage breast cancer (Presentation OT3-17-02)
Presenter: Crozier, J., et al.
Session: On-going Trial Response Predictions
Date/Time: Friday, December 13 at 5:00 – 7:00 p.m.
Location: Poster Session OT3, Hall 1

The full SABCS 2019 abstract book can be found at View Source Visit www.agendia.com for additional information about Agendia.

International Isotopes Inc. Announces Financial Results for The Third Quarter 2019

On November 19, 2019 International Isotopes Inc. (OTCQB: INIS) (the "Company") reported its financial results for the three and nine months ended September 30, 2019 (Press release, Institute of Isotopes Co, NOV 19, 2019, View Source [SID1234551499]).

Revenue for the three months ended September 30, 2019 was $2,337,488 as compared to $2,680,760 for the same period in 2018, a decrease of approximately 13%. Revenue for the nine-month period ended September 30, 2019 was $ 7,001,179 as compared to $7,874,092 for the same period in 2018, a decrease of approximately 11%. This decrease in revenue for both periods was largely the result of revenue decreases in the Company’s cobalt products and radiological services segments.

Gross profit for the three months ended September 30, 2019 increased approximately 10% compared with the same period in 2018. Gross profit for the nine-month period ended September 30, 2019 increased approximately 9% compared to the same period in 2018. The increase in gross profit for both periods was largely the result of increased gross profit in the radiochemical products segment. Operating expense increased approximately 9% for the three months ended September 30, 2019. Operating expenses increased approximately 6% for the nine-month period ended September 30, 2019, compared to the same period in 2018. The increase in operating expense for both periods was primarily due to an increase in general and administrative costs.

The Company reported a net income for the three months ended September 30, 2019, of $236,462 compared to a net loss of $333,222 for the same period in 2018. The net loss for the nine-month period ended September 30, 2019, was $972,689 as compared to $631,097 for the same period in 2018, an increase in loss of approximately 54%. The increase in net income for the three-month period was a result of the timing of recognition of estimated cost recovery of expenses related to the cleanup of a contamination event that occurred in the State of Washington during the second quarter 2019. The increase in net loss for the nine-month period was due to increased costs attributed to the cleanup and recovery from the same contamination event. Further discussion of this event and the impact to the Company financial statements is included in the radiological services segment discussion in this release.

Further detail on the performance of each of the Company’s business segments is provided in the following paragraphs.

Revenue from radiochemical products for the three months ended September 30, 2019 increased approximately 99% compared to the same period in 2018. Revenue from radiochemical products for the nine-month period ended September 30, 2019 increased approximately 31% compared to the same period in 2018. The major contributor to increased revenue within this segment for both periods was attributed to increased revenue from contract manufacturing operations.

Revenue from the sale of cobalt products for the three months ended September 30, 2019 decreased approximately 91% compared to the same period in 2018. Revenue from the sale of cobalt products for the nine-month period ended September 30, 2019 decreased approximately 61% compared to the same period in 2018. The Company has been working toward a resumption of cobalt sales by producing cobalt in the U.S. Department of Energy’s (DOE) Advanced Test Reactor (ATR) under a ten-year agreement with the DOE. Revenue from the sales of that material should begin in 2020. In the meantime, the Company had acquired cobalt from an alternate supplier in 2018, which allowed the resumption of some cobalt product manufacturing. Similar alternate supplies were not available in 2019 and that caused the decline in revenue for both period comparisons.

Revenue from radiological services for the three months ended September 30, 2019 increased approximately 91% compared to the same period in 2018, but the Company reported a decrease in revenue in this segment of approximately 29% for the nine-month period ended September 30, 2019 compared to the same period in 2018. Most of the radiological services revenue is generated by the performance of contract field service activities for the DOE and International Atomic Energy Agency (IAEA). The increase in revenue for the three-month comparison was due to the timing of these contracts where revenue may fluctuate quarter to quarter based on when the contracts are completed. The decrease in revenue for the nine-month period comparison is the result of the decrease in the amount of these contracts the Company has been able to secure in 2019.

In May 2019, the Company’s radiological services team was involved in a contamination event involving a breached cesium-137 source at an off-site location in the state of Washington. This work was being performed under a contract with the DOE. The Company is supporting an investigation, in conjunction with the DOE, to help determine the cause of this event. The Company supported the initial onsite contamination clean-up operations at that location as well as completing the removal of the cesium source for shipment to an off-site location and the disassembly and removal of all Company equipment used in the facility for source removal. All of the Company operations were successfully completed in the third quarter. Since that time the DOE has assumed full control of the ongoing cleanup operations and has assumed all of the past and future financial obligations associated with the contractor currently hired to carry out all of the facility recovery operations. Under the terms of the contract with the DOE the Company believes it should be indemnified from financial liability for this event under the Price Anderson Act. Such indemnification would allow the Company to recoup all its allowed costs associated with this contamination event. During the nine months ended September 30, 2019, the Company incurred $2,141,559 in expenses related to the contamination and its cleanup. These costs are recorded as "other expense" in the Company’s Condensed Consolidated Statements of Operations. During the nine months ended September 30, 2019, the Company received $964,958 in reimbursements from its insurance company for expenses related to the contamination and its cleanup, and the Company has determined that an additional $970,417 of its incurred expenses related to the contamination and its cleanup are probable for recovery pursuit to ASC 410-30. These actual and estimated reimbursements are recorded as "other income" in the Company’s Condensed Consolidated Statements of Operations.

Revenue from nuclear medicine products for the three months ended September 30, 2019 increased approximately 7% compared to the same period in 2018. Revenue from nuclear medicine products for the nine-month period ended September 30, 2019 increased approximately 4% compared to the same period in 2018. The increase in revenue within this segment for both period comparisons is primarily due to price increases of these products.

Steve Laflin, President and CEO of the Company, said, "The Company continued to face a significant challenge during the third quarter dealing with the radiological services contamination event in the State of Washington. I believe our staff did an outstanding job responding to the event and completing all of the recovery efforts within the Company’s scope of work. The Company is continuing to support the ongoing investigation into the cause of this event and will work to ensure that appropriate measures are put in place to prevent a similar event from occurring in the future. The long term impact to the Company’s prospects for further field service work are not known at this time.

We believe the major highlight of our third quarter performance was the 99% increase in revenue in the radiochemical segment for the three-month period compared to the same period in 2018. Revenue in this segment also increased 31% over the nine-month period compared to the same period in 2018. The increase in revenue for both periods was attributed to payments we received for the start-up of our contract manufacturing operations to fulfill our agreement with Progenics Pharmaceuticals Inc. to provide contract manufacturing services for AZEDRA (Ultratrace Iobenguane I-131) and other iodine products. Construction of the new facility spaces are going well and we expect to start commercial production of this product during the first quarter of 2020.

Also on the horizon is our expected return to cobalt product sales beginning in the first quarter of 2020. Our cobalt production from the DOE’s reactor has been curtailed since 2012. Resuming cobalt sales will again place the Company in the position of being the sole U.S. supplier of high specific activity cobalt, an isotope important for multiple medical and industrial applications."

ThermoGenesis Holdings Announces Improved Third Quarter 2019 Financial Results And Provides Corporate Update

On November 19, 2019 ThermoGenesis Holdings, Inc. (Nasdaq: THMO), formerly known as Cesca Therapeutics Inc., a market leader in automated cell processing tools and services in the cell and gene therapy field, reported improved financial and operating results for the third quarter ended September 30, 2019 and provided a corporate strategic update (Press release, Thermogenesis, NOV 19, 2019, View Source [SID1234551498]).

The Company’s main financial objective for 2019 has been to achieve positive cash flow from operations before the end of this calendar year. In order to achieve that, the Company has implemented a series of aggressive measures through new product launches and operational cost reductions. For the third quarter of 2019, using Adjusted EBITDA as a key metric to determine cash flow based financial performance, the Company has reported a positive outcome for the second consecutive quarter.

Third Quarter and Subsequent Achievements:

The Company reported a 30% increase in revenue compared to the same period in 2018.
The Company reported net income (loss) of ($2.4) million for the quarter ended September 30, 2019 compared to ($2.8) million for the same period in 2018.
Using Adjusted EBITDA as a key metric to determine cash based financial performance, the Company reported positive Adjusted EBITDA of $125,000, up 136% compared to a reported $53,000 Adjusted EBITDA in the second quarter of 2019, and ($1.6) million Adjusted EBITDA in the third quarter 2018.
Received validations of system performance for the Company’s X-Series products from research teams at two prestigious academic medical centers — Duke University School of Medicine and the University of North Carolina.
Signed a global distribution agreement with a major Fortune 500 company for global distribution of the X-Series products, excluding certain regions. Received a $2 million upfront distribution fee as part of the five-year, renewable, global distribution agreement.
Executed definitive agreement with HealthBanks Biotech (USA), to form joint venture, ImmuneCyte, to commercialize the CAR-TXpress cell processing platform for immune cell banking and cell-based CMO/CDMO services. Intended to be operational in the fourth quarter of 2019, ImmuneCyte will be the first cGMP compliant immune cell bank in the United States.
Divested clinical development assets, allowing the Company to stay focused on its cell processing device and service business going forward.
As a result of these most recent activities, on October 31, 2019, the Company announced that it had changed its name to ThermoGenesis Holdings, Inc. to better reflect its new strategic focus to become a key solution provider for cell processing tools and services in the cell and gene therapy markets. The Company simultaneously changed its Nasdaq trading symbol from KOOL to THMO, which became effective on November 1, 2019.

"For more than two decades, ThermoGenesis has developed and commercialized novel cell processing systems and devices providing global researchers, biomanufacturing organizations and clinicians with highly efficient tools that have helped them to deliver better outcomes in various applications in the cell and gene therapy field," said Chris Xu, PhD, Chief Executive Officer of ThermoGenesis. "We continue to address significant unmet needs in the CAR-T therapeutic field. In particular, our recent joint venture to form ImmuneCyte is integral to our strategy, providing GMP compliant immune cell banking and contract development and manufacturing services with our proprietary CAR-TXpress platform, creating significant competitive advantages."

Jeff Cauble, Vice President of Finance and Principal Accounting Officer of ThermoGenesis, added, "Our previous cost-cutting measures, along with steadily improving sales of AXP and CAR-TXpress, have combined to yield another quarter of improved results. Revenues during the third quarter of 2019 increased by 30% as compared to the same period last year, while gross profit continued to improve, increasing to 47% of revenues in the third quarter of 2019. As a result, adjusted EBITDA, the metric we use to best approximate operational cash flow, was positive for the second quarter in a row."

Financial Results for the Quarter Ended September 30, 2019

Net revenues. Net revenues for the three months ended September 30, 2019 were $4.1 million compared to $3.1 million for the third quarter in 2018, an increase of $945,000 or 30% year over year. The increase was driven primarily by AXP and CAR-TXpress sales in the Device Segment. The AXP increase was driven by approximately 270 more cases sold to domestic end users in the current quarter. CAR-TXpress sales increased primarily due to new customers that adopted the system in the current quarter.

Gross profit. Gross profit for the three months ended September 30, 2019 was $1.9 million or 47% of net revenue, compared to $655,000 or 21% of net revenue for the comparable period in 2018. The gross profit margin increase was due to an increase in AXP disposable sales and lower AXP disposable costs generated by price efficiencies from contract manufacturers. A reduction in inventory reserves and increased sales of CAR-TXpress also positively affected gross profit for the period ended September 30, 2019.

Sales and marketing expenses. Sales and marketing expenses for the three months ended September 30, 2019 were $502,000, compared to $364,000 for the comparable period in 2018. The variance was driven by stock compensation expense for performance goals achieved by employees during the third quarter.

Research and development expenses. Research and development (R&D) expenses for the three months ended September 30, 2019 were $584,000, compared to $611,000 for the comparable period in 2018. The decrease was due to lower payroll related expenses as the result of having an open position for part of the third quarter of 2019.

General and administrative expenses. General and administrative expenses for the three months ended September 30, 2019 were $1.1 million, compared to $1.6 million for the comparable period in 2018. The decrease was driven by a reduction in personnel costs and payroll related expenses as the result of eliminating some senior management positions in 2019, as well as reduced payroll expenses in the Company’s India operations due to a reorganization in the first quarter of 2019 and a reduction in bad debt expense.

Interest Expense. Interest expense increased to $1.2 million for the three months ended September 30, 2019 as compared to $835,000 for the three months ended September 30, 2018. The increase is due to interest expense and the amortization of the debt discount related to the January 2019 convertible promissory note issued by the Company and additional interest and amortization of the debt discount related to the Revolving Credit Agreement with Boyalife.

Loss on Extinguishment of Debt. The Company recorded a loss on extinguishment of debt of $840,000 for the three months ended September 30, 2019 as compared to $0 for the three months ended September 30, 2018. The increase is due to the loss on the extinguishment of the January 2019 Note.

Net loss. For the three months ended September 30, 2019, the Company reported a comprehensive loss attributable to common stockholders of $2.3 million, or ($0.78) per share, based on approximately 2.9 million weighted average basic and diluted common shares outstanding. This compares to a comprehensive net loss of $2.6 million, or ($1.17) per share, based on approximately 2.2 million weighted average basic and diluted common shares outstanding for the three months ended September 30, 2018.

Adjusted EBITDA. In addition to the results reported under US GAAP, the Company also uses a non-GAAP measure, Adjusted EBITDA, to evaluate operating performance and to facilitate the comparison of our historical results and trends. The Company uses the metric to determine operational cash flow. Adjusted EBITDA for the three months ended September 30, 2019 was a positive $125,000, as compared to an adjusted EBITDA loss of $1.6 million for the three months ended September 30, 2018. The increase in the current period was due to $1.2 million in additional gross profit as a result of higher sales, while decreasing overhead expenses through price efficiencies from contract manufacturers. The Company also had decreased personnel expenses as a result of eliminating some positions in October 2018, as well as reduced payroll expenses in India due to a reorganization in the first quarter of 2019. A reconciliation of adjusted EBITDA to Net Income (Loss) is shown below.

At September 30, 2019, the Company had cash and cash equivalents totaling $2.8 million, compared with $2.4 million at December 31, 2018. Working capital improved to $5.4 million at September 30, 2019 as compared to $2.3 million at December 31, 2018.

Conference Call and Webcast Information

ThermoGenesis will host a conference call today at 1:30pm PST/4:30pm EST. To participate in the conference call, please dial 1-844-889-4331 (domestic), 1-412-380-7406 (international) or 1-866-605-3852 (Canada). To access a live webcast of the call, please visit: View Source

A replay of the call will be available until December 10 and can be accessed by dialing 1-877-344-7529 (domestic), 1-412-317-0088 (international) or 855-669-9658 (Canada), and referencing access code 10136101 The webcast will be available for three months.

Penumbra, Inc. Announces Investor Day 2019

On November 19, 2019 Penumbra, Inc. (NYSE: PEN) reported that it will host an Investor Day on Tuesday, December 3, 2019 in Boston, MA at 8:30am Eastern Time (Press release, Penumbra, NOV 19, 2019, View Source [SID1234551497]).

Webcast & Conference Call Information
A webcast of the event can be accessed on the "Events" section under the "Investors" tab of the Company’s website at: www.penumbrainc.com. The webcast will be available on the Company’s website for at least two weeks following the completion of the event.

West Announces Participation in Upcoming Investor Conference

On November 19, 2019 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that management will present an overview of the business at the Jefferies 2019 London Healthcare Conference in London, United Kingdom on Wednesday, November 20, 2019 (Press release, West Pharmaceutical Services, NOV 19, 2019, View Source [SID1234551496]).

A live audio webcast will be accessible from the Company’s website at www.westpharma.com/en/investors.