On November 19, 2019 Samsung Bioepis Co., Ltd. reported that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) under the 351(k) pathway for SB8, a biosimilar candidate referencing AVASTINi (bevacizumab) (Press release, Samsung Bioepis, NOV 19, 2019, View Source [SID1234551481]). The BLA for SB8 was submitted by Samsung Bioepis in September 2019.

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If approved, SB8 will be commercialized in the United States (US) by Merck & Co., Inc., Kenilworth, NJ, USA, which is known as MSD outside the US and Canada.

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]).

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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.

On November 19, 2019 Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN), a cutting-edge biotechnology company developing new treatments for life-threatening medical conditions by improving the body’s ability to bring oxygen to the areas where it is needed most, reported increased survival in inoperable glioblastoma patients enrolled in the 19-patient, open-label, dose-escalation lead-in portion of its Phase 3 study with Trans Sodium Crocetinate (TSC) plus standard of care (SOC) (Press release, Diffusion Pharmaceuticals, NOV 19, 2019, View Source [SID1234551466]). John Gainer, Ph.D., the Company’s chief scientific officer, will present details of these findings at the inaugural Glioblastoma Drug Development Summit being held in Boston December 10-11, and sponsored by Hanson Wade. Dr. Gainer’s slide presentation will be posted to the Company’s website at www.diffusionpharma.com immediately prior to the conference.

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In an earlier Phase 2 study testing TSC in newly diagnosed glioblastoma multiforme (GBM) brain cancer patients, an almost fourfold increase in 2-year survival was seen versus historical controls in inoperable patients. The current Phase 3 INTACT (INvestigating Tsc Against Cancerous Tumors) study – an open-label, randomized, controlled trial – is designed to examine this finding in a fully powered safety and efficacy registration study, which, if successful, could be the basis for US FDA approval.

In the INTACT trial, subjects are randomized at baseline to SOC for first-line treatment of GBM plus TSC, or to SOC alone. The SOC for GBM is temozolomide plus radiation therapy for 6 weeks, followed by 28 days of rest, then by 6 cycles of post-radiation temozolomide treatment. In a modification to the Phase 2 dosing regimen, patients in the INTACT trial will also receive high-dose TSC during the post-radiation chemotherapy phase.

A 19-patient, open-label, dose-escalation lead-in portion to the INTACT trial was recently completed, sending a positive safety signal across all patients receiving TSC. In addition, six of the seven patients who received the high dose TSC treatment are still alive, with a median survival at the present time of 14.3 months. This is compared with 9.2 months for the historical standard of patients with inoperable GBM. Since six of the TSC-treated patients are still alive, median survival time is actually increasing with the passage of time, suggesting the INTACT trial may confirm or better the efficacy findings seen in the Phase 2 study.

Patients’ abilities to perform their daily activities as measured by Karnofsky performance scores increased from the baseline following completion of high dose treatment with TSC. Investigators have also reported instances of inoperable GBM patients treated with the higher dose TSC regimen leaving hospice or returning to work after treatment in the open-label portion of the study.

"We are encouraged by these early findings showing that patients enrolled in the lead-in portion of the INTACT trial have experienced increased survival with our new protocol," said Dr. Gainer. "Although final conclusions will depend on the completion of the randomized portion of the trial, we believe that TSC helps to eradicate the low oxygen status of cancerous tumors, and it appears this may also result in a survival benefit compared with the current standard therapy."

The Company previously announced it is seeking a partner to continue development of TSC in the GBM indication and has begun patient enrollment in its Phase 2 on-ambulance trial with TSC for the treatment of stroke.

About Hanson Wade

Hanson Wade’s goal is to accelerate progress within organizations and across industries. Its primary method for achieving this is by creating exclusive business conferences that gather together the world’s smartest thinkers and doers. The inaugural Glioblastoma Drug Development Summit is designed with two critical and ambitious objectives: to help overcome the major biological challenges limiting effective Glioblastoma treatment; and to evaluate novel therapies and innovative trial design to prevent more tragic Phase 2 failures.

On November 19, 2019 Relay Therapeutics, a new breed of company at the intersection of computation and biotechnology, reported that Ben B. Wolf, M.D., Ph.D., has joined as chief medical officer, Mrunal "Monica" Phadnis has joined as vice president of clinical operations and Iain Martin, Ph.D., has joined as vice president, drug metabolism and pharmacokinetics (Press release, Relay Therapeutics, NOV 19, 2019, View Source [SID1234551482]).

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"As we advance multiple programs into the clinic in the coming year and continue to deepen our early stage pipeline, Ben’s extensive experience in clinical development and translational medicine, Monica’s background in clinical operations, and Iain’s expertise in drug discovery will be critical in helping propel the company in the next phase of our growth," said Don Bergstrom, M.D., Ph.D., executive vice president and head of research and development of Relay Therapeutics. "We are pleased to welcome these respected leaders, who together bring a wealth of expertise to our growing team."

Dr. Ben B. Wolf is a precision oncologist who brings to Relay Therapeutics nearly 20 years of experience in the biopharmaceutical industry, with expertise advancing new oncology programs in the clinic and optimizing patient selection to enable rapid proof of concept and registration. He has authored more than 30 peer-reviewed publications and multiple patents related to drug discoveries. Most recently, Dr. Wolf served as chief medical officer at KSQ Therapeutics, a biotechnology company advancing a pipeline of CRISPR-based tumor- and immune-focused drug candidates for the treatment of cancer. Prior to KSQ, Dr. Wolf was senior vice president, clinical development at Blueprint Medicines, where he advanced three oncology programs for novel kinase inhibitors from investigational new drug (IND) applications to clinical proof-of-concept. Prior to Blueprint, Dr. Wolf held clinical and medical director roles at Merrimack Pharmaceuticals, ImmunoGen, Amgen and Genentech. Dr. Wolf holds an M.D. and Ph.D. in biochemistry from the University of Virginia and a B.S. from Union College. He completed medical training in internal medicine and medical oncology at the University of California at San Diego.

Monica Phadnis is an end-to-end delivery expert with more than 15 years in clinical oncology research. Prior to joining Relay Therapeutics, she was the executive director of clinical development in oncology and hematology at Syneos Health, where she worked primarily on early phase solid tumors. Before Syneos, she was the director and clinical operations lead at EMD Serono, where she led Precision Medicine clinical programs in Non-Small Cell Lung Cancer. Additionally, she held roles of growing responsibility at Quintiles Translational Corporation, Sanofi-Aventis, Memorial Sloan-Kettering Cancer Center and Selventa Inc. Ms. Phadnis received a B.S. in mathematics from the University of Mumbai in Mumbai, India and a pre-medical diploma with specialization in genetics from Harvard University.

Dr. Iain Martin brings to Relay Therapeutics more than 30 years of experience in pharmaceutical drug metabolism and pharmacokinetics (DMPK) across therapeutic areas, including oncology and neuroscience. Prior to joining Relay Therapeutics, he was executive director within the department of pharmacokinetics, pharmacodynamics and drug metabolism at Merck, where he led groups responsible for DMPK support of small molecule and peptide programs across the company. Prior to Merck, Dr. Martin held roles of increasing responsibility at The Upjohn Company, AstraZeneca, Organon and Schering Plough. He received his Ph.D. in drug metabolism and a B.S. in biochemistry from the University of Surrey (UK).

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]).

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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."