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]).

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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.

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 Oncoceutics, Inc. reported a publication in the journal Nature Communications demonstrating selective antagonism of the G-protein coupled receptor (GPCR) dopamine receptor D2 (DRD2) by Oncoceutics’ lead candidate imipridone, ONC201 (Press release, Oncoceutics, NOV 19, 2019, View Source [SID1234558321]).

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ONC201 was found to specifically bind and antagonize DRD2, and its functionally redundant family member DRD3, without affecting other dopamine receptors, other GPCRs, nuclear hormone receptors, kinases, or other drug targets of FDA-approved cancer therapies. Additionally, a biologically inactive isomer of ONC201 did not antagonize DRD2, indicating that antagonism of this receptor may be linked to anti-cancer efficacy as shown in other publications (Clinical Cancer Research and Neoplasia).

The publication also describes the novel approach taken by Oncoceutics collaborators in the laboratory of Olivier Elemento, PhD, Director of the Englander Institute for Precision Medicine at Weill Cornell Medicine. The researchers used a novel machine-learning platform, called BANDIT, created in the Elemento Lab that suggested DRD2 as a target of ONC201. This method used the molecular structure of ONC201, its in vitro efficacy profile, and its publicly available bioactivity assay results as inputs to compare ONC201 against all small molecules with known targets.

"This publication represents years of collaborative work that uncovered DRD2 as the first known binding target of ONC201," said Joshua Allen, PhD and Senior Vice President of R&D of Oncoceutics. "Along with downstream biomarkers, the dopamine pathway has guided tumor type selection and interpretation of activity of ONC201 in clinical trials. So far, we have observed the most robust single agent efficacy in malignancies that exhibit dysregulation of the dopamine pathway and grow in a dopamine-rich microenvironment, such as midline gliomas."

"Our findings have helped uncover imipridone small molecules as a unique chemical scaffold for targeting GPCRs," said Dr. Elemento. "We are pleased to see the clinical translation of our precision medicine efforts in ONC201 clinical trials and hope this information can be used to identify additional indications for this new therapy."

"The unique mechanism of action of ONC201 is now well defined," said Martin Stogniew, PhD and Chief Development Officer of Oncoceutics. "The most conserved downstream effect of ONC201 in tumor cells is activation of the integrated stress response. Several additional downstream effects, such as dual inactivation of Akt/ERK, induction of TRAIL and DR5, and degradation of Myc also occur in many tumor models, along with immunostimulatory effects involving NK cells and cancer stem cell depletion. These effects aggregately explain the broad antitumor activity observed in multiple models and are likely trigged by the interaction ONC201 with DRD2 and/or ClpP, a recently uncovered additional binding target of the molecule."

For further reference, please refer to additional publications on ONC201 and imipridone small molecules.

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.