On November 19, 2019 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported that it is proposing to offer and sell, subject to market conditions, shares of its common stock in an underwritten public offering (Press release, Checkpoint Therapeutics, NOV 19, 2019, View Source [SID1234551464]). Checkpoint expects to grant the underwriters a 45‐day option to purchase up to an additional 15 percent of the shares of common stock offered in the public offering. All of the shares of common stock are being offered by Checkpoint. Checkpoint intends to use the net proceeds from the offering primarily to support the continued development of cosibelimab, including an ongoing Phase 1 clinical trial in checkpoint therapy-naïve patients with selected recurrent or metastatic cancers, including ongoing cohorts intended to support one or more Biologics License Application submissions, and for general corporate purposes. The final terms of the offering will depend on market and other conditions at the time of pricing, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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National Securities Corporation, a wholly owned subsidiary of National Holdings Corporation (NasdaqCM: NHLD), is acting as the sole book running manager for the offering.

A shelf registration statement on Form S‐3 (File. No. 333‐221493) (the "Registration Statement") relating to the shares of common stock being offered was filed with the U.S. Securities and Exchange Commission (SEC) and was declared effective on December 1, 2017. Copies of the preliminary prospectus supplement and accompanying prospectus, when available, may be obtained from National Securities Corporation, Attn: Charles Wanyama, 200 Vesey Street, 25th Floor, New York, New York 10281, telephone: (212) 417-3634, or by email at [email protected]; or the on the SEC’s website at View Source

The offering will be made only by means of a prospectus. A final prospectus supplement to the base prospectus describing the terms of the offering will be filed with the SEC. This press release shall not constitute an offer to sell or a solicitation of an offer to buy securities of the Company, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale is not permitted.

On November 19, 2019 Omeros Corporation (Nasdaq: OMER) reported new findings on GPR174, its novel cancer immunotherapy target, demonstrating that GPR174-deficiency enhances anti-tumor immune responses in animals (Press release, Omeros, NOV 19, 2019, View Source [SID1234551480]).

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The studies were conducted in mouse models of melanoma and of colon carcinoma, each of which was modified to partially deplete regulatory T cells, a subset of immunosuppressive T cells. Partial depletion of regulatory T cells in mice creates a T-cell composition more similar to that in humans. GPR174 deficiency in these mice resulted in significantly reduced tumor growth and improved survival of the animals (p=0.006 in melanoma; p=0.03 in colon cancer) versus normal mice.

These findings are being presented today by Marc Gavin, Ph.D., Omeros’ Director of Immunology, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Conference on Tumor Immunology and Immunotherapy in Boston, Massachusetts.

The presentation also features discoveries regarding phosphatidylserine (PS), a product of cell stress and death that is abundant in the tumor microenvironment. PS has been shown by Omeros to suppress T-cell activity through GPR174. The function of PS is similar to that of adenosine, which is also abundant in the tumor microenvironment and suppresses T cells through adenosine receptors. It was demonstrated that the combination of adenosine pathway inhibition together with Omeros’ novel GPR174 inhibitors results in maximal potentiation of T-cell responses, which should translate to a more effective cancer immunotherapy approach.

"The animal data nicely confirm our cell-based findings and further validate GPR174 as an important immuno-oncology target," said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer. "We look forward to advancing this program to the clinic and providing better treatment options and outcomes to cancer patients."

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.