On November 15, 2019 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing XCART, a personalized chimeric antigen receptor T cell ("CAR T") platform technology engineered to target patient-specific tumor neoantigens, reported its financial results for the quarter ended September 30, 2019 and provided a corporate update (Press release, Xenetic Biosciences, NOV 15, 2019, View Source [SID1234551381]).

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Jeffrey Eisenberg, Chief Executive Officer of Xenetic, commented, "The third quarter marks a pivotal moment in the evolution of Xenetic to date. Following the acquisition of our proprietary XCART platform technology, we believe we have the potential to truly advance CAR T therapy and ultimately address the significant shortcomings that exist in the treatment of many oncology indications. As we look forward to the remainder of 2019 and into 2020, we continue to build momentum and ramp up our efforts to achieve the corporate, clinical and regulatory milestones that we believe will drive significant value for our shareholders."

XCART Platform Technology Overview: Designed to develop cell-based therapeutics for the treatment of multiple tumor types of B-cell Non-Hodgkin lymphomas, an area of significant unmet need, with the potential to address an initial global market opportunity of over $5 billion annually.

Highlights:

Proximity-based screening platform capable of identifying CAR constructs that can target patient-specific tumor neoantigens, with a demonstrated proof of mechanism in B-cell Non-Hodgkin lymphomas.
Believed to have the potential to significantly enhance the safety and efficacy of cell therapy for B-cell lymphomas by generating patient- and tumor-specific CAR T cells.
The XCART technology creates the possibility of personalized treatment of lymphomas utilizing a CAR with an antigen-binding domain that should only recognize, and only be recognized by, the unique BCR of a particular patient’s B-cell lymphoma.
Clinical development program will continue to seek to confirm the early preclinical results, and to demonstrate a more attractive safety profile than existing therapies.
Entered into a research agreement to begin the process of technology transfer of the XCART technology and enable advancement towards the Company’s stated goal of establishing an academic collaboration for XCART development.
PolyXen Platform Technology: Patent-protected enabling platform technology designed for protein or peptide therapeutics, enabling next-generation biological drugs to prolong a drug’s circulating half-life and potentially improve other pharmacological properties.

Highlights:

Exclusive License Agreement with Takeda Pharmaceuticals Co. Ltd. ("Takeda") in the field of coagulation disorders. Takeda currently has one active development program underway utilizing the PolyXen platform technology. In addition, in October 2017, Xenetic granted rights to Takeda to grant a nonexclusive sublicense to certain patents related to PolyXen to a third party.
Royalty stream resulting from the Takeda sublicense expected to commence by the end of 2019.
Summary of Financial Results for Third Quarter and Nine Months Ended September 30, 2019

The Company reported a net loss of approximately $8.9 million and $11.6 million for the three and nine months ended September 30, 2019, respectively, compared to a net loss of approximately $1.8 million and $5.7 million for the same periods in 2018. The results of the three and nine months ended September 30, 2019 included $6.3 million of non-cash expenses composed of in-process research and development expenses of $3.0 million associated with the Company’s acquisition of XCART and Goodwill impairment of $3.3 million, as well as $1.1 million of transaction costs related to our acquisition of XCART. Excluding the $6.3 million of non-cash expenses and $1.1 million of transaction costs, net loss was $1.5 million and $4.2 million for the three and nine months ended September 30, 2019, respectively. The Company has continued to reduce core expenses, control non-essential spending and maximize its available resources to advance its research and development efforts. On July 19, 2019, the Company completed its $15.0 million public offering, resulting in approximately $13.4 million of net proceeds to the Company. The Company ended the third quarter of 2019 with approximately $12.0 million in cash and $11.2 million of working capital.

On November 15, 2019 Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage biopharmaceutical company focused on developing curative cell therapies for cancer, reported its participation in the following upcoming investor conference (Press release, Unum Therapeutics, NOV 15, 2019, View Source [SID1234551380]):

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Piper Jaffray 31st Annual Healthcare Conference, New York
Date: December 5, 2019, New York, NY
Presentation time: 12:10 p.m. ET
Presenter: Chuck Wilson, Ph.D., President and Chief Executive Officer
The presentation will be webcast live here and archived for approximately 90 days.

On November 15, 2019 Sun BioPharma, Inc. (OTCQB: SNBP), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with pancreatic cancer, reported financial results for the quarter ended September 30, 2019 (Press release, Sun BioPharma, NOV 15, 2019, View Source [SID1234551379]).

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First-Line Combination Pancreatic Cancer Dose Escalation Study Expanded
The Company’s second clinical trial, a Phase 1a/1b combination of SBP-101 with gemcitabine and nab-paclitaxel in patients previously untreated for metastatic pancreatic ductal adenocarcinoma ("PDA"), completed enrollment of patients in the third dose level cohort in October. Following an upcoming meeting of the Data Safety Monitoring Board ("DSMB") the Company plans to add a fourth cohort to the study protocol to examine an alternative and more convenient dosing schedule.

In anticipation of continued clinical development new sites are now being added in the U.S. The Company has opened new clinical sites at the University of Rochester in Rochester, New York and Scripps MD Anderson Cancer Center in San Diego, California. Several additional sites are planned to be open in the first half of 2020.

Dr. Darren Sigal, director of GI Oncology and Principal Investigator at Scripps Clinic and Scripps MD Anderson commented, "We are pleased to be joining the Sun BioPharma study of SBP-101 for the treatment of patients with pancreatic cancer. More effective treatments remain urgently needed."

Sale of Common Stock and Warrants to Purchase Common Stock Raised $3.1M
The Company completed a private offering of common stock and warrants in September that raised approximately $3.1 million to support ongoing clinical trials. A total of 902,067 shares of common stock were issued as well as warrants to purchase an equal number of shares of common stock.

Amendment to Worldwide Exclusive License of SBP-101 Eliminates Milestone Payments and Reduces Future Royalty Obligations
In early October, Sun BioPharma and the University of Florida Research Foundation ("UFRF") entered into a second amendment to the License Agreement effective December 22, 2011. The license agreement continues to entitle the Company to a worldwide exclusive license from UFRF for the polyamine analogue compound (SBP-101). The second amendment eliminated the Company’s obligation to make any future milestone or minimum royalty payments to UFRF. It also reduced the period during which Sun BioPharma is required to pay royalties on future commercial sales of SBP-101.

Financial Results for the Three and Nine months ending September 30, 2019

Operating Results
General and administrative ("G&A") expenses increased 33.2% to $622,000 in the third quarter of 2019 up from $467,000 in the second quarter of 2018. G&A expenses decreased 15.4% to 1.5 million in the nine months ended September 30, 2019, down from $1.8 million in the nine months ended September 30, 2018. The increase in the quarter is primarily associated with higher stock compensation expense offset in part by reduced headcount versus the same quarter in the prior year. For the nine-months ended September 30, 2019 the decrease is due to a combination of lower salary expense and lower stock compensation expense.

Research and development ("R&D") expenses increased 60.0% to $720,000 in the third quarter of 2019 up from $450,000 in the third quarter of 2018. R&D expense increased 7.0% to $1.6 million in the nine months ended September 30, 2019, up from $1.5 million in the nine months ended September 30, 2018. The increase in the quarter ended September 30, 2019 was due primarily to incremental expenses associated with a manufacturing study, increased cost of the clinical trial and higher stock compensation expense. The increase in the nine-months ended September 30, 2019 was due to manufacturing and preclinical studies, offset in part by reduced stock compensation expense.

Other net expense was $222,000 and $63,000 for the three months ended September 30, 2019 and 2018, respectively. Other expense in the third quarter of both years is primarily a foreign currency translation loss. Other net expense increased 19.3% to $2.5 million in the nine months ended September 30, 2019. This increase is due primarily to the increase in interest expense associated with the amortization the debt discount on notes sold in December 2018 and January 2019. The debt discount was fully amortized in the first half of 2019 and converted to common stock on June 30, 2019.

Net loss in the third quarter of 2019 was $1.4 million, or $0.23 per diluted share, compared to a net loss of $0.9 million, or $0.18 per diluted share, in the third quarter of 2018. The net loss for the nine months ended September 30, 2019 was $5.2 million, or $0.97 per diluted share, compared to a net loss of $5.2 million, or $1.14 per diluted share, for the first nine months of 2018.

Balance Sheet and Cash Flow
Total cash was $3.4 million and $1.4 million as of September 30, 2019 and December 31, 2018, respectively. Total current assets were $3.8 million and $1.8 million as of September 30, 2019, and December 31, 2018, respectively. During the nine months ended September 30, 2019 proceeds of $810,000 from the sale of unsecured convertible promissory notes in January and proceeds of approximately $3.1 million in the third quarter from a private sale of 902,067 shares of common stock and warrants to purchase an additional 902,067 shares was partially offset by cash used in operations of $1.9 million.

Current liabilities decreased to $689,000 as of September 30, 2019, compared to $1.6 million as of December 31, 2018. The decrease in current liabilities is primarily the result of a vendor payable balance moving to a zero-interest, unsecured promissory note payable on December 31, 2020.

Net cash used in operating activities was $1.9 million in the nine-months ended September 30, 2019, compared to $2.2 million in the same period of the prior year. The net cash used in each of these periods primarily reflects the net loss for these periods and was partially offset by the effects of changes in operating assets and liabilities.

About SBP-101
SBP-101 is a first-in-class, proprietary, polyamine analogue designed to induce polyamine metabolic inhibition (PMI), exploiting a high affinity for the compound specific to the exocrine pancreas and pancreatic ductal adenocarcinoma. Sun BioPharma originally licensed SBP-101 from the University of Florida Research Foundation in 2011. The molecule has been shown to be highly effective in preclinical studies of human pancreatic cancer models, demonstrating superior and complementary activity to existing FDA-approved chemotherapy agents. SBP-101 is expected to differ from current pancreatic cancer therapies in that it specifically targets the exocrine pancreas and pancreatic adenocarcinoma, demonstrating efficacy against primary and metastatic disease in animal models of human pancreatic cancer. Therefore, management believes that SBP-101 may effectively treat both primary and metastatic pancreatic cancer, while leaving the insulin-producing islet cells unharmed. The safety and PMI profile demonstrated in Sun BioPharma’s first-in-human safety study further supports evaluation of the potential for additive or synergistic effects in combination with current standard pancreatic cancer treatment.

On November 15, 2019 Inovio Pharmaceuticals, Inc. (NASDAQ: INO) reported that Dr. J. Joseph Kim, President and CEO, will present in a fireside discussion at the Stifel 2019 Healthcare Conference on Tuesday, November 19, 2019 at 10:20 a.m. Eastern Time in New York, NY (Press release, Inovio, NOV 15, 2019, View Source [SID1234551378]). Dr. Kim will provide a business overview and update.

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The fireside discussion will be webcast live and may be accessed by visiting Inovio’s website at View Source Archived versions of the presentations will be made available through the Inovio Investor Relations Events page.

On November 15, 2019 Heat Biologics, Inc. (Nasdaq:HTBX), a biopharmaceutical company developing therapeutics designed to activate a patient’s immune system against cancer, reported financial and clinical updates for the third quarter ended September 30, 2019 (Press release, Heat Biologics, NOV 15, 2019, View Source [SID1234551377]).

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Jeff Wolf, Heat’s CEO, commented, "We remain encouraged by the positive top line data from our Phase 2 trial for HS-110 in advanced non-small cell lung cancer (NSCLC) in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, Opdivo (nivolumab) and with Merck’s anti-PD-1 checkpoint inhibitor Keytruda (pembrolizumab), which completed enrollment in July 2019. We recently presented a subset of this data in a poster presentation at The Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 34th Annual Meeting, in which we reported that 61% of patients in our Phase 2 Cohort B achieved disease stabilization per iRECIST, a patient population whose disease had progressed following prior checkpoint inhibitor therapy. Based on this data, we look forward to advancing our clinical trials and intend to aggressively explore all options for the future development of HS-110, including possible collaboration and licensing opportunities."

"We ended the quarter with approximately $15.0 million in cash, cash equivalents and short-term investments. We believe we are well funded to advance our clinical activities though additional major milestones and continue to manage expenses accordingly."

Third Quarter 2019 Financial Results

Research and development expenses decreased to $3.1 million for the quarter ended September 30, 2019 compared to $4.4 million for the quarter ended September 30, 2018. The decrease of approximately $1.3 million is due to the lower PTX-35 expense for 2019, primarily reflecting decreased manufacturing costs, offset by increased Phase 2 trial expenses, including outsourced clinical trial support services and payments to investigator sites.
General and administrative expense increased to $2.0 million for the quarter ended September 30, 2019 compared to $1.6 million for the quarter ended September 30, 2018. The $0.4 million increase is primarily attributable to increased personnel costs, including stock-based compensation expense.
Net loss attributable to Heat Biologics was approximately $6.2 million, or ($0.18) per basic and diluted share for the quarter ended September 30, 2019 compared to a net loss of approximately $3.7 million, or ($0.16) per basic and diluted share for the quarter ended September 30, 2018.
As of September 30, 2019, the Company had approximately $15.0 million in cash, cash equivalents and short-term investments with an additional $6.9 million in grant funds from Cancer Prevention Research Institute of Texas (CPRIT) that it expects to receive after filing an IND for PTX-35.