Month: March 2020

Xenetic Biosciences, Inc. Reports 2019 Year End Results and Provides Corporate Update

(Note: companies that
could be impacted by the content of this article are listed at the base of the
story [desktop version]. This article uses third-party references to provide a
bullish, bearish, and balanced point of view; sources are listed after the
Balanced section.)

Jeffrey Eisenberg, Chief Executive Officer of Xenetic, stated, “2019 proved to be a pivotal year for Xenetic with our completion of the acquisition of XCART, a differentiated CAR T platform technology that we believe has the potential to address a significant unmet need in B-cell non-Hodgkin lymphoma. Moving forward we believe 2020 will be an important year for the Company as we plan to continue driving the development of XCART. To that end, we have made encouraging progress with additions to our team and are advancing towards securing an academic collaboration. We believe this pathway will provide many advantages, including access to manufacturing suites, established CMC and regulatory infrastructure and cost and risk mitigation.”

“In the fourth quarter of last year, we received our first royalty payment under our agreement with Takeda involving our proprietary PolyXen^® technology in the field of coagulation disorders. While the recognized payment was modest, it is what we expected given the early stages of this product launch. Importantly, the commencement of royalties reaffirms the value of our PolyXen intellectual property and the opportunity to leverage it to prolong a drug’s circulating half-life and potentially improve other pharmacological properties. Further, in these unprecedented times, we are reviewing our portfolio of intellectual property assets to see if we can contribute in any way to the global effort to address the current health threat of COVID-19,” continued Mr. Eisenberg. “As we advance into the rest of 2020, despite the current climate of financial uncertainty, we are moving our operation and development efforts forward with a strong cash balance which we believe provides us with a cash runway through mid-2021.”

XCART Platform Technology Overview: Significantly differentiated, proprietary CAR T therapy 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.^[1] Xenetic believes XCART has the potential to transform CAR T therapy.

The Company has recently bolstered its cell therapy manufacturing and CMC expertise and capabilities with the appointments of Greg MacMichael, Ph.D. and Maksim Mamonkin, Ph.D., to its Scientific Advisory Board. Both Dr. MacMichael and Dr. Mamonkin are actively engaged with the Company to advance the development of the XCART technology platform.

Expected 2020 Milestones

• INTERACT meeting with the United States Food and Drug Administration (“FDA”)
• Enter into an academic site collaboration
• Advance IND-enabling studies
• Explore opportunities for Orphan Drug designation

PolyXen Platform Technology: Patent-protected platform technology designed for protein or peptide therapeutics, enabling next-generation biological drugs by prolonging a drug’s circulating half-life and potentially improving other pharmacological properties.

Program 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.
• The Company received $17,000 in royalty revenue during the fourth quarter of 2019 representing its first payment under the Company’s license agreement with Takeda. This payment and expected future payments relate to a sublicense of Xenetic’s PolyXen intellectual property, entered into by Takeda with a third party in 2017. The Company expects this quarterly royalty payment to increase as the relevant product launch continues to be rolled out by the sublicensee.

Mr. Eisenberg concluded, “We are closely monitoring the evolving COVID-19 situation. While the situation is very fluid, to date we have not experienced any significant impact or delays on our projected timelines. The safety and wellness of our employees, partners and the community are of the upmost importance to us and we have implemented risk mitigation strategies to ensure the least amount of disruption to our operations as possible.”

Summary of Financial Results for Fiscal Year 2019

Net cash used in operating activities for the year was $6.4 million. During 2019, our working capital increased by $10.1 million primarily due to our March 2019 registered direct offering and our July 2019 public offering that resulted in $16.1 million in combined net proceeds. This increase in working capital was partially offset by the Company’s reported net loss for the year ended December 31, 2019. The Company ended the year with approximately $­10.4 million of cash.

About Xenetic Biosciences

Xenetic Biosciences, Inc. is a biopharmaceutical company focused on progressing XCART^™, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens. The Company is initially advancing cell-based therapeutics targeting the unique B-cell receptor on the surface of an individual patient’s malignant tumor cells for the treatment of B-cell lymphomas. XCART^™ has the potential to fuel a robust pipeline of therapeutic assets targeting high-value oncology indications.

Additionally, Xenetic is leveraging PolyXen^®, its proprietary drug delivery platform, by partnering with biotechnology and pharmaceutical companies. PolyXen^® has demonstrated its ability to improve the half-life and other pharmacological properties of next-generation biologic drugs. The Company has an exclusive license agreement with Takeda Pharmaceuticals Co. Ltd. in the field of coagulation disorders and receives royalty payments under this agreement.

For more information, please visit the Company’s website at www.xeneticbio.com and connect on Twitter, LinkedIn, and Facebook.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates,” and other words of similar meaning, including, but not limited to, statements regarding the Company’s belief that 2020 will be an important year for the Company as it plans to continue driving the development of XCART, statements regarding advancing towards and the timing of securing an academic collaboration for the development of XCART, including the Company’s belief that this pathway will provide many advantages, including access to manufacturing suites, established CMC and regulatory infrastructure and cost and risk mitigation, statements regarding the Company’s belief that moving the Company’s operation and development efforts forward with a strong cash balance will provide Xenetic with a cash runway through mid-2021, statements related to the Company’s belief that XCART has the potential to transform CAR T therapy, all statements under the caption “Expected 2020 Milestones” including expected timing of completing INTERACT meetings with the FDA, entering into academic site collaborations, advancing IND-enabling studies and exploring opportunities for Orphan Drug designation, statements regarding the receipt of future quarterly royalty payments related to a sublicense of Xenetic’s PolyXen intellectual property entered into by Takeda with a third party in 2017, including expectations that this quarterly royalty payment will increase as the relevant product launch continues to be rolled out by the sublicensee, the Company’s plans to initially apply the XCART technology to advance cell-based therapeutics by targeting the unique B-cell receptor on the surface of an individual patient’s malignant tumor cells for the treatment of B-cell lymphomas, the Company’s expectations that XCART has the potential to fuel a robust pipeline of therapeutic assets targeting high-value oncology indications, and the Company’s expectations that XCART has the potential to address a significant unmet need in B-cell Hodgkin lymphoma. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Many factors could cause our actual activities, performance, achievements, or results to differ materially from the activities and results anticipated in forward-looking statements. Important factors that could cause actual activities, performance, achievements, or results to differ materially from such plans, estimates or expectations include, among others, (1) unexpected costs, charges or expenses resulting from the acquisition of XCART; (2) uncertainty of the expected financial performance of the Company following completion of the acquisition of XCART; (3) failure to realize the anticipated potential of the XCART technology; (4) the ability of the Company to implement its business strategy; and (5) other risk factors as detailed from time to time in the Company’s reports filed with the SEC, including its annual report on Form 10-K, periodic quarterly reports on Form 10-Q, periodic current reports on Form 8-K and other documents filed with the SEC. The foregoing list of important factors is not exclusive. In addition, forward-looking statements may also be adversely affected by general market factors, general economic and business conditions, including potential adverse effects of public health issues, such as the COVID-19 outbreak on economic activity, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new product candidates and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and the Company does not undertake any obligation to update forward-looking statements, except as required by law.

Contact:

JTC Team, LLC
Jenene Thomas
(833) 475-8247
xbio@jtcir.com

[1] Market Reports World GLOBAL NON-HODGKIN LYMPHOMA THERAPEUTICS MARKET – SEGMENTED BY TYPE OF TREATMENT – GROWTH, TRENDS AND FORECASTS (2018 – 2023); BioPharm Insight Surveillance, Epidemiology, and End Results (SEER) 9 registries, National Cancer Institute, 2017

View source version on accesswire.com:
https://www.accesswire.com/582778/Xenetic-Biosciences-Inc-Reports-2019-Year-End-Results-and-Provides-Corporate-Update

Released March 27, 2020

Federal Reserve Board Chairman Powell’s Resolve on Display

“There is nothing
fundamentally wrong with the economy” – Federal Reserve Board Chairman Jerome Powell, March 26, 2020

Yesterday morning the chairman of the Federal Reserve Board, Jerome Powell, was interviewed On NBC’s TODAY show. He was there to answer questions concerning the Fed’s actions and to share indications of what’s in store for families and companies in light of the pandemic’s strains on the economy. For the Fed Chairman to appear on a morning talk show is an indicator by itself. It indicates an effort to keep the country informed, patient, and onboard. It is also is an indicator of how important it is for the Fed to explain to people beyond the bankers and corporate executives so they understand all the government is doing and steps being taken related to the economy. Additionally, it allowed him to speak to citizens about where they are right now — And where they are is home, watching shows like TODAY.

He was interviewed by show host Savannah Guthrie who was very direct as she lead off with this very pointed question. “The Federal Reserve doesn’t exactly print money, but as one writer put it, you do have the ability to conjure money out of thin air. My question is simple; is there any limit to the amount of money the Fed is willing to put into this economy to keep it afloat? Is it a blank check?” The Fed Chairman responded by explaining their emergency lending authority and the full security they require for lending.  He said, “…they don’t lose money.” Powell then went on to explain, “…essentially the answer to your question is no, we can continue to make loans. The point of all that is to support the flow of credit in the economy, including households and businesses.”

Other points worth noting is Federal Reserve Chairman Jerome Powell said the economy may be in recession as a result of the coronavirus pandemic but has the potential to rebound depending on how quickly the virus is contained. The reason he gave is that the economy was at a 50-year low in unemployment and in a strong position before CoVID-19 spread to the U.S. “We may well be in a recession,” said Powell during the interview, but added this recession is different from normal, and there is nothing “fundamentally wrong” with the economy.

Throughout the interview, it seemed important for the TODAY show guest to make clear that this is a unique situation, not a typical downturn. “This is a situation where people are being asked to step back from economic activity, close their businesses, stay home from work,” Powell explained. “In principle, if we get the virus spread under control fairly quickly, then economic activity can resume, and we want to make that rebound as vigorous as possible.”

Earlier this month, the Federal Reserve Federal Open Market Committee cut the overnight lending rate target to zero percent.

Suggested Reading:

Will
the Stock Market Survive CoVID-19

ZIRP
Interest Rate Policy and QE5

Capitalism
Versus Coronavirus

Sources:

The
TODAY Show, March 26, 2020

U.S.
Bureau of Labor Statistics

Thursday, March 26, 2020

Onconova Therapeutics Inc. (ONTX)

Q4 2019 Earnings: INSPIRE Topline Data is on Track for H2 2020

Onconova Therapeutics Inc is a clinical-stage biopharmaceutical company operating in the US. It focuses on discovering and developing novel small molecule product candidates primarily to treat cancer. The company has created a library of targeted agents designed to work against cellular pathways important to cancer cells. Its product candidates are Single-agent IV rigosertib, Oral rigosertib + azacitidine, IV Briciclib, Recilisib, and ON 123300. The key product candidate Rigosertib is a small molecule which blocks cellular signaling by targeting RAS effector pathways.

Ahu Demir, Ph.D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

INSPIRE study enrollment is completed, up next topline data readout. Onconova’s main focus has been its pivotal INSPIRE study, assessing rigosertib in 2nd-line high-risk myelodysplastic syndrome (HR-MDS) patients. Enrollment is complete (360 patients). The topline data is anticipated in H2 2020.


Competitive position of rigosertib in MDS. The evolution of MDS landscape is following AML’s footprints (shifting from clinical definition of disease subsets to genetic or biomarker-related segmentation). We think there is room for multiple approvals. Rigosertib continues to represent an advanced and promising program in this competitive landscape. We believe investors will remain cautious until overall survival data from INSPIRE becomes available. However, we believe the company’s Phase 2/3 clinical trial initiation in 1st line MDS and…







Click here to get the full report.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst
certification and important disclosures included in the full report. 
NOTE: investment decisions should not be based upon the content of
this research summary.  Proper due diligence is required before
making any investment decision. 

Thursday, March 26, 2020

Onconova Therapeutics Inc. (ONTX)

Q4 2019 Earnings: INSPIRE Topline Data is on Track for H2 2020

Onconova Therapeutics Inc is a clinical-stage biopharmaceutical company operating in the US. It focuses on discovering and developing novel small molecule product candidates primarily to treat cancer. The company has created a library of targeted agents designed to work against cellular pathways important to cancer cells. Its product candidates are Single-agent IV rigosertib, Oral rigosertib + azacitidine, IV Briciclib, Recilisib, and ON 123300. The key product candidate Rigosertib is a small molecule which blocks cellular signaling by targeting RAS effector pathways.

Ahu Demir, Ph.D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

INSPIRE study enrollment is completed, up next topline data readout. Onconova’s main focus has been its pivotal INSPIRE study, assessing rigosertib in 2nd-line high-risk myelodysplastic syndrome (HR-MDS) patients. Enrollment is complete (360 patients). The topline data is anticipated in H2 2020.


Competitive position of rigosertib in MDS. The evolution of MDS landscape is following AML’s footprints (shifting from clinical definition of disease subsets to genetic or biomarker-related segmentation). We think there is room for multiple approvals. Rigosertib continues to represent an advanced and promising program in this competitive landscape. We believe investors will remain cautious until overall survival data from INSPIRE becomes available. However, we believe the company’s Phase 2/3 clinical trial initiation in 1st line MDS and…







Click here to get the full report.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst
certification and important disclosures included in the full report. 
NOTE: investment decisions should not be based upon the content of
this research summary.  Proper due diligence is required before
making any investment decision. 

Reconciling CoVID-19 with Statistics-101

Today’s go-to conversation with friends, family, and co-workers is about CoVid-19. For people in the investment markets who are well-versed in charting, probabilities, and following trends, the conversation often focuses on statistics, or more specifically, risk analysis. But the current state of this disease makes it even more challenging than calculating the investment markets. With an investment, there is first the decision even to be exposed, and then the only possible outcomes are win, lose, or lost opportunity elsewhere. The coronavirus is different; we can’t just stay away like we can the stock market; it’s a global pandemic. We’re all “involved,” whether we feel we have minimum exposure or greater exposure, we are all somehow impacted, and there are no winners.  So, calculating what we expect the results could be, is important to us.

Aside from wanting to figure how long the pandemic will last, the top question is, “How likely am I to get it” and  “How likely is it that I will die?” We’re investors, not epidemiologists, so we try to get an answer by calculating a simple ratio. Most use bad outcomes divided by either the full population or the population that has been infected. Of course, we should all come up with precisely the same answer.  Then, from this assessment, we can make decisions. Although we would prefer zero risk (no bad outcomes), we’re comfortable with the idea that everything in life has risk, and it is from the level of risk where we make decisions.  The problem is, in calculating this simple ratio, we are running into trouble. Even the most analytical among us come up with numbers that vary from .25% death rates to 10%.  The reason is that our simple ratio involves a numerator and a denominator. While we have fairly good sources of the numerator, the denominator measure is largely assumed.

Measurements in Public Health

The CDC, WHO, and local public health systems are good at counting incidence when monitoring outbreaks of disease, CoVID-19 is a good example of this. WHO reports on the status of the pandemic with detail by country of current cases, cumulative cases, and total deaths. This information is useful for measuring the stress on medical systems, impact on a region, and trends among regions. However, these data are all numerators in the risk assessment equation. It seems health organizations provide little to calculate the population at risk. The risk ratio becomes even more muddied when you consider one’s point of view. People take the total deaths, which is a knowable value, and place that over patients hospitalized, or total tested, number exposed, the entire population, or an extrapolation of other assumed variants.  All of these provide a different denominator and broadly different risk ratios.

Ballpark Numbers

The wide range of estimates, although not pinpoint, most often conclude that the ratio between the contraction of the disease and death is not high. For most individuals, whether the death rate is 0.5% or 2.5%, the change in our behavior will be the same; these percentages don’t seem that great. However, one of these numbers is five times larger than the other. This lack of imprecision may not alter our personal planning, but spread out over a population; it is the difference between 5,000 deaths and 25,000. For people in government, larger death rates are likely to lead to bigger decisions. Those decisions are where we’re impacted.

Unfortunately, as individuals and for the overall public, we don’t have reliable denominators. This can be helped by large scale testing, which is underway in many countries and regions.  This presents other questions, such as the reliability of these tests and those implementing them. One step that will get us closer, if not now, in the future is a step the US Census Bureau just added online reporting to their 2020 effort. For now, the other numbers will still vary greatly. We know how we can lower our personal risk and those around us. Wash our hands and limit contact with others.

Suggested Reading:

CoVID-19, Spread and Threat

How Americans Research and What it Means for Your Business

Do Market Scares Provide Uncommon Opportunity

Sources:

WHO Newsroom

2020 Census Statement on Coronavirus

Picture Credit:

Odd Couple, “Assume” episode

Wednesday, March 25, 2020

electroCore (ECOR)

Q4 2019 Results: Lagged Commercial Success

electrocore Inc is a commercial-stage bioelectronic medicine company with a platform for non-invasive vagus nerve stimulation therapy initially focused on neurology and rheumatology. Its product gammaCore is FDA-cleared for the acute treatment of pain associated with migraine and episodic cluster headache in adults.

Ahu Demir, Ph.D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Fourth quarter 2019 financial results. The company focuses on two channels to commercialize gammaCore: i) the Federal Supply Schedule eligible entities and ii) the United Kingdom’s National Health Service. The net sales in Q4 were $675,000 compared to $683,000 in Q3 2019. There was a 24% sequential growth in paid months of therapy, that was not reflected on sales driven by the timing of revenue recognition and currency exchange fluctuations.

Did it meet our expectations? The company reported total revenue of $2.4 million, operating expenses of $47.3 million, and EPS of ($1.54) for the full year of 2019 compared to our estimates of $3.0 million in revenue, $46.1 in operating expenses and…





Click here to get the full report.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst
certification and important disclosures included in the full report. 
NOTE: investment decisions should not be based upon the content of
this research summary.  Proper due diligence is required before
making any investment decision.