Research – PDS Biotechnology (PDSB) – Well Funded to Advance Cancer Programs

Monday, March 30, 2020

PDS Biotechnology (PDSB)

Well Funded to Advance Cancer Programs

PDS Biotechnology Corp operates as a clinical stage biotechnology company, principally involved in drug discovery in the United States. It is primarily engaged in the treatment of various early-stage and late-stage cancers, including head and neck cancer, prostate cancer, breast cancer, cervical cancer, anal cancer, and other cancers. Its products are based on the proprietary Versamune platform technology, which activates and directs the human immune system to unleash a powerful and targeted attack against cancer cells.

Cosme Ordonez, Senior Research Analyst, Noble Capital Markets, Inc.

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

PDS Biotechnology F2019 Financial Results, Boosting Cash Position. After the close on Friday March 27, PDS Biotechnology announced financial results for F2019. The company reported a net loss of $6.9 mm compared to our estimate of $7.5 mm as our forecast included higher R&D and SG&A expenses. As of December 31, 2019, PDS reported cash and cash equivalents of $12.2 mm. In February, the company raised an additional $11.9 mm. We believe strengthened cash position allows management to advance its cancer clinical programs.

Business update highlights importance of Phase I results. PDS Biotechnology completed a Phase I clinical trial on the use of its lead drug PDS0101 for the treatment of cervical intraepithelial neoplasia (CIN). In the trial, the treatment elicited a potent anti-cancer immune response. 60% of treated patients showed regression of lesions. This year, the company plans to initiate several Phase II clinical trials evaluating PDS0101 for the treatment of…


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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.
 

Research electrocore ecor gammacore received clearance for prevention of migraine

Monday, March 30, 2020

electroCore (ECOR)

gammaCore Received Clearance for Prevention of Migraine

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.

    Label expansion of gammaCore. electroCore announced the 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the label indication of gammaCore therapy to prevention of migraine in adult patients.

    The largest market among approved indications. gammaCore is now approved for the prevention and treatment of migraines and cluster headache in adults. We think this is a significant milestone for the company. Prevention of migraine represents the largest growth opportunity for gammaCore sales. Estimates indicate that migraine sales will grow to $6.5 billion by 2027, potentially tripling in size. The migraine prophylaxis market could nearly quadruple to…



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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.
 

Research dyadic international inc- dyai established another partnership in china

Monday, March 30, 2020

Dyadic International Inc. (DYAI)

Established Another Partnership in China

Dyadic International, Inc. is a global biotechnology company which is developing what it believes will be a potentially significant biopharmaceutical gene expression platform based on the industrially proven hyper productive engineered fungus Thermothelomyces heterothallica (formerly Myceliophthora thermophila), named C1.
The C1 microorganism, which enables the development and large scale manufacture of low cost proteins, has the potential to be further developed into a safe and efficient expression system that may help speed up the development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales. Dyadic is using the C1 technology and other technologies to conduct research, development and commercial activities for the development and manufacturing of human and animal vaccines and drugs, such as virus like particles (VLPs) and antigens, monoclonal antibodies, Fab antibody fragments, Fc-Fusion proteins, biosimilars and/or biobetters, and other therapeutic proteins. Dyadic pursues research and development collaborations, licensing arrangements and other commercial opportunities with its partners and collaborators to leverage the value and benefits of these technologies in development and manufacture of biopharmaceuticals. In particular, as the aging population grows in developed and undeveloped countries, Dyadic believes the C1 technology may help bring biologic vaccines, drugs and other biologic products to market faster, in greater volumes, at lower cost, and with new properties to drug developers and manufacturers, and improve access and cost to patients and the healthcare system, but most importantly save lives.

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

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

    Dyadic added another company to its partnership portfolio. Dyadic entered into a nonexclusive research collaboration with WuXi Biologics to evaluate the C1 technology in a cGMP facility and to perform experiments with the C1 cell lines for any other internal noncommercial purposes. WuXi Biologics is a China-headquartered biologics discovery, development, and manufacturing company. The current portfolio expanded to ten partnerships assessing the C1 platform in biologics manufacturing.

    What do these partnerships mean for Dyadic? The company implements a business model where the C1 expression system is being assessed in multiple biologic modalities (vaccines, gene therapy, antibodies, and others) by multiple partners (Sanofi, Zapi, Serum India, and others). By implementing this business model, Dyadic is keeping its cash burn at a minimum, while diversifying the C1’s portfolio and potentially increasing its probability of success. The company is also…



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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.
 

Research therapeuticsmd inc- txmd not unexpected 2020 guidance is suspended

Monday, March 30, 2020

TherapeuticsMD Inc. (TXMD)

Not Unexpected: 2020 Guidance is Suspended

(current) TherapeuticsMD, Inc. is a women’s healthcare company focused on developing and commercializing products targeted exclusively for women. It manufactures and distributes branded and generic prescription prenatal vitamins, as well as over-the-counter vitamins and cosmetics, under our vitaMedMD’ and BocaGreenMD’ brands. The company is currently developing advanced hormone therapy pharmaceutical products designed to alleviate the symptoms of and reduce the health risks resulting from menopause-related hormone deficiencies. It is also evaluating various other potential indications for our hormone technology, including oral contraception, preterm birth, vulvar and vaginal atrophy, and premature ovarian failure.

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

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

    Business update. Today, TherapeuticsMD announced a business update driven by the impact of COVID-19 pandemic. We think the implemented model is coherent in these difficult and uncertain times for an early stage commercial company like TherapeuticsMD.

    Reduced cost and spending. The Company implemented measures to cut or defer more than $30M in annual spending including $10 million deferral in Q2 marketing spend for Annovera and Imvexxy and $20 million cut in other…



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This 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.
 

Research pds biotechnology pdsb well funded to advance cancer programs

Monday, March 30, 2020

PDS Biotechnology (PDSB)

Well Funded to Advance Cancer Programs

PDS Biotechnology Corp operates as a clinical stage biotechnology company, principally involved in drug discovery in the United States. It is primarily engaged in the treatment of various early-stage and late-stage cancers, including head and neck cancer, prostate cancer, breast cancer, cervical cancer, anal cancer, and other cancers. Its products are based on the proprietary Versamune platform technology, which activates and directs the human immune system to unleash a powerful and targeted attack against cancer cells.

Cosme Ordonez, Senior Research Analyst, Noble Capital Markets, Inc.

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

PDS Biotechnology F2019 Financial Results, Boosting Cash Position. After the close on Friday March 27, PDS Biotechnology announced financial results for F2019. The company reported a net loss of $6.9 mm compared to our estimate of $7.5 mm as our forecast included higher R&D and SG&A expenses. As of December 31, 2019, PDS reported cash and cash equivalents of $12.2 mm. In February, the company raised an additional $11.9 mm. We believe strengthened cash position allows management to advance its cancer clinical programs.

Business update highlights importance of Phase I results. PDS Biotechnology completed a Phase I clinical trial on the use of its lead drug PDS0101 for the treatment of cervical intraepithelial neoplasia (CIN). In the trial, the treatment elicited a potent anti-cancer immune response. 60% of treated patients showed regression of lesions. This year, the company plans to initiate several Phase II clinical trials evaluating PDS0101 for the treatment of…


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.
 

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

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
[email protected]

[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

A Significant Indicator of the Fed’s Resolve

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

Research – Onconova Therapeutics Inc. (ONTX) – Q4 2019 Earnings: INSPIRE Topline Data is on Track for H2 2020

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.
 

Denominators, Disease and Death

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

Research onconova therapeutics inc- ontx q4 2019 earnings inspire topline data is on track for h2 2020

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.
 

Research – electroCore (ECOR) – Q4 2019 Results: Lagged Commercial Success

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.
 

Research electrocore ecor q4 2019 results lagged commercial success

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…


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COVID-19 Spread and Threat

Could a Natural Mutation Slowdown COVID-19?

(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.)

“The
single biggest threat to man’s continued dominance on the planet is the virus”,

quote
by Joshua Lederberg (see photograph below).

The best medical scientists, physicians, epidemiologists, microbiologists, and infectious disease experts are currently joining forces worldwide to find a way to stop the spreading of SARS-CoV-2, the coronavirus causing “Coronavirus Disease of 2019” (Covid-19), which has become a global pandemic. As of March 22, 2020, there are more than 335,400 people infected with SARS-CoV-2 worldwide, and more than 14,610 people have died from the disease.

Figure
1
– Structure of the new coronavirus, SARS-CoV-2, images by transmission electron microscopy. The virus resembles an sphere with spikes. The S-protein or Spike protein is critical for virus entry into human cells.

A picture containing indoor, sitting, old, photo

Description automatically generated

Source
– Science 2020, 367 (6483) p1260-1263

As the biotechnology/pharmaceutical industry collaborates with medical academic institutions in the search for a treatment/vaccine or cure for Covid-19, it is difficult to predict the evolution of the current pandemic and virus behavior in coming weeks, months. As the world waits for the outcome of ongoing clinical trials evaluating potential treatments for Covid-19, it is important keeping aware of what medical science has taught us from previous epidemics such as SARS in 2002, middle east respiratory outbreak (MERS) in 2012 and Spanish flu (1918). Despite of the relatively short history of Covid-19, which started in China in December 2019, knowledge of the biology of the new coronavirus, SARSCoV-2, have grown very quickly.

New
Discoveries Could Speed up Vaccine Development

Recently, scientists at the University of Texas, Austin, discovered the mechanism of entry of SARS-CoV-2 into human cells (Science 2020, 367 (6483) p1260-1263). The Spike protein, or S-protein, is critical for viral entry. Another group of researchers led by Qiang Zhou, a research fellow at Westlake University in Hangzhou, China, have revealed how the new virus attaches to a receptor on respiratory cells called “angiotensin-converting enzyme 2”, or ACE2 (
Science March 4th, 2020: eabb2762 DOI: 10.1126/science.abb2762). Zhou and his team have now discovered the second part of the puzzle by describing how S-protein binds to ACE2 receptor on the surface of respiratory cells. This knowledge could be critical for the success of ongoing efforts to find a treatment or cure.

Figure
2
– Mechanism of entry of SARS-CoV-2 into human cells. The virus mechanism of entry is similar to the one utilized by the virus SARS-CoV, which caused the SARS outbreak of 2002. Panel A depicts “Spike protein” or “S-protein” on the surface of the coronavirus binding to “angiotensin-converting enzyme 2” (ACE-2) receptors on the surface of a human cell. Panel B shows the “type II transmembrane serine protease” (TMPRSS2) binding to and cleaving ACE-2 receptor, which activates the Spike protein of the coronavirus. Panel C shows viral entry. 

Source
– Pathogens 2020, 9(3) 231; https://doi.org/10.3390/pathogens9030231

As the medical community races to find a treatment/cure for Covid-19, experts ponder on the probability that nature might help mankind by slowing down the virus spread. Among many potential mechanisms and strategies, there are three primary events which could curtail viral spreading:

  • Natural Mutations of SARS-CoV-2
  • Increasing Population Immunity
  • Potential anti-viral treatments and Vaccines

The development of a drug treatment and/or effective vaccine will be a medical breakthrough which could save many lives worldwide. However, most experts believe testing of these candidate therapies will take time. As the SARS-CoV-2 virus continues to infect people across the globe, the number of patients with partial immunity could rise, which could eventually curtail viral spreading. However, the virus will probably has to infect many people worldwide before population immunity changes.

Could
a Mutation Reduce SARS-CoV-2 virulence?

(“Maybe
yes, Maybe not, Scientists say”)

The answer to this very important question is not that simple. Experts opinions are divided on this subject. According to Dr. Michael Farzan, a biologist from the Scripps Research Institute in Jupiter, Florida, who identified the structure of the Spike protein of SARS-CoV (Science 2005, 309(5742) p1864-8), SARS-CoV-2 will probably mutate to lose rather than gain virulence. There is the possibility that SARS-CoV-2 could become a seasonal endemic virus such as the influenza virus. Some scientists, including Dr. Farzan, believe the natural evolution of a virus selects for less virulent variants as they will transmit more efficiently. Their belief is that very sick patients are not very good at transmitting the disease, and dead people cannot do it at all. Thus a virus which kills quickly does not transmit infection very efficiently, and does not get naturally selected. In contrast, less virulent viruses transmit very well, as less sick patients act as a very efficient source of infection. In colloquial terms, “the virus wants to live, last longer in the infected population”.

Mutation
Allowing SARS-CoV-2 Jump from Bats to Humans
– It is hypothesized that SARS-CoV-2 evolved through a mutation in the Spike protein allowing the virus to jump from bats to humans causing a zoonotic infection known as Covid-19. The Spike (S) protein of SARS-CoV-2 contains a “variable receptor-binding domain” (RBD), which binds to ACE-2 receptor in human cells facilitating viral cell entry (Figure 2). Using genomic DNA sequencing, scientists have identified a related virus, RaTG13, from bats (http://virological.org/t.the-proximal-origin-of-sars-cov-2/398). The hypothesis is that SARS-CoV-2 originated from bats, mutated, becoming able to infect human cells. A critical mutation of the virus allows human proteases to cut and activate the Spike protein of the virus, which facilitates viral entry and infection of human cells (Figure 2).

Mutations
Might Decrease Virulence
– Some experts believe that in the same fashion the virus experienced this gain of function mutation, allowing cut and activation of Spike protein (Figure 2), increasing virulence, SARS-CoV-2 could also incur mutations causing a decrease in virulence. This was the case for the Spanish flu influenza virus, and for the coronavirus SARS-CoV which caused severe acute respiratory syndrome (SARS) in 2002 (Scientific Reports 2018, volume 8, article number: 15177). Mutated viruses became less virulent, viral spreading stopped, and the epidemics were halted as the viruses fizzle out. In theory, this could happen again with the virus causing Covid-19. Although infection with SARS-CoV-2 has shown a lower fatality rate than SARS-CoV, the new coronavirus SARS-CoV-2 is significantly more contagious. Differences aside, it is theoretically possible that the evolution of the current SARS-CoV-2 pandemic might end up in the same fashion as the SARS epidemic of 2002. In 2018, Dr. Christian Drosten, currently at German Center for Infectious Research in Berlin, published scientific work demonstrating that a variant of SARS-CoV lost part of its genome (29 nucleotides) during the SARS outbreak of 2002-2003, which made the SARS-CoV virus less virulent. The authors demonstrated this hypothesis by testing the SARS-CoV variant in cellular models in the laboratory (Scientific Reports 2018, volume 8, article number: 15177).

Other
Scientists Believe Mutations Will not Matter
– Other experts are not too optimistic. Nature does not always help us, they think. Their belief is that natural mutations do very little to change the outcome of a pandemic. Most viral mutations do not elicit a new biological trait, which could be selected by natural selection. Indeed, most mutations are silent and do not change the outcome of a pandemic. All coronaviruses have shown high mutation rates. There is no reason to believe that SARS-CoV-2 will be any different in terms of mutation rate, despite of being more contagious than other viruses in the coronavirus family. Like SARS-CoV and MERS-CoV, the SARS-CoV-2 originated from an ancestor coronavirus harbored by bats. However, the intermediary host between bats and humans for SARS-CoV-2 has not been identified yet. Given the high mutation rates of these viruses, there is no certainty that a new mutation could cause loss of virulence as the opposite could also occur. Since the start of the pandemic, scientists have been sequencing strains of SARS-CoV-2 isolated from infected patients, and not a single mutation has shown to have an effect on virulence. The virus is very contagious as it is, and it might not need further mutations to be naturally selected. Dr. Andrew Rambaut, a molecular evolutionary biologist at the University of Edinburg, believes that mutations will not help to change virulence or alter the outcome of the current SARS-CoV-2 pandemic. Dr. Rambaut has been studying the genomes of SARS-CoV-2 isolates from patients. SARS-CoV-2 has 30,000 nucleotides. Dr. Rambaut mentioned that SARS-CoV-2 accumulates an average of one to two mutations per month, which although relatively high, it is still a slower mutation rate than what has been seen for the influenza virus. He believes most mutations do not affect the virus behavior.

Monitoring
SARS-CoV-2 Evolution

Monitoring the evolution of SARS-CoV-2 for mutations which could increase or decrease virulence is important (Pathogens 2020, 9, 186; doi:10.3390/pathogens9030186). Mutations in the gene encoding the Spike (S) protein do affect the virulence of SARS-CoV (New England Journal of Medicine 2003, 348 (20) p1948-1951). A very important statistic to monitor during the SARS-CoV-2 pandemic will be the “Basic Reproduction Number”, or “R0”, which measures the average number of people who will catch the disease from one infected person in a population who has never before being exposed to the disease (Emerg Infect Dis 2019, 25, 1-4). Thus far, the R0 for SARS-CoV-2 is estimated between 2 to 3 (Int J
Infect Dis
2020, 92, p214-217; New England Journal of Medicine 2020, doi:10.1056/NEJMoa2001316; Lancet 2020, doi:10.1016/S0140-6736(20)30260-9), which is relatively high. The goal is to reduce R0 to a number below 1.

Racing
to Develop a Vaccine

Moderna (Nasdaq:MRNA), in collaboration with the National Institute of Allergy and Infectious Diseases (NIH, NIAID), is developing mRNA-1273, a candidate vaccine targeting SARS-CoV-2. mRNA-1273 is designed to target the Spike (S) protein of the virus. mRNA vaccines function by encoding proteins, which once made by the cell stimulate the immune system to destroy infected cells. Development of mRNA vaccines is much faster than with traditional vaccines. mRNA-1273 encodes the “prefusion-stabilized” (Science 2020, 367 (6483) p1260-1263, DOI:10.1126/science.abb2507) form of Spike (S) protein of SARS-CoV-2. The candidate vaccine is currently in Phase I human clinical trials, which means it will take months before the effectiveness of this vaccine is known. Repurposing of existing anti-viral medicines is not an ideal strategy, but it could be a short term solution before an effective vaccine becomes available. For a full review of the pipeline of candidate medicines being developed by the biotechnology/pharmaceutical industry for SARS-CoV-2, see the journal Nature
Biotechnology
published on March 20, 2020.

The
Singapore Story – Could a Mutation Partially Explain The City’s Success?

Although SARS-CoV2 genome seems to be more stable than the genomes of SARS-CoV and MERS-CoV, scientists have detected a SARS-CoV-2 variant containing a deletion of 382 nucleotides. This genetic variant of SARS-CoV-2 was isolated from eight infected patients in Singapore (“Discovery of a 382-nt deletion during the
early evolution of SARS-CoV-2
” – bioRxiv preprint doi: https://doi.org/10.1101/2020.03.11.987222). The authors think the SARS-CoV-2 variant is less virulent, which may lead to a more attenuated phenotype of the virus, and less severe Covid-19 disease. A similar genetic deletion mutation, with attenuated phenotype, was observed in SARS-CoV during the SARS outbreak of 2002-2003. At present, the views on the relative success of Singapore dealing with Covid-19 (Singapore was one of the first cities with Covid-19 cases, but statistics are far better than other cities and countries around the world) is attributed to the government’s speed and efficiency dealing with the crisis. However, it is also plausible that Singapore was dealing with a less virulent variant of SARS-CoV-2.

Mankind definitely needs its biggest minds to focus on Covid-19 pandemic. Governments worldwide are working in concert to establish proper quarantine rules and other strict measures to slow the spreading of the disease. We hope new treatments and vaccines will be developed by the biotechnology/pharmaceutical industry. Patients are waiting, many lives could be saved by these efforts.

“The
single biggest threat to man’s continued dominance on the planet is the virus”,

quote
by Joshua Lederberg.

Joshua Lederberg (1925-2008) was an American molecular biologist known for his work in microbial genetics, artificial intelligence, and the United States space program. He was 33 years old when he won the 1958 Nobel Prize in Physiology or Medicine for contributions to the science of genetics.

Dr.
Joshua Lederberg (right) receiving the National Medal of Science from George
H.W. Bush

We need our heroes now, physicians and medical scientists who have dedicated their entire lives to save mankind from the threat of a virus.