Category: Health

Monday, April 13, 2020

Neovasc Inc. (NVCN)

Two Breakthrough Medical Technologies for Cardiovascular Markets

Neovasc Inc is a specialty medical device company. The company develops, manufactures and markets products for the rapidly growing cardiovascular marketplace. Its products include the Tiara for the transcatheter treatment of mitral valve disease and the Neovasc Reducer for the treatment of refractory angina. Neovasc is developing the Tiara for the treatment of mitral valve disease. Neovasc operates its business in one segment.

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

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

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

We are initiating coverage on Neovasc, Inc. 

The Reducer for the Treatment of Refractory Angina. Neovasc is seeking FDA approval to commercialize the Reducer for the treatment of refractory angina in the United States. Patients suffering from refractory angina, a debilitating disease characterized by chronic chest pain, do not have any effective therapeutic options. The Reducer, commercially available in Europe, but not in United States, is a medical device designed to alleviate symptoms and improve heart functions.

Tiara for the Treatment of Mitral Valve Regurgitation. Neovasc is developing a medical device system known as Tiara for the treatment of patients suffering from mitral valve regurgitation, a disease caused by a malfunctioning of the heart’s native mitral valve. Neovasc’s system is designed to replace the defective native mitral valve for the Tiara prosthetic valve. Neovasc is currently seeking CE Mark to commercialize Tiara in Europe first, and…

Get the full report on Channelchek desktop.

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. 

Monday, April 13, 2020

Neovasc Inc. (NVCN)

Two Breakthrough Medical Technologies for Cardiovascular Markets

Neovasc Inc is a specialty medical device company. The company develops, manufactures and markets products for the rapidly growing cardiovascular marketplace. Its products include the Tiara for the transcatheter treatment of mitral valve disease and the Neovasc Reducer for the treatment of refractory angina. Neovasc is developing the Tiara for the treatment of mitral valve disease. Neovasc operates its business in one segment.

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

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

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

We are initiating coverage on Neovasc, Inc. 

The Reducer for the Treatment of Refractory Angina. Neovasc is seeking FDA approval to commercialize the Reducer for the treatment of refractory angina in the United States. Patients suffering from refractory angina, a debilitating disease characterized by chronic chest pain, do not have any effective therapeutic options. The Reducer, commercially available in Europe, but not in United States, is a medical device designed to alleviate symptoms and improve heart functions.

Tiara for the Treatment of Mitral Valve Regurgitation. Neovasc is developing a medical device system known as Tiara for the treatment of patients suffering from mitral valve regurgitation, a disease caused by a malfunctioning of the heart’s native mitral valve. Neovasc’s system is designed to replace the defective native mitral valve for the Tiara prosthetic valve. Neovasc is currently seeking CE Mark to commercialize Tiara in Europe first, and…

Get the full report on Channelchek desktop.

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. 

Wednesday, April 1, 2020

Dyadic International Inc. (DYAI)

Q4 2019: Constructive 2019 Leading to a Promising Year Ahead

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, Senior Research Analyst, Noble Capital Markets, Inc.

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

2019 financial results were in line with expectations. Dyadic International Inc. (DYAI) released the full year of 2019 financial and operational results. The company reported $10.1 million in total expenses. The net loss was $8.3 million or $0.31 per share compared to a net loss of $5.7 million or $0.21 per share in 2018. Our F2019 estimates were for a net loss of $8.8 million and EPS of ($0.31). For F2020 and F2021, we forecast revenue of $1.8 mm, and $1.9 mm, and EPS of ($0.32) and ($0.34), respectively.


Not a month passes without adding another partnership to the pipeline. Dyadic’s business development flow continues by establishing research collaboration with large pharmaceuticals, institutions and biotechnology firms to validate C1 technology in biologics for human and animal health. The company has maintained a low cash-burn while increasing the probability of success of C1 technology’s potential in…






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. 

Wednesday, April 1, 2020

Dyadic International Inc. (DYAI)

Q4 2019: Constructive 2019 Leading to a Promising Year Ahead

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, Senior Research Analyst, Noble Capital Markets, Inc.

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

2019 financial results were in line with expectations. Dyadic International Inc. (DYAI) released the full year of 2019 financial and operational results. The company reported $10.1 million in total expenses. The net loss was $8.3 million or $0.31 per share compared to a net loss of $5.7 million or $0.21 per share in 2018. Our F2019 estimates were for a net loss of $8.8 million and EPS of ($0.31). For F2020 and F2021, we forecast revenue of $1.8 mm, and $1.9 mm, and EPS of ($0.32) and ($0.34), respectively.


Not a month passes without adding another partnership to the pipeline. Dyadic’s business development flow continues by establishing research collaboration with large pharmaceuticals, institutions and biotechnology firms to validate C1 technology in biologics for human and animal health. The company has maintained a low cash-burn while increasing the probability of success of C1 technology’s potential in…






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. 

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…








Get the full report on Channelchek desktop.

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. 

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…









Get the full report on Channelchek desktop.

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. 

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…







Click here to get the full report.

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. 

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. 

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…








Get the full report on Channelchek desktop.

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. 

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…









Get the full report on Channelchek desktop.

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. 

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…







Click here to get the full report.

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. 

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

(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

Released March 27, 2020