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NEWS -- International Stem Cell Corporation Announces Successful Completion of Its Phase 1 Clinical Trial in Parkinson's Disease
CARLSBAD, CA / ACCESSWIRE / June 30, 2021 / International Stem Cell Corporation (OTCQB:ISCO) (https://www.internationalstemcell.com) ("ISCO" or "the Company"), a California-based clinical stage biotechnology company developing stem cell-based therapies and biomedical products, announced today successful completion of its dose escalating phase 1 clinical trial (ClinicalTrials.gov Identifier: NCT02452723) evaluating the safety, tolerability and preliminary efficacy of its lead candidate, ISC-hpNSC® for the treatment of Parkinson's disease (PD).
Dr. Andrew Evans, M.D., Director of Movement Disorders at the Royal Melbourne Hospital, the study's principal investigator commented: "The safety evaluation is based on the initial 12 months of safety data from the first cohort (low dose), the second cohort (mid dose), and the third cohort (high dose). In all three cohorts there have been no serious adverse effects related to the transplanted ISC-hpNSC® cells. Based on all data collected in the clinical trial the therapy is considered safe."
In order to gain initial insight into what dose might show the greatest efficacy we have continued observations on a biannual basis of these patients. All the patients in the clinical trial have now completed at least 24 months of total post-operative observations. Patients treated with the mid dose (cohort 2) have been observed for at least 36 months and patients in the low dose group (Cohort 1) have been followed for 48 months post transplantation.
"We are excited about our phase 1 clinical trial results. Patients, followed for over two years after cell transplantation, have reported, on average, improvements in a Parkinson's Disease specific measures, when compared to baseline evaluations. In this context, the results are very encouraging that the ISC-hpNSC® transplanted cells are not only well tolerated, but also may be effective" commented Dr. Russell Kern, ISCO's Executive Vice President and Chief Scientific Officer.
In terms of preliminary efficacy, where scores are compared against baseline before transplantation, we observed a potential dose-dependent response, with an apparent peak effectiveness at our middle dose. The % OFF-Time, which is the time during the day when levodopa medication is not performing optimally and PD symptoms return, decreased an average 47% from the baseline at 12 months post transplantation in cohort 2. This trend continued through 24 months where the %OFF time in the second cohort dropped by 55% from the initial reading. The same was true for % ON-Time without dyskinesia, which is the time during the day when levodopa medication is performing optimally without dyskinesia. The % ON-Time increased an average of 42% above the initial evaluation at 12 months post-transplantation in the second cohort. The %ON result improved in the second cohort to 65% above the baseline in month 24. The quality of life of the patients as measured by the Parkinson's Disease Quality of Life Score-39 (PDQ-39) Summary Index, improved 43% for the second cohort at twelve months post-transplantation. This improved to a 45% better score in cohort 2 at 48 months.
About the clinical study
The Phase 1 clinical study is a dose escalation safety and preliminary efficacy study of ISC-hpNSC®, intracranially transplanted into patients with Parkinson's disease. The open-label, single center, uncontrolled clinical trial is evaluating three different dose regimens of 30 million to 70 million neural cells. A total of 12 participants with Parkinson's disease were treated. Following transplantation, the patients were monitored for 12 months at specified intervals to evaluate the safety and biologic activity of ISC-hpNSC®. A PET scan was performed at baseline, as part of the screening assessment, and at 6 and 12 months after surgical intervention. Clinical responses compared to baseline after the administration of ISC-hpNSC® will be evaluated using various neurological assessments such as Unified Parkinson Disease Rating Scale (UPDRS), Hoehn and Yahr as well as other rating scales. An extension phase of the study will evaluate patients every 6 months for 5 additional years.
About Parkinson's disease
Parkinson's disease is a degenerative disorder of the central nervous system mainly affecting the motor system. The motor symptoms of Parkinson's disease result from the death of dopamine-generating cells in the substantia nigra, a region of the midbrain. Early in the course of the disease, the most obvious symptoms are movement related. These symptoms include shaking, rigidity, slowness of movement and difficulty with walking and gait. Later, thinking and behavioral problems may arise, with dementia commonly occurring in the advanced stages of the disease. Depression is the most common psychiatric symptom. Parkinson's disease is more common in people over the age of 50. There are no approved treatments that restore the damaged dopaminergic neurons. Medications typically used in the treatment of Parkinson's disease, levodopa and dopamine agonists, improve the early symptoms of the disease. As the disease progresses and dopaminergic neurons continue to be lost, the drugs eventually become ineffective, while at the same time frequently producing a complication marked by involuntary writhing movements. There are over 10 million people afflicted with Parkinson's disease, worldwide. In 2013 Parkinson's disease resulted in about 103,000 deaths, globally. In 1990, the death toll recorded was 44,000.
About ISC-hpNSC®
International Stem Cell Corporation's proprietary ISC-hpNSC® consists of a highly pure population of neural stem cells derived from human parthenogenetic stem cells. ISC-hpNSC® is a suspension of clinical grade cells manufactured under cGMP conditions that have undergone stringent quality control measures and are free of any microbial and viral contaminants. Preclinical studies in rodents and non-human primates have shown improvement in Parkinson's disease symptoms and increase in brain dopamine levels following the intracranial administration of ISC-hpNSC®. ISC-hpNSC® provides neurotrophic support and neuroregeneration to the dying dopaminergic neurons of the recipient Parkinson's disease brain. Additionally, ISC-hpNSC® is safe, well tolerated and has shown not to cause adverse events such as dyskinesia, systemic toxicity or tumors in preclinical models. International Stem Cell Corporation believes that ISC-hpNSC® may have broad therapeutic applications for many neurological diseases affecting the brain, the spinal cord and the eye.
About International Stem Cell Corporation
International Stem Cell Corporation (ISCO) is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide, through its subsidiary Lifeline Cell Technology (https://www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (https://www.lifelineskincare.com). More information is available at https://www.internationalstemcell.com.
Safe harbor statement
Statements pertaining to anticipated developments, clinical studies expectations, potential additional applications for ISC-hpNSC®, and other opportunities for the Company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the Company's Securities and Exchange Commission filings. The Company disclaims any intent or obligation to update forward-looking statements.
Contacts:
International Stem Cell Corporation
Russell A. Kern, PhD
Phone: 760-940-6383
Email: mailto://ir@intlstemcell.com
SOURCE: International Stem Cell Corporation
View source version on accesswire.com:
https://www.accesswire.com/653700/International-Stem-Cell-Corporation-Announces-Successful-Completion-of-Its-Phase-1-Clinical-Trial-in-Parkinsons-Disease
NEWS -- Kintara Reports Topline Results From Phase 2 Clinical Trial of VAL-083 for Recurrent GBM
SAN DIEGO, July 1, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company developing novel cancer therapies for patients who are failing or are resistant to current treatment regimens, today announced topline data results from the recurrent arm of its open-label, Phase 2 clinical study of its lead compound VAL-083 being conducted at the MD Anderson Cancer Center (MD Anderson) in Houston, Texas.
The Phase 2 trial is a two-arm, biomarker-driven study testing VAL-083 in glioblastoma multiforme (GBM) patients who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene. The recurrent arm of the study addressed patients who have been pre-treated with temozolomide prior to disease recurrence.
The recurrent arm of the trial enrolled 89 patients, with 35 patients (35 efficacy evaluable) initially receiving a dose of VAL-083 at 40 mg/m2/day, and 54 patients (48 efficacy evaluable) initially receiving the treatment dose of 30 mg/m2/day on days 1, 2 and 3 of a 21-day cycle. This 30 mg dose corresponds to the dose being studied in the recently initiated and currently enrolling VAL-083 study arm of the GBM AGILE study.
Summary of results:
NEWS -- International Stem Cell Corporation Announces Successful Completion of Its Phase 1 Clinical Trial in Parkinson's Disease
CARLSBAD, CA / ACCESSWIRE / June 30, 2021 / International Stem Cell Corporation (OTCQB:ISCO) (https://www.internationalstemcell.com) ("ISCO" or "the Company"), a California-based clinical stage biotechnology company developing stem cell-based therapies and biomedical products, announced today successful completion of its dose escalating phase 1 clinical trial (ClinicalTrials.gov Identifier: NCT02452723) evaluating the safety, tolerability and preliminary efficacy of its lead candidate, ISC-hpNSC® for the treatment of Parkinson's disease (PD).
Dr. Andrew Evans, M.D., Director of Movement Disorders at the Royal Melbourne Hospital, the study's principal investigator commented: "The safety evaluation is based on the initial 12 months of safety data from the first cohort (low dose), the second cohort (mid dose), and the third cohort (high dose). In all three cohorts there have been no serious adverse effects related to the transplanted ISC-hpNSC® cells. Based on all data collected in the clinical trial the therapy is considered safe."
In order to gain initial insight into what dose might show the greatest efficacy we have continued observations on a biannual basis of these patients. All the patients in the clinical trial have now completed at least 24 months of total post-operative observations. Patients treated with the mid dose (cohort 2) have been observed for at least 36 months and patients in the low dose group (Cohort 1) have been followed for 48 months post transplantation.
"We are excited about our phase 1 clinical trial results. Patients, followed for over two years after cell transplantation, have reported, on average, improvements in a Parkinson's Disease specific measures, when compared to baseline evaluations. In this context, the results are very encouraging that the ISC-hpNSC® transplanted cells are not only well tolerated, but also may be effective" commented Dr. Russell Kern, ISCO's Executive Vice President and Chief Scientific Officer.
In terms of preliminary efficacy, where scores are compared against baseline before transplantation, we observed a potential dose-dependent response, with an apparent peak effectiveness at our middle dose. The % OFF-Time, which is the time during the day when levodopa medication is not performing optimally and PD symptoms return, decreased an average 47% from the baseline at 12 months post transplantation in cohort 2. This trend continued through 24 months where the %OFF time in the second cohort dropped by 55% from the initial reading. The same was true for % ON-Time without dyskinesia, which is the time during the day when levodopa medication is performing optimally without dyskinesia. The % ON-Time increased an average of 42% above the initial evaluation at 12 months post-transplantation in the second cohort. The %ON result improved in the second cohort to 65% above the baseline in month 24. The quality of life of the patients as measured by the Parkinson's Disease Quality of Life Score-39 (PDQ-39) Summary Index, improved 43% for the second cohort at twelve months post-transplantation. This improved to a 45% better score in cohort 2 at 48 months.
About the clinical study
The Phase 1 clinical study is a dose escalation safety and preliminary efficacy study of ISC-hpNSC®, intracranially transplanted into patients with Parkinson's disease. The open-label, single center, uncontrolled clinical trial is evaluating three different dose regimens of 30 million to 70 million neural cells. A total of 12 participants with Parkinson's disease were treated. Following transplantation, the patients were monitored for 12 months at specified intervals to evaluate the safety and biologic activity of ISC-hpNSC®. A PET scan was performed at baseline, as part of the screening assessment, and at 6 and 12 months after surgical intervention. Clinical responses compared to baseline after the administration of ISC-hpNSC® will be evaluated using various neurological assessments such as Unified Parkinson Disease Rating Scale (UPDRS), Hoehn and Yahr as well as other rating scales. An extension phase of the study will evaluate patients every 6 months for 5 additional years.
About Parkinson's disease
Parkinson's disease is a degenerative disorder of the central nervous system mainly affecting the motor system. The motor symptoms of Parkinson's disease result from the death of dopamine-generating cells in the substantia nigra, a region of the midbrain. Early in the course of the disease, the most obvious symptoms are movement related. These symptoms include shaking, rigidity, slowness of movement and difficulty with walking and gait. Later, thinking and behavioral problems may arise, with dementia commonly occurring in the advanced stages of the disease. Depression is the most common psychiatric symptom. Parkinson's disease is more common in people over the age of 50. There are no approved treatments that restore the damaged dopaminergic neurons. Medications typically used in the treatment of Parkinson's disease, levodopa and dopamine agonists, improve the early symptoms of the disease. As the disease progresses and dopaminergic neurons continue to be lost, the drugs eventually become ineffective, while at the same time frequently producing a complication marked by involuntary writhing movements. There are over 10 million people afflicted with Parkinson's disease, worldwide. In 2013 Parkinson's disease resulted in about 103,000 deaths, globally. In 1990, the death toll recorded was 44,000.
About ISC-hpNSC®
International Stem Cell Corporation's proprietary ISC-hpNSC® consists of a highly pure population of neural stem cells derived from human parthenogenetic stem cells. ISC-hpNSC® is a suspension of clinical grade cells manufactured under cGMP conditions that have undergone stringent quality control measures and are free of any microbial and viral contaminants. Preclinical studies in rodents and non-human primates have shown improvement in Parkinson's disease symptoms and increase in brain dopamine levels following the intracranial administration of ISC-hpNSC®. ISC-hpNSC® provides neurotrophic support and neuroregeneration to the dying dopaminergic neurons of the recipient Parkinson's disease brain. Additionally, ISC-hpNSC® is safe, well tolerated and has shown not to cause adverse events such as dyskinesia, systemic toxicity or tumors in preclinical models. International Stem Cell Corporation believes that ISC-hpNSC® may have broad therapeutic applications for many neurological diseases affecting the brain, the spinal cord and the eye.
About International Stem Cell Corporation
International Stem Cell Corporation (ISCO) is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide, through its subsidiary Lifeline Cell Technology (https://www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (https://www.lifelineskincare.com). More information is available at https://www.internationalstemcell.com.
Safe harbor statement
Statements pertaining to anticipated developments, clinical studies expectations, potential additional applications for ISC-hpNSC®, and other opportunities for the Company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the Company's Securities and Exchange Commission filings. The Company disclaims any intent or obligation to update forward-looking statements.
Contacts:
International Stem Cell Corporation
Russell A. Kern, PhD
Phone: 760-940-6383
Email: mailto://ir@intlstemcell.com
SOURCE: International Stem Cell Corporation
View source version on accesswire.com:
https://www.accesswire.com/653700/International-Stem-Cell-Corporation-Announces-Successful-Completion-of-Its-Phase-1-Clinical-Trial-in-Parkinsons-Disease
NEWS -- Oncolytics Biotech® to Present at the Ladenburg Thalmann Healthcare Conference
Presentation to take place on Wednesday, July 14 at 4:30 p.m. ET
SAN DIEGO and CALGARY, AB, June 30, 2021 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that the Company will present a corporate overview at the Ladenburg Thalmann Healthcare Conference, which is taking place virtually from July 13-14, 2021. Presentation details are listed below.
Presenter: Dr. Matt Coffey, President & Chief Executive Officer of Oncolytics Biotech Inc.
Date: Wednesday, July 14, 2021
Time: 4:30 p.m. Eastern Daylight Time
Webcast Link: https://wsw.com/webcast/ladenburg7/oncy/2436435
The Company will also be participating in one-on-one investor meetings at the conference. To schedule a meeting, please contact your Ladenburg Thalmann representative or email mailto://jpatton@oncolytics.ca.
A live webcast of the presentation will also be available on the Investor Relations page of Oncolytics' website (https://ir.oncolyticsbiotech.com/events-presentations) and will be archived for 90 days.
About Oncolytics Biotech Inc.
Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards a registration study in metastatic breast cancer. For further information, please visit: https://www.oncolyticsbiotech.com.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; Oncolytics' expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.
Company Contact
Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com
View original content to download multimedia: https://www.prnewswire.com/news-releases/oncolytics-biotech-to-present-at-the-ladenburg-thalmann-healthcare-conference-301322825.html
SOURCE Oncolytics Biotech® Inc.
NEWS -- Aytu BioPharma Announces Peer-Reviewed Publication of Clinical Results from Healight(TM) Pilot Study
ENGLEWOOD, CO / ACCESSWIRE / June 28, 2021 / Aytu BioPharma, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, announced today that data from the first in-human, open label, clinical trial studying the safety and effectiveness of ultraviolet A (UVA) light endotracheal catheter therapy was published online on June 26, 2021 in the peer-reviewed journal Advances In Therapy. The UVA light catheter technology utilized in this study is the basis of Aytu BioPharma's Healight™ medical device which has been exclusively licensed worldwide for all endotracheal and nasopharyngeal applications.
The study titled, "Endotracheal application of ultraviolet A light in critically ill patients infected with severe acute respiratory syndrome coronavirus-2: A first-in-human study of internal ultraviolet A therapy" concluded that endotracheal UVA light treatment was associated with a significant reduction of SARS-CoV-2 viral load and improvement in WHO clinical severity scores. Additionally, the endotracheal UVA light treatment did not result in any serious adverse device effects and was well tolerated.
A total of five critically ill, mechanically ventilated COVID-19 patients underwent daily UVA light therapy for five consecutive days at a single U.S. center. The UVA light catheter was inserted into the patients' endotracheal tube (ETT) and illuminated for 20 minutes with each treatment. The endotracheal (ET) treatment resulted in significant logarithmic reduction of the SARS-CoV-2 viral load of the ET aspirate, which was the study's primary endpoint. Average log changes from baseline to day five and day six were -2.41 (>99%, p=0.0018) and -3.2 (>99.9%, p=0.0005), respectively. WHO 10-point clinical severity scores improved by an average of 1.6 and 3.6 points on day 15 and day 30, respectively. Excluding subject two who had undetectable viral load, WHO severity scores improved by 4.75 points on day 30. Importantly, no serious adverse device effects or early treatment discontinuation was observed in the study.
Josh Disbrow, Chief Executive Officer of Aytu BioPharma, commented, "These important proof-of-concept first-in-human clinical trial data for the technology underpinning the Healight technology have now been peer-reviewed and published. This pilot study shows the potential clinical utility in treating mechanically ventilated SARS-CoV-2 patients and sets the stage for a larger, sham-controlled clinical study soon to be underway in Europe. That study will include significantly more patients in a well-controlled, randomized clinical trial, and we expect that study to begin in the first quarter of fiscal 2022."
Aside from coronavirus, utilization of internal UVA light may have numerous other clinical applications. Aytu BioPharma will continue to engage with researchers in all therapeutic areas to continue to build on this technology platform.
The peer-reviewed publication can be accessed via the link below:
https://link.springer.com/article/10.1007/s12325-021-01830-7
About Aytu BioPharma, Inc.
Aytu BioPharma is a specialty pharmaceutical company with a growing commercial portfolio of prescription therapeutics and consumer health products. The company's primary prescription products treat attention deficit hyperactivity disorder (ADHD) and other common pediatric conditions. Aytu markets ADHD products Adzenys XR-ODT® (amphetamine) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING), Cotempla XR-ODT® (methylphenidate) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING), and Adzenys-ER® (amphetamine) extended-release oral suspension (see Full Prescribing Information, including Boxed WARNING). The company's other pediatric products include Karbinal® ER (carbinoxamine maleate), an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions, and Poly-Vi-Flor® and Tri-Vi-Flor®, two complementary fluoride-based prescription vitamin product lines containing combinations of fluoride and vitamins in various formulations for infants and children with fluoride deficiency. The company's evolution has been driven by strategic in-licensing, acquisition-based transactions and organic product growth. Aytu is building a complimentary therapeutic development pipeline including a prospective treatment (AR101/enzastaurin) for vascular Ehlers-Danlos Syndrome (vEDS), a rare genetic disease resulting in high morbidity and a significantly shortened lifespan. There are no currently approved treatments for vEDS. To learn more, please visit https://aytubio.com.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. All statements other than statements of historical facts contained in this presentation, are forward-looking statements, including but not limited to any statements regarding the financial results and statements presented in this press release and during the business update call following its release. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: the anticipated start dates, durations and completion dates and the potential future results of ongoing and future Healight clinical trials, the effectiveness of Healight on treating COVID-19, the accuracy of the results of the study, Healight's potential uses for ventilator assisted patients, potential other clinical uses for Healight and the anticipated future regulatory submissions and events related to Healight. We also refer you to (i) the risks described in ''Risk Factors'' in Part I, Item 1A of Aytu's Annual Report on Form 10-K and in the other reports and documents it files with the Securities and Exchange Commission and (ii) the Risk Factors set forth in Aytu's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC.
Contact for Media and Investors:
Sarah McCabe
Stern Investor Relations
212-362-1200
mailto://sarah.mccabe@sternir.com
SOURCE: Aytu BioPharma, Inc.
View source version on accesswire.com:
https://www.accesswire.com/653324/Aytu-BioPharma-Announces-Peer-Reviewed-Publication-of-Clinical-Results-from-HealightTM-Pilot-Study
NEWS -- Lineage Cell Therapeutics Joins Russell 3000® and Russell Microcap® Indexes
CARLSBAD, Calif., June 28, 2021--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that the Company has been added to both the broad-market Russell 3000® Index as well as the Russell Microcap® Index. The 2021 Russell indexes annual reconstitution will be effective after the U.S. market opens today.
"Lineage’s addition to both the Russell 3000® and the Russell Microcap® Indexes reflects continued progress made in establishing the Company as a leader in cell therapy and regenerative medicine and should help us benefit from the tremendous growth that we foresee in the field of cell therapy," stated Brian M. Culley, Lineage’s CEO. "During the past year we have created considerable value for our shareholders by accomplishing significant clinical, manufacturing, and business milestones across our entire novel pipeline. We believe our addition to the Russell indexes can expand awareness of Lineage’s corporate mission and objectives among a broader audience of investors and help drive an increase in the liquidity of our stock."
Annual Russell indexes reconstitution captures the 4,000 largest U.S. stocks as of May 7, 2021, ranking them by total market capitalization. Membership in the U.S. all-cap Russell 3000® Index, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000® Index or small-cap Russell 2000® Index as well as the appropriate growth and value style indexes. Membership in the Russell Microcap® Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.
Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $10.6 trillion in assets are benchmarked against Russell’s US indexes. Russell indexes are part of FTSE Russell.
About FTSE Russell
FTSE Russell is a global index leader that provides innovative benchmarking, analytics and data solutions for investors worldwide. FTSE Russell calculates thousands of indexes that measure and benchmark markets and asset classes in more than 70 countries, covering 98% of the investable market globally. FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately $17.9 trillion is currently benchmarked to FTSE Russell indexes. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create ETFs, structured products and index-based derivatives. A core set of universal principles guides FTSE Russell index design and management: a transparent rules-based methodology is informed by independent committees of leading market participants. FTSE Russell is focused on applying the highest industry standards in index design and governance and embraces the IOSCO Principles. FTSE Russell is also focused on index innovation and customer partnerships as it seeks to enhance the breadth, depth and reach of its offering. FTSE Russell is wholly owned by London Stock Exchange Group. For more information, visit https://www.ftserussell.com.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of subacute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit https://www.lineagecell.com or follow the Company on Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," project," "target," "tend to," "foresee" or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to anticipated growth in the field of cell therapy and the potential benefits to Lineage and its shareholders as a result of that growth and as a result of the Company’s inclusion in the Russell indexes. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
The information in this announcement about the Russell indexes and FTSE Russell was obtained from FTSE Russell. Lineage has not independently verified such information and there can be no assurance as to its accuracy.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210628005131/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Solebury Trout IR
Gitanjali Jain Ogawa
(mailto://Gogawa@soleburytrout.com)
(646) 378-2949
Russo Partners – Media Relations
Nic Johnson or David Schull
mailto://Nic.johnson@russopartnersllc.com
mailto://David.schull@russopartnersllc.com
(212) 845-4242
NEWS -- Heat Biologics Joins Russell Microcap® Index
DURHAM, N.C., June 28, 2021 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (Nasdaq: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today announced that it has been added to the Russell Microcap® Index, following the annual Russell indexes reconstitution, effective after the US market opens today, June 28, 2021, according to a final list of additions posted on June 25, 2021.
Membership in the Russell Microcap® Index, which remains in place for one year, means automatic inclusion in Russell's appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings, and style attributes.
Jeff Wolf, Chief Executive Officer of Heat, commented, “We are extremely pleased to join the Russell Microcap Index and believe that our inclusion will increase our visibility and exposure to investors. Joining this index is a reflection of the progress we have made this year in our clinical programs, including both our oncology program and COVID-19 vaccine program, building a strong balance sheet with over $132 million of cash and short-term investments as of Q1 2021 and increasing shareholder value.”
Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $10.6 trillion in assets are benchmarked against Russell's US indexes. Russell indexes are part of FTSE Russell, a leading global index provider. For more information on the Russell Microcap® Index and the Russell indexes reconstitution, go to the "Russell Reconstitution" section on the FTSE Russell website.
About Heat Biologics, Inc.
Heat Biologics is a biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system. Heat’s gp96 platform is designed to activate immune responses against cancer or infectious diseases. The Company has multiple product candidates in development leveraging the gp96 platform, including HS-110, which has completed enrollment in its Phase 2 trial, and a COVID-19 vaccine program in preclinical development. In addition, Heat Biologics is also developing a pipeline of proprietary immunomodulatory antibodies and cell-based therapies, including PTX-35 and HS-130 in Phase 1 clinical trials.
About FTSE Russell
FTSE Russell is a global index leader that provides innovative benchmarking, analytics and data solutions for investors worldwide. FTSE Russell calculates thousands of indexes that measure and benchmark markets and asset classes in more than 70 countries, covering 98% of the investable market globally.
FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately $17.9 trillion is currently benchmarked to FTSE Russell indexes. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create ETFs, structured products and index-based derivatives.
A core set of universal principles guides FTSE Russell index design and management: a transparent rules-based methodology is informed by independent committees of leading market participants. FTSE Russell is focused on applying the highest industry standards in index design and governance and embraces the IOSCO Principles. FTSE Russell is also focused on index innovation and customer partnerships as it seeks to enhance the breadth, depth and reach of its offering.
FTSE Russell is wholly owned by London Stock Exchange Group.
For more information, visit https://www.ftserussell.com.
Forward Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 on our current expectations and projections about future events. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectation, and assumptions and include statements such as the inclusion in the Russell Microcap Index increasing Heat’s visibility and exposure to investors. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the impact of the inclusion in the Russell Microcap Index, the ability of Heat's therapies to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability of HS-110, in combination with a CPI to be utilized in multiple treatment settings of NSCLC and to improve survival benefit for patients with non-small cell lung cancer (NSCLC), the ability HS-110 to be administered in combination with first line regimens that include a CPI as well as addressing high unmet medical needs for CPI progressors, Heat's vaccine platform to provide protection against COVID-19, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, especially in light of COVID-19, Heat's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to Heat's ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, Heat's ability to maintain its license agreements, the continued maintenance and growth of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities, its ability to continue to maintain its listing on the Nasdaq Capital Market and its ability to retain its key scientists or management personnel, and the other factors described in Heat's most recent annual report on Form 10-K filed with the SEC, and other subsequent filings with the SEC. The information in this release is provided only as of the date of this release, and Heat undertakes no obligation to update any forward-looking statements contained in this release based on new information, future events, or otherwise, except as required by law.
Media and Investor Relations Contact
David Waldman
+1 919 289 4017
mailto://investorrelations@heatbio.com
Here is an interview with Ian Clifford by Proactive that I missed!
NEWS -- OncoSec Appoints Brian Leuthner as Interim Chief Executive Officer
PENNINGTON, N.J. and SAN DIEGO, June 24, 2021 /PRNewswire/ -- OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec") today announced that Daniel O'Connor has resigned and that Brian Leuthner, formerly Chief Operating Officer, has been appointed Interim Chief Executive Officer, effective June 25, 2021. Mr. O' Connor is also stepping down from his seat on the Board of Directors.
"Under Dan's leadership over the past four years, OncoSec has transformed itself into the leading intra-tumoral cancer immunotherapy Company," said Margaret Dalesandro, Ph.D., Chair of the Board of Directors at OncoSec. "Dan operationally drove several value-creating clinical programs with the Company's lead product candidate, TAVO™, including the now fully enrolled pivotal study in anti-PD-1 checkpoint refractory metastatic melanoma patients, KEYNOTE-695, as well as a phase 2 program in metastatic triple negative breast cancer. Under his leadership, OncoSec is well-capitalized to meet important inflection points and has established a string of strategic partnerships with large pharma companies and top research institutions. On behalf of the Board, I want to thank Dan for his tireless work ethic and leadership in delivering to our shareholders a Company that is now extremely well-positioned for success."
Dr. Dalesandro continued, "Brian Leuthner, a former public company CEO with decades of experience, will now step into the CEO role bringing fresh energy and his own brand of leadership, which we are confident will enhance the Company's upward trajectory and further exploit the potential of our platform for the benefit of both cancer patients and our shareholders. In parallel, I, along with the Board, will evaluate and potentially identify a new CEO candidate who will work to ensure that we reach the next evolution as the leading intra-tumoral cancer immunotherapy company."
Mr. Leuthner joined OncoSec in February 2021. Over the course of his 32-year career in biotech and pharmaceuticals, Mr. Leuthner has held several leadership positions, including several public and private CEO positions. For a decade, Mr. Leuthner was co-founder, President, and CEO of Edge Therapeutics, Inc., an orphan disease-focused company.
Mr. Leuthner added, "I came to OncoSec because I saw it as a well-established company with valuable technology that I believed I could further enhance. As OncoSec's Interim Chief Executive Officer, I look forward to adding to the momentum Dan built as we strive to improve the long-term outcomes to patients living with cancer"
About TAVO™
OncoSec's gene therapy technology combines TAVO (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12), with an intra-tumoral electroporation gene delivery platform to achieve endogenous IL-12 production in the tumor microenvironment that enables the immune system to target and attack tumors throughout the body. TAVO has demonstrated a local and systemic anti-tumor response in several clinical trials, including the pivotal Phase 2b trial KEYNOTE-695 for metastatic melanoma and the KEYNOTE-890 Phase 2 trial in triple negative breast cancer (TNBC). TAVO has received both Orphan Drug and Fast-Track Designation by the U.S. Food & Drug Administration for the treatment of metastatic melanoma.
About OncoSec Medical Incorporated
OncoSec Medical Incorporated (the "Company," "OncoSec," "we" or "our") is a biotechnology company focused on developing cytokine-based intratumoral immunotherapies to stimulate the body's immune system to target and attack cancer. OncoSec's lead immunotherapy investigational product candidate – TAVO™ (tavokinogene telseplasmid) – enables the intratumoral delivery of DNA-based interleukin-12 (IL-12), a naturally occurring protein with immune-stimulating functions. The technology, which employs electroporation, is designed to produce a controlled, localized expression of IL-12 in the tumor microenvironment, enabling the immune system to target and attack tumors throughout the body. OncoSec has built a deep and diverse clinical pipeline utilizing TAVO™ as a potential treatment for multiple cancer indications either as a monotherapy or in combination with leading checkpoint inhibitors; with the latter potentially enabling OncoSec to address a great unmet medical need in oncology: anti-PD-1 non-responders. Results from recently completed clinical studies of TAVO™ have demonstrated a local immune response, and subsequently, a systemic effect as either a monotherapy or combination treatment approach along with an acceptable safety profile, warranting further development. In addition to TAVO™, OncoSec is identifying and developing new DNA-encoded therapeutic candidates and tumor indications for use with its new Visceral Lesion Applicator (VLA), to target deep visceral lesions, such as liver, lung or pancreatic lesions. For more information, please visit https://www.oncosec.com.
TAVO™ is a trademark of OncoSec Medical Incorporated.
Risk Factors and Forward-Looking Statements
This release, as well as other information provided from time to time by the Company or its employees, may contain forward-looking statements that involve a number of risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements. Forward-looking statements provide the Company's current beliefs, expectations and intentions regarding future events and involve risks, uncertainties (some of which are beyond the Company's control) and assumptions. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. You can identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. These statements may include words such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "should," "will" and "would" and similar expressions (including the negative of these terms). Although we believe that expectations reflected in the forward- looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. The Company intends these forward-looking statements to speak only at the time they are published on or as otherwise specified and does not undertake to update or revise these statements as more information becomes available, except as required under federal securities laws and the rules and regulations of the Securities Exchange Commission ("SEC"). In particular, you should be aware that the success and timing of our clinical trials, including safety and efficacy of our product candidates, patient accrual, unexpected or expected safety events, the impact of COVID-19 on the supply of our candidates or the initiation or completion of clinical trials and the usability of data generated from our trials may differ and may not meet our estimated timelines. Please refer to the risk factors and other cautionary statements provided in the Company's Annual Report on Form 10-K for the fiscal year ended July 31, 2020 and subsequent periodic and current reports filed with the SEC (each of which can be found at the SEC's website www.sec.gov), as well as other factors described from time to time in the Company's filings with the SEC.
Company Contact
Investor Contact
Mike Moyer
LifeSci Advisors
+1-617-308-4306
mailto://mmoyer@lifesciadvisors.com
Media Contact
Patrick Bursey
LifeSci Communications
+1-646-970-4688
mailto://pbursey@lifescicomms.com
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SOURCE OncoSec Medical Incorporated
NEWS -- Corporate Update: FuelPositive Initiatives Progressing as Planned
TORONTO, June 24, 2021 (GLOBE NEWSWIRE) -- via InvestorWire -- FuelPositive Corporation (TSX.V: NHHH) (OTCMKTS: NHHHF) (“FuelPositive” or the “Company”) is issuing the following update to share the status of the company and its various initiatives.
“With extensive incoming shareholder inquiries over the last several weeks, we felt it would be helpful to provide a detailed update,” said FuelPositive CEO Ian Clifford. “We are in a strong position overall and are pleased with the opportunities unfolding for us to continue to build shareholder value in the company.”
All announced initiatives are progressing as planned. Further details are as follows:
Financing
NEWS -- Vivos Inc Initiates Isopet® Therapy in Horses
Richland WA, June 24, 2021 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL) Vivos Inc announced that it has completed the first IsoPet® therapy on an equoid tumor. It was administered at the University of Missouri on a horse that was transported from Ohio. This is an exciting extension of Isopet®, offering an important and unique treatment alternative for larger animals such as horses. The procedure was conducted under mild sedation with a therapy design that, as always, results in no contamination. This first patient is doing well and already the tumor has stopped growing.
Dr. Mike Korenko stated, “Expanding Isopet® into the equine market is an important expansion of the Vivos’ business plan. Treating large tumors in large animals is an area in which IsoPet® is uniquely suited. We intend to further refine the technique with the next few animals and then to collaborate with a private clinic in either Kentucky or Texas.
Owners of potential equine patients are now eligible to complete our new Expression of Interest form specifically for equine therapy under IsoPet Therapy on our web page https://www.RadioGel.com .”
About Vivos Inc. (OTCQB: RDGL)
Vivos Inc. has developed an Yttrium-90 based injectable brachytherapy device, for the treatment of tumors in animals (IsoPet®) and in humans (RadioGel™). Brachytherapy uses highly localized radiation to destroy cancerous tumors by placing a radioactive isotope directly inside the treatment area using the company’s proprietary hydrogel technology. The injection delivers therapeutic radiation from within the tumor without the entrance skin dose and associated side effects of treatment that characterize external-beam radiation therapy. This feature allows safe delivery of higher doses needed for treating both non-resectable and radiation-resistant cancers.
RadioGel™ is a hydrogel liquid containing tiny yttrium-90 phosphate particles that may be administered directly into a tumor. The hydrogel is an yttrium-90 carrier at room temperature that gels within the tumor interstitial spaces after injection to keep the radiation sources safely in place. The short-range beta radiation from yttrium-90 localizes the dose within the treatment area so that normal organs and tissues are not adversely affected.
RadioGel™ also has a short half-life – delivering more than 90% of its therapeutic radiation within 10 days. This compares favorably to other available treatment options requiring up to six weeks or more to deliver a full course of radiation therapy. Therapy can be safely administered as an out-patient procedure and the patient may return home without subsequent concern for radiation dose to family members.
The IsoPet® Solutions division used university veterinary hospitals to demonstrate the safety and therapeutic effectiveness for different animal cancers. Testing on feline sarcoma at the Washington State University was completed in 2018 and testing on canine soft tissue sarcomas at the University of Missouri was completed in 2019.
In 2018 the Company obtained confirmation from the FDA Center for Veterinary Medicine that IsoPet® is classified as a medical device according to its intended use and means by which it achieves its intended purpose. The FDA also reviewed the product labeling which included canine and feline sarcomas as the initial indications for use. The FDA does not require pre-market approval for veterinary devices so no additional approval is required. Following the demonstration phase, Vivos is able to generate revenue through the sale of IsoPet® to University animal hospitals and private veterinary clinics.
IsoPet® for treating animals uses the same technology as RadioGel™ for treating humans. The Food and Drug Administration advised using different product names in order to avoid confusion and cross-use.
Safe Harbor Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimates," "projects," "intends," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, the Company's ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company's control.
CONTACT:
Vivos Inc.
Michael K. Korenko, Sc.D.
President & CEO
mailto://MKorenko@RadioGel.com
The subsidiary ISOPET could be sold for say 300 million and every shareholder would get $1.00 dollar a share for every share they hold , and still own RDGL for the human side of this technology going forward .
NEWS -- Macrophage Therapeutics, Inc. Wins Delaware Case Against Michael Goldberg for Breach of Fiduciary Duty
DUBLIN, Ohio, June 24, 2021--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that on June 23, 2021, Vice Chancellor Joseph Slights of the Court of Chancery of the State of Delaware (the "Court") ruled in favor of Navidea’s wholly-owned subsidiary, Macrophage Therapeutics, Inc. ("MT") and against its former CEO, Dr. Michael Goldberg, finding that Dr. Goldberg breached his fiduciary duties to MT.
This decision follows an earlier June 12, 2019 ruling in which the Court voided certain transactions putatively authorized by Dr. Goldberg, pursuant to which Dr. Goldberg purported to transfer certain of Navidea’s intellectual property rights (which had been sub-licensed to MT) to a company controlled by Dr. Goldberg, but had previously ruled that there remained factual questions as to whether Dr. Goldberg’s conduct constituted a breach of fiduciary duty to MT.
Following a three-day trial and extensive post-trial briefing, the Court agreed with MT that Dr. Goldberg breached his fiduciary duty. Specifically, the Court ruled: "Dr. Goldberg attempted to take for himself that which belonged to [MT]. In doing so, he breached his duty of loyalty to [MT] stockholders. [MT] was absolutely justified in bringing this action to remedy (in this case undo) the harm caused by Dr. Goldberg’s misconduct." The Court disagreed with MT’s arguments regarding damages and, other than awarding nominal damages, declined to award additional relief beyond that which it had previously granted. With respect to MT’s claim for conversion, the Court found that the claim was not supported because "Dr. Goldberg confirmed that he currently does not own or possess any intellectual property related to either Navidea or [MT]" and that "any IP Dr. Goldberg created while at Navidea or any of its subsidiaries was and remains the property of Navidea and its subsidiaries."
In addition, the Court denied Dr. Goldberg’s motion to hold MT’s directors and CEO in contempt, denied Dr. Goldberg’s motion to dismiss the lawsuit against him, and granted MT’s motion to dismiss Dr. Goldberg’s petition to remove MT’s board members.
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept™ platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, please visit https://www.navidea.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding pending litigation and other matters. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our history of operating losses and uncertainty of future profitability; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; dependence on royalties and grant revenue; our ability to implement our growth strategy; anticipated trends in our business; our limited product line and distribution channels; advances in technologies and development of new competitive products; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at www.sec.gov or at http://ir.navidea.com.
Investors are urged to consider statements that include the words "will," "may," "could," "should," "plan," "continue," "designed," "goal," "forecast," "future," "believe," "intend," "expect," "anticipate," "estimate," "project," and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements.
You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210624005237/en/
Contacts
Navidea Biopharmaceuticals, Inc.
Jed Latkin
Chief Executive Officer
614-973-7490
mailto://jlatkin@navidea.com
NEWS -- Heat Biologics Announces Significant Expansion of R&D and Pre-Clinical Capabilities at Corporate Headquarters
Investments expected to accelerate development timelines and reduce development expenses
DURHAM, N.C., June 23, 2021 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (“Heat”) (NASDAQ: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, today announced the expansion of its research and development facilities in Morrisville, North Carolina. The expansion will support the addition of enhanced research and development capabilities including in-house synthesis of antibodies and other drugs/reagents as well as an expanded vivarium for onsite pre-clinical studies.
Jeff Wolf, Chief Executive Officer of Heat Biologics, stated, “We are delighted to announce plans to double the size of the current facilities to support and accelerate activities around our oncology and non-oncology programs. By bringing more of our development and pre-clinical activities in-house, we expect to accelerate R&D timelines and generate cost savings on research and development that would have otherwise been achieved through use of third-party service providers. We look forward to leveraging these new facilities as we accelerate our discovery and development efforts.”
About Heat Biologics, Inc.
Heat Biologics is a biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system. The company's gp96 platform is designed to activate immune responses against cancer or infectious diseases. The Company has multiple product candidates in development leveraging the gp96 platform, including HS-110, which has completed enrollment in its Phase 2 trial, and a COVID-19 vaccine program in preclinical development. In addition, Heat is also developing a pipeline of proprietary immunomodulatory antibodies and cell-based therapies, including PTX-35 and HS-130, both currently in Phase 1 clinical trials.
For more information, please visit: https://www.heatbio.com, and also follow us on Twitter.
Forward Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 on our current expectations and projections about future events. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectation, and assumptions and include statements such as accelerating R&D timelines and generating cost savings on research and development that would have otherwise been achieved through use of third-party service providers by bringing development and pre-clinical activities in-house and leveraging the new facilities to accelerate our discovery and development efforts. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of Heat to leverage the new facilities to accelerate R&D timelines and generate the ability of Heat's therapies to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, especially in light of COVID-19, Heat's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to Heat's ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, Heat's ability to maintain its license agreements, the continued maintenance and growth of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities, its ability to continue to maintain its listing on the Nasdaq Capital Market and its ability to retain its key scientists or management personnel, and the other factors described in Heat's most recent annual report on Form 10-K filed with the SEC, and other subsequent filings with the SEC. The information in this release is provided only as of the date of this release, and Heat undertakes no obligation to update any forward-looking statements contained in this release based on new information, future events, or otherwise, except as required by law.
Media and Investor Relations Contact
David Waldman
+1 919 289 4017
mailto://investorrelations@heatbio.com
NEWS -- Lineage’s OPC1 Cell Therapy for the Treatment of Spinal Cord Injury to Return to Clinical Testing
NEWS -- Emerging Markets Report: Locking it Up
An Emerging Markets Sponsored Commentary
ORLANDO, Fla., June 21, 2021 (GLOBE NEWSWIRE) -- We know that many of our readers are also fans of the popular investing television show “Shark Tank” where entrepreneurs vie for dollars from the deep pocketed panel. During their pitches you often hear the wealthy investors ask if the product offering is “proprietary.”
It’s essential to know if it is indeed proprietary as it affirms the company’s uniqueness in the industry and reduces competition. It can mean everything.
So when we see FuelPositive Corporation (TSX.V: NHHH) (OTC: NHHHF) starting the process to lock up its proprietary technology by filing for patent protection for the Company’s “Modular Transportable Clean Hydrogen-Ammonia Maker” with the United States Patent and Trademark Office it gets our attention.
As we mentioned in our last report on FuelPositive, we believe that the market opportunity for the Company’s tech is enormous. Having real patent-protected IP in the space would be an enormous boon in our estimation.
Company CEO Ian Clifford lays it out in a nutshell, how this PROPRIETARY technology could deliver tremendous value to the Company while having a real, measurable impact on the environment:
“Our patent-pending carbon-free ammonia (NH3) technology is designed to reduce processing costs through the reduction of operating pressure and temperatures, resulting in significant additional value generated by using less energy than incumbent technologies. Our systems are also modular and scalable to allow for the appropriately sized systems to be installed exactly where our carbon-free ammonia is needed. This milestone for FuelPositive further reinforces the potential for the global implementation of our technology and we are working rapidly toward commercialization, with Phase 2 commercial demonstration systems well on their way to being realized.”
That last little nugget from Clifford shouldn’t be ignored. Achieving a commercialization phase in the short term will be a real boost to the Company – not just via a cash influx as a result of selling their systems - but it will affirm that the product is viable in the marketplace in real time. And protecting their breakthrough technology through a comprehensive patent program is imperative and they’re doing it!
About The Emerging Markets Report:
The Emerging Markets Report is owned and operated by Emerging Markets Consulting (EMC), a syndicate of investor relations consultants representing years of experience. Our network consists of stockbrokers, investment bankers, fund managers, and institutions that actively seek opportunities in the micro and small-cap equity markets.
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NEWS -- FuelPositive Featured in Syndicated Broadcast Covering Recent Filing of Patent Application for Clean Hydrogen and Ammonia Technology
LOS ANGELES, June 18, 2021 (GLOBE NEWSWIRE) -- via InvestorWire -- FuelPositive Corporation (TSX.V: NHHH) (OTC: NHHHF) (“FuelPositive” or the “Company”), a growth-stage company focused on licensing, partnership and acquisition opportunities building upon various technological achievements, announces that it has been featured in a broadcast via NetworkNewsAudio (NNA), a solution that delivers additional visibility, recognition and brand awareness in the investment community via distribution to thousands of syndication points. The audio press release covers the recent announcement regarding the filing of a patent application for the Company’s “Modular Transportable Clean Hydrogen-Ammonia Maker” with the United States Patent and Trademark Office (U.S. provisional patent application number: 63197884).
To hear the audio production, visit: https://www.nnw.fm/IrbLy
To read the original press release, visit: https://www.nnw.fm/BTvqF
“Our carbon-free ammonia (NH3) technology will offer tremendous value by using less energy than incumbent technologies and will reduce processing costs through the reduction of operating pressure and temperatures,” said Ian Clifford, CEO of FuelPositive. “This milestone for FuelPositive further reinforces the potential for the global implementation of our technology, and we are working rapidly toward commercialization, with Phase 2 commercial demonstration systems well on their way to being realized.”
About FuelPositive
FuelPositive is a Canadian-based growth stage company committed to providing commercially viable and sustainable energy solutions, including clean ammonia (NH3), for use across a broad spectrum of industries, systems and applications.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
All statements, other than statements of historical fact, contained in this press release including, but not limited to, (i) generally, or the “About FuelPositive” paragraph, which essentially describes the Company’s outlook and objectives, constitute “forward-looking information” or “forward-looking statements” within the meaning of certain securities laws, and are based on expectations, estimates and projections as of the time of this press release. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect.
Many of these uncertainties and contingencies can directly or indirectly affect, and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Forward-looking statements are provided for the purpose of providing information about management’s expectations and plans relating to the future. The Company disclaims any intention or obligation to update or revise any forward-looking statements or to explain any material difference between subsequent actual events and such forward-looking statements, except to the extent required by applicable law.
For Media or Investor enquiries, please contact:
Mr. Ian Clifford
Chief Executive Officer
mailto://investors@fuelpositive.com
Investor Relations (United States)
RBMG – RB Milestone Group LLC
Trevor Brucato, Managing Director
mailto://fuelpositive@rbmilestone.com
https://www.rbmilestone.com
About NetworkNewsAudio
NetworkNewsAudio (“NNA”), one of 50+ brands within the InvestorBrandNetwork (“IBN”), allows you to sit back and listen to market updates, CEO interviews and AudioPressRelease (“APR”) productions. These audio clips provide snapshots of position, opportunity and momentum. NNA can assist by cutting through the overload of information in today's market, while bringing its clients unparalleled visibility, recognition and brand awareness. IBN is where news, content and information converge. IBN is a comprehensive provider of news aggregation and syndication, enhanced press release services and a full array of social communication solutions. As a multifaceted financial news and distribution company with an extensive team of journalists and writers, IBN has the unparalleled ability to reach a wide audience of investors, consumers, journalists and the general public with an ever-growing distribution network of 5,000+ key syndication outlets across the nation.
For more information, visit: https://www.NetworkNewsAudio.com
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NEWS -- FuelPositive Announces Closing of CAD$5 Million Private Placement with U.S. Institutional Investors
/NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES
OR FOR DISSEMINATION IN THE UNITED STATES/
TORONTO, June 17, 2021 (GLOBE NEWSWIRE) -- FuelPositive Corporation (“FuelPositive” or the “Company”) (TSX.V: NHHH) (OTCMKTS: NHHHF) is pleased to announce it has closed its previously announced subscription agreement with certain U.S. institutional investors for gross proceeds of approximately CAD$5 million in a private placement in the United States, comprised of 20,833,333 common shares and warrants to purchase an aggregate of up to 20,833,333 common shares at a purchase price of CAD$0.24 per common share and associated warrant. The warrants have an exercise price of CAD$0.275 per common share and exercise period of five years. The net proceeds of the private placement will be used by the Company to rapidly advance the production of the Company’s Phase 2 commercial clean NH3 demonstration systems and for general corporate purposes.
H.C. Wainwright & Co. acted as the exclusive placement agent for the private placement in the United States.
No securities were offered or sold to Canadian residents in connection with the private placement.
This news release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. This news release shall not constitute an offer of securities for sale in the United States. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and such securities may not be offered or sold within the United States absent registration under U.S. federal and state securities laws or an applicable exemption from such U.S. registration requirements.
About FuelPositive
FuelPositive is a Canadian-based growth stage company committed to providing commercially viable and sustainable energy solutions, including clean ammonia (NH3), for use across a broad spectrum of industries, systems and applications.
Cautionary Statement
Trading in the securities of the Company should be considered highly speculative. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward-Looking Statements
This news release contains certain “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) that are based on expectations, estimates and projections as at the date of this news release. The information in this release about future plans and objectives of the Company, including the expected expenditures of the proceeds of the private placement, are forward-looking statements.
These forward-looking statements are based on assumptions and estimates of management of the Company at the time they were made and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Forward looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect
Many of these uncertainties and contingencies can directly or indirectly affect, and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that forward-looking information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.
Forward-looking information is provided for the purpose of providing information about management’s expectations and plans relating to the future. The Company disclaims any intention or obligation to update or revise any forward-looking information or to explain any material difference between subsequent actual events and such forward-looking information, except to the extent required by applicable law.
For Media or Investor enquiries, please contact:
Mr. Ian Clifford
Chief Executive Officer
mailto://investors@fuelpositive.com
Investor Relations (United States)
RBMG – RB Milestone Group LLC
Trevor Brucato, Managing Director
mailto://fuelpositive@rbmilestone.com
https://www.rbmilestone.com
NEWS -- Lineage Announces Exclusive Option Agreement With Amasa Therapeutics for Supply and Use of Clinical-Grade Hystem®
CARLSBAD, Calif., Jun 17, 2021--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced it granted an exclusive option to Amasa Therapeutics, Inc. (Amasa), a privately-held biopharmaceutical company focused on the development of novel cell-based targeted biological therapeutics to treat cancer patients with unmet need, to acquire an exclusive, royalty-bearing license to use Lineage’s HyStem technology for the development and commercialization of therapies for local treatment of solid tumors under pre-negotiated terms. Under the option agreement, Amasa will purchase certain amounts of Lineage’s existing supply of clinical-grade HyStem biomaterial and has the right to purchase additional amounts in connection with its up to 12-month option to acquire the exclusive license. Lineage will receive an upfront cash payment and, if the option is exercised, would be entitled to additional payments, including event-specific payments, royalties on net sales and sublicense fees and royalties.
"Lineage is a clinical-stage cell therapy company supported by a vast intellectual property portfolio. From this portfolio, we continue to find opportunities to unlock value from non-core assets through option and license agreements for assets such as HyStem," stated Brian Culley, Lineage CEO. "Many tissue engineering and regenerative cell-based therapies will require the delivery of therapeutic cells in a matrix or scaffold for accurate anatomical placement, cell retention, and engraftment. This option agreement represents an opportunity to provide Amasa with access to our clinical-grade HyStem material for future development of oncology-related products delivered via HyStem and, alongside a previously announced deal with Advanced BioMatrix, is the second HyStem-related transaction we have entered into."
HyStem is a patented biomaterial that is made from and structurally mimics naturally occurring extracellular matrix, the structural network of molecules surrounding cells in organs and tissues that is essential to cellular function and tissue structure. The technology underlying the HyStem hydrogels is based on a unique thiol cross-linking strategy. Building upon this technology, the HyStem family of hydrogels are novel biomaterials that offer unique strategies for cell therapy and bioactive molecule delivery. A distinctive feature of the HyStem hydrogel is that it allows the mixture of cells with the matrix in a liquid form such that the cells and matrix can be injected easily through a small gauge syringe, and then the matrix can polymerize around the cells to create a three-dimensional tissue within the body. When implanted in HyStem hydrogels, cells remain attached and localized within the hydrogel and slowly degrade the implanted matrix and replace it with their natural extracellular matrices. Current research at leading medical institutions has shown that HyStem is compatible with a wide variety of cells and tissue types including brain, bone, skin, cartilage, vascular and heart tissues.
"We believe use of Lineage’s clinical-grade HyStem hydrogels will allow us to quickly move candidates into the clinic with our novel approach of using receptor-targeted cell therapies to address intractable solid tumors such as glioblastoma," stated Arthur Hiller, Amasa CEO. "The physiochemical properties of the HyStem hydrogel and its ability to provide a suitable extracellular matrix give our cell therapies the best opportunity to remain viable, be retained in the targeted tumor resection cavity, and eradicate residual tumor cells," stated Khalid Shah, founder of Amasa.
About HyStem®
Lineage has developed a family of hyaluronan based hydrogels (HyStem) that mimics the natural extracellular matrix and has potential applications in 3-D cell culture, stem cell propagation and differentiation, tissue engineering, regenerative medicine, cell-based therapies, and as delivery vehicles for bioactive molecules. HyStem hydrogels were designed to recapitulate the minimal composition necessary to obtain a functional extracellular matrix (ECM). The individual components of the hydrogels are cross-linkable over time, and thus may be seeded with cells prior to in vivo injection, without compromising either the cells or the recipient tissues. HyStem hydrogels have been shown to support attachment and proliferation of a wide variety of cell types in both 2-D and 3-D cultures and provide timed release of proteins and other bioactive moieties. HyStem hydrogels exhibit a high degree of biocompatibility when implanted in vivo and are readily degraded in vitro and biodegrade in vivo through hydrolysis via naturally occurring enzymes. When implanted in HyStem hydrogels, cells remain attached and localized within the hydrogel and slowly degrade the implanted matrix and replace it with their natural ECMs. When used as a delivery vehicle, bioactive molecules are released by both diffusion as well as degradation of the hydrogel. The patented technology underlying Lineage’s HyStem hydrogel products in development, such as Renevia®, has been exclusively licensed to Lineage for human therapeutic uses. Since the first published report in 2002, there have been over 300 academic scientific publications supporting the biocompatibility of thiol cross-linked hyaluronan-based hydrogels and their applications as medical devices and in cell culture, tissue engineering, and animal models of cell-based therapies. Due to the unique cross-linking chemistry, HyStem hydrogels have the ability to be formulated with cells and can be injected or applied as a liquid and form a gel in situ, which allows the hydrogel to conform to a cavity or space. This property of HyStem hydrogels is expected to offer several distinct advantages over other hydrogels, including the possibility of combining bioactive materials with the hydrogel at the point of use.
About Amasa Therapeutics, Inc.
Amasa Therapeutics is a biopharmaceutical company focused on the development of novel stem cell-based targeted biological therapeutics to treat cancer patients with unmet need. With a vision to develop innovative off-the-shelf cellular therapies possessing wide applicability, Amasa is committed to improving quality of life and increasing progression-free survival for all patients suffering from a variety of advanced cancers, starting with malignant brain tumor, glioblastoma. Amasa’s technology is built upon a unique platform of receptor-targeted cell-based therapies intended to treat the greatest unmet needs within oncology. For more information visit: https://www.amasatx.com/.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit https://www.lineagecell.com or follow the Company on Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to opportunities to add value to Lineage by licensing non-core assets, including HyStem, HyStem’s potential to serve as a safe and effective delivery vehicle for cell therapies and potential payments to Lineage under its option agreement and potential license agreement with Amasa. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210617005082/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Solebury Trout IR
Gitanjali Jain Ogawa
(mailto://Gogawa@soleburytrout.com)
(646) 378-2949
Russo Partners – Media Relations
Nic Johnson or David Schull
mailto://Nic.johnson@russopartnersllc.com
mailto://David.schull@russopartnersllc.com
(212) 845-4242
NEWS -- Plus Therapeutics Announces DSMB Approval to Proceed into Eighth Cohort in ReSPECT™ Glioblastoma Trial
Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing novel, targeted therapies for rare and difficult to treat cancers, today announced that the Data and Safety Monitoring Board recommended the Company proceed to the eighth cohort of the Phase 1 dose escalation ReSPECT™ trial, which is evaluating the Company’s lead investigational drug, Rhenium NanoLiposome (RNL™), in patients with recurrent glioblastoma (GBM).
“We are pleased with the favorable safety profile observed thus far with RNL™ in recurrent GBM,” said Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. “Moving to cohort eight will allow us to continue to push the envelope in terms of addressable tumor size and maximum radiation dose delivered.”
Twenty-one patients with recurrent GBM have been treated in the ReSPECT™ trial across seven cohorts to date. In these patients, RNL™ has had no dose-limiting toxicities observed with absorbed radiation doses of up to 740 Gray per tumor.
The eighth cohort of the ReSPECT™ trial will implement a 40% increase in total radioactivity. The planned infused dose will be 31.2 millicuries in a volume of 12.3 milliliters (increased from 22.3 millicuries and 8.8 milliliters, respectively, used in cohort seven). The planned maximum flow rate will not change.
RNL™ is under investigation as a potentially safe, effective and convenient way to deliver a very high dose of radiation, possibly over 20 times greater than traditional external beam radiation therapy. This trial is supported by the U.S. National Institutes of Health/National Cancer Institute at three trial sites in the U.S., including UT Health Science Center San Antonio, UT Southwestern Medical Center and UT MD Anderson Cancer Center Houston.
The U.S. Food and Drug Administration has granted both Orphan Drug designation and Fast Track designation to RNL™ for the treatment of patients with GBM. Additional details about the ReSPECT™ trial are available at clinicaltrials.gov (NCT01906385).
The latest corporate information can be found on the Company’s Investor Relations page at https://ir.plustherapeutics.com/presentations.
About Plus Therapeutics, Inc.
Plus Therapeutics is a clinical-stage pharmaceutical company whose radiotherapeutic portfolio is concentrated on nanoliposome-encapsulated radionuclides for several cancer targets. Central to the Company’s drug development is a unique nanotechnology platform designed to reformulate, deliver and commercialize multiple drugs targeting rare cancers and other diseases. The platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at https://PlusTherapeutics.com and https://ReSPECT-Trials.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “will,” “believe,” “plan,” “can,” “enable,” “design,” “intend,” “potential,” “expect,” “estimate,” “project,” “prospect,” “target,” “focus,” “anticipate,” “could,” “should,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the design and potential of the Plus Therapeutics portfolio to reformulate, deliver and commercialize multiple novel, proprietary drugs targeting rare cancers and other diseases and to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs; the potential of the Company’s in-licensed portfolio of investigational drugs; the Company’s intent to advance its CNS oncology portfolio through the clinical development process; the ability of RNL to safely, effectively and conveniently deliver a very high dose of radiation directly into the brain tumor; anticipated benefits of strategic collaborations and license agreements, intellectual property, FDA approval process and government regulation; and the Company’s anticipated milestones and events, including with respect to additional sites, enrollment, pivotal trial planning, IND process, and clinical phase plans for RNL, pipeline expansion through additional drug development candidates, and partnership discussions for RNL, DocePLUS and DoxoPLUS; and future development and/or expansion of its product candidates and therapies in its markets. The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that the Company is not able to successfully develop product candidates that can leverage the FDA’s accelerated regulatory pathways; the early stage of the Company’s product candidates and therapies, the results of its research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s history of losses; the Company’s need for, and ability to raise, additional cash or obtain other sources of funding in the immediate future; the Company’s ability to: (a) obtain and maintain regulatory approvals, (b) continue as a going concern, (c) remain listed on the Nasdaq Capital Market, (d) to obtain or maintain sufficient levels of reimbursement for its tests, and (d) to repay or refinance some or all of its outstanding indebtedness; the outcome of the Company’s partnering/licensing efforts; market and economic conditions; the impact of the COVID-19 pandemic on the Company and the effectiveness of the efforts it has taken or may take in the future in response thereto; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Peter Vozzo
Westwicke/ICR
(443) 377-4767
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
Westwicke/ICR
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- Lineage Cell Therapeutics Announces Kevin L. Cook to Join as Chief Financial Officer
CARLSBAD, Calif., Jun 16, 2021--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that Kevin Cook will join as the Company’s Chief Financial Officer, effective June 21, 2021. Mr. Cook will bring more than 20 years of significant strategic, financial, and operational experience to Lineage, with an emphasis in private equity, corporate finance, and investment banking. Mr. Cook has broad expertise across a range of financial matters and has executed over $30 billion of capital raising and corporate development transactions, approximately half of which involved life sciences companies.
"We are excited to welcome Kevin to Lineage as we continue our journey to become a leading cell therapy and cell transplant company," stated Brian M. Culley, Lineage CEO. "Kevin is a talented and skilled executive with a proven track record of execution across an array of strategic and financial disciplines. We believe he will be an important addition to the Lineage team and his breadth of experience will contribute significantly to our future success as we advance our product candidates into later stage clinical trials and seek to align strategically with financial and developmental partners to support our further growth."
Mr. Cook most recently served as Chief Operating Officer of a family office investment firm with an emphasis in the solar energy and infrastructure industries, where he managed existing portfolio companies while pursuing new control investments. From 2012 to 2019, he served as Vice President of Corporate Development and Strategy and Vice President of Business Development for Breitburn GP LLC, where he led aggressive growth and diversification efforts for Breitburn Energy and affiliates. From 2000 to 2011, Mr. Cook served as an investment banker for Merrill Lynch & Co., where he advised life sciences companies and other clients across a range of industries in connection with corporate finance and strategic assignments. Mr. Cook earned his M.B.A. from Northwestern University’s Kellogg Graduate School of Management and his B.S. from the University of California, Davis.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit https://www.lineagecell.com or follow the Company on Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to Mr. Cook’s employment with Lineage and appointment as CFO and the anticipated impact thereof, clinical development of Lineage’s product candidates, and Lineage’s anticipated growth and potential partnerships in furtherance thereof. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210616005304/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Solebury Trout IR
Gitanjali Jain Ogawa
(mailto://Gogawa@soleburytrout.com)
(646) 378-2949
Russo Partners – Media Relations
Nic Johnson or David Schull
mailto://Nic.johnson@russopartnersllc.com
mailto://David.schull@russopartnersllc.com
(212) 845-4242
NEWS -- Lineage Cell Therapeutics to Present at Raymond James 2021 Human Health Innovation Conference on June 22, 2021
CARLSBAD, Calif., Jun 15, 2021--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that Brian M. Culley, Chief Executive Officer, will be presenting at the Raymond James 2021 Human Health Innovation Conference being held virtually on June 22, 2021 at 1:20 p.m. Eastern Time / 10:20 a.m. Pacific Time. Interested investors can access the live and archived webcasts on the Events and Presentations section (https://investor.lineagecell.com/events-and-presentations/upcoming-events) of Lineage’s website. Additional videos are available on the Media page (https://lineagecell.com/media/) of the Lineage website.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit https://www.lineagecell.com or follow the Company on Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210615005498/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Solebury Trout IR
Gitanjali Jain Ogawa
(mailto://Gogawa@soleburytrout.com)
(646) 378-2949
Russo Partners – Media Relations
Nic Johnson or David Schull
mailto://Nic.johnson@russopartnersllc.com
mailto://David.schull@russopartnersllc.com
(212) 845-4242
NEWS -- FuelPositive Announces CAD$5 Million Private Placement with U.S. Institutional Investors
/NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES
OR FOR DISSEMINATION IN THE UNITED STATES/
TORONTO, June 14, 2021 (GLOBE NEWSWIRE) -- FuelPositive Corporation (“FuelPositive” or the “Company”) (TSX.V: NHHH) (OTCMKTS: NHHHF) is pleased to announce it has entered into a subscription agreement with certain U.S. institutional investors for gross proceeds of approximately CAD$5 million in a private placement in the United States, comprised of 20,833,333 common shares and warrants to purchase an aggregate of up to 20,833,333 common shares at a purchase price of CAD$0.24 per common share and associated warrant. The warrants have an exercise price of CAD$0.275 per common share and exercise period of five years. The net proceeds of the private placement will be used by the Company to rapidly advance the production of the Company’s Phase 2 commercial clean NH3 demonstration systems and for general corporate purposes.
The private placement is expected to close on or about June 17, 2021, subject to satisfaction of customary closing conditions and approval of the TSX Venture Exchange.
H.C. Wainwright & Co. is acting as the exclusive placement agent for the private placement in the United States.
No securities were offered or sold to Canadian residents in connection with the private placement.
This news release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. This news release shall not constitute an offer of securities for sale in the United States. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and such securities may not be offered or sold within the United States absent registration under U.S. federal and state securities laws or an applicable exemption from such U.S. registration requirements.
About FuelPositive
FuelPositive is a Canadian-based growth stage company committed to providing commercially viable and sustainable energy solutions, including clean ammonia (NH3), for use across a broad spectrum of industries, systems and applications.
Cautionary Statement
Trading in the securities of the Company should be considered highly speculative. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward-Looking Statements
This news release contains certain “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) that are based on expectations, estimates and projections as at the date of this news release. The information in this release about future plans and objectives of the Company, including the intention to complete the private placement and the expected expenditures of the proceeds of the private placement, are forward-looking statements.
This forward-looking statements are based on assumptions and estimates of management of the Company at the time they were made and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Forward looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect
Many of these uncertainties and contingencies can directly or indirectly affect, and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that forward-looking information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.
Forward-looking information is provided for the purpose of providing information about management’s expectations and plans relating to the future. The Company disclaims any intention or obligation to update or revise any forward-looking information or to explain any material difference between subsequent actual events and such forward-looking information, except to the extent required by applicable law.
For Media or Investor enquiries, please contact:
Mr. Ian Clifford
Chief Executive Officer
mailto://investors@fuelpositive.com
Investor Relations (United States)
RBMG – RB Milestone Group LLC
Trevor Brucato, Managing Director
mailto://fuelpositive@rbmilestone.com
https://www.rbmilestone.com
NEWS -- OncoSec Appoints Industry Leading Electroporation Device Expert, Jeffrey Silverman, as Vice President of Product Engineering
-- Mr. Silverman joins OncoSec with over two decades of electroporation device quality and manufacturing experience --
PENNINGTON, N.J. and SAN DIEGO, June 14, 2021 /PRNewswire/ -- OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec"), today announced the appointment of Jeffrey Silverman as Vice President of Product Engineering, effective June 14, 2021. Mr. Silverman, an engineering management veteran, brings to OncoSec extensive global industry experience spanning more than 20 years, in the development, manufacturing and scale up of Medical Devices including electroporation and gene delivery equipment for the delivery of DNA drugs in support of cancer and vaccine research.
For more than five years, Mr. Silverman served as Vice President at Ichor Medical Systems, Inc., an industry leader focused on the development, manufacture and sale of electroporation devices for the intracellular delivery of nucleic acid-based drugs encoding therapeutic proteins. While at Ichor, he was responsible for establishing and leading the engineering, operations and quality teams for the company's electroporation equipment for the delivery of DNA drugs in support of cancer and vaccine research. Mr. Silverman was also responsible for engineering design execution and planning, supply chain, supplier audits, internal and external manufacturing and contract coordination.
Prior to joining Ichor Medical Systems, Mr. Silverman was the Managing Director at Varioscale, Inc. Adding to his past experience, he held a variety of engineering and business manager roles, including his time at Abbott Laboratories and Guidant Corporation where he managed business alliance, program management, engineering/manufacturing process development and improvements.
"Jeff's extensive clinical development experience with electroporation and intertumoral gene delivery technologies aligns perfectly with OncoSec's mission of utilizing intratumoral electroporation to achieve targeted and sustained delivery of IL-12 for significantly underserved cancer patients. He will be replacing John Rodriguez, former Vice President of Product Engineering and Manufacturing, who is retiring after five years at OncoSec," said Daniel J. O'Connor, President and Chief Executive Officer of OncoSec. "As we continue advancing our lead product candidate, TAVO™, through clinical trials, we believe Jeff's prior experience in R&D and commercialization of electroporation and gene delivery devices will be crucial in our mission to deliver this treatment directly into patients' tumors, thereby avoiding system toxicities while still having a whole-body anti-tumor effect, in the hopes of providing long-term benefits."
Mr. Silverman added, "The preliminary data seen in OncoSec's clinical trials evaluating TAVO™ in combination with KEYTRUDA® for the treatment of anti-PD-1 checkpoint refractory metastatic melanoma and for metastatic triple-negative breast cancer present an encouraging path toward bringing this therapy to market. I look forward to working with Dan and the leadership team to develop and execute OncoSec's clinical trial strategy and lead manufacturing operations."
Mr. Silverman earned his bachelor's degree in biology with minors in chemistry and psychology at the University of California, San Diego (UCSD).
As of June 14, 2021, Mr. Silverman will be granted an initial grant of 35,000 stock options. These stock options will have an exercise price equal to the closing price of the Company's common stock on the date of grant and will be 25% vested on the date of grant, with the remaining 75% vesting quarterly over a two-year period. These stock options were granted as an inducement to Mr. Silverman entering into employment with the Company in accordance with NASDAQ Listing Rule 5635(c)(4).
About TAVO™
OncoSec's gene therapy technology combines TAVO™ (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12), with an intra-tumoral electroporation gene delivery platform to achieve endogenous IL-12 production in the tumor microenvironment that enables the immune system to target and attack tumors throughout the body. TAVO™ has demonstrated a local and systemic anti-tumor response in several clinical trials, including the pivotal Phase 2b trial KEYNOTE-695 for metastatic melanoma and the KEYNOTE-890 Phase 2 trial in triple negative breast cancer (TNBC). TAVO™ has received both Orphan Drug and Fast-Track Designation by the U.S. Food & Drug Administration for the treatment of metastatic melanoma.
About OncoSec Medical Incorporated
OncoSec Medical Incorporated (the "Company," "OncoSec," "we" or "our") is a biotechnology company focused on developing cytokine-based intratumoral immunotherapies to stimulate the body's immune system to target and attack cancer. OncoSec's lead immunotherapy investigational product candidate – TAVO™ (tavokinogene telseplasmid) – enables the intratumoral delivery of DNA-based interleukin-12 (IL-12), a naturally occurring protein with immune-stimulating functions. The technology, which employs electroporation, is designed to produce a controlled, localized expression of IL-12 in the tumor microenvironment, enabling the immune system to target and attack tumors throughout the body. OncoSec has built a deep and diverse clinical pipeline utilizing TAVO™ as a potential treatment for multiple cancer indications either as a monotherapy or in combination with leading checkpoint inhibitors; with the latter potentially enabling OncoSec to address a great unmet medical need in oncology: anti-PD-1 non-responders. Results from recently completed clinical studies of TAVO™ have demonstrated a local immune response, and subsequently, a systemic effect as either a monotherapy or combination treatment approach along with an acceptable safety profile, warranting further development. In addition to TAVO™, OncoSec is identifying and developing new DNA-encoded therapeutic candidates and tumor indications for use with its new Visceral Lesion Applicator (VLA), to target deep visceral lesions, such as liver, lung or pancreatic lesions. For more information, please visit https://www.oncosec.com.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.
TAVO™ is a trademark of OncoSec Medical Incorporated.
Risk Factors and Forward-Looking Statements
This release, as well as other information provided from time to time by the Company or its employees, may contain forward-looking statements that involve a number of risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements. Forward-looking statements provide the Company's current beliefs, expectations and intentions regarding future events and involve risks, uncertainties (some of which are beyond the Company's control) and assumptions. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. You can identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. These statements may include words such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "should," "will" and "would" and similar expressions (including the negative of these terms). Although we believe that expectations reflected in the forward- looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. The Company intends these forward-looking statements to speak only at the time they are published on or as otherwise specified and does not undertake to update or revise these statements as more information becomes available, except as required under federal securities laws and the rules and regulations of the Securities Exchange Commission ("SEC"). In particular, you should be aware that the success and timing of our clinical trials, including safety and efficacy of our product candidates, patient accrual, unexpected or expected safety events, the impact of COVID-19 on the supply of our candidates or the initiation or completion of clinical trials and the usability of data generated from our trials may differ and may not meet our estimated timelines. Please refer to the risk factors and other cautionary statements provided in the Company's Annual Report on Form 10-K for the fiscal year ended July 31, 2020 and subsequent periodic and current reports filed with the SEC (each of which can be found at the SEC's website www.sec.gov), as well as other factors described from time to time in the Company's filings with the SEC.
Company Contact
Brian Leuthner
Chief Operating Officer
mailto://investors@oncosec.com
Media Contact
Patrick Bursey
LifeSci Communications
+1-646-970-4688
mailto://pbursey@lifescicomms.com
View original content to download multimedia: http://www.prnewswire.com/news-releases/oncosec-appoints-industry-leading-electroporation-device-expert-jeffrey-silverman-as-vice-president-of-product-engineering-301311452.html
SOURCE OncoSec Medical Incorporated
A new video interview is out today with Ian Clifford, CEO and Chair of FuelPositive.
It is going up today!!!
NEWS -- Plus Therapeutics Presents at the Sixth Biennial Pediatric Neuro-Oncology Research Conference
AUSTIN, Texas, June 10, 2021 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company, today announced it will present a poster at the 6th Biennial Pediatric Neuro-Oncology Research Conference hosted by the Society for Neuro-Oncology (SNO), being held virtually June 10-12, 2021.
The poster presentation is titled, “A two-part, Phase I study of Rhenium-186 Nanoliposomes (186RNL) delivered by convection enhanced delivery (CED) for recurrent, refractory, or progressive ependymoma and high-grade glioma (HGG).” The lead presenter is Dr. Ashley S. Plant-Fox, Attending Physician, Neuro-Oncology, Assistant Professor of Pediatrics, and A.M. Khokhar Research Scholar at the Northwestern University Feinberg School of Medicine and the Ann & Robert H. Lurie Children’s Hospital of Chicago. A copy of the poster is available under the Presentations tab of the Investors section of the Company’s website. Presented data include a review of relevant preclinical research, the company’s Phase 1 ReSPECTTM clinical trial in recurrent glioblastoma (GBM) and a proposed design for initiating a Phase I clinical trial in pediatric brain tumors.
RNL™, the Company’s lead investigational drug, is a novel radiotherapy that is designed to potentially deliver a very high dose of radiation directly to brain tumors safely, effectively and conveniently.
The company recently received feedback from the U.S. Food and Drug Administration (FDA) regarding its submitted Pre-Investigational New Drug meeting package. Briefly, the FDA provided constructive feedback on the study synopsis that should be helpful as a full protocol is developed, and confirmed that no additional GLP toxicology studies are required to support initiation of a pediatric clinical study.
The FDA has granted both Orphan Drug designation and Fast Track designation to RNL™ for the treatment of patients with GBM. Additional details about the ReSPECT™ trial are available at https://clinicaltrials.gov/ct2/show/NCT01906385.
About Plus Therapeutics, Inc.
Plus Therapeutics (Nasdaq: PSTV) is a clinical-stage pharmaceutical company whose radiotherapeutic portfolio is concentrated on nanoliposome-encapsulated radionuclides for several cancer targets. Central to the Company’s drug development is a unique nanotechnology platform designed to reformulate, deliver and commercialize multiple drugs targeting rare cancers and other diseases. The platform is designed to facilitate new delivery approaches and/or formulations of injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at https://PlusTherapeutics.com and https://ReSPECT-Trials.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “will,” “believe,” “plan,” “can,” “enable,” “design,” “intend,” “potential,” “expect,” “estimate,” “project,” “prospect,” “target,” “focus,” “anticipate,” “could,” “should,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the design and potential of the Plus Therapeutics portfolio to reformulate, deliver and commercialize multiple novel, proprietary drugs targeting rare cancers and other diseases and to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs; the potential of the Company’s in-licensed portfolio of investigational drugs; the Company’s intent to advance its CNS oncology portfolio through the clinical development process; the ability of RNL to safely, effectively and conveniently deliver a very high dose of radiation directly into the brain tumor; anticipated benefits of strategic collaborations and license agreements, intellectual property, FDA approval process and government regulation; and the Company’s anticipated milestones and events, including with respect to additional sites, enrollment, pivotal trial planning, IND process, and clinical phase plans for RNL, pipeline expansion through additional drug development candidates, and partnership discussions for RNL, DocePLUS and DoxoPLUS; and future development and/or expansion of its product candidates and therapies in its markets. The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that the Company is not able to successfully develop product candidates that can leverage the FDA’s accelerated regulatory pathways; the early stage of the Company’s product candidates and therapies, the results of its research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s history of losses; the Company’s need for, and ability to raise, additional cash or obtain other sources of funding in the immediate future; the Company’s ability to: (a) obtain and maintain regulatory approvals, (b) continue as a going concern, (c) remain listed on the Nasdaq Capital Market, (d) to obtain or maintain sufficient levels of reimbursement for its tests, and (d) to repay or refinance some or all of its outstanding indebtedness; the outcome of the Company’s partnering/licensing efforts; market and economic conditions; the impact of the COVID-19 pandemic on the Company and the effectiveness of the efforts it has taken or may take in the future in response thereto; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Peter Vozzo
Westwicke/ICR
(443) 377-4767
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
Westwicke/ICR
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- Emerging Markets Report: The Breakthrough Deal
An Emerging Markets Sponsored Commentary https://www.emergingmarketsllc.com/nhhhf
[ORLANDO, Fla., June 10, 2021 (GLOBE NEWSWIRE) -- Recent news from newly covered company FuelPositive Corporation (TSX.V: NHHH) (OTC: NHHHF) could be a significant breakthrough.
When we say significant we are referring to the potential production of a fossil fuel replacing carbon-free fuel technology that is both highly efficient and good for the environment.
For the record, FuelPositive is a Canadian-based growth stage company committed to providing commercially viable and sustainable clean energy solutions, including Carbon-Free Ammonia (NH3), for use across a broad spectrum of industries and applications. The existing ammonia market is massive, representing more than US$70 billion per year, and in its current production capacity, a major greenhouse gas emission contributor.
If you’re unaware of the significance of ammonia as a replacement fuel for the two billion internal combustion engines on the road today take a look at either of these two articles:
Forbes: A Key To The ‘Hydrogen Economy’ Is Carbon-Free Ammonia
Chemical & Engineering News: Is ammonia the fuel of the future?
A short time ago FuelPositive announced the selection of National Compressed Air Canada Ltd. (NCA) to undertake the manufacturing of the Company’s Phase 2 Ammonia Synthesizer commercial prototype systems for Carbon-Free Ammonia (NH3) production.
This is an enormous step toward commercial sale and monetization.
“This critical milestone for FuelPositive will confirm the broad application potential for our technology and is the backbone of our Carbon-Free NH3 offering,” said Ian Clifford, CEO of FuelPositive. “Partnering with the knowledgeable and experienced team at NCA on this commercialization project will bring our development-stage program to life.”
We agree. To a large extent, bringing NCA on board validates the Company’s technology with this experienced player taking on the manufacturing process. But more than anything it brings ever closer real monetization from the sale of the product.
It is for that reason that this announcement in early 2021 may someday be simply known as the Company’s breakthrough deal.
About The Emerging Markets Report:
The Emerging Markets Report is owned and operated by Emerging Markets Consulting (EMC), a syndicate of investor relations consultants representing years of experience. Our network consists of stockbrokers, investment bankers, fund managers, and institutions that actively seek opportunities in the micro and small-cap equity markets.
For more informative reports such as this, please sign up at http://www.emergingmarketsllc.com/newsletter.php
Must Read OTC Markets/SEC policy on stock promotion and investor protection
NEWS -- Plus Therapeutics to Participate in BIO Digital Conference
Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company, today announced that Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics, will participate in the BIO Digital Conference being held June 10-11 and 14-18, 2021.
The Company’s presentation will be made available through the BIO Digital Conference website and available on demand to registered participants during the conference at https://www.bio.org/events/bio-digital/sessions?sessionTypes=25903. Following the conference, the presentation will be available under the Presentations tab of the Investors section of the Company’s website at https://www.plustherapeutics.com.
About Plus Therapeutics, Inc.
Plus Therapeutics (Nasdaq: PSTV) is a clinical-stage pharmaceutical company whose radiotherapeutic portfolio is concentrated on nanoliposome-encapsulated radionuclides for several cancer targets. Central to the Company’s drug development is a unique nanotechnology platform designed to reformulate, deliver and commercialize multiple drugs targeting rare cancers and other diseases. The platform is designed to facilitate new delivery approaches and/or formulations of injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at https://PlusTherapeutics.com and https://ReSPECT-Trials.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “will,” “believe,” “plan,” “can,” “enable,” “design,” “intend,” “potential,” “expect,” “estimate,” “project,” “prospect,” “target,” “focus,” “anticipate,” “could,” “should,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the design and potential of the Plus Therapeutics portfolio to reformulate, deliver and commercialize multiple novel, proprietary drugs targeting rare cancers and other diseases and to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs; the potential of the Company’s in-licensed portfolio of investigational drugs; the Company’s intent to advance its CNS oncology portfolio through the clinical development process; the ability of RNL to safely, effectively and conveniently deliver a very high dose of radiation directly into the brain tumor; anticipated benefits of strategic collaborations and license agreements, intellectual property, FDA approval process and government regulation; and the Company’s anticipated milestones and events, including with respect to additional sites, enrollment, pivotal trial planning, IND process, and clinical phase plans for RNL, pipeline expansion through additional drug development candidates, and partnership discussions for RNL, DocePLUS and DoxoPLUS; and future development and/or expansion of its product candidates and therapies in its markets. The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that the Company is not able to successfully develop product candidates that can leverage the FDA’s accelerated regulatory pathways; the early stage of the Company’s product candidates and therapies, the results of its research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s history of losses; the Company’s need for, and ability to raise, additional cash or obtain other sources of funding in the immediate future; the Company’s ability to: (a) obtain and maintain regulatory approvals, (b) continue as a going concern, (c) remain listed on the Nasdaq Capital Market, (d) to obtain or maintain sufficient levels of reimbursement for its tests, and (d) to repay or refinance some or all of its outstanding indebtedness; the outcome of the Company’s partnering/licensing efforts; market and economic conditions; the impact of the COVID-19 pandemic on the Company and the effectiveness of the efforts it has taken or may take in the future in response thereto; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Peter Vozzo
Westwicke/ICR
(443) 377-4767
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
Westwicke/ICR
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- Lineage Cell Therapeutics Set to Join Russell 3000® Index and Russell Microcap® Index
Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that it is set to join the broad-market Russell 3000® Index as well as the Russell Microcap® Index at the conclusion of the 2021 Russell indexes annual reconstitution, effective after the U.S. market opens on June 28, 2021, according to a preliminary list of additions posted on June 4, 2021, by FTSE Russell, a leading global index provider.
Annual Russell indexes reconstitution captures the 4,000 largest U.S. stocks as of May 7, 2021, ranking them by total market capitalization. Membership in the U.S. all-cap Russell 3000® Index, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000® Index or small-cap Russell 2000® Index as well as the appropriate growth and value style indexes. Membership in the Russell Microcap® Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.
"Lineage’s inclusion on the preliminary list of additions to the Russell 3000® Index and the Russell Microcap® Index reflects progress we have made to establish ourselves as a leader in cell therapy and regenerative medicine," stated Brian M. Culley, Lineage’s CEO. "During the past year, we have delivered significant clinical, manufacturing, and business milestones which have created considerable value for our shareholders, and we intend to be diligent in our efforts to benefit from the explosive growth we believe the field of cell therapy will experience in the months and years ahead. We believe our inclusion in the Russell indexes will help broaden awareness of Lineage’s corporate mission and objectives among a wider audience of investors and help drive an increase in the liquidity of our stock."
Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $10.6 trillion in assets are benchmarked against Russell’s US indexes. Russell indexes are part of FTSE Russell.
About FTSE Russell
FTSE Russell is a global index leader that provides innovative benchmarking, analytics and data solutions for investors worldwide. FTSE Russell calculates thousands of indexes that measure and benchmark markets and asset classes in more than 70 countries, covering 98% of the investable market globally. FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately $17.9 trillion is currently benchmarked to FTSE Russell indexes. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create ETFs, structured products and index-based derivatives. A core set of universal principles guides FTSE Russell index design and management: a transparent rules-based methodology is informed by independent committees of leading market participants. FTSE Russell is focused on applying the highest industry standards in index design and governance and embraces the IOSCO Principles. FTSE Russell is also focused on index innovation and customer partnerships as it seeks to enhance the breadth, depth and reach of its offering. FTSE Russell is wholly owned by London Stock Exchange Group. For more information, visit https://www.ftserussell.com.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit https://www.lineagecell.com or follow the Company on Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to Lineage’s inclusion in the Russell indexes, anticipated growth in the field of cell therapy, and the potential benefits to Lineage and its shareholders as a result. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
The information in this announcement about the Russell indexes and FTSE Russell was obtained from FTSE Russell. Lineage has not independently verified such information and there can be no assurance as to its accuracy.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210609005268/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Solebury Trout IR
Gitanjali Jain Ogawa
(mailto://Gogawa@soleburytrout.com)
(646) 378-2949
Russo Partners – Media Relations
Nic Johnson or David Schull
mailto://Nic.johnson@russopartnersllc.com
mailto://David.schull@russopartnersllc.com
(212) 845-4242
NEWS -- Provectus Biopharmaceuticals Announces Publication of In Vitro Data from Research on Oral Delivery of PV-10® at American Society of Clinical Oncology (ASCO) 2021 Annual Meeting
KNOXVILLE, TN, June 09, 2021 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that preclinical data from the Company’s research on oral delivery of investigational cancer immunotherapy PV-10 (rose bengal disodium) for the treatment of adult solid tumors were published as an abstract as part at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting, held June 4-8 online.
A copy of the abstract, which was first published by ASCO on May 19th, is available on its website at https://meetinglibrary.asco.org/record/200310/abstract.
This research on the potential oral administration of PV-10 for the prophylactic and/or therapeutic treatment of adult solid tumor cancers is led by Aru Narendran, MD, PhD, Professor, Departments of Pediatrics, Oncology, Biochemistry & Molecular Biology, and Physiology & Pharmacology in the Cumming School of Medicine at the University of Calgary (UCal) in Calgary, Alberta, Canada. In association with their ASCO abstract, Dr. Narendran’s team prepared a brief presentation for inclusion in this press release.
A copy of the presentation is available on Provectus’ website at https://www.provectusbio.com/media/docs/PV10-solid-tumor-in-vitro-2021.pdf.
Highlights from the ASCO 2021 abstract and UCal’s associated presentation:
FuelPositive Corporation's Ian Clifford is Interviewed by Ashton Addison of InvestmentPitch Media
https://www.newsfilecorp.com/release/86869
NEWS -- FuelPositive Files Patent Application for Clean Hydrogen and Ammonia Technology
TORONTO, June 08, 2021 (GLOBE NEWSWIRE) -- Today, the FuelPositive Corporation (TSX.V: NHHH) (OTC: NHHHF) (“FuelPositive” or the “Company”) is pleased to announce that it has filed for patent protection for the Company’s “Modular Transportable Clean Hydrogen-Ammonia Maker” with the United States Patent and Trademark Office (U.S. provisional patent application number: 63197884).
“Our carbon-free ammonia (NH3) technology will offer tremendous value by using less energy than incumbent technologies and will reduce processing costs through the reduction of operating pressure and temperatures,” said Ian Clifford, CEO of FuelPositive. “This milestone for FuelPositive further reinforces the potential for the global implementation of our technology, and we are working rapidly toward commercialization, with Phase 2 commercial demonstration systems well on their way to being realized.”
About FuelPositive
FuelPositive is a Canadian-based growth stage company committed to providing commercially viable and sustainable energy solutions, including clean ammonia (NH3), for use across a broad spectrum of industries, systems and applications.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
All statements, other than statements of historical fact, contained in this press release including, but not limited to, (i) generally, or the “About FuelPositive” paragraph, which essentially describes the Company’s outlook and objectives, constitute “forward-looking information” or “forward-looking statements” within the meaning of certain securities laws, and are based on expectations, estimates and projections as of the time of this press release. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect.
Many of these uncertainties and contingencies can directly or indirectly affect, and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Forward-looking statements are provided for the purpose of providing information about management’s expectations and plans relating to the future. The Company disclaims any intention or obligation to update or revise any forward-looking statements or to explain any material difference between subsequent actual events and such forward-looking statements, except to the extent required by applicable law.
For Media or Investor enquiries, please contact:
Mr. Ian Clifford
Chief Executive Officer
mailto://investors@fuelpositive.com
Investor Relations (United States)
RBMG – RB Milestone Group LLC
Trevor Brucato, Managing Director
mailto://fuelpositive@rbmilestone.com
https://www.rbmilestone.com
The oil killer Fuel Positive!!!
NEWS -- Kintara Therapeutics Set to Join Russell Microcap® Index
SAN DIEGO, June 7, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced Kintara's addition to the Russell MicrocapÒ Index. This milestone will take place at the conclusion of the 2021 Russell Indexes' annual reconstitution, effective after the U.S. market opens on June 28, 2021 according to a preliminary list of additions posted June 4, 2021.
"We are delighted for Kintara to have been added to the FTSE Russell Microcap® Index, which will help increase investor exposure to our Company's mission of developing novel cancer therapies for patients with unmet medical needs," said Saiid Zarrabian, CEO of Kintara. "We look forward to the opportunity to expand awareness of our late-stage oncology pipeline of which our lead product, VAL-083, is currently being tested in GCAR's GBM AGILE registrational study for all three GBM patient subtypes of newly-diagnosed methylated MGMT, newly-diagnosed unmethylated MGMT, and recurrent GBM."
Membership in the Russell Microcap® Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell Indexes primarily by objective, market-capitalization rankings, and style attributes.
Russell Indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $10.6 trillion in assets are benchmarked against Russell's U.S. Indexes. Russell Indexes are part of FTSE Russell, a leading global index provider.
ABOUT KINTARA
Located in San Diego, California, Kintara is dedicated to the development of novel cancer therapies for patients with unmet medical needs.
Kintara is developing two late-stage, Phase 3-ready therapeutics for clear unmet medical needs with reduced risk development programs. The two programs are VAL-083 for GBM and REM-001 for cutaneous metastatic breast cancer (CMBC).
VAL-083 is a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.
Kintara is also advancing its proprietary, late-stage photodynamic therapy platform that holds promise as a localized cutaneous, or visceral, tumor treatment as well as in other potential indications. REM-001 therapy, has been previously studied in four Phase 2/3 clinical trials in patients with CMBC, who had previously received chemotherapy and/or failed radiation therapy. With clinical efficacy to date of 80% complete responses of CMBC evaluable lesions, and with an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing.
SAFE HARBOR STATEMENT
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including statements regarding the status of the Company's clinical trials and the GBM AGILE study. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company's products and technology; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company's filings with the SEC, including the Company's Annual Report on Form 10-K for the year ended June 30, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.
CONTACTS:
Investors:
CORE IR
516-222-2560
mailto://ir@coreir.com
Media:
Jules Abraham
Director of Public Relations
CORE IR
917-885-7378
mailto://julesa@coreir.com
View original content to download multimedia: http://www.prnewswire.com/news-releases/kintara-therapeutics-set-to-join-russell-microcap-index-301306592.html
SOURCE Kintara Therapeutics
NEWS -- Provectus Biopharmaceuticals Announces Presentation of Full Study Data from Metastatic Neuroendocrine Cancer Phase 1 Trial of PV-10® at American Society of Clinical Oncology (ASCO) 2021 Annual Meeting
KNOXVILLE, TN, June 04, 2021 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that preliminary full study data from the Company’s Phase 1 clinical trial of investigational cancer immunotherapy PV-10 (rose bengal disodium) for the treatment of neuroendocrine tumors (NET) metastatic to the liver (mNET) refractory to somatostatin analogs (SSAs) and peptide receptor radionuclide therapy (PRRT) (https://clinicaltrials.gov/ct2/show/NCT02693067) is be presented at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting, held June 4-8 online.
Highlights from the mNET Presentation at ASCO 2021:
NEWS -- Heat Biologics to Showcase Favorable Survival Data of HS-110 in Previously Treated Non-Small Cell Lung Cancer Patients at 2021 American Society of Clinical Oncology Annual Meeting
Survival benefit observed in two treatment settings of previously treated non-small lung cancer patients
DURHAM, N.C., June 04, 2021 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (Nasdaq: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today announced that Dr. Roger B. Cohen, MD, Professor of Medicine at the University of Pennsylvania Perelman School of Medicine, presented an overview of the latest HS-110 data at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting which is being held from June 4-8, 2021. This poster presentation can be viewed on Heat Biologics' website at: https://www.heatbio.com/product-pipeline/scientific-publications. The ASCO Annual Meeting is the world’s largest oncology conference showcasing the latest advancements in cancer research.
HS-110, in combination with a checkpoint inhibitor (CPI), is a potentially transformational agent to improve survival benefit for patients with non-small cell lung cancer (NSCLC). This is a first-in-class, allogeneic, off-the shelf cell-based therapy developed by Heat leveraging its proprietary gp96 platform. At this year’s ASCO meeting, the Company is pleased to report the latest data of HS-110 in combination with OPDIVO® (nivolumab) in two distinct treatment settings in a total of 115 previously treated patients with NSCLC:
Isopet trademark updated https://twitter.com/radiogel?ref_src=twsrc%5Egoogle%7Ctwcamp%5Eserp%7Ctwgr%5Eauthor
2.5 billion shares out and lots of sells , sell on news what a momo.