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Noble Capital Markets Senior Research Analyst Gregory Aurand sits down with Baudax Bio President & CEO Gerri Henwood for this exclusive interview. Research, News, and Advanced Market Data on BXRXView all C-Suite InterviewsThe 2022 C-Suite Interview series is now available on major podcast platforms
About Baudax Bio Baudax Bio is a pharmaceutical company focused on commercializing and developing innovative products for acute care settings. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBs) and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com. |
Category: Health
Lineage Cell Therapeutics To Report Fourth Quarter And Full Year 2021 Financial Results And Provide Business Update On March 10, 2022
Lineage Cell Therapeutics To Report Fourth Quarter And Full Year 2021 Financial Results And Provide Business Update On March 10, 2022
Research, News, and Market Data on Lineage Cell Therapeutics
(NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that it will report its fourth quarter and full year 2021 financial and operating results on
Interested parties may access the conference call by dialing (866) 888-8633 from the
About
(ir@lineagecell.com)
(442) 287-8963
Solebury Trout IR
(Mbiega@soleburytrout.com)
(617) 221-9660
Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com
(212) 845-4242
Source:
Baudax Bio (BXRX) – Public Offering Announced Revising EPS and Price Target
Monday, February 28, 2022
Baudax Bio (BXRX)
Public Offering Announced; Revising EPS and Price Target
Baudax Bio is a biopharmaceutical company focused on developing therapies for post-operative pain, peri-operative pain, and anesthesia. The company currently has one approved therapy in ANJESO for post-operative pain. Proprietary ANJESO (meloxicam) injection is the first and only once-daily IV analgesic. The company also has a pipeline of early-stage candidates with two novel neuromuscular blocking agents (NMBAs), a proprietary related reversal agent to their NMBAs, and Dex-IN, an intranasal formulation of dexmedetomidine (Dex) that has sedative, analgesic, and anti-anxiety properties.
Gregory Aurand, Senior Research Analyst, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Announced offering. Last Friday, Baudax Bio announced a $10 million public offering, composed of 3,508,772 shares of common stock sold together with 3,508,772 warrants allowing for the purchase of a common share at $3.25. The offering price of the stock and warrant unit is $2.85. The warrants will be exercisable immediately after the offering and expire in five years. The offering is expected to close on or about March 1, 2022.
Current market environment increases the share count. While the capital raise was anticipated, the market environment has been decidedly unforgiving. While we believe it is unwarranted, the stock price has declined roughly 70% from where it was prior to the announced split. With the stock price decline, a greater number of shares are required to support company needs. With the weakness, the issued …
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Ocugen (OCGN) – Pipeline Progress Updated With Fourth Quarter Financial Report
Monday, February 28, 2022
Ocugen (OCGN)
Pipeline Progress Updated With Fourth Quarter Financial Report
Ocugen Inc is a clinical stage biopharmaceutical company. It is focused on discovering, developing and commercializing a pipeline of innovative therapies that address rare and underserved eye diseases. Ocugen offers a diversified ophthalmology portfolio that includes novel gene therapies, biologics, and small molecules and targets a broad range of high-need retinal and ocular surface diseases.
Robert LeBoyer, Senior Research Analyst, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Summary. Ocugen reported a net loss of $14.6 million or $(0.07) per share for 4Q21, bringing FY21 loss to $58.4 million or $(0.30) per share. The company also gave updates on recent developments for its development programs. Cash at December 31, 2021 was $95.1 million, excluding proceeds of an offering completed in late February 2022.
Covaxin Is Progressing Through FDA and Heath Canada. The FDA lifted the Clinical Hold on the IND application for the Phase 2/3 clinical trial, allowing the bridging study to continue. The Emergency Use Authorization (EUA) application submitted in November 2022 has been supplemented with safety data and studies showing neutralization of the Delta and Omicron variants …
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Baudax Bio (BXRX) – Public Offering Announced; Revising EPS and Price Target
Monday, February 28, 2022
Baudax Bio (BXRX)
Public Offering Announced; Revising EPS and Price Target
Baudax Bio is a biopharmaceutical company focused on developing therapies for post-operative pain, peri-operative pain, and anesthesia. The company currently has one approved therapy in ANJESO for post-operative pain. Proprietary ANJESO (meloxicam) injection is the first and only once-daily IV analgesic. The company also has a pipeline of early-stage candidates with two novel neuromuscular blocking agents (NMBAs), a proprietary related reversal agent to their NMBAs, and Dex-IN, an intranasal formulation of dexmedetomidine (Dex) that has sedative, analgesic, and anti-anxiety properties.
Gregory Aurand, Senior Research Analyst, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Announced offering. Last Friday, Baudax Bio announced a $10 million public offering, composed of 3,508,772 shares of common stock sold together with 3,508,772 warrants allowing for the purchase of a common share at $3.25. The offering price of the stock and warrant unit is $2.85. The warrants will be exercisable immediately after the offering and expire in five years. The offering is expected to close on or about March 1, 2022.
Current market environment increases the share count. While the capital raise was anticipated, the market environment has been decidedly unforgiving. While we believe it is unwarranted, the stock price has declined roughly 70% from where it was prior to the announced split. With the stock price decline, a greater number of shares are required to support company needs. With the weakness, the issued …
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Ayala Pharmaceuticals (AYLA) – Ayala Completes Phase 2 3 Trial RINGSIDE Part A and Confirms Data Milestone
Thursday, February 24, 2022
Ayala Pharmaceuticals (AYLA)
Ayala Completes Phase 2/3 Trial RINGSIDE Part A and Confirms Data Milestone
Ayala Pharmaceuticals Inc clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations. The company’s current portfolio of product candidates, AL101 and AL102, targets the aberrant activation of the Notch pathway with gamma secretase inhibitors. Its product candidate, AL101, is being developed as a potent, selective, injectable small molecule gamma secretase inhibitor, or GSI. It is also developing AL101 for the treatment of T-ALL, an aggressive, rare form of T-cell specific leukemia.
Robert LeBoyer, Senior Research Analyst, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
First Stage of Phase 2/3 RINGSIDE Trial Completed Enrollment. Ayala has announced that enrollment is complete for Part A of the Phase 2/3 RINGSIDE trial. This trial is testing the oral gamma-secretase inhibitor, AL102, in desmoid tumors. The data from this portion of the trial is expected to be announced in mid-2022, consistent with prior guidance.
Part A Is Designed To Determine Safety, Efficacy, and Dosing For Part B. The first part of the RINGSIDE trial enrolled 36 patients to evaluate safety, tolerability, and changes in tumor volume by MRI scans. These data will be used to select the dose for Part B. A previous sub-study tested pharmacokinetics and found no food restrictions were needed …
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Stem Holdings (STMH)(STEM:CA) – Fiscal First Quarter 2022 Results
Thursday, February 24, 2022
Stem Holdings (STMH)(STEM:CA)
Fiscal First Quarter 2022 Results
Stem Holdings Inc is engaged in the purchasing, improving, and leasing of properties and finance assets which are operated by third parties and are used for the cultivation and retail sale of marijuana. Its properties includes 42nd Street, and Mulino Farm which are used for agriculture. The company generates its revenue in the form of rental income from tenants.
Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
1QFY22 Results. Stem reported net revenue of revenue of $4.2 million compared to $5.3 million last year. The sales decline reflects a decrease in sales resulting from general market conditions. Stem reported a net loss of $4.1 million, or $0.02 per share, for the quarter, including $795,000 of non-cash impairment charges, a $1.75 million loss from discontinued operations, and a $1.7 million gain from the change in the fair value of warrant liability. In 1Q21, Stem recorded a net loss of $3.2 million, or $0.05 per share. Outstanding shares increased to 230.2 million from 69.7 million.
What’s Next? Interim CEO Hubbard continues to work through putting the Stem house in order, in our opinion, with an ultimate goal of focusing on just the California and Oregon businesses. Ultimately, we believe Stem either needs to get bigger, which would require additional capital, or sell to a larger entity. Which way the Company will go is uncertain at this time, but we believe Stem does have …
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Release – Neovasc to Report Fourth Quarter and Full Year 2021 Financial Results on March 10 2022
Neovasc to Report Fourth Quarter and Full Year 2021 Financial Results on March 10, 2022
Research, News, and Market Data on Neovasc
VANCOUVER and MINNEAPOLIS – ( NewMediaWire ) – February 24, 2022 – Neovasc Inc. ( NASDAQ , TSX : NVCN), will report financial results for the quarter and full year ended December 31, 2021 on Thursday, March 10, 2022. Neovasc’s President and Chief Executive Officer Fred Colen, and Chris Clark, Chief Financial Officer, will host a conference call to review the company’s results at 4:30 pm EDT on March 10, 2022.
Interested parties may access the conference call by dialing (877) 407-9208 or (201) 493-6784 (International) and reference Conference ID 13726770. Participants wishing to join the call via webcast should use the link posted on the investor relations section of the Neovasc website at neovasc.com/investors/. A replay of the webcast will be available approximately 30 minutes after the conclusion of the call using the link on the Neovasc website.
About Neovasc Inc.
Neovasc is a specialty medical device company that develops, manufactures, and markets products for the rapidly growing cardiovascular marketplace. Its products include Reducer, for the treatment of refractory angina, which is under clinical investigation in the United States and has been commercially available in Europe since 2015, and Tiara™ for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada, Israel and Europe. For more information, visit: www.neovasc.com.
Contacts
Investors
Mike Cavanaugh
Westwicke/ICR
Phone: +1.617.877.9641
Email: Mike.Cavanaugh@westwicke.com
Media
Sean Leous
Westwicke/ICR
Phone: +1.646.866.4012
Email: Sean.Leous@icrinc.com
Release – PDS Biotech Announces Preliminary Safety Data on PDS0101 in Combination With KEYTRUDA
PDS Biotech Announces Preliminary Safety Data on PDS0101 in Combination With KEYTRUDA® (pembrolizumab) at the 2022 Multidisciplinary Head and Neck Cancers Symposium
Research, News, and Market Data on PDS Biotech
Preliminary safety data has shown that PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) for the treatment of recurrent or metastatic HPV16-positive head and neck cancer is likely safe and well tolerated without evidence of enhanced or significant toxicity
FLORHAM PARK, N.J., Feb. 24, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology, today announced the presentation of preliminary safety data. The data are based on a total of 18 checkpoint inhibitor (CPI) naïve patients from the Company’s ongoing VERSATILE-002 Phase 2 study. The study is being conducted in collaboration with Merck (known as MSD outside the US and Canada) (NCT04260126). The data from the study will be presented at the 2022 Multidisciplinary Head and Neck Cancers Symposium.
The Phase 2 trial studies PDS0101 in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for the treatment of recurrent or metastatic HPV16-positive head and neck cancer. The trial is designed to treat both CPI naïve and refractory patients and will assess the primary efficacy endpoint, as well as partial response per RECIST 1.1. The Company previously announced that it had achieved its preliminary efficacy milestone in the CPI naive arm earlier this month.
Patients in the trial are treated with KEYTRUDA® 200 mg intravenously every three weeks plus PDS0101 delivered subcutaneously with KEYTRUDA® on cycles of 1-4 and again at cycle 12. An initial safety cohort was assessed during cycle 1 and 21 days following for dose-limiting toxicity, and thereafter for safety and tolerability of the combination.
Highlights from the PDS Biotech’s presentation at the 2022 Multidisciplinary Head and Neck Cancers Symposium regarding the preliminary results of the Phase 2 trial studying PDS0101 in combination with KEYTRUDA for the treatment of recurrent or metastatic HPV16-positive head and neck cancer include the absence of dose-limiting toxicities, drug discontinuation related to toxicity, or immune-related adverse events. Subjects received a median of 4 doses of PDS0101 (range 1-5) and a median of 6 doses of KEYTRUDA® (range 1-13). In addition, no treatment-related grade 3 or higher toxicities were reported.
Preliminary safety data has shown that PDS0101 in combination with KEYTRUDA® for the treatment of recurrent or metastatic HPV16-positive head and neck cancer is likely safe and well tolerated without evidence of enhanced or significant toxicity in the first 18 patients evaluated on the study. Accrual in this study has progressed to Stage 2 for the CPI naïve cohort and is ongoing in Stage 1 for the CPI refractory cohort. The full data set can be found under abstract number 157 at the virtual poster library, here.
Receipt of preliminary results are not necessarily indicative of the final-results of the Phase 2 trial studying PDS0101 in combination with KEYTRUDA® for the treatment of recurrent or metastatic HPV16-positive head and neck cancer.
“We are encouraged by the preliminary safety data of PDS0101 in combination with KEYTRUDA® for patients with recurrent or metastatic HPV16-positive head and neck cancer,” commented Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “These data and the preliminary efficacy data continue to support the unique combination of safety and potency of our novel Versamune® platform.”
In addition to the ongoing VERSATILE-002 Phase 2 trial, PDS Biotech is conducting another Phase 2 clinical study in both second-and third-line treatment for multiple advanced HPV-associated cancers with the National Cancer Institute (NCI) (NCT04287868). A third Phase 2 clinical trial, IMMUNOCERV (NCT04580771), in first-line treatment of locally advanced cervical cancer is being performed with The University of Texas, MD Anderson Cancer Center. In addition, the Company recently announced a fourth Phase 2 trial with Mayo Clinic to study PDS0101 with and without KEYTRUDA® prior to surgery in locally advanced HPV-associated oropharyngeal cancer (NCT05232851).
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms.
Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate, and ovarian cancers.
Our Infectimune™-based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses including long-lasting memory T-cell responses. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.
Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® based products; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® based products and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Contact:
Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
pdsb@cg.capital
Ayala Pharmaceuticals (AYLA) – Ayala Completes Phase 2/3 Trial RINGSIDE Part A and Confirms Data Milestone
Thursday, February 24, 2022
Ayala Pharmaceuticals (AYLA)
Ayala Completes Phase 2/3 Trial RINGSIDE Part A and Confirms Data Milestone
Ayala Pharmaceuticals Inc clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations. The company’s current portfolio of product candidates, AL101 and AL102, targets the aberrant activation of the Notch pathway with gamma secretase inhibitors. Its product candidate, AL101, is being developed as a potent, selective, injectable small molecule gamma secretase inhibitor, or GSI. It is also developing AL101 for the treatment of T-ALL, an aggressive, rare form of T-cell specific leukemia.
Robert LeBoyer, Senior Research Analyst, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
First Stage of Phase 2/3 RINGSIDE Trial Completed Enrollment. Ayala has announced that enrollment is complete for Part A of the Phase 2/3 RINGSIDE trial. This trial is testing the oral gamma-secretase inhibitor, AL102, in desmoid tumors. The data from this portion of the trial is expected to be announced in mid-2022, consistent with prior guidance.
Part A Is Designed To Determine Safety, Efficacy, and Dosing For Part B. The first part of the RINGSIDE trial enrolled 36 patients to evaluate safety, tolerability, and changes in tumor volume by MRI scans. These data will be used to select the dose for Part B. A previous sub-study tested pharmacokinetics and found no food restrictions were needed …
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
PDS Biotech Announces Preliminary Safety Data on PDS0101 in Combination With KEYTRUDA® (pembrolizumab) at the 2022 Multidisciplinary Head and Neck Cancers Symposium
PDS Biotech Announces Preliminary Safety Data on PDS0101 in Combination With KEYTRUDA® (pembrolizumab) at the 2022 Multidisciplinary Head and Neck Cancers Symposium
Research, News, and Market Data on PDS Biotech
Preliminary safety data has shown that PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) for the treatment of recurrent or metastatic HPV16-positive head and neck cancer is likely safe and well tolerated without evidence of enhanced or significant toxicity
FLORHAM PARK, N.J., Feb. 24, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology, today announced the presentation of preliminary safety data. The data are based on a total of 18 checkpoint inhibitor (CPI) naïve patients from the Company’s ongoing VERSATILE-002 Phase 2 study. The study is being conducted in collaboration with Merck (known as MSD outside the US and Canada) (NCT04260126). The data from the study will be presented at the 2022 Multidisciplinary Head and Neck Cancers Symposium.
The Phase 2 trial studies PDS0101 in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for the treatment of recurrent or metastatic HPV16-positive head and neck cancer. The trial is designed to treat both CPI naïve and refractory patients and will assess the primary efficacy endpoint, as well as partial response per RECIST 1.1. The Company previously announced that it had achieved its preliminary efficacy milestone in the CPI naive arm earlier this month.
Patients in the trial are treated with KEYTRUDA® 200 mg intravenously every three weeks plus PDS0101 delivered subcutaneously with KEYTRUDA® on cycles of 1-4 and again at cycle 12. An initial safety cohort was assessed during cycle 1 and 21 days following for dose-limiting toxicity, and thereafter for safety and tolerability of the combination.
Highlights from the PDS Biotech’s presentation at the 2022 Multidisciplinary Head and Neck Cancers Symposium regarding the preliminary results of the Phase 2 trial studying PDS0101 in combination with KEYTRUDA for the treatment of recurrent or metastatic HPV16-positive head and neck cancer include the absence of dose-limiting toxicities, drug discontinuation related to toxicity, or immune-related adverse events. Subjects received a median of 4 doses of PDS0101 (range 1-5) and a median of 6 doses of KEYTRUDA® (range 1-13). In addition, no treatment-related grade 3 or higher toxicities were reported.
Preliminary safety data has shown that PDS0101 in combination with KEYTRUDA® for the treatment of recurrent or metastatic HPV16-positive head and neck cancer is likely safe and well tolerated without evidence of enhanced or significant toxicity in the first 18 patients evaluated on the study. Accrual in this study has progressed to Stage 2 for the CPI naïve cohort and is ongoing in Stage 1 for the CPI refractory cohort. The full data set can be found under abstract number 157 at the virtual poster library, here.
Receipt of preliminary results are not necessarily indicative of the final-results of the Phase 2 trial studying PDS0101 in combination with KEYTRUDA® for the treatment of recurrent or metastatic HPV16-positive head and neck cancer.
“We are encouraged by the preliminary safety data of PDS0101 in combination with KEYTRUDA® for patients with recurrent or metastatic HPV16-positive head and neck cancer,” commented Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “These data and the preliminary efficacy data continue to support the unique combination of safety and potency of our novel Versamune® platform.”
In addition to the ongoing VERSATILE-002 Phase 2 trial, PDS Biotech is conducting another Phase 2 clinical study in both second-and third-line treatment for multiple advanced HPV-associated cancers with the National Cancer Institute (NCI) (NCT04287868). A third Phase 2 clinical trial, IMMUNOCERV (NCT04580771), in first-line treatment of locally advanced cervical cancer is being performed with The University of Texas, MD Anderson Cancer Center. In addition, the Company recently announced a fourth Phase 2 trial with Mayo Clinic to study PDS0101 with and without KEYTRUDA® prior to surgery in locally advanced HPV-associated oropharyngeal cancer (NCT05232851).
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms.
Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate, and ovarian cancers.
Our Infectimune™-based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses including long-lasting memory T-cell responses. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.
Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® based products; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® based products and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Contact:
Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
pdsb@cg.capital
Neovasc to Report Fourth Quarter and Full Year 2021 Financial Results on March 10, 2022
Neovasc to Report Fourth Quarter and Full Year 2021 Financial Results on March 10, 2022
Research, News, and Market Data on Neovasc
VANCOUVER and MINNEAPOLIS – ( NewMediaWire ) – February 24, 2022 – Neovasc Inc. ( NASDAQ , TSX : NVCN), will report financial results for the quarter and full year ended December 31, 2021 on Thursday, March 10, 2022. Neovasc’s President and Chief Executive Officer Fred Colen, and Chris Clark, Chief Financial Officer, will host a conference call to review the company’s results at 4:30 pm EDT on March 10, 2022.
Interested parties may access the conference call by dialing (877) 407-9208 or (201) 493-6784 (International) and reference Conference ID 13726770. Participants wishing to join the call via webcast should use the link posted on the investor relations section of the Neovasc website at neovasc.com/investors/. A replay of the webcast will be available approximately 30 minutes after the conclusion of the call using the link on the Neovasc website.
About Neovasc Inc.
Neovasc is a specialty medical device company that develops, manufactures, and markets products for the rapidly growing cardiovascular marketplace. Its products include Reducer, for the treatment of refractory angina, which is under clinical investigation in the United States and has been commercially available in Europe since 2015, and Tiara™ for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada, Israel and Europe. For more information, visit: www.neovasc.com.
Contacts
Investors
Mike Cavanaugh
Westwicke/ICR
Phone: +1.617.877.9641
Email: Mike.Cavanaugh@westwicke.com
Media
Sean Leous
Westwicke/ICR
Phone: +1.646.866.4012
Email: Sean.Leous@icrinc.com
Avivagen Inc. (VIVXF)(VIV:CA) – Receives Approval for OxC-beta in Vietnam
Wednesday, February 23, 2022
Avivagen Inc. (VIVXF)(VIV:CA)
Receives Approval for OxC-beta in Vietnam
Avivagen Inc is a Canadian based company operating in the healthcare sector. It develops science-based, natural health products for animals. It develops and commercializes products for livestock feeds to replace antibiotics for growth promotion and to help prevent disease by supporting the animal’s own health defenses. Its product range includes OxC-beta, Vivamune health chews, Oximunol chewable tablets, and Carotenoid Oxidation products.
Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Vietnam Approval. Yesterday, Avivagen announced a major milestone with the approval for use of OxC-beta in Vietnam. Vietnam represents the largest feed market in Southeast Asia, according to a report by the US Grains Council, which indicates total annual feed consumption of over 32 MMT in 2020. Additionally, the Grains Council report states that Vietnam is a strong growth market which is expected to surpass 35 MMT of feed within the next few years.
Research Trials. The use of Avivagen’s product in the Vietnam feed industry is supported by the positive results of two research trials conducted specifically under Vietnamese commercial production conditions. The trials were run in collaboration with the Institute for Animal Sciences for South Vietnam and were conducted with pigs. Notably, the African Swine Flu is transforming the Vietnam swine …
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.