Author: cpatches

Release – PDS Biotech Announces Exclusive Global License Agreement for Investigational IL-12 Tumor-Targeted Cytokine from Merck KGaA, Darmstadt, Germany

Posted on by cpatches

Research News and Market Data on PDSB

PDS Biotech bolsters immuno-oncology portfolio with a clinical-stage product synergistic with its Versamune® platform

PDS Biotech to host conference call and webcast on Tuesday, January 3, 2023, at 8:00 AM EST

FLORHAM PARK, N.J., Jan. 03, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced an exclusive global license agreement with Merck KGaA, Darmstadt, Germany for the tumor-targeting IL-12 fusion protein M9241 (formerly known as NHS-IL12), which will join the pipeline as PDS0301. M9241 appears to enhance the proliferation, potency and longevity of T cells in the tumor. The combination of Versamune® and IL-12 is patented by PDS Biotech and is designed to overcome tumor immune suppression utilizing a different mechanism from checkpoint inhibitors.

Under the terms of the agreement, PDS Biotech will receive from Merck KGaA, Darmstadt, Germany an exclusive license to M9241. PDS Biotech will assume responsibility for future development, commercialization, and manufacturing of M9241.

Under the terms of the agreement, Merck KGaA, Darmstadt, Germany will receive an upfront cash payment of $5 million and will be entitled to up to $11 million in development and regulatory milestone payments including first commercial sales for the first 2 indications, and up to $105 million in commercial milestones, and a 10% royalty on future sales of M9241 with standard step-down provisions. Merck KGaA will receive 378,787 shares of PDS Biotech’s common stock having a value of $5 million, based on the closing price of PDS Biotech’s common stock on December 30, 2022.

“We are pleased to have partnered with Merck KGaA, Darmstadt, Germany to advance the development of M9241, a highly innovative cytokine therapy,” said Dr. Frank Bedu-Addo, PDS Biotech CEO. “Under the licensing arrangement between Merck KGaA, Darmstadt, Germany and PDS Biotech, assumption of an equity stake by Merck KGaA, Darmstadt, Germany in PDS Biotech further confirms the potential of the Versamune® platform and the data generated to date with this combination therapy. I’d like to thank the Merck KGaA, Darmstadt, Germany team for their support of PDS Biotech’s mission to potentially offer more cancer patients improved treatment options.”

M9241 was studied in a novel triple combination at the National Cancer Institute in a Phase 2 trial (NCT04287868) in combination with PDS0101, a Versamune® based HPV16-targeted immunotherapy, and bintrafusp alfa, a bifunctional fusion protein targeting two independent immunosuppressive pathways (PD-L1 and TGF-β). The triple combination was studied in checkpoint inhibitor (CPI)-naïve and -refractory patients with advanced HPV-positive anal, cervical, head and neck, vaginal, and vulvar cancers who have failed prior therapy.

Data highlights for patients who had failed prior treatments including CPIs:

  • Median overall survival for treated patients is 21 months in 29 CPI refractory patients. The reported historical median OS in patients with CPI refractory disease is 3-4 months.
  • 63% (5/8) of treated patients with the optimal dose combination had significant tumor shrinkage of over 30% (objective response). With the standard of care, the reported percentage of patients having an objective response is less than 10%.
  • 79% (11/14) of treated patients demonstrated a greater than two-fold increase in HPV16-targeted T cells.

Results for patients who had failed prior treatments but were CPI-naïve also continue to appear to be encouraging:

  • 88% (7/8) of CPI naïve patients had an objective response.
  • 38% (3/8) of responders had a complete response.
  • In CPI naïve subjects, 75% (6/8) remain alive at a median follow-up of 27 months. As a result, median OS has not yet been reached. Historically median OS for similar patients with platinum experienced CPI naïve disease is 7-11 months.

PDS Biotech has a scheduled meeting with the Food and Drug Administration (FDA) to discuss a registrational trial for investigating the triple combination of M9241, PDS0101 and a checkpoint inhibitor in recurrent/metastatic HPV-positive cancers.

Dr. Lauren V. Wood, Chief Medical Officer at PDS Biotech, commented, “M9241 seems to be unique in its ability to target the tumor’s microenvironment and appears to further promote proliferation of Versamune®-induced T cells in the tumors while also potentially enhancing the killing potency of the T cells. With the addition of M9241 to our Versamune®-based pipeline products, our goal is to develop and achieve checkpoint inhibitor-agnostic and independent combinations in advanced cancers. We look forward to expanding clinical development of our novel investigational combination products.”

Conference Call and Webcast
PDS Biotech will host a conference call and webcast on Tuesday, January 3, 2023, beginning at 8:00 AM EST. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and reference conference ID 13734890. To access the webcast, please use the following link. The event will be archived in the investor relations section of PDS Biotech’s website for six months. 

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune® and Infectimune™ T cell-activating technology platforms. We believe our targeted Versamune® based candidates have the potential to overcome the limitations of current immunotherapy by inducing large quantities of high-quality, potent polyfunctional tumor specific CD4+ helper and CD8+ killer T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the potential to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV-expressing cancers in multiple Phase 2 clinical trials. Our Infectimune™ based vaccines have also 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 in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About PDS0301
PDS0301 is a tumor-targeting IL-12 that enhances the proliferation, potency and longevity of T cells in the tumor. Together with Versamune® based immunotherapies, PDS0301 works to promote a targeted T cell attack against cancers and also overcome tumor-induced immune suppression. Clinical data suggest this combination may demonstrate significant disease control by shrinking tumors and/or prolonging survival in recurrent/metastatic cancers with poor survival prognosis. A National Cancer Institute-supported Phase 2 clinical study of PDS0301 in a triple combination therapy is being conducted in checkpoint inhibitor refractory patients with multiple advanced HPV-associated cancers.

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® and Infectimune™ based product candidates; 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® and Infectimune™ based product candidates 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 the Company’s ability to fully fund its 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 or preliminary 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 success of the Company’s license agreements, including the potential for the clinical and nonclinical data available under the Company’s exclusive license agreement with Merck KGaA to aid in the development of the Versamune® platform; 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.

Versamune® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology.

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital

Media Contacts:
Bill Borden
Tiberend Strategic Advisors, Inc.
Phone: +1 (732) 910-1620
Email: bborden@tiberend.com

Dave Schemelia
Tiberend Strategic Advisors, Inc.
Phone: +1 (609) 468-9325
Email: dschemelia@tiberend.com

Release – Tonix Pharmaceuticals to Present at Biotech Showcase 2023

Posted on by cpatches

Research News and Market Data on TNXP

CHATHAM, N.J., Jan. 03, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced today that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, will present at Biotech Showcase 2023 being held January 9-11, 2023, at the Hilton San Francisco Union Square.

Details of the Tonix presentation are as follows:

Event:Biotech Showcase 2023
Date:Tuesday, January 10, 2023
Time:3:00 p.m. PT (6:00 p.m. ET)
Location:Hilton San Francisco Union Square
Track:Yosemite C (Ballroom Level)

A live webcast and subsequent archived recording of the Company presentation will be available under the IR Events tab of the Investors section of the Tonix Pharmaceuticals website at www.tonixpharma.com or can be found here. Investors interested in arranging a meeting with the Company’s management during the conference should contact Brandon.Weiner@Westwicke.com.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022 and expects interim data in the third quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the first quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily formulation of tianeptine being developed as a potential treatment for major depressive disorder (MDD) with a Phase 2 study expected to be initiated in the first quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the first half of 2023. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, TNX-801, a next-generation vaccine to prevent COVID-19, TNX-1850, a platform to make fully human monoclonal antibodies to treat COVID-19, TNX-3600, and humanized anti-SARS-CoV-2 monoclonal antibodies, TNX-3800, recently licensed from Curia. TNX-801, Tonix’s vaccine in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in Kenya in the second half of 2023.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com 
(862) 904-8182

Olipriya Das, Ph.D. (media)
Russo Partners
Olipriya.Das@russopartnersllc.com 
(646) 942-5588

Peter Vozzo (investors)
ICR Westwicke
peter.vozzo@westwicke.com 
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Released January 3, 2023

Metals & Mining Fourth Quarter 2022 Review and Outlook

Posted on by cpatches

Monday, January 03, 2023

Mark Reichman, Senior Research Analyst, Natural Resources, Noble Capital Markets, Inc.

Refer to the bottom of the report for important disclosures

Mining companies outperform the broader market. During the fourth quarter, mining companies (as measured by the XME) appreciated 17.2% compared to a gain of 7.1% for the S&P 500 index. The VanEck Vectors Gold Miners (GDX) and Junior Gold Miners (GDXJ) ETFs were up 18.8% and 21.0%, respectively. Gold, silver, copper, and lead futures prices gained 9.2%, 26.3%, 12.3%, and 6.1%, respectively, while zinc declined 1.1%. For the full year 2022, all indices outperformed the S&P 500 which declined 19.4%. Despite aggressive rate hikes by the Federal Reserve and U.S. dollar strength, gold performed as a store of value with the price ending just under where it began the year.

Will precious metals break out to the upside? The U.S. Dollar Index declined 7.7% during the fourth quarter, while the yield on the 10-year treasury note increased from 3.80% to 3.88%. While the Federal Reserve has signaled higher rates, an inflection point may have been reached as investors sought to preserve value amid deteriorating economic conditions, geopolitical uncertainty and market volatility. In our view, interest rates could peak by mid-year with the potential for easing depending on economic conditions. We think precious metals prices around current levels are sufficient for mining companies to be profitable and attract new investment. Our outlook is for range-bound pricing around current levels with a modest upward bias in the first half of 2023.

Less certain near-term outlook for industrial metals. While the price of copper declined 13.2% in 2022, the price rebounded in the fourth quarter. On a full year basis, zinc and lead prices were down 6.1% and up 1.2%, respectively. While the long-term investment case for owning industrial metals mining companies remains favorable, it may be too early to offer a bullish call due to near-term concerns about economic growth in the U.S. and abroad.

Putting it all together. In our view, precious metals mining companies, notably exploration companies, continue to offer attractive return potential. Should gold and silver prices hold recent gains, investors may begin to invest more confidently and aggressively. While the near-term outlook for industrial metals could be negatively impacted by near-term macroeconomic factors, an eventual return to economic growth could result in strong prices due to potential supply and demand imbalances.

GENERAL DISCLAIMERS

All statements or opinions contained herein that include the words “we”, “us”, or “our” are solely the responsibility of Noble Capital Markets, Inc.(“Noble”) and do not necessarily reflect statements or opinions expressed by any person or party affiliated with the company mentioned in this report. Any opinions expressed herein are subject to change without notice. All information provided herein is based on public and non-public information believed to be accurate and reliable, but is not necessarily complete and cannot be guaranteed. No judgment is hereby expressed or should be implied as to the suitability of any security described herein for any specific investor or any specific investment portfolio. The decision to undertake any investment regarding the security mentioned herein should be made by each reader of this publication based on its own appraisal of the implications and risks of such decision.

This publication is intended for information purposes only and shall not constitute an offer to buy/sell or the solicitation of an offer to buy/sell any security mentioned in this report, nor shall there be any sale of the security herein in any state or domicile in which said offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or domicile. This publication and all information, comments, statements or opinions contained or expressed herein are applicable only as of the date of this publication and subject to change without prior notice. Past performance is not indicative of future results. Noble accepts no liability for loss arising from the use of the material in this report, except that this exclusion of liability does not apply to the extent that such liability arises under specific statutes or regulations applicable to Noble. This report is not to be relied upon as a substitute for the exercising of independent judgement. Noble may have published, and may in the future publish, other research reports that are inconsistent with, and reach different conclusions from, the information provided in this report. Noble is under no obligation to bring to the attention of any recipient of this report, any past or future reports. Investors should only consider this report as single factor in making an investment decision.

IMPORTANT DISCLOSURES

This publication is confidential for the information of the addressee only and may not be reproduced in whole or in part, copies circulated, or discussed to another party, without the written consent of Noble Capital Markets, Inc. (“Noble”). Noble seeks to update its research as appropriate, but may be unable to do so based upon various regulatory constraints. Research reports are not published at regular intervals; publication times and dates are based upon the analyst’s judgement. Noble professionals including traders, salespeople and investment bankers may provide written or oral market commentary, or discuss trading strategies to Noble clients and the Noble proprietary trading desk that reflect opinions that are contrary to the opinions expressed in this research report.
The majority of companies that Noble follows are emerging growth companies. Securities in these companies involve a higher degree of risk and more volatility than the securities of more established companies. The securities discussed in Noble research reports may not be suitable for some investors and as such, investors must take extra care and make their own determination of the appropriateness of an investment based upon risk tolerance, investment objectives and financial status.

Company Specific Disclosures

The following disclosures relate to relationships between Noble and the company (the “Company”) covered by the Noble Research Division and referred to in this research report.
Noble is not a market maker in any of the companies mentioned in this report. Noble intends to seek compensation for investment banking services and non-investment banking services (securities and non-securities related) with any or all of the companies mentioned in this report within the next 3 months

ANALYST CREDENTIALS, PROFESSIONAL DESIGNATIONS, AND EXPERIENCE

Senior Equity Analyst focusing on Basic Materials & Mining. 20 years of experience in equity research. BA in Business Administration from Westminster College. MBA with a Finance concentration from the University of Missouri. MA in International Affairs from Washington University in St. Louis.
Named WSJ ‘Best on the Street’ Analyst and Forbes/StarMine’s “Best Brokerage Analyst.”
FINRA licenses 7, 24, 63, 87

WARNING

This report is intended to provide general securities advice, and does not purport to make any recommendation that any securities transaction is appropriate for any recipient particular investment objectives, financial situation or particular needs. Prior to making any investment decision, recipients should assess, or seek advice from their advisors, on whether any relevant part of this report is appropriate to their individual circumstances. If a recipient was referred to Noble Capital Markets, Inc. by an investment advisor, that advisor may receive a benefit in respect of
transactions effected on the recipients behalf, details of which will be available on request in regard to a transaction that involves a personalized securities recommendation. Additional risks associated with the security mentioned in this report that might impede achievement of the target can be found in its initial report issued by Noble Capital Markets, Inc.. This report may not be reproduced, distributed or published for any purpose unless authorized by Noble Capital Markets, Inc..

RESEARCH ANALYST CERTIFICATION

Independence Of View
All views expressed in this report accurately reflect my personal views about the subject securities or issuers.

Receipt of Compensation
No part of my compensation was, is, or will be directly or indirectly related to any specific recommendations or views expressed in the public
appearance and/or research report.

Ownership and Material Conflicts of Interest
Neither I nor anybody in my household has a financial interest in the securities of the subject company or any other company mentioned in this report.

ChitogenX Inc. (CHNXF) – FQ3 2023 Reported; Advancing The Opportunities

Posted on by cpatches


Friday, December 30, 2022

Gregory Aurand, Senior Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.

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

FQ3 2023 reported for the period ending October 31, 2022.  As expected, no revenues were reported by the Company yesterday.  Overall, expenses were higher than expectations, with lower than expected G&A and R&D expenses reported. Fair value adjustments in embedded derivatives, higher share based compensation and financing costs accounted for the difference in reported loss per share of $0.04 vs. our expected $0.03 loss per share. Our full fiscal year 2023 loss per share moves to $0.11 from prior $0.10.

ORTHO-R Phase I trial for rotator cuff completed. The initial portion was completed in early November.  There were no safety issues reported, opening up Phase II enrollment at all 10 clinical sites.  Phase II enrollment is now expected to be completed by end of calendar second quarter 2023, although this is a slight slippage from our earlier expectations.  Patient assessment and scoring will occur after 12-month follow-up.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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 Biotechnology Corp (PDSB) – Triple Therapy Data Shows Large Improvements Over Standard of Care

Posted on by cpatches


Thursday, December 29, 2022

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted 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.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

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

New Data From The Phase 2 Triple Therapy Trial Shows Better Response And Survival Data. PDS Bio announced new data from its Phase 2 trial testing PDS0101 in combination with two immunomodulating drugs. Patients with HPV16-positive cancer received the “Triple Therapy” consisting of PDS0101, an IL-12 fusion protein, and a bivalent checkpoint inhibitor. One of two arms in the trial reached its median objective survival (OS) of 21 months, an improvement over the last interim update and the historical survival of 3 to 4 months.

New Overall Survival Data Shows Improvement Over Last Interim Update. Patients enrolled in the trial had HPV16-positive cancer with progressive disease after standard therapies. Patients who received previous checkpoint inhibitor therapy  but no longer responded (checkpoint inhibitor refractory) reached a medial Overall Survival (OS) of 21 months. This compares to the last interim update of 16 months OS with 66% remaining alive. Expected survival for patients at this stage is 3 to 4 months. In the group that was naïve to checkpoint inhibitors, 75% remained alive at a median follow-up of 27 months, so the median OS has not been reached. Expected survival for similar patients is 7 to 11 months.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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 – PDS Biotech Reports Median Overall Survival (OS) of 21 Months in Advanced, Refractory Cancer Patients Having Few Remaining Treatment Options and with Reported Historical Survival of 3-4 months

Posted on by cpatches

Research News and Market Data on PDSB

Median OS of 21 months in 29 checkpoint inhibitor (CPI) refractory HPV16-positive cancer patients in National Cancer Institute-led Phase 2 clinical trial of PDS0101 triple combination

FLORHAM PARK, N.J., Dec. 28, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced expanded interim data in a Phase 2 clinical trial investigating the PDS0101-based triple combination therapy in advanced human papillomavirus (HPV)-positive cancers. The triple combination of PDS0101 with the tumor-targeting IL-12 fusion protein M9241 (formerly known as NHS-IL12), and bintrafusp alfa, a bifunctional fusion protein targeting two independent immunosuppressive pathways (PD-L1 and TGF-β), is being studied in CPI-naïve and CPI-refractory patients with advanced HPV-positive anal, cervical, head and neck, vaginal, and vulvar cancers.

The triple combination Phase 2 trial (NCT04287868) is being conducted at the Center for Cancer Research (CCR) at the National Cancer Institute (NCI), one of the Institutes of the National Institutes of Health.

All patients in the study had failed prior treatment with chemotherapy and 90% had failed radiation treatment. The interim efficacy data (n=50) involves 37 HPV16-positive evaluable patients, including 29 patients who have, in addition, failed treatment with CPIs (CPI refractory). Highlights of the expanded interim data are as follows and are consistent with the results presented at American Society of Clinical Oncology (ASCO) Annual Meeting 2022 and prior interim data announced in October:

  • Median OS is 21 months in 29 checkpoint inhibitor refractory patients who received the triple combination. The reported historical median OS in patients with CPI refractory disease is 3-4 months.
  • In CPI naïve subjects, 75% remain alive at a median follow-up of 27 months. As a result, median OS has not yet been reached. Historically median OS for similar patients with platinum experienced CPI naïve disease is 7-11 months.
  • Objective response rate (ORR) in CPI refractory patients who received the optimal dose of the triple combination is 63% (5/8). In current approaches ORR is reported to be less than 10%.
  • ORR in CPI naïve patients with the triple combination is 88%. In current approaches ORR is reported to be less than 25% with FDA-approved CPIs in HPV-associated cancers.
  • Safety data have not changed since October’s update. 48% (24/50) of patients experienced Grade 3 (moderate) treatment-related adverse events (AEs), and 4% (2/50) of patients experienced Grade 4 (severe) AEs, compared with approximately 70% of patients receiving the combination of CPIs and chemotherapy reporting Grade 3 and higher treatment-related AEs.

“The expanded data continue to demonstrate the durability and tolerability of the PDS0101-based triple combination therapy in advanced HPV-positive cancers, an extremely challenging population of refractory and previously untreatable HPV-positive patients,” stated Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech. “We are pleased to see the continued consistency in the data with each update and we look forward to meeting with the FDA to discuss the registrational pathway.”

Both M9241 and bintrafusp alfa are owned by Merck KGaA, Darmstadt, Germany, and its affiliates.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune® and Infectimune™ T cell-activating technology platforms. We believe our targeted Versamune® based candidates have the potential to overcome the limitations of current immunotherapy by inducing large quantities of high-quality, potent polyfunctional tumor specific CD4+ helper and CD8+ killer T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the potential to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV-positive cancers in multiple Phase 2 clinical trials. Our Infectimune™ based vaccines have also 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 in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About PDS0101

PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-positive cancers. In partnership with Merck & Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA® in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer, and also in second line treatment of recurrent or metastatic head and neck cancer in patients who have failed prior checkpoint inhibitor therapy. A Phase 2 clinical study is also being conducted in both second- and third-line treatment of multiple advanced HPV-positive cancers in partnership with the National Cancer Institute (NCI). A third phase 2 clinical trial in first line treatment of locally advanced cervical cancer is being performed with The University of Texas, MD Anderson Cancer Center.

KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

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® and Infectimune™ based product candidates; 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® and Infectimune™ based product candidates 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 the Company’s ability to fully fund its 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 or preliminary 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; 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.

Versamune® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology.

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
pdsb@cg.capital

Media
Tiberend Strategic Advisors, Inc.
Dave Schemelia
Phone: +1 (609) 468-9325
dschemelia@tiberend.com

Bill Borden
Phone: +1 (732) 910-1620
bborden@tiberend.com 

Maple Gold Mines (MGMLF) – Looking Ahead to a Catalyst-Rich 2023

Posted on by cpatches


Wednesday, December 28, 2022

Mark Reichman, Senior Research Analyst, Natural Resources, Noble Capital Markets, Inc.

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

A top pick for 2023. During our recent Wall Street Wish List virtual conference, we highlighted our top picks for 2023. Maple Gold Mines Ltd. earned its place based on several competitive advantages, including a large 400 square kilometer land package in a prime location within the highly ranked mining jurisdiction of Quebec, a growing gold resource with significant expansion potential, an experienced management team and industry-leading joint venture partner, and a strong balance sheet.

World class potential. We believe Maple Gold represents an emerging world class gold project in Quebec’s renowned Abitibi Gold Belt. The company is well capitalized and is focused on establishing a new gold district through resource expansion and new discoveries. Both the Douay and Joutel projects have multiple styles of mineralization, including deep controlling structures, which are favorable for exploration and discovery of mineralized systems. Mines in the Abitibi are known for vertical continuity with higher grades at depth. Consequently, there is significant potential to increase the average resource grade with higher grade discoveries at depth.


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

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

Great Lakes Dredge & Dock (GLDD) – Another Difficult Quarter

Posted on by cpatches


Wednesday, December 28, 2022

Great Lakes Dredge & Dock Corporation is the largest provider of dredging services in the United States. In addition, Great Lakes is fully engaged in expanding its core business into the rapidly developing offshore wind energy industry. The Company has a long history of performing significant international projects. The Company employs experienced civil, ocean and mechanical engineering staff in its estimating, production and project management functions. In its over 131-year history, the Company has never failed to complete a marine project. Great Lakes owns and operates the largest and most diverse fleet in the U.S. dredging industry, comprised of approximately 200 specialized vessels. Great Lakes has a disciplined training program for engineers that ensures experienced-based performance as they advance through Company operations. The Company’s Incident-and Injury-Free® (IIF®) safety management program is integrated into all aspects of the Company’s culture. The Company’s commitment to the IIF® culture promotes a work environment where employee safety is paramount.

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.

Lowered Expectations. Last week, Great Lakes provided an update for 4Q22, with revenue and gross margins expected to be below previous forecasts. Recall, management had previously expected revenue of $175-$185 million and gross profit margin (gpm) in the “high single digits” for 4Q22. We had estimated revenue of $175 million and a gpm of 6.9%.

Impacts. The quarter is being impacted by a number of items, including the early retirement of the Terrapin Island, unexpected drydocking scope increases for the Ellis Island and Padre Island, weather delays on several projects in the northeast, and some project production issues.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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. 

Alliance Resource Partners (ARLP) – A Ballast for Portfolios in an Uncertain Market Environment

Posted on by cpatches


Wednesday, December 28, 2022

ARLP is a diversified natural resource company that generates operating and royalty income from coal produced by its mining complexes and royalty income from mineral interests it owns in strategic oil & gas producing regions in the United States, primarily the Permian, Anadarko and Williston basins. ARLP currently produces coal from seven mining complexes its subsidiaries operate in Illinois, Indiana, Kentucky, Maryland and West Virginia. ARLP also operates a coal loading terminal on the Ohio River at Mount Vernon, Indiana. ARLP markets its coal production to major domestic and international utilities and industrial users and is currently the second largest coal producer in the eastern United States. In addition, ARLP is positioning itself as an energy provider for the future by leveraging its core technology and operating competencies to make strategic investments in the fast growing energy and infrastructure transition.

Mark Reichman, Senior Research Analyst, Natural Resources, Noble Capital Markets, Inc.

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

A top pick for 2023. During our recent Wall Street Wish List virtual conference, we highlighted our top picks for 2023. Alliance Resource Partners earned its place based on a superb management team, favorable fundamental outlook, and positive cash flow growth outlook. While fossil fuels are out of favor in some quarters, they power our economy. In our view, the geopolitical weaponizing of global energy supplies, along with the recent cold snap across the U.S. underscore the importance of reliable and affordable domestic supplies of coal, oil, and natural gas. Demand for fossils fuels will likely increase, with renewable energy increasing its share of the market share over time.

Earnings visibility is very strong. During the third quarter, Alliance executed new coal sales commitments for delivery of 5.6 million tons through 2025 at prices supporting higher margins. Based on contracted coal sales volumes in 2023 and 2024, the outlook for cash flow growth appears favorable. Alliance recently added a fifth continuous mining unit at its Gibson South mine and is adding another unit at the Hamilton mine. Within the oil and gas royalty segment, volumes are expected to benefit from two recent acquisitions that added 1,200 producing wells, 101 wells to be completed and 98 permitted locations on the acquired acreage.


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*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. 

Tonix Pharmaceuticals (TNXP) – New Antibodies For Treatment and Prevention of COVID-19 Inlicensed

Posted on by cpatches


Tuesday, December 13, 2022

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-15001 which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL6, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022. Finally, TNX-13007 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

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

New Antibodies For COVID-19. Tonix has in-licensed new monoclonal antibodies for treatment or prophylaxis of SARS-CoV-2, the virus that causes COVID-19. The agreement with Curia Global includes three humanized murine monoclonal antibodies that will be developed as second-generation therapy for high-risk patients, including immunocompromised and organ transplant patients.  

Antibodies May Have Broader Efficacy Against Variants. The licensed technology is based on humanized murine antibodies rather than antibodies derived from the blood of COVID-19 patients or (genetically engineered) humanized mice. This may result in a broader immune response that neutralizes more variants and is more difficult for the virus to evade. Only one antibody product with Emergency Use Authorization (EUA) is currently recommended for COVID-19 prophylaxis.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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 – Alvopetro Announces a 50% Increase to our Quarterly Dividend, an Intention to Launch a Share Buyback Program, and Record Q3 2022 Results

Posted on by cpatches

Research, News and Market Data on ALVOF

CALGARY, AB, Nov. 15, 2022 /CNW/ – Alvopetro Energy Ltd. (TSXV:ALV); (OTCQX: ALVOF) is pleased to announce a 50% increase in our quarterly dividend, to US$0.12 per common share, an intention to launch a share buyback program under a normal course issuer bid (“NCIB”) and operating and financial results for the third quarter of 2022 including another record quarter of funds flow from operations of $13.3 million. We will host a live webcast to discuss Q3 2022 results on Wednesday November 16, 2022, beginning at 9:00 am Mountain time.

President & CEO, Corey C. Ruttan commented:

“With continued strong operating and financial results, and with our debt now fully repaid, we are pleased to announce a 50% increase in our quarterly dividend following on the 33% increase earlier this year. Our dividend program and the proposed NCIB will provide us with maximum flexibility to meet our strategy to maintain a balanced organic growth and stakeholder return model.”

All references herein to $ refer to United States dollars, unless otherwise stated and all tabular amounts are in thousands of United States dollars, except as otherwise noted.

Quarterly Dividend Increased 50% to $0.12 per Share

Alvopetro is pleased to announce that our Board of Directors has approved a 50% increase in our quarterly dividend, to $0.12 per common share, payable in cash on January 13, 2023, to shareholders of record at the close of business on December 30, 2022. This dividend is designated as an “eligible dividend” for Canadian income tax purposes. 

Dividend payments to non-residents of Canada will be subject to withholding taxes at the Canadian statutory rate of 25%.  Shareholders may be entitled to a reduced withholding tax rate under a tax treaty between their country of residence and Canada.  For further information, see Alvopetro’s website at  https://alvopetro.com/Dividends-Non-resident-Shareholders.

Normal Course Issuer Bid

In connection with our long-standing balanced and disciplined stakeholder return and organic growth model, our Board has provided approval to submit an application to launch a share buyback program under a NCIB, subject to securities law and customary approvals. Once approved, the NCIB, combined with our quarterly dividends, will provide us with flexibility in managing our returns to stakeholders.

Financial and Operating Highlights – Third Quarter of 2022

  • Daily sales averaged 2,642 boepd in Q3 2022, a 7% increase from the Q3 2021 average of 2,459 boepd and a 12% increase from the Q2 2022 average of 2,359 boepd. The expansion of our gas processing facility was completed at the end of July and available processing capacity has now increased to 500,000 m3/d (18 MMcfpd) contributing to higher volumes in the quarter.
  • As of August 1, 2022, Alvopetro’s natural gas price has been reset to the new ceiling price of $10.22/MMBtu. Due to the appreciation of the BRL in the first half of 2022 compared to second half of 2021, the BRL contracted price remained consistent at BRL1.94/m3. With all natural gas sales in Q3 2022 at the ceiling price, our average realized natural gas price increased to $11.18/Mcf compared to the Q3 2021 average price of $7.07/Mcf. Higher commodity prices and higher daily sales volumes resulted in a 67% increase in our natural gas, condensate and oil revenue compared to Q3 2021.
  • Our operating netback was $59.83 per boe in Q3 2022, an improvement of $23.45 per boe from Q3 2021 (+64%). Despite consistent BRL denominated natural gas pricing, our operating netback decreased $4.13 per boe from Q2 2022 (-6%) due to the devaluation of the BRL relative to the USD and lower Brent pricing on condensate.
  • We generated cash flows from operating activities of $13.8 million ($0.40 per basic share and $0.37 per diluted share) and funds flows from operations of $13.3 million ($0.39 per basic share and $0.36 per diluted share), increases of $6.6 million and $5.4 million, respectively compared to Q3 2021.
  • We reported net income of $8.8 million in Q3 2022 compared to a loss of $0.02 million in Q3 2021.
  • Capital expenditures totaled $8.7 million, and included drilling costs for our 183-B1, 182-C2 and Unit-C wells, testing costs on our 182-C1 well, long lead purchases and development costs on our Murucututu project.
  • All outstanding warrants were exercised in the quarter, with 1,342,978 warrants exercised by way of cashless exercise and 1,342,978 warrants exercised at a strike price of $1.80 per share. Alvopetro received cash proceeds of $2.4 million and issued a total of 2,081,616 common shares on the exercise.
  • We repaid the final $2.5 million outstanding on the credit facility and the facility has now been cancelled. As at September 30, 2022, we had a net working capital surplus of $12.2 million, including $17.4 million in cash and cash equivalents.
  • Our October 2022 sales volumes averaged 2,720 boepd based on field estimates, with natural gas sales of 15.6MMcfpd and natural gas liquids from condensate of 124 bopd.

The following table provides a summary of Alvopetro’s financial and operating results for three and nine months ended September 30, 2022 and September 30, 2021. The consolidated financial statements with the Management’s Discussion and Analysis (“MD&A) are available on our website at www.alvopetro.com and will be available on the System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com.


Notes:
The 2021 comparative periods in the table above have been restated. See “Restatement of the 2021 Comparative Period” section within the MD&A and Note 14 of the unaudited interim condensed consolidated financial statements for the three and nine months ended September 30, 2022 for further details.
Per share amounts are based on weighted average shares outstanding other than dividends per share, which is based on the number of common shares outstanding at each dividend record date. The weighted average number of diluted common shares outstanding in the computation of funds flow from operations and cash flows from operating activities per share is the same as for net income per share.
 See “Non-GAAP and Other Financial Measures” section within this news release.

Third Quarter 2022 Results Webcast

Alvopetro will host a live webcast to discuss Q3 2022 financial results at 9:00 am Mountain time on November 16, 2022. Details for joining the event are as follows:

Date: November 16, 2022
Time: 9:00 a.m. Mountain/11:00  a.m. Eastern
Link: https://us06web.zoom.us/j/83084021752
Dial-in Numbers: https://us06web.zoom.us/u/kgefFrJiJ
Webinar ID: 830 8402 1752

The webcast will include a question-and-answer period. Online participants will be able to ask questions through the Zoom portal. Dial-in participants can email questions directly to socialmedia@alvopetro.com.

Long-term Incentive Compensation Grants

In connection with our long-term incentive compensation program, Alvopetro’s Board of Directors (the “Board”) has approved the annual rolling grants to officers, directors and certain employees under Alvopetro’s Omnibus Incentive Plan. A total of 536,000 stock options, 122,000 restricted share units (“RSUs”) and 40,000 deferred share units (“DSUs”) were approved by the Board and are expected to be granted on November 24, 2022. Of the total grants, 248,000 stock options, 101,000 RSUs and 40,000 DSUs were granted to directors and officers. Each stock option, RSU and DSU entitles the holder to purchase one common share. Each stock option granted will have an exercise price based on the volume weighted average trading price of Alvopetro’s shares on the TSX Venture Exchange for the five (5) consecutive trading days up to and including November 24, 2022. All stock options, RSUs and DSUs granted expire five (5) years from the date of the grant.

Corporate Presentation

Alvopetro’s updated corporate presentation is available on our website at:
http://www.alvopetro.com/corporate-presentation. 

Social Media

Follow Alvopetro on our social media channels at the following links:

Twitter – https://twitter.com/AlvopetroEnergy
Instagram – https://www.instagram.com/alvopetro/ 
LinkedIn – https://www.linkedin.com/company/alvopetro-energy-ltd

Alvopetro Energy Ltd.’s vision is to become a leading independent upstream and midstream operator in Brazil. Our strategy is to unlock the on-shore natural gas potential in the state of Bahia in Brazil, building off the development of our Caburé natural gas field and our strategic midstream infrastructure.

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 news release.

Abbreviations:

bbls=barrels
boepd=barrels of oil equivalent (“boe”) per day
bopd=barrels of oil and/or natural gas liquids (condensate) per day
BRL=Brazilian Real
m3=cubic metre
Mcf=thousand cubic feet
Mcfpd=thousand cubic feet per day
MMcf=million cubic feet
MMcfpd=million cubic feet per day
NGLs=  natural gas liquids
Q2 2022  =three months ended June 30, 2022
Q3 2021=three months ended September 30, 2021
Q3 2022=three months ended September 30, 2022

Non-GAAP and Other Financial Measures

This news release contains references to various non-GAAP financial measures, non-GAAP ratios, capital management measures and supplementary financial measures as such terms are defined in National Instrument 52-112 Non-GAAP and Other Financial Measures Disclosure. Such measures are not recognized measures under GAAP and do not have a standardized meaning prescribed by IFRS and might not be comparable to similar financial measures disclosed by other issuers. While these measures may be common in the oil and gas industry, the Company’s use of these terms may not be comparable to similarly defined measures presented by other companies. The non-GAAP and other financial measures referred to in this report should not be considered an alternative to, or more meaningful than measures prescribed by IFRS and they are not meant to enhance the Company’s reported financial performance or position. These are complementary measures that are used by management in assessing the Company’s financial performance, efficiency and liquidity and they may be used by investors or other users of this document for the same purpose. Below is a description of the non-GAAP financial measures, non-GAAP ratios, capital management measures and supplementary financial measures used in this news release. For more information with respect to financial measures which have not been defined by GAAP, including reconciliations to the closest comparable GAAP measure, see the “Non-GAAP Measures and Other Financial Measures” section of the Company’s MD&A which may be accessed through the SEDAR website at www.sedar.com.

Non-GAAP Financial Measures

Operating netback

Operating netback is calculated as natural gas, oil and condensate revenues less royalties and production expenses. This calculation is provided in the “Operating Netback” section of the Company’s MD&A using our IFRS measures. The Company’s MD&A may be accessed through the SEDAR website at www.sedar.com. Operating netback is a common metric used in the oil and gas industry used to demonstrate profitability from operations.

Non-GAAP Financial Ratios

Operating netback per boe

Operating netback is calculated on a per unit basis, which is per barrel of oil equivalent (“boe”). It is a common non-GAAP measure used in the oil and gas industry and management believes this measurement assists in evaluating the operating performance of the Company. It is a measure of the economic quality of the Company’s producing assets and is useful for evaluating variable costs as it provides a reliable measure regardless of fluctuations in production. Alvopetro calculated operating netback per boe as operating netback divided by total sales volumes (barrels of oil equivalent). This calculation is provided in the “Operating Netback” section of the Company’s MD&A using our IFRS measures. The Company’s MD&A may be accessed through the SEDAR website at www.sedar.com. Operating netback is a common metric used in the oil and gas industry used to demonstrate profitability from operations on a per unit basis (boe).

Operating netback margin

Operating netback margin is calculated as operating netback per boe divided by the realized sales price per boe. Operating netback margin is a measure of the profitability per boe relative to natural gas, oil and condensate sales revenues per boe and is calculated as follows:

Funds Flow from Operations Per Share

Funds flow from operations per share is a non-GAAP ratio that includes all cash generated from operating activities and is calculated before changes in non-cash working capital, divided by the weighted the weighted average shares outstanding for the respective period. For the periods reported in this news release the cash flows from operating activities per share and funds flow from operations per share is as follows:

Capital Management Measures

Funds Flow from Operations 

Funds flow from operations is a non-GAAP capital management measure that includes all cash generated from operating activities and is calculated before changes in non-cash working capital. The most comparable GAAP measure to funds flow from operations is cash flows from operating activities. Management considers funds flow from operations important as it helps evaluate financial performance and demonstrates the Company’s ability to generate sufficient cash to fund future growth opportunities. Funds flow from operations should not be considered an alternative to, or more meaningful than, cash flows from operating activities however management finds that the impact of working capital items on the cash flows reduces the comparability of the metric from period to period. A reconciliation of funds flow from operations to cash flows from operating activities is as follows:

Net Working Capital

Net working capital is computed as current assets less current liabilities. Net working capital is a measure of liquidity, is used to evaluate financial resources, and is calculated as follows: 

Working Capital Net of Debt

Working capital net of debt is computed as net working capital surplus decreased by the carrying amount of the Credit Facility. Working capital net of debt is used by management to assess the Company’s overall financial position.

Supplementary Financial Measures

“Average realized natural gas price – $/Mcf” is comprised of natural gas sales as determined in accordance with IFRS, divided by the Company’s natural gas sales volumes.

“Average realized NGL – condensate price – $/bbl” is comprised of condensate sales as determined in accordance with IFRS, divided by the Company’s NGL sales volumes from condensate.

“Average realized oil price – $/bbl” is comprised of oil sales as determined in accordance with IFRS, divided by the Company’s oil sales volumes.

“Average realized price – $/boe” is comprised of natural gas, condensate and oil sales as determined in accordance with IFRS, divided by the Company’s total natural gas, condensate and oil sales volumes (barrels of oil equivalent).

“Royalties per boe” is comprised of royalties, as determined in accordance with IFRS, divided by the total natural gas, condensate and oil sales volumes (barrels of oil equivalent).

“Production expenses per boe” is comprised of production expenses, as determined in accordance with IFRS, divided by the total natural gas, condensate and oil sales volumes (barrels of oil equivalent).

BOE Disclosure

The term barrels of oil equivalent (“boe”) may be misleading, particularly if used in isolation. A boe conversion ratio of six thousand cubic feet per barrel (6 Mcf/bbl) of natural gas to barrels of oil equivalence is based on an energy equivalency conversion method primarily applicable at the burner tip and does not represent a value equivalency at the wellhead. All boe conversions in this MD&A are derived from converting gas to oil in the ratio mix of six thousand cubic feet of gas to one barrel of oil.

Forward-Looking Statements and Cautionary Language

This news release contains forward-looking information within the meaning of applicable securities laws. The use of any of the words “will”, “expect”, “intend” and other similar words or expressions are intended to identify forward-looking information. Forward‐looking statements involve significant risks and uncertainties, should not be read as guarantees of future performance or results, and will not necessarily be accurate indications of whether or not such results will be achieved. A number of factors could cause actual results to vary significantly from the expectations discussed in the forward-looking statements. These forward-looking statements reflect current assumptions and expectations regarding future events. Accordingly, when relying on forward-looking statements to make decisions, Alvopetro cautions readers not to place undue reliance on these statements, as forward-looking statements involve significant risks and uncertainties. More particularly and without limitation, this news release contains forward-looking information concerning the Company’s dividend policy, plans for dividends in the future, and the timing and taxation of such dividends, the Company’s intention to proceed with an NCIB, plans relating to the Company’s operational activities, the expected natural gas price, gas sales and gas deliveries under Alvopetro’s long-term gas sales agreement, exploration and development prospects of Alvopetro, the expected timing of certain of Alvopetro’s testing and operational activities, future results from operations, and the Company’s plans for dividends in the future. Forward-looking statements are necessarily based upon assumptions and judgments with respect to the future including, but not limited to, expected approvals and timing thereof with respect to an NCIB, equipment availability, the timing and results of testing the 183-B1 well, the 182-C2 well and the Unit C well, the success of future drilling, completion, recompletion and development activities, foreign exchange rates, expectations regarding Alvopetro’s working interest and the outcome of any redeterminations, the outlook for commodity markets and ability to access capital markets, the impact of the COVID-19 pandemic, the performance of producing wells and reservoirs, well development and operating performance, the timing of regulatory licenses and approvals,  general economic and business conditions, forecasted demand for oil and natural gas, weather and access to drilling locations, the availability and cost of labour and services, environmental regulation, including regulation relating to hydraulic fracturing and stimulation, the ability to monetize hydrocarbons discovered, the regulatory and legal environment and other risks associated with oil and gas operations. The reader is cautioned that assumptions used in the preparation of such information, although considered reasonable at the time of preparation, may prove to be incorrect. Actual results achieved during the forecast period will vary from the information provided herein as a result of numerous known and unknown risks and uncertainties and other factors. In addition, the declaration, timing, amount and payment of future dividends remain at the discretion of the Board of Directors. Although Alvopetro believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because Alvopetro can give no assurance that it will prove to be correct. Readers are cautioned that the foregoing list of factors is not exhaustive. Additional information on factors that could affect the operations or financial results of Alvopetro are included in our restated annual information form which may be accessed on Alvopetro’s SEDAR profile at www.sedar.com. The forward-looking information contained in this news release is made as of the date hereof and Alvopetro undertakes no obligation to update publicly or revise any forward-looking information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws.

SOURCE Alvopetro Energy Ltd.

For further information: Corey C. Ruttan, President, Chief Executive Officer and Director, or Alison Howard, Chief Financial Officer, Phone: 587.794.4224, Email: info@alvopetro.com, www.alvopetro.com, TSX-V: ALV, OTCQX: ALVOF

Release – Sierra Metals Announces Follow Up Shareholder Conference Call to Be Held on Wednesday November 16th, 2022

Posted on by cpatches

Research News and Market Data on SMTS

TORONTO–(BUSINESS WIRE)– Sierra Metals Inc. (TSX: SMT) (BVL or Bolsa de Valores de Lima: SMT) (“Sierra Metals” or the “Company”) will host a conference call on Wednesday November 16th, 2022, at 8:00am EST to provide attendees the opportunity to ask questions with respect to the Company’s financial results for Q3 2022. The Company held its Q3 2022 earnings call earlier today, but due to technical issues attendees were not able to ask questions. Details of the November 16th, 2022 conference call are as follows:

Via phone:

To ensure your participation, please call approximately five minutes prior to the scheduled start time of the call.

Canada dial-in number (Toll Free): 1 833 950 0062
Canada dial-in number (Local): 1 226 828 7575
US dial-in number (Toll Free): 1 844 200 6205
US dial-in number (Local): 1 646 904 5544
All other locations: +1 929 526 1599

Access code: 272699

Press *1 to ask a question, *2 to withdraw your question, or *0 for operator assistance

About Sierra Metals

Sierra Metals Inc. is a diversified Canadian mining company with Green Metal exposure including copper production and base metal production with precious metals byproduct credits, focused on the production and development of its Yauricocha Mine in Peru, and Bolivar and Cusi Mines in Mexico. The Company is focused on increasing production volume and growing mineral resources. The Company has large land packages at all three mines with several prospective regional targets providing longer-term exploration upside and mineral resource growth potential.

The Company’s Common Shares trade on the Bolsa de Valores de Lima and on the Toronto Stock Exchange under the symbol “SMT”.

For further information regarding Sierra Metals, please visit www.sierrametals.com.

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Web: www.sierrametals.com | Twitter: sierrametals | Facebook: SierraMetalsInc |
LinkedIn: Sierra Metals Inc | Instagram: sierrametals

Forward-Looking Statements

This press release contains forward-looking information within the meaning of Canadian and United States securities legislation, including with respect to timing of the conference call. Forward-looking information relates to future events or the anticipated performance of Sierra and reflect management’s expectations or beliefs regarding such future events and anticipated performance based on an assumed set of economic conditions and courses of action. In certain cases, statements that contain forward-looking information can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, “believes” or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, or “will be taken”, “occur” or “be achieved” or the negative of these words or comparable terminology. By its very nature forward-looking information involves known and unknown risks, uncertainties and other factors that may cause actual performance of Sierra to be materially different from any anticipated performance expressed or implied by such forward-looking information.

Forward-looking information is subject to a variety of risks and uncertainties, which could cause actual events or results to differ from those reflected in the forward-looking information, including, without limitation, the risks described under the heading “Risk Factors” in the Company’s annual information form dated March 16, 2022 for its fiscal year ended December 31, 2021 and other risks identified in the Company’s filings with Canadian securities regulators and the United States Securities and Exchange Commission, which filings are available at www.sedar.com and www.sec.gov, respectively.

The risk factors referred to above are not an exhaustive list of the factors that may affect any of the Company’s forward-looking information. Forward-looking information includes statements about the future and is inherently uncertain, and the Company’s actual achievements or other future events or conditions may differ materially from those reflected in the forward-looking information due to a variety of risks, uncertainties and other factors. The Company’s statements containing forward-looking information are based on the beliefs, expectations, and opinions of management on the date the statements are made, and the Company does not assume any obligation to update such forward-looking information if circumstances or management’s beliefs, expectations or opinions should change, other than as required by applicable law. For the reasons set forth above, one should not place undue reliance on forward-looking information.

Investor Relations
Sierra Metals Inc.
Tel: +1 (416) 366-7777
Email: info@sierrametals.com

Luis Marchese
CEO
Sierra Metals Inc.
Tel: +1 (416) 366-7777

Source: Sierra Metals Inc.

Colorado Voted to Allow Psychedelics – What’s Next?

Posted on by cpatches

Image Credit: Megs Harrison (Pexels)

After 50 Years in the Dark, There May Be a Light at the End of the Tunnel for Psychedelics

Last week, voters in Colorado chose to decriminalize psychedelic use for residents over the age of 21, becoming the second state in the nation to move towards acceptance of this burgeoning therapeutic treatment. The ballot measure also set the stage for state-regulated “healing centers” where medical professionals can administer psychedelic treatment as part of a therapeutic regimen. Psychedelics remain a Schedule 1 drug on the Federal level, but the FDA has recently given them a “breakthrough therapy” designation. So, what is next for these so-called magic mushrooms?

What the Vote Means

Decriminalization. This portion of the bill allows residents aged 21 and over to grow, posses, and share psychedelic substances (magic mushrooms) without committing a crime. Sale of the substances is still not allowed.

Supervised Use. The bill also allows state-regulated centers to administer psilocybin and psilocin treatments. These active compounds in psychedelics are being studied as a potential mental health breakthrough, used in-tandem with mental health therapy sessions, capable of treating various conditions, including depression, PTDS, anxiety, eating disorders, and substance abuse disorders.

Where Psychedelics Stand

From ‘A Quick Look at 8 Small Caps in the Growing Psychedelics Space’ – Published to Channelchek last December:

“In recent years, the Food and Drug Administration (FDA) has granted psychedelic compounds Breakthrough Therapy status, which has opened the door to new research studies and the potential development of new medications.  Recently, research and approval of new drugs has progressed past phase 2 trials for the use of psilocybin – the naturally occurring psychedelic prodrug compound produced by numerous fungi species – as treatment for depressive disorder. In another example, a drug proposed for the treatment of certain PTSD diagnoses is heading towards a second phase 3 trial, with full FDA approval possible as early as 2022.”

While full approval in 2022 didn’t happen, psychedelics continue to make headway in the FDA approval process. In July of this year, Filament Health (FLHLF) announced the beginning of dosing in the first FDA-approved clinical trial studying the effects of naturally derived psychedelic drug candidates. This study, designed to compare both the physiological and the psychological effects of psilocin, is expected to conclude towards the end of 2024.

While psychedelics and the FDA have a checkered past, the tide appears to be turning. A growing mental health crisis, along with years of research on the potential positive effects of psychedelic treatments, appear to be nudging the FDA closer to approval. Just last year, Johns Hopkins Medicine was awarded a National Institute of Health grant to stud psychedelic treatment for tobacco addiction. This federal research grant was the first of its kind approved in the past 50 years.

What’s Next

Schedule 1. Under the Controlled Substances Act, psychedelics remain in most restrictive Category 1, which creates numerous hurdles for approval as treatment. FDA approval would help. If current and future clinical trials lead the FDA to approve the drug for various treatments, the DEA would be prompted to reevaluate the drug’s schedule. Ballot initiatives like those in Oregon and Colorado also help on the local level.

Treatment. After more than 50 years, the study of psychedelics as part of a mental health treatment regimen is finally allowed. There’s a lot of lost time to make up for. Clinical trials will be needed for various conditions to determine appropriate dosing and combination therapies. Still deep in an opioid crisis, it’s fair to expect the FDA and DEA to proceed with caution, even with promising early results. 

Parallels. While completely different, it’s easy to draw certain parallels with the medical and recreational legalization of marijuana in the US. Over two decades, we’ve seen various states vote to legalize medical-only use, with others voting in favor of complete decriminalization along with legal recreational use, while a few states remain steadfast in keeping it a crime. Will we see similar results with psychedelics? It’s possible that, with the growing number of nearly untreatable conditions that psychedelics could improve, we see widespread medical acceptance in the coming years. Recreational use will almost certainly take longer with the current Schedule 1 status.

Acceptance and Capital. Acceptance is half the battle. The other is capital. The companies involved in bringing psychedelics to market will need investors backing them to move forward. Between clinical trials, therapeutic training, production, and marketing, these companies will need a great deal of funding to make it to market. But the potential is clear. Efficacy in early studies far surpasses any currently available treatment method for various mental health conditions, creating a market expected to grow to a value of over $3 billion by 2026.

Chris Patches
Channelchek Contributor

Sources

https://www.filament.health/news/filament-health-announces-first-dosing-in-groundbreaking-fda-approved-psilocin-clinical-trial

https://www.channelchek.com/news-channel/a_quick_look_at_8_small_caps_in_the_growing_psychedelics_space-2

https://www.pbs.org/newshour/nation/colorado-voters-approve-initiative-to-decriminalize-psychedelic-mushrooms

https://www.nbcnews.com/data-graphics/magic-mushrooms-psilocybin-map-colorado-us-states-rcna55980

https://clinicaltrials.gov/ct2/show/NCT05317689

https://www.hopkinsmedicine.org/psychiatry/research/psychedelics-research.html

https://www.amjmed.com/article/S0002-9343(21)00521-0/fulltext