Month: August 2022

Release – Ayala Pharmaceuticals Selected to Present Efficacy and Tolerability Data on AL102 in Desmoid Tumors at the European Society for Medical Oncology ESMO 2022 Congress

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Ayala Pharmaceuticals Selected to Present Efficacy and Tolerability Data on AL102 in Desmoid Tumors at the European Society for Medical Oncology (ESMO) 2022 Congress

Research, News, and Market Data on Ayala Pharmaceuticals

Oral presentation will feature results from Part A of the Phase
2/3 RINGSIDE clinical study

REHOVOT, Israel and WILMINGTON, Del., Aug. 24, 2022 (GLOBE NEWSWIRE) — Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, today announced that data on the efficacy and tolerability of investigational new drug AL102 from Part A of the Phase 2/3 RINGSIDE study will be presented in an oral presentation at the European Society for Medical Oncology (ESMO) Congress, to take place September 8-13, 2022 in Paris, France.

The presentation details follow:

 

 

Abstract Title:

Initial Results of Phase 2/3 Trial of AL102
for Treatment of Desmoid Tumors (DT)

Presentation
Number:

1488MO

Session Type:

Mini Oral Session

Session
Title:

Sarcoma

Session Date and Time:

Monday, September 12, 2022, at 2:45 pm CEST / 8:45 am EDT

About the RINGSIDE study
The RINGSIDE pivotal Phase 2/3 study is a randomized multi-center trial. Part A of the study is evaluating the efficacy, safety, tolerability, and tumor volume by MRI after 16 weeks of AL102 in adult patients with desmoid tumors. It enrolled 42 patients and is evaluating 3 doses of AL102. Patients who participated in Part A will be eligible to enroll into an open-label extension study at the selected Part B dose, and long-term efficacy and safety will be monitored. Part B of the study will be double-blind, placebo-controlled, and will start immediately after dose selection from part A, enrolling up to 156 adult and adolescent patients with progressive disease, randomized between AL102 or placebo. The study’s primary endpoint is progression-free survival (PFS) with secondary endpoints including objective response rate (ORR), duration of response (DOR), and patient-reported Quality of Life (QOL) measures.

For more information on the RINGSIDE Phase 2/3 study with AL102 for the treatment of desmoid tumors, please visit ClinicalTrials.gov and reference Identifier NCT04871282 (RINGSIDE).

About Desmoid Tumors
Desmoid tumors also called aggressive fibromatosis or desmoid-type fibromatosis, are rare connective tissue tumors that typically arise in the upper and lower extremities, abdominal wall, head and neck area, mesenteric root, and chest wall with the potential to arise in additional parts of the body. Desmoid tumors do not metastasize, but often aggressively infiltrate neurovascular structures and vital organs. People living with desmoid tumors are often limited in their daily life due to chronic pain, functional deficits, general decrease in their quality of life and organ dysfunction. Desmoid tumors have an annual incidence of approximately 1,700 patients in the United States and typically occur in patients between the ages of 15 and 60 years. They are most commonly diagnosed in young adults between 30-40 years of age and are more prevalent in females. Today, surgery is no longer regarded as the cornerstone treatment of desmoid tumors due to high rate of recurrence post-surgery and there are currently no FDA-approved systemic therapies for the treatment of unresectable, recurrent or progressive desmoid tumors.

About Ayala Pharmaceuticals
Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare tumors and aggressive cancers. Ayala’s approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors including Adenoid Cystic Carcinoma, T-cell Acute Lymphoblastic Leukemia (T-ALL), Desmoid Tumors and Multiple Myeloma (MM). AL101, has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations. AL102 is currently in a Pivotal Phase 2/3 clinical trials for patients with desmoid tumors (RINGSIDE). For more information, visit www.ayalapharma.com. 

Contacts

Investors:
Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602

jallaire@lifesciadvisors.com 

Ayala Pharmaceuticals:
+1-857-444-0553

info@ayalapharma.com 

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements relating to our development of AL101 and AL102, the promise and potential impact of our preclinical or clinical trial data, the timing of and plans to initiate additional clinical trials of AL101 and AL102, the timing and results of any clinical trials or readouts, the sufficiency of cash to fund operations, and the anticipated impact of COVID-19, on our business. These forward-looking statements are based on management’s current expectations. The words ”may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we have incurred significant losses since inception and anticipate that we will continue to incur losses for the foreseeable future. We are not currently profitable, and we may never achieve or sustain profitability; we will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of AL101 and AL102; we have a limited operating history and no history of commercializing pharmaceutical products, which may make it difficult to evaluate the prospects for our future viability; we are heavily dependent on the success of AL101 and AL102, our most advanced product candidates, which are still under clinical development, and if either AL101 or AL102 does not receive regulatory approval or is not successfully commercialized, our business may be harmed; due to our limited resources and access to capital, we must prioritize development of certain programs and product candidates; these decisions may prove to be wrong and may adversely affect our business; the outbreak of COVID-19, may adversely affect our business, including our clinical trials; our ability to use our net operating loss carry forwards to offset future taxable income may be subject to certain limitations; our product candidates are designed for patients with genetically defined cancers, which is a rapidly evolving area of science, and the approach we are taking to discover and develop product candidates is novel and may never lead to marketable products; we were not involved in the early development of our lead product candidates; therefore, we are dependent on third parties having accurately generated, collected and interpreted data from certain preclinical studies and clinical trials for our product candidates; enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control; if we do not achieve our projected development and commercialization goals in the timeframes we announce and expect, the commercialization of our product candidates may be delayed and our business will be harmed; our product candidates may cause serious adverse events or undesirable side effects, which may delay or prevent marketing approval, or, if approved, require them to be taken off the market, require them to include safety warnings or otherwise limit their sales; the market opportunities for AL101 and AL102, if approved, may be smaller than we anticipate; we may not be successful in developing, or collaborating with others to develop, diagnostic tests to identify patients with Notch-activating mutations; we have never obtained marketing approval for a product candidate and we may be unable to obtain, or may be delayed in obtaining, marketing approval for any of our product candidates; even if we obtain FDA approval for our product candidates in the United States, we may never obtain approval for or commercialize them in any other jurisdiction, which would limit our ability to realize their full market potential; we have been granted Orphan Drug Designation for AL101 for the treatment of ACC and may seek Orphan Drug Designation for other indications or product candidates, and we may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for market exclusivity, and may not receive Orphan Drug Designation for other indications or for our other product candidates; although we have received Fast Track designation for AL101, and may seek Fast Track designation for our other product candidates, such designations may not actually lead to a faster development timeline, regulatory review or approval process; we face significant competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete effectively; we are dependent on a small number of suppliers for some of the materials used to manufacture our product candidates, and on one company for the manufacture of the active pharmaceutical ingredient for each of our product candidates; our existing collaboration with Novartis is, and any future collaborations will be, important to our business. If we are unable to maintain our existing collaboration or enter into new collaborations, or if these collaborations are not successful, our business could be adversely affected; enacted and future healthcare legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates, if approved, and may affect the prices we may set; if we are unable to obtain, maintain, protect and enforce patent and other intellectual property protection for our technology and products or if the scope of the patent or other intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and we may not be able to compete effectively in our markets; we may engage in acquisitions or in-licensing transactions that could disrupt our business, cause dilution to our stockholders or reduce our financial resources; and risks related to our operations in Israel could materially adversely impact our business, financial condition and results of operations.

These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2020 filed with the U.S. Securities and Exchange Commission (SEC) on March 24, 2021 and our other filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. New risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

 


Labrador Gold Corp. (NKOSF) – Sampling Program at Golden Glove Yields High-Grade Results

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Wednesday, August 24, 2022

Labrador Gold Corp. (NKOSF)
Sampling Program at Golden Glove Yields High-Grade Results

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

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

High-grade samples taken at Golden Glove. The company released assays from six samples taken from quartz veins containing visible gold collected during prospecting in the Golden Glove area of the company’s flagship Kingsway project. Sampling will help generate and upgrade targets for drilling along the 12-kilometer strike length of the Appleton Fault. Assays of the six samples ranged from 7.51 grams of gold per tonne to 479.51 grams of gold per tonne with the four highest grade samples containing visible gold. The results are comparable to assays from initial samples taken at Golden Glove that ranged from 2.99 grams of gold per tonne to 338.08 grams of gold per tonne.

Reaching the half-way point. Labrador Gold has four drill rigs operating, including two at the Big Vein target, one rig at the Golden Glove target, and one at the CSAMT target. To date, the company has completed roughly 50,000 meters of its 100,000-meter drilling program targeting the Appleton Fault Zone over a 12-kilometer strike length. While Big Vein lies on the west side of the fault, Golden Glove and CSAMT are on the east side of the fault….

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 – BioSig Places Second PURE EP™ System For Evaluation at Cleveland Clinic a Leading Medical Center of Excellence

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BioSig Places Second PURE EP™ System For Evaluation at Cleveland Clinic a Leading Medical Center of Excellence

News and Market Data on BioSig Technologies

August 24, 2022

Westport, CT, Aug. 24, 2022 (GLOBE NEWSWIRE) —

  • Leading Medical Center
    of Excellence adds second PURE EP™ System for evaluation, broadening
    physician access to the Company’s signal processing technology
  • PURE EP™ is now being
    evaluated at both Main and Fairview campuses of Cleveland Clinic’s Heart,
    Vascular & Thoracic Institute 

BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company advancing electrophysiology workflow by delivering greater intracardiac signal fidelity through its proprietary signal processing platform, today announced that it has installed a second evaluation system at the Cleveland Clinic. The additional installation will support the medical center’s clinical evaluation of the PURE EP™ System and expand physician access to the Company’s signal processing technology. 

“I am pleased to see the growing interest and demand for our technology at The Cleveland Clinic. The additional unit will enable more physicians the opportunity to experience the superior signal quality of the PURE EP™ System on a broad range of cases.” commented Gray Fleming, Chief Commercialization Officer, BioSig Technologies, Inc.

Consistent with its stated national commercial strategy, the Company’s customer-centered approach aims to maximize the clinical value and deployment of the PURE EP™ System which has gained interest in several electrophysiology labs in the Midwest. The Company recently expanded its clinical footprint in Illinois with an additional evaluation agreement at a leading medical center in Springfield, the state capital.

Looking ahead, BioSig will serve as a partner at the upcoming Cleveland Clinic Global EP Summit 2022, due to take place this coming September. This annual forum convenes over 40 global experts and highlights the latest practice insights across the spectrum of electrophysiology care.

 

About
Cleveland Clinic

Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. U.S. News & World Report consistently names Cleveland Clinic as one of the nation’s best hospitals in its annual “America’s Best Hospitals” survey. As a leader in arrhythmia treatment and diagnosis, Cleveland Clinic medical centers include state-of-the-art electrophysiology laboratories, world-class physicians and researchers, and the latest cutting-edge technologies and protocols deployed for the treatment of heart abnormalities. To learn more, visit clevelandclinic.org.

 

About
BioSig Technologies

BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

The Company’s first product, PURE EP™ System, is a novel signal processing and acquisition platform designed to extract advanced diagnostic and therapeutic data that enhances physician workflow and increases throughput. PURE EP™ was engineered to address the limitations of existing EP technologies by empowering physicians with superior signals and actionable insights. The Company is in a national commercial launch of the PURE EP™ System. The technology is in regular use in some of the country’s leading centers of excellence, including Mayo Clinic, and Texas Cardiac Arrhythmia Institute at St. David’s Medical Center.

Clinical data acquired by the PURE EP™ System in a multi-center study at centers of excellence including Texas Cardiac Arrhythmia Institute at St. David’s Medical Center  was recently published in the Journal of Cardiovascular Electrophysiology and is available electronically with open access via the Wiley Online Library. Study results showed 93% consensus across the blinded reviewers with a 75% overall improvement in intracardiac signal quality and confidence in interpreting PURE EP(T.M.) signals over conventional sources.

 

Forward-looking
Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market conditions and the Company’s intended use of proceeds, (ii) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (iii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iv) difficulties in obtaining financing on commercially reasonable terms; (v) changes in the size and nature of our competition; (vi) loss of one or more key executives or scientists; and (vii) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.


Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
55 Greens Farms Road
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x133
 

Primary Logo

Source: BioSig Technologies, Inc.

Released
August 24, 2022


Element79 Gold Corp. (ELMGF) – Contemplating Upcoming Catalysts

Posted on by Admin

Tuesday, August 23, 2022

Element79 Gold Corp. (ELMGF)
Contemplating Upcoming Catalysts

Element79 Gold is a mineral exploration company focused on the acquisition, exploration and development of mining properties for gold and associated metals. Element79 Gold has acquired its flagship Maverick Springs Project located in the famous gold mining district of northeastern Nevada, USA, between the Elko and White Pine Counties, where it has recently completed a 43-101-compliant, pit-constrained mineral resource estimate reflecting an Inferred resource of 3.71 million ounces of gold equivalent* “AuEq” at a grade of 0.92 g/t AuEq (0.34 g/t Au and 43.4 g/t Ag)) with an effective date of Feb. 4, 2022. The acquisition of the Maverick Springs Project also included a portfolio of 15 properties along the Battle Mountain trend in Nevada, which the Company is analyzing for further merit of exploration, along with the potential for sale or spin-out. In British Columbia, Element79 Gold has executed a Letter of Intent to acquire a private company which holds the option to 100% interest of the Snowbird High-Grade Gold Project, which consists of 10 mineral claims located in Central British Columbia, approximately 20km west of Fort St. James. In Peru, Element79 Gold has signed a letter of intent to acquire the business and assets of Calipuy Resources Inc., which holds 100% interest in the past-producing Lucero Mine, one of the highest-grade underground mines to be commercially mined in Peru’s history, as well as the past-producing Machacala Mine. The Company also has an option to acquire 100% interest in the Dale Property which consists of 90 unpatented mining claims located approximately 100 km southwest of Timmins, Ontario, Canada in the Timmins Mining Division, Dale Township.

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

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

Near-term catalysts. Upcoming catalysts include: 1) completion of a previously announced private placement to fund work programs through the balance of 2022, 2) potential monetization of properties within the Battle Mountain portfolio, and 3) commencement of work programs in Nevada and Peru. Additionally, we think the company could close on its planned acquisition of the Snowbird High-Grade Gold Project as early as September. Recall the project consists of 2,276 hectares across ten mineral claims in Central British Columbia and can be drilled year-round.

Financing. We expect proceeds of up to C$2 million from a private placement announced previously to help fund exploration through the balance of 2022. We have modeled a larger C$5 million equity financing during the quarter ending in November to accelerate progress into 2023. Partial or full monetization of properties within the Battle Mountain portfolio could allow investors to better value the remaining portfolio in addition to providing a source of funding….

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. 

Lifeway Foods (LWAY) – A Healthy Food Alternative

Posted on by Admin

Tuesday, August 23, 2022

Lifeway Foods (LWAY)
A Healthy Food Alternative

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.

Initiating Coverage. We are initiating research coverage on Lifeway Foods, Inc. with a Market Perform rating. Lifeway is the largest producer and marketer of kefir in the U.S. and an important player in the broader probiotic-based products and natural “better for you” foods. We believe Lifeway is well positioned to leverage its dominant kefir position into ancillary products and distribution channels. We should note, given an accounting error from 2009, Lifeway has yet to release operating results for the first and second quarters of 2022. We believe the issue to be satisfactorily resolved and expect the quarterly results to be released shortly. 

What Is Kefir? Originating in the North Caucasus 
region, 
kefir is a fermented milk drink similar to a thin yogurt or ayran that is made from kefir grains, a specific type of mesophilic symbiotic culture. Lifeway Kefir is tart and tangy as well as high in protein, calcium and vitamin D. As a result of the Company’s exclusive blend of kefir cultures, each cup of Lifeway kefir contains 12 live and active cultures and 25 to 30 billion beneficial CFU (Colony Forming Units) at the time of manufacture.…

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. 

Should Investors Pay Attention to US Strategic Reserve Replenishment?

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Image Credit: Paul B (Flickr)


Will Drivers Continue to be Dogged by High Gas Prices as US Strategic Oil Reserve is Replenished?

The last time the US Strategic Oil Reserves was this low was January 1985. The US population was then 238 million, The Cosby Show was the top-rated on TV, the threat of the AIDS virus was just beginning to be understood, and a newly appointed NIH Director named Anthony Fauci had just been promoted. In 37 years, some things have changed, and some things have not. One that has not is the need for reliable energy.

The Reserves reached their peak in April 2011 with 726.5 million barrels; today, we sit with 453.1 million. Will it take 37 years to replenish the more than 200 million barrels, 160 million of which have been siphoned off since March of this year?

The barrels that are being used in 2022 were ordered released by the White House to offset the domestic loss of production, pipeline distribution, and less supply being compounded by global shortages resulting from a partial embargo against Russia. The order was intended to work to lower gas prices today and help reduce the impact oil prices are having on unacceptably high inflation.

President Biden said in March that the US would release one million barrels of oil a day for six months as petroleum products spiked following the start of the Russian/Ukrainian war. The White House then said, in late July, the US would release another 20 million barrels.

To some degree, it worked as intended. There has been a fall in the price at the gas pumps over the past two months. Much of this has been supply-related, helped by the reserve releases, to a lesser extent, demand has also slowed from receding economic activity. WTI crude, the US benchmark price, has dropped around 24%.

That decline has brought US gasoline prices down from above $5 a gallon in June to $3.89 on Tuesday, August 17. Globally, other countries are tapping into their own strategic reserves as well.


What Happens When we Refill It?

The US consumed about 20 million barrels of oil a day on average in 2021, according to the EIA. During the same year, it produced 11 million barrels a day. The Biden administration is proposing to refill the stockpiles under a plan that is likely to see it order 60 million barrels this fall for delivery at an unspecified time in the future. That leaves at least another 100 million barrels to bring the country back to where we were in March 2022 – over two hundred more to bring us back to the peak. It took 37 years last time for the country to stockpile the same amount.

The current infrastructure is not supporting additional oil output, otherwise, companies would be pumping more now. On July 1, President Biden made public a five-year proposal for offshore oil and gas development in areas of existing production and said the final plan might have anywhere from zero to 11 lease sales.

The range of proposed options was between two auctions a year and none at all. The plan seemed conflicted with a desire to balance the administration’s efforts to reduce the use of fossil fuels and its calls to increase needed oil and gas.


Energy Demand Moving Forward

Does restocking the Reserves point toward high petroleum demand for a much longer time period than ever expected? Does it also create opportunities for producers of biofuels, for example, GEVO?

The current fuel issues are not going to disappear overnight. Borrowing from the future with the intent, and now a plan, to pay it back, will require more production than before. Companies that produce are not inclined to make big investments in building out a platform when the political climate is one of wanting to shut production down as soon as possible.

The cost of reducing energy output and then borrowing from reserves, especially after an unexpected embargo is placed on a major global  supplier, could keep the price of all energy elevated for a much longer time than the end of a war, of installation of coastal wind farms.

Paul Hoffman

Managing Editor, Channelchek

Suggested Content



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Powell is Told by President that He is the Face of Inflation

Understanding Power Grid Blackouts, Brownouts, and Solutions


Sources

https://www.eia.gov/dnav/pet/hist/LeafHandler.ashx?n=PET&s=MCSSTUS1&f=M

https://www.eia.gov/petroleum/gasdiesel/gas_geographies.php#pricesbyregion

https://www.whitehouse.gov/briefing-room/statements-releases/2022/07/26/fact-sheet-department-of-energy-releases-new-notice-of-sale-as-gasoline-prices-continue-to-fall/

https://www.niaid.nih.gov/about/director

https://www.energy.gov/articles/doe-announces-additional-notice-sale-crude-oil-strategic-petroleum-reserve

https://www.reuters.com/business/energy/biden-administration-proposes-offshore-drilling-plan-focused-mainly-us-gulf-2022-07-01/

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Release – Labrador Gold Announces Assays Up to 479.5G-T Au in Surface Samples From Golden Glove

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Labrador Gold Announces Assays Up to 479.5G-T Au in Surface Samples From Golden Glove

News and Market Data on Labrador Gold Corp

TORONTO, Aug. 23, 2022 (GLOBE NEWSWIRE) — Labrador Gold Corp. (TSX.V:LAB | OTCQX:NKOSF | FNR: 2N6) (“LabGold” or the “Company”) is pleased to announce assays from six samples containing visible gold recently collected during prospecting in the Golden Glove area at its 100% owned Kingsway Project. The samples were collected as part of the Company’s continuous efforts to generate and upgrade targets for drilling along the 12km strike length of the Appleton Fault Zone covered by the Kingsway Property.

The samples were taken from quartz veins believed to be splays off the original Golden Glove vein. Assays of the six samples ranged from 7.51 g/t to 479.51 g/t Au. The quartz veins are hosted by grey and black shales and are typically vuggy and locally stylolitic with iron carbonate alteration. The four highest grade samples contain visible gold, and all samples contain between 2 and 5% pyrite and arsenopyrite both in the vein and along the contact with the shale wallrock. These results are comparable to assays from the initial samples taken at Golden Glove that ranged from 2.99 to 338.08g/t Au (see news release dated September 21, 2021).

“The discovery of more veins containing high-grade gold at surface is encouraging as it gives us additional information on the structural context of the mineralization at Golden Glove and will allow more efficient drill targeting.” said Roger Moss, President and CEO. “Drilling to date has been following up recent high-grade intersections of 20.07 g/t Au over 1m in Hole K-22-154 and 6.22 g/t Au over 4m in hole K-22-150 located approximately 160m south of the discovery outcrop. Given the high-grade nature of these veins we will certainly look to specifically target them in our ongoing drilling at Golden Glove.”

Sample
ID

Sample
type

Rock Type

Au (g/t)

853601*

Grab

Quartz Vein

479.51

853602*

Grab

Quartz Vein

81.49

853603*

Grab

Quartz Vein

114.72

853604*

Grab

Quartz Vein

34.90

853605

Grab

Quartz Vein

7.51

853606

Grab

Quartz Vein

12.25

* Sample contains visible gold. Note that grab samples are select samples and
are not necessarily representative of gold mineralization found on the property.

Figure 1. Portion of Sample 853601 showing visible gold grains in quartz and country rock.
https://www.globenewswire.com/NewsRoom/AttachmentNg/535e38c4-278d-4f70-8798-e2338a3eae1a

Figure 2. Location map of Kingsway gold occurrences showing recent results at Golden Glove.
https://www.globenewswire.com/NewsRoom/AttachmentNg/fea783dc-89b0-40f2-9eb0-46afd5858897

QA/QC

All samples are securely stored prior to shipping to Eastern Analytical Laboratory in Springdale, Newfoundland for assay. Eastern Analytical is an ISO/IEC17025 accredited laboratory. Samples were assayed by metallic screen/fire assay. The whole sample is crushed to -10mesh and pulverized to 95% -150mesh. The total sample is then weighed and screened through 150mesh. Both the +150mesh fraction and a 30g subsample of the -150mesh fraction are fire assayed for Au and a calculated weighted average of total Au in the sample is reported. The company routinely submits blanks and certified reference standards at a rate of approximately 5% of the total samples in each batch.

Qualified Person

Roger Moss, PhD., P.Geo., President and CEO of LabGold, a Qualified Person in accordance with Canadian regulatory requirements as set out in NI 43-101, has read and approved the scientific and technical information that forms the basis for the disclosure contained in this release.

The Company gratefully acknowledges the Newfoundland and Labrador Ministry of Natural Resources’ Junior Exploration Assistance (JEA) Program for its financial support for exploration of the Kingsway property.

About Labrador Gold
Labrador Gold is a Canadian based mineral exploration company focused on the acquisition and exploration of prospective gold projects in Eastern Canada.

Labrador Gold’s flagship property is the 100% owned Kingsway project in the Gander area of Newfoundland. The three licenses comprising the Kingsway project cover approximately 12km of the Appleton Fault Zone which is associated with gold occurrences in the region, including those of New Found Gold immediately to the south of Kingsway. Infrastructure in the area is excellent located just 18km from the town of Gander with road access to the project, nearby electricity and abundant local water. LabGold is drilling a projected 100,000 metres targeting high-grade epizonal gold mineralization along the Appleton Fault Zone with encouraging results. The Company has approximately $25 million in working capital and is well funded to carry out the planned program.

The Hopedale property covers much of the Florence Lake greenstone belt that stretches over 60 km. The belt is typical of greenstone belts around the world but has been underexplored by comparison. Work to date by Labrador Gold show gold anomalies in rocks, soils and lake sediments over a 3 kilometre section of the northern portion of the Florence Lake greenstone belt in the vicinity of the known Thurber Dog gold showing where grab samples assayed up to 7.8g/t gold. In addition, anomalous gold in soil and lake sediment samples occur over approximately 40 km along the southern section of the greenstone belt (see news release dated January 25 th 2018 for more details). Labrador Gold now controls approximately 40km strike length of the Florence Lake Greenstone Belt.

The Company has 169,189,979 common shares issued and outstanding and trades on the TSX Venture Exchange under the symbol LAB and on the OTCQX under the symbol NKOSF.

For more information please contact:

Roger Moss, President and CEO      Tel: 416-704-8291

Or visit our website at: www.labradorgold.com

Twitter: @LabGoldCorp

Neither TSX Venture Exchange
nor its Regulation Services Provider (as that term is defined in policies of
the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy
of this release .

Forward-Looking Statements: This news release contains forward-looking statements that involve risks and uncertainties, which may cause actual results to differ materially from the statements made. When used in this document, the words “may”, “would”, “could”, “will”, “intend”, “plan”, “anticipate”, “believe”, “estimate”, “expect” and similar expressions are intended to identify forward-looking statements. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties. Many factors could cause our actual results to differ materially from the statements made, including those factors discussed in filings made by us with the Canadian securities regulatory authorities. Should one or more of these risks and uncertainties, such as actual results of current exploration programs, the general risks associated with the mining industry, the price of gold and other metals, currency and interest rate fluctuations, increased competition and general economic and market factors, occur or should assumptions underlying the forward looking statements prove incorrect, actual results may vary materially from those described herein as intended, planned, anticipated, or expected. We do not intend and do not assume any obligation to update these forward-looking statements, except as required by law. Shareholders are cautioned not to put undue reliance on such forward-looking statements.

 


QuoteMedia Inc. (QMCI) – Not All Pistons Are Firing

Posted on by Admin

Tuesday, August 23, 2022

QuoteMedia Inc. (QMCI)
Not All Pistons Are Firing

QuoteMedia is a leading software developer and cloud-based syndicator of financial market information and streaming financial data solutions to media, corporations, online brokerages, and financial services companies. The Company licenses interactive stock research tools such as streaming real-time quotes, market research, news, charting, option chains, filings, corporate financials, insider reports, market indices, portfolio management systems, and data feeds. QuoteMedia provides industry leading market data solutions and financial services for companies such as the Nasdaq Stock Exchange, TMX Group (TSX Stock Exchange), Canadian Securities Exchange (CSE), London Stock Exchange Group, FIS, U.S. Bank, Broadridge Financial Systems, JPMorgan Chase, CI Financial, Canaccord Genuity Corp., Hilltop Securities, HD Vest, Stockhouse, Zacks Investment Research, General Electric, Boeing, Bombardier, Telus International, Business Wire, PR Newswire, FolioFN, Regal Securities, ChoiceTrade, Cetera Financial Group, Dynamic Trend, Inc., Qtrade Financial, CNW Group, IA Private Wealth, Ally Invest, Inc., Suncor, Virtual Brokers, Leede Jones Gable, Firstrade Securities, Charles Schwab, First Financial, Cirano, Equisolve, Stock-Trak, Mergent, Cision, Day Trade Dash and others. Quotestream®, QModTM and Quotestream ConnectTM are trademarks of QuoteMedia. For more information, please visit www.quotemedia.com.

Michael Kupinski, Director of Research, Noble Capital Markets, Inc.

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

Q2 disappoints. Revenues increased 12% to $4.30 million, but were 7.5% lower than our $4.65 million estimate. Notably, revenues moderated from the 18% revenue growth in the first quarter. We believe that adverse general market conditions and economic concerns impacted the company’s individual Quotestream business, which declined 9% yoy, and slowed revenue growth in its Corporate Quotestream segment, an increase in revenues of a modest 5.3% versus 20.4% in Q1. 

Misses Adj. EBITDA estimate. Gross profit margins were slightly lower than expected. But, more importantly, G&A expenses and Software Development expenses were higher. As such, combined with the revenue miss, adj. EBITDA of $564,000 was lower than our $765,000 estimate. …

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. 

Winter’s Natural Gas Prices are Likely to Heat Up Further?

Posted on by Admin 



Image Credit: Kees Torn (Flickr)


Natural Gas Prices May Continue to Explode Through Winter

Natural-gas futures jumped to nearly $10 per million BTU today (August 23), the highest since July 2008. This is an increase of 20% over the past month, up 146% from a year ago, and up 350% from three years ago. The drop-off in commodity prices that helped bring natural gas prices down has now been more than erased by what has been extreme volatility even by natural gas price standards.

The 14-year highs reached this week in U.S. natural-gas futures point to unrelenting demand pressures, especially in Europe. There are reasons to believe the increases will continue.

The latest price spike is largely fueled by Russia’s plans to shut down one of Europe’s main fuel arteries for a few days at the end of August. It’s unclear if that shutdown, announced Friday, is actual unplanned maintenance along the Nord Stream gas pipeline or related to economic warfare by Russia as retaliation for Western Europe’s support for Ukraine.

Short supply in Europe, above-average hot weather impacting utilities’ needs in the U.S, and concerns related to hurricane season, when storms often halt production on platforms in the Gulf of Mexico, may serve to increase prices higher.


Source: Koyfin

Normally in late Summer, prices ease in anticipation of low demand fall weather. Producers and traders usually squirrel away supplies in underground caverns until winter, when demand and prices typically are at their high for the year.

This year, though, export demand, electric demand related to some of the hottest weather on record, and low production growth have kept U.S. natural-gas supplies from growing ahead of the heating season.

The U.S. Energy Information Administration (EIA) reported an unseasonably paltry offload into storage facilities. Storage grew but left a projected deficit of 12.7% to the average for this point on the calendar.

The lag in storage could be leading to a global situation if winter is colder than normal – a situation where natural gas prices may spike upward.


Production vs. Usage

EIA data show that monthly domestic production reached its highest level since the pandemic in May, though it remained short of the output record set in December 2019. And output has decreased.

U.S. demand is rising. Coal prices that have risen more sharply than gas and scarce supplies of coal have limited electric producers’ options, which have been in high demand to run air conditioners this summer. Government energy forecasters expect average daily U.S. gas consumption this year to be 3% higher. They expect year-over-year production gains at roughly the same rate.

Meanwhile, exports are set to rise this fall when one of the country’s biggest liquefied-natural-gas, or LNG, terminals resume operations. Freeport LNG’s facility on a Texas barrier island has been shut down since a fire in early June. This reduced U.S. export capacity by about one-sixth, or near 2 billion cubic feet a day. It produces roughly enough energy units to power 50,000 homes for a year it went back online and became available for U.S. consumption this summer, which helped to hold prices lower in the US. The facility said it expects to resume exports in October.

Spikes in futures prices don’t immediately translate into higher natural gas prices at home, but eventually, they do increase the average paid.

 

Inflation and Natural Gas

In addition to electricity prices increasing via power plants, other increases, including food prices via fertilizers, and other unexpected impacts such as glass bottle production, that add to overall inflation.

The June-July plunge in natural-gas futures prices had been one of the reasons cited why inflation in the U.S. was seen as having peaked and moving lower. Utility natural gas piped to homes accounts for about 1% of total CPI. As part of the July CPI reading, utility gas piped to homes fell by 3.6% in price from June, the first month-to-month decline since January after repeated spikes., including +8.2% in June from May and +8.0% in May from April.

Spikes in futures prices don’t immediately translate into higher natural gas prices at home, but eventually, they do. Eventually, prices average up, and we will all be sharing the cost as consumers or perhaps benefitting as investors in either natural gas companies, or more directly in funds or futures.

Paul Hoffman

Managing Editor, Channelchek

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Sources

https://globallnghub.com/front-month-rallies-to-5.html

https://www.eia.gov/todayinenergy/detail.php?id=53559

https://www.eia.gov/petroleum/supply/weekly/

A Gas Shortage Could Crunch Beer Bottles Too – WSJ

https://www.cmegroup.com/trading/energy/natural-gas/lng-futures.html

https://www.energy.gov/sites/prod/files/2017/09/f36/Understanding%20Natural%20Gas%20and%20Lng%20Options_general%20no%20appendix.pdf

Stay up to date. Follow us:

 

Baudax Bio (BXRX) – Notice of Patent Allowance For Claims Covering ANJESO

Posted on by Admin

Tuesday, August 23, 2022

Baudax Bio (BXRX)
Notice of Patent Allowance For Claims Covering ANJESO

Baudax Bio is a pharmaceutical company focused on 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.

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.

Notice of Allowance for patent application.  Yesterday, Baudax Bio announced the US Patent and Trademark Office (USPTO) provided a Notice of Allowance for patent application No. 16/297095 (the ‘095 application).  The USPTO typically issues a Notice after determining the patent application should be granted.

The Patent should be granted in the next few months.  The patent application covers the multiple doses of ANJESO for the treatment of moderate to severe pain, and a reduction in use of rescue analgesics 48 hours following the first dose.  The patent from the ‘095 titled application “Methods of administering intravenous meloxicam in a bolus dose”, once issued, will be eligible for listing in the FDA’s Orange Book. …

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 182-C1 Well Results

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Alvopetro Announces 182-C1 Well Results

Research, News, and Market Data on Alvopetro Energy

Aug 22, 2022

CALGARY, AB, Aug. 22, 2022 /CNW/ – Alvopetro Energy Ltd. (TSXV: ALV) (OTCQX: ALVOF) announces that we have suspended testing at the 182-C1 well on our 100% owned and operated Block 182 in the Recôncavo basin. During the testing operation we perforated the entire 25m of net pay section of the well on tubing conveyed perforations in an underbalanced condition. No formation flow was observed after the initial perforations. We injected 124 barrels (“bbls”) of 15% hydrochloric acid to remove possible near wellbore damage. We then removed the liquid from the wellbore with a jet lift operation using nitrogen and coil tubing. After recovering 231 bbls of the initial 303 bbls of brine and acid we discontinued operations, due to lack of progress in removing any further liquids. We have not recovered any hydrocarbons from the wellbore and will continue to monitor the wellbore pressure from surface, but expect to permanently abandon wellbore in the future.

The primary and secondary targets of the 182-C1 well were the Agua Grande and Sergi Formations, respectively. Based on open hole logs, the 182-C1 well encountered net pay in the Agua Grande Formation very close to the main bounding fault and the well crossed over the fault before encountering the secondary target in the Sergi Formation. We plan to drill a follow up well, 182-C2, to assess the Agua Grande reservoir quality and to target the Sergi Formation further east from the bounding fault. We expect to spud the 182-C2 well later in August.

Corporate Presentation

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

Social MediaFollow Alvopetro on our social media channels at the following links:

Twitter – https://twitter.com/AlvopetroEnergyInstagram – 
https://www.instagram.com/alvopetro/LinkedIn – 
https://www.linkedin.com/company/alvopetro-energy-ltdYouTube: https://www.youtube.com/channel/UCgDn_igrQgdlj-maR6fWB0w

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.

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 exploration and development prospects of Alvopetro and
the expected timing of certain of Alvopetro’s operational activities. The
forward?looking
statements are based on certain key expectations and assumptions made by
Alvopetro, including but not limited to expectations and assumptions concerning
testing results, equipment availability, the timing of regulatory licenses and
approvals, the success of future drilling, completion, testing, recompletion
and development activities, 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, foreign
exchange rates, general economic and business conditions, 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. 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 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.

 


Release – Direct Digital Holdings Appoints Maria Vilchez Lowrey as Chief Growth Officer for Next Phase of Growth

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Direct Digital Holdings Appoints Maria Vilchez Lowrey as Chief Growth Officer for Next Phase of Growth

Research, News, and Market Data on Direct Digital Holdings

August 22, 2022 9:00am EDT

Proven Track-Record in Delivering Revenue
& Channel Development Results in the Energy Sector to Power Direct Digital
Holdings’ Business Development

HOUSTON, Aug. 22, 2022 /PRNewswire/ — Direct Digital Holdings (Nasdaq: DRCT), a leading advertising and marketing technology platform and owner of operating companies Colossus SSP, Huddled Masses, and Orange 142, announced today that Maria Vilchez Lowrey has joined as Chief Growth Officer. In this newly created role, reporting to Chairman and CEO Mark Walker as a member of Direct Digital Holdings’ leadership team, Vilchez Lowrey is responsible for leading business development, channel development, and integrating the management of brand related activities across Direct Digital Holdings’ portfolio of brands.

 

Additionally, her appointment marks the professional reunion of Vilchez Lowrey with CEO Walker: they worked together earlier in their careers at NRG Energy, a leading Fortune 300 integrated power company. Vilchez Lowrey is an experienced sales leader with a proven 20-year record in creating business-to-consumer and business-to-business sales capabilities at scale within the Fortune 500.

“Few executives have the depth of experience and track-record to accelerate our business to the next level of growth – all while sharing our values and vision for the company,” said Walker. “Having worked together before, I can confidently say that Maria is a transformational executive leader, and I am certain that she will be instrumental in continuing Direct Digital Holdings’ fast-paced growth, setting us up for continued success.”

Vilchez Lowrey comes to Direct Digital Holdings from Just Energy, where she served as Senior Vice President of Direct Sales and Partnerships for Just Energy, Amigo Energy, Tara Energy, and Terrapass, its affiliate brands. There, she was responsible for diversifying the company’s direct sales channels by launching its first national retail partnership with one of the largest retailers in the world. Prior to that, she served in various key management positions across sales leadership, business development, operations, and project management at NRG Energy, Inc., primarily responsible for building new go-to-market sales channels and developing strategic partnerships with the most well-known brands in the country. Prior to NRG, Maria started her career in the steel industry as global supply chain transportation and procurement manager serving large multi-national consumer companies.

“Mark and his leadership team have built an impressive company, delivering on both the sell-and buy-sides of the advertising technology equation,” said Vilchez Lowrey. “The programmatic advertising and martech solutions that they bring to the marketplace are attracting top-tier and mid-market brands due to their high-levels of performance. I look forward to helping the group, its clients, and partners exceed market expectations.”

Vilchez Lowrey holds a B.S. in Management Information Systems from Texas A&M University.

An active member of the non-profit community, Lowrey serves as a board member for Homemade Hope and is an advisory council member for Houston Arts Alliance and Dress for Success Houston. Maria has been honored as Top 100 Diversity Leaders in Energy by the National Diversity Council in Feb 2021.

About Direct Digital
Holdings:

Direct Digital Holdings (Nasdaq: DRCT), owner of operating companies Colossus SSP, Huddled Masses, and Orange 142, brings state-of-the-art sell- and buy-side advertising platforms together under one umbrella company. Direct Digital Holdings’ sell-side platform, Colossus SSP, offers advertisers of all sizes extensive reach within general market and multicultural media properties. The company’s subsidiaries Huddled Masses and Orange142 deliver significant ROI for middle market advertisers by providing data-optimized programmatic solutions at scale for businesses in sectors that range from energy to healthcare to travel to financial services. Direct Digital Holdings’ sell- and buy-side solutions manage approximately 90,000 clients monthly, generating over 100 billion impressions per month across display, CTV, in-app and other media channels. The company has been named a top minority-owned business by The Houston Business Journal.

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/direct-digital-holdings-appoints-maria-vilchez-lowrey-as-chief-growth-officer-for-next-phase-of-growth-301609598.html

SOURCE Direct Digital Holdings

Released August 22, 2022

 


Release – Baudax Bio receives notice of allowance for U.S. Patent Application covering use of ANJESO® for the treatment of moderate to severe pain

Posted on by Admin



Baudax Bio receives notice of allowance for U.S. Patent Application covering use of ANJESO® for the treatment of moderate to severe pain

Research, News, and Market Data on Baudax Bio

August 22, 2022 8:00am EDT

MALVERN, Pa., Aug. 22, 2022 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, announced today that the United States Patent and Trademark Office (“USPTO”) has provided a Notice of Allowance for patent application No. 16/297,095, titled “Methods of administering intravenous meloxicam in a bolus dose”, which includes claims covering the use of multiple doses of ANJESO® for the treatment of moderate to severe pain resulting in a reduction in summed pain intensity difference and also a reduction in the use of rescue analgesia 48 hours following the first dose. (the “’095 Application”). A Notice of Allowance is issued after the USPTO makes the determination that a patent should be granted from an application. A patent from the recently allowed application is expected to be issued in the coming months. Once issued, the ‘095 Application will be eligible for listing in the United States Food and Drug
Administration’s (FDA) Orange Book: Approved Drug Products with Therapeutic
Equivalence Evaluations as it relates to ANJESO®.

Once issued, the ‘095 Application will be the second ANJESO® patent to be listed in the Orange Book with an expiry date of March 2039. Upon issuance, the ‘095 application will join seven other patents listed in the Orange Book, amongst others owned or licensed by Baudax that currently provide exclusivity to the ANJESO
® franchise. The ‘095 Application emphasizes ANJESO’s
® potential to treat moderate to severe pain while potentially reducing the use of rescue analgesics.

“We are pleased by the progress we have made in the United States Patent and Trademark Office and the continued recognition of the inventive nature of our ANJESO® franchise,” said Gerri Henwood, Baudax Bio’s President and Chief Executive Officer. “The ‘095 Application is expected to provide a significant barrier for generic entry and are expected to be joined by other patents currently pending in the USPTO.”

About ANJESO®

ANJESO® (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis. ANJESO® is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. As a non-opioid, Baudax Bio believes ANJESO® has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain. ANJESO
® was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

About Baudax Bio

Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. Baudax Bio markets ANJESO®, 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®, the Company has a pipeline of other innovative pharmaceutical assets including two clinical-stage, novel neuromuscular blocking (NMBs) agents and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com.

Forward-Looking
Statements

This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,” “intend,” and “expect,” and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site, including statements relating to Baudax Bio’s patent portfolio, and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio’s performance to differ materially from those expressed in, or implied by, these forward-looking statements. These risks and uncertainties include, among other things, risks related to market, economic and other conditions, the ongoing economic and social consequences of the COVID-19 pandemic, Baudax Bio’s ability to advance its current product candidate pipeline through pre-clinical studies and clinical trials, Baudax Bio’s ability to raise future financing for continued development of its product candidates such as BX1000, BX2000 and BX3000, Baudax Bio’s ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio’s ability to comply with the financial and other covenants under its credit facility, Baudax Bio’s ability to manage costs and execute on its operational and budget plans, Baudax Bio’s ability to achieve its financial goals; Baudax Bio’s ability to maintain listing on the Nasdaq Capital Market; and Baudax Bio’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio’s business and future results included in Baudax Bio’s filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to Baudax Bio, and Baudax Bio assumes no obligation to update any forward-looking statements except as required by applicable law.

CONTACT:

Investor Relations
Contact:

Argot Partners
Sam Martin / Kaela Ilami
(212) 600-1902
baudaxbio@argotpartners.com

Media Contact:

Argot Partners
David Rosen
(212) 600-1902
david.rosen@argotpartners.com


Primary Logo

Source: Baudax Bio, Inc.

Released August 22, 2022