Category: Health

The Trend Away from Opioids Provides Investors with Many Opportunities

Posted on by phoffman@channelchek.com
Image Credit: Charles Williams (Flickr)

The Growing Field of Non-Opioid Pain Alleviation

Is there money to be made for investors in the business of controlling pain? There is a decreased willingness or ability of doctors to prescribe opioids because of the risk of addiction. This is just one reason the companies making breakthroughs in controlling or alleviating pain are set to get a bigger chunk of the growing industry. The other driver is an aging populous with increased longevity. The non-opioid pain management developments include novel medicines and medical devices to treat, prevent, or assess causes. Investors could benefit from growing their awareness in this healthcare space, particularly some of the smaller companies concentrating on the pain management sector.

The pain management (PM) industry is rapidly growing. Estimates on the potential for the industry were captured in a report by Zion Market Research. The report shows the trajectory of the pain management therapeutics industry is likely to amass earnings of about $81.9 billion by 2026. This is an increase of $16.3 billion over 2019 earnings. Reduced opioid use has opened a path for inventive new therapeutics to become the new go-to where an opioid would have been prescribed previously. This provides investors with an even broader spectrum of publicly traded opportunities to review.

Segments in Pain Management

Treatment of chronic pain has a large base as a major healthcare service. This base provides a solid footing for the business of pain management therapeutics. Pain-relieving drugs such as opioids have been the “go to” medication for patients with severe pain. But their usage needs to be short-term or limited to treat pain in the terminally ill. The reduced and safer use of opioids leave many sufferers needing new alternatives.

As with any other investment space there is a wide swath of segmentation and sectors within the business. The primary pharmaceutical segments in pain management include:

Anesthetics

NSAIDS

Anticonvulsants

Anti-migraine agents

Antidepressants

Non-narcotic analgesics

Neuropathic Pain

Arthritic Pain

Cancer pain

Post-operative Pain

Chronic Back Pain

Fibromyalgia

Migraines

The anticipated growth of pain management therapeutics within North American healthcare is expected to happen on several fronts. Players include the nimble, creative small growth companies as well as the huge established names. Large companies involved in the segment include Novartis AG, Purdue Pharma L.P., AstraZeneca Plc., Mallinckrodt Pharmaceuticals, GlaxoSmithKline Plc., Teva Pharmaceutical Industries Ltd., Pfizer Inc., Depomed, Inc., Johnson & Johnson Services, Inc., Endo International Plc., Merck & Co., Inc., and Abbott Laboratories. These are big corporations where successful individual products aren’t as impactful to the bottom line or stock price movement.

The smaller, more nimble prospects, where developments have a greater impact on value could be worth learning about. There are a number of them that have developed solutions that are just now becoming adopted and substituted for old methods of treatment. Below is a list of five companies in this space that may be worth becoming familiar with:

Baudax Bio Inc.

(BXRX) is a pharmaceutical company. It is focused on innovative products for acute care settings. Baudax Bio markets ANJESO®, the first and only 24-hour, non-opioid, 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.

BXRX is currently trading at $3.45 and has a market cap of $1.73 million.

PainReform Ltd

PRFX is a clinical-stage specialty pharmaceutical company. It is focused on the reformulation of established therapeutics. The company’s product PRF-110 is based on the local anesthetic ropivacaine, targeting the post-operative pain relief market. PRF-110 is an oil-based, viscous, clear solution that is deposited directly into the surgical wound bed before closure to provide localized and extended post-operative analgesia.

PRFX is currently trading at $0.41 and has a market cap of $4.36 million.

NanoVibronix

NAOV is engaged in manufacturing of noninvasive biological response-activating devices which target wound healing and pain therapy, without the assistance of medical professionals. The primary products of the company include WoundShield which is patch-based therapeutic ultrasound device to help regenerate tissue and healing by using ultrasound to increase local capillary perfusion and tissue oxygenation; PainShield which is a disposable patch-based therapeutic ultrasound technology to treat pain, muscle spasm and joint contractures; and UroShield which is an ultrasound-based product designed to prevent bacterial colonization and biofilm in urinary catheters, increase antibiotic efficacy and decrease pain. Most of the company’s revenue comes from the U.S.

NAOV is currently trading at $0.37 with a market cap of $12.14 million.

electroCore Inc.

ECOR is a commercial-stage bioelectronic medicine company with a platform for non-invasive vagus nerve stimulation therapy initially focused on neurology and rheumatology. The company’s product gammaCore is FDA-cleared for adjunctive use for the preventive treatment of cluster headache and for the acute treatment of pain associated with episodic cluster headache and migraine headache in adult patients.

ECOR is trading at $0.28 and has a market cap of $20.27 million.

Bioelectronics Corp.

BIEL is an electroceutical company. It develops wearable, neuromodulation devices to safely mitigate neurological diseases. Its product line includes Actipatch Musculoskeletal Pain Therapy, Allay menstrual pain therapy, Smart insole heel pain therapy and Recovery RX post-operative and Chronic wounds therapy. The company sells its products to wholesale distributors, directly to hospitals and clinics, and consumers.

BIEL tades for under $0.01 a share, but has a market cap of $59.36 million and average trading volume of 13.4 million shares.

Take Away

Investing based on trends that are building is one method to develop a longer-term investment portfolio. One trend that is likely to continue is the move away from addictive opioids used for pain management and towards both pharmaceutical and device-based solutions. As with many sectors this year, stock valuations are down. Does this make one or more of them a smart buy?

Small and microcap investing come with its challenges. Help sort through the plusses and minuses of life sciences companies, both in biotech and medical devices, as two top equity analysts discuss what they look for when evaluating the fundamentals of a company’s prospects. The free event held online on December 15th will also include analysts with expertise in other industries sharing what they deem important in the industries they cover. All in all, it will help small, and microcap investors in the life sciences and other sectors better understand what the seasoned veterans look at.

Paul Hoffman

Managing Editor, Channelchek

Register Today

Sources:

https://www.zionmarketresearch.com/news/pain-management-therapeutics-market

https://www.channelchek.com

https://channelchek.vercel.app/news-channel/New_Developments_in_Pain_Management___a_NobleCon_Online_Investor_Event___Presenting_Companies

Release – Onconova Therapeutics to Present At The Upcoming Medinvest Oncology Investor Conference

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on ONTX

PDF Version

NEWTOWN, Pa., Dec. 07, 2022 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that it will participate in the MedInvest Oncology Investor Conference being held in New York, NY on December 14-15, 2022.

Steven M. Fruchtman, M.D., President and Chief Executive Officer, will present a corporate overview at the conference on Wednesday, December 14th at 9:40 a.m. ET. Dr. Fruchtman and other members of the Onconova management team will also be available for one-on-one meetings at the conference on December 14th.

Those interested in requesting a one-on-one meeting can submit a registration request using the conference website: https://www.medinvestconferences.com/register.

About Onconova Therapeutics, Inc.

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in two separate and complementary Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China.

Onconova’s product candidate rigosertib is being studied in an investigator-sponsored study program, including in a dose-escalation and expansion Phase 1/2a investigator-sponsored study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer.

For more information, please visit www.onconova.com.

Company Contact:
Mark Guerin
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com

Release – Ocugen Announces Update on Ocu400 Phase 1/2 Clinical Trial Targeting Retinitis Pigmentosa and Leber Congenital Amaurosis

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on OCGN

December 7, 2022

Continued Positive Safety Data for OCU400

Established High Dose as the Maximum Tolerable Dose in Current OCU400
Clinical Trial

MALVERN, Pa., Dec. 07, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that the Data Safety and Monitoring Board (DSMB) for the OCU400 clinical trial recently convened and established high dose as the maximum tolerable dose (MTD) in the dose-escalation phase of the study.

“The DSMB has recommended moving forward to dose subsequent subjects with NR2E3 and RHO gene mutations associated with Retinitis Pigmentosa (RP) and CEP290 gene mutations associated with Leber Congenital Amaurosis (LCA) at the targeted dose in the expansion phase of the study,” said Dr. Peter Y. Chang, MD, FACS, Massachusetts Eye Research & Surgery Institution, DSMB Chair for the OCU400 clinical trial. “No serious adverse events (SAEs) related to OCU400 have been reported to date.”

10 patients with NR2E3 and RHO gene mutations associated with RP have been dosed in the Phase 1/2 clinical trial to date. An additional eight patients with these RP gene mutations, along with three patients with CEP290 gene mutations associated with LCA, will be dosed at MTD and enrollment is expected to be complete by the end of Q1 2023.

Data from the MTD has the potential to navigate strategy for the planned Phase 3 study in the U.S. and other major markets. The Company plans to file a Biologics License Application (BLA) for OCU400 in 2025.

Ocugen is committed to finding solutions for people with inherited retinal disease for whom no effective treatment options exist. Currently, RP is associated with mutations in more than 100 genes, affecting more than 2.5 million people globally. LCA is a rare eye disease associated with mutations in more than 25 genes, affecting more than 150,000 people globally.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
Head of Communications
IR@ocugen.com

Baudax Bio (BXRX) – Closing of $5 million Public Offering is Announced

Posted on by cpereira@noblefcm.com


Wednesday, December 07, 2022

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.

Gross proceeds of nearly $5 million or net proceeds around $4.2 million.  The offering consisted of 1,042,087 shares of common stock (or Series C pre-funded warrants) combined with both a Series A-3 warrant to purchase 1,042,087 common shares and a Series A-4 warrant to purchase 1,042,787 common shares.  The combined unit was publicly offered at $4.795 per unit. The pre-funded warrants were offered to purchasers where the offering would result in beneficial ownership greater than 4.99% (or, at the election of the purchaser, 9.99%).

Warrants exercisable at $4.50 per share.  The Series C pre-funded warrants are exercisable at $0.01 per share. The Series A-3 warrants are exercisable immediately and will expire 5 years from date of issuance.  The Series A-4 warrants are exercisable immediately and expire 13 months from date of issuance.


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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. 

Release – Baudax Bio Announces Closing of $5 Million Public Offering

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on BXRX

December 06, 2022 4:11pm EST

MALVERN, Pa., Dec. 06, 2022 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (the “Company” or “Baudax Bio”) (NASDAQ: BXRX), a pharmaceutical company focused on innovative products for hospital and related settings, today announced the closing of its previously announced public offering of an aggregate of 1,042,787 shares of its common stock (or pre-funded warrants in lieu thereof), Series A-3 warrants to purchase up to 1,042,787 shares of common stock and Series A-4 warrants to purchase 1,042,787 shares of common stock, at a combined public offering price of $4.795 per share (or pre-funded warrant) and accompanying warrants. The Series A-3 warrants have an exercise price of $4.50 per share, are exercisable immediately upon issuance and will expire five years from the date of issuance, and the Series A-4 warrants have an exercise price of $4.50 per share, are exercisable immediately upon issuance and will expire thirteen months from the date of issuance.

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, were approximately $5 million. The Company intends to use the net proceeds from this offering for working capital, pipeline development activities and general corporate purposes.

The securities described above were offered pursuant to a registration statement on Form S-1 (File No. 333-268251), which was declared effective by the Securities and Exchange Commission (the “SEC”) on December 2, 2022. The offering was made only by means of a prospectus which forms a part of the effective registration statement. A preliminary prospectus relating to the offering has been filed with the SEC. Electronic copies of the final prospectus may be obtained on the SEC’s website at http://www.sec.gov and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com.

The Company also has agreed that certain existing warrants to purchase up to an aggregate of 374,114 shares of common stock of the Company that were previously issued to an investor in November 2020, January 2021, June 2021, December 2021, March 2022, May 2022 and September 2022, at exercise prices ranging from $21.00 to $43.60 per share and expiration dates ranging from October 2023 to September 2027, were amended effective upon the closing of the offering so that the amended warrants have a reduced exercise price of $4.50 per share and will expire five years following the closing of the offering.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Baudax Bio

Baudax Bio is a pharmaceutical company focused on innovative products for hospital and related settings. The Company has a pipeline of innovative pharmaceutical assets including two clinical-stage, novel neuromuscular blocking (NMBs) agents, one in a Phase II study and an additional unique NMB in a dose escalation Phase I study, as well as a proprietary chemical reversal agent specific to these NMBs. Baudax Bio has received approval for and marketed ANJESO®, the first and only 24-hour, intravenous (IV) COX-2 preferential non-opioid, non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. 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. Forward-looking statements may include, without limitation, statements regarding the use of net proceeds from the offering. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site, including Baudax Bio’s ability to realize any anticipated benefits from the reverse stock split, including maintaining its listing on the Nasdaq Capital Market and attracting new investors. 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 comply with all listing requirements of 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.

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 

Source: Baudax Bio, Inc.

Released December 6, 2022

Release – BioSig’s PURE EP™ System Highlighted in the Journal of Atrial Fibrillation & Electrophysiology

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on BSGM

December 06, 2022

Clinical abstract focuses on value of PURE EP™’s and its groundbreaking High Frequency Algorithm (HFA) during pulmonary vein isolation

Westport, CT, Dec. 06, 2022 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”) an advanced digital signal processing technology company delivering unprecedented accuracy and precision to intracardiac signal visualization with its proprietary PURE EP™ System, today announced that a peer-reviewed case report titled, “Confirmation of Acute Pulmonary Vein Reconnection with The Utilization of PURE EP’s High-Frequency Algorithm (HFA)” has been published in the Journal of Atrial Fibrillation & Electrophysiology. The publication is available electronically via the JAFIB-EP open access digital journal.

Co-authored by Roy Chung, MD, Clinical Cardiac Electrophysiologist at Cleveland Clinic and Zachary Koch, CCDS, CEPS, Clinical Director at BioSig Technologies, Inc., the case report describes a 65-year-old patient with a medical history of symptomatic and persistent atrial fibrillation undergoing pulmonary vein isolation (PVI). PURE EP™’s HFA signal analysis was observed alongside the simultaneous signal anno New Primary Logo New Primary Logotation produced by a 3D mapping system. PURE EP™’s real-time HFA identified early local activation, providing a clear and precise location that served as the primary target for ablation therapy during the procedure. Results from the case study support the efficacy of PURE EP™’s HFA in identification of the pulmonary vein gap compared to the inferior annotation produced by the 3D mapping system.1 

“This case study adds to the growing pipeline of clinical evidence validating the PURE EP™ System as an essential and valuable technology for today’s EP lab—particularly for challenging cases,” commented Gray Fleming, Chief Commercial Officer, BioSig Technologies, Inc. “We believe that these findings, along with other clinical applications we continue to explore in collaboration with the Cleveland Clinic, demonstrate PURE EP™’s ability to set new standards in the field of electrophysiology.”

In October, the Company signed a master research agreement with Cleveland Clinic to explore expanded applications for its digital signal processing technology.

The proprietary High Frequency Algorithm (HFA)—a proprietary feature found only in the PURE EP™ System—reclaims the specificity lost within the blended data of the traditional bipolar wave. HFA enables electrophysiologists to apply specific near-field frequency data to the treatment of even the most complex arrhythmias. By removing unnecessary distractions, the PURE EP™ System with HFA preserves the value of cardiac signals and delivers clear, actionable insights to today’s electrophysiologist.

About BioSig Technologies
BioSig Technologies is an advanced digital signal processing technology company bringing never-before-seen insights to the treatment of cardiovascular arrhythmias. Through collaboration with physicians, experts, and healthcare leaders across the field of electrophysiology (EP), BioSig is committed to addressing healthcare’s biggest priorities — saving time, saving costs, and saving lives.

The Company’s first product, the PURE EP™ System, an FDA 510(k) cleared non-invasive class II device, provides superior, real-time signal visualization allowing physicians to perform insight-based, highly targeted cardiac ablation procedures with increased procedural efficiency and efficacy.

The PURE EP™ System is currently in a national commercial launch and an integral part of well-respected healthcare systems, such as Mayo Clinic, Texas Cardiac Arrhythmia Institute, Cleveland Clinic, and Kansas City Heart Rhythm Institute. In a blinded clinical study recently published in the Journal of Cardiovascular Electrophysiology, electrophysiologists rated PURE EP™ as equivalent or superior to conventional systems for 93.6% of signal samples, with 75.2% earning a superior rating.

The global EP market is projected to reach $16B in 2028 with a 11.2% growth rate.2

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) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) 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.

1 Koch W. Zachary; Chung, Roy (2022), Confirmation of Acute Pulmonary Vein Reconnection with Case Report: The Utilization of PURE EP’s High-Frequency Algorithm (HFA), Journal of Atrial Fibrillation & Electrophysiology, Volume 15, Issue 6, Nov 2022. https://jafib-ep.com/journal/volume-15-issue-6-nov-2022/confirmation-of-acute-pulmonary-vein-reconnection-with-the-utilization-of-pure-eps-high-frequency-algorithm-hfa/

2 Global Market Insights Inc. March 08, 2022.

Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
55 Greens Farms Road, 1st Floor
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x133
 
 

Source: BioSig Technologies, Inc.

Released December 6, 2022

Schwazze (SHWZ) – A New Location

Posted on by cpereira@noblefcm.com


Tuesday, December 06, 2022

Schwazze (OTCQX:SHWZ, NEO:SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale. The Company is committed to unlocking the full potential of the cannabis plant to improve the human condition. Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector. Schwazze is passionate about making a difference in our communities, promoting diversity and inclusion, and doing our part to incorporate climate-conscious best practices.

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.

A New Dispensary. Yesterday, Schwazze announced the opening of a new dispensary in New Mexico. Located at 2245 Main Street in Los Lunas, the dispensary brings the total of New Mexico dispensaries to 14. The opening continues Schwazze’s expansion strategy within New Mexico, and we expect to see more opening and/or acquisitions in the future, especially near Albuquerque and the Texas-New Mexico border.

Being Positive. We hosted the Company’s CEO Justin Dye and CFO Nancy Huber in a series of Non-Deal Road Show meetings last week, and following are a couple of highlights from the meeting. Significantly, management noted the Company is one of only six MSOs to generate positive cashflow, of which the Company generated $14.5 million from operations LTM as of 3Q 2022.


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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. 

Release – DLH Reports Fiscal 2022 Fourth Quarter Results

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on DLH

 

December 5, 2022

PDF Version

Revenue of $67.2 Million for Quarter, $395.2 Million for Fiscal Year; Debt Reduced to $22.0 Million

ATLANTA, Dec. 05, 2022 (GLOBE NEWSWIRE) — DLH Holdings Corp. (NASDAQ: DLHC) (“DLH” or the “Company”), a leading provider of innovative healthcare services and solutions to federal agencies, today announced financial results for its fiscal fourth quarter ended September 30, 2022.

Highlights

  • Fourth quarter revenue increased to $67.2 million in fiscal 2022 from $65.2 million in fiscal 2021, reflecting growth of 3% year-over-year
  • For the full fiscal year, revenue rose to $395.2 million from $246.1 million, reflecting the previously announced short term FEMA contracts to support Alaska, which contributed $125.8 million to revenue in the fiscal year
  • Excluding these short-term contracts, revenue grew to $269.4 million, an increase of 10% over the prior year, reflecting volume growth on existing contracts
  • Earnings were $3.4 million, or $0.24 per diluted share, for the fiscal 2022 fourth quarter versus $2.9 million, or $0.21 per diluted share, for the fourth quarter of fiscal 2021
  • Earnings for the full year were $23.3 million, or $1.64 per diluted share for fiscal 2022 as compared to earnings for fiscal 2021 of $10.1 million, or $0.75 per diluted share.
  • Excluding the FEMA contracts, earnings on a non-GAAP basis for the full fiscal year were $14.1 million, or $0.99 per diluted share, versus $10.0 million, or $0.74 per diluted share, for fiscal 2021
  • The Company’s secured term loan was reduced from $46.8 million to $22.0 million during the fiscal year
  • Contract backlog was $482.5 million as of September 30, 2022 versus $651.5 million at the end of the prior fiscal year, with approximately $85 million of the latter related to the FEMA contracts

Management Discussion
“Fiscal 2022 was a year that, once again, demonstrated the strength of our people, the ability of our platform to deliver excellent results and the agility of the Company’s advanced technological capabilities, driving us to record performance and positioning us well for the quarters to come,” said DLH President and Chief Executive Officer Zach Parker. “We begin fiscal 2023 with a healthy backlog of $482.5 million representing our diverse programs across numerous agencies in the markets we serve. In addition, we further paid down debt, leaving the Company with a solid balance sheet and the financial flexibility to fund business growth initiatives and invest in our people. As we look towards the future, I’d like to thank our employees for a standout year as you continue to support critical efforts and programs that support our nation. Given the longstanding demand for our services, broad bipartisan support in Congress, and our innovative, data-driven solutions, we remain optimistic about the quarters to come.”

Results for the Three Months Ended September 30, 2022
Revenue for the fourth quarter of fiscal 2022 was $67.2 million versus $65.2 million in the prior-year period. The 3% increase year-over-year reflects continued growth across the Company’s existing contracts.

Income from operations was $4.7 million for the quarter versus $4.0 million in the prior-year period and, as a percent of revenue, the Company reported an operating margin of 7.0% in fiscal 2022 fourth quarter versus 6.2% in same period in fiscal 2021. Income from operations increased due to higher revenue and improved program mix, offset by investments in the human capital and business development functions and increased compliance costs.

Interest expense was $0.5 million in the fiscal fourth quarter of 2022 versus $0.8 million in the prior-year period, reflecting the decrease of debt outstanding. Income before provision for income taxes was $4.2 million this year versus $3.2 million in fiscal 2021, representing 6.3% and 5.0% of revenue, respectively, for each period.

For the three months ended September 30, 2022 and 2021, respectively, DLH recorded a $0.8 million and $0.3 million provision for income taxes. The Company reported net income of approximately $3.4 million, or $0.24 per diluted share, for the fourth quarter of fiscal 2022 versus $2.9 million, or $0.21 per diluted share, for the fourth quarter of fiscal 2021. As a percent of revenue, net income was 5.1% for the fourth quarter of fiscal 2022 versus 4.4% for the prior year period.

On a non-GAAP basis, EBITDA for the three months ended September 30, 2022 was approximately $6.6 million versus $6.0 million in the prior-year period, or 9.8% and 9.3% of revenue, respectively.

Key Financial Indicators
For the 2022 fiscal year, DLH produced $1.2 million in operating cash, reflecting the impact of the $22.3 million deferred revenue on the previously-completed FEMA contracts, for which there were advance payments in the fourth quarter of fiscal 2021. The overall increase in accounts receivable versus the prior-year period reflects normal fluctuations in the timing of customer payments and growth in the overall business volume.

As of September 30, 2022, the Company had cash of $0.2 million and debt outstanding under its credit facilities of $22.0 million versus cash of $24.1 million and debt outstanding of $46.8 million as of September 30, 2021.

At September 30, 2022, total backlog was approximately $482.5 million, including funded backlog of approximately $98.9 million, and unfunded backlog of $383.5 million.

Conference Call and Webcast Details
DLH management will discuss fourth quarter results and provide a general business update, including current competitive conditions and strategies, during a conference call beginning at 10:00 AM Eastern Time today, December 5, 2022. Interested parties may listen to the conference call by dialing 888-347-5290 or 412-317-5256. Presentation materials will also be posted on the Investor Relations section of the DLH website prior to the commencement of the conference call.

A digital recording of the conference call will be available for replay two hours after the completion of the call and can be accessed on the DLH Investor Relations website or by dialing 877-344-7529 and entering the conference ID 3802471.

About DLH

DLH (NASDAQ:DLHC) delivers improved health and readiness solutions for federal programs through research, development, and innovative care processes. The Company’s experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike, leveraging digital transformation, artificial intelligence, advanced analytics, cloud-based applications, telehealth systems, and more. With over 2,400 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of government sector experience, proven methodology, and unwavering commitment to public health to improve the lives of millions. For more information, visit www.DLHcorp.com.

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995:
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or DLH`s future financial performance. Any statements that refer to expectations, projections or other characterizations of future events or circumstances or that are not statements of historical fact (including without limitation statements to the effect that the Company or its management “believes”, “expects”, “anticipates”, “plans”, “intends” and similar expressions) should be considered forward looking statements that involve risks and uncertainties which could cause actual events or DLH’s actual results to differ materially from those indicated by the forward-looking statements. Forward-looking statements in this release include, among others, statements regarding estimates of future revenues, operating income, earnings and cash flow. These statements reflect our belief and assumptions as to future events that may not prove to be accurate. Our actual results may differ materially from such forward-looking statements made in this release due to a variety of factors, including: the impact of the novel coronavirus (“COVID-19”), including the measures to reduce its spread, and its impact on the economy and demand for our services, are uncertain, cannot be predicted, and may precipitate or exacerbate other risks and uncertainties; the risk that we will not realize the anticipated benefits of acquisitions; the challenges of managing larger and more widespread operations; contract awards in connection with re-competes for present business and/or competition for new business; compliance with bank financial and other covenants; changes in client budgetary priorities; government contract procurement (such as bid and award protests, small business set asides, loss of work due to organizational conflicts of interest, etc.) and termination risks; the ability to successfully integrate the operations of acquisitions; the impact of inflation and higher interest rates; and other risks described in our SEC filings. For a discussion of such risks and uncertainties which could cause actual results to differ from those contained in the forward-looking statements, see “Risk Factors” in the Company’s periodic reports filed with the SEC, including our Annual Report on Form 10-K for the fiscal year ended September 30, 2022, as well as subsequent reports filed thereafter. The forward-looking statements contained herein are not historical facts, but rather are based on current expectations, estimates, assumptions and projections about our industry and business.

Such forward-looking statements are made as of the date hereof and may become outdated over time. The Company does not assume any responsibility for updating forward-looking statements, except as may be required by law.

CONTACTS:

INVESTOR RELATIONS
Contact: Chris Witty
Phone: 646-438-9385
Email: cwitty@darrowir.com

TABLES TO FOLLOW

DLH HOLDINGS CORP.
CONSOLIDATED STATEMENTS OF INCOME
(Amounts in thousands except per share amounts)

DLH HOLDINGS CORP.
CONSOLIDATED BALANCE SHEETS
(Amounts in thousands except par value of shares)

DLH HOLDINGS CORP.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Amounts in thousands)

Non-GAAP Financial Measures
The Company uses EBITDA and EBITDA as a percent of revenue as supplemental non-GAAP measures of performance. We define EBITDA as net income excluding (i) interest expense, (ii) provision for or benefit from income taxes and (iii) depreciation and amortization. EBITDA as a percent of revenue is EBITDA for the measurement period divided by revenue for the same period.

The Company is presenting additional non-GAAP measures to describe the impact from two short-term FEMA task orders on its financial performance for the three and twelve months periods ended September 30, 2022. The measures presented are revenue, operating income, net income, diluted earnings per share, and EBITDA for our enterprise contract portfolio less the respective performance on the FEMA task orders. These resulting measures present the remaining contract portfolio’s quarterly financial performance compared to results delivered in the prior year period. Definitions of these additional non-GAAP measures are set forth in the footnotes to the reconciliation table below.

These non-GAAP measures of performance are used by management to conduct and evaluate its business during its review of operating results for the periods presented. Management and the Company’s Board utilize these non-GAAP measures to make decisions about the use of the Company’s resources, analyze performance between periods, develop internal projections and measure management performance. We believe that these non-GAAP measures are useful to investors in evaluating the Company’s ongoing operating and financial results and understanding how such results compare with the Company’s historical performance.

(a): Revenue for the Company’s remaining contract portfolio less the FEMA task orders represents our consolidated revenues less the revenues generated from the FEMA task orders.

(b): Operating income attributable to the remaining contract portfolio less the FEMA task orders represents the Company’s consolidated operating income, determined in accordance with GAAP, less the operating income derived from the FEMA task orders. Similarly, for the year ended September 30, 2022 operating income for the FEMA task orders is derived by subtracting from the revenue attributable to the tasks orders of $125.8 million the following amounts associated with such task orders: contract costs $112.1 million and general & administrative costs of $1.2 million.

(c): Net income attributable to the remaining contract portfolio less the FEMA task orders represents the Company’s consolidated net income, determined in accordance with GAAP, less the net income derived from the FEMA task orders. For the year ended September 30, 2022 net income for the FEMA task orders is derived by subtracting from the revenue attributable to the tasks orders of $125.8 million the following amounts associated with such task orders: contract costs of $112.1 million, general & administrative costs of $1.2 million, and provision for income taxes of $3.2 million.

(d): Diluted earnings per share (diluted EPS) for the FEMA task orders is calculated using the net income attributable to such task orders as opposed to GAAP net income. Diluted EPS for the remaining contract portfolio (total contract portfolio excluding the FEMA task orders) is calculated by subtracting the diluted EPS for the FEMA task orders from the Company’s total diluted EPS.

(e): EBITDA attributable to the FEMA task orders of $12.5 million for the year ended September 30, 2022, is arrived at through the same calculation as operating income as there are not any depreciation and amortization costs attributable to the FEMA task orders. EBITDA for the remaining contract portfolio is calculated by subtracting the EBITDA attributable to the FEMA task orders from the Company’s total EBITDA.

Release – Tonix Pharmaceuticals Announces Collaboration with Boston Children’s Hospital to Study TNX-1500 (Fc-modified anti-CD40L mAb) for the Prevention of Graft-versus-Host Disease (GvHD) Following Hematopoietic Stem Cell Transplantation in Animals

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on TNXP

December 05, 2022 7:00am EST

Hematopoietic Stem Cell Transplantation (HCT) from Unrelated Donors is a Component of the Treatment Protocol for Several Hematologic Malignancies

GvHD Complicates Treatment and Limits the Success of Engraftment after HCT

In addition to GvHD, Tonix is Developing TNX-1500 for Prophylaxis of Organ Transplant Rejection and Treatment of Autoimmune Disorders

Phase 1 Study of TNX-1500 is Expected to Start in First Half 2023

CHATHAM, N.J., Dec. 05, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that it has entered into a sponsored research agreement with Boston Children’s Hospital to study TNX-15001 (Fc-modified anti-CD40L mAb) for the prevention of graft-versus-host disease (GvHD) after hematopoietic stem cell transplantation (HCT) in animals. The principal investigator is Leslie S. Kean M.D., Ph.D., Director, Stem Cell Transplantation Program, Division of Hematology/Oncology, Boston Children’s Hospital, Department of Pediatric Oncology, Dana-Farber Cancer Institute and Robert A. Stranahan Professor of Pediatrics, Harvard Medical School. The primary objective of the preclinical research study is to study the activity of TNX-1500 administered prophylactically to modify GvHD progression in animals after HCT to support an Investigational New Drug (IND) application for human studies. A Phase 1 study of TNX-1500 to assess pharmacokinetics and tolerability is expected to start in the first half of 2023.

“We are excited to work with Leslie Kean on studying the potential of TNX-1500 for preventing GvHD after HCT,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Stem cell transplantation is an essential component of the treatment of several blood cell or hematologic cancers, but GvHD remains the most deadly complication, and limits the success of this otherwise life-saving treatment. To date, there has not been a humanized anti-CD40L antibody that can effectively prevent transplant rejection or GvHD with acceptable levels of tolerability. TNX-1500 is a third generation anti-CD40L monoclonal antibody that has been designed by protein engineering to decrease FcγRII binding and to reduce the potential for thrombosis. We are excited to sponsor this study of testing anti-CD40L in HCT to potentially replace cyclophosphamide in the post-transplant setting.  A positive result would potentially support an IND and human studies.”

Dr. Kean, the principal investigator of the sponsored research said, “GvHD remains one of the most severe complications associated with HCT. For myeloablative MHC-haploidentical HCT, the risk of GvHD is substantial, and with the most severe form of acute GvHD, as many as half of patients can die from this disease. For these high-risk transplants, there is no fully effective GvHD prevention strategy. I have studied first generation anti-CD40L antibodies previously and I’m excited to test the effects of Tonix’s Fc-modified anti-CD40L.”

Dr. Lederman continued, “The application that we envision is for post-HCT, when the GvHD-causing alloreactive T cells are at peak activation.  This is the timing for post-transplant cyclophosphamide that has been shown to decrease chronic GvHD, allow for haplo-identical transplants and shorten the period of profound immunosuppression.  In post-transplant cyclophosphamide therapy, the effect is targeted to the appropriate cells by the cell cycle of activated T cells.  In CD40L therapy, we believe appropriate T cells may be targeted by the transient expression of CD40L.  To be successful, the post-HCT indication requires prolonged engraftment. Anti-CD40L is already used in solid organ transplant tolerance models (and therapy) that only require transient chimerism.”

About TNX-1500

TNX-15001 (Fc-modified anti-CD40L mAb) is a humanized monoclonal antibody that interacts with the CD40-ligand (CD40L), which is also known as CD154. TNX-1500is being developed for the prevention of allograft and xenograft rejection, for the treatment of autoimmune diseases and for the prevention of graft-versus-host disease (GvHD) after hematopoietic stem cell transplantation (HCT). A Phase 1 study of TNX-1500 is expected to be initiated in the first half of 2023. TNX-1500 is a third generation anti-CD40L mAb that has been designed by protein engineering to decrease FcγRII binding and to reduce the potential for thrombosis. In June 2022, Tonix announced data from three oral presentations at the 2022 American Transplant Congress by faculty at the Center for Transplantation Sciences, Massachusetts General Hospital. The data involved studies of TNX-1500 in development for the prevention of organ transplant rejection. The animal studies found that TNX-1500 showed activity in preventing organ rejection and was well tolerated in non-human primates. Blockade of CD40L with TNX-1500 monotherapy consistently and safely prevented pathologic alloimmunity in non-human primate models of cardiac and kidney allograft transplantation without clinical thrombosis. Copies of the presentations are available under Scientific Presentations on the Tonix Pharmaceuticals corporate website at www.tonixpharma.com.

1TNX-1500 is a biologic at the pre-IND stage of development and has not been approved for any indication

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 second 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 consists of a vaccine in development to prevent smallpox and monkeypox, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. 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 first half of 2023. Tonix’s lead vaccine candidate for COVID-19 is TNX-1850, a live virus vaccines based on Tonix’s recombinant pox live virus vector vaccine platform.

*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 December 5, 2022

Release – Schwazze Opens Cannabis Dispensary In New Mexico Serving Los Lunas Community; Second R.Greenleaf Store To Open Within A Week

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on SHWZ

December 5, 2022

NEO: SHWZ
OTCQX: SHWZ

Grand Opening Event Scheduled for Wednesday, December 17th

DENVER, Dec. 5, 2022 /CNW/ – Schwazze, (OTCQX: SHWZ)  (NEO: SHWZ) (“Schwazze” or the “Company”), a premier vertically integrated, multi-state operating cannabis company with assets in Colorado and New Mexico, announces the grand opening of its adult-use dispensary, R.Greenleaf, located in Los Lunas, New Mexico. The new store, located at 2245 Main Street in Los Lunas, officially opened its doors for business on December 1st. Store operating hours are 10a to 10p Monday through Saturday; 10a to 8p on Sunday.

The Los Lunas R.Greenleaf store opening continues the deliberate expansion throughout the state of New Mexico and comes on the heels of the store opening just one week ago in Sunland Park which followed two store openings in Ruidoso and Clovis in the last 60 days. This brings R.Greenleaf’s total number of New Mexico retail dispensaries to 14. All locations serve the needs of medical patients as well as recreational adult-use consumers.

“We are thrilled to be opening up the second R.Greenleaf dispensary in New Mexico within one week’s time. The team has been incredibly hard at work to make this happen,” said Steve Pear, New Mexico Division President for Schwazze. “R.Greenleaf, offering a wide variety of quality products serviced by top-notch, knowledgeable staff, has grown from 10 locations to now 14 in New Mexico since Schwazze purchased the retail banner earlier this year.”

A grand opening celebration of Los Lunas R.Greenleaf will be held on Saturday, December, 17th, beginning at 10a and running until 3p. Swag bags will be available to the first 50 shoppers featuring a tote bag, branded rolling papers and other R.Greenleaf gear. DJ Sonya G will be on site during the event to provide tunes for all in attendance, and Ribs Hickory Pit BBQ will provide free pulled pork sandwiches for the first 50 customers making a purchase.

R.Greenleaf Los Lunas will also offer introductory pricing on flower, edibles, and vapes beginning on the 17th and continuing through December 24th. Enrollment in the Gratify Rewards loyalty program is already open. Gratify Rewards members that make a purchase of any amount on December 17th will automatically be entered to win a $100 R.Greenleaf gift card.  

Los Lunas Store Location
R.Greenleaf
2245 Main Street
Los Lunas, New Mexico 87031

Grand Opening Celebration
Saturday, December 17th
10a to 3p

Since April 2020, Schwazze has acquired, opened or announced the planned acquisition of 39 cannabis retail dispensaries as well as seven cultivation facilities and two manufacturing plants in Colorado and New Mexico. In May 2021, Schwazze announced its Biosciences division and in August 2021 it commenced home delivery services in Colorado.

About Schwazze
Schwazze (OTCQX: SHWZ  NEO: SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale. The Company is committed to unlocking the full potential of the cannabis plant to improve the human condition. Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector. Schwazze is passionate about making a difference in our communities, promoting diversity and inclusion, and doing our part to incorporate climate-conscious best practices.

Medicine Man Technologies, Inc. was Schwazze’s former operating trade name. The corporate entity continues to be named Medicine Man Technologies, Inc. Schwazze derives its name from the pruning technique of a cannabis plant to enhance plant structure and promote healthy growth.

Forward-Looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “plan,” “will,” “may,” “continue,” “predicts,” or similar words. Forward-looking statements are not guarantees of future events or 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. Consequently, actual events and 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) our inability to manufacture our products and product candidates on a commercial scale on our own or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; (v) difficulties in securing regulatory approval to market our products and product candidates; (vi) our ability to successfully execute our growth strategy in Colorado and outside the state, (vii) our ability to consummate the acquisition described in this press release or to identify and consummate future acquisitions that meet our criteria, (viii) our ability to successfully integrate acquired businesses, including the acquisition described in this press release, and realize synergies therefrom, (ix) the ongoing COVID-19 pandemic, * the timing and extent of governmental stimulus programs, and (xi) the uncertainty in the application of federal, state and local laws to our business, and any changes in such laws. 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 except as required by law.

View original content to download multimedia:https://www.prnewswire.com/news-releases/schwazze-opens-cannabis-dispensary-in-new-mexico-serving-los-lunas-community-second-rgreenleaf-store-to-open-within-a-week-301692941.html

SOURCE Schwazze

MustGrow Biologics Corp. (MGROF) – Reports Third Quarter Results

Posted on by cpereira@noblefcm.com


Monday, December 05, 2022

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.

3Q Results. MustGrow reported revenue of $1,308 (all figures in Canadian dollars) in the third quarter of 2022 versus our estimate of zero, as the Company is still in the pre-revenue stage. The Company reported a net loss of $2.13 million, or a loss of $0.04 per share, compared to our estimate of a net loss of $1.32 million or a loss of $0.03 per share. In the year ago period, MustGrow reported revenue of $12,869 and a net loss of $696,115, or a loss of $0.02 per share.

Expenses. The increase in the net loss was driven by a large increase year-over-year in the stock-based compensation line, from $112,469 to $1.11 million, and higher than our estimate of $200,000. All other expenses were roughly in line with our expectations, although we note that the Company can experience fluctuations in expenses due to the regulatory approval processes.


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. 

GABY (GABLF) – Early Indications of Improving Operating Environment

Posted on by cpereira@noblefcm.com


Monday, December 05, 2022

GABY Inc. is a California-focused retail consolidator and the owner of Mankind Dispensary, one of the oldest licensed dispensaries in California. Mankind is a well-known, and highly respected dispensary with deep roots in the California cannabis community operating in San Diego, California. GABY curates and sells a diverse portfolio of products, including its own proprietary brands, Lulu’s™ and Kind Republic™ through Mankind, manufactures Kind Republic, and distributes all its proprietary brands through its wholly owned subsidiary, GABY Manufacturing. A pioneer in the industry with a multi-vertical retail foundation, and a strong management team with experience in retail, consolidation, and cannabis, GABY is poised to­­­ grow its retail operations both organically and through acquisition.

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.

3Q22 Revenue. GABY reported third quarter revenue of $5.35 million (all figures in U.S. $), down from $7.6 million reported last year, although adjusted for the closure of the wholesale distribution business, revenue was down $1.3 million, or 20%. Net loss was $3.76 million, or a loss of $0.01 per share, compared to a loss of $3.41 million, or a loss of $0.01 per share, year-over-year. A still difficult operating environment due to lower pricing and reduced demand combined with increased competition and forex losses impacted results.

A Ray of Light? Notably, on a sequential basis, revenue was up $0.2 million, or 4%, from the second quarter of 2022, potentially indicating an upturn in the depressed California market. Gross margin increased to 46.5% from 43.2%, sequentially, and was up from 39.3% year-over-year. The Mankind dispensary experienced a 2.5% growth in the number of transactions to 74,331, with a consistent average transaction value of $70 when comparing 2Q22 with 3Q22. 


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. 

Is There a Better Drug Patenting System?

Posted on by phoffman@channelchek.com
Image Credit: Alexandros Chatzidimos (Pexels)

Pharma’s Expensive Gaming of the Drug Patent System is Successfully Countered by the Medicines Patent Pool, Which Increases Global Access and Rewards Innovation

Biomedical innovation reached a new era during the COVID-19 pandemic as drug development went into overdrive. But the ways that brand companies license their patented drugs grant them market monopoly, preventing other entities from making generics so they can exclusively profit. This significantly limits the reach of lifesaving drugs, especially to low- and middle-income countries, or LMICs.

This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic experts. It represents the research-based findings and thoughts of Lucy Xiaolu Wang, Assistant Professor of Resource Economics, UMass Amherst

Drug Patents in the Global Landscape

Patents are designed to provide incentives for innovation by granting monopoly power to patent holders for a period of time, typically 20 years from the application filing date.

However, this intention is complicated by strategic patenting. For example, companies can delay the creation of generic versions of a drug by obtaining additional patents based on slight changes to its formulation or method of use, among other tactics. This “evergreens” the company’s patent portfolio without requiring substantial new investments in research and development.

Furthermore, because patents are jurisdiction-specific, patent rights granted in the U.S. do not automatically apply to other countries. Firms often obtain multiple patents covering the same drug in different countries, adapting claims based on what is patentable in each jurisdiction.

To incentivize technology transfer to low- and middle-income countries, member nations of the World Trade Organization signed the 1995 Agreement on Trade-Related Aspects of Intellectual Property Rights, or TRIPS, which set the minimum standards for intellectual property regulation. Under TRIPS, governments and generic drug manufacturers in low- and middle-income countries may infringe on or invalidate patents to bring down patented drug prices under certain conditions. Patents in LMICs were also strengthened to incentivize firms from high-income countries to invest and trade with LMICs.

The 2001 Doha Declaration clarified the scope of TRIPS, emphasizing that patent regulations should not prevent drug access during public health crises. It also allowed compulsory licensing, or the production of patented products or processes without the consent of the patent owner.

One notable example of national patent law in practice after TRIPS is Novartis’ anticancer drug imatinib (Glivec or Gleevec). In 2013, India’s Supreme Court denied Novartis’s patent application for Glivec for obviousness, meaning both experts or the general public could arrive at the invention themselves without requiring much skill or thought. The issue centered on whether new forms of known substances, in this case a crystalline form of imatinib, were too obvious to be patentable. At the time, Glivec had already been patented in 40 other countries. As a result of India’s landmark ruling, the price of Glivec dropped from 150,000 INR (about US$2,200) to 6,000 INR ($88) for one month of treatment.

Patent Challenges and Pools

Although TRIPS seeks to balance incentives for innovation with access to patented technologies, issues with patents still remain. Drug cocktails, for example, can contain multiple patented compounds, each of which can be owned by different companies. Overlapping patent rights can create a “patent thicket” that blocks commercialization. Treatments for chronic conditions that require a stable and inexpensive supply of generics also pose a challenge, as the cost burden of long-term use of patented drugs is often unaffordable for patients in low- and middle-income countries.

One solution to these drug access issues is patent pools. In contrast to the currently decentralized licensing market, where each technology owner negotiates separately with each potential licensee, a patent pool provides a “one-stop shop” where licensees can get the rights for multiple patents at the same time. This can reduce transaction costs, royalty stacking and hold-up problems in drug commercialization.

Patent pools were first used in 1856 for sewing machines and were once ubiquitous across multiple industries. Patent pools gradually disappeared after a 1945 U.S. Supreme Court decision that increased regulatory scrutiny, hindering the formation of new pools. Patent pools were later revived in the 1990s in response to licensing challenges in the information and communication technology sector.

Patent pools create a one-stop shop for multiple patients, allowing multiple licensees to enter the market. Lucy Xiaolu Wang, CC BY-NC-ND

The Medicines Patent Pool

Despite many challenges, the first patent pool created for the purpose of promoting public health formed in 2010 with support from the United Nations and Unitaid. The Medicines Patent Pool, or MPP, aims to spur generic licensing for patented drugs that treat diseases disproportionately affecting low- and middle-income countries. Initially covering only HIV drugs, the MPP later expanded to include hepatitis C and tuberculosis drugs, many medications on the World Health Organization’s essential medicines list and, most recently, COVID-19 treatments and technologies.

But how much has the MPP improved drug access?

I sought to answer this question by examining how the Medicines Patent Pool has affected generic drug distribution in low- and middle-income countries and biomedical research and development in the U.S. To analyze the MPP’s influence on expanding access to generic drugs, I collected data on drug licensing contracts, procurement, public and private patents and other economic variables from over 100 low- and middle-income countries. To analyze the MPP’s influence on pharmaceutical innovation, I examined data on new clinical trials and new drug approvals over this period. This data spanned from 2000 to 2017.

The Medicines Patent Pool works as an intermediary between branded drug companies and generic licensees, increasing access to drugs. Lucy Xiaolu Wang, CC BY-NC-ND
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I found that the MPP led to a 7% increase in the share of generic drugs supplied to LMICs. Increases were greater in countries where drugs are patented and in countries outside of sub-Saharan Africa, where baseline generic shares are lower and can benefit more from market-based licensing.

I also found that the MPP generated positive spillover effects for innovation. Firms outside the pool increased the number of trials they conducted on drug cocktails that included MPP compounds, while branded drug firms participating in the pool shifted their focus to developing new compounds. This suggests that the MPP allowed firms outside the pool to explore new and better ways to use MPP drugs, such as in new study populations or different treatment combinations, while brand name firms participating in the pool could spend more resources to develop new drugs.

The MPP was also able to lessen the burden of post-market surveillance for branded firms, allowing them to push new drugs through clinical trials while generic and other independent firms could monitor the safety and efficacy of approved drugs more cheaply.

Overall, my analysis shows the MPP effectively expanded generic access to HIV drugs in developing countries without diminishing innovation incentives. In fact, it even spurred companies to make better use of existing drugs.

Technology Licensing for COVID-19 and Beyond

Since May 2020, the Medicines Patent Pool has become a key partner of the World Health Organization COVID-19 Technology Access Pool, which works to spur equitable and affordable access to COVID-19 health products globally. The MPP has not only made licensing for COVID-19 health products more accessible to low- and middle-income countries, but also helped establish an mRNA vaccine technology transfer hub in South Africa to provide the technological training needed to develop and sell products treating COVID-19 and beyond.

Licensing COVID-19-related technologies can be complicated by the large amount of trade secrets involved in producing drugs derived from biological sources. These often require additional technology transfer beyond patents, such as manufacturing details. The MPP has also worked to communicate with brand firms, generic manufacturers and public health agencies in low- and middle-income countries to close the licensing knowledge gap.

Questions remain on how to best use licensing institutions like the MPP to increase generic drug access without hampering the incentive to innovate. But the MPP is proving that it is possible to align the interests of Big Pharma and generic manufacturers to save more lives in developing countries. In October 2022, the MPP signed a licensing agreement with Novartis for the leukemia drug nilotinib – the first time a cancer drug has come under a public health-oriented licensing agreement.