Tag: Health

Schwazze (SHWZ) – In for the Long Haul

Posted on by cpereira@noblefcm.com


Friday, May 17, 2024

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, CFA, Managing Director, Equity Research Analyst, Generalist , 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.

1Q24 Results. Revenue of $41.6 million was up 4% y-o-y, driven by new store growth. Gross margin declined to 43.1% from 54.6% due to pricing pressure in New Mexico and a higher mix of lower margined medical sales. Schwazze reported an operating loss of $2.7 million compared to $5.6 million of operating profit in 1Q23. GAAP net loss totaled $18.2 million, or a loss of $0.24/sh, versus essentially breakeven last year. We had estimated revenue of $42.5 million and a net loss of $11.6 million, or a loss of $0.16/sh.

Environment Still Challenging. The Colorado and New Mexico markets remain some of the most competitive cannabis markets in the country. A supply/demand situation still coming into balance and too many retail locations will continue to impact both markets in the near-term.


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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. 

This $850M Biotech Deal Could Disrupt the Atopic Dermatitis Market

Posted on by slightbourne@noblecapitalmarkets.com

In a strategic move to strengthen its dermatology portfolio, pharmaceutical giant Johnson & Johnson has agreed to acquire Proteologix, a privately-held biotech developing bispecific antibody therapies for inflammatory skin diseases like atopic dermatitis. The $850 million all-cash deal gives J&J access to promising clinical and preclinical stage assets.

The crown jewel of the acquisition is Proteologix’s lead candidate PX128, a Phase 1-ready bispecific antibody targeting two key drivers of atopic dermatitis and asthma – interleukin-13 (IL-13) and thymic stromal lymphopoietin (TSLP). By simultaneously blocking these complementary inflammatory pathways, PX128 could provide a substantial efficacy boost over current monospecific antibody treatments.

Proteologix’s second asset, the preclinical bispecific PX130, goes after IL-13 and IL-22 for the treatment of moderate to severe atopic dermatitis. J&J cited the differentiated design of these dual-acting antibodies, highlighting their potential for infrequent, convenient dosing that could improve adherence.

The acquisition aligns with J&J’s strategic focus on building an immunology pipeline centered around bispecific antibodies for improved disease control across a range of inflammatory conditions.

Atopic dermatitis, a chronic inflammatory skin disease, impacts over 100 million adults worldwide, representing a massive market opportunity. However, up to 70% of patients fail to achieve remission on standard systemic treatments, underscoring a significant unmet need.

“We see an opportunity for best-in-disease efficacy for both PX128 and PX130,” said David Lee, global immunology therapeutic area head at J&J. The company believes the bispecifics could be game-changers for underserved patient subgroups by more comprehensively targeting the heterogenous drivers of atopic dermatitis.

The deal comes on the heels of positive Phase 3 data from Eli Lilly’s IL-13 antibody lebrikizumab in atopic dermatitis. After manufacturing setbacks, Lilly resubmitted its lebrikizumab filing in April and anticipates a decision later this year, setting up a potential commercial clash with J&J’s dual-acting antibodies down the road.

Proteologix, based in California, will be eligible for additional milestone payments on top of the $850 million upfront cash paid by J&J. The transaction, expected to close in mid-2024 pending regulatory approval, will fold in Proteologix’s other preclinical bispecific antibody programs focused on autoimmune diseases and cancer.

For J&J, the deal provides a promising path toward next-generation, differentiated therapies for the significant population of atopic dermatitis patients struggling with existing treatment options. Proteologix’s dual-acting bispecific antibodies represent potentially transformative medicines for a disease area that has proven stubbornly difficult to treat.

The acquisition reinforces J&J’s commitment to immunology and dermatology while bolstering its pipeline with innovative, clinically advanced assets that could drive future growth. As the atopic dermatitis market heats up, J&J has made a preemptive strike to secure a competitive edge through its newest biotech addition.

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Ocugen (OCGN) – 1Q24 Reported With Upcoming Clinical Milestones As Expected

Posted on by cpereira@noblefcm.com


Wednesday, May 15, 2024

Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

1Q24 Reported With Clinical Trial Updates. Ocugen reported 1Q24 loss of $11.9 million or $(0.05) per share, and gave updates on progress of its clinical trial during the quarter. Its three main ophthalmic disease programs continued their progress and completed stages of development. Data announcements and milestones are expected for the rest of FY2024. Cash on March 31, 2024 was $26.4 million.

OCU400 Phase 3 Trial Expected Shortly. The Phase 3 trial for OCU400, known as the liMeliGhT incorporating “Master Gene Therapy” into its name, has received FDA clearance and is expected to begin treating retinitis pigmentosa (RP) patients in 2Q24. The trial has a planned enrollment of 150 patients, divided into an arm with 75 RHO mutation patients and 75 patients with any RP associated mutation (gene agnostic). The primary endpoint is luminance dependent navigation assessment (LDNA. As results from the Phase 1/2 study in Leber congenital amaurosis (LCA) become available, the trial could be expanded enroll LCA patients later in 2024.


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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. 

GeoVax Labs (GOVX) – 1Q24 Reported With Clinical Milestones Later In FY2024

Posted on by cpereira@noblefcm.com


Wednesday, May 15, 2024

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

Clinical Trial Treatment Continues With Milestones Ahead. GeoVax reported a 1Q24 loss of $5.6 million or $(2.47) per share. The company gave updates for its three trials testing GM04S1 and its Phase 1/2 trial testing Gedeptin, including the expected announcement about future clinical development for Gedeptin. Cash on March 31, 2024 was $0.8 million.

Gedeptin Is Finishing Its Phase 1/2 Study. The Phase 1/2 trial testing Gedeptin in advanced head and neck cancer has completed enrollment, with the next steps of development in planning stages. The current plan is to continue development in head and neck cancer, with an announcement coming regarding future trials. This could include testing in combination with an immune checkpoint inhibitor (ICI). Trial data and development announcements are expected in 3Q24.


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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. 

Unicycive Therapeutics (UNCY) – 1Q24 Reported With Pivotal OLC Data Coming In 2Q24

Posted on by cpereira@noblefcm.com


Tuesday, May 14, 2024

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

Pivotal Trial Data Expected During 2Q24. Unicycive reported an Operating Loss of $9.2 million, with a Net Loss of $21.2 million or $(0.61) per share. Importantly, the pivotal trial for OLC, its phosphate binder in development to treat hyperphosphatemia in kidney dialysis patients, is on schedule to report topline data in 2Q24. We anticipate an FDA filing for approval in 2H24. Cash on March 31, 2024, was $48.9 million.

OLC Data in 2Q24 With NDA Expected Later In 2024. The pivotal trial is an open-label single arm study. Its primary endpoint is tolerability, with secondary endpoints of safety and pharmacokinetics. Statistical analysis is not required. The trial has a target enrollment of 60 patients. Once the study is completed, a new drug application (NDA) is expected shortly afterward. We anticipate standard FDA review time, with approval in mid-2025.


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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. 

Cocrystal Pharma (COCP) – 1Q24 Reported With Clinical Data Milestones On Schedule

Posted on by cpereira@noblefcm.com


Tuesday, May 14, 2024

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

Clinical Milestones Are On Schedule. Cocrystal reported 1Q loss of $4.0 million or $(0.39) per share. During the quarter,  the company made progress on its clinical trials and reiterated upcoming milestones for its Phase 1 trial testing CDI-988 in norovirus and COVID-19 and its Phase 2a trial testing CC-42344 in influenza. Cash on March 31, 2024, was $21.8 million.

Results Expected Shortly From The CC-42344 Influenza Virus Program. CC-42344 is an oral PB2 inhibitor in development against a broad spectrum of pandemic and seasonal influenza stains. Enrollment for the current Phase 2a human-challenge study was completed in May 2024. This trial is being conducted in the UK, with data expected to be reported in 2H24. The company has received FDA guidance on the IND filing requirements for Phase 2b trials. The IND filing is expected in 2H24.


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Cadrenal Therapeutics (CVKD) – 1Q24 Reported With Preparations Continuing For Tecarfarin Phase 3

Posted on by cpereira@noblefcm.com


Friday, May 10, 2024

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

Cadrenal Therapeutics Reported 1Q2024. Cadrenal announced a 1Q24 loss of $1.7 million or $(0.10) per share. The company continues to prepare for the Phase 3 clinical trial testing tecarfarin, its anticoagulant, in patients having atrial fibrillation associated with end stage renal disease (AFib with ESRD). This has included hiring a Chief Operating Officer and entering into manufacturing contracts for clinical trial supplies and materials. The cash balance on December 31 was $6.6 million.

Tecarfarin Received Its Second Orphan Drug Designation. As discussed in our Research Note on April 12, the FDA granted Orphan Drug designation for tecarfarin as an anticoagulant in patients with implanted mechanical circulatory support devices. This includes patients with ventricular assist devices (VADs) and total artificial hearts. The lead indication, AFib with ESRD,  has also received Orphan Drug designation.


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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. 

PDS Biotechnology (PDSB) – PDS Holds KOL Event and Announces New Trial Design

Posted on by cpereira@noblefcm.com


Thursday, May 09, 2024

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

New Trial Design Will Test Two Drugs Against Standard Of Care. PDS Biotech held a KOL event featuring two prominent oncologists to discuss head and neck cancer and its clinical program data. The presentations included a review of current treatments and its two Phase 2 studies. The new Phase 3 study design was announced, now planned with three arms to test Versamune HPV with Keytruda, Versamune HPV and PDS01ADC with Keytruda, and Keytruda alone.

Phase 2 Trials Greatly Improved Patient Outcomes. The Phase 2 VERSATILE-002 trial testing Versamune HPV with Keytruda had strong improvements over current treatments in several clinical endpoints. During 2023, PDS discussed the path to approval for Versamune with the FDA. This led to design of the Phase 3 VERSATILE-003 trial testing the two-drug combination, similar to VERSATILE-002.


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MustGrow Biologics Corp. (MGROF) – California Joins the TerraSante Approved List

Posted on by cpereira@noblefcm.com


Thursday, May 09, 2024

Joe Gomes, Managing Director, Equity Research Analyst, Generalist , 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.

Another Approval. The Company announced receipt of the California Department of Food Agriculture registration approval for its TerraSante product. MustGrow also received organic certification from California’s Organic Input Material (OIM) Program, specific certification for California. The certification is a requirement for organic products to be sold in California and goes beyond MustGrow’s existing Organic OMRI Listed certifications. California now joins Washington and Oregon as states to authorize product sales of TerraSante.

OIM Program. According to the California Department of Food Agriculture, the OIM program registers materials used for fertilization of organic crops and food production. The material is either bulk or packaged and excludes pesticides. The program is mandated by the Legislature with support from the industry.


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Eledon Pharmaceuticals (ELDN) – Islet Cell Transplant Patient Treated As Kidney Data Presentation Is Announced

Posted on by cpereira@noblefcm.com


Wednesday, May 08, 2024

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

New IIT Study Has Started, With Phase 1b Data Kidney Trial Update In June.  An Investigator-Initiated Trial (IIT) testing tegoprubart in islet cell transplantation has treated its first patient. Interim data from the Phase 1b trial testing tegoprubart in kidney transplantation was announced, with presentation at a medical meeting scheduled for June 1 to June 5, 2024.

Tegoprubart Is Currently In Two Kidney Transplant Trials. Eledon continues to report follow-up data from its Phase 1b open-label trial for tacrolimus as it enrolls patients in the double-blind Phase 2 BESTOW trial. Tegoprubart acts through a different mechanism than tacrolimus (the current standard treatment), with potential to have greater protection against rejection with improved function. 


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MustGrow Biologics Corp. (MGROF) – A Step Towards Revenue Generation

Posted on by cpereira@noblefcm.com


Friday, May 03, 2024

Joe Gomes, Managing Director, Equity Research Analyst, Generalist , 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 Distribution Agreement. Yesterday, MustGrow Biologics announced an exclusive distribution agreement with G.S. Long Co., Inc. for MustGrow’s TerraSante biofertility product in Oregon and Washington State. We view this as the next step in revenue generation for the Company, with meaningful revenue now on the horizon for 2025.

Who Is G.S. Long? G.S. Long is a family-owned and operated agricultural chemical and fertilizer retailer headquartered in Central Washington with additional branches located in both Washington and Oregon State. The firm has deep crop consultant capabilities, including experience with biologics, representing generational grower relationships. G.S. Long has over 40 state-licensed Crop Advisors providing a variety of full-service consulting to its farming customers.


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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. 

ZyVersa Therapeutics, Inc. (ZVSA) – Inflammation Study Links Alzheimer’s Disease With Chronic Heart Disease

Posted on by cpereira@noblefcm.com


Tuesday, April 30, 2024

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

New Study On Inflammasomes Connects Alzheimer’s Disease With Cardiovascular Disease. Research published in a peer-reviewed journal has shown that Alzheimer’s disease produces inflammasome components that can lead a systemic response, including chronic heart disease and stroke. This study links inflammasomes in the brain to inflammation in distant organs, worsening cardiovascular and other chronic diseases.

Alzheimer’s Brains Produces Inflammasome Components That Travel Through the Circulation.  Using models of AD, the study found that parts of the brain had elevated levels of the inflammasome-signaling proteins. When heart ventricles were tested, they also showed significant elevations inflammasome components. Next, serum extracts were administered to cardiovascular cells in culture, resulting in inflammasome activation and significant increases of inflammatory mediators.


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

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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. 

MustGrow Biologics Corp. (MGROF) – Releases Fiscal Year 2023 Results

Posted on by cpereira@noblefcm.com


Thursday, April 25, 2024

Joe Gomes, Managing Director, Equity Research Analyst, Generalist , 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.

Fiscal Year Results. Management reported revenue of CAD$4.7 million for the year from CAD$6,479 last year. This is due to fees earned from technology license, evaluation, and collaboration agreements. The Company had a net loss of CAD$676,940, or a loss of $0.01 per share, from a loss of CAD$5.6 million or $0.11 last year, with the improvement from the increased revenue.

Balance Sheet and Cash Flow. MustGrow ended the year with CAD$6.8 million in cash, slightly down from CAD$7.0 million last year. The Company used CAD$294,764 in CFFO, an improvement from a use of CAD$3.3 million last year. The improvement was due to the revenue from fees earned. Barring any additional revenue, we estimate that the Company currently has an approximate 15-month runaway before needing new capital.


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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.